From owner-sci-resources@net.bio.net Tue Aug 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-015 - V26(25) 08/01/97 Date: 5 Aug 1997 21:53:58 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 631 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5s9016$4v7@net.bio.net> NNTP-Posting-Host: net.bio.net SLEEP ACADEMIC AWARD NIH GUIDE, Volume 26, Number 25, August 1, 1997 RFA: HL-97-015 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: November 20, 1997 Application Receipt Date: December 23, 1997 THIS RFA USES "JUST-IN-TIME" PROCEDURES. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE FOLLOWED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The primary objective of this initiative is to encourage the development and/or improvement of the quality of medical curricula, physician/patient/nurse and community education, and clinical practice for the prevention, management, and control of sleep disorders. A secondary objective is to promote high quality clinical research in sleep. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Sleep Academic Award, is related to the priority areas of heart disease and stroke, diabetes, chronic disabling conditions, mental health and disorders, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by any domestic university or school of medicine or osteopathy. Institutions that have not yet developed a curriculum in sleep medicine are especially encouraged to apply. Eligible institutions may submit only one application in each competition. Institutions that are already receiving support from the Sleep Academic Award program may not apply for this competition. Institutions may sponsor a candidate experienced in both medical education and clinical sleep research or a candidate experienced in clinical sleep research if supported by faculty with expertise in medical education. Institutions should also be committed to implementing the curricula development and educational research programs proposed by candidates. In this competition, there is a special interest in receiving applications from minority institutions and institutions with eligible minority faculty members. Candidates A candidate for the Sleep Academic Award must have the following credentials: o knowledge and skills in sleep and sleep disorders medicine and a demonstrated commitment to one or more areas of medical education for students, physicians, patients, nurses, or the public; o sufficient post graduate training and experience in clinical sleep research, clinical practice, and/or medical education to develop and implement a high quality curriculum in sleep and sleep disorders and to provide leadership in clinical research on sleep; o established appointment on the faculty of an accredited school of medicine or osteopathy in the United States, its territories or its possessions; o unqualified support from the Dean and educational leadership of the institution and; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application. Individuals who have or have had another NIH career development award (K series) or a regular research grant (R01) are eligible for a Sleep Academic Award if the individual meets the requirements of the Sleep Academic Award program. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. Awards will be limited to a maximum of $50,000 for the salary of the Principal Investigator, plus applicable fringe benefits, and a maximum of $30,000 for technical support. Facilities and administrative (indirect) costs may not exceed 8 percent. It is anticipated that support for this program will begin September 1, 1998. Application instructions have been modified to reflect "just-in-time" streamlining efforts being considered by the NIH. The just-in-time concept requires applicants to submit certain materials only when there is the possibility of an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and NHLBI staff. For this RFA, only limited budgetary information is required in the application. However, the anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and key personnel must be included in the research plan. Instructions for completing the Biographical Sketch have been modified. In addition, the Other Support information and application "Checklist" page are not required as part of the initial application. If the possibility of an award exists, the Budget, Other Support, and Checklist information will be requested by NHLBI staff following the initial review. The APPLICATION PROCEDURES section of this RFA provides specific details of these modifications to the standard PHS 398 application kit. FUNDS AVAILABLE It is anticipated that in fiscal year 1998, support will be available for total costs of approximately $300,000 and that approximately three to four grants will be awarded under this program. The actual number of awards each year, however, will depend upon the merit and scope of the applications received and the availability of funds. RESEARCH OBJECTIVES Background Recent estimates suggest that as many as 40 million people may suffer from chronic or intermittent disorders of sleep. Many remain undiagnosed and untreated, the consequences of which include reduced productivity, lowered cognitive performance, increased likelihood of accidents, higher risk of morbidity and mortality and decreased quality of life. It is now apparent that sleep disorders, disturbances of sleep, and sleep deprivation are major public health concerns. Sleep problems occur in both genders, in all races and socioeconomic groups, and increase with age. National attention has been directed to this problem. The National Commission on Sleep Disorders Research submitted their report entitled "Wake Up America: A National Sleep Alert" to the United States Congress in January 1993. The Commission's recommendations include encouraging broader awareness of sleep and training in sleep and sleep disorders, spanning the full range of health care professions, particularly at the primary care level. Several surveys have documented that physician training and knowledge about sleep and sleep disorders is minimal. For example, in 1978 the American Sleep Disorders Association (ASDA) conducted a survey of medical school teaching and found about one third of the medical schools provided between 1-4 hours of teaching in sleep. A more recent (1990) survey found that less than two hours were allocated to teaching about sleep at one third of the medical schools and one third reported no formal teaching about sleep. It was estimated that about 30% of medical students receive no instruction in sleep. These results would suggest that there actually has been a decrease in the amount of medical school training about sleep. The American Thoracic Society (ATS) surveyed pulmonary residency training programs and found that 70% had laboratories, but only 29% had formal training programs about sleep. Of greater concern was that 90% of the trainees diagnosed patients with sleep apnea, but only 33% of the trainees had formal training on how to conduct sleep studies. The major obstacles cited for increasing the attention to sleep in medical schools included low administrative priority, lack of qualified faculty, and limited curriculum time. Given the limited medical school training about sleep and sleep disorders, it is not surprising that several surveys have reported that health practitioners rarely diagnose sleep disorders. In fact, primary care physicians scored less than 50% correctly on factual items for diagnosis and management of sleep disorders. A 1991 Gallup survey showed that primary care physicians failed to correctly diagnose one in three adults with insomnia. Most narcoleptics contact as many as five physicians before a proper diagnosis is made. Clearly, physicians are not well trained or knowledgeable about sleep and sleep disorders. Sleep disorders cut across several medical specialties (e.g., neurology, psychiatry, internal medicine, pulmonary medicine, and otolaryngology etc.), which complicates the development of effective treatment guidelines and research. Although most sleep disorders can be controlled with medical treatment, many patients are not being diagnosed or receiving state-of-the-art medical care. This may be because many people believe that no effective treatments exist and therefore do not seek medical help. Multidimensional research is clearly necessary to improve clinical practice and patient education. Therefore, the aim of this program is to improve the quality of medical education and to stimulate the development of patient and community education, high quality clinical research programs, and clinical practice focused on the control of sleep disorders. Applicants are encouraged to submit program plans in sleep education and applied research that complement each other. Objectives The objectives of the Sleep Academic Award program include the following: o develop high quality curricula in schools of medicine that will significantly increase the knowledge and skills of students, house staff, practicing physicians, and others needed to apply state-of-the-art principles and practice to the prevention, management, and control of sleep disorders; o evaluate the impact of the proposed program and assemble curricular materials that can be adapted and used by other Institutions; o improve communication among specialists in primary care and other specialties to ensure appropriate strategies for the treatment of sleep disorders in patients of various ages and ethnic groups; o foster development of institutional environments facilitating the interchange of information on advances in sleep research and the implementation of improved interdepartmental programs with standardized diagnostic and therapeutic approaches to sleep medicine; o educate community health practitioners and the public about sleep and sleep disorders through the development of outreach programs, especially through the enhancement of sleep education programs in minority medical schools and the communities they serve; o develop the sleep medicine skills of faculty to provide high quality instruction in the diagnosis and management of sleep disorders, with special emphasis on minority faculties; o establish channels of communication between medical educators, institutions, sleep researchers, and community agencies to enhance the transfer of knowledge and ideas on educational requirements and optimal approaches to the prevention and management of sleep disorders; o contribute to public health efforts to address sleep disorders in the United States; o encourage the development of high quality clinical and applied research in the treatment and control of sleep disorders. In this competition, programs targeted to inner city populations and to rural areas needing education about sleep and sleep disorders and to community physicians, nurses, and other health care workers caring for medically undeserved populations are of particular interest. SPECIAL REQUIREMENTS Applicants should develop a comprehensive program that effectively addresses the needs in their area and the objectives of this RFA. The primary focus must be on plans to improve the quality of medical school education on sleep and sleep disorders for students and physicians. Plans and educational materials for curricular improvements must be of a design that facilitates replication at other sites. All applications must also include plans to evaluate the outcome of educational and research initiatives. The responsibilities of the Principal Investigator and key personnel must be specifically stated at the beginning of the research plan and placed in the context of other institutional and research commitments. Since the Sleep Academic Award primarily provides support for the salary of the Principal Investigator, applications that are contingent on receiving support from other agencies and institutions must specifically identify these resources in relationship to the program plan. For revised applications, the comments of the previous review committee should be specifically addressed in a preface to the program plan. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994, (F 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies of the policy from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. Although the Sleep Academic Award is not primarily a mechanism to support research, it is likely that human subjects will be involved. Therefore, protection for human subjects must be addressed, and the approximate percent of women and each minority group that you expect in the total population must be included. LETTER OF INTENT Prospective applicants are asked to submit, by November 20, 1997, a letter of intent that includes a descriptive title of the proposed program plan, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel, participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be faxed or sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). These forms are available at most institutional offices of sponsored research and from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, Email: asknih@odrockm1.od.nih.gov. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, to identify the application as a response to this RFA, check "YES" in item 2 of application page 1 and enter the title "Sleep Academic Award NIH HL-97-015". Use the following modifications in completing the standard PHS 398 application instructions: o BUDGET INFORMATION - No current/future year budgets or justifications (Form Pages 4 and 5) are required in the application. However, the anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and all key personnel must be specifically stated at the beginning of the research plan. Necessary budget information will be requested by NHLBI staff if there is a possibility for an award. o BIOGRAPHICAL SKETCH - In addition to the standard information requested on Form Page 6, the applicant should provide the title and source of any sponsored support relevant to the proposed research. o OTHER SUPPORT - No other support information is required on the "Other Support" page (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete other support information will be requested by NHLBI staff if there is a possibility for an award. o CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by NHLBI staff if there is a possibility for an award. o FACE PAGE - Currently, the Division of Research Grants requires that requested costs be reflected on the face page for computer system tracking purposes. Because no budgetary information is required as part of the "streamlined" application, we are requesting that the following amounts be entered on the face page: 7a. Direct Costs for Initial Budget Period - $80,000; 7b. Total Costs for Initial Budget Period - $86,400; 8a. Direct Costs for Proposed Period of Support - $400,000 and; 8b. Total Costs for Proposed Period of Support - $432,000. It is understood that these levels are strictly for administrative purposes and that actual award levels are subject to negotiation, prior to award. The applicant should provide the name, phone number, and facsimile phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. Submit a signed, typewritten original of the application and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express courier service) At the time of submission, two additional copies of the application must be sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. Applications must be received by December 23, 1997. If an application is received after this date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will also not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. o If an application is determined to be unresponsive to the RFA, the principal investigator will be notified and the application returned. The following sections are specific cost guidelines that will apply to those applications selected for award consideration. 1. Principal Investigator's Salary The salary for the Principal Investigator must not exceed the actual institutional salary rates for the effort being devoted to the Academic Award. In addition, salary rates must not exceed an annual salary level of $125,000 plus fringe benefits (a maximum of $50,000 plus fringe benefits for 40 percent effort). A candidate must devote at least 30 percent effort and no greater than 40 percent effort to this award. The combined efforts of any individual, Principal Investigator or key personnel, on the Sleep Academic Award and any other non-NIH or NIH-supported grant(s) or contract(s) must not exceed 100 percent. 2. Program Support Technical support will be provided up to a maximum of $30,000 per year for the following: o personnel, other than the Principal Investigator, if requested for the development, implementation, and evaluation of the program. Collaborations with consultants possessing medical, educational, or evaluative expertise complementary to that of the principal investigator are strongly encouraged. Salaries and the associated costs for any personnel other than the Principal Investigator are limited to the $30,000 per year allowed for technical support. o consumable supplies essential to the proposed program are allowable, but equipment costs are not allowable; o funds for educational development to enable the awardee to develop educational skills; o funds for the Principal Investigator to travel and meet with other investigators and NHLBI staff to exchange ideas, to develop collaborative projects, and to provide for some needed technical support. (Investigators may be requested to meet as a group up to two times a year; $2,000 should be allocated for this purpose.) 3. Facilities and Administrative Costs Facilities and administrative costs will be provided at eight percent of the total direct costs of each award excluding equipment. 4. Conditions of the Award Institutions must provide documentation that the applicant would have the necessary time and resources to implement the proposed plan. In some cases, it may be necessary for the applicant to be relieved of some responsibilities for the five years of the grant award in order to implement the proposed plan. An institution is expected to apply on behalf of a named individual meeting the criteria for this award. Only one application may be submitted from each eligible institution in each competition. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a noncompetitive basis depending upon progress in meeting the program's objectives and the availability of funds. An annual report that summarizes curriculum development at the institution, other elements of the program plan, and the outline of future plans will be required. This report will serve as the principal basis for renewal of the grant. Awards may not be transferred from one institution to another. If a principal investigator moves to another institution, the award will continue at the original institution only upon acceptance by the National Heart, Lung and Blood Institute of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness to this RFA by NHLBI. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, NHLBI. The roster of the review panel may be found on the NHLBI home page (gopher://fido.nhlbi.nih.gov:70/11/nhlbi/about/meet/sep/irsep) approximately one month prior to the review date. As part of the initial merit review, all applications will receive a written critique and undergo a review in which only those applications deemed to have the highest scientific merit of the applications under review (usually two to three times the number of applications that the NHLBI and participating Institutes anticipate funding under the program) will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria Applications for this Sleep Academic Award will be evaluated in terms of the following criteria: o qualifications and effort level of the candidate and key personnel, including pertinent experience in teaching, curriculum development, program evaluation, administration, and clinical research program planning and conduct; o plans to develop, improve, and integrate an interdepartmental curricula in sleep medicine with existing institutional training programs for medical students, graduates, and post-graduates; o plans to evaluate all proposed educational interventions, including strategies for both process and impact evaluation; o plans for communication and interdepartmental collaboration between medical specialists in appropriate disciplines to ensure the development, implementation, and evaluation of optimal treatment and educational programs; o plans and ability to work cooperatively with other investigators developing innovative and portable curricular materials in sleep medicine for replication at other sites; o the potential impact of the program on the degree of sleep medicine training and on the prevention, management, and control of sleep disorders within the population to be served; o plans for community outreach or collaborative projects with organizations having responsibility for or interest in sleep disorders, such as community centers, health departments, medical and nursing associations, voluntary health agencies, and home care agencies; o description of the need for this program and the magnitude of sleep disorders within the population to be served; o overall merit and feasibility of the proposed five year plan; o institutional commitment to implement the proposed curriculum and to maintain a program in education about sleep and sleep disorders after the termination of the award. AWARD CRITERIA The anticipated date of award is September 1, 1998. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Sleep Academic Award, the NHLBI will provide funds for a project period up to five years. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify issues or answer questions from potential applicants is also welcomed. Direct inquiries regarding programmatic issues to: Michael J. Twery, Ph.D. Division of Lung Diseases National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 10018, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: TweryM@gwgate.nhlbi.nih.gov James P. Kiley, Ph.D. National Center on Sleep Disorders Research 6701 Rockledge Drive, Suite 7024, MSC-7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: KileyJ@nih.gov Direct inquiries regarding review matters to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: ScheireJ@NIH.GOV Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: ZimmermR@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-022 - V26(25) 08/01/97 Date: 5 Aug 1997 21:53:24 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 803 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5s9004$4ul@net.bio.net> NNTP-Posting-Host: net.bio.net INFORMATICS SUPPORT FOR BREAST AND COLON CANCER COOPERATIVE FAMILY REGISTRIES NIH GUIDE, Volume 26, Number 25, August 1, 1997 RFA: CA-97-022 P.T. 34; K.W. 0710078, 0715035, 0715036, 0780030 National Cancer Institute Letter of Intent Receipt Date: September 3, 1997 Application Receipt Date: October 7, 1997 PURPOSE The Extramural Epidemiology and Genetics Program (EEGP), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) invites applications from organizations with demonstrated excellence in information technology (informatics, software development), and operations management (coordination of participating centers, data management and quality assurance, biostatistics and study methodology) for a cooperative agreement (U01) for an Informatics Center (IC) for the NCI Cooperative Family Registries for Breast and Colon Cancer (see RFAs CA-95-003 and CA-96-011). Applicants are referred to the earlier RFAs for a full description of the purpose and organization of the Cooperative Family Registries for Breast and Colon Cancer Studies (CFRBCCS). Copies of the earlier RFAs can be obtained by request from the contact names listed in INQUIRIES, below. The purpose of the current solicitation is to provide technical assistance and resource support services for the Registries. The Registries represent an interdisciplinary consortium of participating centers of excellence in clinical and human genetics and epidemiology, funded as cooperative agreements. The Registries serve as a research infrastructure by linking the collective scientific expertise of the collaborating centers with study populations through a central registry of participating families, and providing access to scientific expertise beyond the scope of a single institution or organization. Technical skills and support services are required to: (1) assist the CFRBCCS investigators to assure the establishment, management and continuing quality of the CFRBCCS databases, including epidemiologic, clinical and repository-related information; (2) provide the technical expertise for the development of key information technologies, statistical methodology and study design that will be integral to the development of the next generation of cancer genetics studies; and (3) provide the technical expertise and training to the CFRBCCS necessary to develop, implement and maintain a central informatics system that facilitates the goals of the Registries and is secure and confidential. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA) is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applicant institutions need not have a formal affiliation with an academic program in human genetics. However, experience in research related to genetic epidemiology and in the design and conduct of multi-site projects with data collection, management and quality assurance is highly desirable. Applications from centers of interdisciplinary research excellence, such as cancer centers, are encouraged. Applications from racial/ethnic minority individuals, women, and persons with disabilities as Principal Investigators are also encouraged. MECHANISM OF SUPPORT Support for this program will be through the cooperative agreement (U01). Substantial programmatic NCI involvement with the recipients is anticipated during development, implementation, and performance. Under the cooperative agreement, NCI will assist, support and/or stimulate the recipient's activities, working jointly with the participating centers and with the IC in a partnership role. Participating organizations will be responsible for planning and executing the proposed projects. Details of the responsibilities, relationship and governance of the project to be funded under cooperative agreements are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA should not exceed five years. The anticipated award date is April 1, 1998. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This RFA is a one-time solicitation. At this time the NCI has not determined whether or how this solicitation will be continued beyond the present RFA. Except as otherwise stated in the RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994. FUNDS AVAILABLE Approximately $850,000 in total costs per year for five years will be committed to fund applications that are submitted in response to this RFA; the NCI anticipates making one award as a result of this RFA. Funding beyond the first and subsequent years of the cooperative agreement will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background The rapid identification of cancer susceptibility genes and the commercial availability of predictive genetic testing have created an urgent need for research to define the clinical implications of inherited mutations, including factors that modulate gene expression and potential preventive interventions, and to communicate up-to-date information about cancer genetics, genetic testing and cancer risk to health care providers and other interested individuals. To obtain answers to the next generation of questions in human cancer genetics, studies of unprecedented size and complexity will be required. By providing an infrastructure for interdisciplinary genetic epidemiology research, the CFRBCCS, in concert with other initiatives, will further our understanding of the genetics of cancer susceptibility, facilitate the translation of research findings into medical practice and address pressing public health issues. The strength of both the Breast and Colon Cancer Registries is based on the multicenter, multidisciplinary talents brought by the various teams and investigators, and on the collection of epidemiologic, clinical and family history data as well as biological specimens from participating families. The IC will provide the means to achieve cross-site analyses. The Cooperative Family Registry for Breast Cancer Studies is a network of investigators at seven sites who have had cooperative agreements since 1995 to collect pedigree information, epidemiologic and clinical data, and biological specimens from individuals and patients with a family history of breast cancer to provide a resource for basic, clinical, epidemiologic, and behavioral breast cancer genetics research, and to identify a population at high risk for breast cancer that could benefit from new preventive and therapeutic strategies. In the past two years, the Breast Cancer Registry has developed core protocols and questionnaires, as well as site-specific protocols reflecting the specific expertise and capability of each center. Participating Breast Cancer Registry institutions include: Northern California Cancer Center, Ontario Cancer Treatment and Research Foundation, Memorial Sloan-Kettering Cancer Center, University of Melbourne, Fox Chase Cancer Center, Huntsman Cancer Institute, University of California at Irvine. Recruitment of Breast Cancer Registry subjects is now actively underway; an estimated total of 8,000 families are projected to be enrolled during the coming two and one-half years. Similar to the Breast Cancer Registry, the Cooperative Family Registry for Epidemiologic Studies of Colon Cancer is envisioned to be a multi-center Registry which serves as a research resource to the scientific community. Plans for data collection are similar to the Breast Cancer Registry; in addition, genetic characterization is to be performed and population-based controls are to be accrued. The IC shall provide support to the Colon Cancer Registry as well as the Breast Cancer Registry. Six Colon Cancer Registry awards are pending. A total of 11,000 families are projected to be enrolled in the Colon Cancer Registry within five years. Illustrative of CFRBCCS projects that are envisioned but which require analysis of multi-site data to achieve adequate power include: Descriptive studies of the prevalence of carriers of specific mutations by ethnicity, religious affiliation, prior primary breast and colon cancer history, etc; assessment of the risk of breast and other cancers by mutation status and other demographic variables; and age-adjusted stage-specific survival from breast and colon cancer among mutation carriers; Pathology studies of the distribution of histologic types among breast and colon cancer cases with specific mutations; Etiologic studies of gene-gene and gene-environmental interactions including variables such as reproductive factors, alcohol consumption, body size, diet, physical activity, and radiation exposure; Psychosocial studies of the impact of registry participation on anxiety, family dynamics; the impact of genetic testing on psychological well-being; and the effectiveness of various interventions to increase understanding of genetic testing and to reduce anxiety; Pathology-based studies which compare histopathologic and molecular characteristics in carriers vs. non-carriers according to various demographic and epidemiologic characteristics. There is a need to provide for coordination of the central database that will permit ready access to cross-site core data from the Registries, conduct range and quality control checks, and ensure the confidentiality of the highly sensitive data. The central database will also include data collected in pilot studies approved by the Advisory and Steering Committees of the Registries (see Collaborative Responsibilities) and data generated from studies conducted by outside investigators who use Registry data for their investigations. Research Goals and Scope This RFA seeks to stimulate a cooperative effort to develop key information technologies and operational systems. Substantial effort should be directed towards design, implementation, maintenance, and technologic advancement of basic Registry activities. To facilitate these functions, this RFA will provide a broad base of support for technical services and developmental research, such as research on key information technologies, statistical methodology and study design integral to cancer genetics studies. Funds may be requested for personnel, for equipment, and for specific research projects relevant to development, implementation and support of the Registries. This RFA will support one group to develop the informatics infrastructure to support the CFRBCCS. Specifically, in collaboration with investigators from the Registry centers, the IC shall, at a minimum: Coordinate the activities of the operations units at the Registry centers, which are providing statistical and logistical support to the local centers as well as preparing data for the central databases; Provide information and software to support local entry of data that will go into the central databases; Provide training materials and conduct on-site training when needed to ensure consistency and quality control of data collection; Perform quality control checks of data collected and entered at local sites but submitted to the central databases, and provide timely feedback to sites to enhance quality control of data collection and entry; Provide service statistics to NCI program officials and to the Advisory and Steering Committees of the Registries concerning recruitment, retention, and protocol compliance; Conduct analyses of cross-site data at the request of Registry investigators or NCI program officials, as approved by the Steering Committees of the Registries; Develop and maintain anonymous databases for use as a research resource as approved by the Advisory Committees of the CFRBCCS; Promote information dissemination through newsletters and a WWW site. SPECIAL REQUIREMENTS Applicants must have existing programs of scientific excellence and technical expertise in areas relevant to the type of application submitted. All applications must address the following questions in a clear and organized manner: (1) How will existing (and proposed) resources and expertise support specific tasks in Registry development and implementation; contribute to support and maintenance of Registry functions; and present unique opportunities for Registry activities? (2) How does past technical experience and performance support the applicant's ability to provide the required technical services; demonstrate the scientific expertise and the ability to apply scientific considerations to technical functions; and show the applicant's ability and willingness to collaborate effectively as a member of a consortium? Study Organization and Function The NCI Cooperative Cancer Family Registries represent a consortium of participating centers of excellence in interdisciplinary genetic epidemiology research that will be linked in a dynamic and interactive fashion through the central informatics and operations functions of the IC into a research resource. To ensure close integration between the IC and the Registry participating centers, the Principal Investigator (PI) of the IC will serve as a full voting member of the Steering Committees of the Registries. The external Advisory Committees (ACs) of the Registries consist of senior scientists with multidisciplinary expertise in cancer genetics research and are responsible for reviewing, evaluating and prioritizing all research proposals involving the Registries. This will include proposals made by the IC. AC members are nominated by the members of the Steering Committees (SCs) and will be appointed by the NCI for a two-year tenure. Terms and Conditions of Award The Terms and Conditions of Award, below, will be included in any award issued as a result of this RFA. It is critical that each applicant include specific plans for responding to these terms. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR Part 74 and 92, and other HHS, PHS and NIH grant administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (U01). This is an assistance mechanism for support of a research resource in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH assist, supports and/or stimulates the recipient's activities, by facilitating performance of the program effort in a partner role. Consistent with this concept, the prime responsibility for the activity resides with the awardee for the project as a whole. I. Awardee Rights and Responsibilities The Informatics Center (IC) awardee will have primary rights and responsibilities to define projects and approaches and to plan and conduct the work of the IC. The IC will have engage in methodological and developmental investigations, and develop novel methodological approaches, using data from the CFRBCCS. The development of standardized instruments for data collection and management for this large multi-site project will provide an opportunity for methodological research that can be exported to other centers engaged in the informatics support of genetic studies. Responsibilities of the IC will include: A. Statistical and Research Design. The IC will provide intellectual input about statistical issues, study design and methodology for the Registries. The IC's responsibilities will include: 1. Providing expert statistical assistance to CFRBCCS investigators in developing design and analytic approaches, estimating sample size requirements for specific research questions, planning and performing interim and final analyses, and preparing reports that summarize the results of such analyses. Expertise in modeling, repeated methods, exploratory data analysis and robust methods will be important for the investigations supported by the CFRBCCS; and 2. Developing approaches to statistical modeling, analysis, and study design to maximize the efficiency of genetic epidemiology studies performed using Registry resources, especially the investigation of gene-gene and gene-environment interactions. B. Data Management and Quality Assurance. 1. The IC will establish an optimal computing environment for processing, storage and retrieval of data through a central data management facility or a distributed data system, including multiple sets of longitudinal data and creation of data files for specific analyses. The IC will maintain and update an information management system for tracking data from the study sites as well as maintain and update codebooks, active files and inventory files. Combined codebooks may need to be created to interface with other genetics and epidemiology databases, such as the Cancer Genetics Network. Archiving of data should be provided. Record-keeping and encrypting procedures should ensure confidentiality of data with personal identifiers. 2. A study-wide quality assurance system should be developed and implemented by the IC to allow for regular evaluation of reliability, validity and completeness of CFRBCCS databases. The IC should provide documentation of any changes in the quality assurance and data entry instruction manuals. The IC should site visit CFRBCCS centers during the first two years of funding, the schedule to be developed in consultation with the ACs and the NCI. The IC should bring any data suggesting quality assurance problems at study sites to the attention of the NCI and the SCs. The IC will play a central role in discussing such problems and suggesting solutions at the periodic AC meetings. 3. The data processing, storage and retrieval procedures and quality assurance systems of the IC will need to be approved by the SCs before implementation. 4. The IC will monitor adherence to the clinical and laboratory protocols, and will coordinate implementation of new or modified protocols approved by the SCs. IC activities related to new or modified protocols include new data collection form development, data management system modifications, operations and training manual updates, and study site staff training. C. Specimen Tracking System for the Storage and Retrieval of Biological Specimens. The IC should provide central coordination of stored specimens in collaboration with Registry site investigators. This includes updating and improving as needed a system for specimen tracking at each stage (collection, processing, transfer, storage and retrieval). The IC should also plan to maintain an electronic inventory updated biannually and integrated into the Registry databases. This inventory should list all specimens from each clinical site, describing the type and quantity of all specimens. To facilitate the evaluation of new studies by the AC, a repository status summary should be prepared and distributed to the AC members before their scheduled meetings. The IC should record requests for biological specimens and work with the repository and the SCs to account for the current amount and type of specimens available. D. Summary Data and Support and Coordination for Data Presentation. 1. The IC will be responsible for preparing and updating operations manuals and data collection forms and providing regular statistical summary reports to the CFRBCCS sites and the NCI, including summary data on descriptive statistics and response rates of the study participants. 2. The IC should coordinate with Registry investigators the process of generating scientific material for presentations at conferences and meetings. The IC should provide datasets for analysis by Registry investigators and outside collaborators, as requested by the SC. The IC will maintain and regularly distribute a list of all publications, manuscripts and presentations that use data from the CFRBCCS. E. Study-wide Communication, Coordination and Administrative Duties. The IC will have overall responsibility for the following activities: 1. Establishing electronic mail linkages among CFRBCCS sites and the NCI; 2. Developing milestones/time lines to identify major steps and anticipated accomplishments. Particular attention is suggested in setting milestones in the following areas: methods of data input; distribution of instruments/operation manuals; ongoing training of Registry site staff; and implementation of quality assurance protocols; 3. Providing regular data "freezes," based on a schedule established by the SCs; 4. Providing meeting-related support for SCs and ACs and working group meetings by distributing agendas and other materials and preparing highlights of meetings and conference calls; and 5. Developing and updating a CFRBCCS WWW site, and, in cooperation with the participating sites, developing a regular newsletter for distribution by the sites to participants. F. Communications with Registry Sites and NCI. Regular reporting of activities will help the Registry sites and the NCI to monitor progress and identify areas of potential interest for further investigation. G. Informatics and Information Technology Development. The IC will develop computer-based tools which will facilitate the data collection and distribution goals of the Registries. This responsibility will include development, implementation and maintenance of an information management system for core data. This management system will incorporate safeguards such as encryption technologies to ensure confidentiality and strictly limit access to databases. The information management system will be flexible enough to accommodate follow-up data collections and to integrate data generated through additional studies which use these resources. H. Software for Genetic Epidemiology Research. The IC will survey research needs for software and Internet-based applications to facilitate the collection, integration and analysis of genetic and pedigree data, evaluate existing software and develop new materials as needed, which will be made available to the genetic epidemiology community. I. Developmental Studies. The IC will provide technical expertise for the development of key information technologies, statistical methodology and study designs that will be integral to the development of the next generation of cancer genetics studies. II. The NCI Program Coordinator will: A. Serve as liaison from the NCI, specifically to coordinate activities among the IC, the Registry awardees, and the NCI program coordinator for the Registries (see INQUIRIES); B. Serve as scientific liaison between the awardees and other program staff at NCI with experience in informatics and multicenter studies; C. Serve as a full participant and voting member of the Registry SCs, and, as appropriate, their subcommittees; and attend AC meetings in a non-voting liaison member role; D. Assist the IC in the standardization of data collection methods across Registry participating centers for data that will go into the central databases; assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations in data collection that require coordinated action; and assist in developing plans for information dissemination through newsletter and a WWW site. The NCI reserves the right to reduce the budget, to withhold support, and to suspend, terminate or curtail a study or an award in the event of delinquent data reporting, inadequate quality control of data collection, refusal to carry out the recommendations of the SCs or ACs, or substantial failure to comply with the terms of the award. Periodic external progress reviews of the program will be carried out as NCI deems appropriate. III. Collaborative Responsibilities The IC awardee will, in a dynamic and interactive fashion, link the NCI Cooperative Cancer Family Registries into a research resource. The PI of the IC will serve as a full voting member of the Steering Committees (SCs) of the Registries. The SCs for the Registries are responsible for development and implementation of CFRBCCS policies and procedures, integrating and coordinating activities of the participating centers and the IC. The SCs have responsibility for approving the procedures for data processing, storage, retrieval and quality assurance that are study-wide. The external Advisory Committees (ACs) of the Registries will evaluate all research proposals (those from Registry investigators as well as from the external research community) on a regular basis. This will include research proposals made by the IC. All reviews will be held according to rules pertaining to the conduct of reviews for NIH grants, contracts, and cooperative agreements, with special attention to issues of conflict of interest (whether real or apparent). The ACs will provide recommendations to the SCs as to the priority of the proposed research projects. The ACs will also provide advice to the SCs on scientific matters, as appropriate and as needed. The IC will provide data to the AC regarding recruitment and repository contents, and provide data for support of research approved by the SCs and ACs. IV. Arbitration Procedures Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the awardee, a second member selected by NCI, and the third member selected by the two previously selected members. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research" which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by September 3, 1997, a letter of intent that includes a descriptive title of the proposed project, the name, address and a telephone number of the Principal Investigator, the names of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information is helpful in planning for the review of applications. It allows NCI staff to estimate the potential workload and to avoid conflicts of interest in the review. The letter of intent is to be sent to Amy Sheon, Ph.D., at the address listed under INQUIRIES below. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Suite 6095, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714, e-mail asknih@odrockm1.od.nih.gov. The RFA label available in the application form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the number and title of the RFA must be typed on line 2 of the face page of the application and YES must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies in one package to the Division of Research Grants at the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must by sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Blvd. Rockville, MD 20850 (if hand delivered or delivery service) Bethesda MD 20892-7399 (if using U.S. Postal Service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the application will be reviewed in competition with other applications received on or before the designated receipt date. Applications must be received by October 7, 1997. If an application is received after that date, it will be returned to the applicant without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the OBJECTIVES of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion of evaluation of a study. Review Method Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness to the RFA by the NCI. Incomplete applications will be returned to the applicant without further consideration. If NCI staff find that the application is not responsive to the RFA, it will be returned and receive no further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process by which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria Applications for IC awards will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the OBJECTIVES of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion of evaluation of an application. Applicants are expected to address all issues identified under SPECIAL REQUIREMENTS of the RFA. In addition, applicants will be evaluated based on the additional criteria listed below. Applications for the IC will be reviewed on the basis of the following criteria: 1. Scientific excellence of the application and the extent to which it addresses the special scientific and technical program requirements presented in the RFA; 2. The adequacy of the applicant's plan for safeguarding confidentiality of the central Registry database and providing technical advice to Registry participating centers in developing protocols to ensure local data security; 3. Demonstrated ability and willingness to provide technical assistance for the development of informatics structures for collaborative multi-center research; 4. Qualifications and research experience of the Principal Investigator and staff with regard to development and implementation of complex informatics structures; previous experience with design and administration and analysis of data from multi-institutional clinical trials and relevant epidemiologic or laboratory studies; competence with regard to the mechanisms for administration, experimental design, quality control, study monitoring, data management and reporting, statistical analysis, and compliance with regulatory requirements; 5. The adequacy of existing physical facilities and resources of the applicants' institution(s); how effectively any proposed resource expansion will enhance the applicant's participation in Registry functions; and the unique resources and capabilities the applicant will bring to the Registries; 6. Adequacy of plans for effective communication and coordination between the participating centers, IC, and NCI; 7. Appropriateness and adequacy of proposed developmental and methodological studies; and 8. Scientific and technical merit of the proposed project as determined by peer review. The review group will also examine the proposed budget and will recommend an appropriate budget and period of support for each application that is recommended for further consideration. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. AWARD CRITERIA Applications recommended by the National Cancer Advisory Board will be considered for award based upon technical merit of the application as reflected in the priority score, availability of resources, and availability of funds. Furthermore, the applicant organization must indicate a commitment to accept provisions outlined under the SPECIAL REQUIREMENTS section, Terms and Conditions of Award. The earliest anticipated date of award is April 1, 1998. INQUIRIES Written and telephone inquiries concerning the RFA and the opportunity to clarify any issues or questions from potential applications are welcome. Direct inquiries regarding RFA-related programmatic and scientific issues to: Amy Sheon, Ph.D. Division of Cancer Epidemiology and Genetics National Cancer Institute 6130 Executive Boulevard, Suite 535 - MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 Email: as31r@nih.gov Direct inquiries regarding the CFRBCCS to: Daniela Seminara, Ph.D., M.P.H. Division of Cancer Epidemiology and Genetics National Cancer Institute 6130 Executive Boulevard, Suite 535 - MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 Direct inquiries regarding fiscal matters to: Ms. Crystal Wolfrey Grants Management Specialist National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 282 Email: wolfreyc@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No.93.393, Cancer Cause and Prevention Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Unless otherwise noted all PHS grants policies apply. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HG-97-003 - V26(25) 08/01/97 Date: 5 Aug 1997 21:52:15 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 475 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5s8vtv$4u0@net.bio.net> NNTP-Posting-Host: net.bio.net MOUSE GENE MAP NIH GUIDE, Volume 26, Number 25, August 1, 1997 RFA: HG-97-003 P.T. National Human Genome Research Institute National Institute of Alcohol Abuse and Alcoholism National Cancer Institute National Institute of Drug Abuse National Institute of Mental Health Letter of Intent Receipt Date: August 18, 1997 Application Receipt Date: September 16, 1997 PURPOSE The purpose of this Request for Applications (RFA) is to solicit applications for research projects to construct a gene-based physical map of the mouse genome consisting of an ordered set of EST-derived markers integrated with the genetic and other physical maps of the mouse genome. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, A Mouse Gene Map, is related to several priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, companies, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications from social/ethnic minority individuals, women, and persons with disabilities are encouraged. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions are allowable, with sufficient justification. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01) mechanism. If more than one grant is funded under this initiative, the investigators will be expected to work cooperatively, and with any other project(s) with similar goals, so that the resources developed will be of maximum usefulness to the community. The total project period for applications submitted in response to the present RFA may not exceed 2 years. The anticipated award date is March 2, 1998. This RFA is a one-time solicitation. This RFA is an initiative of the Institutes listed above. However, the awards will be made by the National Human Genome Research Institute (NHGRI) and will be managed by the NHGRI and the other participating institutes. FUNDS AVAILABLE At least $2 million (including direct and indirect costs) per year will be available. It is anticipated that one to three awards may be made. Proposed funding levels are subject to change due to budgetary, administrative, and/or scientific considerations. RESEARCH OBJECTIVES Background The mouse is an important model for the study of many aspects of mammalian biology, including many human diseases. Among its other advantages, the mouse is the most well developed system for mammalian genetic analysis. In the past few years, genomics has become an increasingly important approach to the development of the resources necessary for molecular genetic analysis of biological questions. In recognition of the important role played by the mouse in modern biomedical research, the development of resources to support study of the mouse genome has been an integral goal of the Human Genome Project (HGP) since its inception. Through HGP funding, a high resolution genetic map of the mouse based on microsatellite markers has been completed, and a physical map including both genetic and random STS markers is currently under development. Although the genomic resources currently being developed will be extremely useful, identifying and isolating mouse genes of interest is still not routine, and investigators involved in such efforts would benefit from additional resources. In particular, a catalogue and map of mouse genes would greatly increase the usefulness of the mouse in studying human disease, health, and behavior. A successful approach to constructing such a gene map has recently been demonstrated for the human. Schuler et al. [Science 274:540 (1996)] used a catalog of human genes to construct a map containing more than 16,000 gene-based markers. STS markers were developed from expressed sequence tags (ESTs) which were derived, in turn, from human cDNA clones. At present, a large number of mouse ESTs is being generated at the Washington University (St. Louis) Sequencing Center, with support from the Howard Hughes Medical Institute (HHMI). To date, approximately 180,000 mouse ESTs have been produced and submitted to the public database and the Washington University-HHMI effort is scheduled to produce a total of 400,000 ESTs within the next two years. Analysis of the existing mouse ESTs has already shown that there are many overlaps and a number of contigs (or clusters), which are comparable to the UniGene clusters that were used to generate STS-based gene markers for the Human Gene Map. The HHMI has recently increased its investment in the mouse EST project to include full insert sequencing of clones representing all of the unique clusters. This will generate sequences covering the 3' ends of the cDNA inserts, thereby increasing the usefulness of the EST information for mapping. Finally, a project to construct a mouse gene map has begun in Europe with plans to incorporate about 15,000 mouse ESTs in the next three years. The European project is financed by the European Commission and will be carried out at the Mouse Genome Centre in the United Kingdom and Genethon in France. This effort plans to anchor the RH panel described below using genetically mapped microsatellite markers and then to put about 15,000 EST-based markers on the commercially available RH panel. Most of the ESTs to be used will be derived from the Washington University-HHMI collection, but a fraction will be obtained from European production efforts on specialized libraries. The European project will focus on ESTs that do not have a human homologue, although approximately 20% will be human homologues in order to relate the gene maps of the two organisms. The availability of a gene map will enhance the value of the mouse as a model for studying human biology. The map will be useful for isolating and cloning mouse genes by the positional cloning and positional candidate cloning methods. Comparison of detailed mouse and human gene maps will increase the efficiency with which investigators can define and take advantage of the syntenic relationships between chromosomes of the two organisms. Adding additional value to this approach will be a rat gene map which is currently being developed under support from the National Heart, Lung, and Blood Institute. Once identified, many genes will be better studied in the mouse (and/or the rat); the information obtained in such studies can then be applied to human studies. Objectives and Scope The purpose of this RFA is to support the development of a gene-based physical map of the mouse genome in the most efficient, timely and cost-effective manner. The resulting map should be cross-referenced to the existing STS-based mouse genetic map and integrated with the mouse gene map being generated by the European effort. There are several reagents that are available to facilitate generation of the mouse gene map. Mapping Reagents. Investigators at the University of Cambridge have developed a mouse radiation hybrid panel, T31. The retention rate is 27.3 percent and preliminary characterization of the panel indicates that it has between 1,000 and 1,500 bins. Investigators at the Whitehead Institute have generated two mouse YAC libraries consisting of approximately 40,000 YACs with an average insert size of 829 kb (approximately 10 genome equivalents). Investigators at the California Institute of Technology have produced a mouse BAC library consists of approximately 200,000 clones with average insert size of 130 kb (approximately 9 genome equivalents). Currently, a non- redundant overlapping set of YAC or BAC clones is not available. The radiation hybrid panel and the clone libraries are available commercially. It is anticipated that applicants may want to utilize one or more of these existing resources for mapping, but NHGRI and the collaborating NIH institutes would be willing to support the cost of developing a new mapping resource, if the applicant presents convincing evidence that the resulting map would be substantially better than one produced using existing mapping resources. Unique Clusters of ESTs. The Washington University Sequencing Center, through support from Howard Hughes Medical Institute, is in the process of sequencing a significant number of ESTs. These ESTs will be reduced to a unique set of clustered ESTs by the National Center for Biotechnology Information, National Library of Medicine, NIH, as has been done for the human gene mapping project. Within the next two years, Washington University plans to have sequenced over 400,000 ESTs. Based on the experience with the human ESTs, it is estimated that there should be about 50,000 unique clusters of ESTs available for mapping. There are already 2,500 unique mouse EST clusters available for mapping. Cross Reference and Integration with Other Mouse Maps. A mouse genetic map has already been constructed (http:\\www- genome.wi.mit.edu). In order for the genetic map and the gene maps being generated by the U.S. and European efforts to be maximally useful to the scientific community, it is essential that the resulting gene map be cross-referenced to the genetic map and integrated with the European gene map. This RFA does not specify the desired resolution or other properties of the gene map to be generated. However, it is expected that most, if not all, of the unique gene clusters emanating from the Washington University-HHMI mouse EST project will be mapped. Each applicant must propose the most cost efficient strategy for producing a mouse gene map and should justify why a map of the proposed resolution would be the most useful resource for studies using the mouse and related studies of human. DATA AND RESOURCE SHARING The sharing of materials and data in a timely manner has been an essential element in the rapid progress made in construction and use of the human and mouse genetic maps. Public Health Service policy requires that investigators make the results and accomplishments of funded activities publicly available. The advisors to the NIH and the DOE genome programs have developed a set of "NIH-DOE Guidelines for Access to Mapping and Sequencing Data and Material Resources" that address the special needs of genome research. These guidelines call for material and information from genome research to be made available within six months of the time the data or materials are generated; more rapid sharing is encouraged and has become the norm in the genome community. Applications submitted in response to this RFA should include detailed plans for sharing data and materials generated through the grant. Where appropriate, grantees may work with the private sector in making unique resources available to the larger biomedical research community at a reasonable cost. The plans proposed for sharing and data release will be reviewed for adequacy by NIH staff prior to award of the grant and the proposed sharing plan will be made a condition of the award. Investigators may request funds to defray the costs of sharing materials or submitting data in their application. Such requests must be adequately justified. POST-AWARD MANAGEMENT During the course of the grant period, technologies will improve, genomic technologies will evolve, and the rate of progress and focus of work supported by the grant(s) may change. It is expected that the Principal Investigator(s) will make any necessary adjustment in scientific direction to accommodate the changing environment. In order to ensure that the project(s) remain(s) focused on appropriate goals, maintain(s) excellent coordination with the other projects funded under this RFA, incorporate(s) new technological advances and make(s) sufficient progress, scientific and programmatic visits to the grantee(s) may be conducted at a frequency to be negotiated with the awardee(s). In addition, applications should include travel funds for the Principal Investigators and the other investigators on the grant to meet annually with NIH staff in the metropolitan Washington D.C. area, should such meetings be advisable. LETTER OF INTENT Prospective applicants are asked to submit, by August 18,1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Any applicant planning to submit an application for more than $500,000 direct cost in any one year must contact the NHGRI staff listed under INQUIRIES in order for the application to be accepted by NIH. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows IC staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Bettie J. Graham, Ph.D. Division of Extramural Research National Human Genome Research Institute Building 38A, Room 614 38 Library Drive, MSC 6050 Bethesda, MD 20892-6050 Tel: (301) 496-7531 Fax: (301) 480-2770 e-mail: bettie_graham@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714; e-mail: ASKNIH@odrockm1.od.nih.gov and from the program director listed under INQUIRIES.. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to Ken Nakamura, Ph.D. Office of Scientific Review National Human Genome Research Institute Building 38A, Room 613, MSC 6050 38 Library Drive Bethesda, MD 20892-6050 Applications must be received by September 16, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness to the RFA by NHGRI program staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHGRI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NHGRI. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. All applicants will receive a summary statement consisting of the reviewer's written comments essentially unedited. Summary Statements for competitive applications will also contain a summary of the review committee's discussion. The second level of review will be provided by the appropriate national advisory council or board. Review criteria will include the following: * scientific and technical merit of the research proposed to meet the objectives of this RFA; * the value of the proposed gene map to the scientific community; * appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; * qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; * adequacy of plans to integrate the resulting gene map with the European gene map; * adequacy of plans to make resources/data available to the community in a timely manner; * availability of the resources and technology necessary to perform the research; * adequacy of facilities and resources and the level of institutional commitment; and * appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The anticipated date of award is March 1, 1998. Factors that will be used to make award decisions are as follows: * Quality of the proposed project as determined by peer review; * Promise of the proposed program to accomplish the goals of this RFA; * Cost effectiveness of the proposed strategy; * Quality of the plans to cooperate with other projects that may be funded under this RFA and with the European effort; * Nature and extent of the plans for sharing and distributing data and resources in a timely manner ; and * Availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Bettie J. Graham, Ph.D. Division of Extramural Research National Human Genome Research Institute Building 38A, Room 610, MSC 6050 Bethesda, MD 20892-6050 Phone: (301) 496-7531 FAX: (301) 480-2770 Email: bettie_graham@nih.gov Robert Karp, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2239 Fax: (301) 594-0673 Email: rkarp@willco.niaaa.nih.gov Grace L. Shen, Ph.D. Cancer Genetics Branch Division of Cancer Biology National Cancer Institute 6130 Executive Boulevard, Room 501, MSC 7381 Rockville, MD 20892-7381 Telephone: (301) 435-5226 Fax: (301) 496-8656 Email: gs35r@nih.gov Theresa Lee, Ph.D. Division of Basic Research National Institute of Drug Abuse 5600 Fishers Lane, Room 10A-19 Rockville, MD 20857 Telephone: (301) 443-6300 Fax: (301) 594-6043 Email: tl37h@nih.gov Stephen H. Koslow, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Rockville, MD 20857 Telephone: (301) 443-3942 Fax: (301) 443-3563 Email: koz@helix.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jean Cahill Grants Management Officer Division of Extramural Research National Human Genome Research Institute Building 38A, Room 613, MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 402-0733 Fax: (301) 402-1951 e-mail: jean_cahill@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-013 - V26(25) 08/01/97 Date: 5 Aug 1997 21:54:15 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 584 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5s901n$4vs@net.bio.net> NNTP-Posting-Host: net.bio.net CLINICAL RESEARCH ON COOLEY'S ANEMIA NIH GUIDE, Volume 26, Number 25, August 1, 1997 RFA NUMBER: HL-97-013 P.T. National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 15, 1997 Application Receipt Date: January 8, 1998 PURPOSE The Blood Diseases Program of the Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute (NHLBI), and the Hematology Program of the Division of Kidney, Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), invite grant applications for support of research efforts to improve the clinical management of patients with Cooley's anemia (beta-thalassemia). The focus of this initiative is to support clinically-related or translational research. Areas of particular importance include studies on improved methods for the non-invasive measurement of tissue iron burden, alternative approaches to iron chelation therapy, and pharmacologic enhancement of fetal hemoglobin. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This request for applications (RFA), Clinical Research on Cooley's Anemia, is related to the priority area of maternal and infant health, and diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Domestic applications may include foreign components. FOREIGN INSTITUTIONS: Awards under this announcement may be made to foreign institutions provided the application (1) is of high scientific merit and (2) offers a special opportunity for furthering research programs through the use of unusual talents, resources, populations, or conditions in other countries which are not readily available in the United States or which augment existing U.S. resources. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. MECHANISM OF SUPPORT This RFA will use the NIH Research Project grant (R01) mechanism of support. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applicants, including those from foreign institutions, may request up to five years of support. It is anticipated that support for this program will begin in July 1998. Administrative adjustments in project period and/or amount may be required at the time of the award. This RFA is a one-time solicitation. Successful applicants, upon completion of their entire project period (up to five years) may submit an unsolicited competing renewal application which will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Awarding of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. Approximately seven awards will be made. The NHLBI is planning for five grants at a total cost of $2,000,000 for the first year of support for this initiative. The NIDDK will award approximately two grants and has budgeted $800,000 for the first year of support. The specific number of grants to be funded will depend on the merit and scope of the applications received and on the availability of funds. Applicants may request up to a 3 percent inflationary increase per year. Increases above this amount must be specifically justified. CONSORTIUM ARRANGEMENTS If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. A consortium application should be prepared so that the scientific, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the business offices of institutions that are eligible for Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, please contact Ms. Jane R. Davis (see below). RESEARCH OBJECTIVES Background Cooley's anemia (also called beta-thalassemia major or thalassemia major) and its clinical management has been the subject of an extensive review (1). Cooley's anemia is a genetic blood disease that results in an inadequate production of hemoglobin, the essential oxygen-carrying substance in blood. This causes severe anemia that begins shortly after birth. As a group, thalassemic disorders are one of the most common single-gene genetic diseases worldwide. In the United States, thalassemia mainly affects specific ethnic groups, including people of Mediterranean, Middle Eastern, African, Southeast Asian, Chinese, and Asiatic Indian origin. Individuals affected with Cooley's anemia require frequent and lifelong blood transfusions to sustain life. Because there are no natural means for the body to eliminate iron, the iron contained in the transfused red blood cells builds up over many years and eventually becomes toxic to tissues and organ systems. This excess iron must be removed from Cooley's anemia patients or they may not survive beyond the second decade of life. To accomplish this, patients must use the iron-binding or chelating drug, deferoxamine, that is administered for about 10 hours every day by pumping it through a needle inserted either under the skin or intravenously. Before the introduction of transfusion and chelation therapy, life expectancy for patients with Cooley's anemia was two or three years. Today, the picture is considerably brighter with some patients living into their thirties and beyond. Survival and quality of life depend upon the absence or control of transfusion complications such as infectious diseases (mainly hepatitis and AIDS) and the adequate removal of excess iron. In spite of the increased survival and quality of life, the current treatment modalities are inadequate. Iron-chelation therapy is extremely demanding, and many patients experience considerable discomfort from administration of the drug. In fact, the therapy is so burdensome that many adolescents and teenagers have refused to continue. The prognosis for these noncompliant patients is quite poor. In addition to the physical and psychological burden of therapy, the financial burden on the family is substantial. The cost of transfusions and iron-chelation therapy amounts to about $30,000 per year per patient, and it has been estimated that the total annual Cooley's anemia-related costs may be as much as $100,000 per year per patient. The search for an improved chelator continues. A variety of compounds have been produced and examined as potential oral iron- chelating agents. One of these, deferiprone (1,2-dimethyl-3- hydroxypyridin-4-one, also known as L1, CP20, and DMHP) has been administered to patients in other countries, but some patients have developed neutropenia or agranulocytosis. The magnitude of the risk of agranulocytosis is being evaluated in a multicenter clinical trial in the U.S. and other countries. No published data, however, are available on the long-term efficacy of deferiprone. A recent prospective evaluation of this orally active chelator (2) has suggested that deferiprone may induce decreases in hepatic iron, but continued use does not result in sufficiently diminished levels of hepatic iron, despite the continued urinary excretion of iron in these patients. This implies that deferiprone may be chelating a pool of iron that may not be readily accessible to deferoxamine and that perhaps therapy utilizing a combination of these two chelators may be clinically superior to a single agent. Experts would still argue that deferiprone alone may be quite efficacious in the prevention, rather than the reversal, of iron overload in young children. There is an urgent need to undertake further studies to firmly establish whether this promising oral iron chelator has a role in the management of iron overload in transfusion-dependent anemias. Other iron chelators are being investigated. A single bolus injection of a long-acting form of deferoxamine linked to a polymeric backbone of hydroxyethyl starch has been reported to induce a urinary iron excretion equal to that excreted after several days of deferoxamine infusions. This approach should be investigated further. Results of animal studies have shown that a new, water soluble, synthetic hexadentate chelator (IRC11) having a higher affinity for iron(III) than deferoxamine, but much less toxic, may be useful in the treatment of transfusional iron overload (4). Progress in our ability to reverse the ontogenic switch from fetal to adult hemoglobin, thereby reactivating the expression of the dormant gamma-globin gene, has increased in the past decade. This holds promise that a new, effective form of therapy for thalassemic patients may soon be available. Three classes of drugs, (a) cytotoxic drugs, (b) hematopoietic growth factors and cytokines, and (c) fatty acids, have been shown to enhance fetal hemoglobin production, but their effects have been minimal. However, there are encouraging suggestions that the effects of these drugs may be additive (5). Clinical studies are needed to test the effectiveness and safety of combinations of these drugs and other new hemoglobin switching agents as they are identified. The importance of the accurate assessment of body iron in patients with thalassemia major has been emphasized by advances in understanding the quantitative relationship between iron burden and clinical outcome. The current gold standard for quantifying tissue iron burden still relies on the chemical analysis of liver biopsy specimens. None of the less invasive clinically available methods of evaluating body iron (serum ferritin concentration, transferrin saturation, or urinary iron excretion after administration of a chelating agent) is sufficiently accurate to permit optimal management of iron-chelation therapy. Magnetic susceptometry measurement of hepatic iron using the Superconducting Quantum Interference Device (SQUID) can provide accurate measurements. However, perhaps due to the liquid helium operating temperature and the large size, only two such instruments are available worldwide. Potential approaches to improving the measurement of body iron include refinements in the assay of serum ferritin (such as the measurement of ferritin iron, glycosylated ferritin, H- or L- subunits, and other methods), advances in the quantitative use of magnetic resonance imaging (MRI), and improvement in the availability of magnetic susceptibility by development of instruments utilizing "high-temperature" (liquid nitrogen) superconducting materials. Approaches that would be useful for measuring cardiac iron levels are of particular importance. Transfusion therapy continues to be the centerpiece of the management of thalassemia. The advantages of regular transfusion of red cells are well established and include improved growth and development, decreased enlargement of the liver and spleen, increased longevity and a vastly improved overall well-being. At the same time, transfusions continue to be the source of toxic iron deposits in vital organs. In addition, patients with thalassemia major are at a particularly high risk of contracting transfusion-transmitted diseases because of their lifelong dependence on blood transfusions. The optimal hemoglobin level at which to maintain patients with thalassemia remains uncertain, and new methods for determining the relationship between hemoglobin level and suppression of bone marrow erythropoietic activity may help clinicians adjust the hemoglobin level to achieve the desired results of transfusion therapy while limiting the number of donor exposures and the amount of newly accumulated iron. Alternative approaches to conventional transfusion therapy, including erythrocytapheresis, have been suggested as methods for decreasing the amount of transfusional iron accumulation but currently remain unproven. Clinical studies are needed to improve the safety and effectiveness of transfusion therapy and to develop alternative methods of blood transfusion to reduce the degree of iron loading. This initiative is intended to stimulate the submission of grant applications which address important clinical issues in the management of Cooley's anemia. GRANT APPLICATIONS MUST INCLUDE STUDIES DIRECTLY INVOLVING PATIENTS, either for an intervention protocol or for the development and testing of diagnostic technologies such as noninvasive measurement of tissue iron concentration. Areas of particular importance include, but are not limited to, the following: 1) Clinical studies of more effective iron chelators, new modes of administration of existing chelators, and combinations of chelators. Such studies must include measurement of patient compliance with drug therapy and accurate assessment of changes in body iron stores. 2) Research on improved technology for the non-invasive measurement of tissue iron deposits. 3) Clinical studies of fetal hemoglobin enhancing drugs and combinations of these agents. 4) Clinical studies to improve the safety and effectiveness of transfusion therapy and to develop alternative methods of blood transfusion to reduce the degree of iron loading. The demographics of beta-thalassemia in the United States have been changing because of the large increases in the Asian population in the last ten years. Therefore, applicants are encouraged to include patients with hemoglobin E beta-thalassemia, hemoglobin H, and hemoglobin H-Constant Spring genotypes if their inclusion would not diminish the scientific merit of the proposed clinical study. References (1) "Thalassemia Management I," Seminars in Hematology, P Beris, Ed., Vol 32, No 4 (October), 1995 and "Thalassemia Management II," Seminars in Hematology, P Beris, Ed., Vol 33, No 1 (January), 1996. (2) Olivieri NF, Long-term follow-up of body iron in patients with thalassemia major during therapy with the orally active iron chelator deferiprone (L1). BLOOD 88 (Suppl. 1):1229a, 1996. (3) Olivieri NF, Nisbet-Brown E, Srichairatanakool S, Dragsten P, Hallaway P, Hedlund B, Porter JB. Studies of iron excretion and non- transferrin-bound plasma iron (NTBPI) following a single infusion of hydroxyethyl starch-deferoxamine (HES-DFO): A new approach to iron chelation therapy. BLOOD 88 (Suppl. 1):1228a, 1996). (4) Hershko C, Rivkin G, Link G, Simhon E, Cyjon RL, Klein JY. IRC11, a new synthetic chelator with selective interaction with catabolic red blood cell iron. BLOOD 88 (Suppl. 1):1951a, 1996. (5) Olivieri NF, Rees DC, Ginder GD, Thein SL, Waye JS, Chang L, Brittenham GM, Dover GJ, Weatherall DJ. First report of long-term elimination of red cell transfusions in thalassemia major through augmentation of fetal hemoglobin with sodium phenylbutyrate (SPB) and hydroxyurea (HU). BLOOD 88 (Suppl. 1):1227a, 1996. SPECIAL REQUIREMENTS Upon initiation of the program, the NHLBI and the NIDDK will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. In the budget for the grant application, applicants should request travel funds for a 1-day meeting each year, most likely to be held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide to Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by October 15, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent may also be helpful to the applicant since it may alert NHLBI staff to the possibility of an application being unresponsive to the goals of the RFA. In such an instance, the applicant would be notified before preparing the application. The letter of intent is to be mailed, or faxed, to: Dr. C. James Scheirer Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 E-mail: James_Scheirer@NIH.GOV APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone: 301-435-0714, E-mail: ASKNIH@odrockm1.od.nih.gov; and from the program staff listed under INQUIRIES. The RFA label found in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to Dr. C. James Scheirer, at the address given above in the section on LETTER OF INTENT. Applications must be received by January 8, 1998. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NHLBI. Incomplete applications will be returned to the applicant without further consideration. If NHLBI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will undergo a peer review streamlining process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Councils of the NHLBI and the NIDDK. A written critique will be provided for all applications, including those that are not discussed and not scored. The NIH will withdraw from further competition those applications that were unscored and the applicant Principal Investigator and institutional official will be notified. The personnel category will be reviewed for appropriate staffing based on the requested percent effort and any changes requested in future years. The total budget request will be reviewed for consistency with the proposed methods and specific aims. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the recommended scope of the project. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC program director could be included with the application. Peer Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In judging the likelihood that the proposed research will have a substantial impact on the pursuit of these goals and those of the RFA, the reviewers will address each of the listed criteria, and consider them in assigning the overall priority score, weighting them as they feel appropriate for each application. Please note that your grant application may not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work, that by its nature is not innovative but is essential to move a field forward. (1) Significance Does the study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator Is the investigator appropriately trained and well suited to carry out this work? Is the proposed study appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment Does the scientific environment in which the work will be performed contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of applicant institutional support? The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other applications submitted in response to this RFA. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. Schedule Letter of Intent Receipt Date: October 15, 1997 Application Receipt Date: January 8, 1998 Initial Review: March 1998 Review by NHLBI and NIDDK Advisory Councils: May 1998 Anticipated Award Date: July 1, 1998 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding scientific and programmatic issues to either of the Program staff below. However, for specific questions regarding the responsiveness of the planned research grant application to the goals of this RFA, please contact the NHLBI Program Administrator. Dr. Helena O. Mishoe Blood Diseases Program Division of Blood Diseases and Resources, NHLBI 6701 Rockledge Drive, Room 10156 Bethesda, MD 20892-7950 Telephone: (301) 435-0050 FAX: (301) 480-0868 E-mail: helena.mishoe@nih.gov or Dr. David G. Badman Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-13C MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 E-mail: David_Badman@nih.gov Direct inquiries regarding fiscal matters to: Ms. Jane R. Davis Grants Management Office National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 E-mail: jane_davis@nih.gov or Aretina Perry-Jones Division of Extramural Activities, NIDDK 45 Center Drive, Room 6AN-38B, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8862 FAX: (301) 480-3504 E-mail: PerryA@extra.niddk.nih.gov AUTHORITY AND REGULATIONS The programs of the Division of Blood Diseases and Resources, NHLBI, and the Division of Kidney, Urologic and Hematologic Diseases, NIDDK are described in the Catalog of Federal Domestic Assistance Nos. 93.839 and 93.849, respectively. Awards are made under the authority of the Public Health Service (PHS) Act, Section 301 (42 USC 241) and administered under PHS grant policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-97-002 - V26(25) 08/01/97 Date: 5 Aug 1997 21:55:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 361 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5s904k$527@net.bio.net> NNTP-Posting-Host: net.bio.net COMPREHENSIVE ORAL HEALTH RESEARCH CENTERS OF DISCOVERY NIH GUIDE, Volume 26, Number 25, August 1, 1997 RFA: DE-97-002 P.T. 04; K.W. 0715048, 0710030 National Institute of Dental Research Letter of Intent Receipt Date: March 1, 1998 Application Receipt Date: May 8, 1998 THIS REQUEST FOR APPLICATIONS (RFA) IS A REVISION OF THE RFA APPEARING IN THE MAY 30 ISSUE OF THE NIH GUIDE. THIS REVISION CORRECTS THE RESEARCH OBJECTIVES SECTION IN THE FULL TEXT OF THE RFA. PURPOSE The National Institute of Dental Research (NIDR) invites applications for Comprehensive Oral Health Research Centers of Discovery (COHRCD). Each COHRCD will be organized around an unifying scientific theme related to dental, oral and craniofacial diseases and disorders. Individual COHRCDs will encompass a full range of outstanding multidisciplinary research pertinent to these diseases and disorders and will be expected to: include basic, translational and applied research projects with behavioral, health services and clinical research components; accelerate transfer of research findings to application by health professionals and the public as well as to facilitate the development of marketable products and other effective health promoting interventions; support research concerning demonstration and outreach programs; and enhance the training of health professionals and the public concerning health promotion and the prevention, improved diagnosis and treatment of the dental, oral or craniofacial diseases and disorders relating to the chosen theme. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000", a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Comprehensive Oral Health Research Centers of Discovery, is related to the priority area of Oral Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone: 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by all domestic for-profit and non- profit organizations, public and private, including universities, colleges, hospitals, laboratories, units of State and local governments and eligible agencies of the Federal government. Applicants need not have submitted proposals or been awarded funds for the developmental grants for these centers (RFA: DE-96-004) nor are applicants required to use the same central theme as the one that may have been supported through the developmental grants. Foreign organizations are not eligible to apply; however, domestic applications may include international components. The NIDR encourages applications that include investigators who are racial/ethnic minority individuals, women and persons with disabilities. Although an application must be submitted from a single institution, collaborative arrangements with other institutions are strongly encouraged. Also, applications are not restricted to traditional dental, oral and craniofacial research settings. MECHANISM OF SUPPORT The mechanism for the support of applications in response to this RFA is the Comprehensive Center (P60). Choice of an appropriate theme and the direction and execution of the proposed activities are solely the responsibility of the applicant. This RFA is a one-time solicitation by NIDR and applicants may apply for and receive up to five years of support. The earliest possible award date will be May, 1999. FUNDS AVAILABLE It is anticipated that the NIDR will allocate approximately $16.5 million to support seven COHRCDs provided that sufficient applications of high scientific merit are received. The direct costs requested for the initial year of these applications may not exceed $1.5 million. The $1.5 million direct cost limit includes any indirect costs associated with subcontracts listed as part of the application. Requested increases in direct costs for subsequent years may not exceed 3 percent. Although support for this program is provided for in the financial plans of the NIDR, the award of grants pursuant to this RFA is contingent upon the availability of appropriated funds. Policies that govern research grant programs of the National Institutes of Health (NIH) will prevail. RESEARCH OBJECTIVES Background The NIDR has very effectively utilized the center concept to advance research in oral biology, periodontology, cariology, craniofacial anomalies, aging and materials science. Specialized research centers were designed to intensify research in these areas and have been and continue to be successful in accomplishing this aim. However, it is becoming increasingly apparent that future meaningful insights concerning the mechanisms involved in the induction and progression as well as in the prevention, diagnosis and treatment of dental, oral and craniofacial diseases and disorders must consider not only basic research but also extensive integration of basic, clinical and behavioral sciences; health services and epidemiologic research as well as demonstration, education and outreach activities. The establishment of the COHRCDs addresses this need to accommodate all aspects of certain dental, oral and craniofacial disease processes by stimulating increased collaborations, partnerships and leveraged funding. It is an opportune time to implement this expansive approach to optimally utilize the current rapid advances being made in biomedical and behavioral sciences. To redirect efforts towards the far-reaching aims described in this RFA, a previous RFA (DE-96- 004, Developmental Grants: Comprehensive Oral Research Centers) announcing support to develop plans for these centers was issued. Goals and Objectives It is the intent of the current RFA to provide support for COHRCDs. These comprehensive centers will broaden the expertise available and approaches taken in addressing major research themes within the mission of the NIDR. Choice of the theme is the responsibility of the applicant. The objectives of the COHRCDs are to: (1) foster integrated biomedical, behavioral, social science and health services research and development at the fundamental, clinical and applied levels and to facilitate transfer of the acquired findings to marketable products and other effective health promoting interventions; (2) initiate and expand research on community education, screening, counseling and related services programs; and (3) promote research related to education of health professionals and the public concerning the etiology, prevention, diagnosis and treatment of dental, oral and craniofacial diseases and disorders. Five organizational components are required for each COHRCD: (1) a biomedical, behavioral, social science and health services research base; (2) a demonstration research component that will, among other things, provide a means for developing effective and efficient outreach and community liaison functions; (3) a component that facilitates and manages research concerning education of health professionals and future scientists as well as the immediate and extended communities within which the center resides; (4) a technology transfer component that would support developmental activities to move fundamental and clinical research products and processes from the laboratory to the marketplace; and (5) administrative and research support cores, including biostatistics, appropriate to the focus of the research. While a strong base of biomedical or behavioral research is an essential prerequisite, all components indicated above need not be developed to the same degree, acknowledging the variety of strengths present within a given group of researchers. Details of the various components of the COHRCDs including all collaborating units as well as acquisition of complementary funding to expand the potential scientific yield of each center must be addressed. Shared resources will be used to enhance productivity, stimulate collaborative efforts and increase cost effectiveness. Award of a COHRCD indicates that the applicant group and the research they propose is at a level of excellence unparalleled in a field. A COHRCD might be located within a single institution but, preferably, would involve consortia with other institutions such as universities, research institutes, hospitals, computer facilities, regional centers, health departments, industry and primate centers. These comprehensive centers may include free-standing specialized centers, program projects, and investigator-initiated research projects as integral components and could typically include research cores, newly proposed research projects, support for feasibility studies and support for demonstration and outreach research. Support will not be provided for routine patient care costs or training expenses. The strength of the COHRCDs lies in the fact that, as thematically-based organizations, they will be capable of incorporating the full range of expertise needed to accomplish the desired objectives. Each COHRCD must be a clearly defined organizational entity with a Director responsible for management of the center. Evidence of his/her strong and effective scientific leadership must be provided. The Director will be responsible for the organization and operation of the center, for communication within the center and with the NIDR on scientific and administrative matters, for maintaining high quality research efforts and for ensuring effective collaboration and communication among scientists and cooperating institutions. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1998, a letter of intent that includes the number and title of this RFA and a descriptive title for the COHRCD grant. Potential applicants also are asked to provide the name, mailing address, FAX, email address and telephone number of the Center Director and the identities of other key personnel and participating institutions and departments. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains is helpful in estimating the potential review workload and avoiding conflict of interest in the review. The letter of intent is to be sent to Dr. Ann L. Sandberg at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the PHS 398 application form kit must be affixed to the bottom of the face page of the original and the original must be placed on top of the entire package. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, in order to identify the application as a response to this RFA, the RFA title (Comprehensive Oral Health Research Centers of Discovery) and number DE-97-002 must be typed in item 2 of the face page of the application form and the YES box must be checked. The instructions accompanying Form PHS 398 must be followed as far as possible. Submit a signed, typewritten original of the application, including a cover letter, the checklist and three signed photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Dr. H. George Hausch Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-38D 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Applications must be received by May 8, 1998. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIDR. If NIDR staff finds that the application io appropriateness and relevance of the cores, their modes of operation and the suitability of their facilities; o the provision of an environment conducive to training of health professionals; o approach and potential effectiveness of outreach research; o evidence that the COHRCD will be able to establish partnerships with other research organizations and agencies that can provide educational and outreach activities; o feasibility of success of the demonstration research; o evidence of the availability of appropriate study populations and ability of the COHRCD to recruit adequate samples consistent with the NIH guidelines; o evidence of the ability to develop potentially marketable products and other effective interventions; o appropriateness of the budget for the proposed activities; o ability to obtain and effectively utilize leveraged funding; and o a plan for monitoring and evaluating the productivity of each of the components and the entire COHRCD. AWARD CRITERIA The earliest anticipated date of award is May, 1999. Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of the proposed project and the availability of funds will be considered by the NIDR staff and the National Advisory Dental Research Council in making funding recommendations. In addition, the NIDR values complementary funding from other public and private sources including foundations and industrial concerns. In circumstances in which applications have similar scientific merit, but vary in cost-competitiveness, the NIDR is likely to select the more cost-competitive application for funding. INQUIRIES Written, email and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Ann L. Sandberg Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-24A 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2419 FAX: (301) 480-8318 Email: ann.sandberg@nih.gov Direct inquiries regarding grants management issues to: Mr. Martin R. Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44A 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: 301-594-4800 Email: Martin.Rubinstein@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-087 - V26(25) 08/01/97 Date: 5 Aug 1997 21:56:45 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 288 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5s906d$53n@net.bio.net> NNTP-Posting-Host: net.bio.net HEARING AID IMPROVEMENT PROGRAM NIH GUIDE, Volume 26, Number 25, August 1, 1997 PA NUMBER: PA-97-087 P.T. National Institute on Deafness and Other Communication Disorders National Aeronautics and Space Administration PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) and the National Aeronautics and Space Administration (NASA) seek research grant applications from multidisciplinary teams to support research needed to transfer federally developed technology to hearing aids, including, but not limited to, the following areas: (1) novel algorithms for signal processing; (2) technologies applicable to hearing aid hardware; and (3) advanced microelectronics. Although not participating in the preliminary activities with the National Aeronautics and Space Administration that led to this Program Announcement, the National Institute on Aging (NIA) has a strong interest in the development of hearing aids that would significantly improve the quality of life of the many elderly persons who suffer from age-related hearing loss; NIA supports both basic and technology-related research in this area. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Hearing Aid Improvement Program, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402- 9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority individuals, women, and individuals with disabilities are encouraged. MECHANISM OF SUPPORT The mechanism of support will be the individual investigator-initiated research project grant (R01) award. The NIDCD/NASA are prepared to fund three to five awards in an amount not to exceed $1,000,000 total costs (direct and indirect costs) for FY 1998. Because the nature and scope of the research proposed in response to the PA may vary, it is anticipated that the size of the awards will vary. However, awards pursuant to this PA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Hearing aids continue to be the management of choice for many people with sensorineural hearing loss. Although hearing aids allow for improved hearing function in many situations, they provide limited benefit in noisy and other adverse listening environments. Thus, user satisfaction remains low for these problematic conditions. However, progress in the miniaturization of circuits and transducers now allows a wide range of signal processing functions to be incorporated into very small devices, thereby alleviating some of the cosmetic concerns expressed by many hearing aid users. Various signal processing algorithms, technologies and microelectronics have been developed for security, military and space applications, yet many of these have not been applied to hearing aids. The NIDCD, NASA and the Department of Veterans Affairs agreed in 1995 to initiate a federal technology transfer program for hearing aids by developing partnerships among scientists, industry and Federal laboratories for commercialization of promising technologies for the benefit of individuals with hearing impairment. A search of Federal laboratories for acoustic and electronic technologies that might improve hearing aids was completed in September, 1996 utilizing a NASA contract with Research Triangle Institute (RTI). The identified technologies were reviewed at the National Institute of Standards and Technology, and the most promising were selected for presentation by their developers at the NIDCD/NASA/VA Hearing Aid Improvement Conference: Facilitating Partnerships for Technology Transfer held on May 1 and 2, 1997 on the NIH campus in Bethesda, Maryland. Scientists, representatives of hearing aid and hearing aid component manufacturers, and individuals from Federal laboratories attended the conference. The purpose of the conference was to initiate the development of partnerships among scientists, hearing aid or hearing aid component manufacturers and Federal laboratories to carry out research that will lead to the commercialization of the promising technologies. This joint NIDCD/NASA Program Announcement is a solicitation for applications to support multidisciplinary collaborative research needed to transfer promising technologies into practical implementation of improvements in hearing aid performance. Objectives The goals and scope of this joint NIDCD/NASA Program Announcement include, but are not limited to: 1. Development, assessment, and implementation of technologies that have the potential to contribute to improved hearing aid performance and that constitute advances in signal processing or microelectronics. 2. Technology transfer support, in which academic/industrial teams work cooperatively with a Federal Laboratory and/or Federally funded grantee or contractor, to apply a Federally developed or funded technology to hearing aid improvement. Appropriate topics that will address the fundamental issues of hearing aid performance include, but are not limited to: 1. Innovative algorithms and approaches to acoustic signal processing, resulting in reduced background noise, increased speech intelligibility, and improved sound quality. 2. New technologies applicable to hearing aid hardware, such as improved microphones and remote control devices. 3. Implementation of low power consumption microelectronics appropriate for use in hearing aids. It is anticipated that multidisciplinary teams will be formed among scientists, hearing aid or hearing aid component manufacturers and Federal or Federally supported laboratories that developed the technology. Participation of hearing aid or hearing aid component manufacturers in these projects is essential to stimulate early assessment of commercial viability and to facilitate technology implementation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Application kits may also be obtained electronically via the WWW at http://www.nih.gov/grants/phs398/phs398.html. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The completed original and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (express/courier service) Applications will be received on the standard NIH application receipt dates, with an initial application receipt date of October 1, 1997. The earliest date of award is July, 1998. If the application submitted in response to this program announcement is substantially similar to a grant application already submitted to the NIH for review, but not yet reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this announcement that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Research Grants in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Deafness and Other Communication Disorders Advisory Council. The review criteria are: scientific, technical, or medical significance and originality of proposed research; appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; availability of the resources necessary to perform the research; appropriateness of the proposed budget and duration in relation to the proposed research; and adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications will compete for available funds with all other applications in response to this PA. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review; availability of funds; and program priorities among research areas of the program announcement. INQUIRIES Written, telephone, and email inquiries concerning this PA are encouraged; the opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding scientific content to: Amy M. Donahue, Ph.D. Chief, Hearing and Balance/Vestibular Sciences Branch Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: Amy_Donahue@nih.gov Direct inquiries regarding fiscal matters to: Sharon Hunt Chief, Grants Management Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-B, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: Sharon_Hunt@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103- 227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Aug 11 23:00:00 1997 Path: biosci!biosci!not-for-mail From: 464@nlreg.com Newsgroups: bionet.sci-resources Subject: NLREG - Nonlinear & linear statistical regression program - 36 0809040349 IJK Date: 12 Aug 1997 11:28:56 -0700 Organization: Nonlinear Regression Software Lines: 54 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5shbii$ren@news.triton.net> NNTP-Posting-Host: net.bio.net ** Announcing NLREG -- Nonlinear Statistical Regression Program ** http://www.sandh.com/sherrod/nlreg.html NLREG is a powerful statistical analysis program for Windows 95 and NT that performs linear and nonlinear regression analysis and curve fitting. NLREG determines the values of parameters for an equation, whose form you specify, that cause the equation to best fit a set of data values. NLREG can handle linear, polynomial, exponential, logistic, periodic, and general nonlinear functions. NLREG features a full programming language with a syntax similar to C for specifying the function that is to be fitted to the data. This allows you to compute intermediate work variables, use conditionals, and even iterate in loops. With NLREG it is easy to construct piecewise functions that change form over different domains. NLREG performs true nonlinear regression, it does not transform the function into a linear form. As a result, it can handle functions that are impossible to linearize such as: Y = Amplitude*SIN(Freq*X+Phase) + A*EXP(X); Another advantage of handing the function in true nonlinear form is that the minimization of the sum of squared residual values (i.e., "least squares") is based on the true nonlinear value rather than some linearized transformation. In addition to computing the optimal values of the parameters, NLREG can generate plots of the data points and the fitted equation. In addition, it can plot the distribution of residual values. In addition to performing classic nonlinear regression, NLREG can be used to find the root or minimum value of a general nonlinear function. It can also be used in a special form where the independent variable is omitted; an interesting application of this is "circular regression" where a circle is fitted to a set of data points. NLREG is in use at hundreds of universities, laboratories, and government agencies around the world (including the U.S. Navy, Harvard, and Duke). The price of NLREG is only $65 ($70 if outside the USA), which is far below the cost of comparable commercial regression programs. And you can download a shareware demonstration version of NLREG to try out before you decide to purchase it. To learn more about NLREG and download your free shareware version, visit the web site: http://www.sandh.com/sherrod/nlreg.html -- 36: bionet.sci-resources 0809040349 -- From owner-sci-resources@net.bio.net Tue Aug 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 26, pt. 1of1, 8 August 1997 Date: 13 Aug 1997 14:25:13 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1143 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5st8np$dg4@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 26 - August 8, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** GENOTYPING RESOURCE FOR MAPPING COMPLEX PHENOTYPES National Human Genome Research Institute INDEX: HUMAN GENOME RESEARCH $$INDEX N2 ********************************************************** NCI TISSUE AND DATA RESOURCES AVAILABLE FOR CANCER RESEARCH National Cancer Institute INDEX: CANCER $$INDEX N3 ********************************************************** NIDDK USE OF INDEPENDENT SCIENTIST AWARD National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 12/11/97 ************************************************* MENTORED CAREER DEVELOPMENT AWARD (RFA CA-97-023) National Cancer Institute INDEX: CANCER $$INDEX P1 ********************************************************** SUPPLEMENTS TO PROMOTE REENTRY INTO BIOMEDICAL AND BEHAVIORAL RESEARCH CAREERS (PA-97-088) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX P2 ********************************************************** MECHANISMS OF THE IMMUNE RESPONSE TO XENOTRANSPLANT ANTIGENS (PA-97- 089) National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Heart, Lung and Blood Institute INDEX: ALLERGY, INFECTIOUS DISEASES; DIABETES, DIGESTIVE, KIDNEY DISEASES; HEART, LUNG, BLOOD $$INDEX P3 ********************************************************** THREE-DIMENSIONAL STRUCTURES OF IMMUNOLOGICAL PROTEINS (PA-97-090) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX P4 *********************************************************** IMMUNOLOGIC BASIS OF FOOD ALLERGY (PA-07-091) National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases INDEX: ALLERGY, INFECTIOUS DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P5 ********************************************************** GENE THERAPY IN AGING (PA-97-092) National Institute on Aging National Heart, Lung and Blood Institute National Institute on Deafness and Other Communication Disorders National Institute of Mental Health National Institute of Neurological Disorders and Stroke INDEX: AGING; HEART, LUNG, BLOOD; DEAFNESS, OTHER COMMUNICATION DISORDERS; MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the NIH gopher (gopher.nih.gov) and the NIH website (http://www.nih.gov). Alternative access is through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing grant applications submitted to the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact aid which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAs, AND RFAs IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** GENOTYPING RESOURCE FOR MAPPING COMPLEX PHENOTYPES NIH GUIDE, Volume 26, Number 26, August 8, 1997 P.T. National Human Genome Research Institute PURPOSE The National Human Genome Research Institute announces the availability of resources and facilities for high throughput genotyping at the Center for Inherited Disease Research (CIDR). CIDR has been established as a resource to provide, on a fee-for-service basis, high throughput genotyping services to research efforts that are attempting to identify genetic loci and allelic variants involved in multifactorial human disease. The mapping activities at CIDR will concentrate on the use of human populations and families but may involve analysis of pertinent animal models as well. The purpose of this document is to describe procedures through which investigators can request access to CIDR. ELIGIBILITY REQUIREMENTS Access to CIDR will be determined on a competitive basis and is intended to be a resource for investigators who receive their primary research funding from NIH. CIDR will also be available on a competitive basis to NIH intramural scientists. Extramural investigators who have or are seeking NIH funding and who would like to use the services offered by CIDR, including those investigators submitting competing continuation (renewal) applications, and investigators submitting applications for competing supplements to add a genotyping component, are encouraged to request CIDR access prior to submitting their research grant applications to the NIH (for details see below). Those already funded for genotyping can also request access to the facilities of CIDR; for further information please contact Dr. Jerry Roberts (see information below). BACKGROUND A major thrust of human genetics research in this decade, the identification and analysis of genes which underlie disease, is now being directed to the common diseases, those that cause major morbidity and mortality in the population and which are usually complex in their etiology. The recent genome-wide searches for genes for insulin dependent diabetes mellitus and multiple sclerosis are representative examples of this approach in medical genetics research. Identification of genes contributing to common diseases brings with it an expansion in our knowledge of the pathophysiology of such disorders as well as the hope of early diagnostic techniques, pharmacological intervention, and effective preventative strategies. Diseases such as diabetes, heart disease, cancer, and psychiatric illness are challenging to analyze since they often result from a number of environmental and genetic factors acting in concert. An important consequence of the identification of the genetic components of such diseases would be the development of the ability to distinguish between genetic effects and environmental effects. To facilitate identification of the genetic factors underlying these diseases, genotyping must be carried out on a scale much larger than has previously been possible. Yet the labor intensive nature of such analyses will discourage many investigators from initiating such studies. This need has led the NIH to develop a new center, the Center for Inherited Disease Research (CIDR), to provide the research community with the resources necessary to conduct such studies. CIDR will specialize in high throughput genotyping in support of NIH- supported investigators. CIDR is a joint effort by eight participating institutes at NIH: the National Human Genome Research Institute (NHGRI), the National Cancer Institute (NCI), the National Institute of Child Health and Human Development (NICHD), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute on Drug Abuse (NIDA), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS). The NHGRI serves as the lead agency and manager of the CIDR facility which will be housed at the Bayview Campus of Johns Hopkins University. While the NIH Institute or Center to which an application may be assigned is not relevant for CIDR access consideration, the charge for this resource will be higher for scientists supported by non-participating institutes. SCOPE OF CIDR SERVICES Using samples provided by the principal investigators, CIDR will carry out genome-wide genotyping scans. A variety of different mapping approaches will be supported, including affected pedigree member methods, transmission disequilibrium testing, and linkage analysis in pedigrees. Consultation on study design and on statistical analysis are available, as additional services, to investigators. The data and analyses will remain the property of the principal investigators and once the studies at CIDR have been completed, will be returned to the principal investigators. At the outset CIDR will use automated fluorescent microsatellite analysis using standard marker sets (^10 cM average spacing) with an initial goal of 1-2 million genotypes (marker x DNA sample) per year. With this capacity, it is estimated that CIDR will initially be able to work on 6 to 9 projects per year, although that number will obviously depend on the size of the projects. Though focusing on genotyping services, CIDR scientists will also be engaged in research efforts across five main components: 1) statistical genetics, which applies the power of statistics to the hereditary patterns of genes to determine modes of inheritance from parents to their children; 2) genetic epidemiology, which applies genetic analysis gathered from disease-prone families to the general population to determine if the genetics patterns of the research families hold in large diverse populations; 3) medical informatics and database management, which uses computer programs to store, manipulate, and analyze the research data; 4) state-of-the-art technology to rapidly scan whole genomes for multiple gene regions associated with a particular disorder; and 5) technology development, which continues to refine existing methods and generate new ways to perform high-capacity genotyping efficiently and cost effectively. While many investigators will only request use of the genotyping capabilities of CIDR, others may wish to avail themselves of the expertise of CIDR personnel in designing the studies and in the analysis of data. Investigators requesting such collaborations with CIDR scientists should detail these collaborations in their requests and include appropriate letters of commitment from those involved. Investigators wishing more information on CIDR personnel for potential collaborations should contact Dr. Jerry Roberts at the CIDR Office in NHGRI (see below under Inquiries.) PROCEDURE FOR REQUESTING CIDR ACCESS Investigators intending to seek NIH support for gene mapping projects and who wish to utilize the genotyping resources of CIDR are encouraged to request CIDR access prior to submitting a research grant application to the NIH. A short document (ideally 5-8 pages, single spaced) describing the project and justifying the need for such a resource is required. The CIDR Access Committee (CAC) will review these requests and determine if a project is suitable for CIDR. If suitable, a letter of commitment will be sent to the investigator. Investigators denied CIDR access will be notified and a letter will briefly detail the reason(s) for denial. The CAC will hold three meetings per year as summarized below. Decisions by the CAC will be transmitted to investigators immediately after the CAC meeting. While no firm deadlines for accepting requests are set, investigators are advised to plan their submission strategy so that they can learn the outcome of the CAC evaluation prior to submitting a research grant application to NIH. For example, investigators planning to submit NIH grant applications for the February/March receipt date are advised to submit their requests to the CAC by mid-November to insure sufficient time for evaluation by the CAC at its regular, scheduled meeting in December/January and transmittal of the CAC's decision to investigators. The following schedule should be used to guide investigators in preparing and submitting requests. Requests for access received too late to transmit to the CAC members will be held and taken to the next CAC meeting. Date for Requesting CAC Meeting/Reporting Date for Submitting CIDR Access NIH Grant Application Mid-November Dec/Jan Feb/Mar Mid-March Apr/May Jun/Jul Mid-July Aug/Sep Oct/Nov Investigators already funded for genotyping are also eligible to apply for CIDR access. Interested investigators should prepare a 5-8 page request as described above. ACCESS CRITERIA Factors that will be weighed in determining the suitability of a project for CIDR access include: - the size and scope of the project and the need for large capacity genotyping to complete the project. - significance and complexity of the disorder/trait. - the quality and completeness of the phenotyping carried out on the subjects. - strength of the evidence for a genetic component to the disease phenotype. - the ability and preparedness of the investigator to manage the large amount of data that is generated by large genotyping projects. - the appropriateness of the study population for the specific disease mapping project. - the availability of adequate numbers of patient samples and the completeness of the patient sample set. - the appropriateness of proposed analytic methods and the ability of the investigators to carry out the methods. - the quality, availability and completeness of the DNA samples. Investigators who are informed that their request for CIDR access has been granted should use this information in preparing their NIH research grant application. Other investigators have the option of seeking genotyping services elsewhere. SCHEDULING OF FUNDED PROJECTS FOR CIDR ACCESS It is anticipated that, because of the demands on CIDR resources, a schedule of priority for project initiation will have to be established. Final scheduling of funded projects will be determined by the CIDR Director in consultation with the Board of Governors, which oversees CIDR. The Board is comprised of the Directors of the eight institutes that are contributing funds to the contract, as well as two non-voting members: the CIDR Director and a representative of Johns Hopkins University, the contractor for this facility. INQUIRIES Inquires are encouraged. The opportunity to clarify any issues or questions is welcomed. Potential investigators who wish to discuss issues related to research grant application submission may contact Dr. Jerry Roberts for identification of an appropriate institute or center staff member. Telephone, electronic and/or written inquiries are welcomed. Direct inquiries regarding CIDR access and CAC review to: Jerry Roberts, Ph.D. National Human Genome Research Institute Building 38A, Room 609 38 Library Drive Bethesda, MD 20892-6050 Telephone: (301) 402-0838 Fax: (301) 480-2770 Email: robertsj@odder.nhgri.nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NCI TISSUE AND DATA RESOURCES AVAILABLE FOR CANCER RESEARCH NIH GUIDE, Volume 26, Number 26, August 8, 1997 P.T. National Cancer Institute The National Cancer Institute (NCI) announces to the scientific community the availability of the following NCI-supported tissue and data resources for cancer research: o NCI Cooperative Human Tissue Network The NCI Cooperative Human Tissue Network (CHTN) provides normal, benign, pre-cancerous and cancerous human tissue to the scientific community for biomedical research. Human tissue specimens are collected according to the investigator's individual protocol. Researchers may specify from among multiple preservation methods including fresh tissue (in any medium), fixed (in any fixative), and frozen (snap frozen or frozen in a tissue embedding media such as OCT). Requests for histological specimens (for blocks and slides) will also be considered. Information routinely provided with the specimens includes pathology reports and histological characterization. Specific additional information may be provided if requested in advance. The specimens are most useful for basic and developmental studies in many areas of cancer research, including molecular biology, immunology and genetics. Further information may be obtained from the CHTN website at http://wwwicic.nci.nih.gov/chtn/chtnmain.html, or Ms. Marianna Bledsoe, Resources Development Branch, Cancer Diagnosis Program, Division of Cancer Treatment, Diagnosis and Centers, NCI. Phone: (301) 496-7147; FAX: (301) 402-7819; e-mail: mb80s@nih.gov. o Gynecologic Oncology Group Tissue Bank The Gynecologic Oncology Group (GOG) Tissue Bank can provide malignant, benign, and normal ovarian, and cervical tissue. Primary tumor, metastatic tumor (when applicable) and normal adjacent tissue are available for most cases. The bank includes snap frozen specimens, formalin fixed sections, OCT embedded primary tumor, touch imprint slides and patient serum collected prior to surgery. Clinical information provided with each case may include patient age and race in addition to the institutional pathology and operative reports. A limited number of tissue specimens are from patients entered into GOG clinical trial protocols. These specimens and the associated treatment, response and survival data may be available through collaboration with GOG investigators following review and approval by the GOG Ovarian Committee. The bank was established to provide carefully preserved specimens needed for molecular biology studies of gynecologic tumors. For further information, contact the GOG Tissue Bank, Children's Hospital, J058, 700 Children's Drive, Columbus, OH 43205; Phone: (614) 722-2890; FAX: (614) 722-2897. o NCI Cooperative Breast Cancer Tissue Resource The NCI Cooperative Breast Cancer Tissue Resource (CBCTR) can provide researchers with access to approximately 8,000 cases of formalin- fixed, paraffin-embedded primary breast cancer tissues, with associated pathology and clinical data. Tissue and data are available from patients treated locally in four diverse geographic areas of the United States. Tissue sections are prepared to meet the criteria of individual research protocols. All specimens are reviewed to verify the pathologic diagnosis. Clinical and outcome data include: diagnosis, demographic data, extent of disease, treatment, follow-up, recurrence, survival, and vital status. Cases are available for study, representing all stages of disease, including a large number of cases who received no adjuvant radiation or chemotherapy or were treated with conserving surgery and radiation but no chemotherapy. The collection is particularly well-suited for validation studies of diagnostic and prognostic markers. Interested researchers may perform searches of the database on the CBCTR's World Wide Web site at http://www-cbctr.ims.nci.nih.gov to determine if tissues appropriate for their experiments exist within the Resource and apply to the Resource for the use of these tissues. For further information, contact Ms. Sherrill Long, Information Management Services, Inc., 12501 Prosperity Drive, Suite 200, Silver Spring MD 20904; Phone: (301) 680-9770, FAX: (301) 680-8304; e-mail: sherrill@ssims.nci.nih.gov. o NCI-NAPBC Breast Cancer Specimen and Data Information System This database, which is available on the World Wide Web, (http://cancernet.nci.nih.gov/breastdata) contains a listing of institutions that are willing to provide breast cancer specimens and/or data to biomedical researchers. Collaborative relationships may be required by some institutions. For each resource listed in the database, information is provided on the number and types of specimens, the availability of associated clinical and outcome data, procedures for obtaining access to the specimens or data, costs, and limitations of use. The database may be searched for key words. For further information, contact Paul Hurwitz, Westat, Inc. Phone: (301) 738 - 8313; e-mail: referral@westat.com. o NCI Cooperative Family Registry for Breast Cancer Studies and NCI Cooperative Family Registry for Colorectal Cancer Studies The Cooperative Family Registry for Breast Cancer Studies (CFRBCS) provides biological specimens from participants with a family history of breast cancer, breast/ovarian cancer, or Li-Fraumeni syndrome, and their relatives, as follows: tissue sections from paraffin embedded breast and ovarian cancers; peripheral blood lymphocytes, serum, fresh frozen tissue (when available), and other biological fluids. The CFRBCS will provide related family history (pedigrees), clinical, demographic and epidemiologic data on risk factors exposures. The CFRBCS will also provide follow-up epidemiologic data as well as data on recurrence, new morbidity, and mortality in the participating families. Biological specimens and the clinical, family history, and epidemiologic data are available to the research community at large. The CFRBCS's repository and related databases are particularly suited to support interdisciplinary and translational breast cancer research. Additional information may be obtained from the CFRBCS site on the World Wide Web at http://www-dceg.ims.nci.nih.gov/cfrbcs or Dr. Daniela Seminara, Division of Cancer Epidemiology and Genetics, NCI, Phone: (301) 496-9600; FAX: (301) 402-4279; e-mail: seminard@epndce.nci.nih.gov. A similar resource for colorectal cancer, the Cooperative Family Registry for Colorectal Cancer Studies, has been recently established, and it is expected that it will be available to the research community at large in early 1998. For further information contact Dr. Daniela Seminara, Division of Cancer Epidemiology and Genetics, NCI, Phone: (301) 496-9600; FAX: (301) 402-4279; e-mail: seminard@epndce.nci.nih.gov. o NCI AIDS Malignancy Bank The NCI AIDS Malignancy Bank (AMB) is a collection of tissues and biological fluids with associated clinical and follow-up data from patients with HIV-related malignancies. The specimens and clinical data are available for research studies, particularly those that translate basic research findings to clinical application. The AMB contains formalin-fixed paraffin embedded tissues, fresh frozen tissues, malignant cell suspensions, fine needle aspirates, and cell lines from patients with HIV-related malignancies. The bank also contains serum, plasma, urine, bone marrow, cervical and anal specimens, saliva, semen and multi-site autopsy tissues from patients with HIV-related malignancies including those who have participated in clinical trials. The bank has an associated database that contains prognostic, staging, outcome and treatment data on patients from whom tissues were obtained. The AMB makes these tissues available to qualified investigators in the United States for research on HIV- related malignancies. Additional information may be obtained from the AMB site on the World Wide Web at http://wwwicic.nci.nih.gov/amb/amb.html, or Dr. Ellen Feigal, Cancer Therapy Evaluation Program, Division of Cancer Treatment, Diagnosis and Centers, NCI, Phone: (301) 496-2522; Fax: (301) 402-0557; e-mail: ef30d@nih.gov. Additional AIDS oncology information may be obtained on the World Wide Web at http://ctep.info.nih.gov by selecting AIDS Oncology Resources. Other human tissue resources for cancer research may be available through collaborative arrangements. For further information, please contact Ms. Marianna Bledsoe, Resources Development Branch, Cancer Diagnosis Program, Division of Cancer Treatment, Diagnosis and Centers, NCI. Phone: (301) 496-7147; FAX: (301) 402-7819; e-mail: mb80s@nih.gov. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NIDDK USE OF INDEPENDENT SCIENTIST AWARD NIH GUIDE, Volume 26, Number 26, August 8, 1997 P.T. National Institute of Diabetes and Digestive and Kidney Diseases This serves to notify the extramural community that the Division of Digestive Diseases and Nutrition (DDDN) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will now accept applications for the Independent Scientist Award (K02) as announced in the NIH Guide for Grants and Contracts (PA-95-053, Vol. 24, No. 15, April 28, 1995). Supplemental information from the NIDDK was published in the NIH Guide for Grants and Contracts, Vol. 24, No. 38, October 27, 1995 and now applies to the DDDN. Consultation with program staff is strongly encouraged prior to submitting an application. INQUIRIES Questions regarding this notice may be directed to: Dr. Judith Podskalny Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AN12E Bethesda, MD 20892-6600 Telephone: (301) 594-8876 Email: jp53s@nih.gov $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN CA-97-023 FULL-TEXT ************************************** MENTORED CAREER DEVELOPMENT AWARD NIH GUIDE, Volume 26, Number 26, August 8, 1997 RFA AVAILABLE: CA-97-023 P.T. National Cancer Institute Letter of Intent Receipt Date: November 6, 1997 Application Receipt Date: December 11, 1997 PURPOSE The Comprehensive Minority Biomedical Program, Division of Extramural Activities, National Cancer Institute (NCI), invites underrepresented minority research scientists who have been the recipient of an NIH Research Supplement for Underrepresented Minority Individuals in Postdoctoral Training (MIPT) or a Minority Investigator Supplement (MIS), funded by the NCI, who need an extended period of sponsored research as a way to gain scientific expertise while bridging the transition from a mentored research environment to an independent research/academic career to submit applications. This award offers opportunities for a mentored peer review experience in cancer research which will enhance the candidates knowledge and understanding of the peer review process with the intended purpose of developing skills with the expectation that the candidate will submit a grant application for nontargeted mechanisms (R29, R01). This award is aimed at fostering the cancer research careers of outstanding, junior underrepresented minority scientists who: o have been the recipient of an NIH Research Supplements for Underrepresented Minorities award, funded by the NCI; o are located at a majority institution; and o are committed to developing and sustaining academic research programs. This award is a novel mechanism that is intended to support underrepresented minority scientists and enhance the likelihood of success for junior underrepresented minority investigators who have committed to basic and clinical research careers in cancer. The estimated total costs available for the first year support of this program is $500,000. There will be approximately five new awards made in response to this solicitation. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This Request for Application (RFA), Career Development Award, is related to the priority area of human resource development in cancer research. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research training objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov). and by mail and e-mail from the program contact listed below. Sanya A. Springfield, Ph.D. Comprehensive Minority Biomedical Program National Cancer Institute 6130 Executive Boulevard, Suite 620 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: springfs@dea.nci.nih.gov $$R1 END ************************************************************ $$P1 BEGIN PA-97-088 FULL-TEXT ************************************** SUPPLEMENTS TO PROMOTE REENTRY INTO BIOMEDICAL AND BEHAVIORAL RESEARCH CAREERS NIH GUIDE, Volume 26, Number 26, August 8, 1997 PA AVAILABLE: PA-97-088 P.T. 34; K.W. 0710030 National Institutes of Health PURPOSE The National Institutes of Health (NIH) reannounces a program for administrative supplements to research grants to support individuals with high potential to reenter an active research career after taking time off to care for children or parents or to attend to other family responsibilities. The aim of these supplements is to encourage fully trained individuals to reenter research careers within the missions of all the program areas of NIH. This program will provide administrative supplements to existing NIH research grants for the purpose of supporting full-time or part-time research by these individuals in a program geared to bring their existing research skills and knowledge up to date. It is anticipated that at the completion of the supplement, the reentry scientist will be in a position to apply for a career development (K) award or for a research (R or P) award. The NIH recognizes the need to increase the number of women and minorities and people with disabilities in basic, behavioral, and clinical science research careers. Among the reasons for the low representation of women may be the fact that women bear a majority of the responsibilities surrounding child and family care. To address this issue, this program is designed to offer opportunities to women and men who have interrupted their research careers to care for children or parents or to attend to other family responsibilities. A second objective of the program is to mentor and guide those who receive support to reestablish careers in biomedical or behavioral research. Participating Institutes and Centers (ICs) include the National Cancer Institute; National Eye Institute; National Heart, Lung, and Blood Institute; National Institute on Aging; National Institute on Alcohol Abuse and Alcoholism; National Institute of Allergy and Infectious Diseases; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Child Health and Human Development; National Institute of Dental Research; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute on Drug Abuse; National Institute of Environmental Health Sciences; National Institute of General Medical Sciences; National Institute of Mental Health; National Institute on Deafness and Other Communication Disorders; National Human Genome Research Institute; and National Center for Research Resources. The National Institute of Neurological Disorders and Stroke previously announced a Mentored Research Scientist Development Award (K01) for scientists reentering the neurological sciences (NIH Guide, Vol. 21, No. 33, 1992). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Supplements to Promote Reentry into Biomedical and Behavioral Research Careers, is related to the priority area of women's health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. National Cancer Institute Toby Friedberg, Referral Officer Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-3428 FAX: (301) 402-0275 National Eye Institute Ralph J. Helmsen, Ph.D., Program Official Executive Plaza South, Suite 350 Bethesda, MD 20892 Telephone: (301) 496-5301 FAX: (301) 402-0528 National Heart, Lung, and Blood Institute Ronald G. Geller, Ph.D., Director of Extramural Affairs Rockledge Building, Room 7100 Bethesda, MD 20892 Telephone: (301) 435-0260 FAX: (301) 594-7424 National Human Genome Research Institute Jane Peterson, Ph.D., Program Official Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-6023 FAX: (301) 480-2770 National Institute on Aging Miriam Kelty, Ph.D., Associate Director of Extramural Affairs Gateway Building, Suite 2C218 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9322 FAX: (301) 402-2945 National Institute on Alcohol Abuse and Alcoholism Tina Vanderveen, Ph.D., Program Official or Linda Hilley, Grants Management Official Willco Building, Suite 402 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-1274 or (301) 443-3885 FAX: (301) 594-0673 National Institute of Allergy and Infectious Disease Milton Hernandez, Ph.D., Program Official Solar Building, Room 4C10 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 National Institute of Arthritis and Musculoskeletal and Skin Diseases Julia Freeman, Ph.D., Centers Program Director Director, Women and Minority Health Issues Natcher Building, Room 525-19F 9000 Rockville Pike Bethesda, MD 20892-6500 Telephone: (301) 594-5052 FAX: (301) 480-4543 National Institute of Child Health and Human Development Darlene Levenson Building 31, Room 2A49 Bethesda, MD 20892 Telephone: (301) 496-1971 FAX: (301) 496-0588 National Institute of Dental Research Patricia S. Bryant, Ph.D., Program Official or Teresa Ringler, Grants Management Official Natcher Building, Room 4AN-24 9000 Rockville Pike Bethesda, MD 20892-6402 Telephone: (301) 594-7710 FAX: (301) 480-9318 National Institute of Diabetes and Digestive and Kidney Diseases Walter Stolz, Ph.D. Director, Division of Extramural Activities Natcher Building, Room 6AS-25C 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 594-8834 FAX: (301) 480-3505 National Institute on Drug Abuse Cora Lee Wetherington Women~s Health Coordinator 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1263 FAX: (301) 443-6043 National Institute of Environmental Health Sciences Anne P. Sassaman, Ph.D., Program Official or David Mineo, Grants Management Official P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7723 or (919) 541-7628 FAX: (919) 541-2843 National Institute of General Medical Sciences Anthony A. Rene, Ph.D., Program Official or Carol Tippery, Grants Management Official Westwood Building, Room 925 5333 Westbard Avenue Bethesda, MD 20892 Telephone: (301) 594-3833 FAX: (301) 594-7701 National Institute on Deafness and Other Communication Disorders Craig A. Jordan, Ph.D., Program Official Acting Director, Division of Extramural Activities 6120 Executive Boulevard Executive Plaza South, Room 400C Rockville, MD 20892 Telephone: (301) 496-8693 FAX: (301) 402-6250 National Institute of Mental Health Delores L. Parron, Ph.D. Associate Director for Special Populations Parklawn Building, Room 17C-14 5600 Fisher Lane Rockville, MD 20857 Telephone: (301) 443-2847 FAX: (301) 443-8552 National Center for Research Resources Louise E. Ramm, Ph.D., Program Official or Lacey J. Durham, Grants Management Official Westwood Building, Room 854 Bethesda, MD 20892 Telephone: (301) 594-7906 or (301) 594-7955 FAX: (301) 594-9121 $$P1 END ************************************************************ $$P2 BEGIN PA-97-089 FULL-TEXT ************************************** MECHANISMS OF THE IMMUNE RESPONSE TO XENOTRANSPLANT ANTIGENS NIH GUIDE, Volume 26, Number 26, August 8, 1997 PA AVAILABLE: PA-97-089 P.T. National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Heart, Lung and Blood Institute PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH), invite applications to enhance our ability to transplant organs and tissues across species barriers (xenotransplantation) by increasing our understanding of: the human immune response to antigens present on the surface of organs or tissues from non-human species, and the development of methods to allow rapid identification and treatment of infectious diseases that might occur by transmission of disease causing organisms across species barriers. This research would lead to the development of new therapies to allow xenografts to survive and function in humans and the generation of new, sensitive detection methods to decrease the risk of infectious disease associated with xenotransplantation. Traditional research project grants (R01) and First Independent Research Support and Transition (FIRST) (R29) award applications may be submitted in response to this PA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Mechanisms of the Immune Response to Xenotransplant Antigens, is related to the priority areas of immunization and infectious diseases, diabetes and chronic disabling disease, and heart disease and stroke. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Stephen M. Rose, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building 6003 Executive Boulevard, Room 4A14 Bethesda, MD 20892-7640 Telephone: (301) 496-5598 Fax: (301) 402-2571 Email: sr8j@nih.gov Judith Massicot-Fisher, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute 6701 Rockledge Drive MSC 7940 Bethesda, MD. 20892-7940 Telephone: (301) 435-0504 Fax: (301) 480-1454 EMAIL: jm294z@nih.gov Joan T. Harmon, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 5An-18G Bethesda, MD 20892-6600 Telephone: (301) 594-8813 FAX: (301) 480-3503 Email: harmonj@ep.niddk.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-97-090 FULL-TEXT ************************************** THREE-DIMENSIONAL STRUCTURES OF IMMUNOLOGICAL PROTEINS NIH GUIDE, Volume 26, Number 26, August 8, 1997 PA AVAILABLE: PA-97-090 P.T. National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for research on the three-dimensional structural properties of proteins involved in initiating and regulating immune responses in human and animal systems. The structural elucidation of protein complexes and development of structural analogs that enhance, inhibit or change the function of native proteins for therapeutic applications are also of interest. Increased knowledge of immunological proteins obtained from such structural studies is important for understanding regulation of the immune system and for the development of effective immunotherapeutic agents. Traditional research project grant (R01)and FIRST (R29) applications may be submitted in response to this program announcement. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), THREE-DIMENSIONAL STRUCTURES OF IMMUNOLOGICAL PROTEINS, is related to the priority area of Immunization and Infectious Diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Helen Quill, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A22 Bethesda, MD 20892-7640 Telephone: (301) 496-7551 FAX: (301) 402-2571 Email: hq1t@nih.gov $$P3 END ************************************************************ $$P4 BEGIN PA-97-091 FULL-TEXT ************************************** IMMUNOLOGIC BASIS OF FOOD ALLERGY NIH GUIDE, Volume 26, Number 26, August 8, 1997 PA AVAILABLE: PA-07-091 P.T. National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health invite applications for research studies on: (a) the mechanisms of mucosal immunity and of tolerance as they apply to food allergy; (b) the genetic basis of food allergy; (c) the molecular identification of food allergens and their epitopes; and (d) immunotherapeutic approaches to treating food allergy. The results of these investigations will be used to develop strategies to prevent food allergy and treat food-allergic patients. Traditional research project grant (R01) and FIRST award (R29) applications may be submitted in response to this PA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Immunologic Basis of Food Allergy, is related to the priority area of nutrition. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Marshall Plaut, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A25 Bethesda, MD 20892-7640 Telephone: (301) 496-8973 FAX: (301) 402-0175 Email: mp27s@nih.gov Gilman D. Grave, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-11 Bethesda, MD 20892-7510 Telephone: (301) 496-5593 FAX: (301) 480-9791 Email: gg37v@nih.gov Frank A. Hamilton, M.D., M.P.H. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building Room 6AN-12B 45 Center Drive, MSC-6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8877 FAX: (301) 480-8300 Email: fh14e@nih.gov $$P4 END ************************************************************ $$P5 BEGIN PA-97-092 FULL-TEXT ************************************** GENE THERAPY IN AGING NIH GUIDE, Volume 26, Number 26, August 8, 1997 PA AVAILABLE: PA-97-092 P.T. National Institute on Aging National Heart, Lung and Blood Institute National Institute on Deafness and Other Communication Disorders National Institute of Mental Health National Institute of Neurological Disorders and Stroke PURPOSE The objective of this initiative is to encourage research on strategies to prevent or delay adverse aging-related changes and diseases, including neurodegenerative disorders, using genetic and cellular engineering approaches. Support for this Program Announcement will be through the NIH research project grant (R01) and FIRST (R29) award. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Gene Therapy in Aging, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Huber R. Warner, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: warnerh@exmur.nia.nih.gov $$P5 END ************************************************************ From owner-sci-resources@net.bio.net Tue Aug 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-089 - V26(26) 08/08/97 Date: 13 Aug 1997 14:26:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 408 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5st8pa$dk9@net.bio.net> NNTP-Posting-Host: net.bio.net MECHANISMS OF THE IMMUNE RESPONSE TO XENOTRANSPLANT ANTIGENS NIH GUIDE, Volume 26, Number 26, August 8, 1997 PA NUMBER: PA-97-089 P.T. 34; K.W. 0705048, 0710125, 0745065 National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Heart, Lung and Blood Institute PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Heart, Lung and Blood Institute (NHLBI) invite applications to enhance our ability to transplant organs and tissues across species barriers (xenotransplantation) by increasing our understanding of: the human immune response to antigens present on the surface of organs or tissues from non-human species, and the development of methods to allow rapid identification and treatment of infectious diseases that might occur by transmission of disease causing organisms across species barriers. This research would lead to the development of new therapies to allow xenografts to survive and function in humans and the generation of new, sensitive detection methods to decrease the risk of infectious disease associated with xenotransplantation. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Mechanisms of the Immune Response to Xenotransplant Antigens, is related to the priority areas of immunization and infectious diseases, diabetes and chronic disabling disease, and heart disease and stroke. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Traditional research project grants (R01) and FIRST award (R29) applications may be submitted in response to this PA. Applications for R01 grants may request up to five years of support; applications for R29 grants must request five years of support. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. RESEARCH OBJECTIVES Background Annually, there are more than 40,000 patients waiting for transplants of kidneys (35,000+), hearts (3,500+), and lungs (2,000+). In 1995, 19,100 people received transplants of these organs and, currently, there are shortages of all organs. Nine patients per day die waiting for an organ transplant. The shortage of human organs has led the transplant community to examine the possibility of using non-human organs. The first modern attempt at cross-species organ transplantation was in 1964, transplanting kidneys from chimpanzees into patients with renal failure. While the transplanted kidneys functioned initially, patients experienced acute rejection and infectious complications. One patient survived with a functioning chimpanzee kidney for nine months. The same year, a series of baboon-to-human kidney transplants was attempted with the same results, acute rejection and infection. The kidneys functioned while the patients remained alive. Twenty years later, the Baby Fae baboon heart transplant was attempted, using the new, highly effective immunosuppressive agent Cyclosporin A. Still, the heart failed after 20 days due to acute rejection. Other isolated cases of clinical xenotransplantation have been attempted, all leading to graft failure or patient death due to infection. Due to worries about transmission of infectious organisms, especially viruses, from non-human primates to humans, the pig may become the organ donor of choice. However, there are major problems to overcome. Humans have preformed antibodies called xenoreactive natural antibodies (XNA). These XNA include IgM, IgG and IgA and appear in the early neonatal period following coliform bacterial colonization of the large bowel. Most XNA recognize bacterial cell wall associated carbohydrates, and are reactive primarily against the terminal Gal-alpha-1,3-Gal moiety. These XNA mediate hyperacute rejection (HAR) of pig organs transplanted in non-human primates via activation of complement. The hallmarks of the HAR are hemorrhage, widespread thrombosis (particularly involving platelets) and ischemia leading to organ failure within minutes of engraftment. Recent research advances may hold promise for stopping or ameliorating the antibody mediated HAR. The use of soluble carbohydrate inhibitors to block the recognition of the xenograft by the preformed XNA has shown limited success in animal models, improving graft survival from days to weeks. In addition, use of Decay Accelerating Factor (DAF) in the recipient has effectively stopped the complement-induced damage to the xenograft in some model systems. Currently, transgenic DAF animals are being bred to try to extend the success of intravenous DAF therapy. Other methods being tested include "knockout" pigs missing the gene for the protein responsible for addition of the terminal carbohydrate moiety, and transgenic pigs that contain the genes for human regulator(s) of complement activation (RCA) to prevent complement damage to the organ. While current efforts are focused on preventing HAR, there is growing evidence that a vigorous immune response is still mounted to the non-human organ beyond the HAR response. This Delayed Xenograft Rejection (DXR), or acute vascular rejection, is characterized by mononuclear cell infiltrates, focal infarcts and interstitial hemorrhage with intravascular coagulation. This damage is due to a series of steps involving mononuclear and endothelial cell activation, cytokine expression and platelet and fibrin deposition, leading to xeno-organ rejection within a few days. While there are new, exciting results that will allow xenografts to survive longer, much is still unknown about the immune response to organs from non-human species. Another major concern in xenotransplantation is the transmission of infectious organisms. Transmission of pathogens, such as swine influenza, from animal reservoirs to humans is well documented in settings other than transplantation. Evolutionary adaptation of pathogenic organisms to a wider host range is also well documented. When infectious agents are transmitted from natural hosts to new species, unpredictable changes in the pathogenic potential of these infectious organisms can result. This inter-species infectivity is a problem for xenotransplantation. The infectious disease research that could be supported by this PA is intended to increase our knowledge of and our ability to characterize the infectious organisms and processes involved in xenotransplantation. This would include the use of modern molecular biological techniques to develop new diagnostic methods to detect potential pathogens before animal organs or tissues are transplanted. Research Objectives and Scope The objectives of the research to be supported under this PA are to: delineate the mechanisms and pathology of the delayed xenograft response to antigens found on the surface of non-human organs, tissues or cells that might be used for transplantation into humans; develop new specific and rapid diagnostic tests to identify potential pathogenic organisms; and quantify the risk of xenogeneic infection. The scope of research to be supported under this PA includes, but is not limited to, the following broad areas of interest and specific examples of investigations. These examples are not meant to be inclusive, but rather illustrative of areas that require further investigation. Investigators are encouraged to develop novel approaches to identify and characterize the human immune response to non-human organs or tissues. o Identification of xenoantigens which are immunogenic, such as Major Histocompatibility Complex (MHC) antigens, Minor Histocompatibility Complex (MiHC) antigens, and other cell surface molecules; o Definition of the modes of interaction between xenoantigens and recipient MHC; o Assessment of the risk of transmission of Xenozoonosis (xeno-infectious disease) in immunocompromised hosts; o Development of new diagnostic methods to detect xenozoonoses before they become frank infections; o Studies involving genetic manipulation of the donor animal to either render it less immunogenic or more resistant to the host immune response; o Elucidation of the inflammatory events in delayed xenograft rejection; o Studies of the role of adhesion molecules on the host cell types; e.g. macrophages, NK cells and endothelial cells; o Studies in animal models of in vivo safety and efficacy of antimicrobial therapeutics in immunocompetent and immunocompromised hosts compared with the in vitro sensitivity of the organisms; and o Development of model systems to study the impact of viral mutants, alterations in pathogenicity, infectivity and transmissibility of xeno-infectious organisms in immunocompromised hosts. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application for PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated on the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES". The PA number and the PA title must also be typed in section 2. The completed, signed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) R29 applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Centers (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?~ The initial review group will also examine: the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Stephen M. Rose, Ph.D. Chief, Genetics and Transplantation Branch Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A14 6003 Executive Blvd. Bethesda, MD 20892-7640 Telephone: (301) 496-5598 FAX: (301) 402-2571 EMAIL: sr8j@nih.gov Judith Massicot-Fisher, Ph.D. Heart Failure SRG Leader Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute 6701 Rockledge Drive MSC 7940 Bethesda, MD. 20892-7940 Telephone: (301) 435-0504 Fax: (301) 480-1454 EMAIL: jm294z@nih.gov Joan T. Harmon, Ph.D. Chief, Diabetes Research Section, Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 5An-18G Bethesda, MD 20892-6600 Telephone: (301) 594-8813 FAX: (301) 480-3503 Email: harmonj@ep.niddk.nih.gov Direct inquiries regarding fiscal matters to: Laura Eisenman Grants Management Branch Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B23 6003 Executive Blvd. Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Fax: (301) 480-3780 Email: le55d@nih.gov William W. Darby Heart Section Grants Management Officer Grants Operations Branch National Heart, Lung and Blood Institute 6701 Rockledge Drive Room 7128, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0177 Fax: (301) 435-3310 EMAIL: William_Darby@nih.gov Linda Stecklein Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6As-49J National Institutes of Health Bethesda, MD 20892-6600 Telephone: (301) 594-8847 FAX: (301)480-3504 Email: steckleinl@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citations are No. 93.855 - Immunology, Allergy, and Transplantation Research, No. 93.848 - Diabetes, Endocrinology and Metabolic Diseases, No. 93.849 - Kidney, Urologic and Hematologic Diseases, and No. 93.837 - Heart and Vascular Diseases Research. Awards will be administered under PHS grants policies and Federal Regulations 24 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-088 - V26(26) 08/08/97 Date: 13 Aug 1997 14:25:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 425 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5st8os$djk@net.bio.net> NNTP-Posting-Host: net.bio.net SUPPLEMENTS TO PROMOTE REENTRY INTO BIOMEDICAL AND BEHAVIORAL RESEARCH CAREERS NIH GUIDE, Volume 26, Number 26, August 8, 1997 PA NUMBER: PA-97-088 P.T. 34; K.W. 0710030 National Institutes of Health PURPOSE The National Institutes of Health (NIH) reannounces a program for administrative supplements to research grants to support individuals with high potential to reenter an active research career after taking time off to care for children or parents or to attend to other family responsibilities. The aim of these supplements is to encourage fully trained individuals to reenter research careers within the missions of all the program areas of NIH. This program will provide administrative supplements to existing NIH research grants for the purpose of supporting full-time or part-time research by these individuals in a program geared to bring their existing research skills and knowledge up to date. It is anticipated that at the completion of the supplement, the reentry scientist will be in a position to apply for a career development (K) award or for a research (R or P) award. The NIH recognizes the need to increase the number of women and minorities and people with disabilities in basic, behavioral, and clinical science research careers. Among the reasons for the low representation of women may be the fact that women bear a majority of the responsibilities surrounding child and family care. To address this issue, this program is designed to offer opportunities to women and men who have interrupted their research careers to care for children or parents or to attend to other family responsibilities. A second objective of the program is to mentor and guide those who receive support to reestablish careers in biomedical or behavioral research. Participating Institutes and Centers (ICs) include the National Cancer Institute; National Eye Institute; National Heart, Lung, and Blood Institute; National Institute on Aging; National Institute on Alcohol Abuse and Alcoholism; National Institute of Allergy and Infectious Diseases; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Child Health and Human Development; National Institute of Dental Research; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute on Drug Abuse; National Institute of Environmental Health Sciences; National Institute of General Medical Sciences; National Institute of Mental Health; National Institute on Deafness and Other Communication Disorders; National Human Genome Research Institute; and National Center for Research Resources. The National Institute of Neurological Disorders and Stroke previously announced a Mentored Research Scientist Development Award (K01) for scientists reentering the neurological sciences (NIH Guide, Vol. 21, No. 33, 1992). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Supplements to Promote Reentry into Biomedical and Behavioral Research Careers, is related to the priority area of women's health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Grants and Cooperative Agreements: Only the following active NIH award mechanisms at domestic institutions are eligible for Supplements to Promote Reentry into Biomedical and Behavioral Research Careers: R01, R10, R18, R24, R35, R37, P01, P40, P41, P50, P51, P60, U01, U10, and G12. Principal Investigators on such awards are invited to submit a request for an administrative supplement to the awarding component of the parent grant to support an eligible candidate interested in reestablishing a research career. The parent grant should have at least two years of support remaining at the time of the proposed beginning date of the supplemental funding. The rationale for this policy is to assure ample opportunity for the candidate to develop further her or his research skills. A maximum of three years supplemental support can be awarded under this program. Usually, a parent grant would support only one administrative supplement (Research Supplements for Underrepresented Minorities, Research Supplements to Promote the Recruitment of Individuals with Disabilities into Biomedical Research Careers, or Research Supplements to Promote Reentry into Biomedical and Behavioral Research Careers). Grants most likely to support more than a single administrative supplement are multicomponent awards. CANDIDATES Candidates must have a doctoral degree, such as M.D., D.D.S., Ph.D., O.D., D.V.M., or equivalent; at least two years of postdoctoral research experience; and must have had sufficient prior research experience to have qualified for a faculty appointment at the assistant professor or equivalent level at the time of their leaving active research. Candidates who have begun the reentry process through a fellowship or similar mechanism are not eligible for this program. The following guidelines will generally be applied with discretion by the individual ICs. In general, the duration of the career interruption should be for at least two years and no more than eight years. Examples of qualifying interruptions would include child rearing; an incapacitating illness or injury of the candidate, spouse, partner, or a member of the immediate family; relocation to accommodate a spouse, partner, or other close family member; pursuit of nonresearch endeavors that would permit earlier retirement of debt incurred in obtaining a doctoral degree; and military service. The program is not intended to support graduate or postdoctoral training and is not intended to support career changes from nonresearch to research careers for individuals without prior research training. Generally, at the time of application, a candidate should not be engaged in full-time paid research activities. Because Ics may have varying degrees of flexibility in interpreting and implementing the reentry program, potential applicants should consult with the IC contact at the earliest possible stage to discuss his or her unique situation. MECHANISM OF SUPPORT In all cases, the proposed research must be directly related to the funded approved ongoing research of the parent grant or cooperative agreement. The individual supported under this supplemental award, hereafter called the reentry candidate, must be afforded the opportunity to act as a full participant in the research project and must be given an opportunity to update and enhance her or his research capabilities. This will allow the candidate to begin the process of establishing or reestablishing a career as an independent, competitive research investigator. Supplemental awards will be consistent with the goals of strengthening the existing research program and with the overall programmatic balance and priorities of the funding program of the NIH. Awards will be made according to the policies and provisions stated in this announcement and in the PHS Grants Policy Statement (rev. 4/94). Administrative supplements (S1) provided under this program may be for either part-time or full-time support for the candidate, and all supported time is to be spent updating and enhancing research skills. Proposed part-time appointments may not be less than 50% effort per week. Supplemental awards may be made for up to three years and may not exceed $50,000 in direct costs per year. A maximum of $40,000 may be requested for the combination of full-time salary and fringe benefits for the reentry candidate. The amount of salary requested must be consistent with the policies of the grantee institution for individuals occupying similar positions and must be related to the percent effort requested for the supplement and the number of months requested for the supplement. An additional amount up to $10,000 may be requested for supplies, domestic travel, and publication costs relevant to the proposed research. Equipment may not be purchased as a part of this supplement without justification and specific prior approval of the NIH. The decision to fund a supplement will take six to eight weeks from the time the necessary information is received by the awarding IC. During the first budget period, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on funding of the parent grant and cannot extend beyond the current competitive segment of the parent grant. APPLICATION PROCEDURES A request for a supplement may be made at any time during the funding year, providing there will be two full years of funding remaining for the parent grant at the time of funding. In making requests, the grantee institution, on behalf of the Principal Investigator, should submit the request for supplemental funds directly to the awarding component that supports the parent grant. The request is NOT to be submitted to the NIH Division of Research Grants. Principal Investigators are encouraged to obtain the address for submission >From the NIH program administrator on the parent grant. The request for a supplemental award must include the following: 1. A complete face page (with appropriate signatures) from grant application form PHS 398 (rev. 5/95), including the title and grant number of the parent grant and "Reentry Supplement" on line 1. 2. A brief, three- or four-page description, prepared by the Principal Investigator of the parent grant, that includes: a. A summary or abstract of the funded grant or project b. A description of the research proposed for the candidate c. How the supplement will expand and foster the independent research capabilities of the candidate d. How the proposed research relates to the specific research goals and objectives of the parent grant e. A description of the scope and nature of the mentoring relationship between the Principal Investigator and the candidate 3. A brief description, prepared by the candidate, that includes: a. Research objectives and career goals b. Length of and reason for career hiatus c. Description of how the candidate has kept current or attempted to keep current in her/his field d. Identification of steps taken toward reentry (if any, such as attending scientific meetings) 4. A biographical sketch of the candidate that includes: a. Curriculum vitae b. Social Security number c. Citizenship status d. Publications e. Other evidence of scientific achievement 5. A proposed budget entered on budget pages from the grant application form PHS 398 (rev. 5/95), related to the percent effort for the research proposed for the reentry candidate during the first and future budget period(s). (The amount requested for the supplement must coincide with the current period of support. Thus, if the initial budget period requested is less than 12 months, the budget must be prorated accordingly.) 6. Documentation, if applicable, that the proposed research is approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) of the grantee institution. 7. Under unusual circumstances where the applicant and mentor would be at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must also be submitted. The request must be signed by the Principal Investigator, the reentry candidate, and the appropriate institution business official. REVIEW CONSIDERATIONS The program staff of the individual ICs will review requests for supplements using the following general criteria: o the qualifications of the reentry candidate, including career goals, prior research training, research potential, and any relevant experience o the plan for the proposed research experience in the supplemental request and its relationship to the parent grant o evidence from the Principal Investigator that the experience will enhance the research potential, knowledge, and/or skills of the reentry candidate o evidence from the Principal Investigator that the activities of the reentry candidate are an integral part of the project o evidence of effort by the reentry candidate to initiate the reentry process, such as attending scientific meetings, keeping current with journals o evidence that proposed research will achieve the stated objectives of the reentry supplements o evidence that the Principal Investigator understands the importance of the mentoring component of this supplement and has prepared a mentoring plan In noncompeting continuation applications, the progress report for the reentry supplement should be clearly delineated from the progress report for the parent grant. The progress report should include information about the research activities supported by the supplement, even if support for future years is not requested. Since these applications will undergo administrative review, summary statements will not be produced. This is consistent with NIH practice for other similar programs, such as those referenced in the ELIGIBILITY REQUIREMENTS section of this program announcement. INQUIRIES For general information about the reentry supplements, candidates and Principal Investigators should contact the program official of the appropriate awarding Institute or Center. Candidates who have not yet made contact with a Principal Investigator are encouraged to contact the program official whose institute or center is specific to the research interest. To discuss business aspects of the parent grant or the supplement, Principal Investigators should contact their grants management official. Program officials and grants management contacts and the respective awarding institutes or centers are listed below. National Cancer Institute Toby Friedberg, Referral Officer Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-3428 FAX: (301) 402-0275 National Eye Institute Ralph J. Helmsen, Ph.D., Program Official Executive Plaza South, Suite 350 Bethesda, MD 20892 Telephone: (301) 496-5301 FAX: (301) 402-0528 National Heart, Lung, and Blood Institute Ronald G. Geller, Ph.D., Director of Extramural Affairs Rockledge Building, Room 7100 Bethesda, MD 20892 Telephone: (301) 435-0260 FAX: (301) 594-7424 National Human Genome Research Institute Jane Peterson, Ph.D., Program Official Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-6023 FAX: (301) 480-2770 National Institute on Aging Miriam Kelty, Ph.D., Associate Director of Extramural Affairs Gateway Building, Suite 2C218 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9322 FAX: (301) 402-2945 National Institute on Alcohol Abuse and Alcoholism Tina Vanderveen, Ph.D., Program Official or Linda Hilley, Grants Management Official Willco Building, Suite 402 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-1274 or (301) 443-3885 FAX: (301) 594-0673 National Institute of Allergy and Infectious Disease Milton Hernandez, Ph.D., Program Official Solar Building, Room 4C10 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 National Institute of Arthritis and Musculoskeletal and Skin Diseases Julia Freeman, Ph.D., Centers Program Director Director, Women and Minority Health Issues Natcher Building, Room 525-19F 9000 Rockville Pike Bethesda, MD 20892-6500 Telephone: (301) 594-5052 FAX: (301) 480-4543 National Institute of Child Health and Human Development Darlene Levenson Building 31, Room 2A49 Bethesda, MD 20892 Telephone: (301) 496-1971 FAX: (301) 496-0588 National Institute of Dental Research Patricia S. Bryant, Ph.D., Program Official or Teresa Ringler, Grants Management Official Natcher Building, Room 4AN-24 9000 Rockville Pike Bethesda, MD 20892-6402 Telephone: (301) 594-7710 FAX: (301) 480-9318 National Institute of Diabetes and Digestive and Kidney Diseases Walter Stolz, Ph.D. Director, Division of Extramural Activities Natcher Building, Room 6AS-25C 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 594-8834 FAX: (301) 480-3505 National Institute on Drug Abuse Cora Lee Wetherington Women~s Health Coordinator 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1263 FAX: (301) 443-6043 National Institute of Environmental Health Sciences Anne P. Sassaman, Ph.D., Program Official or David Mineo, Grants Management Official P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7723 or (919) 541-7628 FAX: (919) 541-2843 National Institute of General Medical Sciences Anthony A. Rene, Ph.D., Program Official or Carol Tippery, Grants Management Official Westwood Building, Room 925 5333 Westbard Avenue Bethesda, MD 20892 Telephone: (301) 594-3833 FAX: (301) 594-7701 National Institute on Deafness and Other Communication Disorders Craig A. Jordan, Ph.D., Program Official Acting Director, Division of Extramural Activities 6120 Executive Boulevard Executive Plaza South, Room 400C Rockville, MD 20892 Telephone: (301) 496-8693 FAX: (301) 402-6250 National Institute of Mental Health Delores L. Parron, Ph.D. Associate Director for Special Populations Parklawn Building, Room 17C-14 5600 Fisher Lane Rockville, MD 20857 Telephone: (301) 443-2847 FAX: (301) 443-8552 National Center for Research Resources Louise E. Ramm, Ph.D., Program Official or Lacey J. Durham, Grants Management Official Westwood Building, Room 854 Bethesda, MD 20892 Telephone: (301) 594-7906 or (301) 594-7955 FAX: (301) 594-9121 From owner-sci-resources@net.bio.net Tue Aug 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-023 - V26(26) 08/08/97 Date: 13 Aug 1997 14:25:31 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 500 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5st8ob$dik@net.bio.net> NNTP-Posting-Host: net.bio.net MENTORED CAREER DEVELOPMENT AWARD NIH GUIDE, Volume 26, Number 26, August 8, 1997 RFA: CA-97-023 P.T. National Cancer Institute Letter of Intent Receipt Date: November 6, 1997 Application Receipt Date: December 11, 1997 PURPOSE The Comprehensive Minority Biomedical Program CMBP), Division of Extramural Activities, National Cancer Institute (NCI), invites underrepresented minority research scientists who have been the recipient of an NIH Research Supplement for Underrepresented Minority Individuals in Postdoctoral Training (MIPT) or a Minority Investigator Supplement (MIS), funded by the NCI, who need an extended period of sponsored research as a way to gain scientific expertise while bridging the transition from a mentored research environment to an independent research/academic career to submit applications. This award offers opportunities for a mentored peer review experience in cancer research which will enhance the candidates knowledge and understanding of the peer review process with the intended purpose of developing skills with the expectation that the candidate will submit a grant application for nontargeted mechanisms (R29, R01). This award is aimed at fostering the cancer research careers of outstanding, junior minority scientists who: o have been the recipient of an NIH Research Supplements for Underrepresented Minorities award, funded by the NCI; o are located at a majority institution; and o are committed to developing and sustaining academic research programs. This award is a novel mechanism which is intended to support underrepresented minority scientists and enhance the likelihood of success for junior underrepesented minority investigators who have committed to basic and clinical research careers in cancer. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This Request for Application (RFA), Career Development Award, is related to the priority area of human resource development in cancer research. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS This award is designed to provide an intensive, supervised research experience for underrepresented minority investigators. For the purpose of this award, underrepresented minorities are defined as individuals belonging to a particular ethnic or racial group that has been determined by the applicant institution to be underrepresented in biomedical and behavioral research. All applicants must submit three letters of recommendation from established investigators and are encouraged to contact the NCI regarding their eligibility for this award (see Inquiries Section). In general, the candidate must have: o a research or a health professional doctorate or its equivalent and must have demonstrated the potential for productive research activity; o been the recipient of an underrepresented minority supplement award at the postdoctoral (MIPT) or junior faculty (MIS) level, funded by the NCI; and o the potential for establishing an independent research program highly relevant to the understanding of human biology and human disease as it relates to the etiology, pathogenesis, prevention, diagnosis, and treatment of cancer. Applications may be submitted on behalf of candidates by domestic, non-profit and for profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government or comparable institutions. Awards will be limited to individuals who are citizens or non-citizen alien nationals, and permanent residents of the United States. Individuals on temporary or student visas are not eligible. Women and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Support for this program will be through the NIH grant-in-aid Mentored Research Scientist Development Award (K01). Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. The project period for an application responding to the RFA will be for up to five years of support depending upon the number of years of prior research experience and the need for additional experiences to achieve independence. Awards are not renewable and are not transferable from one Principal Investigator to another. Funding beyond the first year is contingent upon satisfactory progress during the preceding year, as documented in the required Progress Report. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000 (Rev.), revised April 1, 1994. The earliest possible start date will be July 1, 1998. FUNDS AVAILABLE Up to $500,000 in direct costs the first year and up to $1,500,000 in future years will be committed specifically to fund applications submitted in response to this RFA. It is anticipated that approximately 5 awards will be made from the competition for this K01 solicitation at a direct cost level of $100,000 for the first year and $150,000 per year thereafter. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the continuing availability of funds for this purpose. It is anticipated that this RFA will be reissued as a program announcment in FY 1999 and the terms of award will remain the same. RESEARCH TRAINING OBJECTIVES Environment: The majority institution must have well-established basic biomedical or behavioral and/or clinical cancer research programs and must have received an NIH Research Supplements for Underrepresented Minorities award funded by the NCI. Either the Principal Investigator of the NIH Research Supplements for Underrepresented Minorities award or other established investigator will serve as the mentor to the underrepresented minority candidate. The candidate, mentor and institution must be able to describe a cancer research/career development program that will maximize the use of relevant cancer research and educational resources. Program: The award provides up to five consecutive 12 month appointments and will occur in two phases. In Phase I (years 1-3), the candidate will participate in research activities at the mentored institution. Along with focusing on writing and submitting manuscripts for publication and presenting at scientific meetings, the applicant will begin peer review activities. The candidate will attend review meetings as either an observer or temporary member (depending on prior research experience) and participate in NCI- sponsored workshops on grantsmanship. In Phase II (years 3-5), the applicant will participate in activities leading towards an independent research career. Peer review activities will include serving as either full members of F- or K-type reviews, temporary members on other review committees and/or attending site visit reviews as observers. Other activities will include preparing for and securing an independent research position as well as writing and submitting grant applications for traditional research support (R29, R01). The underrepresented minority candidate must devote at least 75 % of the professional effort to cancer-related research and/or peer review pursuits consistent with the objectives of this award. The candidate must develop knowledge in the basic biomedical, clinical or population-based sciences and research skills relevant to his/her cancer research fields. Where appropriate, research areas in cancer which disproportionately affect minority populations should be incorporated. Beginning the second year of funding, the candidate must plan to participate in NCI-approved peer review activities, such as NCI-sponsored peer review workshops, and/or NIH review committees as determined by CMBP staff. The candidate must agree to report annually on the status of the program and to meet annually to exchange information with NCI staff and other awardees. These activities must be reflected in the career development plan. Mentor: The recipient must receive appropriate mentoring during both phases of the award. These activities are crucial during the mentoring peer review phase as well as during the development and preparation of the traditional investigator initiated grant application (R29/R01). The mentor must be a senior or mid-level faculty member with research competence and a major interest in the training of underrepresented minority investigators in cancer research. Where feasible, women and underrepresented minority mentors should be involved as role models. ALLOWABLE COSTS Salary: This award will provide salary up to $75,000 plus related fringe benefits. The institution may supplement the NCI contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a full-time, 12 month staff appointment. Research Development Support: During Phase I of the award, $25,000 per year will be provided for the following types of expenses: a) research expenses; b) statistical services including personnel and computer time; c) tuition, fees, and books related to career development; d) travel to research meetings, and e) travel to an annual two-day NCI awardee meeting and for peer review related and training expenses. The amount of this support will increase to $75,000 in Phase II when the Principal Investigator moves to a new research environment, as opposed to the environment provided by a mentor, which includes an independent research position either at the same institution or at a different institution. During Phase II of the award funds may be requested for the purchase of equipment. Ancillary Personnel Support: Salary support for technicians is allowed in Phase II. Support for mentors, secretarial and administrative assistance, etc., is not allowed. Indirect Costs: Indirect costs will be reimbursed at eight percent of modified total direct costs. Categorical amounts cited above, notwithstanding, the total award may not exceed $100,000 in direct costs for the first year and $150,000 for subsequent years. TERMINATION OR CHANGE OF INSTITUTION When a grantee institution plans to terminate an award, the NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination (see INQUIRIES section for contacts). If the individual is moving to another eligible institution, career award support may be continued provided: o A formal request for transfer of award is submitted by the new organization. o The period of support requested is no more than the time remaining within the existing award period. o A final progress report, invention statement, and Financial Status Report are submitted upon either termination of an award or relinquishment of an award in a change of institutional situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contract, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies of the policy from these sources or >From the program staff or the contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by November 6, l997, a letter of intent that includes a descriptive title of the proposed career plan, the name, address, telephone, FAX, and E-mail numbers of the Principal Investigator and mentor, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which this application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Sanya A. Springfield, Ph.D. Division of Extramural Activities National Cancer Institute National Institutes of Health 6130 Executive Boulevard, Suite 620 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: springfs@dea.nci.nih.gov APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 5/95) and will be accepted on or before December 11, 1997. Application kits are available at most institutional offices of sponsored research; from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev.5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Three sealed letters of recommendation addressing the candidate's potential for the research career must be included as part of the application. Submit a signed, typewritten original of the application, reference letters, current curriculum vitae with complete bibliography, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (express/courier service) At time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Applications must be received by December 11, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of an application already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete or unresponsive applications will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. Review Criteria Candidate (Principal Investigator) o Evidence of Research Supplements for Underrepresented Minorities award funded by the NCI. o Commitment to an independent cancer research career in terms of effort and future plans. o Quality and breadth of prior scientific training and experience. o Recommendations of three well-established scientists attesting to the special potential of the individual to pursue an independent career in cancer research. Career Development Plan o Likelihood that the plan will contribute substantially to the scientific development of the candidate and the achievement of scientific independence. o Appropriateness of the career development plan in terms of the candidate's prior research and academic experience, and the stated career goals. o Clarity of the goals and scope of the plan and the need for the proposed research experience. o Quality of the proposed training in the peer review process. o Likelihood of successful planning, writing and submitting of traditional grant applications. Research Plan All applicants for this award will have had previous postdoctoral research experience and have been the recipient of an NIH Research Supplements for Underrepresented Minorities award funded by the NCI. A sound research project that is consistent with the development plan for an independent career in cancer research and the candidate's level of research development must be provided. o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan. o The originality and quality of the research hypothesis/question, design and methodology, judged in the context of the candidate's previous training and experience. Mentor o Appropriateness of the research qualifications in the area of the proposed research. o Quality and time commitment to supervising and guiding the candidate during the entire phase of the award. o Previous experience in fostering and developing underrepesented minority cancer researchers. o History of research productivity and support. Institutional Environment and Commitment o Commitment to the scientific development of the investigator according to the terms of this award. o Assurance that the investigator will spend a minimum of 75 percent effort on the career development project. o Adequacy of research facilities and training opportunities. Budget The appropriateness of the budget in relation to career development goals and research aims and plans. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment and conformance with the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research. Following scientific review, the application will receive a second- level review by the National Cancer Advisory Board (NCAB). AWARD CRITERIA Applications will compete for available funds with all other scored applications submitted in response to this RFA. The following will be considered in making decisions: quality of the proposed project as determined by peer review, availability of funds and program priority. The NCI will notify the applicant of the NCAB action. INQUIRIES Written, telephone, FAX, and E-Mail inquiries concerning this RFA are encouraged, especially during the planning phase of the application. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sanya A. Springfield, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Suite 620 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: springfs@dea.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Joan Metcalfe Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7800 ext 228 FAX: (301) 496-8601 Email: metcalfj@gab.nci.nih.gov AUTHORITY AND REGULATION This program is described in the catalog of Federal Domestic Assistance No. 93.398. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52,45 CFR 92, and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American People. From owner-sci-resources@net.bio.net Tue Aug 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-090 - V26(26) 08/08/97 Date: 13 Aug 1997 14:26:17 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 319 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5st8pp$dl7@net.bio.net> NNTP-Posting-Host: net.bio.net THREE-DIMENSIONAL STRUCTURES OF IMMUNOLOGICAL PROTEINS NIH GUIDE, Volume 26, Number 26, August 8, 1997 PA NUMBER: PA-97-090 P.T. National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for research on the three-dimensional structural properties of proteins involved in initiating and regulating immune responses in human and animal systems. The structural elucidation of protein complexes and development of structural analogs that enhance, inhibit or change the function of native proteins for therapeutic applications are also of interest. Increased knowledge of immunological proteins obtained from such structural studies is important for understanding regulation of the immune system and for the development of effective immunotherapeutic agents. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), "THREE-DIMENSIONAL STRUCTURES OF IMMUNOLOGICAL PROTEINS", is related to the priority area of Immunization and Infectious Diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by for profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Domestic and foreign institutions are eligible to apply for R01 grants. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Traditional research project grant(R01)and FIRST (R29) applications may be submitted in response to this program announcement. Applications for R01 grants may request up to five years of support; applications for R29 grants must request five years of support. Applicants for the FIRST award must comply with the NIH Guidelines for FIRST awards and the Just-in-Time procedures announced in the NIH Guide, Vol. 25, No. 10, March 29, 1996. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. RESEARCH OBJECTIVES Background Detailed structural analyses of antibody:antigen and peptide:MHC complexes and, more recently, the T cell antigen receptor, have provided information at the three-dimensional level that is essential for understanding the rules of ligand:receptor associations and specific sites of protein:protein interactions for these fundamental components of the immune system. Many additional immunologically relevant proteins have not yet been defined at the three-dimensional level, and such information would contribute greatly to basic understanding of immune reactions and to the rational design and effective utilization of therapeutic agents that enhance or inhibit immune responses. Although genetic mutational or biochemical studies can provide useful information, biophysical approaches, such as X-ray crystallography or nuclear magnetic resonance (NMR) spectroscopy, provide direct and more definitive descriptions of important structural domains. Detailed knowledge of molecular topography and contact sites that are important for functional activation can, therefore, form the basis for understanding fundamental concepts in immunoregulation and identify new targets for immunotherapy. Three-dimensional structural studies may confirm protein structures postulated from less direct experimental approaches, or may provide surprising and highly instructive data that are relevant for protein function. In addition to work on antibodies, MHC and the T cell antigen receptor, some examples of the importance of X-ray crystallographic or NMR data include the development of HIV-protease inhibitors and understanding the role of invariant chain in MHC class II antigen presentation. In addition, structural analysis of protein dimerization mediated by the immunosuppressive drug, rapamycin, has spurred efforts to design structure-based strategies for regulating intracellular signal transduction pathways and transcription factor activation. Knowledge of three-dimensional structures may also engender novel hypotheses that are amenable to experimental testing to provide a more comprehensive understanding of immune mechanisms. Furthermore, the biophysical data obtained from three-dimensional studies may form the basis for construction of peptidomimetic analogues of immunologically relevant proteins to provide more stable and effective therapeutic drugs. Research Objectives and Scope The purpose of this PA is to support research on three-dimensional structures of immunologically relevant proteins and protein complexes. It is NOT intended to support indirect structure:function studies that rely solely on genetic or biochemical techniques. Research areas of interest include, but are not limited to, structural studies on: o soluble immune mediators, such as antibodies, cytokines and chemokines, and their receptors; o leukocyte membrane adhesion or signaling receptors and their ligands; o signal transduction molecules; o transcription factors involved in leukocyte activation or downregulation; o structural analogues of immunological proteins that enhance, inhibit, or introduce a novel function for therapeutic application; and o novel technologies to facilitate three-dimensional structural analysis. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority group and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results >From the NIH Revitalization Act 1993 (Section 4928 of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application for PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated on the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES". The PA number and the PA title, "THREE-DIMENSIONAL STRUCTURES OF IMMUNOLOGICAL PROTEINS" must be typed in section 2. The completed, signed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Centers (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Helen Quill, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A22 Bethesda, MD 20892-7640 Telephone: (301) 496-7551 Fax: (301) 402-2571 EMAIL: hq1t@nih.gov Direct inquiries regarding fiscal matters to: Lesia Norwood Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B27 6003 Executive Blvd. Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Fax: (301) 480-3780 Email: ln5t@nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citations are No. 93.855 - Immunology, Allergy, and Transplantation Research and No. 93.366 - Aging Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-091 - V26(26) 08/08/97 Date: 13 Aug 1997 14:26:31 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 355 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5st8q7$dlr@net.bio.net> NNTP-Posting-Host: net.bio.net IMMUNOLOGIC BASIS OF FOOD ALLERGY NIH GUIDE, Volume 26, Number 26, August 8, 1997 PA NUMBER: PA-97-091 P.T. 34; K.W. 0715110, 0710070, 0745045 National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite applications for research studies on: (a) the mechanisms of mucosal immunity and of tolerance as they apply to food allergy; (b) the genetic basis of food allergy; (c) the molecular identification of food allergens and their epitopes; and (d) immunotherapeutic approaches to treating food allergy. The results of these investigations will be used to develop strategies to prevent food allergy and treat food-allergic patients. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Immunologic Basis of Food Allergy, is related to the priority area of nutrition. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Training (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Traditional research project grant (R01) and FIRST award (R29) applications may be submitted in response to this PA. Applications for R01 grants may request up to five years of support; applications for FIRST (R29) awards must request five years of support. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. RESEARCH OBJECTIVES Background This PA will support research to investigate mechanisms of allergic responses in food allergic individuals and to develop new strategies to prevent or diminish allergic responses in these individuals. Allergic diseases represent a major cause of morbidity and disability in the United States. Clinically significant food allergy, confirmed by blinded oral challenge, is associated with IgE antibodies to food and occurs in 1-2% of adults and in about 8% of American children under age 6. Life-threatening anaphylactic reactions occur in food-allergic individuals of all ages. Food allergy is the most frequent single cause of emergency room visits for anaphylaxis. Seven foods (milk, eggs, soy, fish, shellfish, nuts and peanuts) are associated with most food allergies, including severe reactions. For those at risk of severe allergic reactions to food, the only effective treatment is strict dietary avoidance, but deaths may occur even in individuals who attempt to avoid suspect foods. Deaths from severe food allergic reactions occur because: some patients are undiagnosed and/or unaware of their risk; some food products and some components of processed foods are not properly labeled; commercial food processing may allow trace (but unlabelled) contamination; and some food allergens are cross-reactive. Although allergen immunotherapy is useful for treating some allergic diseases, immunotherapy has not been proven beneficial in food allergy. Studies in animal models have defined components of the gastrointestinal mucosal immune system and have begun to characterize the circumstances and immunologic mechanisms whereby oral ingestion of antigen stimulates tolerance. However, there are no good animal models, analogous to human food allergy, in which oral ingestion of food stimulates IgE antibody responses. Research Objectives and Scope Research into the underlying mechanisms of food allergic reactions is needed because many important clinical observations about food allergy lack a sound scientific foundation. For example, some individuals become allergic to foods, even though the induction of oral tolerance is the normal response to repetitive dietary challenge. Although several food allergens have been cloned, it is not apparent from their primary structures why only a small number of allergens cause most food-allergic reactions. Allergy to some foods (e.g., milk, eggs) remits in childhood, while allergy to other foods(e.g., peanuts) persists throughout life. Recent research advances suggest that more effective approaches for controlling food allergies might now be developed by integrating basic studies, on such topics as mucosal immunity and tolerance, with clinical studies of food-allergic patients. These advances include: i) the ability to eliminate certain food allergens or allergenic epitopes from the food supply through genetic engineering; ii) the availability of transgenic and knockout mice to test the importance of specific cells and mediators; iii) the identification and cloning of an IgE-dependent histamine releasing factor, a molecule which is linked to severe allergies including allergies to foods; iv) novel approaches to immunization, such as DNA vaccines, which might preferentially stimulate TH1 responses and thus inhibit IgE antibody responses (which are TH2 dependent); and v) identification of a negative signal transduction pathway in basophils and mast cells, activated by cross-linking by immune complexes of both IgE and IgG receptors. Stimulation of negative signalling pathways may be a mechanism by which standard immunotherapy for allergic diseases is effective. Examples of research topics of interest and promising areas of investigation include, but are not limited to, the following: o tolerogenic mechanisms that can modulate immune responses to ingested antigens o studies of signalling pathways that mediate inhibition of mast cells, basophils, and T- and B-cells involved in food allergic responses o development of immunotherapeutic approaches which will result in effective treatment of food allergy o genetic analysis of food allergic patients o cloning and epitope analysis of food allergens o elucidating the mechanism(s) by which allergies to milk and eggs remit during childhood; and o development of animal model(s) of food allergy, including gastrointestinal IgE antibody responses to foods Since food allergies are most prevalent in infancy and childhood, applicants are encouraged to include pediatric populations in studies of the mechanisms of food allergies. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application for PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated on the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES". The PA number and the PA title must also be typed in section 2. The completed, signed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Centers (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?~ The initial review group will also examine: the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Marshall Plaut, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A25 Bethesda, MD 20892-7640 Telephone: (301) 496-8973 FAX: (301) 402-0175 EMAIL: mp27s@nih.gov Gilman D. Grave, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-11 Bethesda, MD 20892-7510 Telephone: (301) 496-5593 FAX: (301) 480-9791 EMAIL: gg37v@nih.gov Frank A. Hamilton, M.D., M.P.H. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AN-12B, MSC-6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8877 FAX: (301) 480-8300 EMAIL: fh14e@nih.gov Direct inquiries regarding fiscal matters to: Sharie Bernard Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B32 6003 Executive Blvd. Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Fax: (301) 480-3780 EMAIL: sb34k@nih.gov E. Douglas Shawver Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A-17, MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 Fax: (301) 402-0915 EMAIL: ds117g@nih.gov George Tucker Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS-49B 45 Center Drive, MSC-6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8853 Fax: (301) 480-3504 EMAIL: gt35v@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance Nos. 93.855, 93.865, and 93.848. Awards are made under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-092 - V26(26) 08/08/97 Date: 13 Aug 1997 14:26:46 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 493 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5st8qm$dn2@net.bio.net> NNTP-Posting-Host: net.bio.net GENE THERAPY IN AGING NIH GUIDE, Volume 26, Number 26, August 8, 1997 PA NUMBER: PA-97-092 P.T. National Institute on Aging National Heart, Lung and Blood Institute National Institute on Deafness and Other Communication Disorders National Institute of Mental Health National Institute of Neurological Disorders and Stroke PURPOSE The objective of this initiative is to encourage research on strategies to prevent or delay adverse aging-related changes and diseases, including neurodegenerative disorders, using genetic and cellular engineering approaches. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Gene Therapy in Aging, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this Program Announcement will be through the NIH research project grant (R01) and FIRST (R29) award. Applicants will be responsible for the planning, direction, and execution of the proposed project. The award of grants in response to this program announcement is also contingent upon the availability of funds. RESEARCH OBJECTIVES Background "The application of molecular genetics to human biology has had a profound effect on our ability to understand, diagnose, and treat a variety of diseases. The identification and cloning of a number of disease-related genes has provided us with a powerful set of tools for identifying susceptibility to disease and, more important, understanding the molecular pathophysiology of many disorders. More recently, the revolution in molecular medicine has also generated considerable enthusiasm for gene therapy." (Leiden, J. 1995. Gene Therapy - Promise, Pitfalls and Prognosis. New Eng. J. of Med.). Gene therapy approaches are currently being developed and tested for a wide variety of pathological conditions such as cystic fibrosis, cancer, AIDS, familial hypercholesterolemia, cancer, adenosine deaminase deficiency, Duchenne muscular dystrophy, etc. Although outright success has so far been limited for gene therapy approaches in humans, it is clear that this exciting technology has remarkable potential. This potential will increase as more genes are identified and cloned, and better vectors and delivery systems are developed. This emerging technology has been the focus of annual Keystone Symposia since 1993, as well as meetings at many other sites. An alternative but technologically related approach, especially in the near-term and with respect specifically to neurodegenerative disease, involves cell-engineering techniques. Examples of cellular engineering could involve the use of appropriate stem cell populations, or the implantation of genetically modified cells. Genetic and cellular engineering techniques could potentially provide a new approach to slow aging processes which may lead to pathology, as well as treat age-related disorders per se. The NIH is thus interested in supporting research to develop or facilitate the development of genetic and cellular engineering strategies to prevent or delay the losses of physiological function associated with aging. In particular, the NIA encourages experimental research which could contribute to therapies or preventive interventions based on altering the underlying aging processes that contribute to or cause age- related disorders. Identification of genetic factors controlling pathophysiologic aging processes may then contribute to development of more fundamental and definitive therapy and prevention of age- related diseases. Gene-based intervention techniques could allow experimental manipulations previously impossible in therapeutic aging studies. These include an increased range of gene products (e.g., intracellular proteins) whose levels can be directly and specifically manipulated, direct control over the level of a gene's expression at any point in the life span or at any phase of diurnal or other cycles, tissue-specific control of gene expression, and an expanded range and improved control of secretory products which could be directly manipulated. Gene-based intervention techniques could also be used to: 1) develop better animal models of human aging changes; 2) introduce markers to track cells transplanted to modify aging changes, and 3) screen potential non-genetic interventions against aging processes in genetically-engineered cells in vitro. The following references provide general background information in support of this initiative: 1. Leiden J. 1995. Gene therapy - Promise, pitfalls and prognosis. N. Eng. J. Med. 333: 871-872. 2. Blau HM, Springer ML. 1995. Gene therapy - A novel form of drug delivery. N. Eng. J. Med. 333: 1204-1207. 3. Evans CH, Robbins PD. 1995. Possible orthopedic applications of gene therapy. J. Bone Joint Surg. 77A: 1103-1114. 4. Smithies O, Malda N. 1995. Gene targeting approaches to complex genetic diseases: Atherosclerosis and essential hypertension. Proc. Natl. Acad. Sci. USA 92: 5266-5272. 5. Lindsay RM. 1995. Neuron saving schemes. Nature 373: 289-290. 6. Barinaga M. 1994. Neurotrophic factors enter the clinic. Science 264: 772-774. Scope This program announcement solicits grant applications for experimental studies to determine effects of genetic interventions on age-associated morbidity, age-related changes in physiologic function and/or life span, in either or both of two major categories: 1. Genetic or cellular engineering interventions initiated in young or middle-aged animals to alter fundamental processes whose functioning throughout the life span may affect rates of progression of degenerative aging changes, or age of onset of morbid conditions. 2. Genetic or cellular engineering interventions to reverse or prevent adverse aging changes or morbidity resulting from altered expression with age of particular genes, or from loss of functioning differentiated cells. In these studies, the use of experimental design and controls that maximize interpretability of results is encouraged. Examples include strategies to determine whether putative genetic effects may be related to alterations in caloric intake, which itself affects many aging processes, and sample sizes and compositions which allow determination of varying effects in different genders and strains, where appropriate. Where feasible, measurement of intervention effects by individuals blinded to the intervention status of the animal is also strongly encouraged. Interventions that are of particular interest include, but are not limited to: * Damage and repair of cell and tissue components (e.g., attenuation of oxidative damage to DNA, proteins and lipids), including in red blood cells. * Cell proliferation, cell death, and maintenance of cell function in specific tissues, including red blood cells. * Production of (and tissue responsiveness to) secretable products such as growth factors, hematopoietic factors, neurotrophic factors, hormones, neurotransmitters, or other extracellular factors. * Maintenance of immune function, prevention of autoimmunity, and wound healing. * Regulation of diurnal cycles, reproductive cycles, and other biological or sleep/wake rhythms. Genes of particular interest for genetic interventions include: * Genes for which comparative biologic or epidemiologic studies suggest relationships of DNA polymorphisms or mutations to aging rates, longevity, or age-related disease. * Genes whose expression is altered by long-term caloric restriction, and which may be causally related to the life span extension and retardation of aging processes induced by caloric restriction in several species. * Genes which are relevant to progeroid syndromes in which several age-related changes are accelerated, e.g. Werner's syndrome, Bloom's syndrome, Down's syndrome, and Cockayne's syndrome. * Genes responsible for recessive conditions which also contribute to accelerated age-related pathology when present in heterozygotes for these loci. * Genes whose role in neurodegeneration is under oxygen-dependent regulation, and which are stimulated by the pattern of hypotoxic insult produced by sleep apnea and other defects in ventilatory control. Interventions with particular relevance to neurodegenerative diseases include: * The delivery of genes or gene products to primate CNS or other appropriate animal model which may be therapeutic in neurodegenerative, neurogenetic and neurovascular diseases in aged brain and sensory organs. Delivery of gene products includes the use of genetically modified stem cells and other cell types. * Improvements in vectors to yield regulatable, sustained long-term expression of transgenes, such as those for neurotransmitter synthesizing enzymes and receptors, or neuroprotective, neurotrophic and neuronal guidance molecules. * The development of strategies to target transgenes to specific cell types within the CNS, to monitor and assess host responses (cytotoxicity) to the vector/gene constructs, and where necessary, to develop novel delivery systems to bypass the blood-brain barrier. This program announcement encourages studies using gene-based intervention techniques to develop better animal models of human aging changes. It also encourages in vitro studies to screen potential non-genetic interventions against aging processes in genetically-engineered cells. This announcement does not solicit research on vector development, but does encourage research on development of regulatable vectors to allow controlled expression of transgenes at desired phases of the life span, to restore cyclic patterns of gene expression which are altered with advancing age, or to solve problems peculiar to gene or cell delivery in older organisms. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the polity. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The program announcement title and number must be typed on line 2 of the face page of the application form, and the YES box must be marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In their written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. * Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? * Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? * Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? * Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? * Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: * The reasonableness of the proposed budget and duration in relation to the proposed research. * The adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. * The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. * Availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States, or which provide augmentation of existing U.S. resources (for foreign applications only). AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: * Quality of the proposed project as determined by peer review * Availability of funds * Program priority INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Huber R. Warner, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: 301/496-6402 FAX: 301/402-0010 Email: warnerh@exmur.nia.nih.gov Bradley C. Wise, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Suite 3C307 Bethesda, MD 20892-9205 Telephone: 301/496-9350 FAX: 301/496-1494 Email: wiseb@exmur.nia.nih.gov Sonia Skarlatos, Ph.D. NIH/NHLBI/DHVD Two Rockledge Center, Room 10186 6701 Rockledge Drive, MSC 7956 Bethesda, MD 20892-7956 Telephone: 301/435-0550 FAX: 301/480-2858 Email: skarlats@gwgate.nih.nhlbi.gov Kenneth A. Gruber, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892-7180 Telephone: 301/402-3458 FAX: 301/402-6251 Email: Kenneth_Gruber@nih.gov Linda S. Brady, Ph.D. Molecular and Cellular Neuroscience Research Branch National Institute of Mental Health Parklawn Building, Room 11C-06 5600 Fishers Lane Rockville, MD 20857 Telephone: 301/443-5288 FAX: 301/443-4822 Email: lb@helix.nih.gov Eugene J. Oliver, Ph.D. Division of Stroke, Trauma, and Neurodegenerative Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 806 7550 Wisconsin Avenue Bethesda, MD 20892-9150 Telephone: 301/496-5680 FAX: 301/480-1080 Email: eo11c@nih.gov Direct inquiries regarding fiscal and administrative matters to: Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892-9205 Telephone: 301/496-1472 FAX: 301/402-3672 Mr. William Darby Grants Operations Branch National Heart, Lung and Blood Institute Two Rockledge Center, Room 7128 6701 Rockledge Drive, MSC 7128 Bethesda, MD 20892-7956 Telephone: 301/435-0177 FAX: 301/480-3310 Email: William Darby@nih.gov Sharon Hunt Chief, Grants Management Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-B, MSC 7180 Bethesda, MD 20892-7180 Telephone: 301/402-0909 FAX: 301/402-1758 Email: Hunts@msmail.nidcd.nih.gov Diana Trunnel Assistant Chief, Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: 301/443-2805 Pat Driscoll Grants Management Specialist Grants Management Branch, DEA National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue Bethesda, MD 20892-9190 Telephone: 301/496-9231 FAX: 301/402-0219 Email: pd23n@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93-866 (NIA) and 93-242 (NIMH). Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 19 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 20 Aug 1997 15:18:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 234 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199708200900.CAA12389@net.bio.net> NNTP-Posting-Host: net.bio.net (LAST REVISION: 30-JUL-95) This BIOSCI "miniFAQ" is designed to answer the questions that come up the *most frequently*. The main BIOSCI FAQ (Frequently Asked Questions) is accessible on the World Wide Web at URL http://www.bio.net/. If you can not find an answer to your question in this or other documentation, the BIOSCI technical support staff answers e-mail queries sent to biosci-help@net.bio.net We can only answer questions about the use of the newsgroups and mailing lists. We unfortunately do not have the staff to do Internet information searches or answer scientific questions. Please post those to the appropriate BIOSCI/bionet newsgroups. Contents: -------- 0) BIOSCI NEEDS YOUR SUPPORT!! 1) Using the WWW to access the BIOSCI/bionet newsgroups. 2) What to do about "spams," i.e., junk mail, ads, etc. 3) Examples of subscribing and unsubscribing to the mailing lists. 4) The BIOSCI user address and research interest directory. 0) BIOSCI NEEDS YOUR SUPPORT!! ------------------------------ BIOSCI's government funding has been expended, and we are now operating solely from advertising revenue that we have raised from our Web site at http://www.bio.net/. We need just a few minutes of your time to help us serve you. You can do two important things which will take very little time for you individually and will immensely help us continue to help you. First, please use our WWW system at http://www.bio.net/ to access the archives. You can post or reply to messages via your Web browser as described in item #1 below. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. 1) Using the WWW to access the BIOSCI/bionet newsgroups. -------------------------------------------------------- As of 10 December 1995, all BIOSCI/bionet full newsgroups are accessible through the World Wide Web (WWW) at URL http://www.bio.net. One can read and reply publicly or privately to both recent postings and archived messages through one's Web browser if it is configured properly to send e-mail. Each newsgroup is equipped with its own WAIS index. The main BIOSCI home page also has access to the BIO-JOURNALS Table of Contents database WAIS index and the BIOSCI user address database described in another item further below. 2) What to do about "spams," i.e., junk mail, ads, etc. ------------------------------------------------------- BIOSCI is a set of parallel USENET newsgroups (the "bionet" groups), mailing lists, and a hypermail archive at URL http://www.bio.net/. The same postings are distributed on all media (except for a small number of mailing-list-only groups at net.bio.net). Unfortunately it is becoming a despicable practice on the Internet (by a few people out to make a fast buck) to do automated mass postings to thousands of newsgroups and mailing lists. These attempts to grab free advertising are refered to as "spams" in the usual, somewhat boneheaded, net terminology. USENET is more susceptible to this practice, and many spams originate on the USENET groups and then are passed on to the mailing lists. However, spammers also get lists of mailing addresses and hit these too, so neither medium is immune. What should you do personally if you get junk mail? --------------------------------------------------- Just delete it and move on without reading it further. Filing a protest is becoming increasingly useless because spammers are often disguising the addresses where the messages are sent from. Unless you really understand Internet mail systems, your attempt at protest by sending replies to the message will often end up being sent to the address of an innocent person that the spammer is victimizing. What can BIOSCI/bionet do to protect its newsgroups? ---------------------------------------------------- The only solution currently available is to moderate the newsgroup. If this newsgroup is already moderated, then you are in good shape. Moderation protects the USENET distribution from about 95% of the spams that are being sent to date and protects the mailing lists completely. Moderation means, however, that someone has to take the time to review each message before it goes out. We have set up software here that simply allows the moderator to forward to an address at net.bio.net messages that (s)he wishes to have distributed. This takes no more time than that needed to read the message and pass it on, say about 1 min. per message. Most newsgroups currently have a discussion leader who is responsible for their newsgroup. The discussions leaders and their e-mail addresses are listed in the BIOSCI Information Sheet which is available on the Web at http://www.bio.net/. If a newsgroup is being hit with too many junk postings, please contact the discussion leader for that group and see if there is interest in moderating the group. Please do not assume that by simply posting a complaint to the newsgroup itself, anyone on the BIOSCI staff will act on your complaint. With close to 100 newsgroups to run, the BIOSCI staff has to rely on the discussion leaders of each newsgroup to report problems directly to us at biosci-help@net.bio.net. We will moderate any of our newsgroups if the discussion leader tells us that the readership of the group wishes to do so and if a moderator is willing to do the work. For most BIOSCI/bionet groups, this entails only a few minutes of work each day. Moderating a newsgroup will resolve probably 95% of the junk postings on the USENET distribution. Unfortunately there are easy ways for determined spammers to override the moderation mechanism on USENET, but we can protect our e-mail subscribers from unwanted postings if the newsgroup is moderated. You can also access our newsgroups over the WWW at URL http://www.bio.net. While this Web interface will not stop spammers from trying to post to the groups, this will give you yet another way, besides using USENET news, to keep the junk out of your personal mail files. For those of you with local USENET news systems, the Web interface will also give you faster access to new newsgroups and recent postings. 3) Examples of subscribing and unsubscribing to the mailing lists. ------------------------------------------------------------------ PLEASE NOTE: The BIOSCI management does NOT act on subscription/unsubscription requests that are posted improperly to the newsgroups and mailing lists. People who do this only bother everyone on the lists to no avail. Please be sure to follow the proper procedures below. Gory details are in the BIOSCI Information sheets on the Web at http://www.bio.net. Below we give an example utilizing the METHODS-AND-REAGENTS list at both of our two BIOSCI sites: Users in the Americas and Pacific Rim countries who use the BIOSCI ------------------------------------------------------------------ node at computer net.bio.net: ---------------------------- A) Determine the "listname" which is the <=8 character mail address ^^^^^^^^^^^^^ for the group. These can be found in the BIOSCI Info. Sheet. For the METHODS-AND-REAGENTS group the mailing address is methods@net.bio.net. The listname is the portion of the address to the left of the @ sign, i.e., "methods". The listname is used with the "subscribe" and "unsubscribe" commands illustrated below. B) Mail all commands in the body of a mail message addressed to biosci-server@net.bio.net. Do NOT send commands to the newsgroup posting addresses! Leave the Subject: line blank, any text on it will be ignored. C) In the body of your message put one or more of the following commands with an "end" command on the last line, e.g., subscribe methods unsubscribe methods end Do NOT put your e-mail address or other text on these lines. The server only allows you to cancel your subscription if the address on your mail header matches the address on our mailing list. Please ask for help at biosci-help@net.bio.net if your address has changed, e.g., if you know you are on the list but the server tells you that you are not a member. Users in Europe, Africa, and Central Asia who use the BIOSCI node at -------------------------------------------------------------------- computer daresbury.ac.uk (also known as dl.ac.uk): ------------------------------------------------- To subscribe and unsubscribe to/from the BIOSCI lists, you need to specify the full USENET newsgroup name with "bionet-news." prepended. The USENET newsgroup names are listed in the BIOSCI Information sheet on the Web at http://www.bio.net/. For the METHODS-AND-REAGENTS list the USENET newsgroup name is bionet.molbio.methds-reagnts, thus the appropriate commands are sub bionet-news.bionet.molbio.methds-reagnts unsub bionet-news.bionet.molbio.methds-reagnts These commands are included in a message addressed to mxt@dl.ac.uk, NOT to the newsgroup mailing addresses. As usual, include the text in the body of the message as text on the Subject: line is ignored. To unsubscribe from all the lists at the UK node, use unsub bionet-news Please note that if the address in the list is different than the one in your mail message header, you will not be able to unsubscribe by this method. If you have problems, please mail biosci@daresbury.ac.uk. 4) The BIOSCI user address and research interest directory. ----------------------------------------------------------- Please take this opportunity to add your name, address, and research interest information to the BIOSCI User Address Database if you have not already done so. You can fill out the address form directly through our Web page at URL http://www.bio.net/adrform.html. The address database is reindexed nightly for WWW access (the URL is http://www.bio.net/). If you are not directly on the Internet but can reach it by e-mail, please use our waismail server to access the user directory. waismail use is described above. You can also request a user address form by e-mail from biosci-help@net.bio.net. Please check your database entry from time-to-time to see if your address information is still up-to-date. Because of our limited personnel resources, we ask that you resubmit a *complete* form to revise your entry; we only replace complete entries and do not have resources to edit old forms. From owner-sci-resources@net.bio.net Fri Aug 22 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA GM-97-009 - V26(27) 08/15/97 Date: 22 Aug 1997 18:28:19 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 348 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5tlebj$9f6@net.bio.net> NNTP-Posting-Host: net.bio.net SUPPORT OF MORE PROGRAM INSTRUCTIONAL WORKSHOPS ON GRANTWRITING NIH Guide, Volume 26, Number 27, August 15, 1997 RFA: GM-97-009 P.T. National Institute of General Medical Sciences Letter of Intent Receipt Date: October 18, 1997 Application Receipt Dates: November 18, 1997 PURPOSE The National Institute of General Medical Sciences (NIGMS) invites cooperative agreement (U13) applications for interactive, instructional workshops on grant writing. The workshops will be targeted toward faculty from minority serving institutions who intend to apply for grants from the Division of Minority Opportunities in Research (MORE), NIGMS or other grants from the National Institutes of Health. Applicants may propose recurring activities. In these cases NIGMS would consider funding applications for up to five years. The MORE Division provides research and training opportunities for: (1) students from minority groups underrepresented in the biomedical sciences, including mathematics; and (2) faculty at institutions with significant enrollment of underrepresented minorities. The MORE Division seeks innovative ways to improve the grantwriting skills and abilities (competitiveness) of program directors, and faculty at institutions eligible for support by MORE programs. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private such as scientific or professional societies, universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Applications from foreign organizations will not be accepted. Minority individuals and women are encouraged to apply. MECHANISM OF SUPPORT Awards made under this RFA will use the cooperative agreement (U13) grant mechanism. The rules and regulations that apply to cooperative agreements (U13) are the same as those that apply to conference grants (R13) with one important distinction. After award, MORE program staff will be substantially involved in the planning and conduct of the workshop, assisting the Principal Investigator according to specific Terms and Conditions. These Terms and Conditions are given below under SPECIAL REQUIREMENTS and will be included in each Notice of Grant Award. Facilities and administrative (FOA) costs will not be allowed on grants in support of scientific or program related meetings except in the most unusual circumstances and then only if an appropriate amount is established between the applicant organization and the NIGMS in advance of the award. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is July 1, 1998. Although this program is provided for in the financial plans of NIGMS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. At this time, NIGMS has not determined whether this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE NIGMS will make up to $250,000 available to support this solicitation. The NIGMS anticipates making one award in response to this RFA. SPECIAL REQUIREMENTS Terms and Conditions of Cooperative Agreement Award. o The Principal Investigator will have the primary authority and responsibility to define objectives and approaches; plan, publicize, and conduct the instructional workshop; and publish the results thereof. o The Principal Investigator will retain custody of and have primary rights to information developed under the cooperative agreement, subject to Government rights of access, consistent with current DHHS, PHS, and NIH policies. o The appropriate MORE program staff member will assist, but not direct, the Principal Investigator in the planning and conduct of the workshop to ensure that the function is relevant and responsive to MORE Division goals. This will include assisting the Principal Investigator in finalizing the format and selecting topics for discussion, and publicizing the availability of the workshop. o Publication and copyright agreements, and the requirements for financial status reports, retention of records, and terminal progress reports will be as stated in the NIH publication, "Support of Scientific Meetings" (May 1997). o An independent, third party individual, acceptable to both the Principal Investigator and the MORE Division will be asked to serve as an arbitrator of any serious differences of opinion on programmatic issues that may arise during the planning and conduct the workshop. This special arbitration process will in no way affect the rights of the recipient to appeal an adverse action in accordance with PHS regulations of 42 CFR Part 50, Subpart D and DHHS regulations of 45 CFR Part 16. These special terms and conditions of cooperative agreement award are in addition, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administrative regulations at 45 CFR Parts 74 and 92, and other DHHS, PHS, and NIH grant administration policies. RESEARCH OBJECTIVES Background The MORE Division administers research and research training grants aimed at increasing the number of underrepresented minority biomedical researchers through three components, the MARC Branch, the MBRS Branch, and Special Initiatives. The MORE Division seeks innovative ways to improve the skills and abilities (competitiveness) of program directors, and faculty at institutions supported by MORE programs. The MARC Branch: The MARC Branch offers special research training grants to four year colleges, universities, and health professions schools with substantial enrollments of underrepresented minority students. The goals of the branch are to increase the number and capabilities of minorities engaged in biomedical research and to strengthen science curricula and student research opportunities at minority and/or minority serving institutions. The branch also provides individual predoctoral fellowships to former MARC undergraduates. The MBRS Branch: The goal of the MBRS Branch is to increase the number of researchers who are members of minority groups that are underrepresented in the biomedical sciences by awarding research grants to two and four year colleges, universities and health professions schools with substantial enrollments of minorities. These grants: (1) support research by faculty members; (2) strengthen the institution's biomedical research capabilities; and (3) provide opportunities for students to participate as part of a research team. Special Initiatives: The MORE Division develops and supports new research and research training programs for underrepresented minority students and scientists via special initiatives. The Division is also responsible for organizing meetings and other activities that build networks among individuals and educational institutions and promote underrepresented minority participation in sponsored research. SPECIAL OBJECTIVES The specific intent of this announcement is to solicit applications for an interactive, writing intensive instructional workshop on writing effective applications for NIH grants. It is anticipated that such an activity would spread over six to ten weeks much as a graduate course might. In such a format participants would receive timely feedback on their submitted writing. In order to reach the target audience of potential MORE Division applicants, which may number 60 to 80 individuals per year who may not be able to spend extended time away from their home campus, it is suggested that the workshop include the use of interactive Internet technology. Evaluation of the effectiveness of the workshop will be required. Therefore the overall plan for the activity must include specific plans for evaluating its effectiveness. LETTER OF INTENT A Letter of Intent is required at least 30 days before the application deadline, i.e. by October 18, 1997. The Letter of Intent must include a descriptive title of the proposed course or workshop, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted, and a brief description of the content, audience and requested budget. The Letter of Intent may be no more than one page. The letter of intent is to be sent to Dr. Clifton Poodry at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge, Bethesda, MD 20892-7910, telephone (301) 435-0714; email: asknih@odrockm1.od.nih.gov. The NIH publication, "Support of Scientific Meetings" (NIH Guide to Grants and Contracts, Vol 26 #15 May 9, 1997) provides important information and supplemental instructions for completing the application including allowable expenditures and the applicable policies. This publication is available from the Office of Extramural Outreach and Information Resources. See Application Procedures for address. Budget requests should be submitted on pages 4 and 5 of form PHS 398. Clear justification is needed for all activities, particularly those proposed for future years. Applications must address the inclusion of women, minorities, and persons with disabilities in the workshops. NIH guidelines on this issue are published in the NIH Guide for Grants and Contracts, Vol. 24, No. 15, April 28, 1995. In the research plan section of the application, describe how the proposed instructional workshop will promote MORE programs goals. This section should also be used to provide a detailed description of the objectives, plans, and logistics of the workshop. Sample instructional materials or workbooks should be included as appendices. In addition, the applicant should provide a statement acknowledging and agreeing to NIGMS staff post-award involvement in planning and conducting the course or workshop, and should describe plans to accommodate this involvement. Plans must be described for evaluating the effectiveness of the workshop. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The complete and signed original application and three exact copies, in one package with any appendices, must be mailed or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the same time, an additional two copies must be sent under separate cover to: Chief, Office of Scientific Review National Institute of General Medical Sciences Building 45, Room 1AS.19 - MSC 6200 Bethesda, MD 20892-6200 REVIEW CONSIDERATIONS Upon receipt, applications will be administratively reviewed by NIH staff. Incomplete and/or unresponsive applications or applications without approved letters of intent, will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory General Medical Sciences Council. Review Criteria o the adequacy of the scope and content of the proposed activity o the qualifications of the proposed director/organizer and other activity coordinators and faculty as evidence by experience in conducting similar workshops and past success in obtaining NIH funding o the appropriateness of the proposed format for achieving the stated goals o the adequacy of the resources and environment including the numbers and availability of faculty. o plans for the appropriate involvement of women, racial and ethnic minorities, and persons with disabilities in the planning and implementation of the proposed workshop o the validity and adequacy of the instruments to be used for evaluation of the activity o the appropriateness of the budget Due to the terms and conditions of the cooperative agreement award, some details of the planning and conduct of the course or workshop will not be known until after the award, when MORE staff assists the Principal Investigator in key areas. AWARD CRITERIA The following will be considered in making funding decisions: o merit of the proposed course or workshop as determined by peer review; o relevance to MORE program goals and objectives; and o availability of funds. The anticipated award date is July 1, 1998. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Potential applicants are strongly encouraged to contact MORE Division staff prior to the preparation and submission of a letter of intent to ascertain whether the NIGMS has an interest in supporting a particular approach to a workshop. Direct inquires regarding programmatic issues to: Clifton Poodry, Ph.D. Minority Opportunities in Research Division National Institutes of General Medical Sciences 45 Center Drive, Room 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2573 Email: PoodryC@nigms.nih.gov Direct inquiries regarding fiscal matters to: Ms. Antoinette Holland Grants Management Office National Institute of General Medical Sciences 45 Center Drive, Room 2AN.50B, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 495-5132 FAX: (301) 480-3423 Email: HollandA@nigms.nih.gov AUTHORITY AND REGULATIONS Awards made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. Applications are not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Aug 22 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-094 - V26(27) 08/15/97 Date: 22 Aug 1997 18:30:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 655 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5tlef3$9lt@net.bio.net> NNTP-Posting-Host: net.bio.net INDIVIDUAL PREDOCTORAL DENTAL SCIENTIST FELLOWSHIP NIH GUIDE, Volume 26, Number 27, August 15, 1997 PA NUMBER: PAR-97-094 P.T. National Institute of Dental Research Application Receipt Dates: April 5, August 5, December 5 PURPOSE The National Institute of Dental Research (NIDR) seeks through this Program Announcement (PA) new National Research Service Award (NRSA) applications for an Individual Predoctoral Dental Scientist Fellowship (PDSF). The purpose of the PDSF is to offer an integrated dental and graduate research training program that leads to attainment of both the D.D.S./D.M.D. and Ph.D. degrees. The PDSF provides an approach to expanding the cadre of well-trained oral health scientists by stimulating early commitment to research careers by outstanding dental students. The NIDR anticipates that graduates of the PDSF will be able to bring into clinical studies of dental, oral and craniofacial health and disease fundamental knowledge and insight from the basic biomedical, behavioral and social sciences, as well as from related fields such as biomimetics, tissue engineering, biostatistics, epidemiology, health services research and the computer and information sciences. BACKGROUND For many years, there has been a recognized need to train and develop clinician-scientists capable of understanding and pursuing dental, oral and craniofacial health research from the basic, behavioral and clinical perspectives. In particular, such researchers can elucidate essential biological processes and apply this knowledge to the prevention, diagnosis, management, care and treatment of individual patients. To facilitate development of clinician-scientists at the predoctoral level, the NIDR started in 1996 the Institutional Dental Scientist Training Program (DSTP). This mechanism provides funds to dental schools which then select two students per year to pursue concurrently the D.D.S./D.M.D. and Ph.D. degrees in an integrated, interdisciplinary program. At present there are three dental schools (State University of New York at Buffalo, University of California at San Francisco and University of Connecticut) which conduct this program. At the postdoctoral level, the NIDR has supported since the mid-1980s the Institutional Dentist Scientist Award (DSA), the Mentored Clinical Scientist Development Award (formerly known as the Individual Dentist Scientist Award or Physician Scientist Award for Dentists) and the Institutional Postdoctoral NRSA. These mechanisms support dentists to obtain the Ph.D. in a research field related to dental, oral and craniofacial health and disease as well as advanced clinical training in a dental specialty. There has been a noticeable decrease over the past few years in the number of highly qualified dentists applying to the postdoctoral Institutional DSA and NRSA programs. Given the implications of such a decline for the future viability of oral health research, the NIDR has embarked on several activities to improve the situation. NIDR staff have communicated with many dental students and recent graduates who are currently involved in research about their perceived obstacles for pursuing a research career. The major reason indicated by most students and recent graduates is the large indebtedness (over $100,000 at some private institutions) with which dentists are burdened upon graduation. However, some of the best and brightest students in dental schools throughout the United States have indicated that they might be more interested in a research career if provided with some financial support while in school, thereby decreasing their level of debt upon graduation. To address this issue and thereby stimulate greater interest in a research career among the most outstanding dental students, the NIDR is proposing in this Program Announcement (PA) an individual Predoctoral Dental Scientist Fellowship Program (PDSF) which would enable students attending any dental school in the United States to obtain both the Ph.D. and dental degree through the NRSA mechanism. This mechanism would decrease the amount that students would have to pay while in dental and graduate school and thus their level of indebtedness by providing at least partial tuition payment, covering some educational expenses and paying an annual stipend. The PDSF is patterned after the Individual Predoctoral NRSA Fellowship for M.D./Ph.D. (F30 mechanism) currently supported by the National Institute of Mental Health, National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism. This model provides individual NRSA fellowships to students in medical school for pursuit of the MD and Ph.D. degrees in an integrated program. Research areas in which the PDSF students are trained must be relevant to the goals of the NIDR, which are to understand, prevent, diagnose and treat dental, oral and craniofacial diseases and disorders. Current special areas of interest include: (i) inherited diseases and disorders, including the development of teeth and bone; (ii) emerging and re-emerging infectious diseases, including bacterial, viral, fungal and parasitic disorders and AIDS; (iii) neoplastic diseases; (iv) chronic disabling diseases, such as osteoporosis and related bone disorders, temporomandibular joint disorders, pain, neuropathies and neurodegenerative diseases and other systemic disorders with oral manifestations; (v) biomimetics, tissue engineering and biomaterials; and (vi) behavior, health promotion and the environment. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000", a PHS-led national activity for setting priority areas. This PA for the Individual Predoctoral Dental Scientist Fellowship is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS At the time of award, fellows must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt card (I-551). Noncitizen nationals are persons born in lands that are not States, but are under United States sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible. Racial/ethnic minority individuals, women and persons with disabilities are strongly encouraged to apply. An applicant for the PDSF must show evidence of both high academic performance in the biological, chemical, physical or behavioral/social sciences and significant interest in research. When the application is submitted, the applicant must meet at least the following requirements: [a] be enrolled in a formal program at an approved dental school that leads to the award of a DDS or DMD; [b] have been accepted in a Ph.D. (or an equivalent degree) program in one of the research fields listed above in the Background section related to dental, oral and craniofacial health and disease; and [c] have a confirmed mentor in that scientific field. Trainees must begin their PDSF not later than the third year of dental school, although preference will be given to starting in the individual~s first or second year. In addition, all fellows must have received a baccalaureate degree by the beginning date of their appointment. Individuals currently enrolled in a joint D.D.S./D.M.D.- Ph.D. program are eligible for consideration as trainees. Individuals who obtained a Ph.D. prior to entering dental school and desire to pursue another research doctorate while in dental school are not eligible. An individual may not have more than one NRSA competing application pending with the Public Health Service concurrently. Although NRSAs are not usually meant or intended for study leading to the D.D.S./D.M.D. or for study that is part of residency training leading to a dental specialty, this program is specifically designed to support training in an established, combined D.D.S./D.M.D.- Ph.D. program. The institutional setting must be a domestic, nonprofit private or public institution. MECHANISM OF SUPPORT Awards resulting from this PA will use the NRSA F30 mechanism to provide combined dental school and predoctoral Ph.D. support for five years. No other predoctoral NRSA support may be received during this time. Any exception to these limitations requires a waiver from the Director of the NIDR based on a review of the justification provided by the individual awardee and his/her sponsor. In general, written requests for additional years of support (up to a total of seven years) will be considered favorably for one year at a time if justified by adequate progress made by the individual in his/her program. Since a fellow~s course of study for the combined degrees may take longer than seven years, all individuals should consider other potential sources of support for additional years of training. Continued support beyond the first year is dependent upon satisfactory progress toward the combined degree. Annual reports are to be provided by the fellow, the Ph.D. department and sponsor and the dental school. RESEARCH OBJECTIVES A. Dental and Graduate Research Training Program An individual PDSF must provide integrated clinical and graduate research training required to obtain the D.D.S./D.M.D. and Ph.D. degrees and to pursue the investigation of dental, oral and craniofacial health and diseases. Each fellow~s program must offer two distinct and integrated components. A clinical component must ensure the acquisition of requisite clinical knowledge and technical expertise in order to meet the requirements for a D.D.S./D.M.D. degree and to obtain a license to practice dentistry. A science field component must be a doctoral (Ph.D. or equivalent) level program that ensures development of knowledge and research skills in scientific areas relevant to dental, oral and craniofacial health and disease. Current areas are stated in the Background section. The interdisciplinary program for the fellow should maximize the research and educational resources of his/her academic institution(s) and any collaborating organizations. The program should be tailored to meet the unique research and clinical development needs of the fellow and ensure that the individual completes the program with requisite competencies. The sequence in which the two components are offered and their integration should be based on the specific circumstances and organization of the training institution and should represent what is deemed most desirable, feasible, and efficient by the administration of the dental and graduate institutions. Each fellow must have a mentor, an accomplished investigator active in the proposed area, to guide the person's development and research project. Usually, a mentor will be the doctoral thesis advisor. The mentor must be committed to continue this involvement throughout the individual's total period of development under the award. A co- mentor, representing the clinical component, also may be named. Where feasible, women and minority mentors should be involved as role models. All fellows must meet the criteria described in ELIGIBILITY REQUIREMENTS. B. Allowable Costs Annual Stipends: The annual trainee stipend is $11,496 per year regardless of previous research experience. A stipend is provided as a subsistence allowance for the fellow to help defray living expenses during the research training experience. Stipends may be supplemented by an institution from non-Federal funds. Other funds from the PHS, such as from the NIH, may not be used to supplement stipends. Non- PHS Federal funds may be used for stipend supplementation only if specifically authorized under the terms of the program from which the supplemental funds are derived. For example, an individual may make use of Federal educational loan funds or Department of Veterans' Affairs benefits when permitted by those programs. Additional support may be provided to the fellow without obligation by the sponsoring institution or may be conditioned on his or her performance of certain services such as teaching or serving as a laboratory assistant. Under no circumstance may the condition of stipend supplementation detract from or prolong the training. The stipend is not a payment for services performed. Fellows supported under individual awards are not considered to be employees either of the Public Health Service (PHS) or their sponsoring institution, even though the payment of the stipend is made through the sponsoring institution. Stipends are subject to State and Federal income tax. The taxability of stipends, however, in no way alters the relationship between NRSA fellows and institutions. NRSA stipends are not salaries. NRSA fellows are not in an employee-employer relationship with the institution in which they are pursuing research training, nor are they considered to be self-employed. Stipends are not subject to self-employment tax (FICA). Tuition, Fees and Health Insurance: Tuition, fees, and self-only health insurance are allowable costs if such charges are required of all individuals in a similar training status at the institution, regardless of their source of support. On an annual basis, the fellowship award will cover 100% of the first $2,000 of the combined cost of tuition, fees, and self-only health insurance and 60% of any amount above $2,000. Up to four years of dental school tuition and up to four years of graduate school tuition, fees and self-only health insurance may be requested under this fellowship, but no more than five years of tuition and fees support in the aggregate can be awarded unless a waiver is obtained. Other Training Costs: Travel, including attendance at scientific meetings, is an allowable cost at an amount of $800 per year. In addition, institutional costs of $1,500 per year may be requested to defray expenses such as consultant costs, equipment and research supplies. Tax Liability: The Tax Reform Act of 1986, Public Law 99-514, affects the tax liability of all individuals supported under the NRSA program. The NIH is not in a position to advise students or institutions about tax liability. Degree candidates may exclude from gross income reported for tax purposes any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at their sponsoring institution. The business office of the sponsoring institution will be responsible for the annual preparation and issuance of the IRS form 1099 for fellows paid through the institution. NIH will issue the form for all fellows paid directly by them (fellows training at Federal laboratories). Payback Provisions: Predoctoral trainees do not incur payback obligations. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the Individual NRSA grant application form (PHS 416-1, rev. 8/95). Application kits are available at most institutional offices of sponsored research and may be obtained from: ASKNIH, Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive MSC 7910, Bethesda, MD 20892-7910; telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. At least three completed sealed letters of reference must be submitted with the application. Applications without the required number of reference letters will be returned without review. Non-citizen applicants must include a notarized statement of permanent residence indicating possession of an Alien Registration Receipt Card or at least application for this card. No award will be activated without proof of possession. Applicants are advised to pay special attention to the following important items in PHS 416-1: Face Page, Part I (Prepared by Applicant): Item 1. Title of Research Training Proposal. Type in "Individual Predoctoral Dental Scientist Fellowship" Item 2. Level of Fellowship. Type in "predoctoral" and the number of the program announcement. Item 3. Leave blank. Item 5. Training Under Proposed Award. Identify the Ph.D. discipline according to the NIH Lexicon of NRSA disciplines on page 31 of the instructions. Item 8. Degree Sought During Proposed Award. Type in both the dental (DDS or DMD) and Ph.D. (or equivalent) degrees with expected completion dates for each. Item 29a. Activities Under Award.. Applicants should describe how they expect to divide their time between dental and graduate school, e.g., dental school courses, graduate school courses, research, research training, etc., during both the school year and the summer for each year of the program. Item 29b. Research Proposal. All applicants should provide a research plan, including a description of a research proposal in which they will be involved as part of their training. The plan should include substantive detail that adds to the information about time allocations requested in Item 29a. In addition to these items, applicants should provide scores for all exams relevant to dental and graduate school that they have taken recently (e.g., GRE, Dental Admissions Test, etc.) Part II (Prepared by Sponsor): Items 32 and 33. Sponsor's Previous Fellows/Trainees, Training Plan, Environment, and Research Facilities. The sponsor should be funded currently to conduct independent research (e.g., Principal Investigator on an R01 or equivalent) and must describe past experience in the guidance of other research trainees and fellows. In addition, the sponsor must describe in detail his/her commitment to and proposed role in guiding the individual applicant. The chairman of the graduate committee for the Ph.D. program also must describe the department's commitment to and proposed role in guiding the individual applicant and any modifications to the department's usual Ph.D. requirements that are necessary to facilitate this fellow~s special needs. The application must include evidence that training in the principles of responsible conduct of research will be incorporated in the research experience of each fellow. This should be presented under Item 33. Issues such as conflict of interest, data recording and retention, professional standards and codes of conduct, responsible authorship, and ethics in biological and behavioral research can provide the substantive base of such training. Application Receipt and Review Schedule Applications for the PDSF will be accepted and reviewed three times a year according to the following schedule: Application Receipt Date: Apr 5 Aug 5 Dec 5 Review Meeting: Jun/Jul Oct/Nov Feb/Mar Notification: Aug/Sept Dec/Jan Apr/May Range of Likely Start Dates: Sept-Dec Jan - Mar May - July The completed original and two legible copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) At the time of submission, two additional copies of the application must be sent to: H. George Hausch, Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN.44F 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2372 REVIEW CONSIDERATIONS It is important to emphasize that the F30 program is a training mechanism and not a research mechanism. The central issues in review are [a] the applicant's potential for a productive scientific career, [b] the role of the sponsor in the research training that is proposed, [c] the record of the sponsor and the Ph.D. program in producing active, funded research scientists, and [d] the probability that the graduate training will enable the fellow to engage in research with dental, oral and craniofacial relevance. Applications will be reviewed for completeness and responsiveness to the PA by NIH staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Remaining applications may be subjected to triage by the NIDR Special Grants Review Committee, a standing NIH initial review group, to determine their merit relative to others received in response to the PA. The NIDR will withdraw applications judged to be noncompetitive and notify the applicant. Applications judged to be competitive will be evaluated further for scientific and technical merit by the review committee. Detailed review criteria are listed below: Applicant: o evidence of the applicant's commitment to a career in research o the applicant's demonstrated potential for a productive research career o quality of the applicant's academic record, awards, and honors o extent and quality of applicant's previous research and/or clinical training Research Training Plan: o specificity and clarity of the description of the research skills and knowledge to be acquired o overall coherence and potential of the research training plan to provide the fellow with individualized supervised experiences that will foster research skills o clarity, completeness, originality, and significance of the goals of the proposed research training plans o adequacy of knowledge of relevant literature and current methods in the proposed research area o adequacy of plans for the protection of human subjects and/or care of animals, if applicable o adequacy of plans to include women and minorities as subjects in research, if applicable o adequacy of plans for training in the responsible conduct of research Sponsor: o adequacy and relevance of sponsor's academic and research qualifications and experience in providing guidance to fellows and trainees o evidence of the proposed sponsor's understanding of and commitment to fulfilling the role of sponsor o evidence of an understanding of the applicant's research training needs and a demonstrated ability, on the part of the sponsor, to assist in meeting these needs o adequacy of the sponsor's ongoing research program as a context for the expected research training Environment: o evidence that there is an established D.D.S./D.M.D.- Ph.D. program o access to facilities and related resources (e.g., equipment, laboratory space, computer time, subject populations) necessary to provide the applicant a high-quality training environment o strength of the institution's commitment to research training as demonstrated by ongoing programs, experienced faculty, and, in particular, commitment to the proposed D.D.S./D.M.D.- Ph.D. student o track record of the department and sponsor in training students who become active researchers o track record of the department in training and graduating women and racial/ethnic minorities o strength of the institution's overall research activities References: o strength and specificity of the proposed sponsor's endorsement of the applicant, including identification of the applicant's strengths and weaknesses o strength and specificity of additional references as well as adequacy of these reports based on the referee's opportunity to observe and evaluate the applicant's potential as a research scientist o Secondary review will be conducted by the National Advisory Dental Research Council (NADRC). Notification: Shortly after the initial review meeting, each candidate will be sent a mailer that includes the IRG recommendation, the priority score, and the name of a program official in the Division of Extramural Research, NIDR. The institute automatically forwards a copy of the summary statement to the applicant as soon as possible after receipt >From the IRG. Following the second-level review, the institute will notify each applicant of the final disposition of the application. Any questions about initial review recommendations and funding possibilities should be directed to the appropriate institute program official. AWARD CRITERIA Applications will compete for available funds with all other approved training and fellowship applications assigned to the NIDR. The following will be considered in making funding decisions: quality of the application as determined by peer review, availability of funds, program priority, and balance among types of research training supported by the NIDR. Activation An awardee has up to 6 months from the issue date on the award notice to activate the award. Under unusual circumstances, an NIH institute may grant an extension of the activation period upon receipt of a specific request from the fellow. Terms and Conditions of Award Awards are made for full-time efforts to achieve the D.D.S./D.M.D. and Ph.D. Fellows are expected to use their time in course studies, clinical duties, research training, research, and other necessary and relevant activities in such a way as to optimize their training experience. Awardees in academic institutions are not entitled to vacations as such. They are, however, entitled to the normal short student holidays observed by their training institution. The time between the spring and fall semester is to be used as an active part of the training period. An NRSA may not be held concurrently with another Federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. An NRSA recipient may, however, accept concurrent educational remuneration from the Department of Veterans' Affairs and loans from Federal funds. No funds may be disbursed until the individual has started training under the award and an Activation Notice (PHS-416-5) has been submitted to PHS. At the end of the total support period, the individual fellow must submit a Termination Notice (PHS-416-7) to the NIDR in order to ensure proper documentation of the fellow's records. Fellowships must be administered in accordance with the current National Research Service Award Guidelines for Individual Awards and Institutional Grants, the current PHS Grants Policy Statement, and any terms and conditions specified on the award notice. The following policies are noted: PHS policy is to make available to the public the results and accomplishments of the activities that it funds. Therefore, it is incumbent upon fellows to make results and accomplishments of their F30 activities available to the public. There should be no restrictions on the publication of results in a timely manner. Publications should acknowledge support from the NIDR, including grant number. Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes. The NIH research training and career development programs are conducted in compliance with applicable laws that provide that no person shall, on the grounds of race, color, national origin, handicap, or age, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity (or, on the basis of sex, with respect to any education program or activity) receiving Federal assistance. INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issue or questions from potential applicants is welcome. Direct inquiries on programmatic issues to: James A. Lipton, DDS, Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-18J 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2618 or 594-7710 FAX: (301) 480-8318 Email: LIPTONJ@DE45.NIDR.NIH.GOV Direct inquiries pertaining to grants management issues to: Mr. Martin Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AS-55 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8303 AUTHORITY AND REGULATIONS NRSA awards are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288), and Title 42 of the Code of Federal Regulations, Part 66. The following Catalog of Federal Domestic Assistance numbers are applicable to these awards: 93.121, 93.172, 93.173, 93.272, 93.278, 93.282, 93.306, 93.361, 93.398, 93.821, 93.837-93.839, 93.846-93.849, 93.853-93.856, 93.859, 93.862- 93.867, 93.880, 93.894, and 93.929. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Aug 22 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAS-97-093 - V26(27) 08/15/97 Date: 22 Aug 1997 18:29:58 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 750 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5tleem$9l7@net.bio.net> NNTP-Posting-Host: net.bio.net DEMOGRAPHIC RESEARCH ON SEXUAL BEHAVIORS RELATED TO HIV NIH GUIDE, Volume 26, Number 27, August 15, 1997 PA AVAILABLE: PAS-97-093 P.T. National Institute of Child Health and Human Development National Institute of Dental Research National Institute of Mental Health Application Receipt dates: May 1, September 1, January 1 PURPOSE NICHD, NIDR and NIMH invite qualified researchers to submit applications to study the social and behavioral aspects of the transmission of HIV through sexual intercourse, including oral sexual practices. NICHD has a longstanding commitment to research focusing on sexual behavior, behavior change and HIV prevention, especially among men and women of reproductive age (including adolescents), and among vulnerable populations. NIDR supports biomedical and behavioral research on the oral transmission of HIV, including research on sexual behavior relevant to oral routes of transmission. NIMH supports an extensive program of HIV prevention research related to various aspects of mental health. This program announcement describes NICHD's, NIDR's and NIMH's programs of behavioral research in the sexual transmission of HIV, which includes four general areas: (1)demographic studies of sexual behaviors related to HIV transmission; (2) studies of the interrelationships among social, institutional, economic and cultural contexts and sexual behavior; (3) studies of the interrelationships between pregnancy, pregnancy prevention and HIV prevention; and (4) theoretically grounded intervention studies within these areas. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA is related to the priority areas of family planning and the prevention of HIV infection and STDs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-0047400) or "Healthy People 2000" (Summary Report: Stock No. 017-001-0047301) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01) and FIRST award (R29) mechanisms. Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years. FUNDS AVAILABLE This program announcement has $2.7 million dollars in total costs set aside for the first year of awards. The NICHD set aside will total $1.7 million. The NIDR set aside will be total of $1.0 million. Additional funding or co-funding will also be available from NIMH. The number of awards and level of support will depend on receipt of applications of high scientific merit. The usual policies governing grants administration and management, including facilities and administrative costs, will apply. Although this program is provided for in the financial plans of the NICHD and NIDR, awards pursuant to this program announcement are contingent upon availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. New applications submitted for the September 1, 1997, January 2 and May 1, 1998 receipt dates will be eligible for funding under this announcement. Competing continuation applications for already funded projects will NOT be eligible. Although the NICHD, NIDR and NIMH have continuing interest in the research area of this PA, the latest anticipated date for new awards to be made with set-aside funds from NICHD and NIDR is February, 1999. RESEARCH OBJECTIVES Background Until such time as vaccines and cures for infection with the HIV virus are a practical reality, prevention of infection must rely upon individuals' practicing protective behavior. Specific sexual behaviors that prevent infection - such as avoiding sexual intercourse with infected individuals and using condoms - are influenced both by personal factors such as attitudes, knowledge, and abilities and by more distal factors characterizing the contexts in which individuals' behaviors are carried out. While most behaviors that are protective have been well-defined, new information may require altered messages regarding risk and protective behaviors. For example, recent reports have suggested that oral sexual practices (e.g. oral-genital receptive sex) previously considered to be relatively risk-free may actually pose significant risks for HIV transmission. Social and cultural environments may predispose people to act in certain ways, and may also influence how easy it is for them to change their behaviors or to maintain protective behaviors. Competing motivations for establishing and maintaining sexual relationships and for pregnancy or pregnancy prevention may interact with HIV prevention motives and with the social environment to influence behavioral outcomes. Such motives are in turn likely to be shaped in important ways by life course experience: health and development; educational and economic achievement, migration, marriage and marital dissolution, and fertility. These personal and contextual factors can interact in powerful and complex ways to determine behavioral risks for HIV infection and the most promising pathways to reducing risk. Methodological advances in data collection and data analytic techniques are beginning to make it possible to examine in detail the contextual factors in which individuals and couples exist, and to understand more clearly the structural factors influencing their sexual decisions. NICHD, NIDR and NIMH seek research applications that draw on both innovative theory and innovative methodologies to address four general areas of study, as described below. The goal of this program announcement is improved knowledge applicable to behavioral strategies for the prevention of sexual transmission of HIV infection. Other sexually transmitted diseases and other sequelae of sexual behavior as well as relevant aspects of sexual behavior itself also may be used as endpoints of proposed research as long as the relationship of the specific research question to HIV prevention is adequately justified. Research Sought (A) Demographic studies Population-based studies of sexual behaviors related to the risk of HIV infection contribute to HIV prevention in many ways. They provide essential information for identifying population groups whose sexual behaviors increase vulnerability to HIV infection as well as groups in which the potential for increasing infection rates may exist; they provide a means of monitoring trends in the prevalence of risky sexual behavior as well as protective behaviors within population groups and they permit the testing of models of the determinants of such behavior over the life course within population samples (that is, not samples recruited from clinics or on the basis of some particular personal behavior or characteristic). Population-based data provide perspectives on the prevalence of such behaviors. For example, they can elucidate changes in behaviors, norms, and status that permeate a larger population and contribute to the characteristics, resources, and behaviors of those most vulnerable to HIV. They can be used to examine processes that influence sexual behavior regardless of HIV risk and to examine how, whether and when heightened risk of, or the perception of heightened risk of HIV affects those processes. Specific topics include but are not limited to: Trends in HIV-related sexual behaviors and the determinants of those trends. (Note: new data collection for the purpose of studying trends in sexual behavior will not be supported unless it makes a substantial scientific contribution beyond that made by ongoing data collection activities conducted by CDC, NIH and other federal and private groups). Studies characterizing trends in the content of information provided to students in the health professions, health care professionals, the public or members of high risk groups about sexual practices (e.g. oral sex) as related to risks for HIV transmission. Group differences in the determinants of HIV risk behaviors. Changes in family structure, organization, marriage and cohabitation, and patterns of partner selection in relation to HIV infection and the risk of such infection. The relationship of HIV-risk sexual behavior to life course transitions such as cohabitation, marriage, separation and divorce, parenthood, and changes in school enrollment, labor force, and economic status. Factors that predispose individuals to initiate sexual behaviors that place them at risk of HIV at an early age. Studies evaluating changes in sexual behaviors in individuals and populations associated with new information on risk and protective behaviors (e.g. concerns regarding oral routes of HIV transmission). Studies of norms and values related to sexual behavior, sexual partnerships, and disease prevention, their variation among population groups and over time, and their relationship to behavioral patterns. Cross-cutting studies that link data collected in large population samples with samples selected based on high risk behaviors. Methodological studies that extend and improve techniques for data collection and analysis in studies of HIV-related sexual behavior. Development of methodologies for identifying populations in which the potential for widespread HIV infection is increasing, and for studying the spread of infection in relation to population characteristics, dynamics, and behaviors (e.g., network studies). Demographic studies must be grounded in an appropriate theoretical framework. Although new data collection may be justifiable under some circumstances, potential applicants are encouraged to consider secondary analysis of existing data. A number of population-based sample studies have been conducted in recent years, some with NICHD funding, and the data are available to researchers (see "Research Designs and Data Sources," below). Several of these have extended traditional survey approaches in ways that improve and enrich data, such as methodological improvements in the quality of self reports, utilization of biospecimens, e.g. salivary or oral measures, and integrating contextual or social network data. B) Contextual Determinants of Sexual Behavior A significant body of evidence suggests that sexual and prophylactic behaviors are influenced in important ways by the contexts in which they occur. Relevant dimensions of context include the social (relationships with partners, family, friends and co-workers), institutional (legal, educational, religious, health infrastructure); cultural (norms, values, and beliefs shared within and across social groups), and physical (community composition, prevalence of disease risk, poverty and housing). The specification of the ways in which these aspects of context can influence behavior is far from complete, yet there is reason to believe that improved understanding of contextual influence could provide a powerful tool for prevention of HIV. Research designs which capture contextual influences as well as individual determinants of behavior are called for. For example, studies might address the following questions: How do individuals' social networks influence their sexual behavior; how does sexual behavior influence change and stability in social networks? How do the economic, social, and institutional characteristics of communities in which social and sexual networks are embedded influence sexual behavior? Do individuals whose lives involve frequent changes of residence change their social and sexual networks? How do social and sexual networks overlap and what are the implications of this for HIV-risk behavior? What principles and processes govern the selection of sexual partners and participation in sexual networks that place individuals at risk of infection with HIV? How does the process of partnership formation vary by age or maturational status, gender, sexual orientation, socioeconomic status, and the prevalence of HIV in the individual's community? How do the circumstances under which sexual partnerships are formed affect the perceptions of HIV risk within the partnership and the behaviors that occur within it? What factors influence the stability and exclusiveness of sexual partnerships, and how do HIV-risk behaviors vary with the duration and other characteristics of partnerships? How does earlier experience of involuntary sex or violence or the fear of violence within a current partnership influence risk behavior in that and subsequent partnerships? How do norms and values -- about morality, marriage, monogamy, childbearing, or appropriate sexual behavior -- develop and change within and across social groups? How do such norms and values interact with other contextual and individual factors to influence individuals' and couples' sexual behavior? How can research methods for studying contextual influences on sexual behavior be improved? How can non-biased but cost-effective methodologies for network studies be developed? How can contextual studies account for the processes by which individuals self-select into social networks, communities, and other contexts? How can studies of sexual partnerships account for partnership formation processes and other sources of sample bias? How can non-biased samples of couples at elevated risk of HIV infection be obtained? There may be challenges in obtaining samples in which one partner is HIV+, or in following samples in which partners are in various stages of relationship formation, change and dissolution. What are appropriate models and analytic methods for examining sexual behavior in the context of a couple, and in relation to networks and the larger social context? C) Integrating pregnancy and HIV prevention Most heterosexual individuals who have sexual intercourse desire to protect themselves from unwanted pregnancy most of the time. At the same time, almost all individuals all of the time wish to avoid infection with HIV. However, many of the medical methods available for pregnancy protection do not provide protection from disease, and condoms, male and female, which are most effective at disease prevention, may not protect as well against unwanted pregnancy. Research is sought which examines the inter-relationships among individuals' and couples' desires for pregnancy, pregnancy prevention and avoidance of the risk of infection with HIV. How do individuals at risk of HIV infection balance pregnancy prevention and disease prevention in making decisions about sexual behavior and the introduction and use of methods to prevent pregnancy and/or disease? How do concerns regarding pregnancy or perceived health risks or attitudes concerning contraception influence oral sexual behaviors? How does the duration and intimacy of the partnership influence the partners' decisions concerning issues of pregnancy, pregnancy prevention and the avoidance of disease? Does this vary over the life course? How do individuals' estimations and abilities to accurately estimate risk -- their own and their partner's for pregnancy and HIV -- influence their use of protection? How do knowledge and beliefs concerning their own or their partner's serostatus affect use of protection? How does actual, objective, epidemiological risk of exposure to disease and to pregnancy affect individuals' use of protection from unwanted pregnancy and from disease? D) Intervention Studies Intervention studies are needed to build on the basic science findings concerning behavior change. Designing, implementing and evaluating interventions which utilize mediating variables such as, for example, communication skills concerning condoms, or sensitivity to peer or media pressure, to enable individuals to acknowledge and modify risky behavior are appropriate research proposals for this program announcement. Understanding of local issues is critical to the successful implementation of targeted interventions. Accordingly, interventions are encouraged which involve community organizations in design, implementation and replication of the project. Such proposals may target any population vulnerable to HIV and may include consideration of co-morbid conditions such as other STDs and oral conditions. This PA particularly encourages studies of populations most vulnerable to the sexual transmission of HIV -- minority men and women, men who have sex with men, and disadvantaged youth. Particular questions of interest include but are not limited to: How can the social context in which individuals live and the changes in those contexts via migration or change of residence -- their social networks, communities, schools, homes, work environment -- be taken into consideration when designing and implementing interventions? How can the influence exerted by elements of the social, institutional and cultural contexts be harnessed in the development of more effective interventions? How can HIV-related behavior change interventions be improved to take account of individuals' potentially competing concerns about pregnancy and disease prevention? Given the need to combine condom (or other barrier) use with hormonal contraception or sterilization to achieve the highest levels of protection against both pregnancy and disease among at-risk sexually active heterosexual people, what interventions, delivered by which agencies or individuals, are effective? How do local conditions, such as condom distribution programs, or support for or opposition to behavior change interventions from the community's civic, educational and religious institutions impact individual behavior? Research Designs and Data Sources The utilization of existing data is strongly encouraged for its cost-efficiency whenever scientific goals can be met by its use. There is a wide range of such data collected in the U.S. and available for research purposes. Each data set has its particular strengths and weaknesses, which the investigator must understand and deal with. Such resources include, but are not limited to, the various rounds of the National Survey of Family Growth, the National Survey of Adolescent Males, the National Survey of Men, The National Longitudinal Study of Adolescent Health, the National Health and Social Life Survey, the Chicago Sexual Health and Life Project, and data made available through the Sociometrics STD/HIV archive. Researchers may be aware of, and have access to, other data that are appropriate for answering the HIV/AIDS behavior questions they wish to pose. Data collected in or from other countries can provide powerful resources for addressing many of the research questions in this announcement. New data collection is justifiable if existing data are not appropriate to the aim of the study. In such cases, scientific sampling procedures are highly desirable to ensure that sample biases do not vitiate the research objectives. Prior contact with the staff named below is strongly encouraged for any applicant considering such an effort, and is mandatory should the direct cost of the project exceed $500,000 in any year. Applicants proposing new data collection are encouraged to make their data available for use by other researchers and should outline plans for accomplishing this in the application. Applicants proposing research that draws on social scientific approaches that have not been widely applied to research on HIV-related sexual behavior are particularly encouraged to apply. As noted recently by an Institute of Medicine workshop, "Assessing the Social and Behavioral Science Base for HIV/AIDS Prevention and Intervention", improved strategies for behavioral intervention will require broader perspectives than have been applied in the past. Collaborations involving anthropologists, historians, economics, sociologists, political scientists, epidemiologists, and psychologists may be needed to advance theoretical and methodological approaches to HIV prevention. Therefore applicants are encouraged to consider research designs which are innovative, integrative of multiple perspectives, and which utilize, as appropriate, a range of methods and analytic techniques. In addition, the recent Ad Hoc Panel on NIDR AIDS Research (June, 1997) strongly recommended pursuing collaborative research on behavioral and/or biological factors influencing oral transmission of HIV. STUDY POPULATIONS Research may focus on samples in the United States and other nations, and on individuals of either or both sexes and of all ages as appropriate to the scientific questions being examined. Studies of populations at heightened vulnerability to the sexual transmission of HIV -- e.g., minority men and women, men who have sex with men, and disadvantaged youth-- are particularly encouraged. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES The research grant application form PHS 398 (revised 5/95) is to be used in applying for these grants. These forms are available at most institutional business offices and from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda MD 20892, telephone 301-435-0714 Email asknih@odrockml.od.nih.gov; and from the program administrator listed under INQUIRIES. In order for the application to be considered for set-aside funds, the PA Title and number must be typed on line 2A of the face page of the application form. Submit a signed, typewritten original of the application including the Checklist, and three signed photocopies, in one package, to: Division of Research Grants National Institutes of Health 6701 Rockledge Dr. Room 1040, MSC 7710 Bethesda Maryland 20892-7710 At the time of submission, one additional copy of the application must be sent to: Susan F. Newcomer, Ph.D. Demographic and Behavioral Sciences Branch Center for Population Research National Institutes of Child Health and Human Development 6100 Executive Boulevard, Room 8B13 Bethesda, Maryland 20892-7510 EXPRESS MAIL: Rockville, Maryland 20852 Applications must be received by the regular deadlines for AIDS-related applications, May 1, September 1 and January 1. REVIEW CONSIDERATIONS Applications will be received by the NIH Division of Research Grants. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further competition and the Principal Investigator and the official signing for the applicant organization will be notified. Following review by the Initial Review Group, applications will be taken to the NICHD, NIDR or NIMH Advisory Council for a second level of review and Institute program staff will make a final funding decision based on scientific merit, program relevance and the advice of Council. REVIEW CRITERIA FOR AND RATING OF UNSOLICITED RESEARCH GRANT APPLICATIONS (as per the NIH GUIDE, Volume 26, Number 22, June 27, 1997) Reviewers will be instructed to (a) address the five review criteria below and (b) assign a single, global score for each scored application. The score should reflect the overall impact that the project could have on the field based on consideration of the five criteria, with the emphasis on each criterion varying from one application to another, depending on the nature of the application and its relative strengths. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: The adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The reasonableness of the proposed budget and duration in relation to the proposed research The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. AWARD CRITERIA Awards will be made based on the scientific merit as determined by peer review, on programmatic priorities and on the availability of funds. INQUIRIES Written, email and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquires regarding programmatic issues to: Susan F. Newcomer, Ph.D. Demographic and Behavioral Science Branch National Institute for Child Health and Human Development 6100 Executive Boulevard, Room 8B13 Bethesda, Maryland 20892 Telephone: 301/496-1174, FAX: 301/496-0962 Email: NewcomeS@hd01.nichd.nih.gov OR Patricia Bryant, Ph.D. Director, Behavior, Health Promotion and Environment National Institute of Dental Research Natcher Building, Room 4AN 18A 45 Center Drive MSC 6402 Bethesda, Maryland 20892-6402 Telephone: 301/594-2095 FAX 301/480-8318 Email: BryantP@de45.nidr.nih.gov OR Willo Pequegnat, Ph.D. Office on AIDS National Institute of Mental Health Parklawn Building 5600 Fishers Lane, Room 10-75 Rockville, Maryland 20857 Telephone: 301 443-6100, FAX 301: 443-9719 Email: wpequegn@nih.gov Direct inquiries regarding fiscal matters to: Ms. Melinda Nelson NICHD, Office of Grants and Contracts Building 61E Room 8A Bethesda, Maryland 20892 Telephone: 301/496-5481 FAX: 301/402-0915 Mr. Martin R. Rubinstein Grants Management Office National Institute of Dental Research Natcher Building, Room 4AN 44A 45 Center Drive MSC 6402 Bethesda MD 20892-6402 Telephone: 301/594-4800 Email: Rubenstein@de45.nidr.nih.gov Ms. Diana Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building 5600 Fishers Lane, Room 7C-08 Rockville, Maryland 20857 Telephone: 301 443-2805 OTHER INSTITUTES HIV-RELATED RESEARCH INTERESTS The interests of the three co-sponsoring Institutes are complemented by those of several other Institutes at NIH. NIAID funds studies which focus on vaccine development, biological endpoints of behavior and treatment of HIV infection; NIAAA supports research which links HIV prevention to alcohol use and abuse; NIDA supports studies which relate to drug use and abuse as a primary focus of HIV infection, including the linkage of drug use to risky sexual behaviors. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864 (Population Research) NO.93.121 and No. 93.242 (NIMH). Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations, 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility ) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people From owner-sci-resources@net.bio.net Fri Aug 22 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-97-002 - V26(27) 08/15/97 Date: 22 Aug 1997 18:28:03 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 923 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5tleb3$9e9@net.bio.net> NNTP-Posting-Host: net.bio.net HUMAN IMMUNE RESISTANCE TO MALARIA IN ENDEMIC AREAS NIH Guide, Volume 26, Number 27, August 15, 1997 RFA: AI-97-002 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 20, 1997 Application Receipt Date: October 28, 1997 APPLICATIONS IN RESPONSE TO THIS RFA MUST BE PREPARED USING A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN "APPLICATION PROCEDURES" BELOW. PURPOSE This initiative seeks to expand, through clinical studies conducted under the cooperative agreement mechanism (U01), the understanding of immunity to Plasmodium falciparum or P. vivax in humans. Naturally acquired or vaccine-elicited protective immunity may involve multiple mechanisms, including cellular and humoral components, that target different antigens from different parasite lifecycle stages, and that may act in concert. A number of immunologic assays exist for such mechanisms. Rapid, simple assays (e.g., ELISA, IFA, etc.) may indicate prevalence, level and specificity of a particular immune response, but to date have not proven predictive of immune protection. Functional assays (e.g., in vitro reduction in parasite numbers or growth) provide an indication of biological activity; none of these, however, has been rigorously evaluated as a surrogate marker of protective immunity in defined, clinical populations (e.g., in longitudinal or case-control studies). The availability of reliable immunologic correlates of protection would facilitate preclinical and clinical evaluation of candidate vaccine antigens and substantially accelerate the vaccine development process. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, "Human Immune Resistance to Malaria in Endemic Areas" is related to the priority areas of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations; public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments; and eligible agencies of the Federal government. Because of the scope of research to be performed, it is expected that foreign institutions will be active participants in the conduct of research supported through awards made under this RFA; foreign institutions, however, are not eligible to submit independent applications directly. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U01), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of a study funded under cooperative agreement(s) are discussed later in this document under the section Terms and Conditions of Award. The total requested project period for applications submitted in response to this RFA may not exceed five years. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for all awards made under this RFA will be $ 2 million. In Fiscal Year 1998 the NIAID plans to fund approximately 3 awards. The usual PHS policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of high scientific merit. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background The World Health Organization has estimated that malaria claims the lives of as many as 3 million people annually, most of these being children living in sub-Saharan Africa. There is no question that vaccines against malaria are desperately needed, especially in light of the current spread of drug resistant strains of the parasite. Effective immunity to malaria has been observed in humans. Many infected individuals who have resided continuously for extended periods of time in endemic areas eventually exhibit few or no episodes of clinical malaria. Moreover, although it is not logistically feasible for widespread use, vaccination with radiation-attenuated, infective sporozoite stage parasites has been repeatedly shown to protect humans from subsequent experimental challenge infection. Over the past decade, however, many candidate malaria subunit vaccines that have proven effective in animal models have failed to reproducibly elicit substantial protection in human trials. As recommended in the Institute of Medicine Report, Malaria: Obstacles and Opportunities (1991), further vaccine research would benefit from identification of the underlying mechanisms of human antimalarial immunity. According to Dr. J.H.L. Playfair in Malaria - Waiting for the Vaccine (1991), "It is unfortunately as true today as ten years ago that we do not fully understand the mechanism(s) by which immunity leads to protection against any stage of malaria. One consequence of this is that there is no reliable in vitro test that would predict a successful outcome in any vaccine trial." In a follow up report from the Institute of Medicine, Vaccines Against Malaria: Hope in a Gathering Storm (1996), it was noted there are still no reliable, validated in vitro correlates of protection, and as described by Miller and colleagues ("The Need for Assays Predictive of Protection in Development of Malaria Bloodstage Vaccines," Parasitology Today, 1997), the need for such predictors is just as great today. This initiative therefore takes as its underlying premise the idea that correlates of protective immunity in malaria should be sought in humans, and that controlled clinical studies are warranted to establish such correlates. Historically, approaches that have defined mechanisms of acquired resistance in humans have contributed substantively to the development of synthetic vaccines for hepatitis B and a variety of encapsulated bacteria (e.g, Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B). Because of the geographic diversity and heterogeneous epidemiology of malaria, however, it will be necessary to validate correlates observed in one site as being relevant in other malaria endemic sites. As correlates are identified, NIAID Program Staff will work with investigators to facilitate such multisite collaborations. Although studies in animal models are not within the purview of and will not be funded under this RFA, NIAID Program Staff will work with investigators to set up collaborations and access to capabilities that will facilitate development of in vitro or animal models to allow screening for induction of these protective responses. Establishment of such models should ease subsequent assessment of the protective potential of malaria vaccine formulations. Thus, this approach should not only contribute to characterization of the mechanism(s) of protective immunity, but also facilitate selection and prioritization of recombinant candidate vaccines for malaria and lay important foundations for future field testing of such vaccines. Research Objectives and Scope The objective of this initiative is to establish a core understanding of the protective immune response to Plasmodium falciparum and Plasmodium vivax in humans in endemic areas. Protective immunity may be acquired either as a result of naturally occurring exposure to P. falciparum or P. vivax or as a demonstrated result in future clinical trials of candidate malaria vaccines. In addition, it may be possible to obtain insights into immune-mediated protection through studies of patient populations participating in trials of other interventions in malaria (e.g., bed net studies, nutritional supplementation, drug efficacy studies). Applicants are encouraged either to undertake new clinical studies or enter into collaborations with other investigators already involved in ongoing interventional trials or clinical studies. It is anticipated that these studies will be carried out largely through collaborative arrangements or subcontracts with one or more foreign investigators, institutions and government agencies located in endemic areas. Relevant research includes, but is not limited to, the following: o Identification and correlation of humoral and cellular immune responses associated with demonstrable resistance in human subjects in endemic areas; such resistance may be reflected in reduced infection, disease, or transmission o Identification and correlation of humoral and cellular immune responses associated with demonstrated differences in resistance of trial participants in endemic areas to reinfection following chemotherapy or other non-immunologic intervention; such resistance may be reflected in reduced infection, disease, or transmission o Identification, correlation and demonstration (validation) of immunologic parameters associated with naturally acquired or vaccine-elicited resistance in human subjects in endemic areas: such parameters might include recognition of specific antigen, immunoregulatory genetic factors, production of certain cytokines, elicitation of specific lymphocyte subpopulations or non-specific immunologic effector mechanisms (e.g., iron binding proteins, nitric oxide) o Development of rapid, field applicable assays for such correlates o Validation of demonstrated correlates of immunologic acquired resistance in more than one endemic site through collaboration and replicate studies The areas outlined above are not intended to be all-inclusive. TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HAS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U01), an "assistance" mechanism rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIAID Scientific Coordinator. A. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the research objectives, approaches and details of the studies within the guidelines of the RFA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below: 1. Research design and protocol development, including definition of objectives and approaches, planning, implementation, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results. 2. Establishing a mandatory Steering Committee composed of the Principal Investigator, Project Directors for subcontracts, and the NIAID Scientific Coordinator to coordinate and manage prospective studies. Following notification of award, awardee(s) will name in a timely manner investigators to serve as members of the Steering Committee which will meet periodically. 3. Designating Study Protocol Chairs. The Principal Investigator shall designate a single Protocol Chairperson (if the P.I. does not assume this role) for each proposed study protocol within the research plan. The Protocol Chairperson shall function as the scientific coordinator for the proposed protocol and shall assume responsibility for developing the proposed protocol and monitoring study performance for the final, implemented protocol. All proposed protocols and modifications will be submitted by the Protocol Chairperson to the Steering Committee for approval. 4. Implementing the core data collection strategy and methods collectively decided upon by the Steering Committee. For each study involving multiple institutions, it is the responsibility of each awardee/site to ensure that data will be collected and submitted in a timely way following such procedures as established by the Steering Committee. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population. 5. Establishing mechanisms for quality control and monitoring. Awardees are responsible for ensuring the accurate and timely assessment of the progress of the study, including development of procedures to ensure that data collection and management are: (a) adequate for quality control and analysis; (b) for clinical trials, as simple as appropriate in order to encourage maximum participation of clinicians and other providers and study subjects and to avoid unnecessary expense; and (c) sufficiently staffed across the participating institutions. For studies involving multiple sites (subcontractors), strategies for the analyses of pooled data will be developed by the Steering Committee. 6. Preparing and submitting interim progress reports, when requested, to the NIAID Program Officer including, as a minimum, summary data on protocol performance. For a multi-site award, the Steering Committee may require additional information from the individual awardees/sites. Such reports are in addition to the annual awardee noncompeting continuation progress reports. 7. Establishing procedures, where applicable, for all participating institutions to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects. 8. Cooperating in the reporting of the study findings. The NIAID will have access to and may periodically review all data generated under an award. Where warranted by appropriate participation, plans for joint publication with NIAID of pooled data and conclusions, are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIAID staff will apply in all cases. In general, to warrant co-authorship, NIAID staff must have contributed to each of following areas: (a) design of the experiments or concepts being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts. The awardee will retain custody of and have primary rights to the data developed under these awards, subject to Government right of access consistent with current HHS, PHS, and NIH policies. B. NIAID Staff Responsibilities NIAID staff assistance will be provided by the Host Immunity Program Officer, Parasitology and International Programs Branch, DMID/NIAID, who will serve as NIAID's Scientific Coordinator. The NIAID Scientific Coordinator will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. It is expected that the dominant role and prime responsibility for the activity will reside with the awardee(s) for the project as a whole. However, specific tasks and activities will be shared among the awardee(s) and the NIAID Program Officer. The NIAID Program Officer will be the contact for all facets of the scientific interaction with the awardee(s). As required for the coordination of activities and to expedite progress, the NIAID Program Officer may designate additional NIAID staff to provide advice or assistance to the awardee on specific scientific, technical, or management issues. The NIAID Program Officer shall retain overall programmatic responsibility for the award(s) and will clearly specify to the awardee(s) the name(s) and role(s) of any such additional individuals and the lines of reporting authority. NIAID Extramural Program staff responsibilities will include: 1. NIAID Scientific Coordinator will provide access to and use of, when appropriate, reagents and assays, and other resources available through NIAID contractors and awardees. NIAID staff may provide assistance by suggesting and/or facilitating the selection of sources or resources, including provision of biological supplies (e.g., DNA primers, genetically engineered or recombinant proteins). 2. NIAID Scientific coordinator will provide assistance and guidance, when appropriate, in complying with regulatory guidelines. For example, NIAID currently offers, through the Clinical and Regulatory Affairs Branch, DMID, guidance on Good Clinical Practice and development of Investigational New Drug Applications for clinical trials. 3. The NIAID Scientific Coordinator will participate in Steering Committee meetings. 4. The NIAID Scientific Coordinator will participate in clinical study design, management and technical performance so as to ensure comparability of data obtained with similar efforts being supported by NIAID and non-NIH partner agencies participating in the Multilateral Initiative Against Malaria (MIM). 5. The NIAID Scientific Coordinator will serve as a liaison with research efforts being undertaken by non-NIH partner agencies participating in the MIM. 6. For multi-institutional protocols, through participation on the Steering Committee and with the agreements of the Principal Investigator(s), the NIAID Scientific Coordinator may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results. 7. The NIAID Scientific Coordinator will provide information on opportunities for collaborations, such as: a. Principal Investigators may not have immediate access to the discoveries stemming from malaria projects supported by other Government agencies, or from NIAID-supported projects that are not directly related to malaria but are germane to the overall goals of the RFA. For example, NIAID, USAID and the United States Army Medical Research and Development Command (USAMRDC) have a Memorandum of Agreement to cooperate in malaria vaccine development. NIAID staff will facilitate the development of cooperation between Principal Investigators and other Institute, USAID or USAMRDC supported researchers and contractors in order to develop promising new leads more rapidly. NIAID's Scientific Coordinator will facilitate such access by suggesting and encouraging collaboration with appropriate Principal Investigators. b. NIAID Scientific Coordinator may facilitate access to other populations and population-based information available through NIAID-supported researchers in the International Collaborations in Infectious Disease Research Program (ICIDR) and the Tropical Medicine Research Centers (TMRC). These populations and data may prove a valuable resource to allow investigators to extend studies beyond or outside those originally proposed. NIAID staff will suggest and encourage further collaborations which may profit from access to ICIDR and TMRC facilities and populations. Similarly, NIAID staff will suggest and encourage further collaborations with other special programs within NIAID, including domestic facilities and investigators in the Tropical Disease Research Units, the university-based Cooperating Groups of the International Centers for Tropical Disease Research, and the Vaccine and Treatment Evaluation Units. c. Through a number of new international initiatives, including the Multilateral Initiative in Malaria (MIM), and the US-European Union (EU) Transatlantic Agenda, and international task forces , e.g., the US-EU task forces on biotechnology and emerging diseases, NIAID staff are frequently aware of relevant programs supported by other agencies, and will transmit this information to Principal Investigators to enable them to take advantage of these opportunities to strengthen their programs. NIAID staff currently maintain close interactions with international agencies such as the World Health Organization (WHO), the Pan-American Health Organization, the World Bank, and the United Nations Development Program, and agencies of other governments, such as International Cooperation with Developing Countries (INCO-DC) Program of the Commission of the European Communities (CEC). C. Collaborative Responsibilities In addition to the interactions defined above, awardees and NIAID Scientific Coordinator shall share responsibility for the following activities: Steering Committee. A Steering Committee organized by the Principal Investigator, Project Directors for Subcontracts, and the NIAID Scientific Coordinator will be the main oversight body of the study. The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient/subject accrual, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIAID Program Officer and will provide periodic supplementary reports upon NIAID request. The Steering Committee usually will meet at least twice yearly. A Chairperson, other than the NIAID Scientific Coordinator, will be selected by vote of the members. The Chairperson is responsible for coordinating the Committee activities, for preparing meeting agendas, and for scheduling and chairing meetings. D. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee (with the NIAID member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the NIAID, and the third member with expertise in the relevant area and selected by the two prior members will be formed to review any scientific or programmatic issue that is significantly restricting progress. While the decisions of the Arbitration Panel are binding, these special arbitration procedures will in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, subpart D, and HAS regulations at 45 CFR Part 16. Cooperative agreements are subject to the administrative requirements outlined in OMB circulars A-102 and A-110. All pertinent HAS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on PHS regulations at 42 CFR Part 52 and HAS regulations at 45 CFR Part 74, are applicable. These special terms and conditions pertaining to the scope and nature of the interaction between the NIAID and the investigators will be incorporated in the Notice of Grant Award. However, these terms will be in addition to, not in lieu of, the customary programmatic and financial negotiations that occur in the administration of cooperative agreements. STUDY POPULATIONS Populations participating in research supported through awards made under this RFA must be located in geographic areas with documented, substantial malaria. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. For studies involving foreign populations, the NIH policy on inclusion of women in research conducted outside the U.S. is the same as that for research conducted in the U.S. With regard to population of the foreign country, the definition of minority groups may be different than in the U.S. If these is a scientific rationale for examining subpopulation group differences within the foreign population, investigators should coniser designing their studies to accommodate these differences. Investigators may obtain copies from these sources or from Dr. B.F. Hall (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 20, 1997, a letter of intent that includes a descriptive title of the overall proposed research; the name, address and telephone number of the Principal Investigator; and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Madelon Halula at the address listed under INQUIRIES. APPLICATION PROCEDURES APPLICATIONS IN RESPONSE TO THIS RFA MUST BE PREPARED USING A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS ARE PRESENTED BELOW. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications submitted in response to this RFA may present their research plan in up to 25 pages. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)435-0714, email: asknih@odrockm1.od.nih.gov. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number "(enter number)" and the words "HUMAN IMMUNE RESISTANCE TO MALARIA IN ENDEMIC AREAS" must be entered on the face page. Applications must be received by October 28, 1997. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/95) Application Kit (as modified in, and superseded by, the special instructions below, for the purposes of this RFA), will be judged non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but that has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application that is essentially identical to one that has already been reviewed cannot be submitted in response to this RFA . This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. It is highly recommended that the NIAID program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contacts under INQUIRIES). Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail or courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to Dr. Madelon Halula at the address listed under INQUIRIES. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA A status report on NIH reinvention activities was provided in the NIH GUIDE (Volume 24, Number 40) of November 24, 1995. Two of these activities are: (1) the use of "Just-in-Time" grant applications; and (2) modular budget requests and funding. Both "Just-in-Time" and "Modular Budgeting" are to be used for applications in response to this RFA. JUST-IN-TIME GRANT APPLICATIONS. The basic principle of "Just-in-Time" is to simplify and reduce the administrative and paperwork burdens of preparing an NIH grant application without compromising the initial review group determination of scientific merit or reasonableness of the proposed budget. To that end, the quantity of information and the amount of detail required is reduced in "Just-in-Time" applications. MODULAR GRANTS. Applications are submitted and/or awards made with direct costs in modules (multiples) of a given amount ($25,000 for this RFA), with work proposed within these incremental categories. The model involves using pre-established funding levels for awards and acknowledging that grantees can and do rebudget post-award. This process eliminates the need for many budget details, thereby reducing administrative burden on both NIH staff and grantee organizations and simplifying cost management by NIH program staff. RESEARCH PLAN CONTENT AND PAGE LIMIT. Sections a - d of the Research Plan may not exceed 25 pages for each proposed research study. It is anticipated that each applicant will propose one or two multi-site studies. Additionally, each applicant shall describe procedures for identifying future collaborative studies. SPECIFIC INSTRUCTIONS The following are specific instructions for sections of the PHS 398 (rev. 5/95) application form, which are to be completed differently than usual (that is, in the "Just-in-Time" and "Modular Grant" format). Some sections in the application are modified and should not be completed. If the application receives a score in the fundable range, additional information will be requested. For all other items in the application, follow the usual instructions on pages 5-20 of the PHS 398 booklet. Form DD, Page 4. Do NOT complete this page. Form EE, Page 5. Budget for Entire Proposed Project Period and Justification: General: Budget - Only summary budget information is to be provided; initial budget period (first year) direct costs must be requested as a multiple of $25,000. Justification - only minimal information on personnel (name, role on project, percentage effort, and brief justification) is requested; only unusual research resources need to be briefly justified. Budget (top half of page 5): o Complete the TOTAL DIRECT COST line entries for all requested budget periods (years) and the TOTAL DIRECT COST FOR ENTIRE PERIOD OF SUPPORT entry. Except for Direct and Indirect Consortium/Contractual Costs, do not provide separate budgets for the individual budget categories. o Requested TOTAL DIRECT COSTS for the INITIAL BUDGET PERIOD must be a multiple of $25,000. Generally, first year costs should be increased by four percent annually thereafter. Justification (bottom of page 5 with continuation sheets as necessary): o Personnel - list the name, role on project, and percent effort for all project personnel and provide a brief narrative justification for each person. o Research Resources - provide a brief narrative justification for any unusual significant resources included in the budget requested for this project. o Additional (future) Year Budgets - for each ADDITIONAL YEARS OF SUPPORT REQUESTED, briefly justify annual changes that are more than or less than four percent increases from the preceding year. Form FF - Page 6 - Biographical Sketch: For all key personnel provide biographical sketches that do not exceed TWO PAGES and include the following information: o Name, Position Title, Education/Training. Complete these sections as instructed in the PHS 398 booklet. o list previous positions directly relevant to this application. o list selected peer-reviewed publications (with full citation) directly relevant to this application. o provide information on ongoing research grants and completed research projects relevant to this application; list title, principal investigator, funding source, and role for each project cited. Form GG - Page 7 - Other Support: Do not complete. (Any required information will be requested from successful applicants prior to grant award.) Form HH - Page 8 - Resources and Environment: Complete selected item(s) only if proposed research requires specialized unique resources for which availability must be documented. Research Plan (Booklet Pages 15-19): Note: Items a - d MAY NOT EXCEED TWENTY FIVE (25) PAGES. Applications with research plans that exceed 25 pages will be returned without review. o Item a - Specific Aims (typically less than one page): List in priority order the broad, long range objectives of the proposed project and describe concisely and realistically the hypothesis to be tested and what the specific research described in this application is intended to accomplish. o Item b - Background and Significance (typically one page): The background and significance has been established by the NIAID in setting aside funds for the release of this RFA. Use this section to describe how the proposed research will contribute to meeting the goals and objectives of the RFA and explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. o Items c - d: Complete as instructed on pages 15-17 of the PHS 398 booklet, noting the reduced page limit stated above. The following is general guidance for information to be presented in this section: - preliminary studies pertinent to the application. - rationale for each particular set of experiments. - general methods that will be utilized. Provide specific details ONLY for those techniques that are unique, or where a significant departure from a generally accepted technique is important for the reviewers to know. - outcome measures that will be used to assess the success or failure of each set of experiments. - potential pitfalls in the experimental design and alternative studies that will be done if the proposed experiment(s) fail. o Items e - f: Complete as described on pages 17-18 of PHS 398 booklet. o Item h - Consortium, Contractual Arrangements (one page only): Provide brief explanation (not to exceed one page) of the scientific, fiscal, and administrative arrangements made with collaborating organizations. o Item I - Consultants/Collaborators: Biographical sketches should conform to the brief format described for Form FF (page 6), above. Appendix (PHS 398 Booklet - Page 24) Complete as instructed. Forms II and JJ - Checklist: Do not complete. Information will be requested by NIAID only from applicants being considered for funding. If you or your business office has any questions regarding these special instructions, E-mail, call, FAX, or write the NIAID staff at the addresses listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and adherence to the Special Instructions above by the NIH DRG and for responsiveness by NIAID staff; those judged to be incomplete will be returned to the applicant without review. Those considered to be non-responsive will be returned without review. Those applications that are complete and responsive may be subjected to a triage by an NIAID peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIAID will withdraw from competition those applications judged to be non-competitive for award and will notify the applicant and institutional business officials. Those applications judged by the reviewers to be competitive for award will be reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program balance, and the availability of funds. In addition, consideration will be given to geographic distribution. The earliest anticipated date of award is August 1998. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic (eligibility and responsiveness) issues to: Dr. B. F. Hall Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A09 6003 Executive Boulevard Bethesda, MD 20892-7630 Telephone: (301) 496-2544 FAX: (301) 402-0659 E-Mail: BH24Q@NIH.GOV Direct inquiries regarding review issues and special instructions for application preparation; address the letter of intent to; and mail two copies of the application and all five sets of appendices to: Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 402-2636 FAX: (301) 402-2638 E-Mail: mh30x@nih.gov Direct inquiries regarding fiscal matters to: Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 Fax: (301) 480-3870 E-mail: tb22j@nih.gov Schedule Letter of intent receipt date: August 20, 1997 Application receipt date: October 28, 1997 Scientific review date: February, 1998 Advisory Council date: June, 1998 Earliest award date: August, 1998 AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is (Sec. 93.856, Microbiology and Infectious Diseases Research, or No. 93.855 - Immunology, Allergy, and Transplantation Research, or both, as appropriate). Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Aug 22 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-97-004 - V26(27) 08/15/97 Date: 22 Aug 1997 18:27:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 736 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5tleak$9bv@net.bio.net> NNTP-Posting-Host: net.bio.net NATIONAL RESEARCH SERVICE AWARD - INSTITUTIONAL TRAINING AWARDS NIH Guide, Volume 26, Number 27, August 15, 1997 RFA: DE-97-004 P.T. National Institute of Dental Research Letter of Intent Receipt Date: September 12, 1997 Application Receipt Date: October 22, 1997 PURPOSE The National Institute of Dental Research (NIDR) invites new and competing applications proposing National Research Service Award (NRSA) Institutional Research Training Grant (T32) programs. The objectives are: (a) to develop highly qualified oral health research investigators, especially clinician scientists, by supporting postdoctoral training of individuals with a health professional degree who are committed to a research career in the basic biomedical, behavioral and clinical sciences pertaining to dental, oral and craniofacial health and disease; (b) to provide re-training opportunities for mid-career scientists and clinical researchers to obtain expertise in particular basic or behavioral sciences relevant to the NIDR areas of research emphasis; and (c) to train pre- and early post-Ph.D. biomedical and behavioral scientists. BACKGROUND Programs must be relevant to the research goals of the NIDR. Primary emphasis is placed upon understanding, preventing, diagnosing, and treating dental, oral and craniofacial diseases and disorders. Current special areas of interest include: inherited diseases and disorders, including the development of teeth and bone; emerging and re-emerging infectious diseases, including bacterial, viral, fungal and parasitic disorders and AIDS; neoplastic diseases; chronic disabling diseases, such as osteoporosis and related bone disorders, temporomandibular joint disorders, pain, neuropathies and neurodegenerative diseases, and other systemic disorders with oral manifestations; biomimetics, tissue engineering and biomaterials; and behavior, health promotion, and environment. These areas of NIDR research emphasis encompass an extensive breadth of basic and behavioral sciences, including molecular and cell biology, neuroimmunology, human and molecular genetics, bioengineering, computer science, molecular epidemiology, clinical trials methodology, biobehavioral medicine, outcomes research, cognitive psychology, medical sociology and health services research. To offer the most appropriate training, applicants are encouraged to consider developing, as deemed necessary, interdisciplinary collaborations among various components of their health science center as well as with other regional academic institutions and private industry so that trainees are provided the strongest background in the particular basic, clinical, and behavioral/social sciences. The NIDR has a strong interest in the training of individuals who will be able to pursue clinical research studies, including clinical trials. Several NIDR and NIH advisory groups and reports from the Institute of Medicine and National Research Council, National Academy of Sciences, have called attention to the need to expand the pool of clinical investigators in order to take advantage of opportunities for translation and transfer of fundamental knowledge to improve oral health care of the public. Clinical or patient-oriented research is defined as "Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects." This area of research includes: the development and evaluation of new diagnostic and therapeutic technologies, techniques and devices; mechanisms of human disease and the characterization of normal and diseased function; therapeutic interventions and clinical drug trials; patient compliance and disease prevention regimens; assessment of health care practices by various population subgroups; and epidemiologic and biobehavioral studies. There is a pool of mid-career oral health researchers, including basic and behavioral scientists and clinical investigators, who wish to update their scientific expertise and keep current with the rapid knowledge developments in the basic, behavioral, and clinical sciences. It is important to provide some re-training mechanism that would enable these individuals to remain viable, active, contributing members of the scientific research community. Additional training also would be relevant for scientists who desire to change their scientific focus and redirect their research efforts toward dental, oral and craniofacial, health and disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), NRSA - Institutional Training Awards, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public, and private institutions, such as dental or medical schools and research institutions. The applicant institution must have a strong research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program. Local collaborations or regional consortia are encouraged where relevant to the field of training being offered and feasible to establish. This is especially important for programs which provide training in interdisciplinary fields, such as tissue engineering, molecular epidemiology, and behavioral medicine. Only one application may be submitted by an institution, unless the proposed training programs are in distinctly different areas of dental, oral and craniofacial health and disease. Levels of Training and Trainee Eligibility Training in an NIDR area of emphasis is to be provided at one or more of the following levels: (1) dentists, physicians, or other health professionals pursuing postdoctoral clinical research training; (2) mid-career scientists and clinical researchers who wish to re-train in a basic or behavioral science area related to dental, oral and craniofacial health and disease; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) dentists wishing to pursue a Ph.D. or equivalent degree in a basic biomedical or behavioral science, although these individuals are encouraged to enter an Institutional Dentist Scientist Award program if they also desire to obtain training in a clinical specialty; and (5) Ph.D. degree holders pursuing postdoctoral research training, although generally they are expected to apply for an individual postdoctoral NRSA fellowship (F32 mechanism). Preference should be given to post-doctoral trainees who have received, as of the beginning of an appointment, a dental or medical degree from an accredited domestic or foreign institution. If the degree has not yet been conferred, a statement, by an authorized official of the degree-granting institution, that all degree requirements have been met is acceptable. Predoctoral trainees must have received a baccalaureate degree as of the beginning of the appointment and be enrolled in a graduate program leading to the award of a Ph.D. or an equivalent degree in biomedical or behavioral oral health research. Individuals who wish to interrupt their professional school studies for one or more years to engage in full-time research training before completing their professional degrees are eligible; however, prior approval by the NIDR, as well as by the institution, is required before an appointment can be offered. Short-term predoctoral research training positions cannot be requested through this RFA. Instead, these types of positions must be supported through NRSA Short-Term Institutional Training grants (T35 mechanism). Trainees must be citizens or noncitizen nationals of the United States, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-551) or other legal verification of such status. Noncitizen nationals, although not citizens of the United States, owe permanent allegiance to the U.S. They are generally born in lands which are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT Awards resulting from this RFA will be the NIH NRSA Institutional Research Training Grants (T32). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for each application submitted in response to this RFA may not exceed five years. Awards may be renewable upon submission of a successful competing continuation application, depending on programmatic needs and the availability of funds. The anticipated award date is July 1, 1998. Trainees may receive up to five years of NRSA support at the predoctoral level and three years of support at the postdoctoral level, including any combination of support from institutional training awards and individual fellowship awards. Extensions beyond these periods require a waiver from the NIH. It is expected that postdoctoral trainees with Ph.D., D.D.S./D.M.D., MD or equivalent degrees will engage in not less than two years training. However, those mid-career scientists and clinical researchers who seek re-training in basic or behavioral science research can spend between one to two years in the program, depending on the desired level of expertise to be obtained and the period of time allowed by their home institutions for sabbatical or leave-of-absence. FUNDS AVAILABLE In response to this RFA, the NIDR expects to make up to four new or competing continuation awards, each with two postdoctoral positions in the first year. The estimated total funding for all awards is $400,000 in the first year. This level of support is dependent on the receipt of a sufficient number of applications of high scientific and educational merit. RESEARCH OBJECTIVES The training program must provide opportunities for individuals to carry out supervised biomedical or behavioral research and develop research skills in an area of NIDR emphasis related to dental, oral and craniofacial health and disease. Clinical research programs must have strong relationships with basic or behavioral scientists to ensure that trainees will have the opportunity to acquire the necessary foundation for independent investigation. The training program director will be responsible for the selection and appointment of trainees and for the overall direction of the program. Applicants can request no more than six postdoctoral positions per year over the five-year period. It is appropriate to have two new appointments in each of the first, second, and third years. In order to address the need for clinical investigators, applicants must allocate not less than two postdoctoral positions during the five years of the program to trainees with a declared interest in receiving training to conduct clinical research. The remaining postdoctoral positions may be allocated to basic, behavioral or clinical research trainees in any of the research emphasis areas relevant to the mission of the NIDR. At least one of these positions should be for re-training a mid-career scientist or clinical research investigator. Up to three predoctoral positions may be requested at any one time during the five year period. The number and types of positions awarded will be determined by the initial review group's assessment of scientific and educational merit, program needs, and the availability of funds. Training grants may not be used to support studies leading to a dental, medical, or other similar professional degrees, or to support residencies, or other training for dentists providing care to patients where the majority of their time is spent in non-research clinical training. However, if a specified period of full-time research training is creditable toward specialty board certification, the training grant may support such research training if the trainee has shown a clear interest in a research career. Applicants are reminded of the importance the NIDR places on recruitment and retention of women and underrepresented minorities to sponsored training and career development programs. Where feasible, women and minority mentors should be involved as role models. Additional information regarding NRSA Institutional Research Training Grants is given in the NIH Guide for Grants and Contracts (NIH Guide), Vol. 26, No. 16, May 16, 1997. Copies of the NIH Guide are usually available through the NIH Home Page, as well as in the office of sponsored research of most academic institutions and from the Office of Grants Information, Division of Research Grants, at the address below. Stipends and Other Training Costs For predoctoral trainees at all levels of experience, the current stipend is $11,496 per year. For postdoctoral trainees, stipends are provided as a subsistence allowance to help defray living expenses during the research training experience. The stipend is not provided as a condition of employment with either the Federal Government or the sponsoring institution. Stipend level for the first year of NRSA support is determined by the number of FULL years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research activities (including industrial); teaching; internship; residency; clinical duties; or other time spent in a health-related field beyond that of the qualifying doctoral degree. The current postdoctoral stipend levels are as follows: Years of Relevant Experience Stipend less than 1 $20,292 greater than or equal to 1 but less than 2 $21,420 greater than or equal to 2 but less than 3 $25,600 greater than or equal to 3 but less than 4 $26,900 greater than or equal to 4 but less than 5 $28,200 greater than or equal to 5 but less than 6 $29,500 greater than or equal to 6 but less than 7 $30,800 greater than or equal to 7 $32,300 The stipend for each subsequent year of NRSA support is the next level in the stipend structure and begins on the anniversary appointment date. No departure from the standard stipend schedule may be negotiated between the institution and trainee. Stipend Supplementation. Supplementation or additional support to offset the cost of living may be provided by the grantee institution. Supplementation does not require any additional effort from the trainee. Federal funds may not be used for supplementation unless specifically authorized under the terms of both the program from which such supplemental funds are to be received and the program whose funds are to be supplemented. Under no circumstances may DHHS funds be used for supplementation. Compensation. An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting research that is part of the research training experience. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program. Educational Loans or G.I. Bill. An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Tuition, Fees, and Health Insurance Tuition, fees, and self-only medical insurance, are allowable trainee costs if such charges are required of all individuals in a similar training status at the institution, regardless of their source of support. Family medical insurance coverage is not an appropriate charge to the NRSA research training grant. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved research training program. On an annual basis, for each trainee, the training grant will cover 100% of the first $2,000 of the combined cost of tuition, fees, and self-only health insurance and 60% of any amount above $2,000. Institutions are instructed to request the full amount of these costs in competing applications. Noncompeting awards will reimburse tuition, fees, and health insurance costs in the amount paid in the previous award year, unless there is a change in the scope of the award Other Trainee Costs Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's training, is an allowable trainee cost in the amount of $800 per year per trainee. Institutional costs of $1,500 per year per predoctoral trainee and $2,500 per year per postdoctoral trainee may be requested to defray the cost of training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. A facilities and administration allowance (indirect cost allowance) based on 8 percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. Applications from State and local government agencies may request full indirect cost reimbursement (see PHS Grants Policy Statement). Payback Provisions Postdoctoral trainees must complete and sign a Payback Agreement Form (PHS 6031) to fulfill the NRSA payback requirement when they are appointed initially to a research training grant. Postdoctoral trainees in the first twelve months of NRSA support incur one month of obligation for each month of support. Postdoctoral trainees in the thirteenth and subsequent months of NRSA support are not required to sign the Payback Agreement Form and do not incur a service payback obligation. The thirteenth and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. Individuals appointed to their initial NRSA postdoctoral period in a project funded in response to this RFA and who continue under that award for two years have fulfilled their obligation by the end of their second year. Service payback obligations also can be paid back by conducting biomedical or health-related behavioral research, teaching in a health professional school, college, or high school, or engaging in additional research training for more than 20 hours per week for a period equal to the period of support, up to 12 months. Clinical practice and administrative responsibilities not directly related to scientific research are unacceptable for payback service. Postdoctoral NRSA recipients must begin to undertake any remaining obligated service on a continuous basis within two years after termination of NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the Division of Extramural Research, NIDR, specifying the need for additional time and the length of the required extension. Recipients of NRSA support are responsible for informing the Division of Extramural Research, NIDR, of changes in status and address. Individuals who fail to fulfill the obligation through service must pay back the total amount of funds paid to the individual for the obligation period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years of the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary of Health and Human Services may extend the period for starting service or for repayment, permit breaks in the period of service or repayment, or otherwise waive or suspend the payback obligation of an individual. Officials of the applicant organization responsible for recruitment of trainees should familiarize themselves with the terms of the payback service requirement and explain them carefully to prospective trainees before an appointment to the training grant is offered. For additional information on aspects of the Institutional NRSA such as payback provisions, trainee reporting requirements, leave, stipends, tax liability and the grounds for approving extensions of support and payback provisions, refer to the announcement in the NIH Guide, "NIH National Research Service Award Institutional Research Training," Volume 26, Number 16, May 16, 1997. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 12, 1997, a letter of intent that includes a descriptive title of the proposed research training program; the name, address, and telephone number of the program director; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDR staff to estimate the potential review workload and to avoid conflicts of interest in the review. The letter of intent is to be sent to Dr. James A. Lipton at the address listed under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Lipton early in the planning phase of application preparation. Applicants must use the grant application form PHS 398. It contains special instructions for Institutional National Research Service Awards (T32). The PHS 398 form is available on the NIH website at http://www.nih.gov and at institutional offices of sponsored research or their equivalent. If not available locally or from the Internet, call 301-435-0714 or send a request, accompanied by a self-addressed mailing label, to: ASKNIH Extramural Outreach and Information Resources National Institutes of Health 6701 Rockledge Drive MSC 7910 Bethesda, MD 20892-7910 Email: asknih@odrockm1.od.nih.gov. For competitive continuation applications, cumulative information on the career development of all former trainees, including information about their minority and gender status, must be included. For new applications, data should be provided about the career accomplishments of individuals who have completed research training programs at the institution(s). Applications must include a description of formal and or informal activities related to instruction about the responsible conduct of research to be incorporated into the proposed research training program. Information must be provided on the rationale, subject matter, appropriateness, format, frequency, and duration of instruction; and the amount and nature of faculty participation. Progress reports in competing and non-competing continuation applications must include the type of instruction, topics covered, and other details, such as attendance by trainees and names of the instructors. No award will be made if an application lacks this component. To identify the application as a response to this RFA, check "YES" on item 2 on the face page of the application and enter "RFA: DE-97-004 after "Number" and "NRSA - Institutional Training Awards" after "Title." The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application also must be sent to: H. George Hausch, Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN.44F Bethesda, MD 20892-6402 Telephone: (301) 594-2372 This RFA is for a single competition. Applications must be received by October 22, 1997. If an application is received after that date or deemed non-responsive to the RFA, it will be returned to the applicant without review. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed for completeness and responsiveness to the RFA by NIH staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Remaining applications may be subjected to triage by the NIDR Special Grants Review Committee, a standing NIH initial review group, to determine their merit, relative to others received in response to the RFA. The NIDR will withdraw applications judged to be noncompetitive and notify the applicant. Applications judged to be competitive will be evaluated further for scientific and educational merit by the review committee. The following review criteria will be applied: o Past research training record of both the program and the designated preceptors as determined by the success of former trainees in seeking further career development and in establishing productive scientific careers. Evidence of further career development caninclude receipt of fellowships, career awards, further training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors, a record of publications,receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. o Objectives, design, and direction of the research training program; o Caliber of preceptors as researchers, including successful competition for research support; o The institutional training environment, including the level of institutional commitment, quality of the facilities, availability of appropriate courses, and availability of research support; o Recruitment and selection plans for trainees and the availability of high quality candidates,especially mid-career basic or behavioral scientists and clinical research investigators and minorities and women. o Record of the research training program in retaining health-professional postdoctoral trainees for at least 2 years in research training or other research activities; o When appropriate, the concomitant research training of health-professional postdoctorates (i.e., individuals with the D.D.S, M.D., D.O., etc.) with basic science postdoctorates (i.e., individuals with a Ph.D., etc.) or linkages with basic science departments. Additional Review Considerations Minority Recruitment Plan: The NIH remains committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research. As first announced in 1989, all competing applications for institutional NRSA researchtraining grants must include a specific plan to recruit and retain underrepresented minorities in the training program. In addition, all competing continuation applications also must include a report on the recruitment and retention of underrepresented minorities during the previous award period. If an application is received without a plan, or without a report on the previous award period, the application will be considered incomplete and will be returned to the applicant without review. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993. As indicated above, competing continuation applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous award period. Information must be included on successful and unsuccessful recruitment strategies. The report should provide information on the racial/ethnic distribution of: o students or postdoctorates who applied for admission or positions within the department(s) relative to the training grant; o students or postdoctorates who were offered admission to or a position within the department(s); o students actually enrolled in the academic program relevant to the training grant; o students or postdoctorates who were appointed to the research training grant. For those trainees who were appointed to the grant, the report should include information about the duration of research training and whether those trainees have finished their training in good standing. After the overall educational and technical merit of an application has been assessed, peer reviewers will examine and evaluate the minority recruitment plan and any record of recruitment and retention. For competing continuation applications, the reviewers will examine and evaluate the record of the program in recruiting and retaining underrepresented minority trainees during the previous award period. The panel also will consider whether the experience in recruitment during the previous award period has been incorporated into the formulation of the recruitment plan for the next award period. The findings of the panel will be included in an administrative note in the summary statement. If the minority recruitment plan or if the record of recruitment and retention of minorities is judged to be unacceptable, funding will be withheld until a revised plan thataddresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable. Training in the Responsible Conduct of Research: Every predoctoral and postdoctoral NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992.) Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be consideredincomplete and may be returned to the applicant without review. NIH initial review groups will assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit,so that the quality of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will bedescribed in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until a revised, acceptable plan is provided by the applicant. The acceptability of the revised plan will be judged by staff within the NIH awarding component. The second level of review will be by the National Advisory Dental Research Council (NADRC). Among the factors that the NADRC considers will be the report of the Special Grants Review Committee on the plans for, and success in, recruitment and retention of women and individuals from underrepresented minority groups. The NIDR will notify the applicant of the NADRC's action shortly after its meeting. Schedule Applications will be processed according to the following schedule: Letter of Intent Receipt Date: September 12, 1997 Application Receipt Date: October 22, 1997 Initial Review Group Meeting: February 1998 Council Meeting: June 1998 Earliest Award Date: July 1, 1998 AWARD CRITERIA Funding decisions will be based on the Special Grant Review Committee's and NADRC's recommendations; the need for research personnel in particular program areas, including the need to train clinical investigators; and the availability of funds. The earliest award date is July 1, 1998. The NIDR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDR. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James A. Lipton, D.D.S., Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-18J Bethesda, MD 20892-6402 Telephone: (301) 594-2618 or 594-7710 FAX: (301) 480-8318 Email: liptonj@de45.nidr.nih.gov Direct inquiries pertaining to fiscal matters to: Mr. Martin R. Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AS-55 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8301 e-mail: rubinstein@de45.nidr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Aug 22 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA TW-98-001 - V26(27) 08/15/97 - pt. 1of2 Date: 22 Aug 1997 18:29:00 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1497 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5tlecs$9j2@net.bio.net> NNTP-Posting-Host: net.bio.net INTERNATIONAL COOPERATIVE BIODIVERSITY GROUPS NIH Guide, Volume 26, Number 27, August 15, 1997 RFA: TW-98-001 P.T. Fogarty International Center National Cancer Institute National Institute of Allergy and Infectious Diseases National Institute of Mental Health National Institute of Child Health and Human Development Office of Alternative Medicine National Heart, Lung and Blood Institute National Science Foundation Foreign Agricultural Service Letter of Intent: October 15, 1997 Application Receipt Date: January 22, 1998 PURPOSE The National Institutes of Health, the National Science Foundation and the Foreign Agricultural Service (hereafter "the Government" or "the Participating Agencies") invite applications for the establishment or continuation of "International Cooperative Biodiversity Groups" to address the interdependent issues of biodiversity conservation, economic growth, and human health through discovery of therapeutic agents for diseases of importance to developed countries as well as those primarily important in developing countries. Particularly relevant disease areas and health needs include cancer, HIV-AIDS and opportunistic infections (e.g. tuberculosis), malaria, central nervous system disorders, contraception and sexually transmitted diseases, and cardiovascular and pulmonary diseases. Applications that propose, in addition to pharmaceutical drug discovery, research and training related to phytomedicine analysis and natural product-based crop protection or veterinary agents are also encouraged. For the purposes of this joint biodiversity and drug development program, the National Institutes of Health (NIH) will be allocated funds from the National Science Foundation (NSF). The Foreign Agricultural Service (FAS) will review all applications that contain agricultural components for possible co-funding in countries where they have available resources. Participating NIH components are the Fogarty International Center, the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health, the National Institute of Child Health and Human Development, the Office of Alternative Medicine and the National Heart, Lung and Blood Institute. It is possible that other organizations may join the program at a later time. The Fogarty International Center (FIC) of the NIH will administer this program under the authority and regulations of the Public Health Service (PHS). There are no plans to reissue this Request for Applications (RFA) at this time. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This RFA, INTERNATIONAL COOPERATIVE BIODIVERSITY GROUPS, is related to the priority needs of several diseases of interest to the National Institutes of Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC, 20402-9325 (telephone 202-512-1800). SUMMARY This RFA calls for the development of interdisciplinary programs through the establishment of International Cooperative Biodiversity Groups (ICBGs), with active and substantial participation by U.S. and developing country scientists and institutions. It is the intent of this RFA to promote the conservation of biological diversity through the discovery of bioactive agents from natural products, and to ensure that equitable benefits from both the research process and any discoveries accrue to the country of origin. Benefits that accrue to the country of origin may take a variety of forms but will include economic benefits and enhancement of research capacity. The RFA is seeking proposals that will build institutional relationships with developing countries that will continue to grow beyond the life of the RFA and will serve as effective models for others to develop similar relationships. BACKGROUND This RFA represents a recompetition of the International Cooperative Biodiversity Groups program following its first five years of funding. The unifying theme underlying this RFA is the concept that the discovery and development of pharmaceutical and other useful agents from natural products can, under appropriate circumstances, promote sustained economic growth in developing countries while conserving the biological resources from which these products are derived. This theme reflects the partnership between the National Institutes of Health, the National Science Foundation and the U.S. Agency for International Development that was the genesis for the original ICBG program. Natural products that hold promise for the development of pharmaceutical agents, as well as those that form the basis for many traditional herbal remedies and serve as leads for agricultural and other uses, are often found in ecosystems that are seriously threatened. These include terrestrial ecosystems such as tropical forests as well as marine ecosystems such as coral reefs, and mangroves. Predominantly found in developing countries of the tropics, these ecosystems are rich in biological diversity. Tropical forests, for example, cover only seven percent of the earth's surface, but they are thought to contain at least one-half of all plant and animal species. Deforestation is apparently proceeding at a rate of 20 million hectares per year, resulting in the loss of species at rates estimated to be 100 to 1000 times greater than background extinction. Cultural diversity is also seriously threatened by habitat conversion and the loss of biological resources on which many traditional societies depend. Recent experience demonstrates that diverse plant, microbial and animal resources, contain a wealth of potentially useful compounds. For example, the demonstrated clinical utility of the Vinca alkaloids, vinblastine and vincristine, of the camptothecin analogues, and the effectiveness of taxol in treatment of ovarian and breast cancers, have generated enthusiastic support for a thorough exploration of natural products. In addition to cancer, natural products are proven and/or possible sources of drugs for malaria, parasitic diseases, diarrheal disorders, AIDS and its opportunistic infections, cardiovascular diseases, respiratory diseases, hepatitis, central nervous system disorders, and other serious illnesses prevalent in developing countries. Natural products have also been a valuable source of crop protection agents such as pyrethrins and of veterinary medicines such as ivermectin. The terrible irony is that as advances in biology expand our ability to use genetic diversity to combat these diseases, the raw material is being lost to extinction. Perhaps even more urgent than the losses of genetic and chemical diversity as sources of potential pharmaceutical and agricultural protection agents, are the immediate repercussions of biodiversity loss in many developing countries where herbal remedies from diverse biota are a primary source of health care. Simultaneous with these biological losses to extinction are accelerating losses of traditional knowledge associated with the biota. This knowledge of the identity and utility of specific organisms for medicinal and other uses has intrinsic value as part of our cultural patrimony, is currently important as a source of health care for many people, and may offer important leads for future treatments of numerous human ailments. The underlying causes of biodiversity loss are many and complex, and involve interwoven social, economic, and political elements. It is clear, however, that poverty, unemployment, and lack of economic opportunities are significant contributing factors. In developing countries struggling to meet the most basic human needs, efforts to protect biological diversity will succeed only if implemented in the context of promoting sustained economic growth. Likewise, to be effective, efforts to protect biological diversity must include the active participation of affected local communities, which ultimately will determine the success or failure of those efforts. Biological resources must benefit local populations if the resources are to be conserved. Consequently, the sustainable economic potential of biological resources, such as developing pharmaceuticals from natural products, can be used to promote biodiversity conservation by providing an economic return from sustainable use of the resources while improving quality of life through better human health. Experience suggests that the development of significant conservation incentives is most likely when both near and long term benefits accrue to stakeholders. ELIGIBILITY REQUIREMENTS Public and private non-profit institutions, for profit institutions, Governments and their agencies, and foreign institutions are eligible to participate as members of a Group. However, the Group Leader must be located in a public or private non-profit institution, Government or Governmental agency of the United States. Foreign and for-profit institutions may participate in an ICBG as Associate Programs. MECHANISM OF SUPPORT 1. Awards will be made as Cooperative Agreements (U01). Assistance via Cooperative Agreement differs from grant awards in that sponsoring Government components anticipate substantial programmatic involvement in achieving the goals and objectives of the project. The nature of the U.S. Government's assistance is described in Section J, Part 3 of this RFA under "Terms and Conditions of Award." There is no intent, real or implied, for Government staff to direct Group activities or to limit the freedom or scientific creativity of investigators. 2. The estimated starting date for the initial year of award under this RFA is August 1, 1998. This RFA is a one-time solicitation. However, should the Government determine that there is continuing program need, the Government may issue a new RFA. 3. An award will be made only to the Group Leader's institution, which will subcontract with the other participating institutions. All Group activities will be coordinated through the Group Leader's institution. Applicants must comply with PHS policies concerning allowable costs. Particularly pertinent to this RFA is the non- allowability of indirect costs to organizations outside the U.S. Any questions about allowable costs may be directed to Ms. Silvia Mandes, Grants Management Officer, FIC. 4. Under the Cooperative Agreement, a relationship between the awardee and the Government is established in which the Group is responsive to the requirements and conditions set forth in the RFA. Specifically, the Group Leader defines the details for the project in response to the RFA, retains primary responsibility for the performance of the Group, and agrees to coordinate with the assistance of the Government in all aspects of scientific and technical management of the project in accordance with the terms and conditions outlined in Section J., Part 3. "Terms and Conditions of Award." 5. Awards pursuant to this RFA are contingent upon availability of funds. Subsequent to receiving awards, the awardees may request supplemental support from the Government to expand their activities. Funding for such expansion must be provided from sources other than the FIC, but should be administered through the FIC if they originate >From one of the agencies sponsoring this RFA. In making such a request the applicant must identify the source of the funds and certify that the funds are committed prior to submission of the supplemental request. Complementary funds could also be supplied, for example, from a non-governmental organization or a U.S. Governmental agency, not currently participating in this RFA. Applicants are encouraged to apply for funds from corporate partners or non-profit foundations to supplement conservation and development activities in the host countries, perhaps utilizing trust funds in those countries for management of such resources. Regardless of the source, any supplemental support for Group activities must be reported to FIC. 6. All policies and requirements that govern the grant program of the U.S. Public Health Service apply, in particular, PHS Grants Policy Statement, DHHS Pub. No. (OASH) 90-50.000 (Rev), October 1, 1990. FUNDS AVAILABLE The Government anticipates making five awards (Cooperative Agreements) for project periods of up to five years. Approximately $2.5 million (total costs) for the initial year's funding has been set aside to cover direct and indirect costs of all awards. Therefore, the cost effectiveness of program design in relation to proposed budgets will be a very important funding criteria, and the limits of overall program funding should be kept in mind. All currently funded Groups that wish to be eligible for funding beyond their fifth year of support under their initial ICBG award must apply under this RFA. DEFINITIONS COOPERATIVE AGREEMENT: An assistance mechanism in which substantial Government scientific and programmatic involvement with the recipient is anticipated during performance of the planned activity. INTERNATIONAL COOPERATIVE BIODIVERSITY GROUP: A consortium of Associate Programs, at least one of which is located in a developing country institution, representing diverse scientific disciplines and organizations which join together under guidance and direction of a single Group Leader (Principal Investigator) and which function as a unit with a common goal: to promote, through multidisciplinary approaches, drug development, biodiversity conservation, and sustained economic growth. In this RFA the terms International Cooperative Biodiversity Group, ICBG, and "Group" are used synonymously. DEVELOPING COUNTRY: It is the responsibility of the applicant to demonstrate that the country (ies) that would host the proposed ICBG qualifies as a developing country with significant biological diversity. In addition, the proposed country must be one that maintains diplomatic relations with the United States Government. While no absolute distinctions are made, it is unlikely that a country that has a per capita gross domestic product greater than $9000 per year would qualify. Applicants are encouraged to examine the data on their proposed country in the statistical summary table, Economic Development and Biodiversity, found on the FIC Biodiversity World Wide Web site (http://www.nih.gov/fic/res/countries.htm). Applicants are also strongly encouraged to consult with the FIC Biodiversity Program Director regarding their proposed collaborating country. ASSOCIATE PROGRAM: A component of the overall Group, with a separate, detailed program plan and budget, that brings to the Group a unique resource, capability or expertise. CENTRAL OPERATIONS OFFICE: An administrative unit located at the Group Leader's institution, which is responsible for coordinating and/or providing administrative support for all Group activities including budgets from the Group's associate programs. NATURAL PRODUCT: In the context of the ICBG, a term used broadly to encompass any naturally occurring bioactive agent selected for preclinical evaluation against a disease or for another medical, agricultural, cosmetic or industrial need. This, of course, excludes materials which are synthesized de novo as well as any semi-synthetic derivatives which do not require the collection of material from nature. GROUP LEADER: The Principal Investigator identified in the application who assembles the ICBG, submits the single application in response to this RFA and who is responsible for the performance of the Group as a whole and of each Associate Program Leader. The Group Leader will coordinate Group activities both scientifically and administratively, and in addition, may lead one of the Associate Programs of the Group. The Group Leader's institution is legally and fiscally accountable for the disbursement of funds awarded. The Group Leader's institution must be a not for profit institution in the United States. ASSOCIATE PROGRAM LEADER: The director of one of the Associate Programs of the ICBG. TECHNICAL ADVISORY GROUP (TAG): A committee of advisors with relevant expertise from the Participating Agencies and Institutes, including the Director of the Fogarty International Center (FIC). The TAG reviews applications to make funding recommendations following the initial peer review, and meets several times per year, as necessary, to review developments in the ICBG program as a whole and progress of individual Groups. FIC BIODIVERSITY PROGRAM DIRECTOR: A representative of the Fogarty International Center, a member of the TAG, and the Government program administrator for all funded Groups. The Program Director has lead responsibility for day to day funding and policy decisions in coordination with the Director of the FIC and the Technical Advisory Group. In conjunction with the Government Scientific Coordinator for each ICBG, the Program Director supports the activities of the Groups where possible through policy and program functions. U.S. GOVERNMENT SCIENTIFIC COORDINATOR: A representative of the TAG who assists a specific ICBG, attends Group meetings, interacts scientifically with the Group, and facilitates the role of the Government as a participant in the Group. The U.S. Government Scientific Coordinator serves as the chair of his or her respective Advisory Committee. ADVISORY COMMITTEE: A subset of two or more U.S. Government scientific advisers from the TAG to assist the work of the Group by providing advice and assistance and through the Scientific Coordinator (Committee Chair), to the Group. The Advisory Committee assists in such matters as reviewing the Group's progress reports and suggesting mid-course corrections and future directions for the Group. The Advisory Committee assembled for each Group is determined by the TAG. Each committee, including the Scientific Coordinator, attends Group meetings, where possible, meets separately at least once per year, and maintains ongoing communication regarding Group progress. PATENTABLE INVENTION: Any new and useful process, machine, manufacture or composition of matter, or any new and useful improvements thereof, as defined under the U.S. Patent Statute (35 USC 101). CONTRACTUAL AGREEMENT: Any formal written agreement negotiated among participating institutions in an ICBG, or between the ICBG and other organizations, that stipulates the rights and responsibilities of the parties with respect to the research process, the treatment of intellectual property and the sharing of benefits. RESEARCH OBJECTIVES 1. The overall goals of the International Cooperative Biodiversity Group Program are drug discovery, biodiversity conservation, and economic development. The following cross-cutting approaches should guide the research and capacity-building efforts toward these goals: a) assisting with the discovery of drugs that address priority health needs of the United States and the participating developing country; b) parallel assistance with research on other natural products-based materials such as herbal medicines, crop protection agents, veterinary medicines, or other useful products; c) developing inventories of native species and indigenous knowledge; d) training, targeted toward achieving the research goals of this RFA and meeting the needs of the participating country; and, e) enhancing the scientific infrastructure within the host country. Specifically, the program objectives are to: a) Discover, isolate, and preclinically evaluate agents from natural sources to treat or prevent diseases of importance to developed countries as well as those primarily important in developing countries. Particularly relevant disease areas and health needs include cancer, HIV-AIDS and opportunistic infections (e.g. tuberculosis), malaria, central nervous system disorders, contraception and sexually transmitted diseases, and cardiovascular and pulmonary diseases. It should be noted that studies required for the later stages of drug development (e.g. formulation development, toxicology, etc.) and the conduct of clinical trials are beyond the scope of this RFA. b) Discover, isolate, and/or evaluate other natural-product based entities such as phytomedicines, crop protection agents, animal veterinary medicines, or other useful products with the potential to provide near to medium term economic benefits to local communities and other developing country partners through product earnings or stimulation of local industries. Such efforts should address local health and development priorities. It is probable that in many cases research in these areas can be carried out in parallel with drug discovery work with minimal additional cost to Groups. This may be achieved by incorporating academic, governmental or commercial partners with the appropriate scientific resources and by utilizing the same or similar samples to those collected for drug discovery. c) Undertake inventories of biological diversity and develop collection practices compatible with conserving biodiversity, and produce documentation of all collected material in the form of museum catalogues, published works, and/or databases, reporting specific locality and all features of biology relevant to standard botanical and zoological collections; assure accessibility of inventory specimens to the public by housing them in public institutions (such as universities and national museums), and accessibility to inventory databases through publication on the Internet. d) Support research training targeted to meet the needs of the developing country represented within the Group and related to the scope of work of the RFA, and to augment field experience and training of U.S. scientists in areas of knowledge unique to the developing country. Support for local health needs would concentrate on joint research and training, focusing on disease prevention and control using locally available resources, and discovery of appropriate therapeutics and other useful products. Examples of relevant areas of training could include systematics, information science, ethnomedicine, chemistry, cell biology, biotechnology, or production methods, data management and quality control in pharmaceutical development. Incumbent Groups should plan to advance the level of training of developing country scientists beyond initial efforts to include advanced field and laboratory work such as the development and conduct of locally appropriate bioassays, isolation chemistry, database development, ecology and biodiversity management techniques. Research training supported through this award may take place in the host country or in the United States and may be linked to degree- earning programs. Types of training may include, but are not limited to: i) practical and applied short-term courses or workshops for professionals or technicians; ii) course work, laboratory, or field training in essential research skills for technical assistants, graduate degree candidates, or professionals; and iii) fellowships for 1 or more years for degree candidates or post-doctoral trainees to conduct research related to the goals of the Group. Training costs and plans, must be specified in the text of the proposal and in the proposal's budget request. e) Assist in enhancing the scientific infrastructure within the participating developing country(ies) where the biodiversity resources are found. Infrastructure support could include both social and physical infrastructure. Social infrastructure might be enhanced through strengthening of networks of scientists or local healers. Physical infrastructure support could include assistance for herbaria, museums, and laboratories, the supply of necessary equipment in these facilities, and the enhancement of collecting and screening capabilities in the host country. Limited renovation of existing facilities, but not construction of new facilities, is allowable under this RFA. All renovation of facilities must be strictly relevant to the research objectives of the Group and requires prior approval of the Government. It is likely that some element of all five approaches (a-e) will be included in successful applications. Without a comprehensive and multi-disciplinary approach, it would be difficult to meet the requirement that drug discovery, biodiversity conservation, and sustained economic growth be addressed. 2. Applications for funding as an ICBG should stress creative, synergistic approaches to biodiversity conservation, drug discovery, and sustainable economic growth. Experience has shown that synergy among these goals is more likely when the varied activities of the ICBG have significant geographical overlap than when they are widely dispersed among different regions and countries. However, legitimate scientific or other considerations may lead to less geographically localized programs. I. COMPOSITION OF GROUPS Groups should be multi-disciplinary, including individuals and organizations with expertise in various relevant disciplines of the biological and physical sciences, as well as areas such as economics and sociology, and may include those who have not collaborated in programs of this type in the past. In addition to being multidisciplinary, it is expected that Groups will be international in scope with participation of developing country institutions to the greatest extent possible. Since it is unlikely that all of the required capabilities will be located within one institution, Groups likely will be multi-institutional as well. The active participation of the private sector is encouraged because it: 1) will allow this segment of the scientific community to contribute its considerable intellectual and material resources; 2) will promote private sector participation in conservation; and 3) will facilitate efforts to negotiate conditions for the equitable distribution of profits and other benefits to all parties, including developing country institutions involved in conservation and sustainable resource use. Furthermore, the interaction of academic and non-profit institutions with industry and Government will encourage the creation of novel, interdisciplinary approaches which may not otherwise develop. 1. The composition of an ICBG is envisioned as follows: a) A Group Leader who is likely to also head an associate program. b) Associate Programs, each headed by an Associate Program Leader, in diverse scientific disciplines, such as ecology, microbiology, cell biology, ethnobiology, sociology, anthropology, botany, zoology, entomology, pharmacology or chemistry, that may be appropriate to the realization of Group objectives. A predominance of developing country and U.S. institutions composing the Associate Programs is strongly encouraged. At least one of the Associate Programs must be located in a developing country and directed by a scientist or program administrator in a developing country institution. c) The U. S. Government Coordinator (Advisory Committee Chairperson) appointed by the Technical Advisory Group to provide assistance to the Group. A schematic diagram is available that represents possible relationships among scientists, disciplines, and associate programs that might form an International Cooperative Biodiversity Group. Please refer to the FIC Biodiversity World Wide Web page for this diagram (http://www.nih.gov/fic/res/rfa.htm), or contact the Biodiversity Program Director at FIC for more information. 2. The Group Leader, in addition to providing scientific and administrative leadership, may head an Associate Program. Associate Program Leaders will be directly responsible to the Group Leader. The formation of the Group, submission of the application in response to this RFA, the overall management of the Group, and the allocation of funds to the various Associate Programs based on anticipated needs, past performance and the overall Group needs at any given time will be the responsibility of the Group Leader and the Group Leader's institution in accordance with PHS policies. 3. The composition of the Group and its Associate Programs should depend on the talents required to accomplish its scientific and technical objectives as perceived by the Group Leader and Associate Program Leaders. The major consideration in structuring an ICBG should be the maximum utilization of intellectual, physical, and financial resources to carry out the proposed research. If the Group includes more than one Associate Program on a specific topic, each should be capable of contributing high quality, necessary, and non- overlapping talents. 4. An individual scientist or a single institution may be proposed as a Group Leader in only one application. However, an individual scientist may be an Associate Program Leader in more than one application, or a Group Leader and an Associate Program Leader on separate applications. If a scientist appears on more than one application, it is the responsibility of the Group Leader to demonstrate in their applications that there are no scientific or budgetary overlaps or proprietary conflicts with each individual's proposed activities. Likewise, individuals currently receiving funding via contracts, grants, gifts, commercial arrangements, or Cooperative Agreements may be funded under this RFA providing that there is no scientific or budgetary overlap or proprietary conflict in funded activities. Any Associate Program Leader must complete their portion of the overall application in detail even if no funds are requested for his or her specific project. NSF Staff or intramural scientists at the NIH or the Department of Agriculture may participate in an ICBG as collaborators or consultants, but may not submit a formal application as an Associate Program Leader, assist in developing other portions of the application, or receive funds from this program. Such a government scientist must obtain appropriate clearances prior to submission, and in the application, provide a letter of commitment, a current curriculum vitae, and documentation of the required clearances. The Group Leader must incorporate into the application, in the usual grant format, a full description of the project, including technical details and methodology. The participation of an intramural scientist is independent of and unrelated to the role of the Advisory Committee or the U.S. Government Scientific Coordinator as described in Section J, Part 3. "Terms and Conditions of Award." 5. More than one Associate Program of a Group might be derived from a single institution. However, the varied talents and technologies required for the effective attainment of the objectives described in this RFA are not likely to be present in an individual institution. It is anticipated that the Associate Program Leaders within a Group will therefore likely be derived from several institutions. 6. No prescribed number of Associate Programs per Group is stipulated. However, the Group Leader could experience difficulty in providing the desirable level of guidance, and Group members might communicate and collaborate less efficiently, if the Group were to contain more than five or six Associate Programs. In addition, to ensure the most effective use of resources, the number of institutions collaborating in a Group should be considered carefully. 7. In forming Groups, potential Group Leaders should remain cognizant of the need for communication, including regular meetings of members, and transfer in a timely manner of data and materials to Group members located in all the participating countries. A plan for communication and material transfer, including all permits and other legal documents required to assure this transfer, must be supplied. 8. Under the provisions of assistance via a Cooperative Agreement, the U.S. Government Scientific Coordinator will assist the ICBG and participate in the Group in a manner specified in Section J. 3 "Terms and Conditions of Award ", and carry out the scientific responsibilities required. The U.S. Government Scientific Coordinator will not conduct Associate Program activities. J. SPECIAL REQUIREMENTS 1. Award Monitoring and Evaluation Progress of each funded Group will be monitored and evaluated using regular technical progress and financial reports prepared by the Group. Detailed reporting instructions are being developed in response to ongoing program reviews, and may be available from the Program Director following the deadline for receipt of a Letter of Intent. The U.S. Government Scientific Coordinator or the ICBG Program Director, with advice from the Advisory Committee, may also elect to conduct site visits or enlist the technical assistance of external consultants to review progress and work with investigators to suggest mid-course changes or recommendations for non-competitive renewal of awards. 2. Intellectual Property and Benefit-Sharing Because the discovery of bioactive agents from natural products is one objective of this effort, along with ensuring an equitable economic benefit accrues to developing country organizations or communities associated with ICBG research, it is essential that applicants develop appropriate research plans and contractual agreements for the treatment of intellectual property. These plans must ensure that inventions and the various intellectual and material contributions that lead to their development are properly protected and compensated. Experience has shown that the development of these plans and agreements is frequently complex and challenging because multiple institutions and countries are involved, often with very different objectives, perceptions and expectations, and occasionally from very different legal environments. In the application each applicant Group must, therefore, provide a detailed description of its approach to intellectual property and to the sharing of benefits from ICBG sponsored research. Descriptions should encompass both the conduct of collaborative research activities and the nature of contractual agreements among the collaborators. The research plan and contractual agreements among Group members must be designed such that they address the program principles that are detailed in Appendix 1. Prior to receiving an award formal agreements specifying the rights and responsibilities of each Group member institution must be signed and dated by the organizational official authorized to enter into such arrangements, and must be on file at the Fogarty International Center. (See Section M., "MINIMUM REQUIREMENTS FOR APPLICATION"). Proposals that represent continuation from previous ICBG awards must also provide updated, revised or new agreements prior to receiving an award. The above applies to all research carried out under this RFA, including any that may involve U.S. Government laboratories. 3. Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator (Group Leader) at the time of award. The "Terms and Conditions of Award" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH grant administration policy statements. a) Awardee Rights and Responsibilities Assistance via Cooperative Agreements differs from that of grants in that, in addition to programmatic and administrative stewardship responsibilities, the U.S. Government in awarding the Cooperative Agreement anticipates substantial scientific involvement during performance of the project. However, the Group must define its objectives and its approaches to attain these objectives in accord with its own interests, scientific creativity, capabilities and perceptions. In this process, Groups are invited to use novel and effective approaches to the interdependent program areas of drug development, biodiversity conservation and sustained economic growth. The Group must develop the details of the program design following the guidance given in this RFA. It is the primary responsibility of the Group Leader to state clearly the objectives of the Group, to direct the research and other activities stipulated in the proposal, and to ensure that the results obtained are properly disseminated, and published. It is anticipated that decisions will be reached by consensus of the Group under the leadership of the Group Leader and that the U.S. Government Scientific Coordinator will have the opportunity to offer input to this process. The Group Leader is responsible for organizing meetings of all Group members at least once per year to review progress, plan and design research and technical activities, and establis