From owner-sci-resources@net.bio.net Sun May 04 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 3 May 1997 Date: 5 May 1997 15:32:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 123 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5kln65$3p9@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending May 3, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: NSF/Tokyo Report: An Overview of Engineering Education in Japan File size (bytes): 13614 STIS Filename: int9712.txt Title: NSF/Tokyo Report: The Prospects for Interdisciplinary Studies File size (bytes): 12787 STIS Filename: int9713.txt Title: NSF/Tokyo Report: Research Report: The Ecological Roles of Soft File size (bytes): 14822 STIS Filename: int9714.txt Title: NSF/Tokyo Report: An Overview of Hazard and Disaster Research File size (bytes): 11531 STIS Filename: int9715.txt Document Type: Letter Title: Dear Colleague Letter search for ENG Program Directors File size (bytes): 4941 STIS Filename: eng973.txt Document Type: Press Release Title: Study of "MIRROR IMAGE" Molecule Supports New Approach for DRUG DESIGN File size (bytes): 4236 STIS Filename: pr9731.txt Title: NSF Recognizes 1997 National Medal of Science Winners File size (bytes): 9223 STIS Filename: pr9732.txt Title: Release and Statement on Loss of Antarctic Employee File size (bytes): 2967 STIS Filename: pr9733.txt Document Type: Program Guideline Title: NSF 96-113 - Instrumentation Grants for Research in Computer and Information Science and Engineering File size (bytes): 13962 STIS Filename: nsf96113.txt Title: NSF 97-64 Small Business Innovation Research Program File size (bytes): 249360 STIS Filename: nsf9764.txt Title: Professional Opportunities for Women in Research and Education POWRE NSF 97-91 File size (bytes): 28479 STIS Filename: nsf9791.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 100216 STIS Filename: reulist.txt Document Type: Program Guideline Title: NSF 97-2--CHEMISTRY RESEARCH INSTRUMENTATION AND FACILITIES File size (bytes): 42384 STIS Filename: nsf972.txt Title: NSF 97-57 -- 1997 Presidential Awards for Excellence in Science, Mathematics & Engineering Mentoring File size (bytes): 12455 STIS Filename: nsf9757.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9757.txt, the text of your message should be as follows: get nsf9757.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9757.txt, you would enter: ftp> get nsf9757.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-97-001 - V26(14) 05/02/97 Date: 8 May 1997 14:04:09 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 422 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ktf49$18d@net.bio.net> NNTP-Posting-Host: net.bio.net KIDNEY RESEARCH CENTERS NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA: DK-97-001 P.T. 04; K.W. 0715133, 0710030 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: August 25, 1997 Application Receipt Date: September 24, 1997 PURPOSE This Request for Applications (RFA) invites investigators to submit research grant applications for the George M. O'Brien Research Centers Program. The emphases for this program are to: (1) attract new scientific expertise into the study of the basic mechanisms of kidney diseases and disorders; and (2) encourage multidisciplinary research focused on the causes of these diseases. In approaching the study of these disease processes, it is anticipated that extensive collaboration will be required between individuals in the clinical and basic sciences, including for example investigators with training and expertise in cell biology, molecular biology, immunology, genetics, epidemiology, biochemistry, physiology, and pathology. It is the express intent of this RFA to attract new investigators not currently active in this field and to explore new basic areas that may have clinical research applications. Individual institutions with both basic and clinical research capabilities are eligible to apply. Inter-institutional collaborative research arrangements are also appropriate and encouraged. Coordination for such arrangements must be evident and clearly meaningful and appropriate for the research proposed. 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, Kidney Research Centers, is related to the priority area of chronic debilitating 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 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT Support of this program will be through the NIH specialized center (P50) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. The total requested project period for applications submitted in response to this RFA may not exceed five years. 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. FUNDS AVAILABLE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) expects to award up to three center grants (P50) for research into kidney disorders in fiscal year 1998. The anticipated awards are for five years and are contingent upon the availability of appropriated funds. The total amount of available funds to support this program is anticipated to be no more than $2.15 million per year. No applicant may request more than $750,000 in total costs (including both direct and indirect costs) in the initial budget period. A standard escalation factor may be used for subsequent budget periods. Two competing continuation applications are anticipated in response to this RFA. The budget for the first year of a competing continuation application may be increased by 10% above the direct cost budget of the last issued noncompetitive (Type 5) award. In all cases, budgets are not to exceed the $750,000 total cost cap. RESEARCH OBJECTIVES Kidney diseases and disorders place a substantial burden on individuals and on society in the United States. They threaten the health, well-being, and longevity of millions of Americans. Chronic renal failure, for example, accounted for an estimated $3.7 billion of direct hospital and physician costs in 1990. Although considerable progress has been made in understanding the basic physiology and pathophysiology of the normal renal systems, there has been only limited progress in unraveling the mechanisms of those processes that lead to progressive deterioration in the function of these systems. Nevertheless, major progress has been made in the management of their clinical consequences. For example, renal dialysis and transplantation are life saving procedures. Unfortunately, these scientific and medical advances have not led to the means to prevent or reverse the consequences of these diseases and disorders; moreover, their incidence is steadily increasing. The proposed multidisciplinary research centers should help to provide an environment for investigators to apply the necessary and appropriate expertise to topical areas of research, related to the pathogenesis of kidney diseases such as: immunologically mediated diseases, diabetes mellitus and other endocrine and metabolic disorders, primary renal hypertension, genetic abnormalities, and nephrotoxins and toxic cell injury. SPECIAL REQUIREMENTS Successful applicants are expected to attend a yearly meeting of Center Directors convened by the NIDDK. Funds to support travel to this meeting may be requested in the budget proposed for the center. 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 sub-populations 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 Vol. 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by August 25, 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 NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. 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. Applications must include the following items: Applicants are to follow the NIDDK Program Project Grants Guidelines (July 1996) for preparation of the Grant Application, Chapter 3. Copies of the Guidelines are available from the Program Director listed under INQUIRIES. Each Research Project proposed (Section F - NIDDK Guidelines) is limited to 25 pages of text. Applications should contain the following: o A Table of Contents o A Rationale for the Proposed Center and a Statement of Objectives. o Institutional Environment and Resources. o Organization and Administrative Structure of the Center. o Specific Managerial Responsibilities for the Center. o Travel funds in the proposed budget for an annual meeting of Center Directors. o A description of the method for the replacement of the Center Director (should the need arise). o A description of the proposed research projects. o A description of the proposed cores. o A description of the procedure to be used for the addition/deletion of cores and projects during the proposed period of operation. o A description of the administrative relationship of the Center to the applicant institution. 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, plus 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 time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 BETHESDA, MD 20892-6600 Applications must be received by September 24, 1997. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed for completeness and responsiveness. Incomplete applications and/or non-responsive applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. Unsolicited material received after September 24, 1997 will not be accepted. 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 NIDDK 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 will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Advisory Board. The review criteria for individual research projects include: o The scientific, technical or medical significance and originality of the proposed research. o The feasibility and adequacy of the experimental design; o The qualifications and research experience of the proposed personnel; o The availability of resources necessary for the research; o The appropriateness of the budget and timetable in relation to the scope of the proposed research. o 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. The review criteria for scientific cores include: o The appropriateness and utility of the core to the proposed Center. o The quality of the proposed facilities or services including administrative arrangements for utilizing the core. o The qualifications, experience, and commitment of the personnel involved in the core. o The appropriateness of the budget. Note: Each core unit must provide facilities or services to at least two research projects recommended for approval; The review criteria for the overall Center program include: o The scientific merit of the program as a whole. o The significance of the overall goals of the Center. o The cohesiveness and multidisciplinary scope of the Center and the coordination and interrelationship of the projects and cores to the common theme of the Center; o The leadership, scientific expertise, and commitment of the proposed Center Director. Administrative considerations include: o The institutional environment for and resources available to Center investigators. o The institutional commitment to the proposed Center. o The administrative leadership necessary to provide for the quality control of supported projects in the Center, the allocation of funds, and the ability to foster communication and cooperation among Center investigators. o The appropriateness of the budget in relation to the proposed activities of the Center. o The adequacy of addressing the protection of human subjects, animal welfare, and biohazard issues. Competing Continuation Applications Applicants are to follow the NIDDK Program Project Grants Guidelines (July 1996) for preparation of the Grant Application, Chapter 4, Part B and Part C. Copies of the Guidelines are available from the Program Director listed under INQUIRIES. For the purposes of this RFA a distinction between a P50 grant and a P01 grant is made as follows: Research projects supported by the P50 center award are of uniformly high scientific merit, and are generally related to central issues in kidney diseases and disorders. Each project should be directed to the development of fundamental knowledge leading to understanding disease processes and the design of curative or preventative strategies. The P50 grant mechanism provides an opportunity to approach multi- disciplinary basic research in a synergistic fashion. Close cooperation, communication, and collaboration among all center personnel of many professional disciplines are characteristics of a successful P50 center. In comparison, each research project of the P01 Program Project Grant must contribute to or be directly related to a clearly defined central unifying theme of the total research effort. The projects should demonstrate essential elements of unity and interdependence. Schedule Letter of Intent Receipt Date: August 25, 1997 Application Receipt Date: September 24, 1997 Initial Review: February/April 1998 Second Level Review: May 1998 Anticipated Date of Award: September 1, 1998 AWARD CRITERIA The earliest 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 Center as determined by peer review and the 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: Ralph L. Bain, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-19 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: bainr@ep.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Ms. Helen Ling Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-44F - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8857 FAX: (301) 480-3504 Email: lingh@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. 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 Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-009 - V26(14) 05/02/97 Date: 8 May 1997 14:03:57 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 461 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ktf3t$167@net.bio.net> NNTP-Posting-Host: net.bio.net NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA: HL-97-009 P.T. 44, K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: July 1, 1997 Application Receipt Date: August 25, 1997 PURPOSE This National Research Service Award Program (NRSA) is intended to train graduate students, health professional students, and postdoctoral students in minority schools that have the potential to develop a meritorious program in cardiovascular, pulmonary, or hematological diseases, and/or sleep disorders for research careers in these areas. Graduate students, health professional students, and postdoctoral students in minority schools need further opportunities to develop biomedical and behavioral research skills. The Minority Institutional National Research Training Program is designed to attract students in their developmental stages and to increase their awareness of cardiovascular, pulmonary, and hematologic diseases, and sleep disorders, and to encourage them to pursue research career opportunities. 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, Minority Institutional Research Training Program, is related to the priority areas of heart disease and stroke, tobacco, educational and community-based programs, environmental health, maternal and infant health, diabetes and chronic disabling diseases, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-1 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 Minority School The Institution must be a domestic medical or non-medical college, university or equivalent school in which students from underrepresented minority groups including Blacks, Hispanics, American Indians, Alaska Natives, and Pacific Islanders comprise a majority or a significant proportion of the school enrollment. It must have ongoing staff and facilities required for the proposed program. The program director at the minority school will be responsible for the selection and appointment of trainees and the overall direction of the training program. Trainees The individual to be trained must be a citizen of the United States, a non-citizen national, or have been lawfully admitted to the United States for permanent residence at the time of appointment for training, and have a baccalaureate degree. Trainees must be enrolled at the post-baccalaureate level (i.e., predoctoral level) in a relevant doctoral program in biomedical or behavioral sciences or the must be enrolled in a minority health professional school, or have a doctoral degree or equivalent in a biomedical or behavioral science. The Minority Institutional Research Training Program may not support studies leading to a health professional degree. Research trainees who have or are pursuing clinical degrees are expected to devote their time to research training and to confine clinical duties to those which are a part of the research training. Research Center The minority institution must identify and collaborate with a research center (medical school or comparable institution) that has strong, well-established cardiovascular, pulmonary, hematologic, or sleep disorders research and research training programs. Cooperation between institutions is needed to provide each trainee with a mentor who is recognized as an accomplished investigator in cardiovascular, pulmonary, hematologic or sleep disorders research and who will assist the advisor at the minority institution in the trainee's development and research plan. Plans for summer training as well as academic year training should be developed by the student and advisor at the trainee's home institution in collaboration with the mentor at the research center. It is expected that both advisor and mentor will guide the trainee through the initial training period and continue this interaction throughout the award. MECHANISM OF SUPPORT The RFA will use the National Institutes of Health (NIH) Institutional National Research Service Award (NRSA) grant (T32) mechanism. Responsibility for the planning, direction, and execution of the proposed training program will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and the availability of funds. Indirect costs will be awarded based on eight percent of total direct costs exclusive of equipment, tuition, and fees. The anticipated award date is May 1, 1998. The Minority Institutional Research Training program may support predoctoral students, postdoctoral trainees, and short-term trainees in health professional schools. Stipend levels for predoctoral and short-term trainees are $11,496 per year and stipend levels for postdoctoral trainees range from $20,292-$32,300 per year. Stipends may be supplemented from non-Federal sources. Training related expenses ($1,500 annually for predoctoral trainees and $2,500 annually for postdoctoral trainees), tuition and fees, and travel expenses ($800 per year) may also be requested for trainees, although the levels may vary depending on the type of training to be supported. The trainees may be appointed to the training program for 9-12 months periods (for short-term trainees, the period of appointment may be of two to three months duration) at any time during the course of the ear after acceptance as a full-time student. A strong interest in a cardiovascular, pulmonary, hematologic, or sleep disorders research career must be evident. Trainees are encouraged to be appointed to the training for at least two years, in order to obtain adequate training. RESEARCH OBJECTIVES Background Many studies have emphasized the need for minority individuals to participate in modern research activities to develop their investigative talents. There are existing programs at the National Institutes of Health that are designed to answer this need, such as the Minority Biomedical Research Support Program, the Minority Access to Research Careers Program, and the Minority Research Supplement Program. Even though these programs are successful in meeting their specific objectives and career development goals, graduate students, health professional students, and individuals in postdoctoral training in minority schools need further opportunities to develop biomedical and behavioral research skills. The Minority Institutional Research Training Program is designed to offer research training grant awards in cardiovascular, pulmonary, hematologic, and sleep disorders research to minority schools to enable qualified graduate students, health professional students, and individuals in postdoctoral training to participate in research programs. It is expected to attract students in their developmental stages, increase their awareness of these diseases, and to encourage them to pursue career opportunities in research related to the mission of the National Heart, Lung, and Blood Institute (NHLBI). Within NHLBI, the term "hematologic" covers research on thrombosis and hemostasis, immunohematology, blood cell disorders, sickle cell disease, blood resources including blood component and derivative therapy, blood substitutes and blood resource management, aspects of AIDS-products in AIDS prevention and treatment, and AIDS-related bone marrow and hematologic disorders. Other Institutes of the NIH are responsible for research on disorders of white cells, including the leukemias and other blood malignancies, and basic immunology related to the lymphoid system. Therefore NHLBI cannot provide support for such studies. Implementation Minority institutions will compete for Institutional National Research Service Awards (NRSA) of up to five years' duration. Funds will be provided on an annual basis to develop and maintain a stable research training experience for qualified students. Awards recommended for the continuation years will be made contingent upon satisfactory progress during the preceding year, upon the availability of funds, and the requisite level authorization for continued support of training activities. Successful applicants may compete for a second award of up to five years' duration upon completion of the initial grant period. The minority institution will identify and complete arrangements with an established cardiovascular, pulmonary, hematologic, or sleep disorders research center(s) before submitting an application. Predoctoral trainees appointed to the grant may receive support for up to five years. Postdoctoral trainees appointed to the grant may receive support for up to three years. The trainee and his or her faculty advisor at the minority institution will jointly select a faculty mentor at the research center. A written commitment to the training plan signed by the intended faculty mentors at the research center, the department(s) involved and countersigned by both institutional officials, must be part of the application. Students may spend not more than 50% time at the research training center over the course of the year, including a period of intensive research training during the summer. Students are expected to pursue their research training on a full-time basis devoting no less than 40 hours per week as specified by the sponsoring institution in accordance with its own policies. Students are expected to meet the degree requirements at their institution. Because the research training environment provides a powerful context in which to promote responsible research practices, all competing Institutional NRSA research training grant applications must include a description of formal or informal activities or instruction related to the responsible conduct of research that will be incorporated into the proposed research training program. LETTER OF INTENT Prospective applicants are asked to submit by, July 1, 1997, a letter of intent that includes 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 allows NIH 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. C. James Scheirer, at the address listed under APPLICATION PROCEDURES. APPLICATION PROCEDURES Submit applications on Form PHS-398 (Rev. 5/95) using substitute pages for the Institutional National Research Service Award. This form is available at the applicant institution's office of sponsored research. An application may also be obtained from the NIH Office of Extramural Research, (301-435-0174, E-mail to asknih@odrockm1.od.nih.gov). When submitting the application, identify the NHLBI Minority Institutional Research Training Program on the face page. Special supplemental instructions for preparing the application are included in the full program guidelines. Applicants must contact the appropriate individual listed under the Program information section for a copy of these guidelines prior to preparation of the application. Send the completed application and four (4) signed exact photocopies by August 25, 1997 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 service) One additional copy of the application must be sent to: Dr. C. James Scheirer Chief, Review Branch NHLBI Research Training Review Special Emphasis Panel Division of Extramural Affairs, NHLBI 6701 Rockledge Drive, MSC 7924 Bethesda, Maryland 20892-7924 Telephone (301) 435-0288 FAX: (301) 480-3541 Internet Address: james_scheirer@nih.gov REVIEW CONSIDERATIONS All applications responding to this announcement will be reviewed for scientific and technical merit by the Research Training Review Special Emphasis Panel of the Division of Extramural Affairs, NHLBI, followed by a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria The factors to be considered in the evaluation of the proposed training program are: Adequacy of faculty, facilities, and resources for the proposed research training, both at the minority institution and the established research center; Adequacy of the cooperative arrangements between the minority institution and the established research center; Commitment of the relevant faculty and the two institutions to the goals of the training program; and Procedures for evaluation of the impact of the program on the trainees involved. PROVISIONS OF THE AWARD The trainees may be appointed for 9-12 months at any time during the course of the budget period. Students must have been accepted on a full-time basis. A strong interest in a cardiovascular, pulmonary, hematologic, or sleep disorders research career must be evident. Short-term training positions for health professional students are allowed under this program. Funds may be requested for: Stipends - The current stipend level for graduate and health professional student trainees at all levels of experience is $11,496 per year. Current stipend levels for postdoctoral trainees range from $20,292 - $32,300 per year, depending on experience. Tuition, Fees, and Medical Insurance (individual coverage) when regularly charged to all students regardless of their source of support, are allowable trainee costs. Please refer to Detailed Budget under Supplemental Instructions for additional information. Trainee Travel Costs - The institution may request funds to cover the costs of trainee travel including attendance at scientific meetings that are necessary to the individual's training. The maximum allowable per student per year is $800. Funds for commuting expenses that are clearly in excess of those incurred during the usual home to work travel of the trainee may also be requested. Training-Related Expenses - Funds are provided to partially defray the cost of training such as staff salaries, equipment, research supplies, staff travel, and other expenses. The current level of training related expenses is $1,500 per annum per full-time graduate student trainee or health professional student trainee, and $2,500 per annum for postdoctoral trainees. Facilities and Administrative (Indirect) Costs - The Notice of Grant Award will provide facilities and administrative (indirect) costs based on 8% of total direct costs, exclusive of equipment, and tuition and fees. Payback Agreement - The NIH Revitalization Act of 1993 substantially modified the service payback requirement for individuals supported by the NRSA program. Beginning with new appointments and reappointments made on or after June 10, 1993, the following new guidelines will apply: Predoctoral trainees will not be required to sign the Payback Agreement Form (PHS Form 6031) and will not incur a service payback obligation. All postdoctoral trainees must sign an agreement to fulfill the NRSA payback requirements when they are appointed initially to a training grant or receive an individual fellowship. Postdoctoral trainees in the first twelve months of postdoctoral NRSA support must sign the payback agreement form and will incur one month of payback obligation for each month of support. Postdoctoral trainees in the thirteenth and subsequent months of NRSA support will not sign the Payback Agreement Form and will incur no obligation for that support. The thirteenth and subsequent months of postdoctoral NRSA support will be considered acceptable payback service for prior postdoctoral support. Individuals who are appointed to their initial NRSA postdoctoral period on or after June 10, 1993, and continue under that award for two years will have fulfilled their first year obligation by the end of the second year. Service payback obligations can also be paid back by engaging in health-related research and/or teaching that averages more than 20 hours per week of a full year. AWARD CRITERIA The following will be considered in making funding decisions: o Technical merit of the application as determined by peer review; o Availability of funds; o Program balance among the research areas of the announcement. INQUIRIES Special supplemental instructions for preparing the application are included in the full program guidelines. Applicants must contact the appropriate individual listed below for a copy of these guidelines prior to preparation of the application. Michael Commarato, Ph.D. or Beth Schucker, M.A. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7940 Bethesda, Maryland 20892-7940 Telephone: (301) 435-0530 FAX: (301) 480-1454 Internet Address: michael_commarato@nih.gov or beth_schucker@nih.gov Mary Reilly, M.S. or Ann Rothgeb Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7952 Bethesda, Maryland 20892-7952 Telephone (301) 435-0222 FAX: (301) 480-3557 Internet Address: mary_reilly@nih.gov or ann_rothgeb@nih.gov Joyce Creamer, MBA or Bette Houston Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7950 Bethesda, Maryland 20892-7950 Telephone: (301) 435-0064 FAX: (301) 480-1046 Internet Address: joyce_creamer@nih.gov or bette_houston@nih.gov Thomas Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7838 Bethesda, Maryland 20892-7838 Telephone: (301) 435-0433 Internet Address: thomas_blaszkowski@nih.gov James P. Kiley, Ph. D. National Center for Sleep Disorders Research National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Internet Address: james_kiley@nih.gov Direct inquiries regarding fiscal matters to: William W. Darby Grants Operations Branch, Heart Section Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0177 FAX: (301) 480-3310 Internet Address: william_darby@nih.gov Raymond L. Zimmerman Grants Operations Branch, Lung Section National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0171 Internet Address: raymond_zimmerm@nih.gov Jane Davis Grants Operations Branch, Blood Section Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Phone: (301) 435-0166 Internet Address: jane_davis@nih.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance numbers 93.837, 93.838, 93.839, and 93.231. Awards are made under the authority 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 at 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 Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-008 - V26(14) 05/02/97 Date: 8 May 1997 14:03:44 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 514 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ktf3g$157@net.bio.net> NNTP-Posting-Host: net.bio.net NHLBI SHORT-TERM RESEARCH TRAINING FOR MINORITY STUDENTS PROGRAM NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA: HL-97-008 P.T. 44, FF; K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: July 1, 1997 Application Receipt Date: August 25, 1997 PURPOSE This program provides short-term research support to minority underrepresented undergraduate students, graduate students, and students in health professional schools to provide them with career opportunities in cardiovascular, pulmonary, and hematologic diseases, and sleep disorders research. The grant provides training experiences of 2-3 consecutive months and exposes talented students to the various possibilities in pursuing a biomedical research career. 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, Short-Term Training for Minority Students Program, is related to the priority areas of Heart Disease and Stroke, Tobacco, Educational and Community-Based Programs, Environmental Health, Maternal and Infant Health, Diabetes and Chronic Disabling Diseases, and HIV Infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001- 00474-1) through or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Applicant Institutions Domestic non-federal private or public nonprofit institutions or organizations engaged in health related research may apply for grants. The applicant institution must have the available research facilities, personnel, and support for the program in either the cardiovascular, pulmonary, hematologic diseases or sleep disorders area. Minority institutions with adequate staff and resources in these research areas are encouraged to apply. Only one application per health professional school may be submitted for a given receipt date and a health professional school may have only one active NHLBI Short-Term Training for Minority Students award at any time. Trainees The grantee institution will be responsible for the selection and appointment of trainees. Underrepresented minority students are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. In making awards, NHLBI may give priority to those programs involving Black, Hispanic, American Indian, Alaska Native, and Pacific Islander or other ethnic or racial group members who have been found to be underrepresented in biomedical and behavioral research nationally. Trainees should have successfully completed at least one undergraduate year at an accredited school or university (including baccalaureate schools of nursing) or have successfully completed one semester at a school of medicine, optometry, osteopathy, dentistry, veterinary medicine, pharmacy or public health or an institution with an accredited graduate program, prior to participating in the short term training program. These grants are intended to introduce students to research that would not otherwise be available through their regular course of studies. For graduate students, this may include students in programs such as mathematics, where they would not normally be exposed to biomedical research, or students who may need a specialized research experience to supplement their normal education. Individuals holding Ph.D., M.D., D.V.M. or equivalent doctoral degrees in the health sciences are not eligible. Trainees must be citizens or noncitizen nationals of the United States, or must have been lawfully admitted for permanent residency (i.e., in possession of the Alien Registration Receipt Card) at the time of appointment. Individuals on temporary or student visas are not eligible. Trainees need not be affiliated with the applicant institution. The applicant's program can be designed to include research experiences for minority individuals at the applicant institution but applicants are strongly encouraged to propose a program that includes a number of individuals from other institutions, schools, colleges or universities. The only requirement for student selection is that the trainees fulfill the above referenced eligibility requirements. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) National Research Service Award Short-Term Research Training grant (T35) mechanism. Responsibility for the planning, direction, and execution of the proposed training program will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and the availability of funds. Facilities and administrative costs will be awarded based on eight percent of total direct costs exclusive of equipment and tuition and fees. The anticipated award date is May 1, 1998. Institutions may request support for at least four but not more than 24, short-term trainees per year. The requested number of short-term trainees must be justified in the application. Trainees may be minority undergraduate, graduate, or health professional students. The stipend level for trainees is $958 per month. Stipends may be supplemented from non-federal funds. Training-related expenses up to $125 per month per trainee may be requested. In addition, up to $250 per month per trainee may be requested to cover the cost of housing at the training site. Trainee tuition and fees, where necessary to the research training, must be covered by the Training Related Expenses. RESEARCH OBJECTIVES Background There is a need for minority students to participate in research activities to develop their investigative talents and increase the pool of accomplished minority biomedical investigators. In 1991, 108 Ph.D.s in the natural sciences were awarded to Blacks. Academic positions totaled 1177 Blacks (1.7%) and 1113 Hispanics (1.6%) in the life sciences out of a total of 69,122 individuals. In medical schools, there were 1748 Black (2.3%) and 2087 Hispanic (2.8%) faculty members in 1993. Blacks represented 7.4% of the total enrollment in medical schools in 1993. Although there is strong interest in the scientific community in attracting minority students into research careers, few minority students opt for science degrees and research careers, and few minority graduates of health professional schools go on to investigative careers. The shortage of qualified minority investigators in research positions may even exacerbate the situation due to a lack of visible role models for students. There are existing programs at the National Institutes of Health that are designed to answer the need for more minority investigators. These include the Minority Biomedical Research Support Program, the Minority Access to Research Careers Program, the NHLBI Minority Institutional Research Training Grant, Predoctoral Fellowship Awards for Minority Students, Mentored Research Scientist Development Award for Minority Faculty, Minority Institution Faculty Mentored Research Scientist Development Award, and the Minority Investigator Research Supplement Program. Although these programs are successful in meeting their specific objectives and career development goals, the need to attract minority students to research careers continues to exist. This NHLBI Short-Term Training for Minority Students program is designed to provide opportunities for underrepresented minority students at the undergraduate and graduate level to become exposed to biomedical research in areas relevant to cardiovascular, pulmonary, and hematologic diseases and sleep disorders through a short-term research experience. Within NHLBI, the term "hematologic" covers research on thrombosis and hemostasis, immunohematology, blood cell disorders, sickle cell disease, blood resources including blood component and derivative therapy, blood substitutes and blood resource management, aspects of AIDS products in AIDS prevention and treatment, and AIDS-related bone marrow and hematologic disorders and the lymphocirculatory system. Other Institutes of the NIH are responsible for research on disorders of white cells, including the leukemias and other blood malignancies, and basic immunology related to the lymphoid system. Therefore NHLBI cannot provide support for such studies. Program Elements Each institution is invited to develop an application that is best suited to its own strengths and characteristics. Applicant institutions need not propose a program that encompasses all types of students, i.e., undergraduate, graduate, and health professional students, but specific types of students should not be excluded without careful consideration and justification. The goal is to identify a cadre of minority students with the potential to pursue careers in biomedical and biobehavioral research in the areas of heart, lung, blood diseases, transfusion medicine, and sleep disorders, and provide the students with a research training experience that may stimulate interest in pursuing a research career. If the proposed area of research is not obviously related to the areas indicated, the principal investigator should explain the benefits of training students in areas not within the mission of the National Heart, Lung, and Blood Institute. The training program director and participating faculty should have a demonstrated record of success in conducting research and in working with research trainees. Each application should describe a plan for widely advertising the program to ensure active competition for appointments. Special attention should be given to the recruitment of individuals from minority groups that now are underrepresented nationally in the biomedical and behavioral sciences, i.e., Blacks, Hispanics, American Indians, Alaska Natives, and Pacific Islanders. The strategy for recruitment is left to the discretion of the applicant institution. The overall training is not restricted to activities in a single discipline or department but should be centered on research activities in the areas of cardiovascular, pulmonary, hematologic diseases, and sleep disorders. The choice of participating training sites and mentors should be carefully described, to show that the institution's best environments and role models have been selected. It is expected that students will be assigned to the institution's strongest research and training programs, which may involve basic or clinical research or a combination of both. For those training programs that include undergraduate students, emphasis should be on providing an interesting, informative, inspiring, and stimulating research experience with close supervision in a nurturing environment. At the end of the research experience, the undergraduate students may be required to write a paper or present a poster of their research endeavors. More rigorous intellectual endeavors, such as research presentations, should be carefully considered, depending on the enthusiasm and talent of the individual trainee. Each institution will be expected to encourage among the trainees a sense of belonging to a community of scientists. Among the methods that may be used is providing a special seminar series, addressing such topics as research methodology, instrumentation, experimental design, grantsmanship, research ethics, scientific publications, etc. A plan for evaluating the impact of the program on the institution and the trainee is required. Grants will be awarded to support no fewer than 4, and not more than 24 trainees per budget period, based on a full-time three month appointment. A trainee may be appointed for a minimum of two months and a maximum of three months during a budget period; however, institutions are encouraged to appoint a trainee for more than one budget period, e.g., two or more successive summer research experiences. A student may be appointed, in special circumstances, to more than one 3-month period during a budget period, provided prior approval is obtained from the staff of the NHLBI. All research training must be full-time during the specific training sequence. It is expected that most programs will be designed to provide a summer research experience but other innovative program designs and time schedules will be considered. Authority: Under authority of Section 487 of the Public Health Service Act as amended (42 USC 288), the National Heart, Lung, and Blood Institute awards National Research Service Award (NRSA) Short-Term Training Students in Health Professional Schools (STSHPS) institutional grants. These grants, by supporting short-term research training experiences of two to three consecutive months, expose talented students in health professional schools to the opportunities inherent in a research career. The Short-Term Training for Minority Students program is based on the STSHPS program and is designed to help ameliorate the shortage of minority biomedical and biobehavioral investigators in the areas of heart, lung, and blood diseases and sleep disorders by attracting minority students in their developmental stages, increasing their awareness of heart, blood vessel, lung, blood diseases, transfusion medicine, and sleep disorders and acquainting them with career opportunities in biomedical and behavioral research. LETTER OF INTENT Prospective applicants are asked to submit, by July 1, 1997, a letter of intent that includes 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 allows NIH 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. C. James Scheirer, at the address listed under APPLICATION PROCEDURES. APPLICATION PROCEDURES Submit applications on Form PHS-398 (Rev. 5/95), Application for Public Health Service Grant, using the Institutional National Research Service Award substitution pages NN-PP. This form is available at the applicant institution's office of sponsored research. An application may also be obtained from the NIH Office of Extramural Research (301-435-0714; E-mail: asknih@odrockm1.od.nih.gov). When submitting the application, identify the NHLBI Short-Term Training for NHLBI Minority Students Program, on the face page in item 1, and the RFA number HL-97-008 in item 2. Special supplemental instructions for preparing the application are included in the full program guidelines. Applicants must contact the appropriate individual listed under the inquiries section for a copy of these guidelines prior to preparation of the application. Send the completed application and four (4) signed exact photocopies by the announced receipt date (August 25, 1997) 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 service) One additional copy of the application must be sent to: Dr. C. James Scheirer Chief, Review Branch NHLBI Research Training Review Special Emphasis Panel Division of Extramural Affairs, NHLBI 6701 Rockledge Drive, MSC 7924 Bethesda, Maryland 20892-7924 Telephone: (301) 435-0288 FAX: (301) 480-3541 REVIEW CONSIDERATIONS All applications responding to this announcement will be reviewed for scientific and technical merit by the Research Training Review Special Emphasis Panel of the Division of Extramural Affairs, NHLBI, followed by a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria The factors to be considered in the evaluation of the proposed training program are: Design of the proposed training program; Qualifications, dedication, and previous training record of the program director and participating faculty; Adequacy of facilities, environment, grant support, and other resources for the proposed research training; Feasibility of proposed methods of recruiting, selecting and assigning minority students; Commitment of the institution and participating faculty to the objectives of the training program; Procedures for evaluation of the effectiveness of the program and the impact of the program on the students involved and its impact on the institution; and Plans for tracking students. PROVISIONS OF THE AWARD Period of Support Institutions applying for a new or a competitive renewal Short-Term Training for Minority Students grant may request up to five years of support. The earliest start date is May 1. Trainee Expenses The stipend level for trainees is $958 per month. Stipends may be supplemented by an institution from non-Federal funds. No Federal funds may be used for stipend supplementation unless specifically authorized under the terms of the program from which the supplemental funds are derived. Under no circumstances may the conditions of stipend supplementation detract from or prolong the training. Trainee Related Expenses Up to $125 per month for each participating student may be requested to defray other costs of training, such as staff salaries, consultant costs, research supplies, etc. Trainee tuition and fees, where necessary to the research training, must be covered by the Training Related Expenses. Trainee Travel Expenses Up to $500 per year per trainee may be requested to cover domestic trainee travel to and from the training site. In addition, up to $250 per month per trainee may be requested to cover housing costs for trainees. Facilities and Administrative (Indirect) Costs Facilities and administrative (indirect) costs for short-term training grants will be reimbursed at 8 percent of total allowable direct costs. Trainee Reporting Requirements A Statement of Appointment form (PHS 2271, rev.1/95) must be submitted at the start of each trainee appointment and reappointment. Individuals supported under this program are not required to sign an NRSA Payback Agreement or submit an NRSA Termination Notice. Applicants for competitive renewal applications will be required to provide information concerning past trainees in the program, the accomplishments of the program, trainee publications, and whether students supported by the program have pursued research careers. Other Terms and Conditions Except as modified by this announcement, the terms and conditions in the National Research Service Awards, Guidelines for Individual Awards - Institutional Grants (January 6,1984), as amended, will be applicable to grants made under this program. AWARD CRITERIA The following will be considered in making funding decisions: o Technical merit of the application as determined by peer review; o Availability of funds; o Program balance among the research areas of the announcement. INQUIRIES Special supplemental instructions for preparing the application are included in the full Program Guidelines. Applicants must contact the appropriate individual listed below for a copy of these guidelines prior to preparation of the application. Michael Commarato, Ph.D. or Beth Schucker, M.A. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7940 Bethesda, Maryland 20892-7940 Telephone: (301) 435-0530 FAX: (301) 480-1454 Internet Address: michael_commarato@nih.gov or beth_schucker@nih.gov Mary Reilly, M.S. or Ann Rothgeb Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7952 Bethesda, Maryland 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Internet Address: mary_reilly@nih.gov or ann_rothgeb@nih.gov Joyce Creamer, MBA or Bette Houston Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7950 Bethesda, Maryland 20892-7950 Telephone: (301) 435-0064 FAX: (301) 480- 0146 Internet Address: joyce_creamer@nih.gov or bette_houston@nih.gov Thomas Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7838 Bethesda, Maryland 20892-7838 Telephone: (301) 435-0433 FAX: (301) 480-1455 Internet Address: thomas_blaszkowski@nih.gov James P. Key, Ph.D. National Center for Sleep Disorders Research National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7920 Bethesda, Maryland 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Internet Address: james_kiley@nih.gov Direct inquiries regarding fiscal matters to: William W. Darby Grants Operations Branch, Heart Section Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0177 FAX: (301) 480-3310 Internet Address: william_darby@nih.gov Raymond L. Zimmerman Grants Operations Branch, Lung Section National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Internet Address: raymond_zimmerm@nih.gov Jane Davis Grants Operations Branch, Blood Section Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 Internet Address: jane_davis@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance numbers 93.837, 93.838, 93.839 and 93.231. Awards are made under the authority 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 at 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 102-277, 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 Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA NOT-97-005 - V26(14) 05/02/97 Date: 8 May 1997 14:02:23 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 92 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ktf0v$s2@net.bio.net> NNTP-Posting-Host: net.bio.net FUNDING STRATEGIES FOR FY 1997 NIH Guide, Volume 26, Number 14, May 2, 1997 P.T. 34; K.W. 1014006 National Institutes of Health The information provided below will guide the NIH Institutes and Centers (IC) in their funding decisions on Research Project Grants in FY 1997. Research Projects are primarily investigator-initiated basic science research, including R01s, R03s, R29s, P01s and U01s. This group does not include SBIR/STTR awards. The core principles, which are not specifically associated with FY 97, remain essentially the same as in recent years. The funding strategies reflect some changes due to the FY 97 appropriation level and associated congressional directives. Core Principles 1. Grants will be awarded on the basis of reasonable and allowable costs consonant with the principles of sound cost management and in consideration of Institute or Center priorities, constraints on the growth of average grant costs, and the availability of funds. 2. The award of noncompeting research project grants at committed levels continues to be the cornerstone of the NIH Financial Management Plan and is the basis of the plan~s credibility with the scientific community and Congress. 3. Determination of commitments for future years must take into consideration stability of support for investigators, optimum portfolio balance, and opportunities to address emerging problems. Fiscal Year 1997 Funding Strategies 1. The direct cost level for the future years of FY 1997 new and competing continuation awards, on the average, will not exceed the direct cost level of the previous budget period by more than 3 percent. The 4 percent adjustment factor used to calculate future year direct costs for grants made prior to FY 97 will remain in effect (see 2. below). NIH staff may make exceptions for specifically justified programmatic requirements and one-time, non- recurring costs such as equipment. 2. For noncompeting grants, every effort will be made to make awards at the committed levels. If fiscal conditions in an IC are such that funding at the committed levels is not possible, the IC will consult with the Deputy Director for Extramural Research, NIH, to determine an appropriate resolution. 3. For competing grants, budgetary reductions from the requested level will be achieved through a combination of initial review and Council/Board recommendations, staff review for cost allocability, allowability, and reasonableness, and programmatic adjustments to arrive at an appropriate funding level. Each IC will develop a plan that specifies the general rationale and methodology for adjustments based on programmatic considerations. This plan will be available as part of the IC official program file. 4. Based on adjustments to the project, IC staff, in consultation with the principal investigator, will decide if a new statement of specific aims is required. When reductions are 25% or more below the IRG recommended level, staff will obtain a revised statement of specific aims, a revised budget and/or revised timetable, as appropriate for the project, which must be approved and countersigned by the institution, and approved by program and grants management staff. This material serves as documentation of budgetary and programmatic adjustments described in this paragraph and in item (3) above. To ensure initial review group understanding of the modified scope of a funded project, the approved statement of revised aims should be submitted by the investigator in competing continuation grant applications. 5. For competing continuation grants, one factor in arriving at the award amount will be the level of support in prior years and the extent to which the IC can permit growth within the existing constraints on average costs. 6. The average length of research project grants will not exceed four years. 7. In making funding decisions, ICs will consider the total costs of a grant, especially for those grants near the IC funding payline. INQUIRIES For further information, contact the Grants Management Specialist or Health Scientist Administrator responsible for your award. Their names and telephone numbers are indicated on the Notice of Grant Award. From owner-sci-resources@net.bio.net Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AG-97-005 - V26(14) 05/02/97 Date: 8 May 1997 14:01:59 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 626 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ktf07$r7@net.bio.net> NNTP-Posting-Host: net.bio.net EDWARD R. ROYBAL CENTERS FOR RESEARCH ON APPLIED GERONTOLOGY NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA: AG-97-005 P.T. 04; K.W. 0710010, 0404000 National Institute on Aging Letter of Intent Receipt Date: July 24, 1997 Application Receipt Date: October 24, 1997 PURPOSE This Request for Applications (RFA) seeks applications in support of the Edward R. Roybal Centers for Research on Applied Gerontology. The Roybal Centers program's purpose is to facilitate the process of translating basic behavioral and social research theories and findings into practical outcomes that will benefit the lives of older people. The Roybal Centers focus on strategies to improve quality of life, enhance productivity, and minimize the need for care. The Roybal Centers have an emphasis distinct from the clinical and biomedical approaches that are sponsored through the Claude D. Pepper Older Americans Independence Centers (RFA AG-96-003, NIH Guide for Grants and Contracts, Vol. 25, No. 12, April 19, 1996). 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 priorities. This RFA, Centers of Research on Applied Gerontology, addresses several priority areas including chronic disabling conditions, physical activity and fitness, violent and abusive behavior, and unintentional injuries as they relate to older people. 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 Domestic, public and private, for-profit and non-profit institutions and organizations, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government are eligible to respond to this RFA. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible to apply. The principal investigator (PI) is required to have held, or to now hold, at least two R01 (or similar grants including a competing continuation as separate) grants as principal investigator. These grants must have been awarded as new or competing continuation awards within 10 years of the receipt date of this RFA. The investigative team, including the PI, is required to have held, or to hold, at least three such awards in the same interval. Questions about eligibility may be referred to the program contact listed under INQUIRIES. MECHANISM OF SUPPORT The support mechanism for these awards will be the specialized center (P50) mechanism. Such awards support activities that comprise a multidimensional approach to a particular problem area. A maximum of five years of support may be requested. At that time, funds may be available for competitive renewal of the Centers. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded in connection with this RFA. FUNDS AVAILABLE An estimated $2,500,000 to $3,000,000 will be made available in Fiscal Year 1998 to support awards made under this RFA. It is expected that up to six awards will be made at a maximum of $400,000 direct costs per award in the first year, exclusive of facilities and administrative costs on consortia. Budget increments for subsequent years will be limited to no more than two percent. Applications with budget requests exceeding this amount will not be accepted by the NIA and will be returned to the applicant. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Awards pursuant to the RFA are contingent upon the availability of funds for this purpose. The NIA 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 NIA. RESEARCH OBJECTIVES Researchers are encouraged to seek funding to apply the theories, paradigms, and methodology of the behavioral and social sciences to address practical problems of late middle aged and older people, such as at work, in the home, in transportation, in health care, or in other areas of concern to the population. The focus of this initiative is on translating research results from basic behavioral and social science into practical benefits for older adults. The organizing principle behind each center should reflect this aim of establishing a pattern of research translation from basic research to practical outcome. Each Center should focus on a single organizing theme, rather than cover the spectrum of problems that may be addressed by the initiative as a whole. The individual projects that are part of the Center should have as their goal a practical end point--improvement in some indicator or indicators of functioning in these different environments. The research may apply to a real world situation, findings and methodologies previously identified through smaller or more selective studies. Alternatively, the research may apply broader scientific knowledge from a related domain to a particular problem. Improvements in behavioral indicators relevant to the practical domain (e.g., laboratory measures of cognitive functioning, health status, or subjective well-being) may be considered interim goals. However, the end-point is improvement in functioning in the practical domain itself. One highly desirable feature of the Centers will be a focus on special populations of older people. The size of minority older populations has been increasing. The oldest old remain the population at greatest risk for dependency. Older adults who have been identified as developmentally disabled face particular problems in later life. Poor older adults in rural areas have severely limited access to health and general services. These and other special populations who have pressing needs warrant attention from researchers in aging. The focus on investigating a practical problem will require applicants to show familiarity with the practical domain or environment being investigated as well as with relevant aspects of aging research. That familiarity may be achieved by collaboration with specialists in the domain or community, or by prior experience in applying aging research successfully to this domain. Because practical problems will likely cross disciplinary backgrounds and benefit from input from practice professionals as well as researchers, applications that reflect such broad-based expertise are particularly encouraged. The following examples illustrate potential research strategies in a number of different practical domains. These examples are illustrative only. Applications are welcome from all domains that are important to older adults in daily life. o Use principles from human factors or training research to design work environments that accommodate the needs of older workers, or improve competence in critical skills that support independence. o Use perceptual and cognitive theory and methods to derive valid functional tests of competence for work, for driving, and for other safety-related activities. o Apply models of information processing (e.g., discourse analysis, text comprehension, and schema-based remembering) in adulthood to design complex instructional materials such as insurance, medical, and financial forms, medical and pharmacological information leaflets, or on the cognitive processes that subserve decision making about social security, financial, insurance, and medical treatments (research on older persons' decisions about medical treatments have typically focused on the antecedents and consequences, but have not focused on the cognitive processes involved in making the decision). o Use knowledge about age-related declines in working memory, prospective memory, and long-term memory to investigate the relationship between cognitive functioning and health behaviors and to develop interventions to reduce associated risks. Memory declines may place older persons at increased risk of not being able to follow complex medical regimens, keep medical appointments, or remember to take prescribed medications. o Adapt principles of health behavior change to modify health promotion programs for specific older populations or to address conditions affecting older people's health status (e.g., dietary change, exercise, self-help). o Use models of family systems and functioning to guide family oriented interventions for enhancing family capacity to care for older relatives. o Use theories of organizational analysis (e.g., from medical sociology or from industrial or organizational psychology) to enhance the quality of care for older persons and the receptivity of organizations to meeting the needs of older people (e.g., work settings). o Use community organization theory to develop and evaluate community-based programs for older adults that focus on social activities, public service, or educational development. Structure of the Centers Each Center must consist of a) a management core, b) 2-4 component projects, c) 2-4 pilot projects (annually), and d) a dissemination core. A recruitment core is recommended, but not required. Management Core The management core is central to each Center. Activities of the core should include: o providing administrative advice and guidance on possible applications that arise from the research projects, and materially assisting the application of these results; o facilitating collaborative work across the funded projects by coordinating data collection and providing technical support and guidance to the individual projects as needed; o monitoring individual component projects and pilot projects that are part of the Center, assessing the progress, and reassigning resources as needed during the course of the award (Major changes must be approved by the NIA before going into effect.); o initiating and maintaining interactions with relevant community groups (e.g., community boards, businesses, health care facilities) in order to facilitate the conduct of the Center's research projects. The day-to-day running of the management core will be coordinated by the PI of the Center. However, this core should have an Advisory Committee that oversees the functioning of the core and the individual projects. The Advisory Committee should consist of at least five members. The PI of the Center should be the chair of the Advisory Committee. At least one member of the committee should have primary background in the proposed field of application through a service or commercial role in that field. At least one member of the committee should be an experienced researcher from another institution, whose only connection with the Center is through serving on the committee. Individual project leaders may serve on this committee. However, individual project leaders together with the Center PI cannot be a voting majority of the committee. During the first year of the Center, the Advisory Committee should meet at least twice (one of these meetings may be a conference call, but at least one meeting must be in person) to review the research plans and status of current projects. Major changes in individual projects, the deletion of projects, or the addition of new projects should be approved by the NIA prior to taking effect. Reports of these meetings should be prepared and provided to NIA. During the out years of the Center, the PI should send the Advisory Committee program reports and seek advice as needed, with the entire committee or with individual members. At least one meeting with the entire Advisory Committee should be held each year during the outyears, either in person or by conference call. Component Projects All component projects to be conducted during the grant period must be included in the application and will be reviewed by the scientific review group. A component project may start or terminate at any time during the project period, but at least two projects (and not more than four) must be active at all times. If additional outside support is available, the number of component projects may exceed four. The decision regarding the number of component projects should be based on the ability to provide adequate funding to program activities. The PI of the Center must be a PI on one of these component projects, and each component project must have a different PI. The projects should each relate to the central organizing theme of the Center. The Roybal Centers are intended to generate practical outcomes. Therefore, all Centers should propose at least one component project that has a plan for field research. The possible practical outcomes of such work should be clearly stated. It is also anticipated that the majority of projects funded will have an intervention phase. Therefore, applications that do not include an intervention phase must explain why no intervention is appropriate. Interventions that are selected must be based on sound theory, have supporting pilot data and show a methodologically sound plan for evaluation of the intervention. The evaluation should contain a plan to monitor intended effects of the intervention and some means to monitor unintended and negative consequences. Pilot Projects The Center application must provide for funds to initiate small-scale pilot research by both junior and established investigators at their institutions. Funding may not exceed $10,000 direct costs per pilot project. A minimum of two and a maximum of four pilot projects will be funded annually. Pilot projects will receive funds for one year only. The Center application must describe a plan to develop, identify, review, and monitor pilot projects. However, descriptions of the pilot projects should not be included in the application and they will not be evaluated individually. Dissemination Core The practical outcomes generated by the Roybal Centers should be widely disseminated to the research community and general public so that the results can be implemented by others. Therefore, each Center must participate in a program of dissemination of research results. The applicant should address how they will include research dissemination activities, such as newsletter publication, presentations at scientific conferences, publication in scientific outlets (book chapters and articles in refereed journals), publications in popular press (magazines, newspapers, etc.), interface with community agencies and programs, and interviews with electronic media. Also important are planned strategies for translating research findings into practical programs or services. Recruitment Core Because this RFA encourages working with special populations and requires research involving practical situations, conventional methods of recruiting and testing subjects may not always be appropriate. Therefore, applicants may choose to set-aside up to $50,000 direct costs annually to establish and staff a recruitment core. The roles of this core would be to: o liaise with community groups who can assist in recruitment and retention; o consult community groups about planned studies; o recruit and maintain contact with subjects; o assist in making assessment arrangements either in the laboratory or at test sites; o collect standardized demographic information from subjects; o administer any general performance testing battery (Applicants may choose to allocate more than $50,000 to the recruitment core if such performance testing is directly relevant to hypotheses being addressed either by the Center as a whole or by individual projects.); o assist project members in collecting information about subjects from public records; and o support modest payments for participation and transportation to facilitate recruitment and retention of hard-to-reach groups. SPECIAL REQUIREMENTS Annual Meeting Investigators are encouraged to request funds to travel once each year to meet with the other investigators who are funded through this RFA. The meetings will be held at the NIH, Bethesda, MD, or at another site agreed to by the PIs and the NIA. The purpose of the meetings is to have investigators working in the same general area share information about research methods and findings. Applicants should include a statement in the application indicating a willingness to participate in such meetings and to cooperate with other researchers in the exchange of data, materials, and ideas. 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," 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. This information is available on the internet at the following URL: http://www.nih.gov LETTER OF INTENT Prospective applicants are asked to submit, by July 24, 1997, a letter of intent that includes identification of all participating investigators and institutions, and a descriptive title. The NIA requests such letters only for the purpose of providing an indication of the number and scope of applications to be received and, therefore, usually does not acknowledge their receipt. A letter of intent is not binding, and it will not enter into the review of any application subsequently submitted, nor is it a necessary requirement for application. The letter of intent is to be sent to: Dr. Jared B. Jobe Behavioral and Social Research National Institute on Aging 7201 Wisconsin Avenue, Room 533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3137 FAX: (301) 402-0051 Email: Jared_Jobe@nih.gov APPLICATION PROCEDURES Prospective applicants are advised to communicate with program and grants management staff as early as possible in the planning phase of application preparation. NIA staff are available to assist applicants to ensure that the objectives, structure, and the budget format for the proposed Center are acceptable. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and prepared according to the directions in the application packet, with the exceptions noted below. 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, e-mail: asknih@odrockm1.od.nih.gov. 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. On the face page of the application: Item 2 Type, "Edward R Roybal Centers for Research on Applied Gerontology." Check the "YES" box. A 10 page limit applies separately for the management core, the recruitment core (if proposed), and the dissemination core. A five page limit applies to the description of the pilot program. A 25 page limit applies separately for each component research project. Complete information, including a budget, must be provided for the management core, each component project, the pilot program, the dissemination core, and the recruitment core (if proposed). For the management core, Section C must describe at least: (1) The major theme and rationale for the Center; (2) the organization of the core; (3) the relation between the core and the individual projects, including oversight responsibilities; (4) the relation between the core and the community or service groups most likely to be affected by the research; and (5) the means by which the core will facilitate application of research results. For each component project, the application should be prepared following the guidelines for a research project contained in the PHS 398 (rev. 5/95). For the pilot program, Section C must describe the Center's plan to (1) develop, (2) identify, (3) select, and (4) monitor pilot projects. For the dissemination core, Section C must describe the plans for (1) newsletters, (2) publications and presentations, (3) interface with community agencies and programs, (4) interface with the media, and (5) strategies for translating research findings into practical programs or services. For the recruitment core, Section C must describe: (1) the nature and characteristics of the proposed recruitment sample(s); (2) any screening instruments used to select people as eligible for the study; (3) any proposed standard batteries of tests that will be administered to the whole sample; and (4) what recruitment and retention procedures will be used to obtain and maintain an adequate sample. Send or deliver the completed application and three signed, exact photocopies in a single package to the following office, making sure that the original application with the RFA label attached is on top. 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: Chief, Scientific Review Office National Institute on Aging Gateway Building, Room 2C212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 It is important to send these copies at the same time as the original and three copies are sent to the Division of Research Grants. The application must be received by October 24, 1997. REVIEW CONSIDERATIONS Upon receipt, DRG staff will review applications for completeness and NIA staff will review applications for responsiveness. Applications that are incomplete, nonresponsive to this RFA, or exceed the annual direct cost limit of $400,000 direct costs per award in the first year, exclusive of facilities and administrative costs on consortia, will be returned to the applicant 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 (IRG) within the NIA, 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, and assigned a priority score. Although the review may involve an applicant interview, a request for additional information, or a site visit, the written application submitted should be complete. The second level of review will be provided by the National Advisory Council on Aging. The most important criterion for scientific merit review will be the proposed Center's demonstrated potential to act as a conduit between basic behavioral and social research and applied outcomes. Both the evidence of past involvement in related research and the specific plans for seeking applied outcomes described in the application will be considered part of that potential. The following specific review criteria reflect how these overall goals will be evaluated in the review process. For competing continuation applications, progress on the criteria listed below and future plans will be considered. For new applications, pilot data and future plans will be considered. 1. Overall, the proposed Center will be evaluated for: a) the theoretically and empirically supported rationale for the particular approach to extending basic behavioral and social research into applied areas; b) quality of coordination of center activities around a theme, as described in the cores; c) commitment from the host institution to the research activity and availability of appropriate facilities for the research activities proposed; and d) appropriateness of the budget for the Center. 2. The management core will be evaluated for: a) quality of the evaluation plan for monitoring the effectiveness of proposed interventions; b) leadership ability, relevant experience in appropriate areas, and scientific stature of the PI. The time commitment of the Center PI must be sufficient to show substantial personal supervision of the various activities of the Center. A past history of applying basic behavioral and social research in a relevant area will be an important advantage; and c) qualifications and experience of members of the advisory committee to the Center. 3. The component projects will be evaluated for: a) scientific and technical significance and originality of the component projects. Pilot data will be advantageous; b) appropriateness and adequacy of the experimental approach and methodology proposed by the component projects to carry out the research; and c) qualifications and experience of the component project investigators and appropriateness of their investment of time in the project. 4. The pilot project program will be evaluated on the quality of the plan to develop, solicit, identify, review, monitor, and evaluate the pilot projects. 5. The recruitment core will be evaluated on: a) the 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 be evaluated; and b) plans to liaise, consult, recruit, and collect data from participants. 6. The dissemination core will be evaluated on the quality of the plans for dissemination activities, such as newsletters, publications and presentations, interface with community agencies and programs, interviews with electronic media, and planned strategies for translating research findings into practical programs or services. 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 Awards will be made on the basis of the availability of funds. Primary weight will be given to the NIH peer review results. Program balance will also be considered. INQUIRIES Inquiries concerning this RFA are encouraged in order to clarify issues or questions. The opportunity to clarify any issues or answer any questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Jared B. Jobe Behavioral and Social Research National Institute on Aging 7201 Wisconsin Avenue, Room 533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3137 FAX: (301) 402-0051 Email: Jared_Jobe@nih.gov Direct inquiries regarding fiscal matters to: Mr. David Reiter Grants and Contracts Management National Institute on Aging 7201 Wisconsin Avenue, Room 2N212, MSC 9205 Bethesda, MD 20892 Telephone: (301) 496-1472 Email: dr36t@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A Section 301 (42 USC 241) and administered under PHS grant policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Parts 74 and 92. Special Terms of Awards applying to projects funded in response to this RFA are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administrative regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH grant administration policies. Awardees will maintain custody of, and primary rights to, their data developed under their awards, subject to Government rights of access, consistent with current HHS, PHS, and NIH policies. 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 Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-97-002 - V26(14) 05/02/97 Date: 8 May 1997 14:00:50 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 457 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5kteu2$n1@net.bio.net> NNTP-Posting-Host: net.bio.net UROLOGY RESEARCH CENTERS NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA: DK 97-002 P.T. 04; K.W. 0785220, 0710030, 0785055, 0745027, 0745070 National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute Letter of Intent Receipt Date: August 25, 1997 Application Receipt Date: September 24, 1997 PURPOSE This Request for Applications (RFA) invites investigators to submit research grant applications for the George M. O'Brien Research Centers Program. The emphases for this program are to: (1) attract new scientific expertise into the study of the basic mechanisms of urological diseases and disorders; (2) encourage multidisciplinary research focused on the causes of these diseases and disorders; and (3) extend the development of innovative clinical and epidemiologic studies of the causes, therapy and possible prevention of urological diseases and disorders. In approaching the study of these disease processes, it is anticipated that extensive collaboration will be required between individuals in the clinical and basic sciences, including for example investigators with training and expertise in cell biology, molecular biology, immunology, genetics, epidemiology, biochemistry, physiology, and pathology. It is the express intent of this RFA to attract new investigators not currently active in this field and to explore new basic areas that may have clinical research applications. Individual institutions with both basic and clinical research capabilities are eligible to apply. Interinstitutional collaborative research arrangements are also appropriate and encouraged. Coordination for such arrangements must be evident and clearly meaningful and appropriate for the research proposed. The National Cancer Institute (NCI) plans to provide support for this initiative in the area of prostate cancer. Studies to be supported include the full range from laboratory to clinical investigations encompassing biology, etiology, detection, diagnosis, treatment, prevention and control. Of particular interest is multidisciplinary research that links basic research to applied settings involving patients and populations. 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. 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, 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. Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT Support of this program will be through the NIH specialized center (P50) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. 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. FUNDS AVAILABLE The NCI and NIDDK expect to award up to four center grants (P50) for research into urologic disorders in fiscal year 1998. The anticipated awards are for five years and are contingent upon the availability of appropriated funds. The total amount of available funds to support this program is anticipated to be no more than $2.75 million per year. No applicant may request more than $750,000 in total costs (including both direct and indirect costs) in the initial budget period. A standard escalation factor may be used for subsequent budget periods. Three competing continuation applications are anticipated in response to this RFA. The budget for the first year of a competing continuation application may be increased by 10% above the direct cost of the last issued noncompetitive (Type 5) award. In all cases, budgets are not to exceed the $750,000 total cost cap. RESEARCH OBJECTIVES Urologic diseases and disorders place a substantial burden on individuals and on society in the United States. Urinary tract infections had a direct hospital and physician cost of over $4 billion in 1990. Benign prostatic hyperplasia (over $2 billion), stone disease (over $1 billion), and bladder disorders (over $1 billion) are disorders whose costs exceed $1 billion annually. These diseases and disorders threaten the health, well-being, and longevity of millions of Americans. Although considerable progress has been made in understanding the basic physiology and pathophysiology of the normal urologic systems, there has been only limited progress in unraveling the mechanisms of those processes that lead to progressive deterioration in the function of these systems. Nevertheless, major progress has been made in the management of their clinical consequences. For example, the clinical management of benign prostatic hyperplasia has improved over the past several years. Unfortunately, these scientific and medical advances have not led to the means to prevent or reverse the consequences of these diseases and disorders; moreover, their incidence is steadily increasing. The proposed multidisciplinary research centers should help to provide an environment for investigators to apply the necessary and appropriate expertise to topical areas of research related to the pathogenesis of urologic diseases such as immunologically mediated diseases, diabetes mellitus and other endocrine and metabolic disorders, genetic abnormalities, bladder physiology and pathophysiology, and developmental and obstructive disorders. Prostate cancer is the most common cancer in U.S. males and is the second leading cause of cancer death in men. Mortality due to prostate cancer is two-fold higher in U.S black men than U.S. white men. Costs attributable to this disease exceed $1 billion annually. The disease results annually in a quarter of a million hospitalizations as well as more than 40,000 deaths. The report from the meeting "NCI Roundtable on Prostate Cancer: Future Research Directions" (Reported in Cancer Research, 51: 2498, 1991) contains information and recommendations defining areas of research that could advance the understanding and management of prostate cancer. Potential applicants requesting support for this area of research are urged to acquaint themselves with the report. SPECIAL REQUIREMENTS Successful applicants are expected to attend a yearly meeting of Center Directors convened by the NIDDK. Funds to support travel to this meeting may be requested in the budget proposed for the center. 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 sub-populations 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 Vol. 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by August 25, 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 NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (5/95) is to be used in applying for these grants. 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. 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, plus 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 time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-E - MSC 6600 Bethesda, MD 20892-6600 Applications must be received by September 24, 1997. If an application is received after that date, it will be returned to the applicant without review. Applicants must follow the NIDDK Program Project Grants Guidelines (July 1996) for Preparation of the Grant Application, Chapter 3. Copies of the Guidelines are available from the Program Director listed under INQUIRIES. Each Research Project proposed (Section F - NIDDK Guidelines) is limited to 25 pages of text. Applications should include the following: A Table of Contents. A Rationale for the Proposed Center and a Statement of Objectives. Institutional Environment and Resources. Organization and Administrative Structure of the Center. Specific Managerial Responsibilities for the Center. Travel funds in the proposed budget for an annual meeting of Center Directors. A description of the method for the replacement of the Center Director (should the need arise). A description of the proposed research projects. A description of the proposed cores. A description of the procedure to be used for the addition/deletion of cores and projects during the proposed period of operation. A description of the administrative relationship of the Center to the applicant institution. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed for completeness and responsiveness. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK and NCI staff function. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by an appropriate peer review group convened by the NIDDK. In cases where the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted and applications withdrawn from further competition when they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Following this review, the applications will be given a secondary review by the NIDDK Advisory Council unless not recommended for further consideration by the initial review group. The review criteria for individual research projects include: The scientific, technical or medical significance and originality of the proposed research. The feasibility and adequacy of the experimental design. The degree to which projects link basic and clinical research. The qualifications and research experience of the proposed personnel. The availability of resources necessary for the research. The appropriateness of the budget and timetable in relation to the scope of the proposed research. The review criteria for scientific cores include: The appropriateness and utility of the core to the proposed Center. The quality of the proposed facilities or services including administrative arrangements for utilizing the core. The qualifications, experience, and commitment of the personnel involved in the core. The appropriateness of the budget. Note: Each core unit must provide facilities or services to at least two research projects recommended for approval. The review criteria for the overall Center program include: The scientific merit of the program as a whole. The significance of the overall goals of the Center. The cohesiveness and multidisciplinary scope of the Center and the coordination and interrelationship of the projects and cores to the common theme of the Center. The leadership, scientific expertise, and commitment of the proposed Center Director. Administrative Considerations include: The institutional environment for and resources available to Center investigators. The institutional commitment to the proposed Center. The administrative leadership necessary to provide for the quality control of supported projects in the Center, the allocation of funds, and the ability to foster communication and cooperation among Center investigators. The appropriateness of the budget in relation to the proposed activities of the Center. The adequacy of addressing the protection of human subjects, animal welfare, and biohazard issues. Adequacy of plans to include both genders(if applicable) 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. Competing Continuation Applications: Applicants must follow the NIDDK Program Project Grants Guidelines (July 1996) for preparation of the Grant Application, Chapter 4, Part B and Part C. Copies of the Guidelines are available from the Program Director listed under INQUIRIES. For the purposes of this RFA a distinction between a P50 grant and a P01 grant is made as follows: Research projects supported by the P50 center award are of uniformly high scientific merit, and are generally related to central issues in urologic diseases and disorders. Each project should be directed to the development of fundamental knowledge leading to understanding disease processes and the design of curative or preventative strategies. The P50 grant mechanism provides an opportunity to approach multidisciplinary basic research in a synergistic fashion. Close cooperation, communication, and collaboration among all center personnel of many professional disciplines are characteristics of a successful P50 center. In comparison, each research project of the P01 Program Project Grant must contribute to or be directly related to a clearly defined central unifying theme of the total research effort. The projects should demonstrate essential elements of unity and interdependence. 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 Center as determined by peer review and the availability of funds. Schedule Letter of Intent Receipt Date: August 25, 1997 Application Receipt Date: September 24, 1997 Initial Review: February - April 1998 Second Level Review: May 1998 Anticipated Date of Award: September 1, 1998 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding non-cancer programmatic issues may be directed to: Ralph L. Bain, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-19 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: bainr@ep.niddk.nih.gov Inquiries regarding cancer-related programmatic issues may be directed to: Andrew Chiarodo, Ph.D. Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Suite 512 Bethesda, MD 20892 Telephone: (301) 496-8528 Email: chiaroda@dcbdep1.nci.nih.gov Inquiries regarding fiscal matters may be directed to: Ms. Helen Ling Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8857 FAX: (301) 480-3504 Email: lingh@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. 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 Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 14, pt. 1of1, 2 May 1997 Date: 8 May 1997 14:00:27 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 798 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ktetb$m9@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 14 - May 2, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FUNDING STRATEGIES FOR FY 1997 National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 06/13/97 ************************************************* MALE GERM CELL GROWTH AND DIFFERENTIATION (RFA HD-97-004) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R2 07/15/97 ************************************************* COLLABORATIVE MINORITY ALCOHOL RESEARCH DEVELOPMENT PROGRAM (RFA AA-97-006) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R3 08/25/97 ************************************************* NHLBI MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY FACULTY (RFA HL-97-006) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R4 08/25/97 ************************************************* MINORITY INSTITUTION FACULTY MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (RFA HL-97-007) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R5 08/25/97 ************************************************* NHLBI SHORT-TERM RESEARCH TRAINING FOR MINORITY STUDENTS PROGRAM (RFA HL-97-008) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R6 08/25/97 ************************************************* NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM (RFA HL-97-009) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R7 09/24/97 ************************************************* KIDNEY RESEARCH CENTERS (RFA DK-97-001) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R8 09/24/97 ************************************************* UROLOGY RESEARCH CENTERS (RFA DK-97-002) National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; CANCER $$INDEX R9 10/24/97 ************************************************* EDWARD R. ROYBAL CENTERS FOR RESEARCH ON APPLIED GERONTOLOGY (RFA AG-97-005) National Institute on Aging INDEX: AGING The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN NOT-97-005 FULL-TEXT ************************************* FUNDING STRATEGIES FOR FY 1997 NIH Guide, Volume 26, Number 14, May 2, 1997 P.T. 34; K.W. 1014006 National Institutes of Health The information provided below will guide the NIH Institutes and Centers (IC) in their funding decisions on Research Project Grants in FY 1997. Research Projects are primarily investigator-initiated basic science research, including R01s, R03s, R29s, P01s and U01s. This group does not include SBIR/STTR awards. The core principles, which are not specifically associated with FY 97, remain essentially the same as in recent years. The funding strategies reflect some changes due to the FY 97 appropriation level and associated congressional directives. Core Principles 1. Grants will be awarded on the basis of reasonable and allowable costs consonant with the principles of sound cost management and in consideration of Institute or Center priorities, constraints on the growth of average grant costs, and the availability of funds. 2. The award of noncompeting research project grants at committed levels continues to be the cornerstone of the NIH Financial Management Plan and is the basis of the plan~s credibility with the scientific community and Congress. 3. Determination of commitments for future years must take into consideration stability of support for investigators, optimum portfolio balance, and opportunities to address emerging problems. Fiscal Year 1997 Funding Strategies 1. The direct cost level for the future years of FY 1997 new and competing continuation awards, on the average, will not exceed the direct cost level of the previous budget period by more than 3 percent. The 4 percent adjustment factor used to calculate future year direct costs for grants made prior to FY 97 will remain in effect (see 2. below). NIH staff may make exceptions for specifically justified programmatic requirements and one-time, non- recurring costs such as equipment. 2. For noncompeting grants, every effort will be made to make awards at the committed levels. If fiscal conditions in an IC are such that funding at the committed levels is not possible, the IC will consult with the Deputy Director for Extramural Research, NIH, to determine an appropriate resolution. 3. For competing grants, budgetary reductions from the requested level will be achieved through a combination of initial review and Council/Board recommendations, staff review for cost allocability, allowability, and reasonableness, and programmatic adjustments to arrive at an appropriate funding level. Each IC will develop a plan that specifies the general rationale and methodology for adjustments based on programmatic considerations. This plan will be available as part of the IC official program file. 4. Based on adjustments to the project, IC staff, in consultation with the principal investigator, will decide if a new statement of specific aims is required. When reductions are 25% or more below the IRG recommended level, staff will obtain a revised statement of specific aims, a revised budget and/or revised timetable, as appropriate for the project, which must be approved and countersigned by the institution, and approved by program and grants management staff. This material serves as documentation of budgetary and programmatic adjustments described in this paragraph and in item (3) above. To ensure initial review group understanding of the modified scope of a funded project, the approved statement of revised aims should be submitted by the investigator in competing continuation grant applications. 5. For competing continuation grants, one factor in arriving at the award amount will be the level of support in prior years and the extent to which the IC can permit growth within the existing constraints on average costs. 6. The average length of research project grants will not exceed four years. 7. In making funding decisions, ICs will consider the total costs of a grant, especially for those grants near the IC funding payline. INQUIRIES For further information, contact the Grants Management Specialist or Health Scientist Administrator responsible for your award. Their names and telephone numbers are indicated on the Notice of Grant Award. $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HD-97-004 FULL-TEXT ************************************** MALE GERM CELL GROWTH AND DIFFERENTIATION NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA AVAILABLE: HD-97-004 P.T. 34; K.W. 1002017, 0413002 National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 30, 1997 Application Receipt Date: June 13, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites research project grant (R01) applications for the support of studies of male germ cell growth and differentiation. The establishment of effective culture systems for male germ cells is a prerequisite to obtaining a better understanding of the developmental mechanisms by which male germ cells develop into mature sperm cells. The lack of such culture systems has greatly hindered progress towards this understanding. One particular goal of this initiative is to improve our ability to culture the self-renewable spermatogonial stem cells in order to be able to conduct cause and effect experiments. It may also be possible to establish lines of these potentially immortal stem cells. These advances, coupled with a recent breakthrough in our ability to transplant these cells into the testes of infertile mice would establish a system for the assessment of the developmental potential of the cultured and transplanted spermatogenic cells. This system also would provide the opportunity to study ways to genetically alter male germ cells such that these alterations can be passed on to the next generation through mature sperm and fertilization. It is expected that the new knowledge derived from these studies will lead to the alleviation of certain forms of male infertility and to the discovery of novel contraceptive approaches as well as to a wide array of other potential benefits. An important part of the mission of NICHD is to gain new knowledge about human reproduction and this Request for Applications (RFA) is designed to address that mission. It is anticipated that an estimated total cost of $540,000 will be available for the first year to support approximately three grants. 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, Male Germ Cell Growth and Differentiation, is related to the priority area of family planning. 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 RFA, 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. Richard J. Tasca, Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: tascar@hd01.nichd.nih.gov $$R1 END ************************************************************ $$R2 BEGIN AA-97-006 FULL-TEXT ************************************** COLLABORATIVE MINORITY ALCOHOL RESEARCH DEVELOPMENT PROGRAM NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA AVAILABLE: AA-97-006 P.T. 34, FF; K.W. 0404003 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: June 16, 1997 Application Receipt Date: July 15, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) in collaboration with the Office for Research on Minority Health (ORMH) of the National Institutes of Health (NIH) invites applications for Collaborative Minority Institution Alcohol Research Development grants (CMIARD). The long range goal of the Collaborative Minority Institution Alcohol Research Development Program is to strengthen the alcohol research capacity of predominantly minority institutions by fostering collaborations with research intensive institutions, and through this means, expand the capabilities of the research scientists in these institutions to research on alcohol-related health issues within minority communities. For the purpose of this solicitation, African Americans, Hispanics, Native Americans, and Alaskan Natives are considered to be racial or ethnic minorities. It is anticipated that up to three five-year cooperative agreement awards will be made in response to this RFA in Fiscal Year 1997. The cost may not exceed $400,000 in direct costs for the initial year. Although the financial plans of the NIAAA provide for the support of this program, awards pursuant to this RFA are contingent upon availability of funds. 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), Collaborative Minority Alcohol Research Development Program, is related to the priority area of alcohol abuse and alcoholism reduction. 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 RFA, 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. Ernestine Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard - MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvander@willco.nih.niaaa.gov $$R2 END ************************************************************ $$R3 BEGIN HL-97-006 FULL-TEXT ************************************** NHLBI MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY FACULTY NIH Guide, Volume 26, Number 14, May 2, 1997 RFA AVAILABLE: HL-97-006 P.T. 34, FF; K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Application Receipt Date: August 25, 1997 PURPOSE This RFA uses "Just-In-Time" concepts. The RFA includes detailed modifications to standard application instructions that must be followed when preparing applications in response to this RFA. This program provides support to underrepresented minority faculty members with varying levels of research experience to prepare them for research careers as independent investigators. The research development programs of the candidates are based on scholastic background, previous research experience, past achievements, and potential to develop into an independent research investigator. The objective of the award is to develop highly trained minority investigators, whose basic or clinical research interests are grounded in the advanced methods and experimental approaches needed to solve problems related to cardiovascular, pulmonary and blood diseases, transfusion medicine, and sleep disorders. 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, Mentored Research Scientist Development Award for Minority Faculty, is related to the priority areas of heart disease and stroke, tobacco, educational and community-based programs, environmental health, maternal and infant health, diabetes and chronic disabling diseases, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-00100474-1 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 RFA, 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. Mary S. Reilly, M.S. or Ann Rothgeb Division of Lung Diseases National Heart, Lung, and Blood Institute 6710 Rockledge Drive, Room 10112 - MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: mary_reilly@nih.gov; ann_rothgeb@nih.gov $$R3 END ************************************************************ $$R4 BEGIN HL-97-007 FULL-TEXT ************************************** MINORITY INSTITUTION FACULTY MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD NIH Guide, Volume 26, Number 14, May 2, 1997 RFA AVAILABLE: HL-97-007 P.T. 34, FF; K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Application Receipt Date: August 25, 1997 PURPOSE This RFA uses "Just-In-Time" concepts. The RFA includes detailed modifications to standard application instructions that must be followed when preparing applications in response to this RFA. This program provides research support to faculty members at minority institutions who have the interest and potential to conduct state of the art research in the areas of cardiovascular, pulmonary, or hematologic disease, or in sleep disorders. This is an effort to enhance the institution's science programs, and to assist in the acquisition of "hands on" research opportunities for minority students at the applicant's institution. 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, Minority Institution Faculty Mentored Research Scientist Development Award, is related to the priority area of heart disease, stroke, tobacco, educational and community-based programs, environmental health, maternal and infant health, diabetes and chronic disabling diseases, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-1 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 RFA, 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. Mary S. Reilly, M.S. or Ann Rothgeb Division of Lung Diseases National Heart, Lung, and Blood Institute 6710 Rockledge Drive, Room 10112 MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: mary_reilly@nih.gov; ann_rothgeb@nih.gov $$R4 END ************************************************************ $$R5 BEGIN HL-97-008 FULL-TEXT ************************************** NHLBI SHORT-TERM RESEARCH TRAINING FOR MINORITY STUDENTS PROGRAM NIH Guide, Volume 26, Number 14, May 2, 1997 RFA AVAILABLE: HL-97-008 P.T. 44, FF; K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Application Receipt Date: August 25, 1997 PURPOSE This program provides short-term research training (T35) support to minority underrepresented undergraduate students, graduate students, and students in health professional schools to provide them with career opportunities in cardiovascular, pulmonary, and hematologic diseases, and sleep disorders research. The grant provides training experiences of two to three consecutive months and exposes talented students to the various possibilities in pursuing a biomedical research career. 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, Short-Term Training for Minority Students Program, is related to the priority areas of heart disease and stroke, tobacco, educational and community-based programs, environmental health, maternal and infant health, diabetes and chronic disabling diseases, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-00100474-1 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 RFA, 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. Mary S. Reilly, M.S. or Ann Rothgeb Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10112 - MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: mary_reilly@nih.gov or ann_rothgeb@nih.gov $$R5 END ************************************************************ $$R6 BEGIN HL-97-009 FULL-TEXT ************************************** NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM NIH Guide, Volume 26, Number 14, May 2, 1997 RFA AVAILABLE: HL-97-009 P.T. 44, K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Application Receipt Date: August 25, 1997 PURPOSE This National Research Service Award Program (NRSA) is intended to train graduate students, health professional students, and postdoctoral students in minority schools that have the potential to develop a meritorious program in cardiovascular, pulmonary, or hematological diseases, and/or sleep disorders for research careers in these areas. Graduate students, health professional students, and postdoctoral students in minority schools need further opportunities to develop biomedical and behavioral research skills. The Minority Institutional National Research Training Program is designed to attract students in their developmental stages and to increase their awareness of cardiovascular, pulmonary, and hematologic diseases, and sleep disorders, and to encourage them to pursue research career opportunities. 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, Minority Institutional Research Training Program, is related to the priority areas of heart disease and stroke, tobacco, educational and community-based programs, environmental health, maternal and infant health, diabetes and chronic disabling diseases, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-1 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 RFA, 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. Mary S. Reilly, M.S. or Ann Rothgeb Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10112 - MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: mary_reilly@nih.gov; ann_rothgeb@nih.gov $$R6 END ************************************************************ $$R7 BEGIN DK-97-001 FULL-TEXT ************************************** KIDNEY RESEARCH CENTERS NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA AVAILABLE: DK-97-001 P.T. 04; K.W. 0715133, 0710030 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: August 25, 1997 Application Receipt Date: September 24, 1997 PURPOSE This Request for Applications (RFA) invites investigators to submit specialized centers (P50) research grant applications for the George M. O'Brien Research Centers Program. The emphases for this program are to: (1) attract new scientific expertise into the study of the basic mechanisms of kidney diseases and disorders; (2) encourage multidisciplinary research focused on the causes of these diseases. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) anticipates three awards to be made in FY 98 and has allocated up to $2.15M to fund meritorious applications received in response to this RFA. 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 getting priority areas. This RFA, Kidney research Centers, is related to the priority area of chronic debilitating 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 RFA, 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. Ralph L. Bain, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: bainr@ep.niddk.nih.gov $$R7 END ************************************************************ $$R8 BEGIN DK-97-002 FULL-TEXT ************************************** UROLOGY RESEARCH CENTERS NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA AVAILABLE: DK-97-002 P.T. 04; K.W. 0785220, 0710030, 0785055, 0745027, 0745070 National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute Letter of Intent Receipt Date: August 25, 1997 Application Receipt Date: September 24, 1997 PURPOSE This Request for Applications (RFA) invites investigators to submit specialized centers (P50) research grant applications for the George M. O'Brien Research Centers Program. The emphases for this program are to: (1) attract new scientific expertise into the study of the basic mechanisms of urological diseases and disorders; (2) encourage multidisciplinary research focused on the causes of these diseases and disorders; and (3) extend the development of innovative clinical and epidemiologic studies of the causes, therapy and possible prevention of urological diseases and disorders. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer Institute (NCI) anticipate four awards to be made in FY 1998 and have allocated up to $2.75 million to fund meritorious applications received in response to this RFA. 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 getting priority areas. This RFA, urology Research Centers, is related to the priority area of chronic debilitating 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 RFA, 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. Ralph L. Bain, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: bainr@ep.niddk.nih.gov $$R8 END ************************************************************ $$R9 BEGIN AG-97-005 FULL-TEXT ************************************** EDWARD R. ROYBAL CENTERS FOR RESEARCH ON APPLIED GERONTOLOGY NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA AVAILABLE: AG-97-005 P.T. 04; K.W. 0710010, 0404000 National Institute on Aging Letter of Intent Receipt Date: July 24, 1997 Application Receipt Date: October 24, 1997 PURPOSE This Request for Applications (RFA) seeks applications in support of the Edward R. Roybal Centers for Research on Applied Gerontology. The Roybal Centers program's purpose is to facilitate the process of translating basic behavioral and social research theories and findings into practical outcomes that will benefit the lives of older people. The Roybal Centers focus on strategies to improve quality of life, enhance productivity, and minimize the need for care. The Roybal Centers have an emphasis distinct from the clinical and biomedical approaches that are sponsored through the Claude D. Pepper Older Americans Independence Centers (RFA AG-96-003, NIH Guide for Grants and Contracts, Vol. 25, No. 12, April 19, 1996). An estimated $2,500,000-$3,000,000 will be made available in Fiscal Year 1998 for support of awards made under this RFA. It is expected that up to six awards will be made at a maximum of $400,000 direct costs per award in the first year, exclusive of facilities and administrative costs on consortia. 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 priorities. This RFA, Centers of Research on Applied Gerontology, addresses several priority areas including chronic disabling conditions, physical activity and fitness, violent and abusive behavior, and unintentional injuries as they relate to older people. 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 RFA, 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. Dr. Jared B. Jobe Behavioral and Social Research National Institute on Aging 7201 Wisconsin Avenue, Room 533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3137 FAX: (301) 402-0051 Email: Jared_Jobe@nih.gov $$R9 END ************************************************************ From owner-sci-resources@net.bio.net Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-007 - V26(14) 05/02/97 Date: 8 May 1997 14:03:25 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 560 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ktf2t$149@net.bio.net> NNTP-Posting-Host: net.bio.net MINORITY INSTITUTION FACULTY MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA: HL-97-007 P.T. 34, FF; K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: July 1, 1997 Application Receipt Date: August 25, 1997 THIS RFA USES "JUST-IN-TIME" CONCEPTS. THE FULL RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE FOLLOWED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE This program provides research support to faculty members at minority institutions who have the interest and potential to conduct state of the art research in the areas of cardiovascular, pulmonary, or hematologic disease, or in sleep disorders. This is an effort to enhance the institution's science programs, and to assist in the acquisition of "hands on" research opportunities for minority students at the applicant's institution. 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, Minority Institution Faculty Mentored Research Scientist Development Award, is related to the priority area of heart disease, stroke, tobacco, educational and community-based programs, environmental health, maternal and infant health, diabetes and chronic disabling diseases, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-1 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 Minority School A minority school is defined as a domestic medical or non-medical college, university or equivalent school in which students of minority ethnic groups including Blacks, Hispanics, American Indians, and Asian or Pacific Islanders comprise a majority or significant proportion of the school enrollment. The commitment of the institution to the faculty candidate's research and development must clearly be presented in the application, including statement(s) from the Dean and the candidate's departmental chair. These signed statements must also indicate that the candidate will be provided with the amount of time and effort designated in the application to accomplish the research goals stated in the proposal. Because the NHLBI views this commitment as vital to the success of the program, the Institute will closely monitor this aspect of the program if an award is made. Faculty Development Award Candidate Candidates for this award are minority school faculty members who (1) are citizens of the United States, non-citizen nationals or permanent residents at the time of application, (2) have a doctoral degree or equivalent in a biomedical or behavioral science, (3) wish to receive specialized training in cardiovascular, pulmonary, hematologic, or sleep disorders research, and (4) have the background and potential to benefit from the training. Mentor at Research Center Each candidate must also identify and complete arrangements with a nearby mentor (within approximately 100 miles) who is recognized as an accomplished investigator in the research area proposed and who will provide guidance for the awardee's development and research plan. Arrangements with mentors at institutions greater than 100 miles from the applicant institution will be considered, but must be strongly justified and clearly outlined in the application. Plans for the intensive training during the summer period (2-3 months) as well as during the academic years should be developed with the mentor. The commitment of the mentor and his institution to both the summer and academic year training period must be evidenced in the application. A statement of commitment from the mentor's departmental chair must also be included in the application. The mentor must provide an annual evaluation of the faculty member's career development. This evaluation is to be included as part of the Application for Continuation Grant if an award is made. Concurrent and Subsequent Applications for NIH Research Support Applicants may not apply for other Public Health Service research grant support or its equivalent at the time of the Minority Institution Faculty Mentored Research Scientist Development Award application, nor may they apply concurrently for any other type of career development award. They may apply for and accept NIH research grant support subsequent to award of the Minority Institution Faculty Mentored Research Scientist Development Award. MECHANISM OF SUPPORT For this RFA, no detailed budget is required. However, total direct costs for all years must be provided in addition to the name, role on project, percent effort and narrative justification for all project personnel. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information for the applicant and the application Checklist page are not required as part of the initial application. However, Other Support information is required for the sponsor and co-sponsor. If there is a possibility for an award, necessary budget, Other Support and Checklist information will be requested by NHLBI staff following the initial review. The Supplemental Instructions section of the full RFA provides specific details of modifications to standard PHS 398 application kit instructions. The programs of the National Heart, Lung, and Blood Institute are identified in the Catalog of Federal Domestic Assistance, numbers 93.837, 93.838, 93.839, and 93.231. The mechanism of support for this activity will be the career development grant, awarded under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended, 42 Part 241). The regulations (Code of Federal Regulations, Title 42, Part 52 and Title 45, Part 74) and policies which govern the research grant programs of the National Institutes of Health will prevail. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency Review. The award of grants pursuant to this announcement is contingent upon availability of appropriated funds. RESEARCH OBJECTIVES Background Measurements of health status indicate that Americans today are, on the whole, healthier than at any other time in our history. Life expectancy has increased while infant mortality statistics indicate that fewer infants are dying at birth or in the first few months of life. Diseases that disabled or killed at the start of the century have virtually disappeared. In spite of this national trend toward better health, there is a continuing disparity in the burden of death and illness experienced by Blacks and other minority Americans. This segment of the population continues to be over represented among those in poor health and with remarkably higher death rates from cardiovascular, pulmonary, and hematologic diseases. Despite a recent decline in the death rate from coronary heart disease, cardiovascular disease continues to be the number one cause of death in the United States. Cardiovascular disease accounts for almost one million deaths annually. An estimated 68 million Americans are estimated to have diseases of the heart and blood vessels, resulting in a large burden of acute and chronic illness and disability. Heart and blood vessel diseases cost the economy tens of billions of dollars per year in lost wages, reduced productivity, and expenses for medical care. Diseases of the lung constitute a major national health problem. About one in every five persons has some chronic respiratory problem resulting in an annual estimated cost to the nation of over $29 billion. In the newborn, the most common cause of death is neonatal respiratory distress syndrome (RDS). Neonatal RDS may be implicated in development of adult respiratory diseases as well. Of the adult respiratory diseases, emphysema and chronic bronchitis are major causes of death. Fibrotic and immunologic lung diseases are serious causes of lung problems in the young adult. Asthma, emphysema and chronic bronchitis represent particularly pressing health problems, affecting an estimated 17 million Americans. Moreover, the death rate and prevalence of these conditions have increased at an alarming rate over the past 15 years. As a disabling disease, chronic obstructive pulmonary disease is a leading cause of worker retirement on Social Security disability payments. Disorders of the blood, including congenital or acquired disorders or deficiencies, are critical contributors to health problems of mankind. As a consequence, they are major causes of death and disability in the United States. Disorders of the blood affect not only the blood itself, but the tissues and organs through which it flows. Recent research findings have revealed the widespread involvement of thrombosis in the pathology of numerous disorders, including the development of atherosclerosis and coronary thrombosis. Aggressive therapy for cancer has resulted in the increased susceptibility of patients to bleeding disorders and has increased the demand for blood products for therapeutic purposes. A significant segment of the population has inherited blood disorders, such as sickle cell disease, hemophilia, or Cooley's anemia, which require life-long hematologic attention and blood product support. Other diseases may be acquired or represent temporary demands, such as transfusion therapy as a result of surgical or accidental trauma. Research opportunities in blood resources and transfusion medicine range from basic to clinical. They cover such diverse topics as the development of new blood products, methods to improve and assure the stability and safety of these products, and ways to improve the benefits and safety of transfusion. Note: Within NHLBI, the term "hematologic" covers research on thrombosis and hemostasis, immunohematology, hematopoiesis, thalassemia, blood cell disorders, sickle cell disease, transfusion medicine including blood component and derivative therapy, blood substitutes and blood resource management, aspects of AIDS-products in AIDS prevention and treatment, and AIDS-related bone marrow and hematologic disorders. Other Institutes of the NIH are responsible for research on disorders of white cells, including the leukemias and other blood malignancies, and basic immunology related to the lymphoid system. Therefore NHLBI cannot provide support for such studies. The National Heart, Lung, and Blood Institute (NHLBI) continues its commitment to address these important medical challenges. One way of meeting these challenges is to increase the pool of well trained investigators, especially in minority groups where the proportion of biomedical investigators is strikingly lower than the percentage of minority U.S. citizens. While 12 percent of the population is Black, less than 0.25 percent of persons holding a Ph.D. in science are Black. The figures are even lower for Black Ph.D.s in the biomedical sciences. Furthermore, the number of doctorates, both M.D.s and Ph.D.s, in other ethnic minority groups (such as American Indians or Hispanics) is proportionally lower than for Blacks. Vigorous recruitment is underway throughout the government, academic institutions, hospitals, research institutions, and industry. The Minority Institution Mentored Research Scientist Development Award is designed to address this critical need by increasing the research and academic capabilities of faculty members at minority schools. In doing so, the pool of well trained biomedical and behavioral investigators in cardiovascular, pulmonary, and hematologic research will be enlarged. Furthermore, their undergraduate and graduate students, most of whom will be underrepresented minority individuals, will become more cognizant of research opportunities in these areas. Thus, the NHLBI anticipates that the Minority Institution Mentored Research Scientist Development Award will help meet this future challenge by providing research support to faculty members at minority institutions who have the interest and potential to conduct state of the art research in the areas of cardiovascular, pulmonary, or hematologic disease, or in sleep disorders. PROGRAM GOALS The major goals of the Minority Institution Faculty Mentored Research Scientist Development Award Program are as follows: Develop or enhance the research skills and abilities of the awardee. Establish collaborative linkages with other investigators that lead to "cutting edge" research opportunities. Publish results in peer-reviewed journals. Enhance skills in grantsmanship to increase the likelihood of obtaining additional grant support from the NIH and other sources. Enhance the science program at the applicant's institution by: o serving as a resource for other scientific faculty; o incorporating new skills and knowledge into the academic curriculum; and o developing or enhancing scientific seminar series at the applicant's institution. Provide/assist in the acquisition of "hands on" research opportunities for minority students at the applicant's institution. Implementation The awards will be made to the minority institution on behalf of the awardee. Each award will have a duration of five years and is non-renewable. These awards may not be transferred to another institution or another faculty member. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year. The progress of the Minority Institution Faculty Mentored Research Scientist Development Award recipient will be reviewed annually using information in the non-competitive renewal application to determine whether the award should be continued. The ability of the department chairman to provide the awardee with the agreed-upon time and effort will be monitored closely. In addition, to assess the effectiveness of the program in fulfilling its objectives, the Institute intends to follow the progress of the recipient for a period of five years after completion of each grant to determine: (1) the investigator's professional affiliation(s); (2) his or her record of subsequent grant or contract support; (3) his or her record of scientific publications; and (4) the institution's research programs. PROVISIONS OF THE AWARD Salary The awardee will receive salary support up to a maximum of $50,000 plus fringe benefits per year for five years. All funds must be used to support the awardee. The level of support will be based upon the candidates' actual salary and must be consistent with the established salary structure of the minority institution for persons of equivalent qualifications, experience, and rank. The actual salary level will be determined by the proportion of effort devoted to this program. Awardees must commit 100 percent of effort during summer and/or off quarter periods and at least 25 percent of effort during the academic year. Supplementation of the awardee's salary from non-Federal sources is permissible. Supplementation of the awardee's salary from other Federal funds is not allowed unless explicitly authorized by both the program from which funds are derived and the NHLBI. In no case may other NIH funds be used to supplement salary support of the awardee. In addition to salary support for the candidate, support for up to 5 percent of the mentor's salary during the summer experience may also be requested. If funds are to be transferred to the mentor's institution for the mentor's salary or for research expenses, arrangements for the transfer of funds and the conduct of activities should be formalized in a contract or written agreement with the mentor's institution. Research Support Up to $30,000 per year beyond that requested for the candidate's and mentor's salaries will be provided for research support. Details regarding the apportionment of these funds between the minority institution and the research center must be worked out with the mentor at the research center and agreed to by representatives of both institutions. A statement of agreement must be provided in the application. These research support funds may be used for: Personnel: support for students or other technical personnel; Equipment: limited to specialized research equipment essential to the proposed program; in accordance with PHS policy, title to such equipment will vest with the grantee institution; Supplies: consumable supplies essential to the proposed program; Travel: domestic travel for the awardee that is essential to the proposed program; and Other: publication costs, computer costs, or other costs necessary for the research program. Facilities and administrative (indirect) costs will be provided for at a rate of 8 percent of the total direct costs of each award, exclusive of equipment. The indirect cost rate on a subcontract with the mentor's institution may not exceed 8 percent. 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, July 1, 1997, a letter of intent that includes 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 subsequent applications, the information that it contains allows NIH 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. C. James Scheirer at the address listed under APPLICATION PROCEDURES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. 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. Special supplemental instructions necessary for preparing the application are included in the program guidelines, which must be obtained by contacting the appropriate individual listed under INQUIRIES prior to preparation of the application. The RFA label available in the PHS 398 application from 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. Send the completed application and four signed exact photocopies 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) One additional copy of the application must be sent to: Dr. C. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0288 FAX: (301) 480-3541 REVIEW CONSIDERATIONS All applications will be reviewed for scientific and technical merit by the Research Training Review Special Emphasis Panel of the Division of Extramural Affairs, NHLBI, followed by a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria The factors to be considered in the evaluation of the proposed training program are: the overall merit of the candidate's five year plan for research and the development of research skills; the candidate's background and the candidate's potential to meet the goals of the program, which are to develop their research skills, strengthen their laboratory research program, and enhance the scientific program at the minority institution; the candidate's commitment to a research career; the ability of both the minority institution and the training center to provide facilities, resources, and opportunities necessary for the candidate's research development; the qualifications, ability, and plans of the sponsor who will provide the candidate with the guidance necessary for career development in research; and the institution's commitment to the development of the candidate. AWARD CRITERIA The following will be considered in making funding decisions: o Technical merit of the application as determined by peer review; o Availability of funds; o Program balance among the research areas of the announcement. INQUIRIES Special Supplemental Instructions for preparing the application are included in the full Program Guidelines. Potential applicants must contact NHLBI staff to obtain these guidelines prior to preparation of an application. Michael Commarato, Ph.D., or Beth Schucker, M.A. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge, MSC 7940 Bethesda, MD 20892-7940 Phone: (301) 435-0530 FAX: (301) 480-1454 Email: michael_commarato@nih.gov or beth_schucker@nih.gov Mary Reilly, M.S., or Ann Rothgeb Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7952 Bethesda, MD 20892-7952 Phone: (301) 435-0222 FAX: (301) 480-3557 E-mail: mary_reilly@nih.gov; ann_rothgeb@nih.gov LeeAnn Jensen, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7950 Bethesda, Maryland 20892-7950 Phone: (301) 435-0065 FAX: (301) 480-1060 E-mail: leeann_jensen@nih.gov Thomas Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7938 Bethesda, Maryland 20892-7938 Phone: (301) 435-0433 FAX: (301) 480-1864 E-mail: thomas_blaszkowski@nih.gov James Kiley, Ph.D. National Center for Sleep Disorders Research National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7920 Bethesda, Maryland 20892-7920 Phone: (301) 435-0199 FAX: (301) 480-3451 E-mail: james_kiley@nih.gov For fiscal and administrative matters, please contact: William W. Darby Grants Operations Branch, Heart Section Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Phone: (301) 435-0177 FAX: (301) 480-0422 E-mail: william_darby@nih.gov Raymond L. Zimmerman Grants Operations Branch, Lung Section National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Phone: (301) 435-0171 FAX: (301) 480-3310 E-mail: raymond_zimmerman@nih.gov Jane Davis Grants Operations Branch, Blood Section Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Phone: (301) 435-0166 FAX: (301) 480-3310 E-mail: jane_davis@nih.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance numbers 93.837, 93.838, 93.839, and 93.231. Awards are made under the authority 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 at 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 Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-006 - V26(14) 05/02/97 Date: 8 May 1997 14:03:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 586 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ktf2f$126@net.bio.net> NNTP-Posting-Host: net.bio.net NHLBI MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY FACULTY NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA: HL-97-006 P.T. 34, FF; K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: July 1, 1997 Application Receipt Date: August 25, 1997 PURPOSE This program provides support to underrepresented minority faculty members with varying levels of research experience to prepare them for research careers as independent investigators. The research development programs of the candidates are based on scholastic background, previous research experience, past achievements, and potential to develop into an independent research investigator. The objective of the award is to develop highly trained minority investigators, whose basic or clinical research interests are grounded in the advanced methods and experimental approaches needed to solve problems related to cardiovascular, pulmonary and blood diseases, transfusion medicine, and sleep disorders. 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, Mentored Research Scientist Development Award for Minority Faculty, is related to the priority areas of heart disease and stroke, tobacco, educational and community-based programs, environmental health, maternal and infant health, diabetes and chronic disabling diseases, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-00100474-1 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 The Mentored Research Scientist Development Award for Minority Faculty provides research development opportunities for underrepresented minority faculty members with varying levels of research experience, who are committed to developing into independent biomedical investigators. This award will enable suitable faculty candidates holding doctoral degrees, such as the Ph.D., M.D., D.O., D.V.M., or equivalent degree, to undertake three to five years of special study and supervised research under a sponsor, competent to provide guidance in the area of research proposed, with the goal of developing the research skills of the minority faculty candidate. The award is intended to serve research career development needs of underrepresented minority faculty members by providing them with research opportunities appropriate for their scholastic background, previous research experience, and past achievements. Minority scientists and physicians with limited research experience needing guided course work and supervised laboratory experiences as well as minority faculty needing only an intensive research experience under the guidance of an established scientist, are eligible to apply. It is envisioned that most candidates for this award will hold non-tenured faculty appointments (such as instructor or assistant professor), although in some instances other individuals may be eligible to apply (such as individuals due to be appointed to a faculty position or individuals with tenured faculty positions). For the purpose of this program, underrepresented minority faculty members are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. In making grant awards under this program, the NHLBI will give priority to projects involving Black, Hispanic, Native American, Pacific Islander or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. At the time of award, it is required that at least two years have elapsed since the receipt of the doctoral degree and that the candidate have at least one year of prior documented research experience. Current or past program directors of an NIH grant or its equivalent, including the Clinical Investigator Award, Physician Scientist Award, Clinical Investigator Development Award, or Mentored Clinical Scientist Development Award are not eligible for the Mentored Research Scientist Development Award for Minority Faculty. Similarly, individuals serving as responsible investigators or project leaders on large grants, such as a Program Project Grant, are not eligible for the Mentored Research Scientist Development Award for Minority Faculty. An individual who has previously received support from the Minority Access to Research Careers (MARC), Minority Biomedical Research Support (MBRS), or Academic Research Enhancement Award (AREA) programs are eligible to apply. MECHANISM OF SUPPORT For this RFA, no detailed budget is required. However, total direct costs for all years must be provided in addition to the name, role on project, percent effort and narrative justification for all project personnel. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page are not required as part of the initial application. If there is a possibility for an award, necessary budget, 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 modifications to standard PHS 398 application kit instructions. The mechanism of support for this activity will be the career development grant. The award of grants pursuant to this RFA is contingent upon availability of appropriated funds. RESEARCH OBJECTIVES Background The proportion of biomedical investigators who are members of underrepresented minority groups is strikingly lower than the percentage of minority U.S. citizens. In 1991, there were 1177 Blacks (1.7%) and 1113 Hispanics (1.6%) in academic positions in the life sciences out of a total 69,122 individuals. Although the number of minority individuals graduating from medical school was approximately 7.4% in 1993, only 5.1% of assistant professors on medical school faculty are minority. One method of addressing this problem is by increasing the research capabilities of minority faculty members. In so doing, the pool of biomedical and biobehavioral investigators in cardiovascular, pulmonary, and hematologic research, transfusion medicine, and sleep disorders will be increased. Furthermore, these individuals may serve as role models for minority undergraduate and graduate students, and stimulate these students to become more cognizant of research opportunities in cardiovascular, pulmonary, and hematologic disease, and sleep disorders. Within NHLBI, the term "hematologic" covers research on thrombosis and hemostatis, immunohematology, hematopoiesis, thalassemia, blood cell disorders, sickle cell disease, transfusion medicine including blood component and derivative therapy, blood substitutes and blood resource management, aspects of AIDS products in AIDS prevention and treatment, and AIDS-related bone marrow and hematologic disorders. Other Institutes of the NIH are responsible for research on disorders of white cells, including the leukemias and other blood malignancies, and basic immunology related to the lymphoid system. Therefore NHLBI cannot provide support for such studies. PROVISIONS OF THE AWARD Applicant Institution Applications will be accepted from domestic colleges or universities, medical schools, or comparable institutions. The application must include a plan that identifies personnel and other resources to be devoted to the candidate. In addition, evidence of institutional commitment to the candidate's research development and level of effort should be included in a statement from the institution. The statement should also address the institution's plans for the candidate during and following the tenure of the award. The statement should be signed by an institutional official (e.g. a dean) and the candidate's departmental chair. Minority Candidate To receive an award under this program, individuals must have been awarded a doctoral degree (a Ph.D., M.D., D.V.M. or D.O., degree or its equivalent) and have a faculty appointment at an accredited college or university at the time of award. Applicants for this award must be either citizens or noncitizen nationals of the United States or have been admitted lawfully to the United States for permanent residence. An individual admitted lawfully for permanent residence must submit with the application, a notarized statement indicating possession of the Alien Registration Receipt Card. Individuals on temporary or student visas are not eligible. Candidates must be nominated by an institution on the basis of qualifications, interests, accomplishments, motivation, and potential for performing quality research. The candidate's academic background, previous experience, and career goals should determine both the necessary length and the kind of program that is appropriate. The sponsoring institution should provide a statement in the application that the candidate is a member of a minority group, indicating the ethnic or racial background of the applicant. Sponsor Each candidate must identify a sponsor(s) who is an accomplished investigator in the research area proposed and has experience in developing independent investigators. The sponsor is not required to be affiliated with the applicant institution. If the sponsor is affiliated with another institution, appropriate documentation must be provided concerning the relationship of the applicant institution and the sponsor's institution, as well as a clear delineation of the arrangements proposed for the research development program at a location distinct from the applicant institution. The sponsor must provide a written plan for the development of the candidate and provide guidance during the preparation of the research project. A secondary sponsor may also be proposed, but the primary sponsor must continue to be involved throughout the award period. In some cases candidates may choose to have both a basic research sponsor and a clinical research sponsor. The sponsor must provide a written plan for the development of the candidate, and the sponsor and candidate should be jointly responsible for the preparation of the research development plan. The sponsor must submit a report each year on the candidate's progress which should be included in the annual progress report. Research Development Program All research development programs should be carefully tailored to meet individual needs and must include a sponsor(s) who is competent to provide appropriate research guidance. All candidates must provide a full description of the research and career development plan for the period of the award. The proposed plan must include hands-on research experience, with either a clinical or a basic science focus, for the entire three to five year period. Awardees, in conjunction with their sponsor(s), are required to submit a detailed annual progress report. For minority candidates with minimal research experience, the development program may be designed to start with a creative and detailed scientific learning experience and progress to an intensive research activity under the guidance of an appropriate sponsor(s). The first year or two of the program may incorporate any needed course work, and seminars and other educational experiences necessary to prepare the candidate for the subsequent research program, but must include a hands-on research experience. This initial phase of the program may resemble a traditional postdoctoral research training program. The remainder of the development plan could include an intensive, fully-described research program and research projects that can be reasonably completed within the planned period. During this latter phase, the program should provide for progressive development of the individual into an independent investigator. If the minority candidate has already acquired some research experience, as might be obtained through a research fellowship, but needs further development under the guidance of an appropriate sponsor(s), the candidate may propose a three to five year program encompassing an advanced research experience focusing on a specific research project. Such a candidate may take additional courses or engage in special instruction in research techniques in other laboratories for a reasonable period of time if needed. During the latter phases of the award, the relationship of the sponsor and candidate may more closely resemble that of collaborators. Individuals with significant research experience in the proposed field of study should not apply for this award but rather should consider applying for independent research grant support. Advisory Committee A committee composed of the candidate's sponsor(s) and two or three other senior faculty members must be identified. This advisory committee should meet with the candidate to review the research development plan and research project, to evaluate the awardee's progress, and to provide guidance for scientific career development. Duration and Effort The award is granted for three to five years depending on the needs of the candidate and the evaluation of the initial review group and the National Heart, Lung, and Blood Advisory Council. It is non-renewable and all funds must be used on behalf of the original candidate. Substitution of another sponsor and/or a change of institution may be permitted with the prior approval of the NHLBI. A minimum of 80 percent effort must be devoted to the research program. The remainder may be devoted to other clinical and teaching pursuits that are consistent with the program goals, i.e., the candidate's development into an independent biomedical scientist or the maintenance of the teaching and/or clinical skills needed for an academic research career. The candidate must have a "full-time" appointment at the applicant institution. In general, candidates who have Veteran's Administration (VA) appointments may not consider part of the VA effort toward satisfying the "full-time" requirement at the applicant institution. However, it is permissible for part or all of the research program to be conducted in a VA laboratory, for example if the sponsor has a VA appointment, so long as the above conditions are satisfied as they apply to the Mentored Research Scientist Development Award for Minority Faculty candidate. Allowable Costs Salary. Individual compensation is based on the institution's salary scale for individuals at an equivalent experience level. Funding from this award for salary may not exceed $50,000 per year plus commensurate fringe benefits with at least 80 percent effort devoted to the research program. If 100 percent effort is to be devoted to the research program during the "summer months," the percent effort for the remainder of the year may be reduced provided that the effort over the course of the year is at least 80 percent. NIH policy permits supplementation of salary from non-Federal sources. Supplementation from other Federal funds is not allowed unless explicitly authorized by the program from which the funds are derived and the NHLBI. In no case may other NIH funds be used for supplementary salary support. Sponsor's Salary. Salary support may be requested for the primary sponsor up to a level commensurate with 5 percent effort. If the sponsor is at a different institution than the applicant institution, arrangements for the transfer of funds for the sponsor's salary and, if necessary, for research expenses should be formalized in a contract or written agreement with the sponsor's institution and included as part of the application. The sponsor's salary support is considered as separate and distinct from funds requested for the candidate's salary or research and development support. The percent effort may exceed 5 percent for selected periods of time, provided the total effort for the budget period (12 months) does not exceed 5 percent. If the sponsor's salary is requested as a consortium cost, the subcontracting grantee is only allowed to request indirect costs based on 8 percent of total allowable direct costs. Research and Development Costs. A maximum of $30,000 per year may be requested for research project requirements and related support, (e.g., technical personnel costs, supplies, equipment, candidate travel, telephone charges, publication costs, and tuition for necessary courses). Facilities and Administrative (Indirect) Costs. Funds will be provided for the reimbursement of facilities and administrative (indirect) costs at a rate of 8 percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures for equipment. Concurrent Applications Mentored Research Scientist Development Award for Minority Faculty applications may not be submitted or awarded concurrently with other NIH applications, such as the Independent Scientist Award, Mentored Clinical Scientist Development Award, FIRST Award, Academic Award, or Research Project Grant. Subsequent Applications for NIH Research Support During the later years of the Mentored Research Scientist Development Award for Minority Faculty (MRSDAMF), incumbents are encouraged to apply for independent research support, such as the FIRST Award or other research project grants. MRSDAMF recipients who are successful in obtaining NIH research grant support may not receive salary support from the research grant for the duration of the MRSDAMF. After the conclusion or termination of the award, salary support should transfer to the research grant. MRSDAMF recipients who apply for research grant support are encouraged to include salary and all other research needs in the research grant application for the period following completion of the MRSDAMF. Alternatively, recipients of research grant awards may terminate the MRSDAMF prior to the start of the research grant. 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. EVALUATION Awardees will be encouraged to provide a detailed report to the National Heart, Lung, and Blood Institute annually for a period of five years subsequent to completion of the award for updates on academic status, publications, and research grants or contracts received. LETTER OF INTENT Prospective applicants are asked to submit, by July 1, 1997, a letter of intent that includes 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 subsequent applications, the information that it contains allows NIH 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. C. James Scheirer, at the address listed under APPLICATION PROCEDURES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. 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. Special instructions for preparing the application are included in the program guidelines. Applicants must contact the appropriate INDIVIDUAL LISTED UNDER THE "INQUIRIES" SECTION FOR A COPY OF THESE GUIDELINES PRIOR TO PREPARATION OF THE APPLICATION. Send the completed application and four signed exact photocopies by to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 701 ROCKLEDGE DRIVE ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier service) One additional copy of the application must be sent to: Dr. C. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0288 FAX: (301) 480-3541 The receipt date for submission of applications is August 25, 1997. Applications will be reviewed for technical merit in the Fall of 1997 and be considered by the National Heart, Lung, and Blood Advisory Council at their meeting in February 1998. REVIEW CONSIDERATIONS Applications received in response to this program will be reviewed in nationwide competition and in accordance with the usual NIH peer review procedure. They will be reviewed initially for the potential to develop the candidate's research career and for scientific and technical merit by an NHLBI review group composed mostly of non-Federal scientific consultants (initial review group). Following the initial review, the applications will be evaluated by the National Heart, Lung, and Blood Advisory Council. The criteria for initial review of applications include: Candidate. The candidate's overall competence as demonstrated by academic record and performance, potential for a career in independent research, and commitment or interest in pursuing an academic research career. Sponsor(s). The sponsor's accomplishments in the scientific research area(s) proposed, experience and track record in training investigators, and commitment for the duration of a candidate's research development. A curriculum vitae with relevant publications and a list of current and pending research support must be included for all sponsors. Sponsors should also include a list of current and past research trainees (not more than the last 10 years) with information on their current positions. Environment. The applicant institution's ability to provide adequate facilities, resources, and opportunities necessary for the candidate's training, and the institutional commitment to the candidate. If different from the applicant institution, the quality and extent of interaction of the faculty in the basic and clinical sciences, and the quality of the research and research training programs at the sponsor's institution. Career Development Plan. The adequacy of the research career development plan, based on the candidate's past research experience, training, and career goals. Research Project. Scientific merit of the proposed research project and its appropriateness as a vehicle for developing the candidate's research skills. Other Considerations. The personnel category will be reviewed for appropriate staffing based on the requested percent effort and justification provided. AWARD CRITERIA The following will be considered in making funding decisions: o Technical merit of the application as determined by peer review; o Availability of funds; o Program balance among the research areas of the announcement. INQUIRIES Special supplemental instructions for preparing the application are included in the full Program Guidelines. Potential applicants must contact NHLBI staff to obtain these guidelines prior to preparation of an application. Michael Commarato, Ph.D. or Beth Schucker, M.A. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0530 FAX: (301) 480-1454 Email: michael_commarato@nih.gov beth_schucker@nih.gov Mary Reilly, M.S. or Ann Rothgeb Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7952 Bethesda, Maryland 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: mary_reilly@nih.gov; ann_rothgeb@nih.gov LeeAnn Jensen, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7950 Bethesda, Maryland 20892-7950 Telephone: (301) 435-0066 FAX: (301) 480-1060 Email: leeann_jensen@nih.gov Thomas Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7938 Bethesda, Maryland 20892-7938 Telephone: (301) 435-0433 FAX: (301) 480-1864 Email: thomas_blaszkowski@nih.gov James Kiley, Ph.D. National Center for Sleep Disorders Research National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7920 Bethesda, Maryland 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: james_kiley@nih.gov For fiscal and administrative matters, please contact: William W. Darby Grants Operations Branch, Heart Section Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0177 FAX: (301) 480-0422 Email: william_darby@nih.gov Raymond L. Zimmerman Grants Operations Branch, Lung Section Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: raymond_zimmerman@nih.gov Jane R. Davis Grants Operations Branch, Blood Section Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 Email: jane_davis@nih.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance numbers 93.837, 93.838, 93.839, and 93.231. Awards are made under the authority 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 at 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 Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-97-006 - V26(14) 05/02/97 Date: 8 May 1997 14:02:54 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 768 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ktf1u$u6@net.bio.net> NNTP-Posting-Host: net.bio.net COLLABORATIVE MINORITY ALCOHOL RESEARCH DEVELOPMENT PROGRAM NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA: AA-97-006 P.T. 34, FF; K.W. 0404003 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: June 16, 1997 Application Receipt Date: July 15, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) in collaboration with the Office for Research on Minority Health (ORMH) of the National Institutes of Health (NIH) invites applications for Collaborative Minority Institution Alcohol Research Development grants (CMIARD). The long range goal of the Collaborative Minority Institution Alcohol Research Development Program is to strengthen the alcohol research capacity of predominantly minority institutions by fostering collaborations with research intensive institutions, and through this means, expand the capabilities of the research scientists in these institutions to research on alcohol-related health issues within minority communities. For the purpose of this solicitation, African Americans, Hispanics, Native Americans, and Alaskan Natives are considered to be racial or ethnic minorities. 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), Collaborative Minority Alcohol Research Development Program, is related to the priority area of alcohol abuse and alcoholism reduction. 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 Only predominantly minority institutions as defined below are eligible to submit applications in response to this request. Applications from foreign institutions are not eligible. Applications may contain a foreign collaborative research project if the project is specifically relevant to an alcohol-related U.S. minority health issue. To be responsive to this RFA, eligible institutions must have documented collaborative agreements with established alcohol research investigators at an institution other than the applicant institution. It is anticipated that in most instances, the collaborating scientists will be located at one or more research intensive institutions. Definitions 1. A "predominantly minority institution" is an academic, health care or research institution with an enrollment and/or faculty predominantly of ethnic minorities. For most academic institutions this would be a school whose student enrollment and/or faculty is composed of 50 percent or more ethnic minorities. "Hispanic Serving Institutions" are defined as having 25 percent Hispanic students and are eligible to apply. 2. An "established research investigator" is an individual who in Fiscal Year 1997 is the recipient of independent research support from any awarding component of the NIH through the one or more of the following mechanisms: R01, R29, R37, or a component director within a P30 or P50 Center. 3. An "established alcohol research investigator" is an individual who is currently the recipient of independent research support from the NIAAA through one or more of the following mechanisms: R01, R29, R37, or a component director within a P50 Center. 4. A "research intensive institution" is a university or research institution which received at least $20 million in NIH research and research training support in Fiscal Year 1996. MECHANISM OF SUPPORT This RFA is a one-time solicitation by the NIAAA. The administrative and funding instrument to be used for this program will be a Resource Related Research Project Cooperative Agreement (U24), an "assistance" mechanism (rather than an "acquisition" mechanism), 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 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 the study to be funded under the cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." FUNDS AVAILABLE It is anticipated that up to three five-year awards will be made in response to this RFA in Fiscal Year 1997. The specific number of awards will be contingent upon the scientific and technical merit of the applications. The cost may not exceed $400,000 in direct costs for the initial year. Although the financial plans of the NIAAA provide for the support of this program, awards pursuant to this RFA are contingent upon availability of funds. RESEARCH OBJECTIVES Epidemiological studies indicate major differences in alcohol morbidity and mortality among different racial and ethnic groups. In the United States, alcohol use is involved in nearly 100,000 deaths annually from traffic crashes, cirrhosis of the liver, self-directed and other-directed violence, falls, burns, drowning, and other unintentional injuries. Alcohol misuse results in violence, family discord, job loss, and serious medical problems, including alcohol-related birth defects. The costs and problems are unevenly distributed across racial and ethnic groups, with disproportionately higher problems observed in some sub-populations of African Americans, Hispanic Americans, and Native Americans. Research has produced both important findings and new questions. A study of alcohol-related mortality in California showed that African Americans and Hispanics had higher rates of mortality from alcoholic cirrhosis than did whites or Asian Americans. Further, death rates attributed to alcohol dependence syndrome also were highest for African Americans, although a higher percentage of African Americans than whites abstain from using alcohol. The higher rates of medical problems seen in African Americans thus occur among a smaller percentage of the African American population when compared with whites. Epidemiological evidence indicates that the incidence of fetal alcohol syndrome (FAS) and other alcohol-related birth defects is greater among both Native American and African American populations than other U.S. populations. The reasons for these observed differential prevalence rates have not been explained. Over the last several years the NIAAA has increasingly focused attention upon enhancing its commitment to research on topics germane to the health and well-being of minority Americans, and involving researchers in minority institutions in alcohol research and training. Recognizing the importance of minority institution involvement in research on minority health issues, the objective of this cooperative agreement is to foster the capability of minority institutions to submit applications for research support that are competitive within the NIH peer review process. As well, the ability to obtain such support, especially from the Federal Government, is, in turn, often dependent on a successful record of previous research and on a research infrastructure capable of supporting proposed research projects as well as on the inherent scientific merit of the projects. Without the opportunity to establish such a research record or to develop the necessary resources to support research, qualified scientists at minority institutions are often disadvantaged when compared with their colleagues at research-intensive institutions. Thus, a central aim of the CMIARD program is to enhance the funding opportunities for scientists at minority institutions by pairing them, through collaborative affiliations, with scientists, typically from research-intensive institutions, who have both the resources and experience necessary to successfully compete in the NIH scientific peer review system. It is anticipated that accomplishment of this aim will not only enhance the research careers of minority scientists but also attract qualified minority undergraduate and graduate students to careers in alcohol research. Scientific and Research Opportunities The following topics are suggested for inclusion in CMIARD applications. These, however, are not listed in priority order nor are they exhaustive, and other research topics relevant to alcohol research may be proposed. o Studies of the incidence and prevalence of alcohol abuse and alcoholism in minority populations and subpopulations o Studies of the relationship of the general health status of minorities to the prevalence of alcohol related disorders. o Studies designed to investigate factors contributing to the excess morbidity and mortality associated with alcohol abuse and alcoholism in minority populations. o Biological and behavioral studies on the interrelationship of alcohol use and abuse to AIDS/HIV in minority populations. o Studies of the underlying genetic and environmental factors involved in alcohol abuse and alcoholism. o Studies of fetal alcohol syndrome, alcohol-related birth defects and alcohol-related neurobehavioral disorder. o Studies of factors contributing to differences in the rates of alcohol dependence in minorities and non-minorities. o Studies to investigate the pathogenesis and treatment of alcoholism. o Studies of use and barriers to use of alcohol-related health services. APPLICATION CHARACTERISTICS The CMIARD award is expected to support a minimum of three alcohol research projects. The projects may be of a pilot or exploratory nature. Each project will involve participation by co-investigators from the applicant minority institution and at least one external scientist, preferentially from a research-intensive institution(s)(see Definitions). Each project should have at least one collaborative scientist who meets the qualifications of an "established research investigator" (see Definitions, above). The complete CMIARD application should have at least two collaborating scientists who meet the qualifications of "established alcohol research investigator" (see Definitions, above). Projects involving outreach to minority populations are encouraged, and at least one project must focus on a topic of significance to an alcohol related minority health issue. Each CMIARD will have its own unique Project Advisory Committee (PAC); membership requirements for this Committee are described below. The role of the PAC is provide advice to the Principal Investigator on scientific and related issues pertinent to the operation of the CMIARD. Among its duties, the PAC will assess interim progress of all projects within the CMIARD, and review projects proposed for future implementation. Core resources such as development activities, administrative services, unique clinical facilities, animal facilities, biostatistical and computer services, and shared equipment may be supported. The level of support for core resources should be commensurate with the level of research proposed and funded. The administrative core might include support of meetings or other activities to explore new and expanded collaborative research and research training. Travel to the site of an annual CMIARD Directors' meeting should be budgeted in the administrative core. Budgetary constraints, however, preclude expenditures for expensive items of equipment or renovations. While formal research training activities cannot be supported directly by this grant mechanism, there is realization that participation in research supported by the CMIARD program can have a significant impact on the career development of minority faculty members. In addition, the more traditional mechanisms of support for career development (i.e., K01, K08) remain available. The application should address each of the following elements: I. Administrative Core The CMIARD must have strong and experienced central leadership to coordinate proposed activities and to keep all components informed of important activities. Critical elements of the Administrative Core follow: The Principal Investigator should be a senior experienced investigator from the minority institution who will have substantial involvement in the operation of the CMIARD program. The Administrative Core must establish a Project Advisory Committee (PAC) of four to six members. At least one PAC member should be from a relevant community group and two members should be experienced alcohol researchers. The NIAAA staff collaborator will be an additional voting member of the PAC. The PAC will meet at least twice yearly to review activities and make recommendations on CMIARD functions. The Administrative Core will have the responsibility of preparing a yearly progress report for the project, and attending an annual meeting of CMIARD Directors. II. Information Transfer Each CMIARD should create a program for disseminating alcohol research information. The audiences for these activities should include health care students and professionals, community based organizations and researchers at the host institution as well as investigators at other institutions. Information transfer activities may include, but are not limited to, activities such as training programs, short courses, telemedicine, presentations at professional meetings and publications. The content of these activities must be developed in collaboration with the NIAAA and established alcohol research scientists. The CMIARD may wish to seek Continuing Health Education credit for participants. The information transfer and faculty development function should work closely with the Administrative Core. III. Five-Year Research Plan Each CMIARD shall develop a 5-year research plan based on areas of alcohol research interests. The selection of proposed projects must reflect the goals of the research plan and must be relevant to the research program and priorities of the NIAAA. The plan should state how the institution will build on its strengths and capabilities to conduct alcohol research and address the needs of the institution in furthering its goals. IV. Development of Summary Report The Administrative Core will prepare a yearly progress report and a document near the conclusion of the first 5 years of CMIARD experience. The document will contain, but not be limited to, the CMIARD description; findings regarding the collaborative approach to project development and the enhancement of faculty expertise. Research findings and observations on the administration of the program should be included. TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) 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 Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a resource related research project cooperative agreement (U24), an "assistance" mechanism (rather than an "acquisition" mechanism) 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 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 project as a whole resides with the awardee(s), although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIAAA project staff. Details of the roles of the parties are described later in this section. A. Awardee Rights and Responsibilities Awardees will have primary and lead responsibilities for the project including, as appropriate, protocol development; subject recruitment; data collection, analysis and quality control; safety monitoring; and preparation of publications. The Principal Investigator defines the details for the project; retains primary responsibility for the performance of the activity; and agrees to close coordination, cooperation, and assistance of NIAAA extramural staff in aspects of scientific and technical management of the project as described herein. 1. Project Advisory Committee Membership and Meeting Attendance Each CMIARD must establish a Project Advisory Committee (PAC), composed of at least four and no more than six members (not including the NIAAA staff collaborator). An NIAAA staff collaborator will serve as a member of each PAC, and exercise one vote on that committee. The PAC should not include any of the external researchers involved in any of the projects. The Chairperson of the PAC will be selected by vote of the PAC members; the NIAAA staff collaborator may not serve as Chairperson. Each member will have one vote, should a vote of the PAC be necessary to make a decision. Each PAC will meet at least twice a year. 2. Role of Awardee Institution Each awardee institution and its corresponding investigators will be responsible for developing and implementing its research programs taking into consideration the recommendations of the PAC. 3. Role of Project Advisory Committee The Project Advisory Committee (PAC) will be the major advisory body to the Principal Investigator (PI) for all scientific decisions pertaining to project selection and conduct within the approved scope of the award. The PAC will facilitate collaborative interactions between the minority institution scientists and external collaborating scientists; monitor progress of existing projects within the individual CMIARD award; and, review and make recommendations for new pilot and exploratory projects within the program. B. NIAAA Staff Responsibilities The NIAAA staff role in a cooperative agreement will extend beyond the level normally required for stewardship of a grant because of the developmental nature of the research program, the potential need for technical assistance, and for monitoring and possible reassessment of project objectives. The NIAAA extramural program official and staff collaborator perform different functions in research projects supported under the cooperative agreement mechanism. 1. Program Official The Program Official provides normal stewardship of the award and has overall responsibility for monitoring the conduct, progress, and fiscal management of the program. Progress of the project will be reviewed by the Program Official annually at the time of each continuation application to assure that satisfactory progress is being made in achieving the objectives of the project. 2. NIAAA Staff Collaborator The NIAAA Staff Collaborator has substantial scientific input in collaboration with award recipients, in both planning and conduct of the research. The NIAAA Staff Collaborator will a) facilitate the coordination necessary to manage this complex project; b) participate in all PAC duties and responsibilities; c) participate in monitoring progress of ongoing studies; d) participate in planning and implementing efforts to disseminate information; e) provide instruction in faculty development activities; f) participate in data interpretation and, when appropriate, in the preparation of publications and presentations. The NIAAA staff is subject to the same publication/authorship policies governing all participants in the study, as well as to the official NIH Publication Policy governing extramural employees. 3. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIAAA may be brought to arbitration. An arbitration panel will be composed of three members; one selected by the Principal Investigator of the CMIARD, a second member selected by the NIAAA, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation 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 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 June 16, 1997, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and 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 allows the NIAAA 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: RFA-AA-97-006 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409 - MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. 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, E-mail: ASKNIH@odrockm1.od.nih.gov. Applications must address the requirements as outlined above, research objectives, special requirements and terms, and conditions. SPECIAL REQUIREMENTS 1. A 5-year research plan is required. This plan must describe how the scientific agenda of the CMIARD will be pursued and how the institution plans to develop and expand its alcohol research capabilities. 2. All costs required for the proposed CMIARD application must be included in the application and must be fully justified. Requested budgets should include travel to the Washington, D.C., for three individuals to attend one annual CMIARD Director's meeting. 3. The CMIARD application should be organized into discrete components that comprise a cohesive application. Each component is either a research component or a core component for which a detailed budget is included in the application. The application must include an administrative core and at least three pilot or exploratory projects. Shared scientific resource core (s), if any, should be included within the administrative core. 4. The administrative core component is limited to 15 pages. Each pilot or exploratory project should be described in no more than seven pages . The description of each pilot or exploratory project should contain a statement of the problem, the methods to be used, the anticipated results, and subsequent planned efforts leading to an independent investigator award. Pilot or exploratory studies are limited to 2 years. 5. Biographical Sketches for both the minority institution investigators and external collaborators should be included in the application. Signed letter(s) of agreement between the collaborating investigators and the minority institution should be included in the application. 6. The CMIARD application must include the description of a process by which its PAC and PI will select future pilot and exploratory studies, including criteria to be used in this decision process. 7. Facilities and Environment--Applicants must demonstrate the availability of adequate laboratory, clinical, and office facilities to carry out the objectives of the CMIARD. 8. Organization and Administration--The CMIARD application must have an identifiable organizational structure with clear lines of authority which will facilitate coordination among CMIARD participants. The applicant organization must designate an appropriate institutional official to serve as principal investigator for the CMIARD. This individual must demonstrate the ability to organize, administer, and direct the CMIARD projects. The principal investigator will have direct authority over the administrative core. The administrative core should be described in sufficient detail to assure that all proposed activities will function optimally. 9. Budget Considerations----All CMIARD applicants should request and provide justification for 5 years of support. The total costs for the first year of support may not exceed $400,000 in direct costs. Future year costs requests should be in accord with NIH cost containment principles. The distribution of funds within the CMIARD to each participating project is at the discretion of the applicant institution and must be justified by the activities of each project component. Support for secretarial and administrative staff may be provided to the extent that their activities relate to meeting specified CMIARD objectives. Similarly, travel by project personnel must be justified as meeting project objectives. Travel and per diem for three persons to attend an annual day and a half meeting CMIARD Director's meeting in the Washington, D.C., area and for travel of four investigators to attend appropriate annual meetings of the alcohol research professional societies should be included in the budget. Consultants' costs and costs for the participation of collaborators are anticipated and these should be described and included as required by the CMIARD's objectives. 10. 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 2a of the face page of the application form and the YES box must be marked. 11. 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 20817-7710 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: RFA-AA-97-006 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard MSC 7003 Bethesda, Maryland 20892-7003 Rockville, Maryland 20852-7003 (for express/courier service) Applications must be received by July 15, 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 a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW METHOD Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the NIAAA. Incomplete or unresponsive applications will be returned to the applicant 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 Institute in accordance with the review criteria stated below. As part of the initial merit review, a streamlined review process may be used by the initial review group in which applications may or may not be discussed based on their scientific merit relative to other applications received in response to the RFA. Applications which are fully discussed will be assigned a priority score. Applications which are not discussed will be withdrawn from further considerations and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Each application must be thorough and complete enough to stand on its own. Additional materials or revisions will not be accepted after the receipt date. It is strongly recommended that Institutional Review Board (IRB) approval be secured prior to submission. Major factors to be considered in the overall evaluation of the applications include: I. The following criteria will be used in judging the adequacy of plans for the administrative core: o Evidence of the overall 5-year plan of research reflecting the goals of the CMIARD. o Evidence of experience in coordinating multi-disciplinary projects and administrative core activities. o Evidence of experience with, and a commitment to, fostering working relationships with minority populations. o The degree to which the proposed collaboration presents opportunities for furthering research programs in the minority institution. o Evidence of the ability to disseminate information through professional and less formal mechanisms. o Appropriateness of the proposed budget. o Evidence of the establishment of collaborations between faculty from the minority institution and external scientists from research intensive institutions. o Evidence that the proposed PAC has appropriate scientific experience, including alcohol research, and minority community membership, and that the individuals are committed to the success of the program. o The promise and potential of the pilot and exploratory studies proposed; and the potential of the proposed research as a building block in the development of future research. o The adequacy of the qualifications and relevant experience of the principal investigator, key personnel and the ability of the collaborator to undertake the research activities proposed in the project. o Evidence that the mechanisms for review and administration of the pilot studies will function to produce studies that meet substantive objectives and have a reasonable expectation of subsequent independent funding. II. The following criteria will be used to evaluate the commitment of the applicant institution to program objectives: o Evidence that the academic environment(s) and its/their resources committed to the application including space, equipment, and facilities are adequate to meet the proposed objectives. o Evidence that the host institution is sufficiently flexible to foster multi-disciplinary interaction with investigators internal and external to the university. III. The following criteria will be used to evaluate the potential for productive collaborative studies and the potential of the proposed projects: Review of developmental research projects is based not only on the traditional considerations necessary for peer evaluation of scientific merit, but also takes into account the preliminary nature of the proposed studies and, in a broader sense, the extent to which the research activity will contribute to the goals of the CMIARD. The criteria for review of these developmental research projects include: o Evidence of a minimum of three well-developed projects. o The availability of adequate facilities, general environment for the conduct of the proposed studies and other resources and collaborative arrangements. o If studies involving human subjects are proposed, evidence of an ability to recruit and retain subjects for study will also be evaluated. o The scientific, health or medical significance of the proposed project. o Adequacy of procedures for the protection of human and animal subjects and for the environment. o Adequacy of plans for addressing compliance with NIH policies on inclusion of women and minorities in studies involving human subjects. AWARD CRITERIA Award decisions will be based on the technical merit of the application as determined by peer review, availability of funds, and other programmatic priorities to ensure a balance among the various types of programs, populations served, and/or geographic distribution. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Ernestine Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard - MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852-7003 (for express/courier service) Telephone: (301) 443-1273 FAX: (301) 594-0673 E-mail: tvander@willco.nih.niaaa.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 E-mail: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 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 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 Wed May 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-97-004 - V26(14) 05/02/97 Date: 8 May 1997 14:02:39 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 474 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ktf1f$sv@net.bio.net> NNTP-Posting-Host: net.bio.net MALE GERM CELL GROWTH AND DIFFERENTIATION NIH GUIDE, Volume 26, Number 14, May 2, 1997 RFA: HD-97-004 P.T. 34; K.W. 1002017, 0413002 National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 30, 1997 Application Receipt Date: June 13, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites research project grant (R01) applications for the support of studies of male germ cell growth and differentiation. The establishment of effective culture systems for male germ cells is a prerequisite to obtaining a better understanding of the developmental mechanisms by which male germ cells develop into mature sperm cells. The lack of such culture systems has greatly hindered progress towards this understanding. One particular goal of this initiative is to improve our ability to culture the self-renewable spermatogonial stem cells in order to be able to conduct cause and effect experiments. It may also be possible to establish lines of these potentially immortal stem cells. These advances, coupled with a recent breakthrough in our ability to transplant these cells into the testes of infertile mice would establish a test system for the assessment of the developmental potential of the cultured and transplanted spermatogenic cells. This system also would provide the opportunity to study ways to genetically alter male germ cells such that these alterations can be passed on to the next generation through mature sperm and fertilization. It is expected that the new knowledge derived from these studies will lead to the alleviation of certain forms of male infertility and to the discovery of novel contraceptive approaches as well as to a wide array of other potential benefits. An important part of the mission of NICHD is to gain new knowledge about human reproduction and this Request for Applications (RFA) is designed to address that mission. 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, Male Germ Cell Growth and Differentiation, is related to the priority area of family planning. 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. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The funding mechanism to be used to assist the scientific community in achieving the objectives of this RFA will be the National Institutes of Health (NIH) research project grant (R01). 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 RFA may not exceed five years. The earliest expected award date is December 1, 1997. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. New applications, as well as competing renewal applications for an ongoing research project, may be submitted in response to this RFA. FUNDS AVAILABLE Although this solicitation is included in the NICHD plans, support for these grants is contingent upon the availability of funds for this purpose. The number of grants to be awarded is also contingent upon a sufficient number of applications deemed meritorious enough to be considered for an award. It is anticipated that an estimated total cost of $540,000 will be available for the first year to support approximately three grants. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will also vary within the funding limits available. RESEARCH OBJECTIVES Background It is estimated that as many as 10% of reproductive age couples in the United States are infertile. Within this context, approximately 40% of human infertility cases are correlated with disorders in the male. We also recognize that there have been pills and other contraceptive methods available for female contraception for many years, but male contraceptive methods have been limited mostly to vasectomies and condoms. This should not be surprising since our knowledge of the process of spermatogenesis is negligible. New technologies and motivations now exist that could improve this knowledge. With this improved knowledge, it should be possible to greatly increase our ability to regulate male reproduction and to address these two issues of male infertility and male-side contraception, using new modes of diagnosis and therapy as well as providing additional contraceptive choices. Accordingly, the purpose of this RFA is to stimulate and encourage the development of culture systems for spermatogonial stem cells, the most immature, yet completely self-renewable, germ cells in the testis. These cells undergo growth, meiosis and differentiation in their development into mature sperm cells. However, the male and female gametes of mammals develop internally from spermatogonial and oogonial stem cells in the testis and ovary, respectively. Likewise, mammalian fertilization is internal and the various stages of embryonic development also occur internally so that it is difficult to observe these processes as they occur naturally. For egg development, as well as fertilization and early embryo development, culture systems have now been devised that allow one to observe and to conduct experiments and then to test the developmental potency of the oocyte or fertilized egg or early embryo by placing them back into the female reproductive tract for further development. These culture systems are still far from ideal, but they do permit considerable experimental manipulations to be done and cause and effect conclusions to be made. However, our ability to culture male germ cells is severely limited to brief and disconnected periods during the transition from spermatogonial stem cells to mature sperm. Thus, we have a very poor understanding of the mechanisms that control the development of spermatogonial stem cells into mature sperm. A recent breakthrough in male reproduction was the successful transplantation of spermatogonial stem cells from one testis to an infertile testis of the same or a different species and the ability to cryopreserve these spermatogonial stem cells prior to transplantation. The transplanted stem cells were able to undergo apparently normal spermatogenesis. This, then, established an in vivo system for assessment of the developmental potency of male germ cells after various in vivo or in vitro treatments, that might include production of cell lines with specific genetic alterations. With this technology, it will now be possible to test the in vivo developmental potential of stem cells that have developed in vitro. This opportunity to conduct rigorous in vivo tests of the developmental potential of male germ cells produced in this manner fills in one of the key voids in the technical armamentarium for male reproduction. This technology will be necessary in order to make rapid progress towards improved scientific understanding of male reproduction and towards practical applications that will have broad benefits to human health. Some of the benefits to human health that may be derived from increased knowledge of spermatogenesis through culture system improvements for spermatogonial stem cells include 1) major new insights into the genetic and other causes of certain types of male infertility that could lead to 2) development of effective points of alleviation of this infertility through assisted reproductive technologies, 3) discovery of novel contraceptive approaches, 4) the possibility that defective genes can be corrected in spermatogonial stem cell lines that can then be used therapeutically to eliminate certain devastating genetic diseases, 5) a vastly enhanced opportunity to understand how stem cells work in general since the spermatogonial stem cell population has the property of self-renewal, and 6) provide an additional method to generate transgenic animals as models of human diseases and disorders that may have certain advantages over the egg microinjection and the embryonic stem cell methods. There have been several recent NIH conferences and workshops and a detailed Institute of Medicine study that clarified the need for enhanced support of research in the area of this RFA. The conferences were 1) October 1991, "Meiosis II: Contemporary Approaches to the Study of Meiosis," 2) February 1992, "Opportunities in Contraception: Research and Development," 3) March 1993, "A New Look at Spermatogenesis," 4) August 1994, "Male Infertility and Impotence: Current Perspectives and New Directions for Basic and Clinical Research," 5) November 1994, "The Germ Line," and 6) May 1996, "Workshop on Transgenic Mouse Sperm Cryopreservation." The Institute of Medicine Report published in 1996 by the National Academy Press is on "Contraceptive Research and Development: Looking to the Future," and was based largely upon the "Workshop on Contraceptive Research and Development and the Frontiers of Contemporary Science," that was held in December, 1994 at the National Academy of Sciences. Much of the research reported and discussed at these meetings revealed a massive increase in molecular genetic approaches that could be applied to male reproduction. It was clear from these meetings that full advantage of this modern technology could not be currently applied to testicular germ cells owing to the unavailability of culture systems for these cells. Objectives The principal objective of this RFA is to stimulate and encourage the development of culture systems for spermatogonial stem cells. Our knowledge of the mechanisms by which spermatogonial stem cells develop into mature sperm is negligible. In order to fill this void in our knowledge it is imperative that we be able to conduct experimentation and make detailed observations of the various phases of spermatogenesis that include cell proliferation, meiosis and spermiogenesis. Meeting this principal objective is expected to help to improve our basic knowledge of sperm development and to rapidly advance our ability to apply this knowledge to key aspects of the mission of NICHD in alleviating infertility and in discovering novel contraceptive leads. In order to create a satisfactory culture system for this objective, it will be necessary to be able to obtain, identify and characterize high quality spermatogonial stem cells. These will be spermatogonia that are capable of self-renewal. Primary culture systems for these spermatogonial stem cells could be established that would allow for cell replication and observations and testing. The establishment of stable tissue culture lines of these spermatogonial stem cells would vastly facilitate reaching the objectives of this research, for these could then be used as a starting point for development of full in vitro or in vivo development of spermatogenic cells through the formation of mature sperm. The spermatogonial stem cell lines could be genetically altered, and then sperm could be used to carry altered genes into the next generation. While there has been considerable success in obtaining highly purified yields of these spermatogonial stem cells from mouse and rat testes, there is still much work to be done in identifying and characterizing them. The determination that they are of high quality can only be accomplished by showing that they have full developmental potential to develop into mature sperm that are capable of fertilizing an egg and resulting in healthy offspring. Currently, this latter aspect of the research can be done through transplantation of spermatogonial stem cells into infertile testes, where development has been shown to proceed through spermatogenesis and result in mature sperm. This procedure is presently inefficient, however, and improving the efficiency is a necessary part of the objectives of this RFA. It may be that a more favorable genetically or chemically-induced infertile testis model may be selected or developed that would provide better efficiency than those that have been used to date. Research Scope For this RFA, an application could focus upon, but would not be limited to, any of the following: o improvements in the isolation, identification, characterization and culture of spermatogonial stem cells of mammals o improvements in the ability to culture spermatogonial stem cells in such a way as to maintain their developmental potential o establishment of stable tissue culture lines of spermatogonial stem cells o improvements in the in vitro development of spermatogonial stem cells into mature sperm or advanced stages of spermatogenesis o improvements in the efficiency of transplantation of spermatogonial stem cells into seminiferous tubules Since this list is not meant to be all inclusive, prospective applicants are encouraged to discuss program relevancy issues with the program staff contact listed under INQUIRIES. In addition, be aware that awards made through this RFA would be restricted from supporting research on attempting to fertilize human eggs or on human eggs that (1) failed to fertilize, (2) are polyspermic, (3) are parthenogenetic, either by attempts to specifically activate or that were discarded after attempted IVF, or (4) are derived from fetal ovaries with the intent to attempt fertilization or artificial activation. Other research on human embryos that is not part of clinical protocols and/or general procedures in human IVF clinics as specifically authorized by prior approval of the NICHD is also restricted from support through an award from this RFA. 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 May 30, 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 subsequent applications, the information that it contains allows NICHD 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. Richard J. Tasca 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 awards. These forms are available at most institutional offices of sponsored research; and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892, telephone 301-435-0714, e-mail asknih@odrockm1.od.nih.gov. 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, MALE GERM CELL GROWTH AND DIFFERENTIATION, and number, RFA HD-97-004, must be typed on line 2a of the face page of the application form and the YES box must be checked. 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 must also be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Building 61E, Room 5E03 Bethesda, MD 20892-7510 Bethesda, MD 20852 (for express/courier service) Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: StreufeS@hd01.nichd.nih.gov Applications must be received by June 13, 1997. 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. The NICHD will not accept for review competing new or continuation applications that have been revised more than one time. If a revised competing continuation application is not selected for funding, the applicant institution may then only submit a new, substantially different application. Schedule Letter of Intent Receipt Date: May 30, 1997 Application Receipt Date: June 13, 1997 NACHHD Council Review: September 1997 Earliest Award Date: December 1, 1997 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness to the RFA by NICHD staff. Incomplete applications will be returned to the applicant without further consideration. Any application that does not meet the minimum requirements of this RFA will be considered unresponsive to the RFA and returned to the applicant. Applications meeting the minimum requirements and 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 NICHD in accordance with the usual NIH peer review procedures for research grants and the review criteria stated below. As part of the initial merit review, a process may be used in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to this RFA. Applications determined to be noncompetitive by the review committee will be withdrawn from further consideration, and the principal investigator will receive a summary statement reflecting the reviewers' evaluation. Applications judged to be competitive will be further discussed and assigned a priority score. They will then receive a second level review by the National Advisory Child Health and Human Development Council (NACHHD). Review criteria for RFAs are generally the same as those for unsolicited research grant applications, including: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, and of collaborators, if applicable; o adequacy of time and effort dedicated to the project; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o 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. (See INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS); o appropriateness of policies to ensure the protection of human subjects and the humane care and use of laboratory animals. AWARD CRITERIA The anticipated date of award is December 1, 1997. Applications approved by the NACHHD Council will be considered for award based upon scientific and technical merit, program balance, and availability of funds. 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 scientific program issues and address the letter of intent to: Richard J. Tasca, Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: tascar@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8A17 Bethesda, MD 20892-7510 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: nelsonm@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This Program is described in the Catalog of Federal Domestic Assistance Number 93.864, Population Research. Awards are made under the authority 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). These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines administered under PHS grants policies and Federal Regulations 45 CFR 52 and 45 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 Thu May 08 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 15, pt. 1of2, 9 May 1997 Date: 9 May 1997 13:45:38 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1495 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5l02di$euq@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 15 - May 9, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** GUIDELINES FOR SUPPORT OF SCIENTIFIC MEETINGS BY NIH National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** AHCPR POLICY ON THE INCLUSION OF CHILDREN IN HEALTH SERVICES RESEARCH Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX N4 ********************************************************** NIMH POLICY FOR CAREER AWARDS (K-SERIES): CHANGE OF INSTITUTION National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX N5 ********************************************************** IMMUNOLOGIC FACTORS IN SALIVA AND BLOOD AS DETERMINANTS OF HIV- RELATED DISEASES National Institute of Dental Research INDEX: DENTAL RESEARCH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** THERAPEUTIC STRATEGIES FOR PAPILLOMAVIRUS INFECTIONS (RFP NIAID-DMID- 98-10) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 07/30/97 ************************************************* THE NCI SCHOLARS PROGRAM (RFA CA-97-007) National Cancer Institute INDEX: CANCER $$INDEX R3 08/22/97 ************************************************* CANCER DRUG DISCOVERY: DIVERSITY GENERATION AND SMART ASSAYS (RFA CA-97-006) National Cancer Institute INDEX: CANCER $$INDEX R4 08/26/97 ************************************************* INTERSTITIAL CYSTITIS CLINICAL TRIALS GROUP (RFA DK-97-011) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available 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 (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from 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 to 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 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 26, Number 15, May 9, 1997 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made a final finding of scientific misconduct in the following cases: Ann Marie Huelskamp, M.H.S., The Johns Hopkins University School of Medicine: Based upon a report forwarded to the Office of Research Integrity (ORI) by The Johns Hopkins University School of Medicine, information obtained by ORI during its oversight review, and Ms. Huelskamp~s own admission, ORI found that Ms. Huelskamp, a research program coordinator in the Oncology Center, The Johns Hopkins University School of Medicine, engaged in scientific misconduct by fabricating patient interview data for a study of quality of life measures in cancer patients. The research was supported by a grant >From the National Cancer Institute (NCI), National Institutes of Health (NIH). ORI also found that Ms. Huelskamp engaged in scientific misconduct by falsifying patient status data by failing to update the status of treated breast cancer patients and misrepresenting data from previous contacts as the updated status for a study. These data were reported in a grant application to NCI and gave the appearance that some patients~ outcomes were more favorable than they actually were. Ms. Huelskamp cooperated fully with the Johns Hopkins investigation. The investigation report acknowledged her excessive workload, the difficulties associated with recruiting and following up on patients, and a lack of supervisory oversight. Ms. Huelskamp has accepted the ORI finding and has entered into a Voluntary Exclusion Agreement with ORI in which she has voluntarily agreed, for the three (3) year period beginning April 17, 1997: (1) to exclude herself from serving in any advisory capacity to the Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and (2) that any institution that submits an application for PHS support for a research project on which Ms. Huelskamp~s participation is proposed or which uses her in any capacity on PHS-supported research must concurrently submit a plan for supervision of her duties. The supervisory plan must be designed to ensure the scientific integrity of Ms. Huelskamp~s research contribution. The institution must submit a copy of the supervisory plan to ORI. No scientific publications were required to be corrected as part of this Agreement. William G. McCown, Ph.D., Integra, Inc.: Based upon a report forwarded to the Office of Research Integrity (ORI) by Compass Information Services, Inc., and information obtained by ORI during its oversight review, ORI found that Dr. McCown, former Project Director at Integra, Inc. (now Compass Information Services, Inc.), engaged in scientific misconduct by falsifying answer sheets for an ~Item Count Substance Abuse Survey~ supported by a grant from the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Dr. McCown has entered into a Voluntary Exclusion Agreement with ORI in which he does not admit to any acts of scientific misconduct but has voluntarily agreed, for the three (3) year period beginning April 17, 1997: (1) to exclude himself from serving in any advisory capacity to the Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and (2) that any institution that submits an application for PHS support for a research project on which Dr. McCown~s participation is proposed or which uses him in any capacity on PHS supported research must concurrently submit a plan for supervision of his duties. The supervisory plan must be designed to ensure the scientific integrity of Dr. McCown~s research contribution. The institution must submit a copy of the supervisory plan to ORI. No scientific publications were required to be corrected as part of this Agreement. Weidong Sun, M.D., Ph.D., Medical College of Pennsylvania and Hahnemann University: Based upon a report forwarded to the Office of Research Integrity (ORI) by the Medical College of Pennsylvania and Hahnemann University as well as information obtained by ORI during its oversight review, ORI found that Dr. Sun, a former graduate student in the Department of Physiology, Medical College of Pennsylvania and Hahnemann University, engaged in scientific misconduct by falsifying data in conducting and reporting research supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH). The research also was reported in applications requesting funding from NIAMS and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH. Specifically, Dr. Sun falsified data by misrepresenting cloned DNA sequences from chicken non-muscle myosin as an isoform of neuronal myosin II from rat brain. The falsified cDNA was included in the following publications and nucleotide sequences in GenBank and EMBL databases: o Sun, W.D., & Chantler, P.D. ~Cloning of the cDNA encoding a neuronal myosin heavy chain from mammalian brand and its differential expression within the central nervous system.~ Journal of Molecular Biology 224(4):1185-1193, 1992; o Sun, W.D., & Chantler, P.D. ~A unique cellular myosin II exhibiting differential expression in the cerebral cortex.~ Biochemical and Biophysical Research Communications 175(1):244-249, 1991; o Sun, W., Chen, X., & Chantler, P.D. ~Inhibition of neuritogenesis by antisense arrest of the expression of a specific isoform of brain myosin II.~ Journal of Muscle Research and Cell Motility 15:184-185, 1994; om M64596, ~Rat myosin II mRNA, 3' end.~ [RETMYOSII]; o M80591, ~Rat neuronal myosin heavy chain mRNA, 3' end.~ [RATMYOH3E]; o M94962, ~Rattus rattus neuronal myosin heavy chain gene promoter sequence.~ [RATMYOPRO]; and o X62659, S98128, ~R.rattus MRNA for brain neuronal myosin heavy chain.~ [RRNMYOHC]. Retractions of the publications and deletions from the public data banks have been requested. Dr. Sun has accepted the ORI finding and has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed, for the three (3) year period beginning April 17, 1997: (1) to exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government as defined in 45 C.F.R. Part 76 (Debarment Regulations); and (2) to exclude himself from serving in any advisory capacity to the Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. INQUIRIES For further information contact: Acting Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN NOT-97-006 FULL-TEXT ************************************* GUIDELINES FOR SUPPORT OF SCIENTIFIC MEETINGS BY NIH NIH Guide, Volume 26, Number 15, May 9, 1997 P.T. 42; K.W. 1014006 National Institutes of Health PURPOSE The National Institutes of Health (NIH) recognizes the value of supporting scientific meetings, conferences, and workshops that are relevant to its scientific mission and to public health. Support of these meetings is contingent on the interests and priorities of the individual Institutes and Centers (I/C) as well as the investment that each I/C determines is appropriate. Each I/C has the flexibility to support conferences according to its specific needs. As indicated in this document, changes have been introduced to reduce some of the burdensome and time-consuming processes for applicant organizations as well as NIH. Some Institutes and Centers require prior contact and/or approval before submission. The guidelines presented here are general guidance for applicant organizations in the development of applications for requesting support for scientific meetings. Potential applicants are encouraged to contact the individual I/C staff listed in this document for specific I/C information. This document contains information about o NIH policy and procedures concerning the application process for the support of scientific meetings o NIH Staff contacts and funding opportunities available from each NIH component for support of scientific meetings via grants or cooperative agreements (See Attachment 1) o Supplemental Instructions for Application Form PHS-398 (See Attachment 2) o "Guidelines on Inclusion of Women, Minorities, and Persons with Disabilities in NIH-Sponsored and/or -Supported Intramural and Extramural Scientific Meetings and Conferences" (NIH Guide, Vol. 24, No. 15, April 28, 1995) (See Attachment 3) This document only applies to those conferences, workshops, or scientific meetings supported by NIH grants or cooperative agreements. It does not apply to those conferences, workshops, or scientific meetings sponsored or initiated by NIH and funded by contracts or by direct operating funds, or workshops conducted as an adjunct to scientific peer review group activities. POLICY Scientific meetings may be funded by assistance mechanisms (grants and cooperative agreements) and may be funded for up to five (5) years. All applications for such meetings will be evaluated for programmatic relevance by Institute/Center (I/C) staff and reviewed for merit by the Institute/Center/Division. Each NIH I/C may support those applications that are within its mission. Applications of interest to more than one NIH component may be co-funded. Each NIH I/C has designated a conference award contact; this individual is the I/C focal point for information on the NIH component's general interest in supporting a scientific meeting on a specific topic or by a specific mechanism, for any I/C-specific guidelines, and for identification of the appropriate program staff within the I/C for further presubmission discussions. Please note that Institutes/Centers may also include in their guidelines a requirement for prior approval before submission of an application for support of scientific meetings; in this case, a letter of intent may be requested. Institutes/Centers may also include in their guidelines dollar limits and other budget guidelines. Organizers of scientific meetings must comply with the ~Guidelines on Inclusion of Women, Minorities, and Persons with Disabilities in NIH- Sponsored and/or -Supported Intramural and Extramural Meetings and Conferences.~ (See attachment 3). Appropriate representation of women, racial/ethnic minorities, and persons with disabilities, and other individuals who have been traditionally underrepresented in science, must be included in all aspects of planning, organization and implementation of NIH-sponsored and/or -supported meetings. "Appropriate" means representation based on the availability of scientists from these groups known to be working in a particular field of biomedical or behavioral research. If appropriate representation is not apparent, no award will be issued until program staff are assured of concerted efforts. ELIGIBILITY A U.S. institution or organization, including an established scientific or professional society, is eligible to apply. An individual is not eligible to receive an award for the support of a scientific meeting. Both domestic and international meetings may be supported; however, an international meeting can be supported only through the United States representative organization of an established international scientific or professional society. GENERAL PROCEDURES A scientific meeting is defined as a gathering, symposium, seminar, workshop or any other organized, formal conference where persons assemble to coordinate, exchange and disseminate information or to explore or clarify a defined subject, problem or area of knowledge. Types of Support o Investigator-initiated conference grants (R13 awards) o Cooperative agreement awards, with substantial programmatic involvement by NIH staff after award (U13 awards) o Multiple year awards (R13 or U13) for up to five years to a permanently sponsoring organization for conferences held annually or biennially on a recurring topic. Application Instructions Prospective applicants are encouraged to inquire in advance concerning NIH's interest in supporting a scientific meeting by contacting the appropriate conference award contact who is the I/C's focal point for identification of appropriate program staff for further presubmission discussions, including requirements for letters of intent and prior approval. Applicants may contact another I/C, if one I/C is not interested in supporting the scientific meeting. All information regarding supplemental instructions for preparation of application Form PHS 398 is outlined in attachment 2. Multiple year conference applications for up to five years may be submitted by permanent sponsoring organizations for conferences held annually or biennially. Continued funding beyond the first year is contingent upon scientific progress as determined annually by I/C procedures. Receipt dates will be determined by the individual I/C; however, potential applicants are encouraged to submit applications on the three DRG deadlines(February 1, June 1, October 1). All applications must be submitted at least 6 months prior to the conference. The conference award contact can provide specific information on receipt dates. Application Assignment within NIH Each application will be assigned to one or more I/C by the Division of Research Grants (DRG) Referral Office based on established Institute/Center guidelines for relevance. However, program staff will accept applications for assignment, including secondary assignments, only if there is interest in supporting the scientific meeting; thus, submission of an application does not assure acceptance. Evaluation of Applications Applications will be evaluated by the I/C or DRG by means deemed appropriate. Review criteria include: o the need and timeliness for the scientific meeting; o its format and agenda; o qualifications of the organizers and proposed participants; o past performance where applicable; o appropriateness of the meeting site; o plans for the appropriate* involvement of women, racial/ethnic minorities and persons with disabilities in the planning and implementation of the proposed meeting; and o appropriateness of budget, per Institute/Center guidelines. [* See "policy" section of this document and Attachment 3.] Recommendations are documented in a standard summary statement format and sent to the applicant. Depending on I/C policy, applications may be reviewed by the appropriate National Advisory Council or Board. Funding Each I/C may support any application that is within its mission, interests and support guidelines, and which has been recommended for support by the review group. Applications of interest to more than one I/C may be co-funded. Notice of Grant Awards for awards covering conferences for up to five years will contain information in the Terms and Conditions that a shift in conference focus would preclude further funding in subsequent years. Funding by Cooperative Agreement When the I/C determines that there is sufficient need to have substantial involvement in the planning and conduct of a scientific meeting, the I/C may determine that a cooperative agreement (U13) award should be made. Specific terms and conditions of the award may be obtained from the I/C contact. Reporting Requirements A report of the meeting must be prepared and two copies submitted to the awarding unit that supported the meeting within 90 days after the completion of the meeting. The report should include (a) the grant number, (b) the title, date and place of the meeting, (c) the name of the person shown on the application as the conference director, principal investigator, or program director, (d) the name of the organization that conducted the meeting, (e) a list of the individuals, and their institutional affiliations, who participated as speakers or discussants in the formally planned sessions of the meeting, and (f) a summary of topics discussed/conclusions. Multiple year awards require an annual progress report that contains a description of specific plans for the next award period, in similar detail and format as for a single meeting; this should be submitted six months before the next conference. NIH Program staff will evaluate these reports and plans in approving annual non-competing continuation awards. Copies of proceedings or publications resulting from the meeting, including items (a) through (f) listed above, may be substituted for the annual and final progress report, with approval of the NIH awarding unit. Additional information on support of conferences is available in Appendix 7 of the PHS Grants Policy Statement at gopher://gopher.nih.gov:70/11/res/PHSGPS. SUPPORT OPPORTUNITIES FOR SCIENTIFIC MEETINGS AND GUIDELINES AT EACH NIH COMPONENT The following listing provides the names of the conference award contacts at each of the NIH Institutes and Centers (I/C) and the general programmatic and funding guidelines for support of scientific meetings at that Institute or Center. Details for each I/C~s program and budget guidelines and information on NIH application instructions for support of scientific meetings may be obtained from the conference award contact listed. Detailed information about the I/C programs may also be obtained from the NIH Extramural Programs book, which is available on the NIH Homepage on the WWW at http://www.nih.gov/grants/funding/funding.htm or on the Internet at gopher://gopher.nih.gov:70/11/res/nih-ep. Specific information about program areas is provided. RECEIPT DATES: All applications must be submitted at least six (6) months prior to the meeting. Applications will be received on the three DRG receipt deadlines of February l, June l and October 1, unless otherwise noted below. LETTER OF INTENT: Letters of Intent are required by some I/Cs as noted below. These letters should be submitted to the I/C contact person noted below at least 30 days before the application deadline. Potential applicants are encouraged to talk to the I/C contacts as well. Budget guidelines are also provided by several I/Cs. 1. NATIONAL INSTITUTE ON AGING (NIA) NIA Contacts: Behavioral and Social Research Program Ronald Abeles, Ph. D. phone: 301-594-5943 fax: 301-402-0051 e-mail: ra20x@nih.gov (rabeles@box-r.nih.gov) Biology of Aging Program Richard Sprott, Ph.D. phone: 301-496-4996 fax: 301-402-0010 email to: rs51r@nih.gov (sprottr@gw.nia.nih.gov Geriatrics Program Evan Hadley, M.D. phone: 301-496-6761 email to: eh21f@nih.gov (hadleye@gw.nia.nih.gov) Neuroscience & Neuropsychology of Aging Program Neil Buckholtz, Ph.D. phone: 301-496-9350 email to: nb12s@nih.gov (buckholn@gw.nia.nih.gov) The NIA is interested in supporting scientific meetings, conferences, and workshops in the following areas: biology of aging, geriatrics, behavioral and social research on aging, neuroscience and neuropsychology of aging. Letter of Intent: NIA does not require a letter of intent prior to acceptance of submission of applications. However, applicants are encouraged to contact NIA staff before preparing their applications. Applications of interest to more than one IC will be cofunded. NIA will also provide partial support in conjunction with other funding sources. 2. NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) NIAAA Contact: Ernestine Vanderveen, Ph.D. Telephone: 301-443-1273 E-mail: Tvanderv@willco.niaaa.nih.gov The NIAAA is interested in supporting scientific meetings, conferences, and workshops on all health issues related to alcohol abuse and alcoholism, including the biomedical, behavioral, and social consequences of alcohol use and abuse. The NIAAA does require a letter of intent prior to acceptance of submission of a grant application. The NIAAA does not have any specific requirements regarding partial funding by applicants, dollar limits on applications or other funding policies. 3.NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) NIAID Contacts: Dr. Robert Quackenbush Div. of Microbiology and Infectious Diseases (301) 496-5644 rq1i@nih.gov Joan Kondratick Division of AIDS (301) 402-0755 jk37k@nih.gov Dr. Lawrence Prograis Div. of Allergy, Immunology and Transplantation (301) 496-1886 lp13r@nih.gov NIAID is interested in supporting scientific meetings, conferences, and workshops in the following areas: AIDS, Microbiology and Infectious Diseases, and Allergy, Immunology and Transplantation. NIAID encourages applicants of major annual or biennial conferences to contact staff concerning submission of applications for up to five years of conference support. Receipt Dates: All applications must be submitted at least six (6) months prior to the meeting. NIAID will accept applications on the 3 DRG deadlines. NIAID will also accept applications throughout the fiscal year with prior approval from NIAID staff (see contacts above). Letter of Intent: NIAID requires a letter of intent prior to acceptance of submission of conference applications. NIAID will accept applications for full or partial support. NIAID will not support any conference for less than $2,500. When NIAID is the awarding NIH component and NIAID staff will participate significantly in conference planning, conduct, and reporting, NIAID will normally award the grant as a cooperative agreement (U13). Details for NIAID's program and budget guidelines and information on application instructions for support of scientific meetings may be obtained from the NIAID conference award contacts listed above. 4. NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) NIAMS Contacts: Rheumatic Diseases Branch Dr. Susana Serrate-Szein, Chief 301/594-5032 Steins@ep.niams.nih.gov Skin Diseases Branch Dr. Alan Moshell, Chief 301/594-5017 moshella@ep.niams.nih.gov Musculoskeletal Diseases Branch Dr. Joan McGowan, Chief 301/594-5055 mcgowanj@ep.niams.nih.gov Muscle Biology Branch Dr. Richard Lymn, Chief 301/594-5128 lymnr@ep.niams.nih.gov Specific I/C information: The NIAMS is interested in supporting conferences in any of the basic and clinical areas related to the numerous rheumatic diseases, disorders of the musculoskeletal system, and diseases of muscle, bone, and skin. The NIAMS is also interested in research on the normal structure and function of the joints, muscles, bones, connective tissue, and skin. Areas of special emphasis within the NIAMS include: osteoporosis, Paget's disease, autoimmune diseases such as lupus, connective tissue diseases, exercise physiology and musculoskeletal fitness, sports injuries and occupational diseases. Letter of Intent: The NIAMS would appreciate receiving a letter of intent prior to acceptance of submission of applications for support of conferences of more than one year. The NIAMS, in general, only provides partial support for scientific conferences and workshops. Specific information about fiscal limitations can be obtained from program staff. 5. NATIONAL CANCER INSTITUTE (NCI) NCI Conference Award Contact: Dr. Ray Bramhall Division of Extramural Activities, NCI Phone: (301) 496-3428 Email: bramhalr@dea.nci.nih.gov Specific NCI Information: The NCI is interested in supporting scientific meetings, conferences, and workshops in the scientific program priority areas indicated in the NIH Extramural Programs book available on the Internet at gopher://gopher.nih.gov:70/11/res/nih-ep. Letter of Intent: NCI requires a letter of intent prior to acceptance of submission of all applications. In recent years, NCI has provided partial support for scientific meetings which has been in the range of 3 to 15 thousand dollars per award. Additional support which may be anticipated by the applicant should be requested from other sources. Therefore it is important for prospective applicants to inquire in advance concerning NCI~s interest in supporting a scientific meeting, especially where more than one of the NIH institutes and centers might be involved in providing funding for the same meeting. 6. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) NICHD Contacts: Dr. Marcus Fuhrer Director, National Center for Medical Rehabilitation Research 301-402-2242 fuhrerm@hd01.nichd.nih.gov Dr. Florence Haseltine Director, Center for Population Research 301-496-1101 haseltif@hd01.nichd.nih.gov Dr. Sumner J. Yaffe Director, Center for Research for Mothers and Children 301-496-5097 yaffes@hd01.nichd.nih.gov Conference grant applications are accepted in all areas related to the mission of the NICHD. Letter of Intent: NICHD does not require a letter of intent prior to acceptance of submission of applications, but applicants are encouraged to discuss their plans with the Center contact listed above. Applications of interest to more than one IC will be cofunded. 7. NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS (NIDCD) NIDCD Contact: Judith A. Cooper, Ph.D. 301-496-5061 judith_cooper@nih.gov NIDCD supports scientific meetings, conferences, and workshops in the areas of hearing, balance, smell, taste, voice, speech and language. Letter of Intent: NIDCD does not require a letter of intent prior to acceptance of submission of applications. However, contact with Institute staff prior to submission is strongly encouraged. All applications are reviewed by program staff to determine relevance to the mission of the NIDCD. Budget Considerations: NIDCD will accept applications with a budget limit of $30,000. The Institute usually supplies significantly less than the $30,000 award ceiling and frequently supplies only partial support for a conference. NIDCD often co-funds conferences with other NIH Institutes. 8. NATIONAL INSTITUTE OF DENTAL RESEARCH (NIDR) NIDR Contact: Dr. Norman S. Braveman Phone: 42089 Email: BravemanN@de45.nidr.nih.gov The NIDR is interested in supporting scientific meetings, conferences and workshops in the following areas: Inherited Diseases and Disorders - Infectious Diseases - Neoplastic Diseases - Chronic Disabling Diseases - Biomaterials, Biomimetics, and Tissue Engineering - Behavior, Health Promotion and Environment - Diversity Programs - Clinical Trials - Receipt Dates: NIDR will accept applications on the three DRG deadlines only. Exceptions to this can be made on a case-by-case basis with permission from the Institute. Letter of Intent: NIDR requests a letter of intent for all conference grant applications. Budget Guidelines: NIDR practice is to provide partial support for all conference grants at three levels as follows: (1) Applications directly relevant to the mission of NIDR and for which we are the primary awarding IC and for which NIDR program staff have been contacted prior to application - up to $35,000; (2) Applications relevant to the mission of NIDR and for which we are a secondary or other assignee - up to $10,000 (depending on the degree of relevance to current program priorities); (3) Applications minimally relevant to the mission of NIDR which includes major grantees of the Institute as participants - up to $3,000. 9. NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) NIDDK Contact: Walter S. Stolz, Ph.D. Address 45 Center Drive, Room 6As25C Phone 301.594.8834 E-mail ws23e@nih.gov The NIDDK is interested in supporting conferences in all scientific areas related to its mission including diabetes, endocrinology, metabolic diseases, digestive diseases, nutrition and obesity, kidney diseases, urologic diseases and disorders, and hematologic diseases and disorders Letter of Intent: NIDDK requires a letter of intent to be submitted approximately 30 days prior to submission of a conference grant application. Institute staff must accept the letter of intent before an application will be accepted for review. Early consultation with Institute staff is highly recommended. NIDDK will accept applications under the following budget guidelines: The Institute, in general, will provide only partial support for conferences and workshops. (A special interest of the Institute is to support the attendance of new, minority, and disabled investigators.) Although the NIDDK does not have absolute ceilings on the size of awards made for the support of conferences, awards of more than $20,000 are highly unusual, and the majority of awards are for less than $10,000. Prospective applicants should discuss the size of their anticipated request with Institute staff prior to submission. 10. NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) NIDA Contacts: Teresa Levitin, Ph.D. Office of Extramural Program Review Phone: (301) 443-2755 E-mail: TL25U@nih.gov Chisato Asanuma, Ph.D. Etiology/Clinical Neurobiology Research Branch Division of Clinical and Services Research Phone: 443-4877 E-mail: cs2j@nih.gov Charles Sharp, Ph.D. Division of Basic Research Phone: 443-1887 E-mail: cs107m@nih.gov Susan David, MPH Division of Epidemiology and Prevention Research Phone: (301) 443-6543 E-mail: sd69t@nih.gov Jamie Biswas, Ph.D. Chemistry/Pharmaceutics Branch Medications Development Division Phone: (301) 443-5280 E-mail: jb168r@nih.gov Cindy Miner, Ph.D. Office of Science Policy and Communication Phone: (301) 443-6036 E-mail: cm171w@nih.gov The NIDA is interested in supporting scientific meetings, conferences, and workshops in the following areas: basic and clinical neurosciences, behavioral and social sciences, treatment, prevention, epidemiology, health services, etiology, genetics, community research, HIV/AIDS, and medications development. Letter of Intent: The NIDA will require a letter of intent prior to acceptance of submission of all conference applications. Budget Guidelines: NIDA will support applications for partial or full funding. Applications of interest to more than one IC will be cofunded. 11. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS) NIEHS Contact: Allen Dearry, Ph.D. NIEHS, P.O. BOX 12233, RESEARCH TRIANGLE PARK, NC 27709 919/541-4500 DEARRY@NIEHS.NIH.GOV NIEHS has recently formulated and published a set of ~special emphasis areas~ that represent a broad spectrum of research opportunities within environmental health sciences (see http://www.niehs.nih.gov/dert/programs/special/special.htm). Consistent with this scientific focus, NIEHS is currently interested in supporting scientific meetings, conferences, and workshops in the following areas: o basic molecular mechanisms of environmental insult; o development of alternative models for toxicology testing; o genetic susceptibility; o human health effects of complex mixtures; o human health effects of endocrine disrupting chemicals; o impact of environmental exposures on women, children, and minorities. o prevention research, including basic molecular approaches as well as applied community-based strategies and environmental justice; o role of the environment in neurodegenerative diseases. Special areas of emphasis will be updated periodically. Thus, potential applicants are encouraged to refer to the NIEHS homepage (www.niehs.nih.gov) and/or contact program staff for additional information. Applications should be submitted at least six months before the conference takes place. NIEHS will accept applications throughout the fiscal year. A letter of intent is required prior to submission for cooperative agreement (U13) applications. This letter should provide a brief description of the purpose, significance, content, audience, and requested budget of the proposed conference. No application for a U13 will be accepted without prior receipt and review of a letter of intent. These letters will be accepted on an ongoing basis throughout the year. For applications grants (R13), a letter of intent is not required. However, potential applicants are encouraged to consult with program staff prior to application submission. NIEHS will accept applications under the following budgets guidelines: For R13s, the maximum level of support is $25,000; an average award is $7,500. For U13s, the maximum level of support is $50,000. NIEHS actively participates in cofunding with other NIH institutes for conferences related to environmental health sciences. 12. NATIONAL EYE INSTITUTE (NEI) NEI Contact: Ralph J. Helmsen, Ph.D. (301) 496-5301 (301) 402-0528 FAX rjh@eps.nei.nih.gov Specific NEI information: The National Eye Institute (NEI) supports investigator-initiated scientific meetings using the conference cooperative agreement mechanism, in most instances, rather than the traditional conference grant mechanism. The scientific meeting must be relevant and responsive to NEI scientific program goals and key research questions identified in "Vision Research - A National Plan: 1994-1998," a report of the National Advisory Eye Council. Letter of Intent: The NEI does not require a formal letter of intent. However, potential applicants are strongly encouraged to contact Dr. Helmsen for general information regarding this notice and for referral to the appropriate NEI extramural program director. If the application is funded as a cooperative agreement, NEI extramural program staff will be substantially involved in the planning and conduct of the scientific meeting, assisting the Principal Investigator according to specific Terms and Conditions. Budget Guidelines: No special guidelines. 13. NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS) NIGMS CONTACTS: Dr. James C. Cassatt Director, Division of Cell Biology and Biophysics (301) 594-0828 email: CASSATJ@GM1.NIGMS.NIH.GOV Dr. Judith H. Greenberg Director, Division of Genetics and Developmental Biology (301) 594-0943 email: GREENBERJ@GM1.NIGMS.NIH.GOV Dr. Michael E. Rogers Director, Division of Pharmacology, Physiology, and Biological Chemistry (301) 594-3827 email: ROGERSM@GM1.NIGMS.NIH.GOV The NIGMS is interested in supporting scientific meetings, conferences, and workshops in the following areas: The National Institute of General Medical Sciences (NIGMS) primarily supports basic biomedical research that is not targeted to specific diseases or disorders. NIGMS has three divisions that support research in basic biomedical science fields (additional information can be obtained from the NIGMS Home page: http://www.nih.gov/nigms/about_nigms/about.html). The Division of Cell Biology and Biophysics seeks greater understanding of the structure and function of cells, cellular components, and the biological macromolecules that make up these components. The Division of Genetics and Developmental Biology supports studies directed toward gaining a better understanding of the fundamental mechanisms of inheritance and development. The Division of Pharmacology, Physiology, and Biological Chemistry supports a broad spectrum of research aimed at improving the molecular-level understanding of fundamental biological processes and discovering approaches to their control. The NIGMS publication, "NIGMS Programs and Grant Award Mechanisms," provides additional information and is available on the NIGMS Home Page (The web address for the NIGMS homepage is http://www.nih.gov/nigms) and from: Office of Research Reports National Institute of General Medical Sciences National Institutes of Health 45 Center Drive MSC 6200 Bethesda, MD 20892-6200 (301)496-7301 email: PUB_INFO @GM1.NIGMS.NIH.GOV LETTER OF INTENT: NIGMS will require a letter of intent prior to acceptance of submission of all applications. For this announcement NIGMS does not wish to state any budget limits. 14. NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) NHLBI Conference Award Contacts Thomas P. Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications Phone: (301) 435-0417 E-mail blaszkot@gwgate.nhlbi.nih.gov John Fakunding , Ph.D. Division of Heart and Vascular Diseases Phone (301) 435-0505 E-mail: jf46f@nih.gov Carol E. Vreim, Ph.D. Division of Lung Diseases Phone: (301) 435-0233 E-mail: vreimc@gwgate.nhlbi.nih.gov Carol H. Letendre, Ph.D. Division of Blood Diseases and Resources Phone: (301) 435-0080 E-mail: letendrc@gwgate.nhlbi.nih.gov Specific NHLBI information: The NHLBI is interested in supporting scientific meetings, conferences, and workshops in potentially any relevant program area (Heart and Vascular Diseases, Lung Diseases, Blood Diseases and Resources, Epidemiology and Clinical applications). Receipt Dates: All applications for conference grants must be submitted at least six months prior to the meeting. Applications require approval of the NHLBI before they will be accepted by the Institute. Letter of Intent: NHLBI requires a letter of intent which must be received at least six weeks prior to the submission of an application. Letters should be submitted to the conference coordinators listed above. NHLBI will accept applications under the following budget guidelines: NHLBI will provide a minimum support level of $10,000 for each conference grant. This most likely will represent partial support for the conference. These same financial guidelines will apply to any conference grant cofunded with another I/C. In FY 95 and FY 96, NHLBI provided support to 14 conference grants. 15. NATIONAL HUMAN GENOME RESEARCH INSTITUTE (NHGRI) NHGRI Contact: . Name: Elise Feingold, Ph.D Phone: 301 496-7531 E-mail: elise_feingold@nih The NHGRI is interested in supporting scientific meetings, conferences, and workshops in the following areas: new and improved technologies for DNA sequencing; development and application of new technologies for comprehensive sequence-based approaches to the understanding of genome function, including the elucidation of the biological roles of gene products and non-coding functional elements, the interaction among functional elements in the cell, the biological consequences of genome organization; the study of DNA sequence variation, including the dynamics of polymorphisms in populations and the functional significance of genomic variation; and the ethical, legal, and social implications of genetic research. Receipt Dates: All applications must be submitted at least six (6) months prior to the meeting. NHGRI will accept applications on: Dec. 1, Apr. 1, Aug. 1 Letter of Intent: A letter of intent, or direct program contact, is encouraged at least two months prior to the receipt deadline, but is not required. NHGRI will accept applications for full or partial support. However, as a rule, NHGRI will not support the travel of foreign scientists to meetings in the U.S. NHGRI is willing to co-fund with other ICs. 16. NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) NIMH CONTACTS: Richard K. Nakamura, Ph.D. Associate Director for Science Policy phone: 301-443-4335 fax: 301-443-3225 e-mail: rn3p@nih.gov Nancy L. Ostrowski, Ph.D. Office of Science Policy and Program Planning phone: 301-443-4335 fax: 301-443-3225 e-mail: no5d@nih.gov The NIMH is interested in supporting scientific meetings, conferences, and workshops designed to focus research attention on understanding, treating, and preventing mental illnesses through basic research on the brain and behavior, and through clinical, epidemiological, and mental health services research. Letter of Intent: The NIMH suggests applicants submit a letter of intent prior to submission of applications. 17. NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) NINDS Contacts: General Information and Conference Grant Guidelines: Constance W. Atwell, Ph.D. Director, Division of Extramural Activities Phone(301) 496-9248 E-mail ca23c@nih.gov Discussions concerning potential program interest in conference or assistance in constructing application: Michael D. Walker, M.D. Director, Division of Stroke, Trauma and Neurodegenerative Disorders Phone (301) 496-2581 E-mail: mw163m@nih.gov Floyd J. Brinley, Jr., M.D., Ph.D. Director, Division of Convulsive, Infectious and Immune Disorders Phone: (301) 496-6541 E-mail: fb18u@nih.gov Robert W. Baughman, Ph.D. Co-Director, Division of Fundamental Neuroscience and Developmental Disorders Phone: (301) 496-5745 E-mail: rb175y@nih.gov Conference grant applications are accepted in all areas related to the mission of the NINDS. Letter of Intent: NINDS does not require a letter of intent prior to acceptance of submission of applications, but applicants are strongly encouraged to discuss their plans with the Division contact listed above. NINDS supports conferences in part or in full and participates in co-funding with other I/Cs. Awards are typically under $10,000, but larger awards are sometimes made. Discussions with program staff are especially important if larger amounts are requested. 18. NATIONAL INSTITUTE OF NURSING RESEARCH (NINR) The NINR does not offer conference grants. 19. NATIONAL LIBRARY OF MEDICINE (NLM) NLM Contact: Milton Corn, M.D. Division of Extramural Programs National Library of Medicine 301-496-4621 corn@nlm.nih.gov Prospective applicants are advised to contact Dr. Corn before submitting applications. 20. NATIONAL CENTER FOR RESEARCH RESOURCES (NCRR) NCRR Program contact for R13s Louise E. Ramm, Ph.D. Deputy Director, NCRR Phone: (301) 496-6023 Fax: (301) 402-0006 e-mail: louiser@ep.ncrr.nih.gov The NCRR is interested in supporting scientific meetings, conferences and workshops in the following areas: animal (both mammalian and nonmammalian) models; clinical research; biomedical technology; bioengineering; and science education. Receipt Dates: All applications must be submitted at least six months prior to the meeting. Letter of Intent: NCRR does not require a letter of intent prior to acceptance; however, if an application~s budget is over $25,000, program staff must be contacted prior to submission. Also, applicants are encouraged to contact NCRR staff before preparing their applications. Applications of interest to more than one IC will be cofunded. 21. FOGARTY INTERNATIONAL CENTER (FIC) The Fogarty International Center does not provide support for conference grants. 22. OFFICE OF RARE DISEASES (ORD) Conference Award Contact: Stephen C. Groft, Pharm.D. Office of Rare Diseases Phone: 301-402-4336 Fax: 301-402-0420 E-Mail: sg18b@nih.gov The Office of Rare Diseases provides support for scientific workshops and symposia to stimulate research on rare diseases and conditions. Primary consideration for support will be given to those rare diseases and conditions or groups of related diseases where current research is lacking or lagging or the likelihood of stimulating research is a possible outcome of the workshop or symposia. A rare diseases is defined as a disease or condition with a prevalence of less than 200,000 people in the United States. Letter of Intent: The Office of Rare Diseases does not require a letter of intent prior to acceptance of submission of applications. The Office of Rare Diseases will accept applications under the following budget guidelines: Full or partial support contributed by Office of Rare Diseases will be no more than $20,000 per award. All awards will be made through one of the categorical research institutes of NIH following the customary review process of the categorical research Institutes and Centers of the NIH. SUPPLEMENTAL INSTRUCTIONS FOR APPLICATION FORM PHS 398 FOR CONFERENCE AWARDS The following instructions are to be used in conjunction with the instructions accompanying application form PHS 398 (rev. 5/95). They refer only to selected items in the application. All PHS 398 requirements should be adhered to, with the exception of those items modified by the following instructions. Please note that some information to be omitted from the application at the time of submission may be requested by NIH staff following review if an application may be funded. Face Page : Item 1: Provide the title of the meeting. Item 2: Check the box marked "YES," if appropriate. Enter "PA" and the code "R13." Item 6: Enter the exact, inclusive dates of the meeting. Page 2: Description: Complete a very brief description of the proposed meeting, including the dates, location, types of participants, goals, and topics to be covered. Performance Site(s): Enter the site of the meeting or workshop. Key Personnel: List only those key individuals responsible for the planning and conduct of the meeting. Detailed Budget for Initial Budget Period (Page 4) : Do not complete or submit this page. Budget for Entire Proposed Period of Support (Page 5): Composite Budget Table: Enter total direct costs requested. Justification: Provide a narrative justification for each proposed personnel position, including role and proposed level of effort. Provide narrative justification for the support requested within the context of the total budget for the conference. Please note the following general NIH policy covering allowable and non-allowable costs for conference awards. The appropriate Institute/Center conference award contact should be consulted for specific guidance: Allowable Costs: Salaries in proportion to the time or effort spent directly on the meeting; rental of necessary equipment; travel and personal expenses (prior approval authority is suspended); supplies needed for conduct of the meeting only if received for use during the budget period; conference services; publication costs; registration fees; speaker's fees. Non-allowable Costs: Purchase of equipment; transportation costs exceeding coach class fares; visas; passports; entertainment; tips; bar charges; personal telephone calls; laundry charges; per diem, travel or expenses other than local mileage for local participants; organization dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; indirect costs. Biographical Sketch (Page 6): (Complete for each of the key personnel listed on Page 2.) Research and Professional Experience: List current position(s) and those previous positions directly relevant to the application. List selected peer-reviewed publications directly relevant to the proposed meeting, with full citations. Provide information on research projects completed and/or research grants in which the investigator participated during the last 5 years that are relevant to the proposed meeting. For each project or grant listed, provide title, name of principal investigator, funding source, and role on project (if not principal investigator). Other Support (Page 7): Do not complete or submit this section. Research Plan (This section may not exceed 13 pages.): 1. Single Year Applications Use this section of the application to describe the objectives, specific program, and logistical arrangements for the meeting. Describe the format and agenda, including the principal topics to be covered, problems to be addressed, and developments or contributions the meeting might stimulate. Provide a detailed justification for the meeting, including the scientific need, timeliness, and usefulness of the meeting to the scientific community. Describe the composition and role of the organizing committee, and provide the names and credentials of key participants in the meeting, including the basis for their selection and documentation of their agreement to participate. Describe plans for the appropriate involvement of women, minorities, and persons with disabilities in the planning and implementation of the proposed meeting (See Attachment 3). Estimate the expected size and composition of the audience, as well as the method of selection. Describe plans for publicizing the meeting and publication of proceedings. Identify related meetings held on the subject during the past 3 years. If this is one of a series of periodic meetings held by a permanent sponsoring organization, briefly describe and evaluate the last meeting in the series. 2. Multiple Year Applications Applications for multiple year awards for up to five years may be submitted when a series of annual or biennial meetings is proposed by a sponsoring organization. Support for meetings to be held on a less frequent schedule must be applied for individually. For applications requesting multiple years of support, the following additional information must be provided for each future year requested, in as much detail as possible: (1) meeting topic; (2) tentative dates, locations, and participants; (3) contingency plans for future meetings dependent on, for example, outcome of the first year's meeting or developments in the field. For multiple year awards, the noncompeting application (PHS 2590) must be submitted no later than six (6) months prior to the next scheduled meeting. It should include a report on the previous meeting supported by the current grant, as well as a full description of the next planned meeting including all information requested under section 1, above. Appendix: The Appendix is limited to the following items: 1. Announcement and report of previous meetings under the same sponsorship. 2. Letters of agreement from participants. Checklist: The Checklist should not be submitted. "Guidelines on Inclusion of Women, Minorities, and Persons with Disabilities in NIH-Sponsored and/or -Supported Intramural and Extramural Scientific Meetings and Conferences" (NIH Guide, Vol. 24, No. 15, April 28, 1995). Available through the NIH/OER Homepage(http://www.nih.gov/grants/oer.htm) or gopher://gopher.nih.gov:70/0R34019-43774-/gopherlib/data/nih-guide/OL DGUIDES/95.04.28.data. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** AHCPR POLICY ON THE INCLUSION OF CHILDREN IN HEALTH SERVICES RESEARCH NIH GUIDE, Volume 26, Number 15, May 9, 1997 P.T. 34; K.W. 1014006 Agency for Health Care Policy and Research The Agency for Health Care Policy and Research (AHCPR) announces that it is developing a policy and an implementation plan to encourage greater inclusion of children in health services research. The National Institutes of Health (NIH) and the American Academy of Pediatrics sponsored a joint workshop in June 1996, in which AHCPR participated, concerning the participation of children in clinical research. Valid concerns were raised that treatment modalities developed based on research conducted on adults are being used to treat children for many diseases/disorders without adequate data on children. One of the outcomes of the workshop was the recommendation that NIH develop a policy for including children in clinical research. An announcement by NIH was published in the NIH Guide, Volume 26, Number 3, January 31, 1997. AHCPR believes that when there is a sound scientific rationale for including children in health services research, investigators should be expected to do so unless there is a strong overriding reason that justifies their exclusion from the studies. Although this is the same scientific rationale that is the basis for the policy requiring the inclusion of women and minority populations in research, this policy does not mandate the inclusion of children in all research because the issues and sensitivities surrounding children's participation in research are significantly different from those regarding women and minorities. Nonetheless, applicants for AHCPR funding will be expected to address this issue in their applications. If an applicant proposes research that addresses conditions or disorders that affect adults and may also affect children, or that deals with issues in the health care system that are relevant to children, the applicant will be expected to describe the plans for including or justification for excluding children in the research. AHCPR recognizes, as does NIH, that the development and implementation of a policy on inclusion of children will require adjustments in administrative mechanisms and, most importantly, the education and preparation of the scientific community, parents, Institutional Review Boards, Initial Review Groups, advisory bodies and program staff. NIH has formed several working groups on these topics and will share and coordinate efforts with other PHS components. AHCPR will use the results of these efforts and the perspectives of the health services research community in further developing and implementing this policy. Ample advance notice will be provided before formal implementation. In the meantime, investigators are encouraged to consider the inclusion of children in their health services research projects. INQUIRIES Questions or concerns regarding this notice may be directed to: Patricia Thompson, Ph.D. Office of Scientific Affairs Executive Office Center, Suite 400 2101 E. Jefferson Street Rockville, MD 20852 Telephone: (301) 594-1437 x1607 Email: pthompso@ahcpr.gov $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NIMH POLICY FOR CAREER AWARDS (K-SERIES): CHANGE OF INSTITUTION NIH GUIDE,Volume 26, Number 15, May 9, 1997 P.T. 34; K.W. 1014006 National Institute of Mental Health This notice is intended to provide current National Institute of Mental Health (NIMH) career award (K-series) holders with the latest policy clarification regarding change of institution. This policy applies to all existing individual career development awards, including those awarded under previous program announcements (such as the K20 and K21 awards), prior to the issuance of the new NIH-wide career award program announcements (see below), but does not apply to programmatic career development awards (K12). This notice supplements the two previous notices, which appeared in the NIH Guide: (1) NIMH Supplemental Information to the NIH Career Development Announcements (K Awards) (NIH Guide, Vol. 24, No. 18, May 19, 1995); and (2) NIMH Policy Changes for Career Awards (K-Series) and Supplemental Instructions to the NIH K Award Program From owner-sci-resources@net.bio.net Thu May 08 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 15, pt. 2of2, 9 May 1997 Date: 9 May 1997 13:47:39 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 468 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5l02hb$fc1@net.bio.net> NNTP-Posting-Host: net.bio.net Announcements (NIH GUIDE, Vol. 25, No. 31, Sept. 20, 1996). The program announcements addressed in this Notice are the following: PA-95-049: Mentored Research Scientist Development Award (K01) PA-95-050: Independent Scientist Award (K02) PA-95-051: Senior Scientist Award (K05) PA-95-052: Academic Career Award (K07) PA-95-053: Mentored Clinical Scientist Development Award (K08) PAR-95-040: Mentored Scientist Development Award for New Minority Faculty (K01) POLICY STATEMENT Effective immediately, this notice applies to the "Termination or Change of Institution" section of the above listed Program Announcements. More specifically, however, this policy applies to Change of Institution: If the individual is moving to another eligible institution, and wishes to transfer the K Award to the new institution, the following steps should be carried out: o An abbreviated (see below) application must be submitted by the new institution. o The period of support requested can be no more than the time remaining within the existing original award project period. o The request must be submitted at least three months in advance of the desired effective date to allow the necessary time for staff review. No transfer will be allowed for awards with less than six months remaining in the project period. Note: NIMH will continue to allow an awardee to transfer from one institution to another for the last year of the award, with prior approval of the responsible Program Official (Project Officer). However, no transfer will be allowed during a period of administrative extension or after the project has terminated. The abbreviated application (use Form PHS 398, Research Career Award Section), which will initially be evaluated by the Project Officer, should provide detailed information in the areas outlined below: Section I: Basic Administrative Data A complete face page (AA) should provide information on all items and include all appropriate signatures. The "abstract" page (BB) should include a brief summary of the goals of the research and career plans, as well as the reason(s) for the transfer of institution, and identify key personnel. The table of contents substitute page (LL) should be used to indicate the page numbers for appropriate sections (see ahead). The budget pages (DD and EE) should provide information for the period of support remaining within the existing award project period. Budgets in the new application cannot exceed the amounts previously approved for the same project periods. Justifications are required for any costs that differ significantly from previously approved budget items (e.g., personnel costs, equipment, other expenses). The biographical sketch and other support pages (FF and GG) should include only information relevant to the transfer. The resources page (HH) and continuations, as necessary, should provide detailed information about the new institution. A completed checklist (page II) is required, and the personnel effort report page (JJ) should be included if new collaborators have been added. The personal data page (KK) should be omitted. Section II: Specialized Information 1. The Candidate. Part (a). Letters of Reference (for mentored awards): New letters of reference are not required. Parts (b, c, d). Candidate's background, Career Goals, and Career Development: Since this is an important aspect of a career development award, provide (where pertinent) detailed information on these topics. Give examples of how the career goals and development might be enhanced by the move to the new institution. 2. Statement by Sponsor(s), Consultant(s), and Collaborator(s). Provide detailed information, if sponsor(s), consultant(s) and/or collaborator(s) will change from the original application, or the applicant's modes of interaction with these individuals will differ. It is critically important to provide a detailed statement by any new sponsor(s) for mentored career development awards (K01, K07, K08, K20, K21), especially indicating the scientific credentials of the new sponsor. 3. Environment and Institutional Commitment to Candidate. Parts (a, b). This section is perhaps the most important in terms of evaluation of the merit of the request to transfer the grant to another institution. Applicants should carefully read and follow not only the guidelines in form PHS 398, but should pay particular attention to the section on Institutional Environment and Commitment in the "NIMH Policy Changes for Career Awards (K-Series) and Supplemental Instructions to the NIH K Award Program Announcements" (NIH GUIDE, Vol. 25, No. 31, Sept. 20, 1996). 4. Research Plan. Describe any changes to the original research plan, and explain how the research plan may be enhanced by the move to the new institution. K02 and K05 awardees should give examples of potential new collaborations (provide letters of commitment under #2 above) which might improve the overall plan. NIMH Staff Review: Prior to the final year of awards, transfer of career grants to another institution may be approved, without peer review, under the circumstances stipulated below. Therefore, early consultation with NIMH Program staff is critical for transfer of the grant to a new institution. It is strongly recommended that potential applicants contact the individuals identified below under INQUIRIES for consultation and guidance, prior to contacting the responsible Project Officer, to whom the abbreviated application should be sent. The Project Officer's review will be based on the degree to which the goals of the original peer reviewed application (as evidenced in the most recent summary statement) will be met in the new institution. Critical among these considerations will be the continued capacity to carry out full-time research; potential to contribute significantly to the scientific field of study as evidenced by research productivity; clear and high likelihood that the new environment will contribute to scientific development and productivity; scientific and technical merit of the research plan and its consistency with the career development plan; the new mentor's research and mentoring qualifications in the scientific area of study; and strong institutional environment and commitment. After consideration, the Project Officer will recommend, to the Director of the funding Division, either approval or disapproval of the requested transfer. In the event of disapproval (which will not be subject to request for reconsideration), the grantee has the option of submitting a new, complete application from the new institution which will be peer reviewed in the next review cycle. INQUIRIES Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hk11b@nih.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@nih.gov Leonard L. Mitnick, Ph.D. Office on AIDS 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: lmitnick@nih.gov George Niederehe, Ph.D. Division of Clinical and Treatment Research 5600 Fishers Lane, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 443-6784 Email: gniedere@nih.gov Sherman Ragland Office for Special Populations 5600 Fishers Lane, Room 17C-14 Rockville, MD 20857 Telephone: (301) 443-2847 FAX: (301) 443-8552 Email: sragland@ngmsmtp.nimh.nih.gov $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** IMMUNOLOGIC FACTORS IN SALIVA AND BLOOD AS DETERMINANTS OF HIV- RELATED DISEASES NIH GUIDE, Volume 26, Number 15, May 9, 1997 RFP AVAILABLE: NIH-NIDR-3-97-9R P.T. 34; K.W. 0710070, 0715008, 0404081 National Institute of Dental Research Request for Proposals (RFP) NIH-NIDR-3-97-9R, which was published in the NIH Guide, Vol. No. on April 25, 1997, is canceled as full and open competition. There is no RFP at this time. The National Institute of Dental Research (NIDR) is conducting a market survey to determine the availability and potential capability of small businesses for this effort. INQUIRIES Inquiries may be directed to: Marilyn R. Zuckerman Contracts Management Section National Institute of Dental Research Natcher Building, Room 4AN-44J 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 $$N5 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIAID-DMID-98-10 ***************************************** THERAPEUTIC STRATEGIES FOR PAPILLOMAVIRUS INFECTIONS NIH GUIDE, Volume 26, Number 15, May 9, 1997 RFA AVAILABLE: NIAID-DMID-98-10 P.T. National Institute of Allergy and Infectious Diseases The Virology Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, has a requirement for the evaluation of clinical potential of experimental therapeutic agents for the treatment of human papillomavirus infections. The requirement includes facilitation of the entry of these agents into clinical trials. The work will include delineation of viral pathogenic processes. Both in vitro and animal model systems will be used. Adequate animal facilities will be mandatory for contract award. It is anticipated that two cost - reimbursement term contracts will be awarded, both for a period of five years. Both contracts will involve coordination of in vitro and animal model studies. RFP NIAID-DMID-98-10 will be available electronically on or about May 5, 1997, and may be accessed through the NIH Home Page or the NIH Gopher by using the following electronic mail addresses and instructions: NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov . Once you are at the NIH Home Page, select Grants & Contracts, then under the ~Contracts~ page heading, select ~NIH gopher directory~ to access the ~R&D Requests for Proposals (RFP)~ in the gopher directory. Once in the gopher directory, select ~RFP~s Available~; ~NIAID~; and finally, ~RFP NIH-NIAID-DMID-98-11.~ This RFP is only available via the NIH Home Page. Instructions for this acquisition and for proper submission are set forth at the Web Site mentioned above. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due on or about June 30, 1997. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. $$R1 END ************************************************************ $$R2 BEGIN CA-97-007 FULL-TEXT ************************************** THE NCI SCHOLARS PROGRAM NIH GUIDE, Volume 26, Number 15, May 9, 1997 RFA AVAILABLE: CA-97-007 P.T. 34; K.W. 0715035, 0710030 National Cancer Institute Letter of Intent Receipt Date: June 27, 1997 Application Receipt Date: July 30, 1997 PURPOSE The purpose of the NCI Scholars Program is to provide outstanding new research investigators who are ready to initiate their first independent program in cancer research with an opportunity to develop their program in the supportive and uniquely interactive intramural environment of the National Cancer Institute (NCI). The overall goal is to facilitate their successful transition to an extramural environment as independent researchers. This program is also intended to continually enhance and invigorate the NCI intramural community by providing a cadre of new, creative scientists who will interact with and expand the collaborative research opportunities of NCI intramural scientists. This program will uniquely address the need of the NCI intramural laboratories to attract outstanding scientists, and of the extramural cancer research community to identify for staff appointments new investigators capable of sustaining a successful research program. There will be about 10 awards made for approximately $1,500,000 per year in total costs excluding equipment for up to four years for the Intramural Support Phase. There will be about 10 awards made for approximately $1,250,000 per year in direct costs for up to two years for the Extramural Support Phase. 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 for the NCI Scholars Program is related to the priority area of human resource development. 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 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) and 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. Vincent J. Cairoli, Ph.D. Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute 6130 Executive Boulevard, Room 520 - MSC 7390 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: VC14Z@NIH.GOV $$R2 END ************************************************************ $$R3 BEGIN CA-97-006 FULL-TEXT ************************************** CANCER DRUG DISCOVERY: DIVERSITY GENERATION AND SMART ASSAYS NIH GUIDE, Volume 26, Number 15, May 9, 1997 RFA AVAILABLE: CA-97-006 P.T. 34; K.W. 0715035, 1003012, 0710080, 0740020, 0755025 National Cancer Institute Letter of Intent Receipt Date: June 20, 1997 Application Receipt Date: August 22, 1997 PURPOSE The Developmental Therapeutics Program (DTP), Division of Cancer Treatment, Diagnosis and Centers (DCTDC), National Cancer Institute (NCI) invites Program Project (P01) grant applications proposing innovative combinatorial chemical and biosynthetic approaches to the generation of structural diversity and smart assay development for cancer drug discovery (Nature, Supplement to Volume 384, Issue No. 6604, 7 November 1996). Applications responsive to this RFA will bring together chemists and biologists who will propose novel approaches to the discovery of compound classes potentially active against cancer. This initiative seeks to catalyze the formation of multidisciplinary teams for the discovery of new agents that will exploit opportunities presented by the rapidly advancing state of contemporary chemistry and biology. It is estimated that $3.75 million total costs (direct plus facilities and administrative costs) will be available for the first year to support approximately four to five awards for up to five years. 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), Cancer Drug Discovery: Diversity Generation and Smart Assays, 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). INQUIRIES The RFA, 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. Mary K. Wolpert, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 841 - MSC 7456 Bethesda, MD 20892-7456 Telephone: (301) 496-8783 FAX: (301) 402-5200 Email: wolpertm@dtpepn.nci.nih.gov $$R3 END ************************************************************ $$R4 BEGIN DK-97-011 FULL-TEXT ************************************** INTERSTITIAL CYSTITIS CLINICAL TRIALS GROUP NIH GUIDE, Volume 26, Number 15, May 9, 1997 RFA AVAILABLE: DK-97-011 P.T. 34; K.W. 0715085, 0755015 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: July 25, 1997 Application Receipt Date: August 26, 1997 PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces the availability of a Request for Applications (RFA) to establish an Interstitial Cystitis Clinical Trials Group. The purpose of this RFA is to solicit cooperative agreements (U01) applications from institutions interested in participating in a cooperative group to plan, direct, and conduct clinical trials in patients with interstitial cystitis (IC). This RFA will establish and maintain clinical centers required to perform multiple therapeutic trials, either sequentially or concurrently, for treatments of IC using common protocols with appropriate sample sizes. This RFA will also establish a Data Coordinating Center for the clinical trials group to coordinate the development of protocols for the trials and to support the collection, quality control, and analysis of the data. It is anticipated that 2.0 million will be available to fund approximately five awards. 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, Interstitial Cystitis Clinical Trials Group, relates to the priority areas of chronic disabling conditions and 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 Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone number 202-512-1800) INQUIRIES The RFA, which describes the research objectives, applications 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 email from the program contact listed below John W. Kusek, Ph.D. or Leroy M. Nyberg, Ph.D., M.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 Email: kusekj@ep.niddk.nih.gov or nybergl@ep.niddk.gov $$R4 END ************************************************************ From owner-sci-resources@net.bio.net Thu May 08 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-006 - V26(15) 05/09/97 Date: 9 May 1997 13:48:45 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 616 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5l02jd$fjk@net.bio.net> NNTP-Posting-Host: net.bio.net CANCER DRUG DISCOVERY: DIVERSITY GENERATION AND SMART ASSAYS NIH GUIDE, Volume 26, Number 15, May 9, 1997 RFA: CA-97-006 P.T. 34; K.W. 0715035, 1003012, 0710080, 0740020, 0755025 National Cancer Institute Letter of Intent Receipt Date: June 20, 1997 Application Receipt Date: August 22, 1997 PURPOSE The Developmental Therapeutics Program (DTP), Division of Cancer Treatment, Diagnosis and Centers (DCTDC), National Cancer Institute (NCI) invites Program Project grant applications (P01s) proposing innovative combinatorial approaches to the generation of structural diversity and smart assay development for cancer drug discovery (Nature, Supplement to Volume 384, Issue No. 6604, November 7, 1996). Applications responsive to this RFA will bring together chemists and biologists who will propose novel approaches to the discovery of compound classes potentially active against cancer. This initiative seeks to catalyze the formation of multidisciplinary teams for the discovery of new agents that will exploit opportunities presented by the rapidly advancing state of contemporary chemistry and biology. Participants may come from the same or different departments in the same academic institution, or from different institutions, or from (an) academic department(s) and industry. Approaches will include the application of synthetic combinatorial or biosynthetic approaches to generate libraries of novel structures. Conceivably both techniques might be utilized by different components of the same research group, and active products of the biosynthetic approach may serve as novel scaffolds for elaboration using combinatorial synthetic technology. In close association with the generation of compound libraries, applicants should also propose the development or application of novel assays directed at molecular events or targets important in the neoplastic process and suitable for assaying the compound libraries. Applicants may employ any biological system that is likely to be informative in the context of this initiative. Structures based on clinically-approved anticancer drugs will not be considered responsive to the RFA. Although it is recognized that drug discovery can be a long and arduous process involving many steps, including lead discovery, lead optimization, and evaluation of promising candidates in pharmacology, toxicology, formulation and other studies in an effort to identify the most promising candidates for development to clinical trial, NCI is prepared to assist any awardee in bringing promising therapeutic candidates to clinical trial through its Decision Network process (Edward A. Sausville, "Working with the National Cancer Institute", Anticancer Drug Development Guide: Practical Screening, Clinical Trial, and Approval edited by B. Teicher, Humana Press Inc., Totowa, NJ, 1997 - in press) (available from Dr. Wolpert listed under INQUIRIES). Industrial partners also may be interested in supporting developmental activities. The goal of this RFA is to identify and optimize lead structures. Drug development activities, such as large-scale production of an agent, are beyond the scope of the RFA. 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), Cancer Drug Discovery: Diversity Generation and Smart Assays, 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, 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. Applications may not be submitted by foreign institutions; however, an application from a domestic institution may include foreign components as research projects or core activities, as defined below under MECHANISM OF SUPPORT. Applications may include participants from the same or different departments in the same institutions, or from different institutions, or from academic departments and industry. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators (PIs). MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health (NIH) program project grant (P01) mechanism. The applications should be constructed using the P01 application guidelines of the NCI, which are available from the NCI Referral Officer as described below under APPLICATION PROCEDURES. The P01 mechanism is designed to support multiple, interacting projects focused on a central theme. P01s must have a minimum of three projects and also may include cores. A core is a separately budgeted component of a P01 that provides essential facilities or services to two or more of the proposed research projects. A core may not count as one of the three research projects. Cost sharing arrangements with industry are encouraged, but detailed project descriptions must be provided even if no funds are requested for a project or core activity. P01s may support projects that are performed at multiple sites but coordinated by a single Principal Investigator at the grantee institution. PIs will be responsible for the planning, direction and execution of the proposed project. An award will be made only to the PI's institution. All activities will be coordinated through an administrative core located at the PI's institution. An administrative core is recommended, especially if multiple institutions are involved in the P01. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator- initiated applications and will be reviewed according the customary peer review procedures. 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 Publications No. (OASH) 90-50-000, revised April 1, 1994. FUNDS AVAILABLE The NCI has set aside $3.75 million total costs (direct plus facilities and administrative costs) for the first year of funding. The number of awards and level of support is dependent on the receipt of a sufficient number and diversity of applications with high scientific merit. Applicants may request up to $950,000 total costs (direct plus facilities and administrative costs) for year one with no more than a 3% per year increase for future years. Budget requests should be carefully justified and commensurate with the needs of the project. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards may vary. It is anticipated that four to five awards will be made for periods up to five years, with the earliest expected award date being 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. RESEARCH OBJECTIVES Background Recent developments in chemistry and biology suggest possibilities for an entirely new vision for cancer drug discovery. The unprecedented power of chemical and biological combinatorial techniques have made it possible to generate impressive structural variation in the laboratory. At the same time the fast-paced identification of gene products, gene sequences, and pathways relevant to neoplasia enables the creation of novel assays for biological functions relevant to cancer. These should permit a much more informative exploration of "diversity space" than has been possible previously for biological activities with therapeutic implications. Implementation of such assays on a large scale is now much more practical by remarkable engineering advances in robotics, miniaturization, and information processing. NCI proposes the present initiative to create multidisciplinary teams for drug discovery featuring close collaboration between chemists and biologists to explore novel approaches that will take full advantage of the opportunities presented by scientific advances. For many years, there have been extensive programs for the acquisition of novel structures from both natural and synthetic sources and for testing extracts and compounds in in vivo and in vitro screens for antiproliferative activity. This approach has been productive and has, in fact, yielded most of the agents in the current armamentarium (platinum complexes, nucleoside analogs, antifolates, vinca alkaloids, taxanes and camptothecin derivatives). The current state of the relevant science and technology suggests now, however, that a very different paradigm for the discovery of anticancer agents might be at hand. It seems clear, for example, that a vast diversity of chemical structures can be generated in the laboratory over surprisingly short time frames. There is no consensus at present that the degree of diversity derivable from laboratory experiments yet approximates what can be found in nature, but experience to date suggests that many millions of distinct structures can result from synthetic efforts extending over only a few months. In a similarly revolutionary vein, assays for biological relevance can now be designed to give information not only about phenotypic alteration, such as growth arrest or cell death, but about the effect on particular molecular targets of pathways known or suspected to have biological relevance to cancer. Research Goals and Scope Structural diversity may be generated by a variety of approaches, including combinatorial or parallel synthesis, or by genetic manipulation of biosynthetic pathways in producer organisms. The molecules produced may represent de novo collections of novel structures, or efforts to optimize lead structures with promising but incompletely developed potential. In no case should the compounds to be studied represent iterations of structures already FDA-approved for use in the treatment of human malignancy. Combinatorial Organic Synthesis: A key feature of combinatorial techniques is that compound synthesis can be designed such that a range of structures can be produced simultaneously as mixtures in the same reaction vessel or individually in parallel using semi- automated synthesis. The repetitive nature of the synthetic processes involved in most combinatorial applications lends itself to automation or semi-automation. This key feature means that the bench chemist can singlehandedly prepare tens, hundreds, or thousands of compounds of known structures in the time that it would take to prepare only a few pure entities by orthodox methodology. Combinatorial technology can be practiced in either a solution or solid-phase format. Solution techniques utilize methods essentially similar to standard methods for the synthesis of single compounds, except that instead of utilizing one well-defined reaction partner of each type per reaction, mixtures of several known reaction partners are utilized as building blocks, thus resulting in mixtures of analogs. The type of the chosen chemical reaction and the number of reactants depend on the nature of the desired structures. These mixtures may not be purified elaborately but are directly subjected to screening against the desired target (e.g., receptor, enzyme, antibody, cell). The chemistry is then repeated a few times in batches using different but well defined mixtures of reaction partners, and the products isolated and screened. In order to identify the leads, the chemistry is repeated several times using fewer reaction partners in each run, and the products are screened. This deconvolution process is repeated until the most potent lead is identified. In solid-phase approaches, pin or bead techniques permit the synthesis of different molecules on each pin (i.e., "one molecule- one bead"). The products of solid-phase synthesis can be cleaved from the backbone matrix for solution screening (which is essential when the screening target is a cell), or the most active molecules displayed on the polymer surface may be detected using molecular targets (receptor, enzyme, antibody) pre-tagged with a means of detection (visible color, fluorescence, radioactivity, chromophore, etc.) and then isolated and identified. Manipulation of Biosynthetic Pathways: Biosynthetic approaches to generating diversity may also be used to produce large numbers of novel structures. Recent progress has focused on the creation of hybrid antibiotics through genetic engineering (Katz et al., Ann. Rev. Microbiol 47: 875-912, 1993) and in the production of novel structures based on genetic manipulation of the aromatic polyketide biosynthesis pathways in prokaryotic microorganisms (Khosla et al., Nature 375: 549-554, 1995). A set of programming rules, which helps to predict the potential structures of novel polyketides produced by strains carrying these recombinants, has begun to emerge and forms the basis for the use of biosynthesis as a route to new aromatic polyketides. Polyketides are described in biosynthetic rather than structural terms. Broadly, this category comprises structures derived wholly or partly from poly- -ketomethylene chains, and includes a rich source of bioactive molecules, including antibiotics, such as the tetracyclines, anticancer agents, such as daunomycin, and immunosuppressants, such as FK506 and rapamycin. Outside the polyketide area there is still much to be learned in elucidating the biosynthetic pathways of secondary metabolites from other microbes, plants, or marine organisms. The exploration of biosynthetic pathways in plants and marine organisms has been much more difficult than that of their prokaryotic counterparts because of slower growth rates, the often more complicated structures of the secondary metabolites, the existence of multi-gene pathways that are not clustered in the genome, and the presence of enzyme-inactivating constituents. Definition of the pathways involved in the production of non-polyketide-derived structures especially by employing cell culture and modern molecular biologic techniques may also be tied to the generation of structural diversity. Applications which define and manipulate biosynthetic pathways but do not address the generation of chemical diversity will not be considered responsive to this RFA. Novel Screening Approaches: "Smart" assays may be operationally defined as a screening system that by its very operation conveys information about new chemistry or biology of "hits" in the system. For example, assays of interest to promote may couple the use of a cloned and expressed target protein or a nucleic acid sequence in tandem with a chemical or biosynthetic process that generates molecules for further study. Alternatively, the use of genetically definable yet underexplored organisms such as yeast, Drosophila, or C. elegans, production of expression vectors that may operate only in the presence of a compound with the desired properties, development of detection techniques based on novel patterns of molecular recognition, or strategies that require the operation of a particular molecular target to be a basis for detection would all examples clearly responsive to the RFA. SPECIAL REQUIREMENTS This initiative invites grant applications to support the assembly of inter-disciplinary teams with the skills needed to pursue successfully the generation of novel structures, their screening against defined biological or biochemical target(s), and the optimization of lead structures. The NCI recognizes that source countries retain interests in samples collected in their domains. All applicants who propose to use organisms or other naturally-derived materials of foreign origin in their studies must provide a plan, signed by representatives of all participating institutions, for equitable return of a portion of any profits or royalties, or other acceptable forms of compensation, derived from their discoveries to indigenous peoples, research collaborators, cooperating institutions or Governmental entities in the countries of origin, as appropriate to their contributions. It is preferred that this plan be submitted with the application. If this plan is not included as part of the application, it must be submitted as a condition for award to a Program Official to be designated at the time of award. Since the discovery of new anticancer agents may result from these P01 projects, it is essential that applicants provide plans to assure patent coverage. The situation could be complicated since multiple institutions, including industry, may be involved. Each applicant must therefore provide a detailed description of the approach to be used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution. Procedures must be described for resolution of legal problems should they arise. Your attention is drawn to P.L. 96-517 as amended by P.L. 98-620 and 37 CFR Part 401. Instructions were also published in the NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 19, No. 23, June 22, 1990. NOTE: A formal statement of Patent Agreement among participants and their institutions, as well as a detailed description of procedures to be followed for resolution of legal problems which may develop, signed and dated by the organizational official authorized to enter into patent arrangements for each participant and participating institution is preferred with the application. If this signed agreement is not included in the application, it must be submitted as a condition for award to a Program Official to be designated at the time of award. 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. LETTER OF INTENT Prospective applicants are asked to submit, by June 20, 1997, a letter of intent that includes a descriptive title of the proposed research and a list of titles for the anticipated components of the P01, 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 NCI staff to estimate the potential review workload and avoid conflict of interest in the review. Applicants requesting budgets greater than $500,000 total costs in any year of their proposed application are required to contact NCI program staff prior to submitting their applications (NIH GUIDE, Volume 25, Number 14, May 3, 1996). Applications with budgets of more than $500,000 received without prior communication with at least one of the NCI program staff listed under INQUIRIES will not be accepted for review. The letter of intent should be sent to the Referral Officer, National Cancer Institute at the address listed under APPLICATION PROCEDURES. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (revised 5/95) in conformance with the P01 application guidelines of the NCI (revised 1995), which are available from the NCI Referral Officer, Division of Extramural Activities, National Cancer Institute Executive Plaza North, Room 636A, 6130 EXECUTIVE BLVD MSC 7405, BETHESDA, MD 20892 (Telephone: 301-496-3428, FAX: 301-402-0275, Email: FRIEDBET@DEA.NCI.NIH.GOV). PHS 398 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 RFA label available in the PHS 398 (revised 5/95) application form must be affixed to the bottom of the face page of the application such that it may not reach the review committee in time for review. 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 title and number of the RFA must be typed on line 2 of the face page of the application 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, SUITE 1040, MSC 7710 BETHESDA, MD 20892-7710 NORTH BETHESDA, MD 20817 (for express/courier service) In addition, at the time of submission, send two complete copies under separate cover to: REFERRAL OFFICER NATIONAL CANCER INSTITUTE 6130 EXECUTIVE BOULEVARD, Room 636A MSC 7405 BETHESDA, MD 20892-7405 (or ROCKVILLE, MD 20852 for overnight mail service.) Telephone: 301-496-3428 FAX: 301-402-0275 The deadline for submission of applications will be August 22, 1997. Late applications will not be accepted. If an application is received after the due 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 the Division of Research Grants and responsiveness 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 to the PI without further consideration. The PI may submit the application as an unsolicited, investigator-initiated P01 at the next deadline for competing P01 applications. 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 Review Logistics Branch of the Division of Extramural Activities of NCI. As part of the initial merit review, all applicants will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level of review by the National Cancer Advisory Board. Because of the time allotted for the review, no site visits are planned. Therefore, it is important that all information necessary for an informed review be included in the written application by the due date. The Scientific Review Administrator (SRA) will contact the PI for the opportunity to provide supplementary material, such as recent publications, before the review. No material should be submitted unsolicited. The initial review group will also examine the provisions for the protection of human and animal subjects, if any, and the safety of the research environment. In addition to the standard Review Criteria used to evaluate P01 applications (as described in the P01 Guidelines), the following Review Criteria will be used to assess the scientific merit of each application: o scientific and technical merit and originality of the proposed research plans; o appropriateness and adequacy of the experimental approach, including the design strategies for combinatorial synthesis or biosynthesis of new leads; novelty and suitability of screens for the discovery of lead structures; optimization strategy; o relevance of screens to the neoplastic process; o decision-making process in identifying leads for optimization; o plans for data storage and manipulation; o evidence of research plans encompassing inter-disciplinary collaboration and coordination addressing the goals of generation of novel structures not based on clinically-approved anti-cancer drugs, the screening of novel structures against defined biological or biochemical target(s), and the optimization of lead structures; o adequacy of the scientific disciplines and specific competencies represented by the Principal Investigator and Project Leaders; research experience, competence, commitment, and time availability of Principal Investigator, Project Leaders, and other key personnel; o leadership, scientific ability, and administrative experience and competence of the Principal Investigator in the development, implementation, and management of comprehensive, inter-disciplinary research programs; o adequacy of plans for effective team communication and coordination; o evidence of the approval and commitment of institutions represented by team members to project goals, and the availability and adequacy of the existing physical facilities and resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; AWARD CRITERIA The earliest date of award is April 1, 1998. The following will be considered in making funding decisions: o Scientific merit as determined by peer review o Diversity of applications and programmatic priorities o Availability of funds o Responsiveness to the goals and objectives of the RFA. 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: Biosynthetic Issues Gordon M. Cragg, Ph.D. Natural Products Branch, Developmental Therapeutics Program Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute-FCRDC Fairview Center, Suite 206 P.O. Box B Frederick, MD 21702-1201 Telephone: (301) 846-5387 FAX: (301) 846-6178 Email: cragg@dtpax2.ncifcrf.gov Chemistry Issues Ven Narayanan, Ph.D. Drug Synthesis and Chemistry Branch Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 831 6130 Executive Boulevard, MSC 7448 Bethesda, MD 20892-7448 Telephone: (301) 496-8795 FAX: (301) 480-4817 Email: narayananv@dtpepn.nci.nih.gov Screening Issues George S. Johnson, Ph.D. Grants and Contracts Operations Branch Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 841 6130 Executive Boulevard, MSC 7456 Bethesda, MD 20892-7456 Telephone: (301)-496-8783 FAX: (301)-402-5200 Email: johnsong@dtpepn.nci.nih.gov Program Issues Mary K. Wolpert, Ph.D. Grants and Contracts Operations Branch Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 841 6130 Executive Boulevard, MSC 7456 Bethesda, MD 20892-7456 Telephone: (301)-496-8783 FAX: (301)-402-5200 Email: wolpertm@dtpepn.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Cynthia W. Mead Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 228 FAX: (301) 496-8601 Email: meadc@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395, Cancer Treatment 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 Parts 52 and 45 CFR Parts 74 and 92. 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. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. 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. From owner-sci-resources@net.bio.net Thu May 08 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-007 - V26(15) 05/09/97 Date: 9 May 1997 13:48:24 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 666 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5l02io$fie@net.bio.net> NNTP-Posting-Host: net.bio.net THE NCI SCHOLARS PROGRAM NIH GUIDE, Volume 26, Number 15, May 9, 1997 RFA: CA-97-007 P.T. 34; K.W. 0715035, 0710030 National Cancer Institute Letter of Intent Receipt Date: June 27, 1997 Application Receipt Date: July 30, 1997 PURPOSE The purpose of the NCI Scholars Program is to provide outstanding new research investigators who are ready to initiate their first independent program in cancer research with an opportunity to develop their program in the supportive and uniquely interactive intramural environment of the National Cancer Institute (NCI). The overall goal is to facilitate their successful transition to an extramural environment as independent researchers. This program is also intended to continually enhance and invigorate the NCI intramural community by providing a cadre of new, creative scientists who will interact with and expand the collaborative research opportunities of NCI intramural scientists. This program will uniquely address the need of the NCI intramural laboratories to attract outstanding scientists, and of the extramural cancer research community to identify for staff appointments new investigators capable of sustaining a successful research program. 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 for the NCI Scholars Program is related to the priority area of human resource development. 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 Individuals with a research or health professional doctoral level degree or equivalent, with no more than five years of postdoctoral research training at the time of application, and with demonstrated outstanding abilities in basic, clinical or population-based (e.g., epidemiological) research, are eligible to apply. This includes individuals with postdoctoral research experience in any environment (e.g., academic, industry, government). Individuals who have had more than five years of postdoctoral research training or who have held research or other professorship positions or equivalent in academe or elsewhere are NOT eligible to apply. However, years of clinical training will not count against the five years of relevant research experience. Individuals who have been principal investigators on either PHS research grants (e.g. R29, R01, P01 or its subprojects) or non-PHS peer reviewed research grants are NOT eligible to apply for this award. Postdoctoral fellows at the NCI who meet other eligibility requirements are eligible to apply, but will not be considered for placement in Laboratories/Branches where they have previously trained. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Card (I-151 or I-152) or some other verification of legal admission as a permanent U.S. resident, at the time of award. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are NOT eligible to apply. All applicants are encouraged to contact the NCI regarding their eligibility for this award (see Inquiries Section). MECHANISM OF SUPPORT The NCI Scholars Program will use the National Institutes of Health (NIH) Career Transition Award (K22). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The NCI Scholars Program will consist of two phases: an intramural phase and an extramural phase. The maximum total period of combined intramural support at NCI and at the extramural institution for an NCI Scholar will be six years. Initially, up to four years of the Scholar's research program will be an Intramural Support Phase in which the salary and the research costs of the successful Scholar will be derived entirely from Intramural NCI resources. The budget cannot exceed $150,000 total costs per year or $600,000 total costs over a four-year period, which is the maximum duration of the Intramural Support Phase. The final two years of the Scholar's research program will be an Extramural Support Phase funded through the NIH Career Transition Award (K03) mechanism. The budget cannot exceed $125,000 plus fringe benefits in direct costs per year or $250,000 plus fringe benefits in direct costs over a two-year period which is the maximum duration of the Extramural Support Phase. Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based upon the success of the Scholar's research program, as determined by a formal NCI scientific progress review which will take place no later than the end of the third year of the Intramural Support Phase. Scholars who are approved to proceed with this second phase of support will receive notification of approval in writing from the NCI. Once approved for the Extramural Support Phase, the NCI will process the change in organization in response to a request from the sponsoring institution that has recruited the Scholar for the final two years of the award (see section on INQUIRIES). FUNDS AVAILABLE It is anticipated that applications to the NCI Scholar's Program will be solicited annually through the reissuance of this RFA. Each annual solicitation will indicate the general areas of research and the number of positions that will be sponsored in that year. For the Intramural Support Phase, approximately $1,500,000 per year for up to four years will be set aside to fund about 10 applications submitted in response to this RFA. However, this funding level is dependent upon the receipt of a sufficient number of applications of outstanding scientific merit as evaluated by peer review (see section on REVIEW CONSIDERATIONS). The number of Scholars who can be supported is based upon the availability of resources and space in each sponsoring intramural Division. For the Extramural Support Phase, approximately $1,250,000 per year in direct costs will be available to fund about 10 awards, providing support for salaries and partial operating costs. It is important to note that a sponsoring extramural institution may submit a noncompeting continuation application only after the Scholar has been notified in writing that the NCI Progress Review Committee has recommended approval of the transition to the extramural support phase of the award. The individuals noted in the section on INQUIRIES should be consulted for any clarifications of intent or content. The earliest feasible start date for the initial awards will be December 31, 1997. Although this program is provided for in the financial plans of the NCI, the support of research programs pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH TRAINING OBJECTIVES Background For decades, the intramural scientists and facilities of the National Cancer Institute have provided a research environment for the training of new scientists who have subsequently entered the extramural biomedical research community and have become leaders in their fields of investigation. This has been accomplished primarily through staff fellow and senior staff fellow programs that, to varying degrees, have afforded independent research opportunities to new scientists. With the continuing effort of the NCI to develop an intramural research environment of the highest scientific quality, there is a new opportunity to use the unique intramural environment of the NCI to effectively foster the research careers of individuals who will pursue their careers as extramural scientists. Goals and Scope The NCI Scholars Program is designed for promising new investigators in basic, clinical or population-based biomedical research (e.g., epidemiology) who have demonstrated outstanding scientific abilities during their training, to enable them to establish their first independent research program. The major objective of the program is to sustain and advance the early research careers of the most promising investigators while they consolidate and focus their independent research programs. NCI Scholars will independently design and pursue research projects in their area of interest for which they would be provided with facilities, operating budget, salary and personnel. NCI Scholars will be responsible for all aspects of their research program, including the progress of the research and the management of allocated resources. The participating NCI intramural divisions invite applications for the support of Scholars who wish to develop independent research programs in the following scientific areas: o The Division of Basic Sciences encourages applications from candidates with experience and interest in pursuing research in the general areas of cell biology, cancer genetics, and immunology. Specific areas of interest include: chromatin structure, gene regulation, signal transduction, cell transformation, cell cycle and apoptosis. o The Division of Epidemiology and Genetics encourages applications from candidates with experience and interest in pursuing epidemiologic or interdisciplinary research into the environmental and genetic determinants of cancer. Areas of specific research interest include: lifestyle and environmental risk factors, genetic susceptibility, occupational exposures, infectious agents, pharmacoepidemiology, radiation exposures, methodologic and statistical research, or interdisciplinary studies (molecular epidemiology). o The Division of Clinical Sciences encourages applications from candidates engaged in cancer genetics and cancer biology research. Specific topics of interest include: exploratory technologies in interrogating the human genome, in genetic instability, and the molecular biology of angiogenesis, and of the cell cycle. Consonant with the goals of the division, applicants should be interested in participating in the translation of basic findings to the clinical setting. ALLOWABLE COSTS Intramural Support Phase: The budget for the intramural support phase cannot exceed $150,000 per year in total costs excluding equipment. The final budget for this phase of the award will be negotiated with the sponsoring NCI intramural division and will depend upon the nature and scope of the research as recommended by the peer review process. o Salaries will be provided for the Scholar and no more than two additional positions (e.g. postdoctoral trainee and technician). Salaries of the Scholar and other personnel must be commensurate with the level of training and experience specified in the Federal pay schedule. o Up to $25,000 per person will be provided for annual operating expenses (e.g. supplies, disposables, copying, etc.). o Up to $50,000 in the first year will be provided for laboratory equipment. - Laboratory equipment purchased for the Scholar during the intramural phase will not be transferable to the extramural position. Extramural Support Phase: The budget for the two year extramural transition phase may not exceed $125,000 plus fringe benefits per year in direct costs. o Scholars will be provided salary support of up to $75,000 plus applicable fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. The total salary requested must be based on a full-time, 12 month staff appointment and there should be no less than 75 percent effort devoted by the Scholar specifically to the proposed research program. The institution may supplement the NCI contribution; 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, institutions may carry-over unexpended funds into the next budget period and rebudget funds within the total costs awarded but may not rebudget funds involving the salary component of the budget. The total salary requested must be based on a full-time 12 month staff appointment. o Up to $50,000 per year in direct costs will be provided to partially support ancillary personnel, supplies, equipment, travel, tuition, and other costs which are deemed essential for the individual's research program. o Indirect costs will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. Special Restrictions: Acceptance into the NCI Scholar's Program does not convey any commitment or intent of the NCI to consider the Scholar for a tenure track position within the NCI. The NCI Scholars Program is specifically intended to help develop scientists who will pursue their careers in the extramural biomedical research community. However, NCI Scholars are not explicitly precluded from applying for available tenure track positions at the NIH. If a Scholar obtains an NIH position, the NCI Scholar's Career Transition Award (K22) will be terminated. 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 (Public Law 103-43) that added Section 492B of the Public Health Service Act. The new policy supersedes and strengthens the previous policies (Concerning the inclusion of Women in Study Populations) which have been in effect since 1990. Investigators proposing research involving human subjects should read the NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research which were 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. LETTER OF INTENT Prospective applicants are asked to submit, by June 27, 1997 a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone and FAX numbers, E-mail address of the Principal Investigator, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, it 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: Dr. Vincent J. Cairoli Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: VC14Z@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 and may be obtained 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, E-mail: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. 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: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892-7407 (for U.S. Postal Service) Rockville, MD 20852 (for express/courier service) Applications must be received by July 30, 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. Supplemental Application Guidelines o The RFA title (NCI Scholar's Program) and the RFA number must be typed on line 2 of the face page of the application, and the YES box must be marked. o The applicant must provide her/his signature in item 15; a signature is not required for item 16. o Leave items 9-14 and 16 on the face page blank. o Enter in item 6 (Dates of Proposed Period of Support) the combined 6 years of support needed to complete the intramural and the extramural support phases of the NCI Scholars Program. o A Checklist Page should NOT be submitted. o The applicant must provide an official certified transcript covering medical school or the graduate school level of education. o Three sealed letters of reference from well-established basic or clinical scientists must be provided. One should be from the applicant's thesis advisor if applicable and one should be from the most recent mentor in a postdoctoral research setting. These letters should be attached to the face page of the original application. The letters should address the following issues: - The applicant's past contributions to scientific achievements; - The applicant's special potential to pursue and develop an independent research program; - The applicant's ability to work with other scientists in various interactive situations (e.g.. seminars, journal clubs, etc.), on collaborative research projects, and with support staff (e.g., technicians, secretaries). o Career Development Plan: - Applicants should describe their career goals and plans to achieve an independent research career, e.g. the need for any courses, research techniques or methods, etc. o Research Plan: - The scientific objectives and specific aims should describe research plans that are sufficient to justify up to four years of support. Applicants should also provide future research directions for the extramural support phase should be provided, i.e. what are the broad research goals and potential avenues of research that would be stimulated by your specific research project. o Budget: - The budget should span the proposed total duration of the award (maximum 6 years) including both the intramural and extramural phases (see section on ALLOWABLE COSTS). Using continuation pages as needed, provide in a detailed narrative format justification for the budgetary needs of the proposed research program, including personnel, consultants,equipment, supplies and travel. The narrative must be prepared carefully, as it will be a critical factor used by peer reviewers in evaluating the applicant's ability to manage the research program as proposed. Extramural (Transition) Support Phase After the Scholar/Awardee receives approval in writing for the transition to extramural support (See section on SELECTION PROCESS, Extramural Support Phase), the Scholar should contact NCI staff for change of institution procedures (see section on INQUIRIES). REVIEW CONSIDERATIONS Application Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) staff for completeness. Incomplete applications will be returned to the applicant without further consideration. Applications also will be evaluated for responsiveness to this RFA. This will be done by program staff of the NCI, the main criteria being the applicant's eligibility and whether or not the research proposal is reasonably within the scientific areas of interest declared by the participating intramural divisions of the NCI (see section on RESEARCH TRAINING OBJECTIVES, Goals and Scope). Applications that are not responsive to the objectives of the RFA will be returned to the applicant. Applications which are complete and responsive to this RFA will be evaluated for scientific and technical merit in accordance with the review criteria stated below by an appropriate extramural initial peer review group (IRG) convened by the NCI Division of Extramural Activities. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. All applications will receive a second level of review by the National Cancer Advisory Board. Review Criteria The initial peer review criteria for applications submitted in response to this RFA will include the following: Candidate o Capacity to carry out independent research based on level of training, experience and competence commensurate with the purposes of this award. o Past and present research productivity, e.g. contributions to the scientific literature; success in obtaining fellowships. o Ability to conceptualize and organize a research approach that will make full use of the six years of support offered under this program. o The special qualities of the applicant to work in a scientifically interactive setting and collaborate with other scientists. This should be addressed in the letters of reference (see section on APPLICATION PROCEDURES). o Appropriateness of the applicant's career development plan and the likelihood that the award will contribute substantially to the continued scientific development and productivity of the candidate. o Potential to become an outstanding scientist who will make significant contributions to the field. Research Plan o Quality and innovativeness of the research plan, including appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Potential of the research plan for contributing to the scientific literature. o Suitability of the proposed research plan for a six year research program. o Consistency of the research plan with the candidate's career goals. o Where appropriate, adequacy of plans to include both genders and minorities and their subgroups for the scientific goals of the research. Plans for recruitment and retention of subjects will also be evaluated. Budget o Justification of budget requests in relation to career development goals, research aims and plans. SELECTION PROCESS Intramural Support Phase The priority score assigned to the application and the critique of the IRG will be mailed to the applicant. The peer review-evaluated applications will be ranked according to priority score, and an NCI Selection Committee (NSC) consisting of Senior Scientists from the NCI Intramural Programs and the Chief of the NCI Cancer Training Branch will identify the pool of highly meritorious candidates to be invited to the NCI for interviews/seminars. Criteria for this recommendation will include the priority score of the candidate's application and programmatic needs. The recommendations of the NSC for each candidate will be reviewed for approval by the NCI Executive Committee. Following the interviews, a ranking and matching process by both the applicants and the sponsoring intramural departments will be used to determine the final awards. The Cancer Training Branch will coordinate the notification of the candidates about the status of their application. Extramural Support Phase The NCI will conduct a formal scientific progress review no later than the end of the third year of the intramural support phase to determine whether or not the Scholar will be recommended for the extramural phase of support. This review will be conducted by an NCI Progress Review Committee comprised of members of the NSC and other ad hoc intramural and extramural scientists. The results of the review will constitute a final progress report for the intramural phase and be presented in writing to the Scholar. Approval will result in eligibility for the extramural phase funding of the Career Transition Award and up to a fourth additional year of intramural support to facilitate the transition to an extramural laboratory. Disapproval will result in a terminal fourth year of intramural support with no transition funding. Approval for the transition of the Scholar to the extramural support phase could be made at any time prior to the third year of the intramural support phase. In such a case, the Scholar would remain eligible for up to one additional year of intramural support. However, the remaining unused portion of the intramural support phase will not be carried over into the two year extramural support phase. The Scholar must be accepted by an extramural institution which will request a change in institution by submitting a form PHS 398 noncompeting application which must include an updated research proposal and budget.. The application submitted by the Scholar and the extramural institution for activation of the extramural phase of the program will be evaluated by the NCI Cancer Training Branch and Grants Administration Branch for completeness and responsiveness to the RFA. 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 funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and programmatic priorities. All NSC recommendations will be forwarded to the NCAB as informational items. EVALUATION Intramural Support Phase Each Scholar's research program will be evaluated for progress on an annual basis like all other independent intramural scientific research programs. For this purpose, the Scholar will prepare on an annual basis a progress report, which will subsequently be evaluated by the corresponding laboratory/ branch chief and the appropriate NCI division director. Additionally, the NCI will conduct a formal scientific progress review (See section on SELECTION PROCESS, Extramural Support Phase) by no later than the end of the third year. Extramural (Transition) Support Phase The awardee will be required to submit a form PHS 2590 non-competing continuation application for the final year of extramural support. The application should provide a description of the research and career progress of the awardee, including: 1) Publications in press or submitted; 2) Current investigator-initiated research grant support, and 3) All applications submitted for investigator-initiated research grant support. These annual reports will be closely monitored by NCI staff to ensure that the awardee is achieving the goals of the NCI Scholars Program. The NCI may solicit information from the awardee after completion of the extramural transition support phase regarding their career progress, for the purpose of evaluating outcomes of the NCI Scholars Program.. INQUIRIES Inquiries concerning this RFA are encouraged, especially during the planning phase of the application to clarify any issues or questions from potential applicants. NCI contacts for specific areas of expertise are listed below: Direct inquiries regarding programmatic issues to: Dr. Vincent J. Cairoli Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892-7390 Telephone: 301/496-8580 FAX: 301/402-4472 Email: VC14Z@NIH.GOV Direct inquiries regarding fiscal/administrative matters. At least two months prior to transition to the extramural phase, contact the following official for information on application procedures for submitting a PHS 398 application from the new applicant organization: Ms. Sara Stone Office of Administrative Management National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: 301/496-7800 FAX: 301/496-8601 Email: STONES@GAB.NCI.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.398, Cancer Research Manpower. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-41 0, 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 45 CFR Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 123 72 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of 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 for 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 Thu May 08 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA NOT-97-006 - V26(15) 05/09/97 Date: 9 May 1997 13:48:10 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1120 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5l02ia$fg5@net.bio.net> NNTP-Posting-Host: net.bio.net GUIDELINES FOR SUPPORT OF SCIENTIFIC MEETINGS BY NIH NIH Guide, Volume 26, Number 15, May 9, 1997 P.T. 42; K.W. 1014006 National Institutes of Health PURPOSE The National Institutes of Health (NIH) recognizes the value of supporting scientific meetings, conferences, and workshops that are relevant to its scientific mission and to public health. Support of these meetings is contingent on the interests and priorities of the individual Institutes and Centers (I/C) as well as the investment that each I/C determines is appropriate. Each I/C has the flexibility to support conferences according to its specific needs. As indicated in this document, changes have been introduced to reduce some of the burdensome and time-consuming processes for applicant organizations as well as NIH. Some Institutes and Centers require prior contact and/or approval before submission. The guidelines presented here are general guidance for applicant organizations in the development of applications for requesting support for scientific meetings. Potential applicants are encouraged to contact the individual I/C staff listed in this document for specific I/C information. This document contains information about o NIH policy and procedures concerning the application process for the support of scientific meetings o NIH Staff contacts and funding opportunities available from each NIH component for support of scientific meetings via grants or cooperative agreements (See Attachment 1) o Supplemental Instructions for Application Form PHS-398 (See Attachment 2) o "Guidelines on Inclusion of Women, Minorities, and Persons with Disabilities in NIH-Sponsored and/or -Supported Intramural and Extramural Scientific Meetings and Conferences" (NIH Guide, Vol. 24, No. 15, April 28, 1995) (See Attachment 3) This document only applies to those conferences, workshops, or scientific meetings supported by NIH grants or cooperative agreements. It does not apply to those conferences, workshops, or scientific meetings sponsored or initiated by NIH and funded by contracts or by direct operating funds, or workshops conducted as an adjunct to scientific peer review group activities. POLICY Scientific meetings may be funded by assistance mechanisms (grants and cooperative agreements) and may be funded for up to five (5) years. All applications for such meetings will be evaluated for programmatic relevance by Institute/Center (I/C) staff and reviewed for merit by the Institute/Center/Division. Each NIH I/C may support those applications that are within its mission. Applications of interest to more than one NIH component may be co-funded. Each NIH I/C has designated a conference award contact; this individual is the I/C focal point for information on the NIH component's general interest in supporting a scientific meeting on a specific topic or by a specific mechanism, for any I/C-specific guidelines, and for identification of the appropriate program staff within the I/C for further presubmission discussions. Please note that Institutes/Centers may also include in their guidelines a requirement for prior approval before submission of an application for support of scientific meetings; in this case, a letter of intent may be requested. Institutes/Centers may also include in their guidelines dollar limits and other budget guidelines. Organizers of scientific meetings must comply with the ~Guidelines on Inclusion of Women, Minorities, and Persons with Disabilities in NIH- Sponsored and/or -Supported Intramural and Extramural Meetings and Conferences.~ (See attachment 3). Appropriate representation of women, racial/ethnic minorities, and persons with disabilities, and other individuals who have been traditionally underrepresented in science, must be included in all aspects of planning, organization and implementation of NIH-sponsored and/or -supported meetings. "Appropriate" means representation based on the availability of scientists from these groups known to be working in a particular field of biomedical or behavioral research. If appropriate representation is not apparent, no award will be issued until program staff are assured of concerted efforts. ELIGIBILITY A U.S. institution or organization, including an established scientific or professional society, is eligible to apply. An individual is not eligible to receive an award for the support of a scientific meeting. Both domestic and international meetings may be supported; however, an international meeting can be supported only through the United States representative organization of an established international scientific or professional society. GENERAL PROCEDURES A scientific meeting is defined as a gathering, symposium, seminar, workshop or any other organized, formal conference where persons assemble to coordinate, exchange and disseminate information or to explore or clarify a defined subject, problem or area of knowledge. Types of Support o Investigator-initiated conference grants (R13 awards) o Cooperative agreement awards, with substantial programmatic involvement by NIH staff after award (U13 awards) o Multiple year awards (R13 or U13) for up to five years to a permanently sponsoring organization for conferences held annually or biennially on a recurring topic. Application Instructions Prospective applicants are encouraged to inquire in advance concerning NIH's interest in supporting a scientific meeting by contacting the appropriate conference award contact who is the I/C's focal point for identification of appropriate program staff for further presubmission discussions, including requirements for letters of intent and prior approval. Applicants may contact another I/C, if one I/C is not interested in supporting the scientific meeting. All information regarding supplemental instructions for preparation of application Form PHS 398 is outlined in attachment 2. Multiple year conference applications for up to five years may be submitted by permanent sponsoring organizations for conferences held annually or biennially. Continued funding beyond the first year is contingent upon scientific progress as determined annually by I/C procedures. Receipt dates will be determined by the individual I/C; however, potential applicants are encouraged to submit applications on the three DRG deadlines(February 1, June 1, October 1). All applications must be submitted at least 6 months prior to the conference. The conference award contact can provide specific information on receipt dates. Application Assignment within NIH Each application will be assigned to one or more I/C by the Division of Research Grants (DRG) Referral Office based on established Institute/Center guidelines for relevance. However, program staff will accept applications for assignment, including secondary assignments, only if there is interest in supporting the scientific meeting; thus, submission of an application does not assure acceptance. Evaluation of Applications Applications will be evaluated by the I/C or DRG by means deemed appropriate. Review criteria include: o the need and timeliness for the scientific meeting; o its format and agenda; o qualifications of the organizers and proposed participants; o past performance where applicable; o appropriateness of the meeting site; o plans for the appropriate* involvement of women, racial/ethnic minorities and persons with disabilities in the planning and implementation of the proposed meeting; and o appropriateness of budget, per Institute/Center guidelines. [* See "policy" section of this document and Attachment 3.] Recommendations are documented in a standard summary statement format and sent to the applicant. Depending on I/C policy, applications may be reviewed by the appropriate National Advisory Council or Board. Funding Each I/C may support any application that is within its mission, interests and support guidelines, and which has been recommended for support by the review group. Applications of interest to more than one I/C may be co-funded. Notice of Grant Awards for awards covering conferences for up to five years will contain information in the Terms and Conditions that a shift in conference focus would preclude further funding in subsequent years. Funding by Cooperative Agreement When the I/C determines that there is sufficient need to have substantial involvement in the planning and conduct of a scientific meeting, the I/C may determine that a cooperative agreement (U13) award should be made. Specific terms and conditions of the award may be obtained from the I/C contact. Reporting Requirements A report of the meeting must be prepared and two copies submitted to the awarding unit that supported the meeting within 90 days after the completion of the meeting. The report should include (a) the grant number, (b) the title, date and place of the meeting, (c) the name of the person shown on the application as the conference director, principal investigator, or program director, (d) the name of the organization that conducted the meeting, (e) a list of the individuals, and their institutional affiliations, who participated as speakers or discussants in the formally planned sessions of the meeting, and (f) a summary of topics discussed/conclusions. Multiple year awards require an annual progress report that contains a description of specific plans for the next award period, in similar detail and format as for a single meeting; this should be submitted six months before the next conference. NIH Program staff will evaluate these reports and plans in approving annual non-competing continuation awards. Copies of proceedings or publications resulting from the meeting, including items (a) through (f) listed above, may be substituted for the annual and final progress report, with approval of the NIH awarding unit. Additional information on support of conferences is available in Appendix 7 of the PHS Grants Policy Statement at gopher://gopher.nih.gov:70/11/res/PHSGPS. SUPPORT OPPORTUNITIES FOR SCIENTIFIC MEETINGS AND GUIDELINES AT EACH NIH COMPONENT The following listing provides the names of the conference award contacts at each of the NIH Institutes and Centers (I/C) and the general programmatic and funding guidelines for support of scientific meetings at that Institute or Center. Details for each I/C~s program and budget guidelines and information on NIH application instructions for support of scientific meetings may be obtained from the conference award contact listed. Detailed information about the I/C programs may also be obtained from the NIH Extramural Programs book, which is available on the NIH Homepage on the WWW at http://www.nih.gov/grants/funding/funding.htm or on the Internet at gopher://gopher.nih.gov:70/11/res/nih-ep. Specific information about program areas is provided. RECEIPT DATES: All applications must be submitted at least six (6) months prior to the meeting. Applications will be received on the three DRG receipt deadlines of February l, June l and October 1, unless otherwise noted below. LETTER OF INTENT: Letters of Intent are required by some I/Cs as noted below. These letters should be submitted to the I/C contact person noted below at least 30 days before the application deadline. Potential applicants are encouraged to talk to the I/C contacts as well. Budget guidelines are also provided by several I/Cs. 1. NATIONAL INSTITUTE ON AGING (NIA) NIA Contacts: Behavioral and Social Research Program Ronald Abeles, Ph. D. phone: 301-594-5943 fax: 301-402-0051 e-mail: ra20x@nih.gov (rabeles@box-r.nih.gov) Biology of Aging Program Richard Sprott, Ph.D. phone: 301-496-4996 fax: 301-402-0010 email to: rs51r@nih.gov (sprottr@gw.nia.nih.gov Geriatrics Program Evan Hadley, M.D. phone: 301-496-6761 email to: eh21f@nih.gov (hadleye@gw.nia.nih.gov) Neuroscience & Neuropsychology of Aging Program Neil Buckholtz, Ph.D. phone: 301-496-9350 email to: nb12s@nih.gov (buckholn@gw.nia.nih.gov) The NIA is interested in supporting scientific meetings, conferences, and workshops in the following areas: biology of aging, geriatrics, behavioral and social research on aging, neuroscience and neuropsychology of aging. Letter of Intent: NIA does not require a letter of intent prior to acceptance of submission of applications. However, applicants are encouraged to contact NIA staff before preparing their applications. Applications of interest to more than one IC will be cofunded. NIA will also provide partial support in conjunction with other funding sources. 2. NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) NIAAA Contact: Ernestine Vanderveen, Ph.D. Telephone: 301-443-1273 E-mail: Tvanderv@willco.niaaa.nih.gov The NIAAA is interested in supporting scientific meetings, conferences, and workshops on all health issues related to alcohol abuse and alcoholism, including the biomedical, behavioral, and social consequences of alcohol use and abuse. The NIAAA does require a letter of intent prior to acceptance of submission of a grant application. The NIAAA does not have any specific requirements regarding partial funding by applicants, dollar limits on applications or other funding policies. 3.NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) NIAID Contacts: Dr. Robert Quackenbush Div. of Microbiology and Infectious Diseases (301) 496-5644 rq1i@nih.gov Joan Kondratick Division of AIDS (301) 402-0755 jk37k@nih.gov Dr. Lawrence Prograis Div. of Allergy, Immunology and Transplantation (301) 496-1886 lp13r@nih.gov NIAID is interested in supporting scientific meetings, conferences, and workshops in the following areas: AIDS, Microbiology and Infectious Diseases, and Allergy, Immunology and Transplantation. NIAID encourages applicants of major annual or biennial conferences to contact staff concerning submission of applications for up to five years of conference support. Receipt Dates: All applications must be submitted at least six (6) months prior to the meeting. NIAID will accept applications on the 3 DRG deadlines. NIAID will also accept applications throughout the fiscal year with prior approval from NIAID staff (see contacts above). Letter of Intent: NIAID requires a letter of intent prior to acceptance of submission of conference applications. NIAID will accept applications for full or partial support. NIAID will not support any conference for less than $2,500. When NIAID is the awarding NIH component and NIAID staff will participate significantly in conference planning, conduct, and reporting, NIAID will normally award the grant as a cooperative agreement (U13). Details for NIAID's program and budget guidelines and information on application instructions for support of scientific meetings may be obtained from the NIAID conference award contacts listed above. 4. NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) NIAMS Contacts: Rheumatic Diseases Branch Dr. Susana Serrate-Szein, Chief 301/594-5032 Steins@ep.niams.nih.gov Skin Diseases Branch Dr. Alan Moshell, Chief 301/594-5017 moshella@ep.niams.nih.gov Musculoskeletal Diseases Branch Dr. Joan McGowan, Chief 301/594-5055 mcgowanj@ep.niams.nih.gov Muscle Biology Branch Dr. Richard Lymn, Chief 301/594-5128 lymnr@ep.niams.nih.gov Specific I/C information: The NIAMS is interested in supporting conferences in any of the basic and clinical areas related to the numerous rheumatic diseases, disorders of the musculoskeletal system, and diseases of muscle, bone, and skin. The NIAMS is also interested in research on the normal structure and function of the joints, muscles, bones, connective tissue, and skin. Areas of special emphasis within the NIAMS include: osteoporosis, Paget's disease, autoimmune diseases such as lupus, connective tissue diseases, exercise physiology and musculoskeletal fitness, sports injuries and occupational diseases. Letter of Intent: The NIAMS would appreciate receiving a letter of intent prior to acceptance of submission of applications for support of conferences of more than one year. The NIAMS, in general, only provides partial support for scientific conferences and workshops. Specific information about fiscal limitations can be obtained from program staff. 5. NATIONAL CANCER INSTITUTE (NCI) NCI Conference Award Contact: Dr. Ray Bramhall Division of Extramural Activities, NCI Phone: (301) 496-3428 Email: bramhalr@dea.nci.nih.gov Specific NCI Information: The NCI is interested in supporting scientific meetings, conferences, and workshops in the scientific program priority areas indicated in the NIH Extramural Programs book available on the Internet at gopher://gopher.nih.gov:70/11/res/nih-ep. Letter of Intent: NCI requires a letter of intent prior to acceptance of submission of all applications. In recent years, NCI has provided partial support for scientific meetings which has been in the range of 3 to 15 thousand dollars per award. Additional support which may be anticipated by the applicant should be requested from other sources. Therefore it is important for prospective applicants to inquire in advance concerning NCI~s interest in supporting a scientific meeting, especially where more than one of the NIH institutes and centers might be involved in providing funding for the same meeting. 6. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) NICHD Contacts: Dr. Marcus Fuhrer Director, National Center for Medical Rehabilitation Research 301-402-2242 fuhrerm@hd01.nichd.nih.gov Dr. Florence Haseltine Director, Center for Population Research 301-496-1101 haseltif@hd01.nichd.nih.gov Dr. Sumner J. Yaffe Director, Center for Research for Mothers and Children 301-496-5097 yaffes@hd01.nichd.nih.gov Conference grant applications are accepted in all areas related to the mission of the NICHD. Letter of Intent: NICHD does not require a letter of intent prior to acceptance of submission of applications, but applicants are encouraged to discuss their plans with the Center contact listed above. Applications of interest to more than one IC will be cofunded. 7. NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS (NIDCD) NIDCD Contact: Judith A. Cooper, Ph.D. 301-496-5061 judith_cooper@nih.gov NIDCD supports scientific meetings, conferences, and workshops in the areas of hearing, balance, smell, taste, voice, speech and language. Letter of Intent: NIDCD does not require a letter of intent prior to acceptance of submission of applications. However, contact with Institute staff prior to submission is strongly encouraged. All applications are reviewed by program staff to determine relevance to the mission of the NIDCD. Budget Considerations: NIDCD will accept applications with a budget limit of $30,000. The Institute usually supplies significantly less than the $30,000 award ceiling and frequently supplies only partial support for a conference. NIDCD often co-funds conferences with other NIH Institutes. 8. NATIONAL INSTITUTE OF DENTAL RESEARCH (NIDR) NIDR Contact: Dr. Norman S. Braveman Phone: 42089 Email: BravemanN@de45.nidr.nih.gov The NIDR is interested in supporting scientific meetings, conferences and workshops in the following areas: Inherited Diseases and Disorders - Infectious Diseases - Neoplastic Diseases - Chronic Disabling Diseases - Biomaterials, Biomimetics, and Tissue Engineering - Behavior, Health Promotion and Environment - Diversity Programs - Clinical Trials - Receipt Dates: NIDR will accept applications on the three DRG deadlines only. Exceptions to this can be made on a case-by-case basis with permission from the Institute. Letter of Intent: NIDR requests a letter of intent for all conference grant applications. Budget Guidelines: NIDR practice is to provide partial support for all conference grants at three levels as follows: (1) Applications directly relevant to the mission of NIDR and for which we are the primary awarding IC and for which NIDR program staff have been contacted prior to application - up to $35,000; (2) Applications relevant to the mission of NIDR and for which we are a secondary or other assignee - up to $10,000 (depending on the degree of relevance to current program priorities); (3) Applications minimally relevant to the mission of NIDR which includes major grantees of the Institute as participants - up to $3,000. 9. NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) NIDDK Contact: Walter S. Stolz, Ph.D. Address 45 Center Drive, Room 6As25C Phone 301.594.8834 E-mail ws23e@nih.gov The NIDDK is interested in supporting conferences in all scientific areas related to its mission including diabetes, endocrinology, metabolic diseases, digestive diseases, nutrition and obesity, kidney diseases, urologic diseases and disorders, and hematologic diseases and disorders Letter of Intent: NIDDK requires a letter of intent to be submitted approximately 30 days prior to submission of a conference grant application. Institute staff must accept the letter of intent before an application will be accepted for review. Early consultation with Institute staff is highly recommended. NIDDK will accept applications under the following budget guidelines: The Institute, in general, will provide only partial support for conferences and workshops. (A special interest of the Institute is to support the attendance of new, minority, and disabled investigators.) Although the NIDDK does not have absolute ceilings on the size of awards made for the support of conferences, awards of more than $20,000 are highly unusual, and the majority of awards are for less than $10,000. Prospective applicants should discuss the size of their anticipated request with Institute staff prior to submission. 10. NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) NIDA Contacts: Teresa Levitin, Ph.D. Office of Extramural Program Review Phone: (301) 443-2755 E-mail: TL25U@nih.gov Chisato Asanuma, Ph.D. Etiology/Clinical Neurobiology Research Branch Division of Clinical and Services Research Phone: 443-4877 E-mail: cs2j@nih.gov Charles Sharp, Ph.D. Division of Basic Research Phone: 443-1887 E-mail: cs107m@nih.gov Susan David, MPH Division of Epidemiology and Prevention Research Phone: (301) 443-6543 E-mail: sd69t@nih.gov Jamie Biswas, Ph.D. Chemistry/Pharmaceutics Branch Medications Development Division Phone: (301) 443-5280 E-mail: jb168r@nih.gov Cindy Miner, Ph.D. Office of Science Policy and Communication Phone: (301) 443-6036 E-mail: cm171w@nih.gov The NIDA is interested in supporting scientific meetings, conferences, and workshops in the following areas: basic and clinical neurosciences, behavioral and social sciences, treatment, prevention, epidemiology, health services, etiology, genetics, community research, HIV/AIDS, and medications development. Letter of Intent: The NIDA will require a letter of intent prior to acceptance of submission of all conference applications. Budget Guidelines: NIDA will support applications for partial or full funding. Applications of interest to more than one IC will be cofunded. 11. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS) NIEHS Contact: Allen Dearry, Ph.D. NIEHS, P.O. BOX 12233, RESEARCH TRIANGLE PARK, NC 27709 919/541-4500 DEARRY@NIEHS.NIH.GOV NIEHS has recently formulated and published a set of ~special emphasis areas~ that represent a broad spectrum of research opportunities within environmental health sciences (see http://www.niehs.nih.gov/dert/programs/special/special.htm). Consistent with this scientific focus, NIEHS is currently interested in supporting scientific meetings, conferences, and workshops in the following areas: o basic molecular mechanisms of environmental insult; o development of alternative models for toxicology testing; o genetic susceptibility; o human health effects of complex mixtures; o human health effects of endocrine disrupting chemicals; o impact of environmental exposures on women, children, and minorities. o prevention research, including basic molecular approaches as well as applied community-based strategies and environmental justice; o role of the environment in neurodegenerative diseases. Special areas of emphasis will be updated periodically. Thus, potential applicants are encouraged to refer to the NIEHS homepage (www.niehs.nih.gov) and/or contact program staff for additional information. Applications should be submitted at least six months before the conference takes place. NIEHS will accept applications throughout the fiscal year. A letter of intent is required prior to submission for cooperative agreement (U13) applications. This letter should provide a brief description of the purpose, significance, content, audience, and requested budget of the proposed conference. No application for a U13 will be accepted without prior receipt and review of a letter of intent. These letters will be accepted on an ongoing basis throughout the year. For applications grants (R13), a letter of intent is not required. However, potential applicants are encouraged to consult with program staff prior to application submission. NIEHS will accept applications under the following budgets guidelines: For R13s, the maximum level of support is $25,000; an average award is $7,500. For U13s, the maximum level of support is $50,000. NIEHS actively participates in cofunding with other NIH institutes for conferences related to environmental health sciences. 12. NATIONAL EYE INSTITUTE (NEI) NEI Contact: Ralph J. Helmsen, Ph.D. (301) 496-5301 (301) 402-0528 FAX rjh@eps.nei.nih.gov Specific NEI information: The National Eye Institute (NEI) supports investigator-initiated scientific meetings using the conference cooperative agreement mechanism, in most instances, rather than the traditional conference grant mechanism. The scientific meeting must be relevant and responsive to NEI scientific program goals and key research questions identified in "Vision Research - A National Plan: 1994-1998," a report of the National Advisory Eye Council. Letter of Intent: The NEI does not require a formal letter of intent. However, potential applicants are strongly encouraged to contact Dr. Helmsen for general information regarding this notice and for referral to the appropriate NEI extramural program director. If the application is funded as a cooperative agreement, NEI extramural program staff will be substantially involved in the planning and conduct of the scientific meeting, assisting the Principal Investigator according to specific Terms and Conditions. Budget Guidelines: No special guidelines. 13. NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS) NIGMS CONTACTS: Dr. James C. Cassatt Director, Division of Cell Biology and Biophysics (301) 594-0828 email: CASSATJ@GM1.NIGMS.NIH.GOV Dr. Judith H. Greenberg Director, Division of Genetics and Developmental Biology (301) 594-0943 email: GREENBERJ@GM1.NIGMS.NIH.GOV Dr. Michael E. Rogers Director, Division of Pharmacology, Physiology, and Biological Chemistry (301) 594-3827 email: ROGERSM@GM1.NIGMS.NIH.GOV The NIGMS is interested in supporting scientific meetings, conferences, and workshops in the following areas: The National Institute of General Medical Sciences (NIGMS) primarily supports basic biomedical research that is not targeted to specific diseases or disorders. NIGMS has three divisions that support research in basic biomedical science fields (additional information can be obtained from the NIGMS Home page: http://www.nih.gov/nigms/about_nigms/about.html). The Division of Cell Biology and Biophysics seeks greater understanding of the structure and function of cells, cellular components, and the biological macromolecules that make up these components. The Division of Genetics and Developmental Biology supports studies directed toward gaining a better understanding of the fundamental mechanisms of inheritance and development. The Division of Pharmacology, Physiology, and Biological Chemistry supports a broad spectrum of research aimed at improving the molecular-level understanding of fundamental biological processes and discovering approaches to their control. The NIGMS publication, "NIGMS Programs and Grant Award Mechanisms," provides additional information and is available on the NIGMS Home Page (The web address for the NIGMS homepage is http://www.nih.gov/nigms) and from: Office of Research Reports National Institute of General Medical Sciences National Institutes of Health 45 Center Drive MSC 6200 Bethesda, MD 20892-6200 (301)496-7301 email: PUB_INFO @GM1.NIGMS.NIH.GOV LETTER OF INTENT: NIGMS will require a letter of intent prior to acceptance of submission of all applications. For this announcement NIGMS does not wish to state any budget limits. 14. NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) NHLBI Conference Award Contacts Thomas P. Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications Phone: (301) 435-0417 E-mail blaszkot@gwgate.nhlbi.nih.gov John Fakunding , Ph.D. Division of Heart and Vascular Diseases Phone (301) 435-0505 E-mail: jf46f@nih.gov Carol E. Vreim, Ph.D. Division of Lung Diseases Phone: (301) 435-0233 E-mail: vreimc@gwgate.nhlbi.nih.gov Carol H. Letendre, Ph.D. Division of Blood Diseases and Resources Phone: (301) 435-0080 E-mail: letendrc@gwgate.nhlbi.nih.gov Specific NHLBI information: The NHLBI is interested in supporting scientific meetings, conferences, and workshops in potentially any relevant program area (Heart and Vascular Diseases, Lung Diseases, Blood Diseases and Resources, Epidemiology and Clinical applications). Receipt Dates: All applications for conference grants must be submitted at least six months prior to the meeting. Applications require approval of the NHLBI before they will be accepted by the Institute. Letter of Intent: NHLBI requires a letter of intent which must be received at least six weeks prior to the submission of an application. Letters should be submitted to the conference coordinators listed above. NHLBI will accept applications under the following budget guidelines: NHLBI will provide a minimum support level of $10,000 for each conference grant. This most likely will represent partial support for the conference. These same financial guidelines will apply to any conference grant cofunded with another I/C. In FY 95 and FY 96, NHLBI provided support to 14 conference grants. 15. NATIONAL HUMAN GENOME RESEARCH INSTITUTE (NHGRI) NHGRI Contact: . Name: Elise Feingold, Ph.D Phone: 301 496-7531 E-mail: elise_feingold@nih The NHGRI is interested in supporting scientific meetings, conferences, and workshops in the following areas: new and improved technologies for DNA sequencing; development and application of new technologies for comprehensive sequence-based approaches to the understanding of genome function, including the elucidation of the biological roles of gene products and non-coding functional elements, the interaction among functional elements in the cell, the biological consequences of genome organization; the study of DNA sequence variation, including the dynamics of polymorphisms in populations and the functional significance of genomic variation; and the ethical, legal, and social implications of genetic research. Receipt Dates: All applications must be submitted at least six (6) months prior to the meeting. NHGRI will accept applications on: Dec. 1, Apr. 1, Aug. 1 Letter of Intent: A letter of intent, or direct program contact, is encouraged at least two months prior to the receipt deadline, but is not required. NHGRI will accept applications for full or partial support. However, as a rule, NHGRI will not support the travel of foreign scientists to meetings in the U.S. NHGRI is willing to co-fund with other ICs. 16. NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) NIMH CONTACTS: Richard K. Nakamura, Ph.D. Associate Director for Science Policy phone: 301-443-4335 fax: 301-443-3225 e-mail: rn3p@nih.gov Nancy L. Ostrowski, Ph.D. Office of Science Policy and Program Planning phone: 301-443-4335 fax: 301-443-3225 e-mail: no5d@nih.gov The NIMH is interested in supporting scientific meetings, conferences, and workshops designed to focus research attention on understanding, treating, and preventing mental illnesses through basic research on the brain and behavior, and through clinical, epidemiological, and mental health services research. Letter of Intent: The NIMH suggests applicants submit a letter of intent prior to submission of applications. 17. NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) NINDS Contacts: General Information and Conference Grant Guidelines: Constance W. Atwell, Ph.D. Director, Division of Extramural Activities Phone(301) 496-9248 E-mail ca23c@nih.gov Discussions concerning potential program interest in conference or assistance in constructing application: Michael D. Walker, M.D. Director, Division of Stroke, Trauma and Neurodegenerative Disorders Phone (301) 496-2581 E-mail: mw163m@nih.gov Floyd J. Brinley, Jr., M.D., Ph.D. Director, Division of Convulsive, Infectious and Immune Disorders Phone: (301) 496-6541 E-mail: fb18u@nih.gov Robert W. Baughman, Ph.D. Co-Director, Division of Fundamental Neuroscience and Developmental Disorders Phone: (301) 496-5745 E-mail: rb175y@nih.gov Conference grant applications are accepted in all areas related to the mission of the NINDS. Letter of Intent: NINDS does not require a letter of intent prior to acceptance of submission of applications, but applicants are strongly encouraged to discuss their plans with the Division contact listed above. NINDS supports conferences in part or in full and participates in co-funding with other I/Cs. Awards are typically under $10,000, but larger awards are sometimes made. Discussions with program staff are especially important if larger amounts are requested. 18. NATIONAL INSTITUTE OF NURSING RESEARCH (NINR) The NINR does not offer conference grants. 19. NATIONAL LIBRARY OF MEDICINE (NLM) NLM Contact: Milton Corn, M.D. Division of Extramural Programs National Library of Medicine 301-496-4621 corn@nlm.nih.gov Prospective applicants are advised to contact Dr. Corn before submitting applications. 20. NATIONAL CENTER FOR RESEARCH RESOURCES (NCRR) NCRR Program contact for R13s Louise E. Ramm, Ph.D. Deputy Director, NCRR Phone: (301) 496-6023 Fax: (301) 402-0006 e-mail: louiser@ep.ncrr.nih.gov The NCRR is interested in supporting scientific meetings, conferences and workshops in the following areas: animal (both mammalian and nonmammalian) models; clinical research; biomedical technology; bioengineering; and science education. Receipt Dates: All applications must be submitted at least six months prior to the meeting. Letter of Intent: NCRR does not require a letter of intent prior to acceptance; however, if an application~s budget is over $25,000, program staff must be contacted prior to submission. Also, applicants are encouraged to contact NCRR staff before preparing their applications. Applications of interest to more than one IC will be cofunded. 21. FOGARTY INTERNATIONAL CENTER (FIC) The Fogarty International Center does not provide support for conference grants. 22. OFFICE OF RARE DISEASES (ORD) Conference Award Contact: Stephen C. Groft, Pharm.D. Office of Rare Diseases Phone: 301-402-4336 Fax: 301-402-0420 E-Mail: sg18b@nih.gov The Office of Rare Diseases provides support for scientific workshops and symposia to stimulate research on rare diseases and conditions. Primary consideration for support will be given to those rare diseases and conditions or groups of related diseases where current research is lacking or lagging or the likelihood of stimulating research is a possible outcome of the workshop or symposia. A rare diseases is defined as a disease or condition with a prevalence of less than 200,000 people in the United States. Letter of Intent: The Office of Rare Diseases does not require a letter of intent prior to acceptance of submission of applications. The Office of Rare Diseases will accept applications under the following budget guidelines: Full or partial support contributed by Office of Rare Diseases will be no more than $20,000 per award. All awards will be made through one of the categorical research institutes of NIH following the customary review process of the categorical research Institutes and Centers of the NIH. SUPPLEMENTAL INSTRUCTIONS FOR APPLICATION FORM PHS 398 FOR CONFERENCE AWARDS The following instructions are to be used in conjunction with the instructions accompanying application form PHS 398 (rev. 5/95). They refer only to selected items in the application. All PHS 398 requirements should be adhered to, with the exception of those items modified by the following instructions. Please note that some information to be omitted from the application at the time of submission may be requested by NIH staff following review if an application may be funded. Face Page : Item 1: Provide the title of the meeting. Item 2: Check the box marked "YES," if appropriate. Enter "PA" and the code "R13." Item 6: Enter the exact, inclusive dates of the meeting. Page 2: Description: Complete a very brief description of the proposed meeting, including the dates, location, types of participants, goals, and topics to be covered. Performance Site(s): Enter the site of the meeting or workshop. Key Personnel: List only those key individuals responsible for the planning and conduct of the meeting. Detailed Budget for Initial Budget Period (Page 4) : Do not complete or submit this page. Budget for Entire Proposed Period of Support (Page 5): Composite Budget Table: Enter total direct costs requested. Justification: Provide a narrative justification for each proposed personnel position, including role and proposed level of effort. Provide narrative justification for the support requested within the context of the total budget for the conference. Please note the following general NIH policy covering allowable and non-allowable costs for conference awards. The appropriate Institute/Center conference award contact should be consulted for specific guidance: Allowable Costs: Salaries in proportion to the time or effort spent directly on the meeting; rental of necessary equipment; travel and personal expenses (prior approval authority is suspended); supplies needed for conduct of the meeting only if received for use during the budget period; conference services; publication costs; registration fees; speaker's fees. Non-allowable Costs: Purchase of equipment; transportation costs exceeding coach class fares; visas; passports; entertainment; tips; bar charges; personal telephone calls; laundry charges; per diem, travel or expenses other than local mileage for local participants; organization dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; indirect costs. Biographical Sketch (Page 6): (Complete for each of the key personnel listed on Page 2.) Research and Professional Experience: List current position(s) and those previous positions directly relevant to the application. List selected peer-reviewed publications directly relevant to the proposed meeting, with full citations. Provide information on research projects completed and/or research grants in which the investigator participated during the last 5 years that are relevant to the proposed meeting. For each project or grant listed, provide title, name of principal investigator, funding source, and role on project (if not principal investigator). Other Support (Page 7): Do not complete or submit this section. Research Plan (This section may not exceed 13 pages.): 1. Single Year Applications Use this section of the application to describe the objectives, specific program, and logistical arrangements for the meeting. Describe the format and agenda, including the principal topics to be covered, problems to be addressed, and developments or contributions the meeting might stimulate. Provide a detailed justification for the meeting, including the scientific need, timeliness, and usefulness of the meeting to the scientific community. Describe the composition and role of the organizing committee, and provide the names and credentials of key participants in the meeting, including the basis for their selection and documentation of their agreement to participate. Describe plans for the appropriate involvement of women, minorities, and persons with disabilities in the planning and implementation of the proposed meeting (See Attachment 3). Estimate the expected size and composition of the audience, as well as the method of selection. Describe plans for publicizing the meeting and publication of proceedings. Identify related meetings held on the subject during the past 3 years. If this is one of a series of periodic meetings held by a permanent sponsoring organization, briefly describe and evaluate the last meeting in the series. 2. Multiple Year Applications Applications for multiple year awards for up to five years may be submitted when a series of annual or biennial meetings is proposed by a sponsoring organization. Support for meetings to be held on a less frequent schedule must be applied for individually. For applications requesting multiple years of support, the following additional information must be provided for each future year requested, in as much detail as possible: (1) meeting topic; (2) tentative dates, locations, and participants; (3) contingency plans for future meetings dependent on, for example, outcome of the first year's meeting or developments in the field. For multiple year awards, the noncompeting application (PHS 2590) must be submitted no later than six (6) months prior to the next scheduled meeting. It should include a report on the previous meeting supported by the current grant, as well as a full description of the next planned meeting including all information requested under section 1, above. Appendix: The Appendix is limited to the following items: 1. Announcement and report of previous meetings under the same sponsorship. 2. Letters of agreement from participants. Checklist: The Checklist should not be submitted. "Guidelines on Inclusion of Women, Minorities, and Persons with Disabilities in NIH-Sponsored and/or -Supported Intramural and Extramural Scientific Meetings and Conferences" (NIH Guide, Vol. 24, No. 15, April 28, 1995). Available through the NIH/OER Homepage(http://www.nih.gov/grants/oer.htm) or gopher://gopher.nih.gov:70/0R34019-43774-/gopherlib/data/nih-guide/OL DGUIDES/95.04.28.data. From owner-sci-resources@net.bio.net Thu May 08 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-97-011 - V26(15) 05/09/97 Date: 9 May 1997 13:49:05 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 763 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5l02k1$foh@net.bio.net> NNTP-Posting-Host: net.bio.net INTERSTITIAL CYSTITIS CLINICAL TRIALS GROUP NIH GUIDE, Volume 26, Number 15, May 9, 1997 RFA: DK-97-011 P.T. 34; K.W. 0715085, 0755015 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: July 25, 1997 Application Receipt Date: August 26, 1997 PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces the availability of a Request for Applications (RFA) to establish an Interstitial Cystitis Clinical Trials Group. The purpose of this RFA is to solicit applications from institutions interested in participating in a cooperative group to plan, direct, and conduct clinical trials in patients with interstitial cystitis (IC). This RFA will establish and maintain clinical centers required to perform multiple therapeutic trials, either sequentially or concurrently, for treatments of IC using common protocols with appropriate sample sizes. This RFA will also establish a Data Coordinating Center for the clinical trials group to coordinate the development of protocols for the trials and to support the collection, quality control, and analysis of the data. 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, Interstitial Cystitis Clinical Trials Group, relates to the priority areas of chronic disabling conditions and prevention services. 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 Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone number 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic institutions; public and private organizations (for-profit and non-profit), such as universities, colleges, hospitals, units of State and local government; and eligible agencies of the Federal government. Foreign institutions are not eligible to apply. Racial/ethnic minorities, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The administrative and funding instrument to be used for these awards will be the cooperative agreement (U01). The cooperative agreement is an assistance mechanism in which substantial NIDDK scientific and programmatic involvement is anticipated during performance of the activity. Under the cooperative agreement, the NIDDK's purpose is to support and encourage the recipient's activities by working jointly with the awardees in a partnership role, but not to assume direction, prime responsibility, or dominance. Details of the responsibilities, relationships, and governance of a study funded under a cooperative agreement are described under the section entitled "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed five (5) years. The anticipated award date is March 1, 1998. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will also vary. At this time, the NIDDK has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The NIDDK plans to make five awards for clinical centers and one award for a Data Coordinating Center. Approximately $2,000,000 total cost (total cost = direct plus indirect costs) is expected to be available for the first year of support under this RFA. It is anticipated that the award for each clinical center will be about $275,000 total cost for the first year and the award for the Data Coordinating Center will be about $625,000 total cost for the first year. The number of awards to be made is dependent on the receipt of a sufficient number of applications of high scientific merit and availability of funds. Although this program is provided for in the financial plans of the NIDDK, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background Interstitial cystitis is often times a disabling disease characterized by bladder pain, urgency, frequency, nocturia, and dysuria. The disease primarily affects women, the female to male ratio being 9:1 in several studies. Realizing that IC was often misdiagnosed, workshops on IC held in 1987 and 1988 by the NIDDK resulted in the development of inclusion and exclusion criteria for patients being considered for research studies of the disease. Despite the development of these criteria, meaningful epidemiological studies on IC have not been conducted in the United States during the past decade. Thus, our knowledge about the epidemiology, natural history, and risk factors for IC is rudimentary. Moreover, the cause(s) of IC is not known. Because of this lack of information, the NIDDK initiated a prospective, clinical, longitudinal study on IC called "The Interstitial Cystitis Database (ICDB) Study." Begun in 1991, the ICDB Study, a cooperative agreement supported program, has enrolled over 600 women and men into this project that is scheduled to complete the follow-up of participants in the fall of 1997. A wealth of clinical, demographic, and pathological (bladder biopsies) information has been collected by ICDB Study investigators which has provided valuable insights into this disease. Based on the findings from the ICDB Study, investigators are now in a position to better characterize the spectrum of disease severity observed in IC patients and to consider outcome measures that are meaningful to these patients. In addition, the distribution of medical and non-traditional treatments utilized by ICDB Study participants has also been well documented. Because the etiology and pathophysiology of IC are not known, physicians are limited to treating the symptoms of IC patients. Although a number of medical therapies are available for treatments, neither their long-term effectiveness nor their specificity for the individual characteristics of the disease is well known. Many previous clinical trials for IC therapy have suffered from a number of design flaws including small sample size, lack of masking of treatment, short-term follow-up, ambiguous definitions of IC, absence of characterizing disease severity, and questionable endpoints. In addition, little is known about the effectiveness of medical treatments used in combination. The lack of conclusive outcomes from well-organized and conducted randomized clinical trials has resulted in many physicians using a trial-and-error approach to therapy and this management has led many IC patients to seek non-traditional approaches to control their disease. Based on the findings from the ICDB Study, the NIDDK has determined that a series of randomized, controlled multicenter clinical trials studying well-characterized patients and measuring meaningful subjective and objective endpoints, are now feasible to evaluate the effectiveness of currently available and newly developed medical therapies for patients with IC. B. Research Goals and Scope The purpose of this RFA is to initiate a collaborative study of treatment interventions for IC. This program will provide a mechanism to establish and maintain Clinical Centers which will perform multiple therapeutic trials in patients with IC. The therapeutic trials may involve investigational drugs, approved agents not currently used, drugs currently used in treatment of IC, or non-drug approaches. It is expected that these trials will take place in five Clinical Centers over a period of five years. The Clinical Centers will randomize approximately 1,000 participants for the various clinical trials conducted during the lifetime of this program. The data collection activities of the Clinical Centers will be supported by a single Data Coordinating Center. C. Study Design It is envisioned that over the five-year period, several multicenter clinical trials will be developed and implemented by the Principal Investigators. The individual Clinical Centers within the IC Clinical Trials Group should emphasize clinical trials that can be conducted under mutually agreed upon protocols. The study population is envisioned to be IC patients encompassing a broad range of age groups and consisting of appropriate gender and minority representation. Patients with a broad range of disease severity should also be included. Applicants for both Clinical Centers and the Data Coordinating Center should propose two examples (conducted either concurrently or sequentially) of clinical protocols requiring multicenter participation that they consider important. For each example applicants should submit concept documents not more than four pages long, that briefly outline the rationale and background of the proposed clinical trials, study design, type of patients to be included in the protocols, eligibility criteria, and baseline and outcome measures. For each of the clinical protocols, Clinical Center applicants should discuss the characteristics and number of potential participants that would be available from their own geographic region. The topics for the Clinical Trials Group will be proposed and prioritized by the Steering and Planning Committee based on protocols submitted and approved during review, but the actual number of clinical trials conducted will be dependent upon availability of funds. STUDY COMPONENTS 1. Clinical Centers A Clinical Center is an institution that is actively involved in the recruitment, evaluation, treatment, and follow-up of study participants. It should consist of an interdisciplinary team of clinical investigators and appropriate personnel, such as a research coordinator and clerical staff. An application for a Clinical Center should provide evidence that the investigators are capable of recruiting a sufficient number of participants for the proposed trials. Applicants for Clinical Centers should describe the target population from which they expect to randomize the required number of study participants and plans for recruitment of women and minorities. Clinical Centers will be required to submit protocol data expeditiously. Clinical Centers must work in concert with the Data Coordinating Center to implement procedures for data audits and other data quality control procedures as established by the study protocol. The Principal Investigator and Co-Investigators in each Clinical Center should be skilled in collaborative clinical investigation. There should be evidence of strong institutional support for the Clinical Center, including adequate space in which to conduct clinic activities and office space for staff. An organizational structure for the Clinical Center should be set forth in the application delineating lines of authority and responsibility for dealing with problems in all general areas as well as stated willingness to follow the stated common protocols. The applicant should include a succinct discussion of previous relevant investigational efforts. The applicant should also discuss in detail the recruitment strategies to procure the expected number of randomized participants, approaches to attain high levels of adherence to the interventions, and high rates of follow-up. Specific plans for recruitment of minority participants must also be discussed. 2. Data Coordinating Center The Data Coordinating Center will have primary responsibility for collecting, editing, storing, and analyzing data generated by the Clinical Centers. It should be prepared to assume a key role in overseeing implementation and adherence to the study protocol, and assuring quality control of the data collected. The Data Coordinating Center will be expected to provide appropriate biostatistical, data management, and coordination expertise. The Data Coordinating Center also will be expected to provide appropriately detailed reports to the Steering and Planning Committee and to the External Advisory Committee at regular intervals and will be responsible for the logistics and planning of the meeting of these committees and their subcommittees. Applicants for the Data Coordinating Center should provide a detailed description of prior experience in multicenter studies. 3. Steering and Planning Committee The primary governing body of the study will be the Steering and Planning Committee comprised of each of the Principal Investigators of the Clinical Centers and the Data Coordinating Center, the Chairperson of the Steering and Planning Committee, and the NIDDK Project Scientist (described in detail under Terms and Conditions). 4. External Advisory Committee An independent committee supported by the NIDDK and composed of experts in urology, biostatistics, clinical trials, and bioethics who are not otherwise involved in the study will be established to review periodically the progress of the study (described in detail under Terms and Conditions). This Committee will also be responsible for reviewing the acceptability of initial data quality monitoring plans established by the Steering and Planning Committee and the subsequent monitoring of data quality by means of reports prepared by the Data Coordinating Center. 5. Project Scientist The NIDDK will identify a Project Scientist for the study. The Project Scientist will assist the Steering and Planning Committee and External Advisory Committee in carrying out the study (described in detail under Terms and Conditions). 6. Study Phases The timetable for the study may be subdivided into three phases over a five-year period. There may be some overlap in functions within each of the phases, and the time estimates are only approximations. The purpose of the phases is to provide broad guidelines of the total scope of work to be accomplished for this RFA. Phase I: Planning and development of the clinical trial group infrastructure, protocol development; months 1 to 12. Phase II: Patient recruitment; protocol implementation, further protocol development; months 13 to 60. Phase III: Data Analysis; report preparation; protocol development and recruitment for next studies; months 24-60. The first twelve months of the study (Phase I) may be devoted to planning and development of the clinical trials group infrastructure and committee structure. Possible objectives for the Steering and Planning Committee are to determine patient eligibility criteria for initial clinical trials; train staff in procedures; help set up data acquisition and consent forms; define terms and outcome measures; develop a manual of operations, questionnaires, procedures for quality control; determine priorities for protocol development; and begin to develop specific protocols. The Data Coordinating Center will also play a key role in the planning and development stage. Possible objectives for the planning and development stage for the Data Coordinating Center, in addition to assisting Clinical Centers in their planning and organization of the clinical trials group, are to help develop study protocols, randomization and analytic plans; select a data acquisition, transfer, and management system; develop procedures for quality control, training, and certification; develop and produce a Manual of Operations; and take the lead for the orderly accumulation and transmission of data for the clinical trials group. In Phase II, the Clinical Centers will select and prioritize common protocols, proceed with subject recruitment and protocol implementation for the first studies ,and concurrently develop additional protocols. Possible objectives for Phase II for the Data Coordinating Center are to assist the Clinical Centers with respect to completing protocol development, patient recruitment, randomization, data acquisition, and ongoing quality control. In Phase III, after the last patients in the first study have completed their follow-up measurements, Clinical Centers will review their data and assist the Data Coordinating Center in the close-out of the initial study. Initiation of patient accrual will begin for the next studies, and protocol development will continue for subsequent trials. Depending upon the sample sizes and resources available to the Clinical Centers and the Data Coordinating Center, it may be possible to conduct two or more trials concurrently. The Data Coordinating Center will continue with its activities in data management, editing, data analysis, and protocol development. It will also support manuscript preparation through data analysis, statistical consultation, editorial tasks, and coordination of meetings. 7. Budget Applications for the Clinical Centers and the Data Coordinating Center must include a year-by-year budget that is adequately justified. For a Clinical Center, the budget should request support for the minimum number of full-and/or part-time staff to successfully carry out the proposed trials. A Clinical Center could include a Principal Investigator, Co-Investigator, Study Coordinator, and Data Entry Clerk. The budget should include support for travel for two key investigators to attend bi-monthly Steering and Planning Committee Meetings during Phase I and quarterly meetings during Phase II. Steering and Planning Committee Meetings will be held in the Washington, D.C. area. Travel for centralized training of the study coordinator and data entry clerk must also be budgeted (assume central training to be held in the Washington, D.C. annually during years 1 through 5). For applications for the Data Coordinating Center, the budget should also include the time and effort of key personnel needed to conduct the trials and the required number of and cost of computers to be used at the Clinical Centers for distributed data entry. Travel to Washington, D.C. for External Advisory Committee Meetings (two per year), Steering and Planning Committee Meetings (six in Year 1-Phase I and three annually in Phases II and III -Budget Years 2-5), and site visits (five visits for years 2-5) is to be included in the budget. The Data Coordinating Center should also budget for travel for the Chairperson of the Steering and Planning Committee (six meetings in Year 1 and three in Years 2-5). SPECIAL REQUIREMENTS Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to each Principal Investigator as well as to the institutional officials at the time of the award. These terms are in addition to, not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92, and other HHS, PHS, and NIH Grants 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 the cooperative agreement concept, the dominant role and prime responsibility for the planned activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the activity will be shared among the awardees and NIDDK Project Scientist. A. Awardee Rights and Responsibilities Awardees will have substantial and lead responsibilities in all tasks and activities. These include protocol development, patient recruitment and follow-up, data collection, quality control, final data analysis and interpretation, and preparation of publications. The awardee agrees to work cooperatively with the other Clinical and Data Coordinating Centers and agrees to follow the common protocol and Manual of Operations developed by the Steering Committee. The awardee also agrees to transmit all study data to a central Data Coordinating Center for combination and analysis. Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government (e.g., NIDDK, NIH, or PHS) rights or access consistent with current HHS, PHS, and NIH policies. B. NIDDK Staff Responsibilities The NIDDK will name a Project Scientist from within the Division of Kidney, Urologic and Hematologic Diseases whose function will be to assist the Steering and Planning Committee and External Advisory Committee in carrying out the study. The Project Scientist will be a voting member of all key study group subcommittees and will serve as Executive Secretary of the External Advisory Committee. The Project Scientist will have substantial scientific-programmatic involvement in quality control, interim data analysis, safety monitoring, and final data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The dominant role and prime responsibility for these activities resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK Project Scientist. The NIDDK Project Scientist will have voting membership on the Steering and Planning Committee and, as determined by that committee, its subcommittees. The NIDDK reserves the right to terminate or curtail the study (or an individual award) in the event of substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, reaching a major study endpoint substantially before schedule with persuasive statistical significance or human subject ethical issues that may dictate a premature termination. C. Collaborative Responsibilities A Steering and Planning Committee, composed of the Principal Investigators of each Clinical Center, the Principal Investigator of the Data Coordinating Center, and the NIDDK Project Scientist will be the main governing board of the study and will have primary responsibility for developing common study designs, protocols and manuals; facilitating the conduct and monitoring of studies, and reporting study results. Each Principal Investigator from a Clinical Center and the Data Coordinating Center as well as the NIDDK Project Scientist, will have one vote. The chairperson, who will be someone other than an NIDDK staff member, will be selected by the Steering and Planning Committee. Subcommittees will be established by the Steering and Planning Committee, as it deems appropriate; the Project Scientist will serve on subcommittees as he/she deems appropriate. The collaborative protocols will be developed by the Steering and Planning Committee. Data will be submitted centrally to the Data Coordinating Center. Protocols will define access to data and publications. An independent External Advisory Committee, to be appointed by the NIDDK, will review progress at least annually and report to the NIDDK. Awardees will be required to accept and implement the common protocol(s) and procedures approved by the Steering and Planning Committee. D. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between recipients and the NIDDK may be brought to arbitration. An arbitration panel will be composed of three members - one selected by the Steering and Planning Committee (with the NIDDK member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NIDDK, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 1003-43). 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 of March 18, 1994, Volume 23, Number 11. LETTER OF INTENT Prospective applicants are asked to submit, by July 25, 1997, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application is 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 the NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: CHIEF, REVIEW BRANCH DIVISION OF EXTRAMURAL ACTIVITIES National Institute of Diabetes, Digestive, and Kidney Diseases 45 CENTER DRIVE ROOM 6AS-37F MSC 6600 BETHESDA, MD 20892-6600 FAX: (301)480-3505 Email: hagana@ep.niddk.nih.gov APPLICATION PROCEDURES Applications must be submitted on the standard research 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 Division 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. The RFA label in the 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. For purposes of identification and processing, item 2 of the face page of the application must be marked "YES" and the RFA number and the words "Interstitial Cystitis Clinical Trials Group" must be typed in. 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 must be sent to: CHIEF, REVIEW BRANCH DIVISION OF EXTRAMURAL ACTIVITIES National Institute of Diabetes, Digestive, and Kidney Diseases 45 CENTER DRIVE ROOM 6AS-37F MSC 6600 BETHESDA, MD 20892-6600 Applications must be received by August 26,1997. 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 not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS 398 applications instructions for the preparation of revised applications, including 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 RESEARCH OBJECTIVES of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion for evaluation of a study. Other considerations, such as the ability to recruit minority participants and geographic location, will be part of the evaluation criteria. Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the NIDDK. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Review Criteria Applicants are encouraged to submit and describe their own ideas about how best to meet the goals of the cooperative study and their specific protocols. The Initial Review Group evaluates the merit of each grant application according to specific criteria. The principal criteria for the initial review of all research applications, as required in the PHS Scientific Peer Review Regulations, include: 1. scientific, technical, or medical significance and originality of the proposed research; 2. appropriateness and adequacy of the experimental approach and methodology to be used; 3. qualifications of the Principal Investigator and staff in the area of research; 4. the Principal Investigator's experience and record in previous research activity; 5. reasonable availability of resources; 6. reasonableness and adequacy of justification of the proposed budget and duration of support; 7. adequacy of the proposed means for protecting against adverse effects upon humans, vertebrate animals, or the environment. The evaluation of applications for Clinical Centers and the Data Coordinating Center will be based primarily on the scientific merit of the proposed studies. Specific criteria for review of applications will be as follows: For Clinical Centers: 1. The scientific merit of the proposed study design(s) to address the objectives of the RFA. 2. Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the operation of a Clinical Center in the proposed Clinical Trial Group. Evaluation will include the following: familiarity with and experience in recruiting participants in a randomized trial; handling laboratory specimens; working in collaboration with other investigators under a common protocol; ability to implement study procedures; and meticulous and expeditious handling of study data. 3. Documentation of access to patient population(s) from which a substantial number of trial participants can be recruited in sufficient numbers to meet the goals specified in the RFA. 4. Ability to recruit representative minority populations. 5. Understanding and awareness of the scientific, ethical, and practical issues underlying the proposed trials and appropriateness of plans to deal with them. 6. Responsible budgeting and staffing and distribution of available resources appropriate for the work proposed. 7. Adequacy of the proposed facility and space. 8. Evidence of the degree of institutional commitment and support for the proposed program, including the relative position of the proposed project staff within the applicant's organizational structure. 9. Willingness to carry out a developed study protocol. 10. Adequacy of plans to ensure accurate collection and timely transmission of study data. For the Data Coordinating Center: 1. The scientific merit of the proposed approach to study design, data collection and management for interventions as outlined in the RFA. 2. Documentation of the specific competence and private experience of professional, technical, and administrative staff pertinent to the trial. Prior experience in similar studies, in the collection of data and patient specimens from multiple locations, as well as experience in monitoring the quality and timeliness of such data, should be demonstrated. 3. Demonstrable knowledge of the potential problems associated with the conduct of this study and possible solutions must be demonstrated. 4. Suitability of proposed data management and data analysis plans. 5. Ability to design, implement and maintain a distributed data entry system for the Clinical Centers. 6. The approach to and likelihood of soliciting cooperation from the participating Clinical Centers and exercising appropriate leadership in matters of study design and protocol revisions, and data acquisition, management, and analysis. Specific plans for ensuring quality control of data collection across all study sites are required. 7. Appropriateness of the budget for the work proposed. 8. The adequacy of the proposed facility, technical hardware, and space. 9. The organizational and administrative structure of the proposed program. 10. Evidence of the degree of commitment and support of the organization/institution for the proposed program, including the relative position of the proposed project staff within the applicant's organizational structure. AWARD CRITERIA Applications recommended by the National Diabetes and Digestive and Kidney Diseases Advisory Council will be considered for award based upon (a) scientific and technical merit; (b) program balance, including in this instance sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; (c) availability of funds; (d) appropriate minority representation in the trial; and (e) geographic balance among clinical centers. SCHEDULE Letter of Intent Receipt Date: July 25, 1997 Application Receipt Date: August 26, 1997 Special Review Committee: October/November 1997 NIDDK Advisory Council: February 4-5, 1998 Anticipated Award Date: March 1, 1998 INQUIRIES Written and telephone Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: John W. Kusek, Ph.D. or Leroy M. Nyberg, Ph.D., M.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DRIVE MSC 6600 BETHESDA, MD 20892-6600 Telephone (301) 594-7717 Email: kusekj@ep.niddk.nih.gov or nybergl@ep.niddk.gov Direct inquiries regarding fiscal and administrative matters to: Trude Hilliard Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DRIVE Room 6AN-44B MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8859 FAX: (301) 480-3504 Email: hilliardt@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.849. 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 work place 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 May 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 10 May 1997 Date: 13 May 1997 16:32:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 94 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5latml$pg@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending May 10, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: National Science Board Members Confirmed - Tipsheet File size (bytes): 4573 STIS Filename: tip0509.txt Document Type: Program Guideline Title: NSF 97-51 - Experimental Program to Stimulate Competitive Research (EPSCoR) File size (bytes): 44431 STIS Filename: nsf9751.txt Document Type: Recruit Title: Science Education Administrator (Section Head) File size (bytes): 7188 STIS Filename: vex9713.txt Title: Science Education Analyst for Evaluation (K-12) File size (bytes): 8094 STIS Filename: vex9714.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 111544 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112674 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 127601 STIS Filename: phnorg.txt Document Type: Program Guideline Title: Professional Opportunities for Women in Research and Education POWRE NSF 97-91 File size (bytes): 28468 STIS Filename: nsf9791.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9791.txt, the text of your message should be as follows: get nsf9791.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9791.txt, you would enter: ftp> get nsf9791.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Mon May 19 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 17 May 1997 Date: 20 May 1997 13:30:10 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 80 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5lt1ki$kt2@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending May 17, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: National Science Board Members Confirmed - Tipsheet File size (bytes): 4574 STIS Filename: tip70509.txt Document Type: Press Release Title: First Circadian Clock Gene Identified and Cloned in Mammals File size (bytes): 4167 STIS Filename: pr9735.txt Title: VALUE OF THE WORLD'S ECOSYSTEM SERVICES File size (bytes): 4550 STIS Filename: pr9736.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 9028 STIS Filename: cmmtg.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112678 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 127553 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Wed May 21 23:00:00 1997 Path: biosci!biosci!not-for-mail From: David Kristofferson Newsgroups: bionet.sci-resources Subject: IMPORTANT - BIOSCI moving to Stanford! Date: 21 May 1997 21:11:31 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 56 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199705220407.VAA04993@net.bio.net> NNTP-Posting-Host: net.bio.net After more than a decade of serving the biology community on the BIOSCI project, I have decided that it is time for me to pass the torch. The demands of my career and family are making it increasingly difficult for me to run BIOSCI adequately on a part-time basis, and I've decided that I would do the project more harm than good by clinging to it. Therefore I have concluded an agreement with the Stanford University Libraries to take over the management of the BIOSCI project effective 6 June 1997. Many of you know the work of the Stanford Libraries through HighWire Press which has done an excellent job bringing the Journal of Biological Chemistry, Science Magazine, and other prestigious journals to the WWW (see http://highwire.stanford.edu/). I have every confidence that Stanford will provide an environment where the BIOSCI project can flourish. The BIOSCI team at Daresbury will continue to support the project in Europe, and Dave Mack and Julie Lawrence on the current BIOSCI staff will continue to assist the new team at Stanford. The project will be managed by Serge Taylor of the Stanford Libraries who is responsible for developing Web-based "knowledge environments" for scientists. I will still participate with the project in an advisory capacity but have to phase myself out of day-to-day operations. Many of you who read bionet.announce, bionet.biology.computational, and bionet.jobs.offered (the groups that I moderate) have been aware of the recent posting delays that my busy schedule has inflicted on those newsgroups. I am pleased to announce that Todd McGee, Scientific Advisor of the HighWire Press, will be taking over moderation of those groups from me this week. ** NOTE ** - The BIOSCI hardware will be down for backups on 6 June and will be moved over the weekend of June 7 and 8. We will be changing the IP number of the machine, but the host name and all mailing addresses will remain unchanged. There may be a few days of service disruption during this time due to the move unfortunately, just as we experienced in BIOSCI's previous move. We hope to keep this to a minimum. We will post status reports on the move to bionet.announce before and after it happens. Please watch that newsgroup for details. It has been a pleasure serving all of you since the "early days" of biology on the Internet. I've had the pleasure of not only "knowing" many of you over the Internet, but have also met literally thousands of biologists around the U.S. and elsewhere during the many Internet training seminars that I gave over the last decade. I've been truly fortunate to have been given the chance to play a role in the growth of biology on the Internet. This is something I will always treasure. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net From owner-sci-resources@net.bio.net Wed May 21 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 16, pt. 1of2, 16 May 1997 Date: 22 May 1997 13:35:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1495 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5m2an3$6s3@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 16 - May 16, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 NOT-97-007 *********************************************** NIH NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL RESEARCH TRAINING GRANTS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N4 ********************************************************** CENTERS FOR AIDS RESEARCH (CFARS) (PAR-97-027) National Cancer Institute National Heart, Lung, and Blood Institute National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Mental Health INDEX: CANCER; HEART, LUNG, BLOOD; ALLERGY, INFECTIOUS DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; DRUG ABUSE; MENTAL HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** AIDS VACCINE EVALUATION GROUP MUCOSAL IMMUNOLOGY LABORATORY (RFP NIH-NIAID-DAIDS-98-06) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 10/16/97 ************************************************* LOW-COST, HIGH-ACCURACY DNA SEQUENCING TECHNOLOGIES (RFA HG-97-002) National Human Genome Research Institute INDEX: HUMAN GENOME RESEARCH $$INDEX R3 10/28/97 ************************************************* ORGANIZATION AND MANAGEMENT OF DRUG ABUSE TREATMENT SERVICES (RFA DA-98-002) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P1 ********************************************************** RESEARCH ON LOW BACK PAIN AND COMMON SPINAL DISORDERS (PA-97-058) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute of Neurological Disorders and Stroke National Institute for Occupational Safety and Health INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; NEUROLOGICAL DISORDERS, STROKE; OCCUPATIONAL SAFETY, HEALTH $$INDEX P2 ********************************************************** RESEARCH ON REPETITIVE MOTION DISORDERS (PA-97-059) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute of Neurological Disorders and Stroke National Institute for Occupational Safety and Health INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; NEUROLOGICAL DISORDERS, STROKE; OCCUPATIONAL SAFETY, HEALTH The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available 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. 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. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from 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 to 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. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 26, Number 16, May 16, 1997 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services A Notice beginning on page 22950 in the Federal Register issue of April 28, 1997, entitled "Findings of Scientific Misconduct" is hereby revised to correct the name of the University's organizational unit referenced in the original printing: Weidong Sun, M.D., Ph.D., was a graduate student in the Department of Anatomy and Neurosciences (not the Department of Physiology), Medical College of Pennsylvania and Hahnemann University, at the time of the misconduct. INQUIRIES For further information, contact: Acting Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN NOT-97-007 FULL-TEXT ************************************* NIH NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL RESEARCH TRAINING GRANTS NIH GUIDE, Volume 26, Number 16, May 16, 1997 P.T. 34; K.W. 0720005, 1014006 National Institutes of Health PURPOSE The National Institutes of Health (NIH) will award National Research Service Award (NRSA) Institutional Training Grants (T32) to eligible institutions to develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers in specified areas of biomedical and behavioral research. The purpose of the NRSA program is to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the Nation's biomedical and behavioral research agenda. Accordingly, the NRSA program supports predoctoral, postdoctoral, and short-term research training experiences. Predoctoral Training. Predoctoral research training must lead to the Ph.D. degree or a comparable research doctoral degree. Students enrolled in health-professional programs that are not part of a formal, combined program (e.g. M.D./Ph.D. or D.D.S./Ph.D.) and who wish to postpone their professional studies in order to gain research experience may also be appointed to an Institutional Research Training Grant. Predoctoral research training must emphasize fundamental training in areas of biomedical and behavioral sciences. Postdoctoral Training. Postdoctoral research training is for individuals who have received a Ph.D., an M.D., or a comparable doctoral degree from an accredited domestic or foreign institution. Research training at the postdoctoral level must emphasize specialized training to meet national research priorities in the biomedical and behavioral sciences. Research training grants are a desirable mechanism for the postdoctoral training of physicians and other health professionals who may have extensive clinical training but limited research experience. For such individuals, the training may be a part of a research degree program. In all cases, postdoctoral trainees should agree to engage in at least 2 years of research, research training, or comparable activities beginning at the time of appointment since the duration of training has been shown to be strongly correlated with post-training research activity. Short-Term Research Training for Health-Professional Students. Applications for Institutional Research Training Grants may include a request for short-term predoctoral positions reserved specifically to train medical or other health-professional students on a full-time basis during the summer or other "off-quarter" periods. Short-term appointments are intended to provide health-professional students with opportunities to participate in biomedical and/or behavioral research in an effort to attract these individuals into research careers. Short-term research training positions should last at least 2 months but must not exceed 3 months. Individual health-professional students selected for appointment should be encouraged to obtain multiple periods of short-term research training during the years leading to their degree. Such appointments may be consecutive or may be reserved for summers or other "off-quarter" periods. Since not all NIH institutes and centers support short-term research training positions applicants are strongly urged to contact the appropriate NIH institute representative, listed at the end of this announcement, before requesting short-term research training positions. 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, ~NRSA Institutional Research Training Grant~, is related to the priority area of human resource development. 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 202-783-3238). Applicant Eligibility Requirements Only domestic, non-profit, private or public institutions may apply for grants to support research training programs. 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. The research training program director at the institution will be responsible for the selection and appointment of trainees to receive NRSA support and for the overall direction of the program. Trainees appointed to the training program must have the opportunity to carry out supervised biomedical or behavioral research with the primary objective of developing or extending their research skills and knowledge in preparation for a research career. Trainee Eligibility Requirements Positions on NRSA institutional grants may not be used for study leading to the M.D., D.D.S., or other clinical, health-professional degrees except when those studies are a part of a formal combined research degree program, such as the M.D./Ph.D. Similarly, trainees may not accept NRSA support for studies which are part of residency training leading to certification in a medical or dental specialty or subspecialty, except when the residency program credits a period of full-time, postdoctoral research training toward board certification and the trainee intends to pursue a research career. Students enrolled in health-professional doctoral degree programs may receive support for short-term research training as described above. Additionally, health-professional students may interrupt their studies for a year or more to engage in an extended period of full-time research training before completing their professional degree. Trainees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the program. Within the 40 hours per week training period, research trainees in clinical areas must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. Citizenship. To be appointed to a training position supported by an NRSA research training grant, an individual must be a citizen or noncitizen national of the United States or must have been lawfully admitted for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or must be in possession of other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Predoctoral Trainees. Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at the postbaccalaureate level and enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their professional degrees are also eligible. Postdoctoral Trainees. Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D. or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.D.S., D.M.D., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D. Pharm., D.S.W., and Psy.D. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of training is acceptable. Short-Term Health-Professional Trainees. To be eligible for short-term predoctoral research training positions, health-professional students must have completed at least one quarter in a program leading to a clinical doctorate prior to participating in the program. Individuals matriculated in a formal research degree program, or those holding a research doctorate or masters degree or a combined health-professional/research doctorate are not eligible for short-term training positions. Within schools of pharmacy, only individuals who are candidates for the Pharm.D. degree are eligible for short-term positions. Mechanism of Support Institutional NRSA research training grants may be made for periods up to 5 years and are renewable. Awards within an approved competitive segment are normally made in 12-month increments with support for additional years based on satisfactory progress and the continued availability of funds. Trainee appointments are normally made in 12-month increments. No trainee may be appointed for less than 9 months during the initial period of appointment, except with the prior approval of the NIH awarding unit or when health-professional students are appointed to approved, short- term research training positions. No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Any extension of the total duration of trainee support at either the predoctoral or postdoctoral level requires approval by the director of the NIH Institute or Center that supports the award. Requests for extension must be made in writing by the trainee, endorsed by the director of the training program and the appropriate institutional official, and addressed to the director of the awarding component. The request must include a sound justification for an extension of the statutory limits on the period of support. Special Program Considerations The primary objective of the NRSA program is to prepare qualified individuals for careers that significantly impact the Nation~s research agenda. Within the framework of the program's longstanding commitment to excellence and projected need for investigators in particular areas of research, attention must be given to recruiting individuals from minority groups underrepresented nationally in the biomedical and behavioral sciences. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups. Other considerations relate to the duration of training and the transition of trainees to individual support mechanisms. Studies have shown that the length of the appointment to a training grant for postdoctoral trainees with health-professional degrees strongly correlates with subsequent application for and receipt of independent NIH research support. Program directors, therefore, should limit appointments to individuals who are committed to a career in research and plan to remain on the training grant or in some other type of research experience for a minimum of 2 years. It has also been shown that individuals who have been supported by an individual postdoctoral fellowship are more likely to subsequently apply for and receive NIH research support than are individuals who have received support only from a research training grant. Therefore, program directors should encourage trainees to apply for individual postdoctoral fellowships or mentored career development awards (K awards). During the review of training grants applications, peer reviewers will examine the training record to determine the average duration of training appointments for health-professional postdoctoral trainees and whether there is a record of transition to individual support mechanisms. Past studies have shown that trainees from programs oriented exclusively toward health professionals are less likely to subsequently apply for and receive research grant support than health professionals who train with postdoctoral researchers who have an intensive background in research. Programs located in clinical departments that focus on research training for individuals with an M.D. or other health-professional degrees should consider developing strong ties to basic science departments or modifying their program to include individuals with research doctoral degrees if such changes are consistent with the goals of the program. Applications should describe the basic science department's contribution to the research training experience and also indicate if both health professional trainees and trainees with research doctorates are included in the training program. Payback Provisions As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation only during their first 12 months of postdoctoral support. Additionally, the NIH Revitalization Act of 1993 specifies that the second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply: o Predoctoral trainees are not required to sign the payback agreement and do not incur a service payback obligation. o Postdoctoral trainees in the first 12 months of postdoctoral NRSA support must sign the payback agreement form (PHS form 6031) and will incur a period of service payback obligation equal to the period of support. o Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payback agreement form and will not incur a service payback obligation. o The 13th and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. Individuals who continue under that award for 2 years have fulfilled their obligation by the end of the second year. Service payback obligations can also be paid back by conducting health-related research or teaching averaging more than 20 hours per week of a full work year after terminating NRSA support. o Recipients must begin to undertake obligated service on a continuous basis within two years of NRSA support termination. 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 awarding component specifying the need for additional time and the length of the required extension. o Recipients of NRSA support are responsible for informing the NIH awarding component of changes in status or address. o For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the total amount of NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within 3 years beginning on the date the United States becomes entitled to recover such amount. o Under certain conditions, the Secretary, U.S. Department of Health and Human Services (or those delegated this authority) may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, the approving official may waive or suspend the payback obligation of an individual. o Officials at the awardee institution have the responsibility of explaining the terms of the payback requirements to all prospective training candidates before appointment to the training grant. Additionally, all trainees recruited into the training program should be provided with information related to the career options available to individuals who complete the program and whether the types of positions available are consistent with the nature of the training provided and, where applicable, whether those positions are likely to satisfy any outstanding service payback obligation. Trainee Reporting Requirements The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant at the beginning of the appointment period. Additionally, a completed Payback Agreement (PHS Form 6031) must be submitted for each trainee in their first twelve months of postdoctoral support. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure to submit the required forms in a timely manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Leave In general, trainees ma