From owner-sci-resources@net.bio.net Tue Jul 02 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-96-017 - V25(21) 06/28/96 Date: 3 Jul 1996 12:04:23 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 556 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4reg7n$60f@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA96017 CA-96-017 P1O1 *************************************** INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH NIH GUIDE, Volume 25, Number 20, June 21, 1996 RFA: CA-96-017 P.T. 34; K.W. 0715035, 0740000, 0745000, 0755015 National Cancer Institute Letter of Intent Receipt Date: August 30, 1996 Application Receipt Date: November 8, 1996 PURPOSE The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment Diagnosis and Centers (DCTDC), National Cancer Institute (NCI) invites research grant applications to conduct therapeutic clinical trials research employing new agents, concepts, or strategies for the treatment of cancer. This initiative is aimed at encouraging new clinical investigators who have not previously had independent grant funding to submit research applications in this area of research. 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), Investigator Grants for Clinical Cancer Therapy Research, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. Principal investigators should be new to the clinical research field and should not have been awarded a previous R01 or R29 grant. An important principle to remember is that the more extensive the prior independent research experiences, regardless of funding sources, the greater likelihood there will be diminished priority for award. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01) as its funding mechanism. 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 four years. The direct cost for the four year period may not exceed $500,000. The direct cost in any budget period may not exceed $150,000 (not including indirect costs for collaborating institutions). The anticipated award date is July 1997. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is contingent upon the continuing availability of funds for this purpose. This RFA is a one-time solicitation for new applications for award in FY 97. NCI encourages investigators who responded to the previous solicitation (RFA CA-95-012) to resubmit. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $2,000,000 in total costs per year for each of four years will be committed to fund applications submitted in response to this RFA. It is anticipated that ten new individual awards will be made. RESEARCH OBJECTIVES Background In the past year, a number of groups have expressed concern over the declining number of clinical investigators entering and remaining in academic research. Clinical investigators are a critical component in translating new therapeutic agents and modalities from the laboratory into the clinic. They must maintain a broad perspective and knowledge concerning clinical and basic sciences, while developing new cancer therapies that are hypothesis driven. They are highly interactive with basic and clinical researchers in related disciplines. This translational clinician is considered distinct >From the clinician who also has a PhD or equivalent training and concentrates on basic research or the clinician who participates in cancer research solely by entering patients on clinical trials. The Clinical Investigations Task Force of the National Cancer Advisory Board and a sub-committee of the American Association of Clinical Oncology (ASCO) have both been addressing the problem of the decreasing number of academic clinical investigators. One of the problems identified is the lack of suitable mechanisms for the training and funding of clinical oriented investigators involved in translating basic research into new cancer treatments. The traditional grants mechanisms (R01, R29) are under-utilized and often do not fit the needs of young clinical investigators for the support of clinical trials research. The R29 grant mechanism requires the investigator to devote at least 50 percent effort to a five year project and the yearly budget is limited to approximately $70,000. Most clinicians have major clinical and teaching responsibilities and it is impossible to support both the clinical and laboratory components needed within the budget limitations of an R29 grant. New clinical investigators often do not have the publication or research track record to be competitive for R01 grant support. Thus, very few clinical trial research applications are submitted by new clinical investigators. DCT would like to reverse this trend and encourage new clinical investigators, who have not previously received R01 or R29 grant support, to submit grant applications for the conduct of translational clinical trials research. Project Description The Cancer Therapy Evaluations Program encourages qualified clinical investigators to develop R01 grant applications for the conduct of cancer clinical trials research on new therapeutic agents and modalities. Grant applications must include clinical trials involving human subjects and designed to ultimately improve cancer survival. The clinical trials must have a strong rationale and be based upon preclinical data, preferably generated by the applicant or collaborators, that support the underlying hypotheses. New clinical therapeutic trials employing drugs (including differentiating agents), biologics (including cytokines, antibodies), vaccine strategies, radiation, or surgery whether used as a single agent/modality or in combination are appropriate. Laboratory studies to monitor patients or to study the mechanism of antitumor effect and resistance should be included. The laboratory studies should be in support of the clinical trial, such that their conduct leads to a greater understanding of the relationship of the therapy and biological changes in the patient or the mechanism of action of an anti-tumor response. Laboratory studies would include pharmacokinetic studies of cytotoxic, immune-modulating, differentiation-inducing, and/or targeted therapeutic agents or relevant pharmacodynamic correlative studies. Measurement of particular biological responses would also be desirable particularly when this information would be relevant to the interpretation of the success or failure of the therapy in individual patients on the clinical trial. It is expected that a significant level of effort, at least 25 percent, will be committed to the research project by the Principle Investigator. 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 must be included with the application. 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 4928 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 August 30, 1996, 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 is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is be sent to: Ms. Diane Bronzert Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 734 6130 Executive Boulevard MSC 7432 Bethesda, MD 20892-7432 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8866 FAX: (301) 480-4663 APPLICATION PROCEDURES The research grant application form PHS 398, (rev. 5/95) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.od.nih.gov. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. 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 number and title must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact 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: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Bethesda, MD 20852 (for express mail) Applications must be received by November 8, 1996. If an application is received after that date, it will be returned. 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. B. Special Instructions for the Completion of the PHS 398 Application "Just-in-Time" is an initiative of the National Institutes of Health (NIH) Extramural Reinvention Laboratory under the auspices of the National Performance Review and government-wide efforts to create a government that works better and costs less. JIT postpones the collection of certain information that currently must be included in all competing applications when submitted. The information for the applications with a likelihood of funding is submitted "just-in-time" for awards to be made. This delayed exchange of information significantly relieves the administrative burden for the 75 to 80 percent of applicants who will not receive an award. In addition, the information that is exchanged "just-in-time" for award will be current, rather than several months old as is currently the case (which often necessitates a request for updated information, e.g., for other support). In responding to the RFA, the following are specific instructions for sections of the PHS 398 application form (rev. 9/95) that should be completed differently from usual. Some sections are modified and others in the application do not need to be completed for the submission of the application but WILL be requested if your application receives a priority score in the fundable range. For all other items in the application, follow the usual instructions on pages 5-20 of the PHS 398 booklet. FACE PAGE (Form AA) - The title and number of the RFA must be typed in line 2a. Failure to do so could result in delayed processing of your application such that it may not reach the review committee in time for review. FORM DD - PAGE 4 - DETAILED BUDGET PAGE FOR INITIAL BUDGET PERIOD Enter direct costs only for the following: o Personnel, Patient Care Costs, Alterations-Renovations - Complete these sections as instructed in the PHS 398 booklet. o Consultant Costs - Itemize only if proposed consultant costs exceed $10,000 or if a consultant is identified as key personnel. o Equipment - Itemize only individual equipment items in excess of $10,000. o Supplies - Itemize (a) all animal costs and (b) any individual supply item which costs more than $10,000. If animals are involved, state their unit purchase and care costs. Enter total animal costs and supply costs on separate lines. o Travel and Other Expenses - Itemize any expense category that exceeds $5,000. FORM EE - PAGE 5 - BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD Do not complete the categorical budget table on form page 5 in the PHS 398 (rev. 5/95). Only the requested total direct costs for each year and total direct costs for the entire proposed period of support should be shown. Begin the budget justification in the space provided, using continuation pages as needed. Budget Justification o List the name, role on project and percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person based on his/her role on the project and proposed level of effort. o Identify all consultants by name and organizational affiliation and describe the services to be performed. o Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project that would be considered unusual for the scope of research. No specific costs for items or categories should be shown. o Indirect costs will be calculated at the time of the award using the institution's actual indirect cost rate. Applicants will be asked to identify the indirect cost exclusions prior to award. o If consortium/contractual costs are requested, provide the percentage of the subcontract total costs (direct and indirect) relative to the total direct costs of the overall project. The subcontract budget justification should be prepared following the instructions provided above. FORM FF - PAGE 6 - BIOGRAPHICAL SKETCH - A biographical sketch is required for all key personnel, following the modified instructions below. Do not exceed the two page limit for each person. o Complete the education block at the top of the form page. o List current position(s) and those previous positions directly relevant to the application. o List selected peer-reviewed publications directly relevant to the proposed project, with full citation. o Provide information on research projects completed and/or research grants participated in during the last 5 years which are relevant to the proposed project. Title, principal investigator, funding source, and role on project must be provided. Please state whether you have previously served as Principal Investigator on a R01 or R29 grant. FORM GG - PAGE 7 - OTHER SUPPORT - Do not complete. Updated information will be requested by NCI staff from only those applicants being considered for funding. SPECIFIC INSTRUCTIONS - RESEARCH PLAN (Booklet Pages 15-19) - Applications in response to this RFA should be concise and shorter than regular grant applications. Items a-d may not exceed 20 pages in total. a. Specific Aims - In one page or less, list in priority order, the broad, long-range objectives. Describe concisely and realistically the hypothesis to be tested and what the specific research described in this application is intended to accomplish. b. Background and Significance - In two to three pages, use this section to describe (a) how the proposed research will contribute to meeting the goals and objectives of the RFA; and, (b) explain the rationale for the selection of the general methods and approaches proposed to accomplish your specific aims. c-d. Progress Report/Preliminary Studies, Research Design and Methods - In seventeen pages or less, complete as instructed on pages 20-21 of the PHS 398 booklet with the modification that the clinical protocol(s) and up to six publications, manuscripts submitted or accepted for publication, patents, or invention reports can be included in the Appendix (see below). Investigator may use this section to address the following: o preliminary studies pertinent to the application; o rationale and hypothesis for the clinical trial and laboratory studies; o general methods that will be utilized; provide specific details for those techniques which are unique or where a significant departure from a generally accepted technique is important for reviewers to know; o outcome measures that will be used to assess the success or failure of each set of experiments (include statistical analyses for laboratory and clinical studies); o plans for the rigorous data management and verification of research data; o potential pitfalls in the experimental design and alternative studies that will be done if the proposed experiments fail. Items e-f - Human Subjects, Vertebrate Animals - Complete as described on pages 17-18. State clearly the plans for early detection of and protection against adverse effects on human subjects. Documentation for the composition of the proposed study population in terms of gender and racial/ethnic group together with a rationale for its choice must be included in the Human Subjects section (see page 30 for format). APPENDIX (Page 19) - Up to 10 publications, manuscripts submitted or accepted for publication, patents, and invention reports may be provided. Clinical protocol(s) must be included in this section. CHECKLIST (Page 19) - Do not submit the checklist page. For amended applications, applicants must complete the block in the upper right corner of the face page to indicate the previous grant number. A completed checklist will be required prior to award. Questions regarding these instructions may be directed to the program staff listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness and by the NCI for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the Request for Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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 review by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies using the following review criteria: 1. Importance, timeliness, and clinical merit of the clinical trials. 2. Quality of data supporting the proposed clinical trial. 3. Scientific and technical merit of the proposed laboratory studies. 4. Relevance of the proposed laboratory studies to the clinical trials. 5. Research training and clinical qualifications of the Principal Investigator and staff in the area of the proposed research. 6. Availability and quality of the resources necessary to perform research. 7. Quality of data verification and management plans and statistical analysis. The initial review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. They will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications considered by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit; (b) availability of funds; and (c) programmatic priorities. Preference will also be given to clinical investigators who are new to this research area. Letter of Intent Receipt Date: August 30, 1996 Application Receipt Date: November 8, 1996 Review by National Cancer Advisory Board: May 1997 Anticipated Award Date: July 1997 INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged. The program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding general programmatic issues and chemotherapy agents to: Ms. Diane Bronzert, Program Director Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 734 6130 Executive Boulevard MSC 7432 Bethesda, MD 20892-7432 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: BRONZERD@DCT.NCI.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Eileen M. Natoli 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. 256 FAX: (301) 496-8601 Email: NATOLIE@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 the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241 and 285) and administered under HHS grants 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 routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Tue Jul 02 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-96-011 - V25(21) 06/28/96 Date: 3 Jul 1996 12:03:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1023 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4reg6j$5uj@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA96011 CA-96-011 P1O1 *************************************** COOPERATIVE FAMILY REGISTRY FOR EPIDEMIOLOGIC STUDIES OF COLON CANCER NIH GUIDE, Volume 25, Number 20, June 21, 1996 RFA: CA-96-011 P.T. 34; K.W. 0715035, 0785055, 0780030 National Cancer Institute Letter of Intent Receipt Date: August 6, 1996 Application Receipt Date: September 20, 1996 PURPOSE The Extramural Programs Branch, Epidemiology and Biostatistics Program, Division of Cancer Epidemiology and Genetics, National Cancer Institute (NCI), and the Early Detection Branch, Division of Cancer Prevention and Control, NCI invite Cooperative Agreement applications from investigators to participate, with the assistance of the NCI, in a network of organizations constituting a Cooperative Family Registry for Colorectal Cancer Studies (CFRCCS). The purpose of the proposed awards is to stimulate a cooperative effort to: 1. Collect pedigree information, epidemiological data and related biological specimens from patients with a family history of colon cancer in order to provide a registry resource for interdisciplinary studies on the etiology of colon cancer, and to encourage translational research in this area. 2. Identify a population at high risk for colon cancer that could benefit from new preventive and therapeutic strategies. 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), Cooperative Family Registry for Colon Cancer Studies, relates 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 and foreign non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Support of this program will be through the cooperative agreement (U01), an assistance mechanism in which substantial NCI scientific and programmatic involvement with the recipients during performance of the planned activity is anticipated. Under the cooperative agreement, the NIH intention is to support and/or stimulate the recipient's activity by involvement in, and otherwise working jointly with, the awardee in a partner role, but is not to assume direction, prime responsibility, or a dominant role in the activity. This mechanism is appropriate because the participant organizations will be responsible for defining their scientific objectives and approaches. Substantial NCI involvement is anticipated in order to facilitate interaction between the groups, to coordinate their efforts with other ongoing initiatives, and to promote the knowledge and use of this resource among the scientific community. Details of the responsibilities, relationship and governance of the study to be funded under cooperative agreements are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA should not exceed four years. The anticipated award date is April 1, 1997. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. Awards and level of support depend on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This RFA is a one-time solicitation. At this time, the NCI has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE Approximately $3 million in total costs per year for four years will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that two to five awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES Background Recommendations from a panel of scientists convened at the first conference on "Genetic Epidemiology of Cancer: an Interdisciplinary Approach", published in 1994, stated that a resource should be created to support the identification of families with increased occurrence of cancer with a recognized genetic component, to initiate the coordinated collection of pertinent clinical and epidemiologic data and biological specimens, and to establish a much needed resource for interdisciplinary and translational studies on the etiology of cancer. As new knowledge about cancer molecular genetics increases at an extremely rapid pace, these family registries would create and preserve a resource that would otherwise be lost, provide the infrastructure for population-based and collaborative studies that cannot easily be supported through traditional investigator-initiated research grants, and provide the opportunity to design appropriate intervention and therapeutic approaches for the high-risk populations so identified, as well as developing appropriate genetic counseling strategies for this at-risk population. This proposed cooperative agreement, responding to the above and to further specific recommendations from a recent workshop on "Genetic Screening for Colorectal Cancer", is intended to complement and expand previous family registry initiatives by creating a Cooperative Family Registry for Colorectal Cancer Studies (CFRCCS). Colorectal cancer is the third most common malignancy in the world. In the U.S. over 157,000 people are diagnosed with colorectal cancer each year, and 60,500 die of this disease annually. Mortality from colorectal cancer has changed very little in the last 50 years, and early detection is one of the most important factors for a good prognosis. It is estimated that approximately 10 to 15 percent of colorectal cancer is familial, and that one person in 200 may carry high-risk alleles of the genes causing inherited colorectal cancer. It is also estimated that the same genes may be involved in as much as 13 percent of sporadic tumors. Currently, germline mutations of several identified genes have been shown to be responsible for hereditary forms of colorectal cancer. Familial adenomatous polyposis (FAP) is a rare inherited condition leading to colorectal cancer. Even though the clinical characteristics of this disease were first described more than one hundred years ago, its molecular bases are only now being elucidated. Germline mutations of the APC gene seem to be responsible for this condition. The APC gene was mapped to the long arm of chromosome 5 in 1991. The APC gene is involved as well in the etiology of Gardner syndrome, a variant of familial polyposis in which desmoid tumors, osteomas, and other neoplasms occur together with multiple adenomas of the colon and rectum. Hereditary non-polyposis colorectal cancer (HNPCC) is one of the most common cancer susceptibility syndromes. It is characterized by dominant transmission and high penetrance. Families with HNPCC are delineated as having at least three relatives in two generations with colorectal cancer, with one diagnosed before age 50. These families also have elevated incidence of cancers of the endometrium, stomach, urinary tract, and other sites. Four different mismatch repair genes have been implicated recently in the etiology of HNPCC. Mutations in hMSH2, mapping to chromosome 2 and to the gene that encodes a human homologue of the E.coli mismatch repair protein mutS, account for the majority of cases of HNPCC. Mutations in hMLH1, homologue of the bacterial repair gene mutL, map to chromosome 3 and are also found in families with HNPCC. Mutations in hPMS1 and hPMS2, encoding homologues of the bacterial MutL and yeast PMS1, are thought to account for a minor fraction of HNPCC. In families with HNPCC a mutation of one gene copy is inherited, and a somatic mutation in the second copy is associated with a particular form of genetic instability termed microsatellite instability or replication error (RER). Microsatellite instability is caused by slippage of one strand relative to the other, and consequent increases of oligonucleotides containing repetitive sequences. Such defects are usually repaired by mismatch repair genes. The implication of this observation is that lack of mismatch repair causes the accumulation of mutations at increased rate in key oncogenes or tumor suppressor genes, thus speeding the development of malignancy. In addition, the observation of microsatellite instability in a variety of sporadic tumors seen in the syndrome suggests that somatic mutations, or low penetrance germline mutations causing mismatch repair defects, may be the cause of a significant portion of many types of cancers seen in the general population. The ongoing identification of additional susceptibility genes for colorectal cancer will soon make it possible to fully characterize hereditary cancer patients and high-risk relatives and provide them with an assessment of their cancer risk using molecular techniques. However, much knowledge needs still to be acquired and a higher grade of technical development achieved, before this strategy becomes applicable to the general population. It is an NCI commitment to reduce morbidity and mortality from malignancies, and a currently pressing issue is how the recent advances in colon cancer genetics and genetic epidemiology can be translated into public health strategies aimed at early detection. An important strategy is predictive testing through the use of molecular genetic assays to detect inherited cancer-predisposing mutations in clinically healthy individuals. Appropriate and timely translation of discoveries in molecular genetics into the reduction of morbidity and mortality for inherited forms of cancer through predictive testing will entail seeking the answer to a series of immediate and specific scientific questions which are beyond the laborious task of gene identification. The CFRCCS will facilitate high-priority multidisciplinary investigations necessary to complete the translational research process that will lead to the application of predictive testing for colorectal cancer susceptibility in high-risk populations, and to the design of effective prevention and therapeutic approaches. Such investigations may include, but are not limited to: mutational analysis to determine the spectrum of significant mutations versus rare polymorphisms; the study of the penetrance of these inherited mutations (age-dependent risk of being affected in mutation carriers), their expressivity (organ and tissue affected) and the clinical consequences (natural history of the disease); the study of gene penetrance, gene-gene interaction, and the interaction with factors influenced by lifestyle, such as dietary, and reproductive and hormonal factors; and the study of the ethical, legal, and social implication of genetic testing for colorectal cancer and associated syndromes. Research Goals and Scope The purpose of this RFA is to stimulate a collaborative effort for the establishment of a cooperative family registry for epidemiologic and interdisciplinary studies of individuals at high risk for colorectal cancer. A population-based approach, utilizing resources such as the SEER registries, or other cancer registries, is strongly encouraged. Limited funding will be available for pilot or feasibility studies using the family registry resources, to provide preliminary data for the subsequent submission of regular research grant applications in epidemiologic, prevention or basic biological research. Many different approaches to colon cancer research will be able to take advantage of family registry resources, as new knowledge and molecular tools become available. The existence of the CFRCCS would enhance the cost-effectiveness of: (1) the identification and follow-up of high-, intermediate-, and low-risk individuals for the purpose of preventive intervention; (2) the evaluation of the effectiveness of optional treatment strategies as they become available; (3) molecular epidemiology studies generating and testing etiologic hypotheses; and (4) the integration of laboratory studies on cancerogenic mechanisms with epidemiologic and genetic data for colorectal cancer. Current epidemiologic studies of familial colorectal cancer are limited by the feasibility and expense of collecting a sufficient number of high- and intermediate-risk families to define the genetic heterogeneity of the familial disorder. Moreover, as new statistical approaches become available to explore the interaction between genetic and environmental factors in the etiology of colorectal cancer, the collection of appropriate epidemiologic data on exposure to potential risk factors in high-risk families becomes extremely important. Other limitations are the lack of archival or fresh-frozen tissue specimens and blood samples, and the difficulty in collecting and validating clinical and epidemiologic data, and the lack of population-based controls. The CFRCCS will enable participant organizations to: identify individuals with a family history of colorectal cancer and various familial syndromes that include colorectal cancer and propose the best sampling design to this end; collect and define the related pedigrees; and collect clinical (tumor type, stage at diagnosis, hormonal evaluation, etc), epidemiologic (age at diagnosis, sociodemographic status, risk factors, etc.), and other relevant baseline and follow-up data (such as treatment history) to correlate with pedigree information. Support for collection of population-based controls may be included. Support for the collection, processing, and storage of related biological specimens, including at a minimum blood samples and paraffin blocks, must be included. Support for molecular genetic analyses of participants may be included. The CFRCCS is intended to assist investigators funded through other sources by providing data and biological specimens to be used for multidisciplinary and translational studies on the etiology of colorectal cancer and associated syndromes, and to identify a population at high-risk that could be prospectively followed for the purpose of prevention and treatment-oriented research. The applicants should demonstrate the capability and willingness to develop common protocols during the first six months of the award, including but not limited to: o ascertainment of colorectal cancer patients and families o epidemiologic, family history, and clinical data collection. validation, and management (statistical support) o collection and banking of biological specimens o follow-up for outcomes, recurrence, and mortality o appropriate genetic counseling of patients and family members The awardees should demonstrate capability and willingness to provide the data so collected to a central NCI coordinating database. The awardees will provide to the research community at large pedigree information, epidemiological data, and biological specimens for high- priority research studies. It is anticipated that prioritization of the research study proposals requesting access to the CFRCCS' resources will be made by an Advisory Committee (AC), and will be based on scientific validity criteria established by the Steering Committee (SC) as described below: The NCI will help to coordinate and promote this process through the Program Coordinator's membership in these committees. SPECIAL REQUIREMENTS A number of issues need to be discussed by the applicants to promote the development of a CFRCCS site. Applicants are encouraged to submit and describe their own ideas on the best scientific approach to meet the goals of this RFA. Applicants must propose detailed plans for how to organize the CFRCCS in the most cost- effective and scientifically sound manner, as well as their plans for establishing collaborations. Advantages and disadvantages of the proposed approaches should be discussed. Plans should describe resources, including the availability of probands and a reasonable estimate of the expected availability and quality of pedigree information and related epidemiological data and biological specimens. Each application must have an Operation Core for statistical and logistic support, capable of providing the necessary coordination for specimen and data collection, and functioning as a central facility at the applicant's institution for management and storage of data and specimens. Appropriate data retrieval and data management procedures and quality control methods for the epidemiological and clinical data. Procedures for quality control for specimen collection and storage and pathology review should be described. Applicants must address coordination of quality control among awardees with regard to collection and storage of data and specimens and state their willingness to cooperate with other awardees in developing policies for quality control and to share data and protocols with other awardees, as well as providing the collected data to a central NCI coordinating database. The Operation Core should be adequately described, including the facilities for data collection and storage and specimen storage, as well as the investigators' experience in this area. The applicants must provide details on appropriate facilities and biohazard precautions and comply with the applicable Federal, State, and Local regulations, laws and finances in the operation of the Registry. Information on the nature of the data collected at baseline and follow-up should be provided. Examples of data forms, epidemiologic questionnaire, medical records and abstracting procedures, and software that may be appropriate for the use of the CFRCCS should be included in the appendix. Methods should be proposed to retrieve and establish an inventory of biological specimens, such as blood, fresh-frozen tissue, tissue blocks and slides. Procedures for quality control of specimens, storage and pathology review should be described. Applicants should discuss their rationale for the selection of families and controls to be included in the CFRCCS site, should document their ability to recruit a sufficient number of participants, must be able and willing to interact effectively with each other, and should state their willingness to follow the common "core" protocols that will be developed and agreed upon during the first six months of the registry. The applicants should demonstrate the capability for developing common protocols including, but not limited to: o ascertainment of colorectal cancer families; o epidemiologic and clinical data collection, validation and management (statistical support); o collection and banking of biological specimens (blood and tissues); o follow-up for cancer treatment, recurrence, mortality, and core epidemiologic data; o counseling of family members on risk and possible preventive or therapeutic interventions. The applicants must state a willingness and should discuss their approach to cooperate with the SC and the AC in evaluating research proposals utilizing the CFRCCS resources, and to abide by the decisions of the AC in prioritizing such proposals, after final approval by the SC based on data and specimen availability. The applicant should provide the name and qualifications for the second investigator from his/her Institution to be designated as a member of the SC. As the principal investigators of the funded applications and one designee will be members of a SC which will meet three times in the first year and twice in each subsequent year, travel funds for these meetings should be set aside as a budget item. As the AC will meet with the SC once a year, funds should also be included to support travel by one member of the AC to one SC meeting once a year, plus any additional travel anticipated for AC members. Study Organization and Function The overall structure of the CFRCCS will consist of two to five funded Institutions (awardees) that are governed and coordinated through the SC. Each awardee unit will be composed of one funded site, an Operation Core at the funded site, and a P.I. providing the scientific and administrative leadership for the unit and serving as the Head of the Operation Core. The overall function of the CFRCCS is to promote multidisciplinary and translational research in the framework of studies in the genetic epidemiology of colorectal cancer, by serving as a national resource to the research community at large. Requests for specimen and data >From the awardees and their collaborators will be reviewed, prioritized by the AC, and approved by the SC along with all other requests from investigators in the research community at-large. The Terms and Conditions of Award, below, will be included in all awards issued as a result of this RFA. It is critical that each applicant include specific plans for responding to these terms. Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (UO1), 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 activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Coordinator. 1. Awardee Rights and Responsibilities Awardees will have primary rights and responsibilities to define projects and approaches and to plan and conduct the project, including: o The Awardee's PI will participate as a permanent member of the SC and designate a second investigator from his/her institution to be a permanent member of such committee; o The Awardee will work together with the other Awardees through the SC to establish the CFRCCS operating policies, uniform core protocols, and quality control procedures for specimens and data. The Awardee will be required to accept and implement the common policies and procedures approved by the SC; o The Awardee must agree to provide access to both specimens and data to investigators both within and outside the awardee's institutions, based on the prioritization of the research proposals set by the AC and final approval by the SC. The Awardee will abide by the decisions of the SC based on recommendations from the AC; o The Awardee will retain custody of, and have primary rights to, the data developed under this awards, subject to the Government rights of access consistent with current HHS, PHS, and NIH policies; o Each awardee will need to implement and comply with the common study protocols as established by the SC, and in compliance with the agreed upon timetable, but additional elements could be appended by individual institutions to address issues of unique interest or capabilities in each center; o The Awardee must provide a semi-annual progress report to the EPB, DCEG, NCI, and a copy to the chairperson of the SC, in a format that is compatible with the annual progress report of the other awardees. Information on the operation of the CFRCCS site as well as performance and progress on pilot studies are to be included; o Collaboration among awardees in the reporting of findings originated from this initiative is encouraged. Collaborative publications among awardees and NCI are anticipated; Immediately after the notification of award, the successful applicant should also provide the name of one scientist not affiliated with his/her Institution as a potential member of the SC. In addition, each applicant should provide the names and qualifications of two scientists not affiliated with his/her Institutions as potential members of the AC. Letters of commitment and CV's from the potential members of the AC and SC should be attached. 2. National Cancer Institute Staff Responsibilities The NCI Program Coordinator will be designated by the Chief, Extramural Programs Branch, EBP, DCEG, NCI. He/she will have substantial scientific-programmatic involvement during conduct of this activity through participation in the SC and AC activities. The Program Coordinator will provide technical assistance, advice and coordination, assure that the SC and the AC follow the NIH guidelines on conflict of interest issues, and play a critical role in promoting the availability and use of the registry. The role of the Program Coordinator is to assist and facilitate, but not to direct, the activities supported by the CFRCCS. The NCI Program Coordinator will: o Lend his/her expertise and overall knowledge of the NCI- and NIH-sponsored colorectal cancer research to facilitate the selection of scientists non-affiliated with the awardees institutions who are to serve in the AC and SC; o Serve as liaison, helping to coordinate activities among the awardees; act as a liaison to the NCI, and as an information resource about extramural multidisciplinary cancer research activities in the area of genetics and molecular epidemiology of colorectal cancer; o Attend the SC meetings as a voting member, assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action; o Serve as liaison between the SC and the AC, attending AC meetings in a non-voting liaison member role, and lending a degree of continuity between AC and SC, as the ad-hoc AC composition may change depending on the expertise required to review the submitted research proposals; o Serve on subcommittees of the SC and the AC as required; o Assist in the monitoring of field data collection, helping to ensure standardization in methods across study centers; and assist in the interpretation and reporting of the collected information. This will be necessary because of the complexity of this multisite structure, requiring an high degree of coordination and program involvement to achieve adequate standardization of procedures; o Assist by providing advice in the management and technical performance of the investigation. The Program Coordinator will serve as scientific liaison between the awardees and other program staff at NCI who have previous experience in the establishment of cancer registries and tumor bank; o Assist in promoting the availability of the CFRCCS resources to the scientific community at large, for use in translational and prevention-oriented colorectal cancer research, as stated in this RFA goals. The NCI reserves the right to reduce the budget, to withhold support, and to suspend, terminate or curtail a study or an award in the event of substantial shortfall in specimen accrual, data reporting, inadequate quality control in specimens or clinical data collection, non-adherence to biohazard precautions, refusal to carry out the recommendations of the SC and AC, or substantial failure to comply with the terms of the award. 3. Collaborative Responsibilities a. Steering Committee The SC will serve as the main governing board of the CFRCCS (see "Terms and Conditions of Award"). The SC membership includes the NCI Coordinator, the P.I., one other investigator from each awarded cooperative agreement, and one research scientist with expertise in the field of multidisciplinary and translational colorectal cancer research who is not affiliated with any of the awardees institutions. This last member will be appointed by mutual agreement of the NCI Coordinator and the PI's. Additional members can be added by action of the SC. Other appropriate NCI staff may need to attend the SC meetings if their expertise is required, to participate in specific discussions. The SC will be responsible for reviewing the plans for development of the CFRCCS proposed in the individual applications of the awardees. This Committee will develop uniform procedures for data collection and management, tissue collection, processing and distribution, and quality control. The SC will develop the criteria for review and prioritization of research proposals requiring the use of the CFRCCS's resources. The NCI Program Coordinator will assist the other members of the SC in all these tasks. Furthermore, the NCI Program Coordinator will serve as the scientific liaison between the awardees and the other program staff of NCI who have previous experience in the establishment of family cancer registries. Awardees will be required to accept and implement the common guidelines and procedures approved by the SC. The first meeting of the SC will be called by the NCI Program Coordinator shortly after award of the cooperative agreements. At this initial meeting, the Committee will elect a Chairperson (someone other than the Program Coordinator). The Chair of the SC is responsible for coordinating the Committee's activities, for preparing meeting agendas, and for scheduling and chairing meetings. The Program Coordinator attends and participates in all meetings of the SC, and should be informed of any major interactions. Subsequent meetings will be planned and scheduled at this meeting. Two additional meetings will be held during the first year of operation, and there two meetings a year thereafter, one of which with the AC. The meetings will be held in Bethesda or at another convenient location. Accordingly, respondents must request sufficient funds within the submitted budgets to accommodate travel expenses for the P.I. and his designee. Subcommittees will be established by the SC as it deems appropriate. The SC will be responsible for confirming the availability and accessibility of specimens and data for use by investigators requesting the use of the registry resources for approved research proposals. In no circumstance will the SC overturn the recommendation of the AC, except when specimens and/or data are not available. The SC will select members for the AC. The SC, in the conduct of all business matters, will pay particular attention to conflict of interest issues, and will bring such matters to the attention of the AC and of the NCI Program Coordinator. b. Advisory Committee The AC is responsible for reviewing, evaluating and approving research proposals submitted by investigators from the research community at large, as well as from the awardees, for the use of the registry resources. A recommendation in terms of priority of the proposed research will be provided to the SC after review of each application. The AC will meet with the SC at least once yearly, at one of the two scheduled SC meetings. Accordingly, respondents must request sufficient funds in the submitted budget to accommodate travel expenses of the selected AC members. The AC will be composed of senior scientists with expertise in multidisciplinary and translational research in the field of colorectal cancer, which may include epidemiologists, laboratory researchers, clinicians, or other expertise that the SC deems needed. The membership of the AC may vary, depending on the scientific areas of the proposed research to be reviewed and evaluated, and temporary "ad hoc" members can be selected if additional expertise is required for specific applications. All members will be selected by the SC (two nominee per awarded site). The tenure of the permanent AC members will be of two years. The Program Coordinator will function as a non-voting liaison member between the AC and the SC, and attend the AC meetings. The members of the AC will evaluate all research proposals (those of the awardees as well as from the research community at large) proposing to utilize the CFRCCS resources, according to the evaluation and review criteria provided by the SC. The review of proposals can be conducted either in person, by conference call or by mail at least twice a year. All reviews will be conducted according to rules pertaining to the conduct of reviews for NIH grants, contracts, and cooperative agreements and to the review criteria developed by the SC, paying special attention to issues of conflict of interest, whether real or apparent. The AC will provide a recommendation to the SC as to the priority of the proposed research. The AC Chair will forward the final recommendation to the SC. The AC will provide advice to the SC on scientific matters as appropriate and needed. 4. Arbitration Procedures Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between the award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members, one selected by the SC (without the vote of the Program Coordinator) or by the individual awardee in the event of an individual disagreement, a second member selected by the NCI, 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 regulation 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 subpopulation must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies of the policy from these sources or >From the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 6, 1996, 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, the participating institution(s), 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. The letter of intent is to be sent to Dr. Daniela Seminara, at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the 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. A number of issues need to be discussed by the applicants to promote the development of a CFRCCS site. Applicants are encouraged to submit and describe their own ideas on the best scientific approach to meet the goals of this RFA. Applicants must propose detailed plans for how to organize the CFRCCS in the most cost-effective and scientifically sound manner, as well as their plans for establishing collaborations. Advantages and disadvantages of the proposed approaches should be discussed. Plans should describe resources, including the availability of probands and a reasonable estimate of the expected availability and quality of pedigree information and related epidemiological data and biological specimens. Each application must have an Operation Core for statistical and logistic support, capable of providing the necessary coordination for specimen and data collection, and functioning as a central facility at the applicant's institution for data and specimens management and storage. Appropriate data retrieval and data management procedures and quality control methods for the epidemiological and clinical data. Procedures for quality control for specimen collection and storage and pathology review should be described. Applicants must address coordination of quality control among awardees with regard to collection and storage of data and specimens, state their willingness to cooperate with other awardees in developing policies for quality control and to share data and protocols with other awardees, as well as providing the collected data to a central NCI coordinating database. The Operation Core should be adequately described, including the facilities for data collection and storage and specimen storage, as well as the investigators' experience in this area. The applicants must provide details on appropriate facilities and biohazard precautions and comply with the applicable Federal, State, and Local regulations, laws and finances in the operation of the Registry. Information on the nature of the data collected at baseline and follow-up should be provided. Examples of data forms, epidemiologic questionnaire, medical records and abstracting procedures, and software that may be appropriate for the use of the CFRCCS should be included in the appendix. Methods should be proposed to retrieve and establish an inventory of biological specimens, such as blood, fresh-frozen tissue, tissue blocks and slides. Procedures for quality control of specimens, storage and pathology review should be described. Applicants should discuss their rationale for the selection of families and controls to be included in the CFRCCS site, should document their ability to recruit a sufficient number of participants, must be able and willing to interact effectively with each other, and should state their willingness to follow the common "core" protocols that will be developed and agreed upon during the first six months of the registry. The applicants should demonstrate the capability for developing common protocols including, but not limited to: the ascertainment of colorectal cancer families; the collection of epidemiologic, family history and clinical data and their validation and management; the collection and banking of biological specimens; follow-up of the identified population for cancer treatment, recurrence, mortality, and core epidemiologic data; and the appropriate counseling of family members on risk and possible preventive or therapeutic interventions. The applicants must state a willingness and should discuss their approach to cooperate with the SC and the AC in evaluating research proposals utilizing the CFRCCS resources, and to abide by the decisions of the AC in prioritizing such proposals, after final approval by the SC based on data and specimen availability. The applicant should provide the name and qualifications for the second investigator from his/her Institution to be designated as a member of the SC. As the principal investigators of the funded applications and one designee will be members of a SC which will meet three times in the first year and twice in each subsequent year, travel funds for these meetings should be set aside as a budget item. As the AC will meet with the SC once a year, funds should also be included to support travel by one member of the AC to one SC meeting once a year, plus any additional travel anticipated for AC members. Of the funds provided by this RFA, at least 90% of the total cost proposed in each application must be directed to the basic CFRCCS activities (accrual of families, data and specimen collection, management, and retrieval). Up to 10% of the total cost, or $50,000 per year (whichever is smaller, starting from the second year of the cooperative agreement), can be requested for pilot or feasibility studies utilizing the family registry resources. Applicants seeking these funds for pilot studies utilizing the CFRCCS resources, should document their ability to conduct colorectal cancer research and document any of their ongoing work in this area. The research hypothesis, background and rationale and design of the pilot study should be described as part of the research plan, keeping within the allowed page limits. The SC and the AC will review the pilot studies proposed in the application in response to this RFA even if the studies received approval under peer review. Moneys for pilot studies will be restricted until the AC gives these pilot studies high priority ratings, and the requested specimens and/or data are available and have been released by the SC. The review of these pilot studies will occur along with the review and prioritization of other requests submitted by investigators in the research community at large. The pilot studies will begin no sooner than year two of the cooperative agreement. However, if the AC does not rank the pilot project as a high priority, a new pilot study that is rated as high priority by the AC can be substituted. Pilot/feasibility studies should be designed to obtain sufficient data to form the foundation for future RO1 research grant applications, to help identify new areas where additional investigations are warranted, and to promote interdisciplinary and translational colorectal cancer research. The RFA label available in the application form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the number and title of the RFA must be typed on line 2a of the face page of the application and YES must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies in one package to the Division of Research Grants at the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892 It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the application will be reviewed in competition with other applications received on or before the designated receipt date. Applications must be received by September 20, 1996. If an application is received after that date, it will be returned to the applicant without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS General 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 of evaluation of a study. Other considerations, such as the importance and timeliness of the proposed study, access to patients, and multidisciplinary and translational nature of the studies, will be part of the evaluation criteria. Review Method Upon receipt, applications will be reviewed for completeness by the DRG 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 for further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance to the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria Applicants are encouraged to submit and describe their own ideas about how to best meet the goals of the cooperative study and their specific protocols, and are expected to address issues identified under SPECIAL REQUIREMENTS of the RFA. The review group will assess the scientific merit of the protocols and related factors, including: o extent to which the application addresses the goals and objectives of the RFA; o adequacy of the applicant's plans for addressing the special scientific and technical program requirements presented in the RFA; o merit of the proposed activities and organizational plans for implementing the CFRCCS; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o time availability of the PI and staff; o availability of, and access to, a suitable patient population; o adequacy of existing physical facilities and resources of the applicants' Institutions; o demonstrated ability and willingness to carry out common protocol; o adequacy of plans for effective cooperation and coordination among participating awardees and the NCI Program Coordinator, as per Special Requirements of the RFA; o adequacy of proposed number of study subjects to be recruited and plans for inclusion of minorities; o adequacy of proposed data to be collected and procedures for data handling, managing, and preparing for analyses; o evidence that appropriate steps have been taken to insure the rights of human subjects; o adequacy of the proposed plan to provide counseling appropriate for the CFRCCS activities o the scientific and technical significance or originality of the proposed pilot studies in the field of translational colorectal cancer research. It is to be noted that the review of this part of the grant application will be given much less weight relative to the review of the registry facilities, procedures and epidemiological data base, as no more than 10 percent of the total cost, or up to $ 50,000 per year for three years (whichever number is smaller, starting the second year of the Cooperative Agreement) may be requested for these studies. The review group will also examine the proposed budget and will recommend an appropriate budget and period of support for each application that is recommended for further consideration. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. AWARD CRITERIA The earliest anticipated date of award is April 1, 1997. The following will be considered for making funding decisions: o scientific and technical merit of the proposed project as determined by peer review; o adequate effort to represent the minority groups in the population sampled; o availability of funds; o program balance among research areas. INQUIRIES Written and telephone inquiries concerning the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct inquiries regarding programmatic and scientific issues to: Dr. Daniela Seminara Extramural Programs Branch National Cancer Institute Executive Plaza North, Suite 535 6130 Executive Boulevard MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 Email: seminard@epndce.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Catherine Blount Grants Management Branch National Cancer Institute 6120 Executive Boulevard Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 262 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393, Cancer Cause and Prevention Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Unless otherwise noted all PHS grants policies apply. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Jul 02 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 21, pt. 1of1, 28 June 1996 Date: 3 Jul 1996 11:24:07 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 459 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4reds7$pfi@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960628 V25N21 P1O1 ************************************ X-comment: RFAS described: CA-96-011, CA-96-016, CA-96-017, PAR-96-060, PA-96 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.06.28 NIH GUIDE - Vol. 25, No. 21 - June 28, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NCI POLICY ON SMALL SHORT-TERM GRANTS National Cancer Institute INDEX: CANCER NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 09/20/96 ************************************************ COOPERATIVE FAMILY REGISTRY FOR EPIDEMIOLOGIC STUDIES OF COLON CANCER (RFA CA-96-011) National Cancer Institute INDEX: CANCER $$INDEX R2 09/15/96 ************************************************ MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM (RFA CA-96-016) National Cancer Institute INDEX: CANCER $$INDEX R3 11/08/96 ************************************************* INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH (RFA CA-96-017) National Cancer Institute INDEX: CANCER $$INDEX P1 ********************************************************** ACUTE INFECTION AND EARLY DISEASE RESEARCH NETWORK (PAR-96-060) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX P2 ********************************************************** MODERN VACCINES FOR MYCOSES AND MEASLES (PA-96-061) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. 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 GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NCI POLICY ON SMALL SHORT-TERM GRANTS NIH Guide, Volume 25, Number 21, June 28, 1996 P.T. 34; K.W. 1014006 National Cancer Institute The National Cancer Institute (NCI) advises potential grant applicants that acceptance by the NCI of small research project grants (R03) will be considered only in response to an NCI announcement specifically inviting such applications. Unsolicited grant applications in areas not covered by the announcements proposing preliminary short-term research projects limited in time and amount of support will not be accepted by the NCI. Currently, three specific program announcements inviting small grant (R03) applications are ongoing annually but as of this date will have newly assigned receipt dates of September 15, January 15, and May 15 annually. o PAR-95-091, Cancer Prevention and Control Research Small Grant Program, NIH Guide, Vol. 24, No. 33, Sept 22, 1995. o PAR-95-077, Small Grants Program for Cancer Epidemiology, NIH Guide, Vol. 24, No. 26, July 21, 1995. o PAR-95-023, Small Grants for Therapeutic Clinical Trials of Malignancies, NIH Guide, Vol. 24, No. 3, January 27, 1995. INQUIRIES Written, telephone and email requests for additional information concerning this notice may be directed to: Vincent T. Oliverio, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 600 Bethesda, MD 20892 Telephone: (301) 496-9138 Email: oliveriv@dea.nci.nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN CA-96-011 FULL-TEXT ************************************** COOPERATIVE FAMILY REGISTRY FOR EPIDEMIOLOGIC STUDIES OF COLON CANCER NIH Guide, Volume 25, Number 21, June 28, 1996 RFA AVAILABLE: CA-96-011 P.T. 34; K.W. 0715035, 0785055, 0780030 National Cancer Institute Letter of Intent Receipt Date: August 6, 1996 Application Receipt Date: September 20, 1996 PURPOSE The Division of Cancer Epidemiology and Genetics, National Cancer Institute (NCI), and the Division of Cancer Prevention and Control, NCI invite cooperative agreement (U01) applications from investigators to participate, with the assistance of the NCI, in a network of organizations constituting a Cooperative Family Registry for Colorectal Cancer Studies (CFRCCS). Approximately $3 million in total costs per year for four years will be committed to fund between two and five applications submitted in response to this RFA. The purpose of the proposed awards is to stimulate a cooperative effort to: (1) collect pedigree information, epidemiological data and related biological specimens from patients with a family history of colon cancer in order to provide a registry resource for interdisciplinary studies on the etiology of colon cancer, and to encourage translational research in this area; and (2) identify a population at high risk for colon cancer that could benefit from new preventive and therapeutic strategies. 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, Cooperative Family Registry for Epidemiologic Studies of Colon Cancer, relates 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. Dr. Daniela Seminara Division of Cancer Epidemiology and Genetics National Cancer Institute Executive Plaza North, Suite 535 - MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 Email: seminard@epndce.nci.nih.gov $$R1 END ************************************************************ $$R2 BEGIN CA-96-016 FULL-TEXT ************************************** MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH Guide, Volume 25, Number 21, June 28, 1996 RFA AVAILABLE: CA-96-016 P.T. 34, FF; K.W. 0715015, 0785140, 0745027, 0745070, 0755015 National Cancer Institute Letter of Intent Receipt Date: August 7, 1996 Application Receipt Date: September 25, 1996 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements to the Minority-Based Community Clinical Oncology Program (Minority-Based CCOP). New community and research base applicants and currently funded programs are invited to respond to this Request for Applications (RFA). This issuance of the Minority-Based CCOP RFA seeks to build on the strength and demonstrated success of the program over the past six years by continuing the program to support community participation in cancer treatment and cancer prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI) and utilizing the Minority-Based CCOP network for conducting NCI-assisted cancer prevention and control research. It is anticipated that up to ten Minority-Based CCOP awards will be made. Up to $2.7 million in total costs per year for three years will be set aside to fund applications submitted 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 setting priority areas. This RFA, Minority-Based Community Clinical Oncology Program, 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. Otis W. Brawley, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-D 6130 Executive Boulevard, MSC-7340, Bethesda, MD 20892-7340 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: ob6g@nih.gov $$R2 END ************************************************************ $$R3 BEGIN CA-96-017 FULL-TEXT ************************************** INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH NIH Guide, Volume 25, Number 21, June 28, 1996 RFA AVAILABLE: CA-96-017 P.T. 34; K.W. 0715035, 0740000, 0745000, 0755015 National Cancer Institute Letter of Intent Receipt Date: August 30, 1996 Application Receipt Date: November 8, 1996 PURPOSE The Division of Cancer Treatment, Diagnosis, and Centers (DCTDC), National Cancer Institute (NCI) invites research project grant (R01) applications to conduct therapeutic clinical trials research employing new agents, concepts, or strategies for the treatment of cancer. This initiative is aimed at encouraging new clinical investigators who have not previously had independent grant funding to submit research applications in this area of research. Approximately $2,000,000 in total costs per year for four years will be committed to fund applications submitted in response to this Request for Applications (RFA). It is anticipated that ten new individual awards will be made. 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, Investigator Grants for Clinical Cancer Therapy Research, 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. Ms. Diane Bronzert Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 734 - MSC 7432 Bethesda, MD 20892-7432 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: BRONZERD@DCT.NCI.NIH.GOV $$R3 END ************************************************************ $$P1 BEGIN PAR-96-060 FULL-TEXT ************************************* ACUTE INFECTION AND EARLY DISEASE RESEARCH NETWORK NIH Guide, Volume 25, Number 21, June 28, 1996 PA AVAILABLE: PAR-96-060 P.T. 34; K.W. 0715008, 0765033, 0745000 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 1, 1996 Application Receipt Dates: October 11, 1996; September 1, 1997; and September 1, 1998 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious application in response to Program Announcements. Program Announcements identify areas of ongoing research emphasis for the NIAID. The Division of AIDS (DAIDS), solicits applications to study the pathogenesis of acute/early HIV-1 infection in adults and to evaluate the impact of therapeutic interventions at this early stage of HIV-1 infection on HIV disease. This initiative will fund, through cooperative agreements (U01), five to six HIV-1 Acute Infection and Early Disease Research Units. Each awarded unit will perform innovative, integrated, investigator- initiated pathogenesis and clinical research on acute and early (up to 12 months post initial infection) HIV-1 infection. Each awarded unit will be part of the Acute Infection Research and Early Disease Research Network. The multi-site format (Network) is required to enroll sufficient numbers of these hard-to-identify patients for study. 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, Acute Infection and Early Disease Research Network, is related to the priority area of HIV infection. 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. Carla B. Pettinelli, M.D., Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C-14 - MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-0700 FAX: (301) 402-3171 Email: cp22n@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-96-061 FULL-TEXT ************************************** MODERN VACCINES FOR MYCOSES AND MEASLES NIH Guide, Volume 25, Number 21, June 28, 1996 PA AVAILABLE: PA-96-061 P.T. 34; K.W. 0740075, 0715103, 1002045 National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to Program Announcements. Program Announcements identify areas of ongoing research emphasis for the NIAID. The purpose of this PA is to stimulate research on selected emerging and re-emerging diseases for which new or improved vaccines are needed. For the mycoses, the goal is to identify and characterize antigens that induce a protective immune response for coccidioidomycosis, histoplasmosis, blastomycosis, and cryptococcosis. For measles, the goal is to develop safe, new measles vaccines that are highly efficacious when administered in early infancy and that will aid in the control and eventual eradication of measles. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of"Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Modern Vaccines for Mycoses and Measles, is related to priority area of immunization-infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dennis M. Dixon, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-06 6003 Executive Boulevard - MSC 7630 BETHESDA, MD 20892-7630 Telephone: (301) 496-7728 FAX: (301) 402-0508 Email: dd24a@nih.gov $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Tue Jul 02 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-96-060 - V25(21) 06/28/96 Date: 3 Jul 1996 12:04:21 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 739 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4reg7l$612@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR96060 PAR-96-060 P1O1 ************************************* ACUTE INFECTION AND EARLY DISEASE RESEARCH NETWORK NIH GUIDE, Volume 25, Number 20, June 21, 1996 PA NUMBER: PAR-96-060 P.T. 34; K.W. 0715008, 0765033, 0745000 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 1, 1996 Application Receipt Dates: October 11, 1996; September 1, 1997; September 1, 1998 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to Program Announcements (PA). Program Announcements identify areas of ongoing research emphasis for the NIAID. In this PA, The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), solicits applications to study the pathogenesis of acute/early HIV-1 infection in adult humans, and to develop and evaluate the impact of therapeutic interventions at this early stage of HIV-1 infection on HIV disease. The goal of this initiative is to build a network of three to five HIV-1 Acute Infection and Early Disease Research Units through cooperative agreements (U01) during the first year, with additional units funded over the next several years as this emerging area of science matures. Each awarded unit will perform innovative, integrated, investigator-initiated pathogenesis and clinical research on acute (i.e, within one month post initial infection) and early (i.e., up to 12 months post initial infection) HIV-1 infection and will be part of the Acute Infection and Early Disease Research Network (AIEDRN). The multi-unit format (Network) is required to enroll sufficient numbers of these hard-to-identify patients for study. 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, Acute Infection and Early Disease Research Network, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. While foreign organizations are not eligible to apply, domestic organizations may include foreign components. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the cooperative agreement (U01), an "assistance" mechanism in which substantial NIH scientific and/or programmatic involvement is anticipated. 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. Cooperative agreements may include a combination of academic, non-profit research, and commercial organizations; applications that include collaborations with domestic or international organizations with access to larger numbers of people with acute infection and early HIV disease are strongly encouraged. RESEARCH OBJECTIVES Background Approximately 40,000 individuals are newly infected with HIV in the United States each year. Nonetheless, acute HIV infection is an under-diagnosed entity because it is often asymptomatic and because risk behavior associated with HIV infection is not identified. Acute infection is characterized by high levels of viral replication/dissemination to lymphoid tissues and immunologic activation. Observations from several small cohorts suggest that: (a) the concentration of HIV circulating in the blood (viral load) reaches a peak in the first two to four weeks of HIV infection and subsequently declines, and (b) the CD4+ T cell count of acutely infected individuals declines precipitously during the first days of HIV infection, however this rapid decline reverses itself, with a subsequent rebound in the CD4+ T cell count. Individuals with high levels of plasma HIV-1 RNA within six months from seroconversion experience more than tenfold increase in the risk for AIDS development, suggesting that inadequate suppression of viremia during the acute infection may be a critical factor in disease progression. The identification of both host and viral factors that influence the early establishment of a chronic HIV reservoir will facilitate the development, selection and administration of treatment and prevention modalities. Antiviral and/or immunological interventions during acute/early infection may have a great impact on the rate of disease progression and survival in HIV+ individuals. Preliminary results of a placebo controlled European- Australian study of ZDV are promising as CD4+ lymphocytes counts were higher in individuals receiving ZDV. Because of the difficulties associated with identifying individuals at this stage of infection, there have been few studies to analyze the associated viral and immunological changes as well as the effect of therapeutic interventions. Scope of Research This initiative will support innovative, integrated pathogenesis and clinical research for acute (up to one month post initial infection) and early (up to 12 months post initial infection) HIV-1 infection in adult humans. It will support single-unit and multi-unit clinical research and conduct in-depth studies of HIV pathogenesis and factors that influence response to interventions. The treatment strategies will be based on state-of-the-art concepts of early disease pathogenesis. The goal of this initiative is to build a network of three to five HIV-1 Acute Infection and Early Disease Research Units through cooperative agreements (U01) in the first year. Each unit will comprise basic and clinical scientists coordinated under the direction of a single Principal Investigator, and each unit will be part of the Acute Infection and Early Research Disease Network. Unlike many other major NIH cooperative research projects, the structure of the groups and funding are not linked to a specific experiment or clinical trial. Thus this mechanism has the potential for considerable flexibility in resource allocation which will facilitate the rapid testing of hypotheses about the pathogenesis of HIV-1 infection and early phase clinical trials of promising treatments of acute/early HIV infection. The multi year nature of a program announcement provides additional and necessary flexibility to allow the support for the scientific capability to expand and keep pace, as warranted, with this emerging, rapidly developing and high priority area of HIV-related research. In order to address these scientific needs, each unit should: o identify, accrue and retain acute/early HIV-1 positive individuals for pathogenesis studies and clinical trials. This requires strong linkages with and intense screening from unique referral sources such as Sexually Transmitted Diseases (STD) Clinics, emergency rooms, blood banks, and primary care centers, as well as close collaboration with centers and investigators studying existing natural history cohorts. The projected enrollment in the application should be at least 30 to 50 patients per year. Of the total number of subjects, a minimum of 10 to 15 subjects per year should be acutely infected, i.e., within one month post initial infection. Applicants may include studies on ways to improve detection and recruitment of new infected individuals. o conduct independent and collaborative (both through the Network and with outside investigators) studies of the in vivo pathogenesis of early HIV disease. o evaluate and optimize therapeutic interventions in small, focused clinical studies; perform extensive virologic and immunologic evaluation that will provide new insights into the pathogenesis of acute/early HIV infection and the efficacy of therapeutic approaches. The identification and use of existing resources (such as the Centers For AIDS Research, CFAR) should be maximized. The banking and storage of specimens for later analyses and for use in collaboration with investigators outside the network is encouraged. o have the potential capability of supporting, through participation in the Network activities, multi-unit evaluation (Phase I/II and Phase II clinical studies) of novel therapeutic interventions for acute infection and/or early HIV disease. The Network will include the awarded units' clinical sites and laboratories. In order to facilitate interpretation of data across the network, central quality assurance and data management of the laboratories can be provided by the Division of AIDS as needed. The Network activities will be coordinated by a Steering Committee formed by the Unit Principal Investigators. The Network serves to facilitate information exchange, foster collaboration and coordinate activities to minimize duplication. Additionally, the Network should have the capability and flexibility to conduct multi-unit clinical trials involving a larger number of patients (Phase II studies) as scientific opportunities become available. These studies may also require international collaboration. In summary, the primary objective of this PA is to conduct intense pathogenesis research and single- and multi-unit early phase clinical intervention studies into acute infection and early HIV disease. SPECIAL REQUIREMENTS Terms and Conditions of Award A. Applicability. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used by the NIAID to award research projects involving (1) clinical trials, (2) prevention, education and control studies, and (3) epidemiological studies in excess of $500,000 direct cost per year at a single institution or in the aggregate for studies proposing multi-institution collaborative arrangements submitted either as subcontracts to a single application or as separate applications shall be a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIAID scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. For single applications, the dollar limit excludes indirect costs of any subcontracts that are reported as a direct cost on the application budget page summary. Under the cooperative agreement, the NIAID purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the study will be shared among the awardees and the NIAID Program Officer or designee. Under the cooperative agreement, a relationship will exist between the award recipient(s) and the NIAID in which the performers of the activities (1) are responsible for the requirements and conditions described below and (2) agree to accept program assistance from a named NIAID Program Officer in achieving project objectives. Failure of an awardee to meet the performance requirements, including these special terms and conditions of award, or significant changes in the level of performance, may result in a reduction in budget, withholding of support, or suspension and/or termination of the award. B. Awardee Rights and Responsibilities The awardee is responsible for: 1. Research design and protocol development, including definition of objectives and approaches, planning, implementation, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results. 2. Establishing with the other Principal Investigators a mandatory AIEDRN Steering Committee to facilitate information exchange, foster collaboration and coordinate activities to minimize duplication. The Steering Committee should designate a single Protocol Chairperson for each multi-unit clinical trial protocol within the research plan and define core data collection strategies, methods and cross-study analyses. 3. Functioning as the scientific coordinator for protocols (Protocol Chairpersons) and assuming responsibility for developing protocols and monitoring study performance for their protocols. All proposed protocols will be submitted by the Protocol Chair through the Principal Investigator to the NIAID Program Officer for review. Multi-unit clinical studies will be submitted to the NIAID Program Officer for review and approval, subject to negotiation with the awardees. 4. Implementing the core data collection strategy and methods for multi-unit studies and cross-study analyses collectively decided upon by the Steering Committee. For each study involving multiple institutions, it is the responsibility of each awardee/site to ensure that data will be collected and submitted in a timely way following such procedures as agreed to by the Steering Committee. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population. 5. Establishing mechanisms for internal quality control and monitoring. Awardees are responsible for ensuring the accurate and timely assessment of the progress of studies, including development of procedures to ensure that data collection and management are: (a) adequate for quality control and analysis; (b) for clinical trials, as simple as appropriate in order to encourage maximum participation of clinicians and other providers and study subjects and to avoid unnecessary expense; and (c) sufficiently staffed across the participating institutions. 6. Preparing and submitting interim progress reports, when requested, to the NIAID Program Officer including, as a minimum, summary data on performance of multi-unit studies. The Steering Committee may require additional information on multi-unit studies >From the individual awardees/sites. Such reports are in addition to the annual awardee noncompeting continuation progress reports. 7. Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects. 8. Cooperating in the reporting of the study findings. The NIAID will have access to and may periodically review all data generated under an award. Where warranted by appropriate participation, plans for joint publication with NIAID of pooled data and conclusions, are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIAID staff will apply in all cases. C. NIAID Staff Responsibilities It is expected that the dominant role and prime responsibility for the activity will reside with the awardee(s) for the project as a whole. However, specific tasks and activities will be shared among the awardee(s) and the NIAID Program Officer and/or Scientific Coordinator(s). The Scientific Coordinator(s) will be the contact for all facets of the scientific interaction with the awardee(s), while the Program Officer will be the contact for issues such as administration and budget. As required for the coordination of activities and to expedite progress, the NIAID Program Officer may designate additional scientific coordinator(s) to provide advice or assistance to the awardee on specific scientific, technical or management issues. The NIAID Program Officer shall retain overall programmatic responsibility for the award(s) and will clearly specify to the awardee(s) the name(s) and role(s) of any such additional individuals and the lines of reporting authority. NIAID Extramural Program staff responsibilities will include: 1. Interacting with the Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include: (a) regular communications with the Principal Investigator and staff, (b) periodic site visits for discussions with awardee research teams, (c) observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters, as well as (d) attendance at and participation in Steering Committee and other meetings. The NIAID retains, as an option, periodic external review of progress. 2. For multi-unit protocols, convening the first meeting of and subsequent participation in the Steering Committee that oversees study conduct. The NIAID Program Officer will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees. 3. Serving as a resource with respect to ongoing NIAID activities that may be relevant to the research to facilitate compatibility and avoid unnecessary duplication. 4. Substantial assistance in the design and coordination of research activities for awardees including: a. Assisting by providing advice on the management and technical performance of the investigations. b. Providing access to and use of, when appropriate, reagents and assays, and other resources available through NIAID contractors and awardees. c. Technical advice and assistance with meeting FDA requirements for investigational drugs. d. For multi-unit protocols, through participation on the Steering Committee and with the agreements of the Principal Investigator(s), the NIAID Program Officer may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results. e. Reviewing and approving multi-unit clinical trial protocols to insure that they are within the scope of peer review and for adequacy of safety, human subjects, and representation of women and minorities, as required by Federal regulations. The NIAID Program Officer will monitor protocol progress, and may request that a protocol be closed to accrual for reasons including: (1) accrual rate insufficient to complete study in a timely fashion; (2) accrual goals met early; (3) poor protocol performance; (4) patient safety, human subjects, and women/minority recruitment concerns; (5) study results that are already conclusive; and (6) emergence of new information that diminishes the scientific importance of the study. The NIAID will not permit further expenditure of NIAID funds for a study after requesting closure (except for patients/subjects on-study and final data analysis and reporting). f. Reviewing and providing advice regarding the establishment of mechanisms for quality control and study monitoring for multi-center clinical trials. 5. Making recommendations for continued funding based on: (a) overall study progress, including study subject and/or data accrual; (b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with terms of award and reporting requirements); and/or (c) maintenance of a high quality of research which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements. D. Collaborative Responsibilities In addition to the interactions defined above, awardees and NIAID staff shall share responsibility for the following activities: 1. Steering Committee. A Steering Committee will have primary responsibility to facilitate information exchange, foster collaboration and coordinate activities to minimize duplication. For multi-unit clinical trials the committee will establish scientific priorities, develop (through appropriate designees) common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient/subject accrual, coordinate and standardize data management and cooperate on the publication of results. Major scientific decisions regarding the core data of multi-unit clinical trials will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIAID Program Officer and will provide periodic supplementary reports upon NIAID request. The Steering Committee will be composed of all Principal Investigators and, as deemed necessary, co-investigators and the NIAID Program Officer (or designee). An initial meeting of the Steering Committee will be convened early after award by the NIAID Program Officer. The final structure of the Steering Committee will be established at the first meeting. The NIAID Program Officer or designee will have voting membership on the Steering Committee and, as appropriate, its subcommittees. The Steering Committee usually will meet at least twice yearly. A Chairperson, other than the NIAID staff, will be selected by vote of the members. The Chairperson is responsible for coordinating the Committee activities, for preparing meeting agendas, and for scheduling and chairing meetings. E. IND Responsibilities For pilot studies, either the Principal Investigator or a pharmaceutical company may file an Investigational New Drug (IND) application to the United States Food and Drug Administration. The sponsor of the IND has responsibility for the conduct of trials under that IND, which includes adhering to applicable Federal regulations. For larger scale, multi center (Phase II) studies, NIAID will retain the option to cross-file or independently file an IND. Reports of data generated by the Network or any of its members required for inclusion in INDs and Clinical Brochures and for cross-filing purposes will be submitted by the Principal Investigator to the NIAID Program Officer upon request. Such reports will be in final draft form and include background information, methods, results, and conclusions. They will be subject to approval and revision by NIAID and may be augmented with test results from other Government-sponsored projects prior to submission to the appropriate regulatory agency. If NIAID holds the IND for a trial, a DAIDS Program Officer will monitor the safety of the treatment(s) being evaluated. Regulatory responsibilities will be the responsibility of NIAID. Standard procedures (e.g., registration of sites participating in clinical trials) will apply. Interim and final reports on toxicity for all sponsored clinical trials will be routinely provided to the DAIDS Scientific Coordinator. F. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee (with the NIAID member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the NIAID, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's rights 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 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 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 printed 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 August 1, 1996, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this PA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to contact NIAID program staff with any questions regarding the responsiveness of their proposed project to the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 9/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, 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 NIH policy ypdate on acceptance for review of unsolicited applications that requires more than $500,000 direct cost for any one year applies to applications to become part of the Acute Infection and Early Disease Research Network. The policy update was published in the NIH Guide, Vol. 25, No. 14, May 3, 1996, and is effective June 1, 1996. The policy requires the applicant to contact, in writing or by telephone, NIAID program staff (see INQUIRIES) when the application development process begins. If the NIAID is willing to accept assignment of the application for consideration of funding, the staff will notify the Division of Research Grants before the application is submitted. The applicant Principal Investigator must identify, in a cover letter sent with the application, the NIAID program staff member who agreed to accept assignment of the application. An application received without indication of prior staff concurrence and identification of that contact will be returned to the applicant without review. For purposes of identification and processing, mark "YES" in item 2 on the face page of the application and type in the PA number PA-96-060 and the title "Acute Infection And Early Disease Research Network". Applications that are not received as a single package on a receipt date or that do not conform to the instructions contained in PHS 398 (rev 9/95) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged not responsive and will be returned to the applicant. 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 could be included with the application. Applicants from an institution receiving government funds under Center for AIDS Research (CFAR), Strategic Program For Innovative Research On AIDS Treatment (SPIRAT), AIDS Clinical Trial Unit (ACTU), AIDS Vaccine Evaluation Unit (AVEU), DATRI, and CPCRA programs, should describe how these programs are integrated with the proposed studies, if applicable, and ensure that no scientific and budget overlap exists with the proposed project. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to Dr. Tingley at the address listed under INQUIRIES. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and for responsiveness by NIAID staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the PA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration 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 Allergy and Infectious Diseases Council. Review Criteria The review criteria for this PA are essentially the same as those for unsolicited research project grant applications, with specific areas of emphasis as noted below: A. Scientific, technical, or clinical significance and originality of the proposed research. B. Appropriateness and adequacy of the experimental approach and the methodology proposed to carry out the research, specifically including the adequacy and feasibility of the applicant's plans, methods, approaches and problem solving strategies to: (1) identify, screen and recruit into research projects individuals with acute or early HIV-1 infection; (2) follow subjects for the long term and retain them in research studies; and (3) perform and quality assure laboratory assays in support of these studies. The applicant should demonstrate the ability to enroll and retain an adequate number of subjects given the size of the unit and the proposed scientific agenda. The Network will be encouraged to develop mechanisms, when appropriate, to assure comparability and standardization of laboratory testing across Units. C. Qualifications and research experience of the Group Leader and key staff in the area of the proposed research, specifically: (1) the scientific ability and track record of the applicants in conducting research on the pathogenesis of HIV; (2) the experience, leadership scientific ability and administrative competence of the applicant for the development, implementation and management of pilot Phase I/II clinical trials; and (3) experience of the applicants in performing virologic, immunologic and pharmacologic assays in support of state-of-the-art pathogenesis research and AIDS clinical trials. D. Availability of necessary resources to conduct the research. E. Adequacy of the proposed means for protecting against adverse effects of the research upon humans, animals or the environment, where such are involved. F. In clinical studies, if there is inadequate representation of women and/or minorities in a study design AND this affects the potential to answer the scientific question(s) addressed, such inadequacy will be considered to be a weakness or deficiency in the study design. This weakness will be reflected in the priority score assigned to the project, unless a convincing justification is provided by the investigator to explain the inadequate representation. AWARD CRITERIA Funding decisions will be based on scientific and technical merit as determined by peer review, the availability of funds and program priority. However, the predominant criteria for funding priorities will be the scientific and technical merit of the applications. Schedule Application Receipt Date: September 1, 1996 Scientific Review Date: November 1996 Earliest Date of Award: February 1997 INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues: Michael Hedderman, R.N., M.P.H Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B30 Bethesda, MD 20892 Telephone: (301) 496-8214 FAX: (301) 480-4582 Email: mh33a@nih.gov Direct inquiries regarding scientific issues to: Carla B. Pettinelli, M.D. Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C14 Bethesda, MD 20892 Telephone: (301) 496-0700 FAX: (301) 402-3171 Email: cp22n@nih.gov Direct Inquiries regarding review issues: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C07 Bethesda, MD 20892 Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: dt15g@nih.gov Direct inquiries regarding fiscal matters and the special instructions for preparation of the grant application to: Linda Shaw Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B31 Bethesda, MD 20892-7610 Telephone: (301) 402-6611 FAX: (301) 480-3780 Email: ls15k@nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is (Sec. 93.856, Microbiology and Infectious Diseases Research, or No. 93.855 - Immunology, Allergy, and Transplantation Research, or both, as appropriate). Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Jul 02 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-96-016 - V25(21) 06/28/96 Date: 3 Jul 1996 12:03:53 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1180 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4reg6p$5v6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA96016 CA-96-016 P1O1 *************************************** MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH GUIDE, Volume 25, Number 20, June 21, 1996 RFA: CA-96-016 P.T. 34, FF; K.W. 0715015, 0785140, 0745027, 0745070, 0755015 National Cancer Institute Letter of Intent Receipt Date: August 7, 1996 Application Receipt Date: September 25, 1996 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), is continuing the established cancer control effort, which involves practicing oncologists who serve large minority populations in the NCI clinical trials program. The Community Oncology and Rehabilitation Branch (CORB), DCPC, invites applications >From domestic institutions with greater than 50 percent of new cancer patients from minority populations for cooperative agreements in response to this Minority-Based Community Clinical Oncology Program (Minority-Based CCOP) Request for Applications (RFA). Applicants for new and currently funded Minority-Based CCOPs are invited to respond to this RFA. The NCI clinical trials network provides support for clinical research in cancer centers, major university centers, and community programs. The purpose of this program is to support as a national resource those physicians involved in the care of minority cancer patients who are available for treatment and cancer prevention and control clinical trials research. The linkage of minority cancer patients to the current clinical trials network will also facilitate the transfer of new technology in treatment and cancer prevention and control practices to minority communities and their physicians. The Minority-Based CCOP will: (1) provide support for expanding clinical research in minority community settings; (2) bring the advantages of state-of-the-art treatment and cancer prevention and control research to minority individuals in their own communities; (3) increase the involvement of primary health care providers and other specialists in cancer prevention and control studies; (4) establish an operational base for extending cancer prevention and control and reducing cancer incidence, morbidity, and mortality in minority populations; and (5) examine selected issues in Minority-Based CCOP performance (e.g., patient recruitment, accrual, eligibility). This Minority-Based CCOP RFA seeks to strengthen the Minority- Based CCOP by: (1) continuing the program as a vehicle for supporting community participation in cancer treatment and prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI); (2) expanding and strengthening the cancer prevention and control research effort; (3) utilizing the Minority-Based CCOP network for conducting NCI-assisted cancer prevention and control research; and (4) evaluating on a continuing basis Minority-Based CCOP performance and its impact in the community. 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-Based Community Clinical Oncology Program, 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 institutions for cooperative agreements to continue the Minority-Based CCOP. Institutions, organizations and/or physician group applicants for the Minority-Based CCOP must have greater than 50 percent of newly diagnosed cancer patients from minority populations. Other eligibility requirements for new applicants and currently funded programs are described below. o An applicant may be a hospital, clinic, group of practicing physicians, health maintenance organization (HMO), or consortium of hospitals and/or clinics and/or physicians and/or HMOs that agree to work together with a Principal Investigator and a single administrative focus. o A university hospital that is the major teaching institution for that university AND has greater than 50 percent of new cancer patients from minority populations is eligible. o A military or Veterans Administration hospital may be included in an application as a nondominant member of a consortium led by a community institution. o Funded Cooperative Group Outreach Program (CGOP) participants are eligible to apply, but should state in the application that CGOP support will be relinquished if a CCOP award is received. o An unfunded nonuniversity clinical trials cooperative group member is eligible. o Funded Minority Satellite Supplement Program (MSSP) participants are eligible, but the application should include a statement that MSSP support will be relinquished if a Minority- Based CCOP award is received. Institutions and organizations NOT eligible to apply as a Minority-Based CCOP include: o A comprehensive, consortial, or clinical cancer center holding an NCI Cancer Center Support (CORE) grant. o A university hospital clinical trials cooperative group member funded by the Division of Cancer treatment, Diagnosis, and Centers (DCTDC), NCI. o Currently funded Community Clinical Oncology Programs (CCOPs). MECHANISM OF SUPPORT Support of this program will be through the Cooperative Agreement (U10), an "assistance" mechanism rather than an "acquisition" mechanism in which substantial NCI scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. The anticipated amount of the direct cost awards will range from $100,000 to $250,000. The total project period for applications submitted in response to this RFA may not exceed three years for new applicants and five years for applicants currently supported under this program. Currently supported applicants will be funded for three, four, or five years, depending upon priority score/percentile, review committee recommendations, and programmatic considerations. FUNDS AVAILABLE The NCI has determined that there is a continuing program need for community participation in cancer clinical research trials, both cancer treatment and prevention and control. Although this RFA is a one-time issuance, it is expected that a Minority-Based RFA will be published in the NIH Guide for Grants and Contracts in approximately three years, provided funds are available. It is anticipated that up to $2.7 million in total costs per year for three years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that up to ten awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Awards for research bases affiliated with Minority-Based CCOPs will be made through Cooperative Agreements under the Community Clinical Oncology Program RFA. NCI program staff will take into account demographic and geographic distributions of peer-reviewed and approved Minority-Based CCOPs in the final funding selection process. Multiple Minority-Based CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. RESEARCH OBJECTIVES A. Background The NCI clinical trials network has evolved over the past 30 years. The major NCI program initiatives supporting this network are the Clinical Cooperative Group Program, the Cancer Centers Program, and the Community Clinical Oncology Program (CCOP). Treatment and cancer prevention and control clinical trials research funded through these programs provides patients and their physicians with access to state-of-the-art cancer care management opportunities, and provides oncologists with a source of continuing education on innovations in cancer prevention and control interventions, diagnostic techniques, and treatment applications. One of the major efforts of NCI has been to design and implement program interventions to assure that patients treated in their own communities have access to the same quality of cancer care and the same technological advances available to patients treated in major centers. The CCOP, which was first initiated in 1983, has proven to be a successful model for bringing the benefits of clinical research to cancer patients in their communities by providing support for community physicians to enter patients on treatment research protocols. In addition to increasing patient accrual to treatment clinical trials, the CCOP stimulated many communities to organize their cancer activities and expedited the development of local-regional cancer programs. Increased numbers of physicians, hospitals, and other health care professionals participated in CCOP, accruing patients and meeting the same quality control standards as other members and affiliates. In 1987, the CCOP expanded the cancer prevention and control effort to include support for research in prevention, health promotion, smoking cessation, chemoprevention, treatment applications, continuing care and rehabilitation. With the development and implementation of cancer control research through the clinical trials network, opportunities exist for the implementation of effective preventive strategies for reducing cancer incidence, morbidity, and mortality. When compared to the general population, African Americans have an increased incidence of a number of malignancies and worse overall survival rates. Greater involvement in clinical trials research by Black, Hispanic, Asian-American, American Indian, and other racial/ethnic minority patients is needed if the advances in clinical research are to be extended to all groups, and the results of clinical trials generalizable to the entire population. In general, there has been limited participation in clinical trials research by minority cancer patients. Broader access to clinical research protocols is needed in order to develop and implement effective treatment and cancer prevention and control strategies in minority populations. Areas of research where minority involvement is especially needed include: cancer prevention and control interventions to improve screening and early detection practices; methodological research on ways to increase the educational awareness of individuals at risk for cancer; and studies of barriers to prevention and treatment applications. The Minority-Based CCOP has become an important part of these efforts. It links physicians caring for large numbers of minority patients to the NCI clinical trials network. The CCOP model has been an effective mechanism for facilitating the linkage of investigators and their institutions with the clinical trials network. The Minority-Based CCOP was initially approved by the NCI, Division of Cancer Prevention and Control Board of Scientific Counselors in January 1989. Implementation began in the fall of 1990. By 1992 the program was beginning to succeed in its goal of providing minority populations access to clinical trials. In the year ending 1995, there were ten programs in nine states and Puerto Rico involving approximately 45 hospitals (15 affiliates and 30 components) and over 200 physicians. While components of each of the current ten programs were accruing patients to clinical trials prior to funding, the grant and the Minority-Based CCOP structure has enabled these groups of physicians to double and, in some cases, triple previous accrual to treatment trials. Approximately 70 percent of Minority-Based CCOP patients entered on study during that period are from minority populations. In a recent study, 14.1 percent of all patients entered onto NCI sponsored treatment trials were from ethnic minorities. These ten programs contributed more than 10 percent of all minority accrual to NCI-sponsored cancer treatment trials. B. Goals and Scope The Minority-Based CCOP initiative is designed to: o Bring the advantages of state-of-the-art cancer treatment and prevention and control research to minority individuals in their own communities by having practicing physicians and their patients/subjects participate in NCI-approved cancer treatment and prevention and control clinical trials; o Provide a basis for involving a wider segment of the community in cancer prevention and control research and investigate the impact of cancer therapy and control advances in community medical practices; o Increase the involvement of primary health care providers and other specialists (e.g., surgeons, family practioners, urologists, gynecologists) with the Minority-Based CCOP investigators in cancer treatment and prevention and control research, providing an opportunity for education and exchange of information; o Facilitate wider community participation among racial/ethnic minorities, women, and other underserved populations in cancer treatment and prevention and control research approved by NCI; o Provide an operational base for extending cancer control and reducing cancer incidence, morbidity, and mortality in minority populations by accelerating the transfer of newly developed cancer prevention, early detection, treatment, patient management, rehabilitation, and continuing care technology to widespread community application; and o Examine selected issues in Minority-Based CCOP performance (e.g., patient recruitment, accrual, eligibility) and evaluate its impact in the community. Participating community programs (Minority-Based CCOPs) will be required to enter patients/subjects onto NCI-approved cancer treatment and prevention and control clinical trials through the research base(s) with which each Minority-Based CCOP is affiliated. Minority-Based CCOPs may relate directly to NCI for assistance and participation in selected cancer prevention and control protocols. Minority-based CCOP performance will be evaluated on a continuing basis by the NCI program director. Minority-Based CCOP applicants must demonstrate the potential for accessing appropriate cancer patients/subjects within their communities for participation in cancer treatment and prevention and control protocols provided by their research bases. SPECIAL REQUIREMENTS A. Terms and Conditions of Award The administrative and funding instrument used for this program is a cooperative agreement (U10), and anticipated assistance to awardees >From the NCI Program Staff will include: clarification of Minority-Based CCOP requirements; review of accrual to clinical trials; monitoring of community efforts to increase minority participation in clinical research; participation in protocol review; and discussions on the continuing needs of the program for enhancing Minority-Based CCOP performance. 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 partnership role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Staff. In addition to the customary programmatic and financial negotia- tions that occur in the administration of grants, the following terms and conditions pertaining to the scope and nature of the interaction between NCI and the investigators will be incorporated in the Notice of Award. The "Terms and Conditions of Award: Responsibilities of Awardees" and "Terms and Conditions of Award: Nature of NCI Staff Involvement" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; DHHS grant administration regulations 45 CFR 74; other DHHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms of award. B. Responsibilities of Minority-Based CCOP Awardees The awardee's programmatic responsibilities for the conduct of the research supported by this cooperative agreement are described in the INVESTIGATOR'S HANDBOOK, a Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment, Diagnosis, and Centers (DCTDC), National Cancer Institute, and the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES and any subsequent modifications of these documents. These documents are hereby incorporated by reference as term of award and are available on request from the Cancer Therapy Evaluation Program (CTEP) or the CORB/DCPC. 1. Protocols All protocols used by Minority-Based CCOPs must been reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), Division of Cancer Prevention and Control (DCPC) and/or the Protocol Review Committee (PRC), Division of Cancer Treatment, Diagnosis, and Centers (DCTDC), NCI, prior to implementation. To be eligible to receive credit for accrual to a research base protocol, the Minority-Based CCOP must have an affiliation agreement with the research base responsible to NCI for that protocol. The research base is responsible for the development and implementation of high-quality cancer treatment and control clinical trials and for evaluation of the results of such studies. 2. Research Base Affiliation(s) Each Minority-Based CCOP must affiliate with a national multispecialty cooperative group (research base) having a spectrum of cancer treatment and prevention and control clinical trials. A Minority-Based CCOP cannot affiliate with more than one national multispecialty cooperative group. Each Minority-Based CCOP may also affiliate with a maximum of four additional research bases. Note: A list of currently eligible research bases may be obtained >From the program official listed under INQUIRIES. If participation in the protocols of one group competes with that of another group with which the Minority-Based CCOP is affiliated, the Minority-Based CCOP must prioritize the protocols in order to avoid bias in the allocation of patients to competing protocols. Initial affiliations should be maintained for the duration of the funding cycle. When circumstances require changes in research base affiliations, prior written approval from the DCPC Program Director is required. 3. Accrual Patient accrual to clinical trials is expected to be reflective of the new cancer patient distribution of the participating physicians, that is, greater than 50 percent of new cancer patients from minority populations. As one measure of performance, it is expected that at least 10 percent of all new cancer patients for whom protocols are available will be placed on clinical trials by Minority-Based CCOP physicians. Each Minority-Based CCOP is required to accrue a minimum of 50 credits* per year to treatment clinical trials that have been approved by the PRC, DCTDC, NCI. For applicants whose specialty is pediatrics, the 50 credit minimum requirement may be waived for those applicants who are able to place a majority of their eligible patients on protocols. Each Minority-Based CCOP is eventually required to accrue a minimum of 50* credits per year to cancer prevention and control clinical trials that have been approved by the CCPRC, DCPC. Cancer prevention and control research should be intervention- oriented and may include such areas as cancer prevention, early detection, patient management, rehabilitation, and continuing care. New applicants for the Minority-Based CCOP award are required to accrue a minimum of 30 credits* in the first year of funding, 40 credits in the second year, and 50 credits thereafter in cancer prevention and control. The Minority-Based CCOP's ability to meet projected accrual goals to both cancer treatment and prevention and control clinical trials will also be assessed. Existing Minority-Based CCOPs undergoing competitive continuation are expected to accrue a minimum of 50 credits per year in cancer treatment and 50 credits per year in prevention and control. * Each protocol approved for CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. For example, each patient accrued to a typical Phase II or Phase III treatment protocol will count 1 credit; a NCI-designated high-priority protocol, 1.5 credits; and a childhood acute lymphocytic leukemia protocol, 2 credits. Cancer prevention and control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per subject entered. Cancer control protocols involving limited interventions will receive credit that is commensurate with the amount of data management effort required, usually an assignment of 0.3 or 0.5 credit per subject entered. 4. Quality Control The Minority-Based CCOP must establish and follow procedures for the assurance of data quality and quality control in accordance with research base guidelines and NCI policies. The Minority- Based CCOP must follow NCI-approved procedures developed by the research base for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected by the research base. The Minority-Based CCOP must follow policies developed by the research base and approved by the NCI for auditing the accuracy of scientific data submitted to them by the research base participants. 5. Data Management The Minority-Based CCOP must provide the DCPC Program Director with access to all data generated under this award for periodic review of data management procedures of the Minority-Based CCOP. Data must also be available for external monitoring, if required by NCI's agreement with other Federal agencies such as the FDA, and with NCI's agreements with pharmaceutical companies for the codevelopment of investigational agents. The awardees will retain custody of and primary rights to their data. 6. Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. 7. Organizational Changes Certain Minority-Based CCOP organizational changes must have the prior written approval of the DCPC Program Director. These include the addition/deletion of a participating physician, a health care professional other than a physician (who actively enters patients to cancer prevention and control trials), an affiliate, component, or research base. 8. Radiotherapy Equipment Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in protocols requiring radiation therapy, as required by the affiliated research base(s). 9. Monitoring Each Minority-Based CCOP must agree to periodic on-site audits by representatives of its research base(s), NCI, or an NCI-designee. Such on-site audits may include review of the following: use of investigational drugs; compliance with regulations for institutional review board IRB approval and informed consent (compliance with 45 CFR 46); compliance with protocol specifications; quality control and accuracy of data recording; and completeness of reporting adverse drug reactions. Research Base evaluation reports of such on-site audits will be reviewed by the Clinical Trials Monitoring Branch (CTMB), Cancer Therapy Evaluation Program (CTEP), DCTDC, and by the DCPC Program Director. In addition, NCI program and grants management staff will review protocol accrual, fiscal, and administrative procedures. All institutions participating or collaborating in the Minority- Based CCOPs on NCI-supported multi-institutional clinical trials must be in compliance with the monitoring standards established by the research base. These should include the following standards: o Medical records submitted in support of NCI multi- institutional trials must conform to usual standards for the maintenance of clear, accurate, and unambiguous medical records. White-outs on medical records are unacceptable. o If it is the usual and customary practice of a department, laboratory, clinic or office to prepare or issue official reports, then only that department, laboratory, clinic or office can change the report, and alterations of the medical record must be initialed and dated by the person making such alterations. For clinical progress notes, the change must be dated and initialled by the person making the change. Only one line should be placed through the initial entry, so that both the original entry and the change are legible. o The improper modification of important patient records will result in additional investigations by the NCI clinical Trials Monitoring Branch (CTMB) and may lead to suspension of accrual and funding. 10. Reporting Requirements Annual progress reports must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The inability of a Minority-Based CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension, or termination of the award. 11. Network Participation Minority-Based CCOPs are part of a national network for conducting cancer treatment and prevention and control clinical trials. As such, each Minority-Based CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the program and its impact in the community. 12. Patient/Subject Log Each Minority-Based CCOP may be asked to periodically maintain a new patient/subject log or minimal registry to include age, sex, race, ethnicity, insurance status, risk factors, primary site of cancer, stage of disease, and disposition for the potentially eligible patient/subject pool seen by the Minority-Based CCOP investigators. 13. Federally Mandated Regulatory Requirements Each Minority-Based CCOP must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. At a minimum, these include: o methods for assuring that each facility at which CCOP investigators are conducting clinical trials has a current, approved assurance on file with the Office for Protection from Research Risks (OPRR); that each protocol is reviewed by the responsible IRB prior to patient entry; and that each protocol is reviewed annually by the IRB so long as the protocol is active; o methods for assuring or documenting that each patient (or patient's parent/legal guardian) gives fully informed written consent to participation in a research protocol prior to the initiation of the experimental intervention; o a system for assuring timely reporting of all serious and unexpected toxicities to the Investigational Drug Branch, CTEP, DCTDC, according to DCTDC guidelines and/or to DCPC according to DCPC guidelines; and o implementation of DCPC/DCTDC requirements for storage and accounting for investigational agents provided under DCPC/DCTDC sponsorship. 14. Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgement of NCI support. C. Nature of NCI Staff Involvement 1. Protocol Review All protocols used by the Minority-Based CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), Division of Cancer Prevention and Control (DCPC) and/or the Protocol Review Committee (PRC), DCTDC, NCI, prior to implementation. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved or that has been closed (except for patients already on study). 2. Monitoring There will be periodic on-site audits of each Minority-Based CCOP by representatives of its research base(s), NCI, or an NCI-designee, such as DTCDC's current Clinical Trials Monitoring Service contractor. The DCPC and CTMB/CTEP will review and provide advice regarding mechanisms established for study monitoring, including the on-site auditing program. DCPC/CTEP and/or its contractor staff may attend the on-site audits conducted by the research base or its NCI designee as observers. 3. Data Management The DCPC Program Director will have access to all data generated under this award and will periodically review the data management procedures of the Minority-Based CCOPs. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the Food and Drug Administration (FDA). 4. Investigational Drug Management The Regulatory Affairs Branch (RAB), PMB, CTEP, DCTDC and Chemoprevention Investigational Studies Branch (CISB), Chemoprevention Research Program (CPRP), and DCPC staff will advise investigators of specific requirements and changes in requirements about investigational drug management that the FDA and NCI may mandate. 5. Organizational Changes The DCPC Program Director will review requests for certain organizational changes and provide written approval. These changes include the addition/deletion of a participating physician or other health professional entering patients/subjects in cancer prevention and control research in the Minority-Based CCOP, an affiliate, component, or research base. 6. Program Review The DCPC Program Director will review the annual progress report submitted by each Minority-Based CCOP. A suggested format will be developed by the DCPC Program Director for this purpose. The DCPC Program Director will review the progress of each Minority- Based CCOP through consideration of the Minority-Based CCOP annual report, program site visits, and reports from affiliated research bases. This review may include, but not be limited to, overall accrual credits, percent of available patients/subjects - placed on study, eligibility and evaluability of individuals entered on study, and timeliness and quality of data reporting. The inability of a Minority-Based CCOP to meet the performance requirements set forth in the Terms and Conditions of Award, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 7. Strategy Sessions The DCPC Program Director or designee will sponsor strategy sessions when indicated, attended by principal investigators from the Minority-Based CCOPs and appropriate DCPC/DCTDC staff. At these meetings, information relevant to the Minority-Based CCOPs will be reviewed and discussed, including such issues as overall Minority-Based CCOP performance and the science of current or proposed clinical trials. Data will be analyzed and the outstanding research questions established and prioritized into national research goals by Minority-Based CCOP investigators and the DCPC/DCTDC attendees. The principal investigators will have the primary responsibility for analyzing and prioritizing the research questions to be developed into clinical trials. The DCPC Program Director will also assist the Minority-Based investigators in exploring mutual interests in cancer prevention and control research. 8. Federally Mandated Regulatory Requirements The DCPC Program Director or designee and DCTDC staff will review mechanisms established by each Minority-Based CCOP to meet the Department of Health and Human Service (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. 9. Arbitration Process The Terms and Conditions of Award require that the DCPC Program Director make post-award administrative decisions related to program performance, programmatic decisions on scientific- technical matters, and funding adjustments. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the DCPC Program Director. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, DCPC. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which were published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 7, 1996, 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 is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Otis W. Brawley, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-D 6130 Executive Boulevard MSC-7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: ob6g@nih.gov APPLICATION PROCEDURES A. Preparation of Applications General instructions for the preparation of the cooperative agreement application are contained in the research grant application form PHS-398 (rev. 5/95). Responses to the instructions concerning "Human Subjects" verification must be provided when the application is initially submitted. Because the Terms and Conditions of Award (discussed in the SPECIAL REQUIREMENTS Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded program will be a competitive continuation and must include a progress report that, at a minimum, consists of the following: 1. A summary of prior Minority-Based CCOP activities/accomplish- ments, including: a clear presentation of yearly accrual over the funding period; accrual tables from previous annual progress reports; a summary of accrual to all cancer treatment and a summary of accrual to all cancer prevention and control protocols by gender and ethnicity; and progress in meeting DCPC's established accrual goals. 2. A plan for continuing to meet prevention and control accrual requirements, including plans for follow-up of subjects from the large prevention trials as well as plans for implementation of additional cancer control protocols. 3. Tables of the current budget and FTEs with a justification for any request for additional resources. 4. An evaluation of Minority-Based CCOP performance by affiliated research base(s). 5. A complete description of how the applicant has met the special cooperative agreement terms and conditions of the award. Both new and currently funded applicants should address the following: 1. Each applicant must demonstrate access to a population with greater than 50 percent of new cancer patients from minority groups and must include plans for recruiting women and minority participants. Data from hospital registries, admission, discharge, clinic, and billing records may be used to document the new minority cancer patient population available to the applicant organization and its physician participants. 2. Each applicant must delineate its catchment area. A map of the service area should be provided, designating counties or zip codes >From which approximately 80 percent of the patients will be drawn. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) that are not part of the application should be included. In describing the study population, a breakdown, by percentage of the gender and minority composition of the study population, should be provided. This information may be based on the institutional records and/or prior experience. 3. Each applicant must demonstrate the potential and stated commitment to accrue a minimum of 50 credits per year to treatment clinical trials (except if waived for applicants whose specialty is pediatrics). Documentation must include any prior participation in treatment research clinical trials with a clear presentation of the number of patients and credits accrued to NCI-approved treatment clinical trials. A list of the NCI- approved treatment protocols in which the applicant expects to participate and the projected accrual to each must be provided. 4. Each new applicant must demonstrate the potential and plans for accrual of a minimum of 30 credits in the first year of funding, 40 credits in the second year, and 50 credits in the third year to cancer prevention and control protocols. Documentation must include any prior participation in cancer prevention and control research clinical trials with a clear presentation of the total number of patients and credits accrued to NCI-approved cancer prevention and control clinical trials. A list of the NCI-approved prevention and control protocols in which the applicant expects to participate and the projected accrual to each must be provided. 5. New applicants must provide at least two examples of NCI- approved intervention cancer prevention and control protocols appropriate for Minority-Based CCOP participation. For these two protocols, the applicant should describe their implementation, including specifics on patient/subject recruitment, compliance, and follow-up. These studies must come from research bases with which they propose to affiliate. The Minority-Based CCOP applicant must document the ability to access the appropriate physicians and patient/subject populations and adequate facilities to participate in the proposed clinical trials. 6. A designated Principal Investigator is required. An associate Principal Investigator should also be named to assure continuity in the event of resignation of the Principal Investigator. The qualifications and experience of both must be described in terms of ability to organize and manage a community oncology program which includes cancer treatment and prevention and control research and related activities. 7. Each applicant is expected to have a committed multidisciplinary professional group appropriate for its expected protocol participation. This team may include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family practice) as appropriate. The training and experience of participating physicians must be provided, along with a description of working relationships. Any experience working together as a group, particularly in implementing clinical cancer treatment and prevention and control research and related activities, should be included. An organizational chart showing how the group will function must also be included. Special personnel resources needed to support the recruitment and retention of eligible minority patients on clinical trials may be requested. 8. Each applicant must provide the qualifications and experience of all proposed support personnel as well as a description of the proposed duties for each position. 9. Through formal affiliations with a maximum of five research bases, only one of which may be a national multispecialty cooperative group, each applicant must demonstrate access to both cancer treatment and prevention and control research protocols. Evidence must be provided that an affiliation has been established with at least one NCI-funded research base that has the capacity to provide both clinical cancer treatment and prevention and control protocols. In addition, affiliations with research bases offering only cancer prevention and control protocols are appropriate. The conditions of affiliation must be provided in the Minority-Based CCOP-research base affiliation agreement(s). Initial affiliations should be maintained during the funding cycle. Multiple research base affiliations are permitted provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing protocols will be resolved. Note: A list of currently eligible research bases may be obtained >From the program official listed in the Letter of Intent Section. 10. Quality control procedures must be described in detail. Assurance of quality is the joint responsibility of the Minority-Based CCOP and its research base(s). Quality control procedures of the research base will be applied to the Minority-Based CCOPs and should be specified in the affiliation agreement between the Minority-Based CCOP and the research base. Procedures for investigational drug monitoring and data management must also be described. 11. The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization and/or documentation of consortium arrangements must be provided. Evidence of involvement with community-based voluntary organizations may be submitted. In addition, each applicant must have a defined space for administrative activities and administrative personnel which will serve as a focus for data management, quality control, and communication. 12. Allocation of funds to support community costs for receipt, handling, and quality control of patient data must be specified. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., reimbursement of patient care expenses; transportation costs). Funding is not allowed for clinical support personnel (e.g., pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on Minority-Based CCOP organizational/administrative tasks. Justification must be provided for personnel time, effort, and funds requested. B. Method of Applying The research grant application form PHS-398 (rev. 5/95) must be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov; and from the NCI program official listed under INQUIRIES. A suggested format will be sent to all applicants requesting an RFA or submitting a letter of intent. All applicants are encouraged to obtain and use the suggested format instructions for organizing the specific information concerning the RFA programmatic requirements in the PHS 398. The RFA label available in the PHS-398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear and single-sided photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North - Room 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received by the designated receipt date. Applications must be received by September 25, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed for completeness by DRG staff and for responsiveness by NCI staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will return it. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all 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 recieve a second level review by the appropriate National Cancer Advisory Board. B. Review Criteria 1. Ability to access through participating Minority-Based CCOP physicians a population with greater than 50 percent of new cancer patients from minority groups. In describing the study population, it is required that a description of the gender and minority population served be provided, as well as an outreach plan. This information may be based on institutional records and/or prior experience. 2. For new applicants, ability to accrue a minimum of 50 credits per year to treatment clinical trials and a minimum of 30 credits per year to cancer prevention and control clinical trials in the first year, increasing to 50 credits per year in the third year. Established Minority-Based CCOPs will be funded at a yearly accrual goal that may be higher than 50 credits for treatment clinical trials and 50 credits for cancer prevention and control clinical trials. These established Minority-Based CCOPs will be evaluated for their past performance in meeting the accrual goals The minimum accrual requirement may be waived for applicants whose specialty is pediatrics. Each applicant's ability to access the appropriate populations, professional disciplines, and facilities to participate with affiliated research bases in NCI- approved cancer prevention and control intervention protocols will be appraised. Any prior participation in cancer treatment and prevention and control research will be considered. 3. Qualifications and experience of the Principal Investigator/associate Principal Investigator, in terms of ability to organize and manage a community oncology program that includes both cancer treatment and prevention and control research and related activities. 4. Training, experience, and commitment of participating physicians for accruing individuals to protocols in which the applicant has agreed to participate. The experience of proposed investigators in the entry and treatment of cancer patients on research trials (gained >From residency, fellowships, postdoctoral training and/or subsequent practice) will be appraised. For multidisciplinary studies, evidence of the availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, pathology, internal medicine, family practice, nursing, and nutrition) will be required. Experience or special skills in cancer prevention and control research and related activities will be considered, together with availability of other community resources and personnel for such clinical trials. 5. Stability of the functional unit or group applying to become a Minority-Based CCOP. Preexisting organizational affiliations of at least a core of the group applying and evidence of stable working relationships will be appraised. Examples of established consortium arrangements and committee structure which demonstrate the participation of appropriate physicians and administrators may be submitted. Evidence of previous success as a group in implementing clinical cancer treatment and prevention and control research and related activities will be considered. 6. Qualifications and experience of all proposed support personnel relative to their position descriptions. The relevant credentials and expected contributions to the program of personnel resources not fiscally supported by the award will be considered. 7. Adequacy of quality assurance mechanisms for both cancer treatment and prevention and control interventions, and adequacy of procedures for investigational drug monitoring and data management identification of false or otherwise unreliable data. 8. Adequacy of available facilities, including laboratories, in- patient and outpatient resources, cancer registries, etc., and adequacy of space for administrative activities and personnel. 9. Appropriateness of research base affiliations and of the cancer treatment and prevention and control research protocols chosen. Affiliation agreements must be provided in the application. 10. For competitive continuations, adequacy of progress during the funding period, including ability to meet the minimum accrual credits in cancer treatment and prevention and control, progress made as a Minority-Based CCOP, and evaluation of Minority-Based CCOP performance by affiliated research bases(s). Consideration will be given to previous accrual and the ability to meet the previous accrual projections for which the Minority-Based CCOP was funded. Minority-Based CCOP evaluation by affiliated research bases must be provided. Plans for continued accrual and follow-up of subjects on protocols will be evaluated. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/ workshops, local travel). Special personnel resources needed to support the recruitment and retention of eligible minority patients on clinical trials will be considered. Funding is not allowed for clinical care provided to patients. (e.g., patient care reimbursement, transportation costs). Funding is not allowed for clinical support personnel (e.g., pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on Minority-Based CCOP organizational/administrative tasks. Justification must be provided for personnel time and effort and funds requested. The intitial review group will also examine the provisions for the protection of human subjects, recruitment plans for the inclusion of women, minorities and subpopulations to clinical trials, and the safety of the research environment. AWARD CRITERIA The anticipated date of award is June 1, 1997. NCI program staff will take into account demographic and geographic distribution of applicants in the final funding selection process to assure inclusion of minority and underserved populations. Multiple Minority-Based CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are encouraged. The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Otis W. Brawley, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-D 6130 Executive Boulevard MSC-7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: ob6g@nih.gov Direct inquiries regarding fiscal matters to: Ms. Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 282 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control. 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 grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Jul 02 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-061 - V25(21) 06/28/96 Date: 3 Jul 1996 12:04:25 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 389 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4reg7p$61j@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96061 PA-96-061 P1O1 *************************************** MODERN VACCINES FOR MYCOSES AND MEASLES NIH GUIDE, Volume 25, Number 20, June 21, 1996 PA NUMBER: PA-96-061 P.T. 34; K.W. 0740075, 0715103, 1002045 National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to Program Announcements. Program Announcements identify areas of ongoing research emphasis for the NIAID. The purpose of this PA is to stimulate research on selected emerging and re-emerging diseases for which new or improved vaccines are needed. For the mycoses, the goal is to identify and characterize antigens that induce a protective immune response for coccidioidomycosis, histoplasmosis, blastomycosis, and cryptococcosis. For measles, the goal is to develop safe, new measles vaccines that are highly efficacious when administered in early infancy and that will aid in the control and eventual eradication of measles. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of"Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Modern Vaccines for Mycoses and Measles, is related to priority area of immunization-infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities and 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 for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT Traditional research project grant (R01) ,FIRST award (R29), and small grant (R03) applications may be submitted in response to this program announcement. NIAID uses R03 grants to support small highly innovative or pilot projects. Applicants for R03 grants may request up to $50,000 annual direct costs for a period not to exceed three years. Funds and time requested should be appropriate for the research proposed. Applicants for R03 grants must follow the special application guidelines and Terms and Conditions of Award for NIAID SMALL RESEARCH GRANTS, which appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 9, March 22, 1996. RESEARCH OBJECTIVES AND SCOPE Background The purpose of this initiative is to advance the development of new vaccines in two specific areas: the mycoses and measles. Prior to AIDS, it was estimated on the basis of skin tests that there were between 25,000 and 100,000 new infections with C. immitis each year. Presently, it is estimated that there are 500,000 new infections of histoplasmosis each year in the United States. The incidence of clinically apparent coccidioidomycosis and histoplasmosis in HIV+ individuals in highly endemic areas, although variable, has been found to be as high as 25 percent for each mycosis. Disease is not limited to immunocompromised hosts. The recent epidemic of coccidioidomycosis in California resulted in more than 3,000 cases in 1992 in Kern County alone, with medical costs estimated at more than $67 million for an 18-month period. A NIAID workshop (September 1991) on Mycology Research in the 1990s stated that vaccines should be considered for histoplasmosis, coccidioidomycosis and cryptococcosis, and recent NIAID workshops have reinforced these concepts. Vaccine approaches for these and selected other fungal diseases are under exploited. The devastating consequences of these diseases, and the less than satisfactory response to available drugs, suggest that research should explore prevention. Between 1981 and 1988, a steady average of 3,000 cases of measles occurred each year. This rate was a reduction of over 99 percent >From the 400,000 to 700,000 annual cases reported before the introduction of a vaccine in 1963. A recent resurgence of measles has occurred in the United States. From 1989-1991, 55,165 cases with 123 deaths were reported. The major cause of the re-emergence of measles in the U.S. was the failure to vaccinate children at the appropriate age rather than failure of vaccine efficacy. However, currently licensed vaccines do have deficiencies as public health tools, particularly in regard to efficacy in very young infants. In developing countries, measles continues to be a deadly disease claiming over one and a half million lives each year. In those countries, infants are at greatest risk for serious disease and complications during the interval between loss of maternal antibody and receipt of vaccine at 9-12 months of age. During the recent re-emergence of measles in the U.S., the epidemiology of the disease has changed, and the distribution of cases shifted from older, previously vaccinated, school-age children, to younger, unvaccinated children often less than 1-year-old. Thus, both internationally and domestically, there is a need for an efficacious vaccine that can be safely administered earlier in infancy. Additionally, a need for an improved measles vaccine is foreseen since proposed future immunization schedules will emphasize administration at earlier ages in infancy, and will utilize multiple combinations of vaccines. Unfortunately, measles is a difficult virus to study because there are no satisfactory animal models. An RFA issued by NIAID in late 1992 stimulated measles research and resulted in the development of a number of potentially new measles vaccine candidates and promising new animal model systems. This PA will attempt to stimulate the preclinical development and comparative evaluation of these potential new vaccines, and the further establishment and definition of animal models. Research Objectives and Experimental Approaches Mycoses: Given the advances in molecular biology, it should now be possible to engineer candidate antifungal vaccines based upon specific immunoreactive molecules. Recent evidence derived from investigators working independently confirm that these approaches are possible with the medically important fungi. It is anticipated that coordinated research supported under this PA will result in the identification of antigens with immunoprotective effects demonstrable in animal models for one or more of the endemic mycoses, and/or cryptococcosis. Relevant projects for the mycoses could address one or more of the following objectives: o The identification of fungal antigens that generate a protective immune response. Studies could be focused on the isolation and identification of antigens that can be utilized in vaccine production to prevent or treat the above mentioned mycoses and their evaluation in the appropriate model system. o The modification or presentation of fungal antigens in a manner that affords maximal immunoprotective effect. Studies could include, for example, epitope mapping; construction of multiple antigenic peptides; use of adjuvants or immune enhancers; use of improved conjugation techniques for enhanced immogenicity. Measles This program announcement is intended to stimulate innovative research on measles, with a strong emphasis on studies to develop improved vaccines that can safely overcome the maternal antibody barrier and induce long-lasting protective immunity. Research projects are sought which investigate topics including, but not limited to, those listed below. Relevant projects for measles will address one or more of the following issues: o Determination of which measles antigens are required to safely elicit long-lasting, protective humoral and cellular immunity in the developing immune system of the young infant. o Elucidation of the impact of maternal antibody on infant immune response, and development of strategies to overcome maternal antibody as a block to effective immunization in very young infants. o Development of an animal model of measles virus infection and disease which parallels human disease, and which could be used to study the multiple host and viral factors influencing establishment of protective immunity in the young infant. o Elucidation of viral and host factors contributing to measles immunization-induced adverse events. o Investigation of elements of measles virus pathogenesis, including virus-induced immune suppression, and viral correlates of virulence and attenuation. o Characterization of the quantitative and qualitative differences between measles vaccine-induced and naturally-induced protective immunity. o Pre-clinical development of efficient immunization methods for the safe delivery of appropriate measles antigens required for the establishment of protective immunity. INCLUSIONS 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 printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES APPLICANTS FOR SMALL RESEARCH (R03) GRANTS ARE TO FOLLOW THE APPLICATION GUIDELINES IN THE "NIAID SMALL RESEARCH GRANTS" NOTICE WHICH APPEARED IN THE NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 25, No. 9, March 22, 1996 and are available from program staff listed under INQUIRIES. Applicants are strongly encouraged to call NIAID program staff with any questions regarding the responsiveness of their proposed project to the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.od.nih.gov. Each application must be identified by checking "YES" on line 2 of the PHS face page, and the number and title of this program announcement must be typed in section 2a. The completed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS APPLICANTS FOR SMALL RESEARCH (R03) GRANTS ARE TO FOLLOW THE APPLICATION GUIDELINES IN THE "NIAID SMALL RESEARCH GRANTS" NOTICE WHICH APPEARED IN THE NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 25, No. 9, March 22, 1996 and are available from program staff listed under INQUIRIES. Applications will be assigned on the basis of established PHS referral guidelines. Program staff will be responsible for determining whether an application is responsive to the goals of the PA. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific/technical review, the applications will receive secondary review by the appropriate national advisory council. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria o scientific, technical, or medical significance and originality of the 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, particularly, but not exclusively, in the area of the proposed research; 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. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding mycoses programmatic (eligibility and responsiveness) issues to: Dennis M. Dixon, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-06 6003 Executive Boulevard - MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7728 FAX: (301) 402-0508 Email: dd24a@nih.gov Direct inquiries regarding fiscal matters to: Louise Kreh Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-27 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: lk5k@nih.gov Direct inquiries regarding review issues and special instructions for application preparation and mail two copies of the R03 application and all five sets of any appendices to: Stanley Oaks, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C06 6003 Executive Boulevard - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7042 FAX: (301) 402-7042 Email: sol4s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and infectious Disease 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 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 Mon Jul 08 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DA-97-002 - V25(22) 07/05/96 Date: 9 Jul 1996 15:31:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 378 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4rumjf$auc@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DA97002 DA-97-002 P1O1 *************************************** NEUROBIOLOGICAL EFFECTS OF DRUG ABUSE THERAPIES NIH Guide, Volume 25, Number 22, July 5, 1996 RFA: DA-97-002 P.T. 34; K.W. 0404009, 0745070, 0705055 National Institute on Drug Abuse Letter of Intent Receipt Date: September 18, 1996 Application Receipt Date: October 18, 1996 PURPOSE This Request for Applications (RFA) solicits research grant applications on the neurobiological effects of pharmacological and/or nonpharmacological drug abuse treatments upon structure and/or function of the human central nervous system. Results from such studies should ultimately provide a basis for the development and improvement of behavioral and medication treatment of patients with drug abuse disorders. This research program is intended to support individual research project grants and mentored career development awards on the clinical neurobiological effects of specific treatments for drug abuse disorders. Research using animals is not excluded, but any animal research in projects submitted under this RFA must serve an essential, but secondary role, in a predominantly clinical study. 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, Neurobiological Effects of Drug Abuse Therapies, is related to the priority area of alcohol and other drugs. 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 foreign and domestic, for-profit and non-profit organizations, public and private such as colleges, universities, hospitals, laboratories, units of State and local government, 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 for First Independent Research Support and Transition (FIRST) (R29) awards or career development (K- series) awards. Awards to foreign institutions under other mechanisms are limited to three years. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grants (R01), exploratory/developmental grant (R21), small grant (R03), and FIRST Award (R29), as well as Mentored Research Scientist Development (K01) and Mentored Clinical Scientist Development (K08) Awards. Most investigator-initiated research is supported by research project grants (R01). The total project period for an application submitted in response to this RFA may not exceed five years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to customary peer review procedures. Applications judged to be non-responsive to the RFA will be held for the next regular receipt date. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will vary also. The exploratory/developmental (R21) and small grant (R03) applications are limited to two years, non-renewable, and limited in direct cost amount per year (R03, $50,000; R21, $90,000) The R03 mechanism is intended for newer, less experienced investigators, investigators at institutions without a research tradition and experienced investigators wishing to change research directions or test new methods or techniques. The R21 mechanism is intended to encourage new research projects in underdeveloped research areas of drug abuse. Applicants for the R21 mechanism are expected to be experienced investigators whose previous research may have been distantly related areas to drug abuse (e.g., mental health) but whose expertise is applicable to drug abuse research. Mentored Research Scientist Development Award (K01) and Mentored Clinical Scientist Development Award (K08) are both mid-career grants intended to provide a period of sponsored research experience which will then enable the applicant to pursue an independent research career. The K01 and K08 awards support three to five years of mentored research experience and applicant are required to devote at least 75 percent time to the program. K01 Awards require a research or a health-professional doctorate or equivalent, while K08 Awards require a clinical degree or equivalent. There are additional special requirements for these mechanisms; if any applicant intends to apply for them under this RFA, they should contact the program official listed under the INQUIRIES section for further information. FUNDS AVAILABLE In FY 1997, it is anticipated that approximately ten to twelve awards may be funded at a total cost of up to $1.5 million. Approximately five regular grant (R01) awards at an average of $200,000, and five to seven awards under the other mechanisms are anticipated. RESEARCH OBJECTIVES Recent advances in clinical neurobiological methods have armed researchers with a powerful set of approaches to investigate how drugs of abuse affect the brain. However, little is known about how brain function may be influenced by drug abuse treatment. The principal goal of the research to be supported through this initiative is to identify how structure and/or function of neuronal systems are affected by specific treatments for drug abuse disorders. Toward this goal, NIDA is particularly interested in proposals that will utilize brain imaging or other state-of-the-art clinical neurobiological approaches for assessment of alterations in human brain function and structure during treatment for drug abuse disorders. The following specific research questions serve as a guide to the types of research areas that are encouraged in this RFA: o Important relationships between substance abuse disorders and comorbid neuropsychiatric disorders have been described, but the mechanisms underlying these interactions and their implications for drug abuse treatment remain poorly understood. Investigators are encouraged to determine the neurobiological mechanisms underlying these relationships in the drug-abuse treatment situation. o Concurrent use of multiple drugs of abuse poses a serious and frequent clinical challenge in drug abuse research and treatment. NIDA encourages studies aimed at detection and neurobiological characterization of differences in treatment response between single- and polydrug abusers. o Both pharmacological and behavioral treatment modalities have been shown to be effective, and clinically significant interactions between these modalities have been demonstrated. Very little is known, however, about the mechanisms underlying these interactions. Therefore, studies characterizing the mechanistic commonalities and differences between these treatment modalities are encouraged, as are studies that elucidate the neurobiological basis of interactions between combined treatments. o Similarly, studies that will detect and characterize neurobiological markers predictive of treatment efficacy are also of interest. o Recent research has demonstrated that gender differences may vary depending upon the combination of drugs of abuse. Further studies assessing gender differences in neurobiological response to treatment are strongly encouraged. Also, studies assessing ethnicity or HIV/AIDS status-differences in neurobiological effects of treatment are particularly welcome. All applications must address issues of project feasibility, implementation of the study, study design, sampling procedure, instrumentation and measurement, data collection, tracking of subjects, follow-up, and data analysis, as appropriate. Investigators are encouraged to offer HIV testing and counseling in accordance with current guidelines to subjects identified during the course of the research as being at risk for HIV acquisition or transmission. 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 September 18, 1996, 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 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, the information that it contains allows NIDA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse Parklawn Building, Room 10-42 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2620 FAX: (301) 443-0538 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 from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Room 3034, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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. 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 courier/overnight mail service) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse Parklawn Building, Room 10-42 5600 Fishers Lane Rockville, MD 20857 Applications must be received by October 18, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NIDA staff. Incomplete and/or non- responsive 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 NIDA in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level by the National Advisory Council on Drug Abuse. Review Criteria o scientific technical merit and clinical significance and originality of proposed research; o relevance to the goals and objectives of this RFA; 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, particularly, but not exclusively, in the area of the proposed research; 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. The initial review group will also examine the provisions for the protection of human or animal subjects and the safety of the research environment. The above criteria apply to R01 applications and there are separate criteria for other mechanisms. When applying under other mechanisms, the applicants should obtain a copy of the relevant announcement from either their office of sponsored research (if located in a university) or from Grants Management Branch at NIDA (301-443-6710). These announcements contain instructions for the preparation of grant applications that must be strictly adhered to and describe review criteria that would be used by a peer review committee in evaluating submitted applications. In addition to the above mentioned criteria, relevance of the application to the goal and objectives of this RFA will also be an important consideration. AWARD CRITERIA Award criteria that will be used to make award decisions include: scientific merit as determined by peer review, availability of funds, and programmatic priorities. 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: Arthur MacNeill Horton, Jr., Ed.D. Division of Clinical and Services Research National Institute on Drug Abuse Parklawn Building, Room Number 10A-46 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4877 FAX: (301) 443-2317 Email: ah61x@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse Parklawn Building, Room Number 8A-54 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6710 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. 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 recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Jul 08 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 22, pt. 1of1, 5 July 1996 Date: 9 Jul 1996 15:30:06 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 966 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4rumhe$ani@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960705 V25N22 P1O1 ************************************ X-comment: RFAs described: DA-97-002, PA-96-062, PA-96-063 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.07.05 NIH GUIDE - Vol. 25, No. 22 - July 5, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** PEER REVIEW REBUTTAL AND APPEAL PROCESSES National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** MODIFIED FINANCIAL REPORTING REQUIREMENTS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** NIDR GUIDELINES ON SUPPLEMENT APPLICATIONS National Institute of Dental Research INDEX: DENTAL RESEARCH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** POPULATION INDEX (RFP NICHD-DBSB-96-10) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R2 10/18/96 ************************************************* NEUROBIOLOGICAL EFFECTS OF DRUG ABUSE THERAPIES (RFA DA-97-002) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P1 ********************************************************** RESEARCH ON HIV INFECTION IN THE GENITOURINARY TRACT (PA-96-062) National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P2 ********************************************************** EFFECTS OF HIV INFECTIONS ON THE KIDNEY (PA-96-063) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES ERRATA $$INDEX E1 ********************************************************** ACUTE INFECTION AND EARLY DISEASE RESEARCH NETWORK (PAR-96-060) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. 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 GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 22, July 5, 1996 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 final findings of scientific misconduct in the following cases: Robert J. Altman, M.D., University of California at San Francisco (UCSF): Based on an investigation conducted by the institution as well as information obtained by ORI during its oversight review, ORI found that Robert J. Altman, M.D., Research Fellow, Department of Obstetrics, Gynecology, and Reproductive Sciences, UCSF, committed scientific misconduct by fabricating and falsifying data in research supported by two National Institutes of Health grants. Specifically, Dr. Altman fabricated an experiment related to an ovarian cell line injected intraperitoneally into 12 nude mice. The resulting data were reported in (1) a manuscript in page proof entitled "Inhibiting vascular endothelial growth factor arrests growth of ovarian cancer in an intraperitoneal model" (Journal of the National Cancer Institute); (2) a manuscript entitled "Vascular endothelial growth factor is essential for human ovarian carcinoma growth in vivo," submitted to the Journal of Clinical Investigation (JCI manuscript); and (3) a published abstract entitled "Vascular endothelial growth factor is essential for ovarian cancer growth in vivo" (Society for Gynecologic Investigation, abstract #079). Further, in the JCI manuscript, Dr. Altman (1) falsified the number of subjects with ovarian tumors from whom he obtained sections of tissue for examination of the expression of vascular endothelial growth factor (VEGF) purportedly by both in situ hybridization and immunohistochemistry, and (2) falsely reported that VEGF expression was examined by in situ hybridization and immunohistochemistry in papillary serous- (n=7) and mucinous- (n=5) cystadenocarcinomas, when the number of surgical cases involving papillary serous tumors was four and the number of mucinous tumors was zero. Dr. Altman examined VEGF expression in only three papillary serous tumor specimens, one specimen both in situ and by immunohistochemistry and the remaining two solely by immunohistochemistry. Dr. Altman has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed, for the three year period beginning June 11, 1996, to exclude himself from: (1) 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) 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. The above voluntary exclusion shall not apply to Dr. Altman's future training or practice of clinical medicine whether as a medical student, resident, fellow, or licensed practitioner, as the case may be, unless that practice involves research or research training. Vipin Kumar, Ph.D., California Institute of Technology: Based upon a report forwarded to the Office of Research Integrity (ORI) by the California Institute of Technology (C.I.T.) dated January 10, 1991, as well as information obtained by ORI during its oversight review, ORI found that Vipin Kumar, Ph.D., formerly a scientist at C.I.T., engaged in scientific misconduct in biomedical research supported by Public Health Service (PHS) funds. Specifically, ORI found that Dr. Kumar committed scientific misconduct by falsifying and/or fabricating Figures 2a and 2b in a scientific paper published in the Journal of Experimental Medicine, 170:2183-2188 (1989) (JEM paper). ORI accepted the C.I.T. conclusion that Dr. Kumar ~freely admitted~ that he mislabeled the lanes in Figures 2a and 2b, which are labeled to indicate they represent the results of research from different DNA samples when in fact a number of lanes are duplicates. Although Dr. Kumar denies that he intended to deceive anyone, C.I.T. concluded in its Report that the "deliberate presentation of duplications of one experiment which are labeled to indicate they came from separate DNA samples deceives the reader as to the real source of the DNA in the experiment, where the central point of the experiment is the similarity of results among different sources." ORI also accepted the C.I.T. conclusion that Dr. Kumar presented Figure 2c of the JEM paper "in a very misleading fashion." The central observation of the JEM paper is that both alleles of the alpha chain of the T-cell receptor gene are frequently rearranged. This conclusion was based, in part, on Figure 2c, which C.I.T. found had been labeled in a misleading fashion that led the reader to believe that the heavy band at the top of the blot was an 8kb restriction fragment (i.e., representing an internal control) rather than undigested material that failed to enter the gel. Examination of the original film indicates that there was no evidence that the second alpha-chain rearranges in mature T-cells. Thus, ORI further accepted the C.I.T. conclusion that Figure 2 was intentionally falsified and/or fabricated and that, as a result, "one of the main scientific results of this paper was not substantiated by the original data." In addition, ORI found that Dr. Kumar committed scientific misconduct by falsifying and/or fabricating Figure 5b of a manuscript that was submitted for publication to the journal Cell (Cell manuscript), but was later withdrawn. ORI accepted the C.I.T. conclusion that lanes 6, 7 and 8 of Figure 5b are the same as lanes 11, 12 and 13, respectively, even though they are labeled as being from different samples. ORI also accepted the C.I.T. conclusion that Dr. Kumar made a number of other materially misleading statements in the Cell manuscript that were not supported by the primary data. For example, C.I.T. concluded that Dr. Kumar made a number of materially misleading statements about the age of mice and the timing of the injection of peptides into these mice in a paper published in the Proceedings of the National Academy of Sciences, 87:1337-1341 (1990) (PNAS paper). This information is material because induction of the disease studied (i.e., allergic encephalomyelitis) is dependent upon the age of the mice. Based upon the findings of scientific misconduct in the C.I.T. Report, the JEM and PNAS papers were retracted prior to ORI's findings in this case. ORI and Dr. Kumar agreed to resolve the case through a negotiated settlement and limited voluntary exclusion agreement (Agreement), which the parties agreed shall not be construed as an admission of liability or wrongdoing on the part of the Dr. Kumar. Dr. Kumar plans to submit a letter to ORI in which he summarizes his response to ORI's findings. Dr. Kumar has agreed to exclude himself voluntarily from serving in any advisory capacity to the PHS, including service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three years. Dr. Kumar has also agreed to exclude himself voluntarily, for a period of 18 months 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. However, this provision will not apply to a currently pending PHS grant application involving Dr. Kumar. In addition, any institution that uses Dr. Kumar in any capacity on PHS supported research must concurrently submit a plan for supervision of Dr. Kumar's duties, designed to ensure the scientific integrity of Dr. Kumar's research, for a period of three years. Similarly, any institution employing Dr. Kumar must submit, in conjunction with each application for PHS funds or report of PHS funded research in which Dr. Kumar is involved, a certification that the data provided by Dr. Kumar are based on actual experiments or are otherwise legitimately derived and that the data, procedures and methodology are accurately reported in the application or research report, for a period of three (3) years. INQUIRIES For further information, contact: 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 ********************************************************** PEER REVIEW REBUTTAL AND APPEAL PROCESSES NIH GUIDE, Volume 25, Number 22, July 5, 1996 P.T. 34; K.W. 1014006 National Institutes of Health The National Institutes of Health (NIH) provide an applicant who feels that some aspect of the handling or peer review of his/her grant application has been inappropriate, biased, or wrong with two sequential opportunities, respectively referred to as "rebuttals" and "appeals," to have his/her concerns addressed. The first opportunity, or rebuttal, is available after the applicant has received the summary statement that documents the results of the initial review of the application's scientific and/or technical merit. The applicant should submit a detailed letter rebutting the review, not to the Scientific Review Administrator of the initial review group that reviewed the application, but to the Program Administrator of the relevant NIH Institute/Center (IC) who is responsible for the application. If the letter is judged to be a rebuttal and not simply a communication providing additional information, it will usually be made available to the IC's National Advisory Council/Board for consideration, if the IC staff cannot handle the concerns administratively. If the Council takes a specific action on the rebuttal, and if the Council deems that the applicant's objections have merit, it may recommend that the application be deferred and rereviewed. However, if the Council does not recommend deferral and rereview but concurs with the initial review and deems that it should stand, then the applicant has a second opportunity to have his/her concerns heard, by submitting a formal appeal of the Council's decision. "The PI and the applicant institution, represented by the institutional official authorized to sign applications, must jointly sign an appeal and send it to the NIH Peer Review Appeals Officer. The official representative's signature indicates that the applicant institution endorses both the form and substance of the appeal" (ref: NIH Manual Chapter 4518). The appeal letter must explain fully the reasons for the disagreement, append supporting documentation, and be sent to: NIH Appeals Officer Office of the Director National Institutes of Health 6701 Rockledge Drive, Room 6192 Bethesda, MD 20892 Two points that are important for applicants considering an appeal to weigh for themselves concern the possible outcomes and the timing of the appeal process. The most favorable possible outcome for an applicant in an appeal case can only be a decision that the application in question be rereviewed, since appeals cases examine only whether there were any flaws in the peer review process. The other possible outcome is that the review of the application was not substantially flawed and any minor flaws in the review did not affect the recommendation regarding the application. In that case, the review would stand and the application would not be rereviewed. As the conduct of an appeal case involves several steps of process and review, it may take at least four months (or one review cycle) to complete. Thus, given the possible outcomes and the timing of the appeal process, an applicant may wish to consider whether deficiencies in the review of his/her application were substantive enough to have had a major deleterious effect on the review of the application and, if not, to revise and resubmit it instead. Applicant concerns about the acceptance for review, responsiveness to a Request for Applications (RFA), other receipt issues, or the referral of their application, when submitted prior to the initial review, are entirely the responsibility of the Division of Research Grants (DRG) or of the IC assigned to review the application (as indicated on the computer-generated notice of assignments sent to applicants). This DRG or IC process also provides two opportunities (both of which are internal to either the DRG or the IC) for applicant concerns to be addressed. Decisions regarding the funding of applications, as they are actions that are external to the peer review process, may not be appealed. INQUIRIES For additional information about the peer review rebuttal and appeal processes or to discuss a particular matter, contact the NIH Appeal Officer, Dr. Janet Cuca, at 301/435-2691 or email: cucaj@odrockm1.od.nih.gov. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** MODIFIED FINANCIAL REPORTING REQUIREMENTS NIH GUIDE, Volume 25, Number 22, July 5, 1996 P.T. 34; K.W. 1014006 National Institutes of Health INTRODUCTION In FY 1995, the National Institutes of Health (NIH) implemented the Streamlined Non-Competing Award Process (SNAP), which simplified the requirements of the non-competing application process (Phase I). In Phase II of SNAP, which was begun in FY 96, the Notice of Grant Award was changed to reflect only direct and indirect costs, and indirect costs are now included in the future year recommended levels. In an attempt to further streamline the non-competing process, NIH is implementing Phase III of SNAP by modifying the financial reporting requirements. Effective for grants (competing and non-competing) with July 1, 1995 start dates, a Financial Status Report (FSR) will only be required at the end of the competitive segment rather than annually. If the award which was effective July 1, 1995 was the final award for the competitive segment, an FSR will be required. SNAP applies to all mechanisms routinely covered under expanded authorities (see NIH Guide for Grants and Contracts, Vol. 23, No. 45, December 23, 1994), except Program Project Grants (P01s) and Outstanding Investigator Grants (R35s). Awards may be specifically included or excluded from SNAP by a term and condition on the Notice of Grant Award. Questions concerning the status of a specific award should be addressed to the Grants Management Officer of the awarding component. Throughout its efforts to simplify and streamline the policy requirements for Federal grants, NIH has emphasized the importance of continued effective and efficient monitoring of Federal grant funds. Federal grant managers and grantee staff are required to assure that Federal funds are expended for the purpose for which the grant was awarded and in compliance with Federal regulations. Monitoring the financial aspects of grants is a requirement for both grantee and NIH staff and is of paramount importance. This requirement does not diminish because of the modified reporting requirements under this announcement. IMPLEMENTATION For all grant awards under SNAP with July 1, 1995 start dates, annual FSRs will no longer be required. FSRs will be required 90 days after the end of the competitive segment. This FSR should reflect cumulative support provided for the entire competitive segment. The FSR must be submitted whether or not the grant receives funding for a competitive renewal. It must also be submitted if a grant terminates early or transfers to a new institution. NIH staff will use the Federal Cash Transaction Report (FCTR) to continue to monitor the financial aspects of grants. The FCTR provides a quarterly breakdown of cash transactions on a grant record basis. These transactions will be monitored to determine if the pattern of cash expenditures indicates possible problems. For example, if it appears that funds are being drawn too quickly, this could be an indication of an inappropriate acceleration of expenditures; or if funds are not being drawn at all, this could indicate poor progress, delayed hiring, or a significant unobligated balance. If the pattern of cash expenditures appears inappropriate, grants management staff will request additional information (e.g., annual accounting records) from the grantee to determine if there are issues related to the grant that need closer monitoring. It is incumbent upon grantee organizations to have in place accounting and internal control systems which provide for appropriate monitoring of grant accounts to assure that areas of concern are addressed and communicated to the awarding component's Chief Grants Management Officer. Internal control systems should assure that obligations and expenditures are reasonable, allocable and allowable and provide for identification of large unanticipated unobligated balances, accelerated expenditures, inappropriate cost transfers, and other inappropriate expenditure and obligation of funds. These are all areas that could be indicators of problems with the progress of the project and/or the maintenance of grantee stewardship responsibilities for the funds provided with the grant. It is also incumbent upon the grantee organization to assure that day-to-day financial monitoring is being accomplished at all levels of the organization. Accordingly, appropriate training, support, and internal controls must be available to departmental administrators and other grantee staff who are in a position to assist investigators in the day-to-day management of Federal funds. WHO WILL BENEFIT This effort to streamline the financial reporting requirements for most grant mechanisms should benefit NIH and grantee staff. Resources currently focused on compliance with timely financial reports on an annual basis can be reallocated to provide assistance to investigators and administrators and oversight to assure that grants are operated in accordance with Federal regulations. INQUIRIES Questions regarding this policy may be directed to the Grants Management Specialist identified on the Notice of Grant Award. $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NIDR GUIDELINES ON SUPPLEMENT APPLICATIONS NIH Guide, Volume 25, Number 20, June 21, 1996 P.T. 34; K.W. 1014006, 0715148 National Institute of Dental Research The National Institute of Dental Research (NIDR) is committed to increasing the pool of talented men and women involved in oral and craniofacial research. The National Institutes of Health (NIH) Research Supplements for Underrepresented Minorities, Research Supplements for Individuals with Disabilities, and Supplements to Promote Reentry into Biomedical and Behavioral Research Careers, respectively, have proven to be effective mechanisms for NIDR to accomplish this goal. These programs provide support for individuals at various stages of their careers ranging from high school through undergraduate and predoctoral studies to postdoctoral and faculty levels to participate in ongoing NIH-supported research. The full guidelines for these programs were published in the NIH Guide for Grants and Contracts, Vol. 22, No. 23, November 26, 1993 (Supplements for Minority Individuals), Volume 21, Number 3, Part I of II, January 24, 1992 (Supplements for Individuals with Disabilities), and Vol. 23, No. 18, May 13, 1994 (Reentry Supplements). These guidelines contain pertinent and important information on submitting an application and must be followed in preparing an application. While the NIDR is in compliance with the general provisions and application procedures, the Division of Extramural Research (DER) has developed additional guidelines that will aid in the completion of an application. APPLICATION PROCEDURES Applicants are encouraged to communicate with the DER Program Director responsible for the portfolio in which the parent grant is housed prior to submission in order to obtain specific information about preparing and submitting a supplemental application. A listing of program staff in DER is listed under INQUIRIES. An original and three copies of the application must be sent directly to the DER Program Director. Staff will notify the Principal Investigator of the receipt of the application by letter. Following the review of the application the Principal Investigator and Business Office will be notified by letter of the action taken. The request for supplemental award must follow the procedures outlined in the NIH Guide with the exception of the provisions stated below. 1. Participants in the Dentist Scientist Award Program who have not completed their Ph.D degree are NOT eligible for a minority supplement. 2. Travel allowance for meeting attendance for all awardees is limited to $800 per year. 3. Equipment may be purchased only in unusual circumstances with prior approval by NIDR program staff. 4. Funds for supplies will be provided up to $1,500 and $2,500 for a graduate student and postdoctoral individual, respectively. All costs must be justified by the extent of the commitment and the aims of the research. 5. Salaries for individuals applying for a supplement for postdoctoral training may not exceed those in the table below. Fringe benefits are also an allowable cost. Years of Postdoctoral Research Experience Salary/Year 0 $19,608 1 $20,700 2 $25,600 3 $26,900 4 $28,200 5 $29,500 6 $30,800 7 or more $32,300 6. Tuition remission is considered a part of compensation and is an allowable expense for all candidates pursuing a graduate research degree (Masters, PhD or Doctorate of Sciences) but not the DDS or MD degrees. Individuals with a DDS or DMD degree are encouraged to pursue graduate research degrees and, therefore, tuition remission requests are allowable for these candidates. NIDR does not provide tuition remission reimbursement for high school and undergraduate students. Courses may be taken at the institution where the research is being conducted or at another institution. 7. The level of graduate student compensation is determined by the guidelines published in the NIH Guide for Grants and Contracts, Vol. 25, No. 8, March 15, 1996. According to these guidelines an NIH institute may award the actual amount of total compensation requested up to a maximum of $23,000. Total compensation for graduate students includes salary, including fringe benefits, and tuition remission. Applications not in compliance with these guidelines will be returned. 8. It is important for mentors at all levels of the program to provide specific steps and training experiences that will be included to prepare the individual for a career in biomedical and behavioral research. INQUIRIES For further information, contact: Dr. Norman S. Braveman Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN.24 - MSC 6402 Bethesda, MD 20892 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: Norman.Braveman@nih.gov Dr. Dennis F. Mangan Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN.24 - MSC 6402 Bethesda, MD 20892 Telephone: (301) 594-2421 FAX: (301) 480-8318 Email: Dennis.Mangan@nih.gov Dr. Eleni Kousvelari Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN.24 - MSC 6402 Bethesda, MD 20892 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: Eleni.Kousvelari@nih.gov Dr. Linda A. Thomas Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN.24 - MSC 6402 Bethesda, MD 20892 Telephone: (301) 594-2425 FAX: (301) 480-8318 Email: ThomasL@de45.nidr.nih.gov Dr. Ann Sandberg Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN.24 - MSC 6402 Bethesda, MD 20892 Telephone: (301) 594-2419 FAX: (301) 480-8318 Email: Ann.Sandberg@nih.gov Dr. Patricia Bryant Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN.24 - MSC 6402 Bethesda, MD 20892 Telephone: (301) 594-2095 FAX: (301) 480-8318 Email: Patricia.Bryant@nih.gov Dr. James Lipton Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN.24 - MSC 6402 Bethesda, MD 20892 Telephone: (301) 594-2618 FAX: (301) 480-8319 Email: James.Lipton@nih.gov Mr. Martin Rubinstein Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN.38 - MSC 6402 Bethesda, MD 20892 Telephone: (301) 594-4799 FAX: (301) 480-8303 Email: Martin.Rubinstein@nih.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NICHD-DBSB-96-10 ***************************************** POPULATION INDEX NIH GUIDE, Volume 25, Number 22, July 5, 1996 RFP AVAILABLE: NICHD-DBSB-96-10 P.T. 34; K.W. 0413000, 0413001, 1004017 National Institute of Child Health and Human Development The National Institute of Child Health and Human Development (NICHD) is planning to continue the collection and annotation of population literature for use as a research resource. The project involves the systematic review of key population-related publications worldwide supplemented by population-related materials from selected major sources and by the subsequent preparation of citations and abstracts for the items selected. The Contractor will be required to scan both primary and secondary source materials from all significant works of central demographic relevance and prepare a complete bibliographic citation indicating the work's range and content. The citations will be organized into a conceptual demographic scheme supplemented by cross-reference by author and geographical indices for publication. The Contractor shall have the technical ability, expertise and judgement to prepare the Population Index and to work closely with population, library and information agencies to assure that the products will evolve to meet changing research needs and changing technical capabilities. It is anticipated that the Population Index will be made available through the World Wide Web, at a minimum. This announcement is a new solicitation. It is anticipated that one cost-reimbursement, level of effort contract will be awarded for a period of five years. RFP NICHD-DBSB-96-10 will be available electronically on or about July 1, 1996, and may be accessed through either the NIH Home Page or the NIH Gopher by using the following electronic mail addresses and instructions: (1) 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 select "R&D Requests for Proposals (RFP)"; (2) To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOVPORT 70 (you should now be in the NIH Gopher). Select "Grant & Research Information", then select "R&D Requests for Proposals (RFP)." The following information within the RFP should enable you to determine whether you or your organization has the interest, capability, and resources to devote to the preparation of an offer to the Government for the performance of a contract if selected for an award: the Statement of Work, Reporting Requirements, the Technical Evaluation Criteria, and project background information. This information should be sufficient for you to make this determination without reading the entire, lengthy RFP with all of the boilerplate information. All information required to submit an offer is contained in the electronic RFP package. 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 by 4:00 PM (EDT) August 16, 1996. Questions may be directed to program contacted listed under INQUIRIES. INQUIRIES All requests must cite the RFP number above and should include two self addressed mailing labels (if a mail request). All sources who consider themselves qualified are encouraged to submit proposals. Those organizations desiring a hard copy of the RFP may mail or FAX a written request to: Virginia A. DeSeau Contracts Management Branch National Institute of Child Health and Human Development 6100 Executive Building, Suite 7A07 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-4611 FAX: (301) 402-3676 Email: deseaug@hd01.nichd.nih.gov $$R1 END ************************************************************ $$R2 BEGIN DA-97-002 FULL-TEXT ************************************** NEUROBIOLOGICAL EFFECTS OF DRUG ABUSE THERAPIES NIH GUIDE, Volume 25, Number 22, July 5, 1996 RFA AVAILABLE: DA-97-002 P.T. 34; K.W. 0404009, 0745070, 0705055 National Institute on Drug Abuse Letter of Intent Receipt Date: September 18, 1996 Application Receipt Date: October 18, 1996 PURPOSE This Request for Applications (RFA) solicits research grant applications on the neurobiological effects of pharmacological and/or nonpharmacological drug abuse treatments upon structure and/or function of the human central nervous system. Results from such studies should ultimately provide a basis for the development and improvement of behavioral and medication treatment of patients with drug abuse disorders. This research program is intended to support individual research project grants (R01, R03, R21, R29) and mentored career development awards (K01, K08) on the clinical neurobiological effects of specific treatments for drug abuse disorders. Research using animals is not excluded, but any animal research in projects submitted under this RFA must serve an essential, but secondary role, in a predominantly clinical study. In FY 1997, it is anticipated that approximately ten to twelve awards may be funded at a total cost of up to $1.5 million. Approximately five regular grant (R01) awards at an average of $200,000, and five to seven awards under the other mechanisms are anticipated. 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, Neurobiological Effects of Drug Abuse Therapies, is related to the priority area of alcohol and other drugs. 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. Arthur MacNeill Horton, Jr., Ed.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room Number 10A-46 Rockville, MD 20857 Telephone: (301) 443-4877 FAX: (301) 443-2317 Email: ah61x@nih.gov $$R2 END ************************************************************ $$P1 BEGIN PA-96-062 FULL-TEXT ************************************** RESEARCH ON HIV INFECTION IN THE GENITOURINARY TRACT NIH Guide, Volume 25, Number 22, July 5, 1996 PA AVAILABLE: PA-96-062 P.T. 34; K.W 0715008, 1002004, 1002008, 0705075 National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Child Health and Human Development (NICHD) solicit research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award applications for support of studies focused on infections of the Human Immunodeficiency Viruses (HIV) and the effects of such infections on the genitourinary tract. 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). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), the NIDDK Website (http://www.niddk.nih.gov), and by mail or email from the program official 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, Room 6AS-19B MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: Ralph_Bain@nih.gov Donna L. Vogel, M.D., Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Building 61E, Room 8B01 MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: Vogeld@hd01.nichd.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-96-063 FULL-TEXT ************************************** EFFECTS OF HIV INFECTIONS ON THE KIDNEY NIH Guide, Volume 25, Number 22, July 5, 1996 PA AVAILABLE: PA-96-063 P.T. 34; K.W. 0715008,0715133, 1002004, 1002008 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award applications for support of research addressing the infections of the Human Immunodeficiency Viruses (HIV) and the effects of such infections on the kidney, on patients undergoing treatment with dialysis, and/or patients with a renal allograft. 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). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), the NIDDK Website (http://www.niddk.nih.gov), and by mail or email from the program official 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, Room 6AS-19B MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: Ralph_Bain@nih.gov $$P2 END ************************************************************ ERRATA $$E1 BEGIN P1 19960628 APPEND PAR-96-060 BOTH ************************** ACUTE INFECTION AND EARLY DISEASE RESEARCH NETWORK NIH Guide, Volume 25, Number 22, July 5, 1996 PA AVAILABLE: PAR-96-060 P.T. 34; K.W. 0715008, 0765033, 0745000 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 1, 1996 Application Receipt Dates: October 11, 1996; September 1, 1997; and September 1, 1998 The following correction is issued for PAR-96-060, which was published in the NIH Guide, Vol. 25, No. 21. June 28, 1996: SCHEDULE: Letter of Intent Receipt Date: August 1. 1996 Application Receipt Date: October 11, 1996 Scientific Review Date: February 1997 Earliest Date of Award: May 1997 INQUIRIES Inquiries regarding programmatic issues may be directed to: Michael Hedderman, R.N., M.P.H Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B30 Bethesda, MD 20892 Telephone: (301) 496-8214 FAX: (301) 480-4582 Email: mh33a@nih.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Mon Jul 08 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-063 - V25(22) 07/05/96 Date: 9 Jul 1996 15:32:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 256 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4rumm5$bhc@net.bio.net> NNTP-Posting-Host: net.bio.net EFFECTS OF HIV INFECTIONS ON THE KIDNEY NIH Guide, Volume 25, Number 22, July 5, 1996 PA NUMBER: PA-96-063 P.T. 34; K.W. 0715008,0715133, 1002004, 1002008 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites grant applications for support of research addressing the infections of the Human Immunodeficiency Viruses (HIV) and the effects of such infections on the kidney, on patients undergoing treatment with dialysis, and/or patients with a renal allograft. 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 and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) award mechanisms. Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. Because the nature and scope of the research proposal in response to this PA may vary, it is anticipated that the size of an award will vary also; however, the support of requests exceeding the NIDDK average grant size of $160,000 direct cost for R01 grants would be unusual and require ample justification. FIRST (R29) awards are limited to $350,000 direct cost over the five year period. RESEARCH OBJECTIVES The purpose of this program announcement is to solicit applications in order to support cellular and molecular studies that focus on the effects of the HIV infection on renal structure and function. Studies that focus on the pathogenesis of the nephropathy associated with HIV infection are especially sought. The various factors that influence the renal manifestations of the HIV infections need to be elucidated as well as the effects on renal function as a result of the various treatment modalities for HIV. Studies that focus on the clinical course of the HIV infection in dialysis patients are encouraged. Studies could include for example: (1) factors that modulate progression from initial infection and seropositive response to HIV to the development of ARC and/or AIDS; (2) effects of blood transfusions, immunizations and vaccinations; (3) effects of co-infection with the hepatitis virus; (4) treatment of anemia and the effects of HIV treatment modalities. Studies involving renal transplant recipients who have the HIV infection are encouraged. Such studies might focus on factors such as: immunosuppression; histocompatibility; co-infections; patient survival; and the immunosuppression regimen. Applications for clinical studies in dialysis and/or with renal transplant patients not infected with HIV are not applicable. Program project grant applications (P01) are not suited to this announcement. 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. Animal Welfare Considerations Investigators are encouraged to consider alternative methods and approaches in their research grant applications that do not require the use of whole animals, use alternative species such as nonmammals or invertebrates, reduce the number of animals required, and incorporate refinements to procedures that will result in the elimination or further minimization of pain and distress in animals. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The program announcement title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Potential R29 applicants should refer to the notice on Just-in-Time Procedures for FIRST and Career Awards (NIH Guide for Grants and Contracts, Vol. 25, No. 10, March 29, 1996) for information on recent changes in guidelines for FIRST award format. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria 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, particularly, but not exclusively, in the area of the proposed research; 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. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. For Applications from Foreign Organizations: o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries that are not readily available in the United States or that provide augmentation of existing U.S. resources. AWARD CRITERIA Applications will compete for available funds with other approved applications assigned to the National Institute of Diabetes and Digestive and Kidney Diseases. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: 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-19B MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: Ralph_Bain@nih.gov Inquiries regarding fiscal matters may be directed to: Trude Hillard Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-44J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8859 Email: HillardT@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 PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Jul 08 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-062 - V25(22) 07/05/96 Date: 9 Jul 1996 15:32:04 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 274 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4ruml4$bfu@net.bio.net> NNTP-Posting-Host: net.bio.net RESEARCH ON HIV INFECTION IN THE GENITOURINARY TRACT NIH Guide, Volume 25, Number 22, July 5, 1996 PA NUMBER: PA-96-062 P.T. 34; K.W 0715008, 1002004, 1002008, 0705075 National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Child Health and Human Development (NICHD) solicit research grant applications for support of studies focused on infections of the Human Immunodeficiency Viruses (HIV) and the effects of such infections on the genitourinary tract. 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 and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This Program Announcement (PA) will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will vary also; however, the support of requests exceeding the NIDDK average grant size of $160,000 direct cost for R01 grants would be unusual and require ample justification. FIRST (R29) awards are limited to $350,000 direct cost over the five year period. RESEARCH OBJECTIVES The purpose of this program announcement is to solicit applications in order to support cellular and molecular studies which focus on the effects of the HIV infection on the genitourinary tract. Such studies might include for example: tissues/fluid/secretions involving the urine, semen, bladder, urethra, prostate, testes, seminal vesicles, and epididymides. Broad areas for investigation could include the location of the HIV in such tissues and the effect(s) of the HIV infection on the cellular structure/function of these tissues. It is also of interest to study the effectiveness of pharmacological therapy on eradicating HIV infection in these tissues and to study the pathogenesis and treatment of urological disorders secondary to HIV infection. Studies that focus on the effect(s) of HIV infections on the physiology of the genitourinary tract as monitored by established clinical methodologies such as urodynamics, radiographic and sonographic technologies are encouraged. The various factors that influence the genitourinary manifestations of HIV infections need to be elucidated as well as the effects on the function(s) of the genitourinary tract as a result of the various treatment modalities for HIV. Applications for clinical studies in urodynamics and urinary tract infections that have no relationship to HIV infection are not requested. Program project grant applications (P01) are not suited to this announcement. 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. Animal Welfare Considerations Investigators are encouraged to consider alternative methods and approaches in their research grant applications that do not require the use of whole animals, use alternative species such as nonmammals or invertebrates, reduce the number of animals required, and incorporate refinements to procedures that will result in the elimination or further minimization of pain and distress in animals. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The program announcement title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Potential R29 applicants should refer to the notice on Just-in-Time Procedures for FIRST and Career Awards (NIH Guide for Grants and Contracts, Vol. 25, No. 10, March 29, 1996) for information on recent changes in guidelines for FIRST award format. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria 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, particularly, but not exclusively, in the area of the proposed research; 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. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. For Applications from Foreign Organizations: o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries that are not readily available in the United States or that provide augmentation of existing U.S. resources. AWARD CRITERIA Applications will compete for available funds with other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: 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-19B MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: Ralph_Bain@nih.gov Donna L. Vogel, M.D., Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Building 61E, Room 8B01 MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: Vogeld@hd01.nichd.nih.gov Inquiries regarding fiscal matters may be directed to: Trude Hillard Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-44J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8859 Email: HillardT@ep.niddk.nih.gov Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8A17 Bethesda, MD 20892 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 No. 93.849 and 93.864. 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 PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Jul 08 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 9 July 1996 Date: 9 Jul 1996 15:23:58 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 98 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4rum5u$acv@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 July 9, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: General Publication Title: NSF 96-23 Engineering Research Centers File size (bytes): A Partnership for Competitiveness STIS Filename: nsf9623.txt (NSF) Title: PECASE -- Presidential Early Career Awards for Scientists and Engineers File size (bytes): 17641 STIS Filename: pecase.txt Document Type: Recruit Title: Executive Officer, Division of Chemistry File size (bytes): 7247 STIS Filename: vep967.txt Title: Chemist (Program Director) File size (bytes): 5410 STIS Filename: vex9620.txt Title: Office Automation Clerk File size (bytes): 8191 STIS Filename: vgs9648.txt Title: Program Assistant (Office Automation) File size (bytes): 8383 STIS Filename: vgs9649.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113740 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Alpha Telephone Directory File size (bytes): 113740 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 124588 STIS Filename: phnorg.txt Title: NSF Organization Telephone Directory File size (bytes): 124588 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). 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 WAIS or Gopher: Do a word search on the filename as shown in the summary. 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" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Sun Jul 14 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 13 July 1996 Date: 15 Jul 1996 11:39:52 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 98 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4se39o$ja1@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 July 13, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 96-15 - JAPAN'S MONBUSHO RESEARCH EXPERIENCE FELLOWSHIPS FOR YOUNG FOREIGN RESEARCHERS, 1996 File size (bytes): 3137 STIS Filename: int9615.txt Title: INT 96-16 - INNOVATIVE INDUSTRIAL TECHNOLOGY R&D PROMOTION PROGRAM File size (bytes): 1855 STIS Filename: int9616.txt Document Type: Press Release Title: RAINFALL ENHANCEMENT TECHNIQUE TESTED IN DROUGHT-RIDDEN MEXICO File size (bytes): 3648 STIS Filename: pr9637.txt Document Type: Recruit Title: Supervisory Computer Specialist (Section Head) File size (bytes): 9417 STIS Filename: vgs9650.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 94781 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113740 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 124588 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 96-14 International Opportunities for Scientists and Engineers File size (bytes): 160157 STIS Filename: nsf9614.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9614.txt, the text of your message should be as follows: get nsf9614.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9614.txt, you would enter: ftp> get nsf9614.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. 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" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Tue Jul 16 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 23, pt. 1of1, 12 July 1996 Date: 16 Jul 1996 20:24:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1483 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4shme0$gr7@net.bio.net> NNTP-Posting-Host: net.bio.net X-comment: RFAs described: HL-96-014, PA-96-064, PA-96-065 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.07.12 NIH GUIDE - Vol. 25, No. 23 - July 12, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE - - - HOW TO OBTAIN CURRENT AND PAST ISSUES National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** NIH REINVENTION ACTIVITIES: STATUS REPORT National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** PUBLIC HEALTH SERVICE POLICY RELATING TO DISTRIBUTION OF UNIQUE RESEARCH RESOURCES PRODUCED WITH PHS FUNDING Public Health Service INDEX: PUBLIC HEALTH SERVICE $$INDEX N4 ********************************************************** NATIONAL INSTITUTE OF MENTAL HEALTH GENETICS INITIATIVE National Institute of Mental Health INDEX: MENTAL HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 07/22/96 ************************************************* SCOR IN NEUROBIOLOGY OF SLEEP AND SLEEP APNEA, AIRWAY BIOLOGY AND PATHOGENESIS OF CYSTIC FIBROSIS, AND ACUTE LUNG INJURY (RFA HL-96-014) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX P1 ********************************************************** MENTAL HEALTH RESEARCH IN EATING DISORDERS (PA-96-064) National Institute of Mental Health National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases Office of Research on Women's Health INDEX: MENTAL HEALTH; DENTAL RESEARCH; DIABETES, DIGESTIVE, KIDNEY DISEASES; WOMEN'S HEALTH $$INDEX P2 ********************************************************** NEURONAL CEROID LIPOFUSCINOSIS, INCLUDING BATTEN DISEASE (PA-96-065) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NIH GUIDE - - - HOW TO OBTAIN CURRENT AND PAST ISSUES NIH Guide, Volume 25, Number 23, July 12, 1996 P.T. 34; K.W. 1014006, 1014017 National Institutes of Health The following is an update of instructions for obtaining the NIH Guide for Grants and Contracts by subscribing to a LISTSERV edition, through the internet, and on an electronic bulletin board. The NIH Guide for Grants and Contracts is published in one printed and several electronic editions. One copy of the printed edition, which includes notices regarding NIH policy and notices of the availability of Program Announcements, Requests for Applications, and Requests for Proposals, is provided to the office of sponsored research or equivalent of any interested organization. The electronic editions and procedures for obtaining them are provided below. o LISTSERV SUBSCRIPTION for full text The NIHGDE-L is an electronic edition of the full text of the NIH Guide for Grants and Contracts. Subscribing and unsubscribing to/from the LIST is done via email, using customary LISTSERV commands. To subscribe to the LIST, send mail to listserv@list.nih.gov. The text of the mail should read ONLY: SUBSCRIBE NIHGDE-L First-name Last-name The First & Last names should be in upper & lower case; e.g.: SUBSCRIBE NIHGDE-L Bill Jones This will subscribe the email address from which the mail was sent. To subscribe an address from which mail cannot be sent (e.g., an internal distribution list), send mail to wkj@cu.nih.gov. To remove an address from this LIST, send mail to listserv@list.nih.gov from that address. The text of the mail should read ONLY: UNSUBSCRIBE NIHGDE-L o LISTSERV SUBSCRIPTION to Table of Contents The NIHTOC-L list contains only the Table of Contents of each issue of the NIH Guide. The full text version of any notice, program announcement (PA), or request for applications (RFA) can be obtained through other means such as the NIH website, the NIH Grant Line Bulletin Board, or via ftp. Each issue of the TOC contains the URL that may be used via Gopher to access that issue of the E-Guide and/or the full text of a Program Announcement or Request for Applications on the NIH Gopher server. (see also item 4., below) To subscribe to the NIHTOC-L, send mail to LISTSERV@list.nih.gov. The text of the mail should read ONLY: SUBSCRIBE NIHTOC-L First-name Last-name To unsubscribe, the command is: UNSUBSCRIBE NIHTOC-L o NIH GRANT LINE BULLETIN BOARD To access the NIH Grant Line, the terminal emulator must be configured as follows: 2400 or 9600 baud, even parity, 7 data bits, 1 stop bit, half duplex. Using the procedure specified in the communication software, dial 1-301-402-2221. When a response indicates that a connection has been made, type ,GEN1 (the comma is mandatory) and press ENTER; the NIH system will prompt for INITIALS?. Type BB5 and press ENTER. A prompt will ask for ACCOUNT? Type CCS2 and press ENTER. Messages and a menu will be displayed that allow one to read Bulletins and download Files. Back issues of the NIH Guide are found in different Directories. GUIDE90 has issues going back to July 6, 1990; GUIDE91, GUIDE92, and GUIDE93 have all issues for each year. Type F (for FILES) to access any of the files that are arranged into directories. To get an overview of the kinds of information available, type D (for Directory). Access to the NIH Grant Line via the Internet To access the NIH Grant Line in an interactive Internet session, Telnet to wylbur.cu.nih.gov and, when a message has been received that the connection is open, type VT100. At the INITIALS? prompt, type BB5 and at the ACCOUNT? prompt, type CCS2. This puts the user into the NIH Grant Line. o WORLD WIDE WEB (WWW) Current and past issues of the NIH Guide for Grants and Contracts may be accessed via the World Wide Web. The NIH gopher server, which contains the printed edition of the NIH Guide in ASCII text format and the full text of Program Announcements, Requests for Applications, and Notices, is accessible through the NIH Home Page, URL http://www.nih.gov. Select "Grants and Contracts" and then ~Funding Opportunities~ to find the NIH Guide. o INDIVIDUAL ANNOUNCEMENTS AND BACK ISSUES FROM THE LIST ARCHIVES Each mailing distributed via the NIHGDE-L LIST is automatically archived by LISTSERV. All issues after 1/19/90 have been saved with the text of each RFA and PA as a separate document. Retrieving files from the LISTSERV archives is a two step process: a list of the available archive files is obtained by sending an INDEX NIHGDE-L command to listserv@list.nih.gov. These files can then be retrieved by means of a ET NIHGDE-L filetype command or by using the database search facilities of LISTSERV. Send an INFO DATABASE command for more information on the latter. The following is a sample of the INDEX command file information: filename filetype GET PUT -fm lrecl nrecs date time Remarks -------- -------- --- --- --- ----- ----- -------- ----------- NIHGDE-L 90-00027 PRV OWN V 80 969 90/01/18 16:12:44 -> NIH Guide, Vol. 19, No. 3, January 19, 1990 The information for each entry consists of two lines. The first line contains information necessary for retrieval and the beginning of the Remarks, and the second contains the rest of the Remarks. The important information is the number (90-xxxxx) and the Remarks. The Remarks field is the subject line of the mail distributed and shows which documents can be retrieved. The number is the value used in the GET command. To retrieve files, send mail (to listserv@list.nih.gov) that contains one line for each document as follows: GET NIHGDE-L number For example, to get the main body of the NIH Guide for 1/19/90, the mail would contain the line: GET NIHGDE-L 90-00027 The documents referenced in the GET commands will be sent back as files. o ANONYMOUS FTP The NIH Guide is available via anonymous ftp at the NIH Computer Utility. The files contain both the main body of the printed edition of the NIH Guide and the full text of the notices, Program Announcements, and Requests For Applications. The format of the delimited records is slightly different and is explained in the README file. The file names are of the form Gmmddyy, where mmddyy is the month/day/year of the date of the NIH Guide. To access the NIH Guide via Anonymous ftp: ftp to ftp.cu.nih.gov (specify ANONYMOUS as the userid and GUEST as the password) cd nih-eguide All usual ftp commands are available. INQUIRIES For information regarding the production of and obtaining an electronic edition of the NIH Guide, contact: Myra Brockett Office of Extramural Outreach and Information Resources, NIH 6701 Rockledge Drive MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-2801 FAX: (301) 480-8443 Email: asknih@odrockm1.od.nih.gov For matters (subscribe, unsubscribe, and change of address) about a subscription to the printed edition of the NIH Guide, contact: Jahna Stanton Office of Extramural Outreach and Information Resources, NIH 6701 Rockledge Drive MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-2801 FAX: (301) 480-8443 Email: asknih@odrockm1.od.nih.gov For information about the NIH Grant Line Bulletin Board, contact: John C. James, Ph.D. Office of Extramural Outreach and Information Resources Email: JQJ@cu.nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NIH REINVENTION ACTIVITIES: STATUS REPORT NIH Guide, Volume 25, Number 23, July 12, 1996 P.T. 34; K.W. 1014006, 1014017 National Institutes of Health This is the fourth status report on NIH reinvention activities. The previous reports were published in the NIH Guide for Grants and Contracts, Vol. 23, No. 44, December 16, 1994; Vol. 24, No. 14, April 14, 1995, and Vol. 24, No. 40, November 24, 1995. The initiatives described below represent the high priority areas for the NIH at this time. Initiatives that have been fully implemented and described in previous status report are not repeated below, nor are other initiatives that are under preliminary discussion and not yet at the pilot testing stage. As the NIH continues to undertake reinvention activities and new initiatives, we recognize the need to establish a framework to provide the necessary structure for optimal interactions and complementarity of the various reinvention activities. The framework delineates four major goals for reinvention: (1) maximize scientific opportunities through optimal use of resources; (2) enhance NIH interactions with the scientific community; (3) clarify and streamline decision-making processes; and (4) focus internal operations on outcomes and results. Each of these goals are further developed into specific reinvention objectives, and the plan is to use these goals and objectives as guide-posts as the NIH moves forward with the myriad of reinvention projects. The initiatives described in this report support the reinvention goals mentioned above. For example, the electronic research administration (ERA) initiative is developed as a set of tools and systems that enable the NIH to improve its interactions with the scientific community. Other reinvention goals are met through initiatives that streamline the application processes, focus peer review and Council or Board functions, reduce administrative burdens for the grantee institutions and the NIH staff, etc. Collectively, they are aimed to achieve the NIH mission: to improve health through science. The NIH reinvention laboratory, as designated under Vice President Gore's National Performance Review (http://www.npr.gov), is an open forum, grounded on the important principles that value its employees and their input as well as feedback from the scientific community. Reinvention is an evolving operation, which will continue to rely on the valued input of all interested parties. Comments or suggestions on the implemented changes and pilot experiments are welcome and may be sent to the following email address: DDER@nih.gov. I. ELECTRONIC REPORTING AND SUBMISSION OF GRANT AND CONTRACT MATERIALS A. ELECTRONIC RESEARCH ADMINISTRATION (ERA): (expanded pilot project under way) -- This initiative represents a commitment to improve administrative operations through information technologies and reengineering of process. A key feature of the reengineering effort is the idea of maintaining the information required for various NIH processes within a client-server common file database. This common file is envisioned as the electronic interface between the NIH and the awardee community and the repository for information generated during the life cycle of each award. The database would be accessible to authorized applicants, awardees and NIH staff, who could each review and add information as required. Proposed components of the system include the application shell, institutional profile, status system (including review dates, scores, and summary statements), notice of grant award, invention reporting, progress reporting, and other required reporting (e.g., women and minorities in clinical research, trainee appointments, and financial reporting). Of these, four are currently in pilot mode: the application shell, invention reporting (EDISON), trainee appointments, and streamlined noncompeting award process (SNAP). (updated 7/96) ELECTRONIC SUBMISSION OF THE GRANT APPLICATION SHELL: (pilot study under way) -- Under a Department of Energy (DOE) Cooperative Agreement, the NIH and several Department of Defense (DoD) agencies are participating in a pilot study to test a new system for the submission of grant application information. These agencies and eight research institutions will test the Electronic Data Interchange (EDI) standards developed collaboratively by the Federal agencies. Key administrative information in R01 grant applications, such as face page information, scientific abstract, certain budget items, and personal data for the Principal Investigator (but not including the project description), will be submitted directly into NIH's database, without intervening paper copies or manual rekeying of data. The rest of the application will be submitted on paper. The "institutional profile" will contain administrative information specific to each grantee organization that can be electronically linked to grant applications through the use of unique, organizational, identifying numbers. The institutional profile database will eliminate the need to provide the same information for each application submitted by an organization. By using EDI standards, commercial software vendors will be able to develop software that can create data streams for transmission to the NIH without the need for compatible processing systems. In December 1995, the NIH began receiving test EDI submissions from several of the cooperative agreement participants. The next phase of the pilot is to test the integration of grant application information submitted electronically with the IMPAC II data system. (updated 7/96) EDISON INVENTION REPORTING: (on-going production) -- The system, designed to receive, store, sort, and report, is now in production with forty grantee organizations authorized to report inventions, patents, and licensing information resulting from NIH support. Additional organizations continue to participate, and all grantee organizations are encouraged to explore the EDISON homepage (http://era.info.nih.gov/EDISON/). EDISON uses a world wide web (WWW) interface in a client server architecture whereby authorized grantee organizations and NIH staff can access a shared relational database. By using a browser that supports secure socket layer standards, e.g., Netscape or Microsoft Internet Explorer, grantees are able to send their information in a fully secured electronic environment. Data can be viewed and modified in real time in an interactive setting. An additional version of EDISON has been designed to simplify submission of invention information for grantee organizations with resident databases. Rather than asking these organizations to rekey information into EDISON via the web browser, the NIH has developed software, available free for use on all platforms. The software, called Internet Talkers, will enable computer to computer transfer of data and is now in beta testing. As a result of interagency cooperation and collaboration, most of the Federal agencies with invention reporting requirements such as DoD, USDA, NSF, DOE, USAID will be using EDISON as the common interface to government invention reporting in the near future. Further efforts to this end involve elaboration of the EDISON data elements to become a full public standard and finalization of a transaction set to be presented to the American National Standard Institute X12 committee. Many features of the user friendly EDISON prototype such as differential access to data, electronic security, and establishing test accounts to try out the system will be incorporated in future electronic research administration projects deployed by NIH such as the Streamlined Noncompeting Award Process (SNAP), the status system, and institutional profile. (updated 7/96) ELECTRONIC REPORTING OF TRAINEE APPOINTMENTS: (pilot project under way) -- The Office of Extramural Research (OER) has developed an interface for the collection of trainee appointment information. Like EDISON, the trainee appointment system is an interface on the world wide web (WWW) through which information about trainees appointed to a National Research Service Act (NRSA) Institutional Research Training Grant may be entered. This system will replace the printed Statement of Appointment form 2271. All eight DOE Cooperative Agreement demonstration centers are participating in the pilot project. It is anticipated that this system of reporting will be expanded to additional grantee users in FY 97. (updated 7/96) STREAMLINED NONCOMPETING AWARD PROCESS (SNAP): (electronic version will be piloted in September 1996)--In FY 95, NIH instituted a simplified noncompeting award process (SNAP) for the majority of noncompeting continuation awards that carry the expanded authorities (see notice in the NIH GUIDE 1/20/95 and the PHS 2590). Under SNAP, certain components of the noncompeting application are not required if there are no significant changes. This streamlined process eliminated, where nonessential, two of the financial documents that were part of the noncompeting application kit (PHS 2590): a categorical budget for the next budget period and an estimated report of expenditures for the current budget period. Three key questions must be answered in the annual progress report pertaining to significant changes in budget (rebudgeting or unobligated balance), other support, and effort of key personnel. If these responses indicate significant changes, then the supporting documentation (e.g., budget page) must be provided; if they are in the negative, then the budget and/or other support pages do not need to be submitted. In FY 96, NIH implemented Phase II of SNAP (see the NIH GUIDE 10/27/95), in which the Notice of Grant Award was changed to reflect only direct and indirect costs and indirect costs are now included in the future year recommended levels. In an attempt to further streamline the non-competing process, in FY 97 the NIH is implementing Phase III of SNAP by modifying the financial reporting requirements. Effective for SNAP awards with budget start dates of July 1, 1995 or later, the annual Financial Status Report (FSR, SF 269) will no longer be required. The FSR will only be required at the end of each competitive segment rather than at the end of the budget period. It is important to stress that this change in administrative requirements does not alter the grantee's responsibility to account for costs on a project basis and ensure that grant funds are expended in accordance with all applicable grant regulations and policies in support of the approved project. A detailed notice is published in the NIH GUIDE (Volume 25, Number 22, July 5, 1996) to further explain implementation guidelines for SNAP Phase III. Consistent with the ERA initiative, the Office of Extramural Research (OER) is developing a World Wide Web-based procedure for electronic submission of the SNAP information. This function, which eventually will be a part of the common file, will permit the applicant to submit electronically all the information necessary to initiate the noncompeting award process for SNAP awards. The principal investigator (PI) will see on the computer screen the information that NIH has on file for that grant. The PI and institution business official will then be able to make changes in that information, as appropriate, and add the progress report. Once the information has been submitted to NIH, it will be presented automatically to the program and grants management staff responsible for preparing the noncompeting award. It is expected that the electronic SNAP pilots will begin this fall and will involve testing with several Federal Demonstration Project participants, including the 8 DOE cooperative agreement participants. (updated 7/96) B. INTERAGENCY ELECTRONIC COMMERCE IN RESEARCH ADMINISTRATION -- Beginning in 1993, 11 federal agencies began to develop an integrated approach to electronic commerce in research administration. The term 'electronic commerce' is used broadly to include any use of automated information systems or electronic data that drives paper from the work place -- in the agencies and in the research community. Electronic commerce requires a variety of tools operating in many different environments to be successful. The tools include electronic mail, electronic funds transfer (EFT), electronic data interchange (EDI), World Wide Web (WWW), CD-ROM, electronic imaging, etc. The agencies have developed a strategic plan to guide their electronic commerce activities. The plan is grounded in the important principles that government-wide standards and multiple agency approaches should be developed wherever appropriate and practicable, while providing flexibility for each agency's unique mission and business requirement. The agencies have implemented several pilot projects, e.g., NIH Edison, NSF FastLane, DOE Electronic Research Administration, and ONR Electronic Invoicing. Based on the results of such pilot projects, the agencies will develop standards and systems that provide a variety of implementation assuring a common interface (e.g., a common interface for retrieving status information for multiple agencies). In establishing a shared system for organization or institution profiles, the obvious benefit is the reduction of applicants' repetitive submission of standard, seldom changing information, e.g., when the same or similar proposal is submitted to multiple agencies. Other benefits to the agencies and the recipient institutions are cost and time savings in receiving and evaluating proposals and also simplifying the awards process. The agencies will continue to use a wide variety of outreach mechanisms to assure the involvement of and communication with institutions, researchers, and others affected by electronic commerce in research administration. C. CONTRACTS REQUEST FOR PROPOSALS (RFP) ON THE NIH GOPHER SERVER: (expanded pilot experiments)-- The National Institute of Allergy and Infectious Diseases (NIAID) is posting all of its RFPs on the NIH Gopher server. A substantial savings in the cost of mailing and copying, and in contract staff effort will be realized through electronic distribution of RFPs. The re-engineered RFP provides information in a more logical sequence, making the process of reviewing the document much more efficient and effective for potential offerors. For example, the information generally used by potential offerors to determine their interest in responding to a requirement (the Work statement, Delivery/Reporting Requirements, and Evaluation Criteria) is now contained in the first section of the RFP. Instructions for proposal preparation and other documents (the contract format, clauses, and required forms) appear in separate sections. The National Cancer Institute (NCI) and the National Heart, Lung, and Blood Institute (NHLBI) have developed standard language for RFPs posted on the Gopher server. Other ICDs are expected to begin posting RFPs on the Gopher server using the standard language and instructions. (updated 7/96) PAPERLESS ACQUISITION: (pilot experiment) -- The NIAID is developing a system that will provide for electronic solicitation, receipt, and review of proposals. The entire text of an RFP is being posted on the Internet and will provide: information necessary for offerors to assess the nature of the Government's requirement; instructions for submitting an electronic proposal; and, details describing how resultant proposals will be evaluated. Proposals are planned to be submitted by offerors and reviewed using electronic mail. The "paperless" acquisition system will reduce the time and expense of all parties involved in the acquisition process. (added 7/96) II. APPLICATION OR PROPOSAL SUBMISSION A. GRANTS AMENDED APPLICATIONS: ( October 1996) -- Beginning with the October 1996 receipt date, the NIH will no longer consider any A3 or higher amendments to an application and, regardless of the number of amendments, the NIH will not accept an amended application that is submitted later than two years beyond the date of the receipt of the initial, unamended application. In FY 1995 the proportion of amended applications has risen to 34 percent of all research project grant (RPG) applications. Approximately half of the unfunded grant applications are amended and resubmitted in the hope that the quality of each resubmission will have improved sufficiently to reach the payline. Although a number of these applications are eventually funded, the statistics also indicate that investigators who receive initial funding based on an amended application, whether for a new submission (Type 1) or a competing renewal (Type 2), experience a lower success rate in subsequent efforts to secure funding for a competing renewal application, and the probability of subsequent success in the competing renewal process diminishes as the number of amendments per application goes up. We believe that after three unsuccessful attempts at funding, it is preferable for all applicants to take a fresh start at their research plans. Therefore, the NIH has adopted a policy that limits the number of amendments to two. This limit allows principal investigators sufficient time to generate preliminary data if it is required by the reviewers, and to consider new findings in the area of research. (added 7/96) EXPEDITED ASSIGNMENT OF AMENDED AND COMPETITIVE CONTINUATION APPLICATIONS: (fully implemented July 1994)-- The Division of Research Grants (DRG) has the responsibility for the receipt and assignment of all research grants to the appropriate ICs and initial review group (IRG). For each new application this referral process requires time and careful attention to reference the aims of the application with identified program areas of the ICs and expertise of the IRG. Since amended and competitive continuation applications have already gone through this referral process, the steps involved in making the referral for these applications could be abbreviated by automatically assigning these applications to the IC and IRG that previously were assigned to the original application. Of the 4,066 amended and competitive continuation applications that were received in July 1994, 96 percent were successfully assigned using either a fully automated referral to both ICs and IRG or partially automated referral to ICs with re-evaluation of the IRG. The most common reasons for the need for re-evaluation of the IRG were that the previous review had been conducted as a special review, thus the review group no longer existed, the investigator requested assignment to a different review group, or the application had been amended several times and required consideration for appropriate assignment. (added 7/96) JUST-IN-TIME: (expanded pilot experiments) -- The basic principle of "Just-in-Time" is to simplify and reduce the administrative and paperwork burdens of preparing an NIH grant application without compromising the initial review group determination of scientific merit or reasonableness of the proposed budget. Thus institutions are not required to submit certain kinds of information at the time of application, such as detailed budget for the initial budget period, the year-by-year categorical budget table, other support, and the checklist. An abbreviated budget justification and biographical sketch will suffice. The information for the applications with a likelihood of funding is submitted "just-in-time" for awards to be made. This delayed exchange of information significantly relieves the administrative burden for applicants who will not receive an award. Beginning in FY 1996, all NIH ICs have been encouraged to incorporate Just-In-Time procedures for RFAs, and the ICs may choose to incorporate modular budget instructions as well (see below). In addition, beginning with the June 1, 1996 receipt date for applications, all (new and revised) unsolicited First Independent Research Support and Transition (FIRST) (R29) award and career award (K) applications will be submitted with Just-In-Time procedures, which were published in the NIH Guide on March 29, 1996 and May 17, 1996 as well as the NIH Home Page. Under these special Just-In-Time instructions for R29 and K awards, a simplified budget and justification is submitted; a modified biographical sketch is required; no other support information is submitted; and no checklist page is required at the time of application. All other components of the regular application instructions and FIRST or K award guidelines apply. Those R29 and K award applicants with a likelihood of funding will be contacted for the necessary information prior to award. NIH is considering future expansion of the JIT principles to other unsolicited research grants mechanisms, which in addition to the core JIT features (delayed receipt of other support and checklist pages and a modified biographical sketch) would specify simplified budget instructions which are still under development. (updated 7/96) MODULAR GRANT: (limited implementation) -- All NIH ICs have been encouraged to incorporate modular budget instructions in RFAs that also incorporate the Just-In-Time procedures. Under the modular grant approach, applications are submitted with direct costs in modules (multiples) of $25,000, usually up to a maximum direct cost level. The model involves using pre-established funding levels for awards and acknowledging that grantees can and do rebudget post- award. This process eliminates the need for much of the budget detail, thereby relieving administrative burdens on both NIH staff and grantee organizations and simplifying cost management by NIH program staff. (updated 7/96) MODIFICATIONS TO THE FIRST (R29) AWARD PROGRAM: (implemented) -- Beginning with the JUNE 1, 1996 receipt date, unsolicited applications for FIRST (R29) awards must be prepared according to the requirements of Just-In-Time (JIT) procedures, as announced in the NIH Guide for Grants and Contracts, Volume 25, Number 10, March 29, 1996. There may be a significant delay in the processing and review of any application that has not been prepared according the instructions in the notice cited above. In addition to the procedural change, the NIH has discussed options for the R29 award mechanism to determine if it is effective in attracting and supporting beginning investigators. The R29 is a successful tool but may need certain modifications. While the budget cap ($75,000 a year) permits a longer period of support, it has not been adjusted for inflation. To encourage wider use, several options for increasing the amount of the award are under consideration. (added 7/96) B. CONTRACT JUST-IN-TIME: (pilot experiment) -- In keeping with the philosophy of JIT described above, the NIH has developed a proposal to postpone the collection of a fairly substantial amount of information that currently must be provided in all proposals. Specifically, substantiating cost information, financial statements, institutional travel policies, compensation plans, and subcontracting plans will no longer be required to be submitted with the initial proposal, but will be required at the time of submission of the best and final offer. This will relieve administrative and paperwork burdens for offerors who are not included in the competitive range, without compromising the determination of technical acceptability or the determination of the competitive range. The NCI has revised the R&D RFP work form to include procedures for implementing JIT, which will be utilized for all R&D requirements. (updated 7/96) III. PEER REVIEW AND COUNCIL REVIEW A. GRANTS RATING GRANT APPLICATIONS: (under discussion) -- As an ongoing effort to maintain high standards for peer review, the NIH undertook an examination of the process by which scientific review groups rate grant applications. The Rating of Grant Applications (RGA) subcommittee was established by the Extramural Reinvention Committee for this activity. The subcommittee has completed its deliberation and the report detailing a comprehensive set of recommendations is under discussion by the NIH and the scientific community. The NIH recognizes that changes to so critical an element of peer review as the system of rating grant applications should not be implemented without the participation and contributions of the scientific community that they will affect. While the report has been scrutinized by the NIH, and is the product of a careful and conscientious working group, the NIH has posted an overview as well as the full report on the NIH home page in order to facilitate inputs from the scientific community. It should be noted that the recommendations need not be considered as a package, but rather each can be implemented independently of each other. We are currently considering the pros and cons of each recommendation, and the positive and negative impacts that each could have on the peer review system and on other aspects of the awarding of research grants at NIH. Decisions on implementation of any of these recommendations would need to be made by January of 1997 if they were to be in place for the review of grant applications to be funded in fiscal year 1998. (updated 7/96) EXPEDITED REVIEW OF APPLICATIONS NEAR THE PAYLINE: (pilot under way) -- Currently, relatively strong applications for which reviewers may have raised a few minor criticisms are revised and resubmitted in the hope of achieving a fundable score. This process takes about nine months. For these applications the process is clearly inefficient, since such criticisms could be addressed by submitting an abbreviated revision with expedited review rather than resubmitting a complete application that must wait for the next review cycle. As part of an overall initiative to shorten the time from application to review, the NIH has developed new procedures to streamline the process for reconsideration of unsuccessful applications. The initiative focuses on unfunded, original type 1 and type 2 R01 applications that IC staff would identify with predetermined criteria developed in concert with their advisory councils or boards. For example, the ICs may consider only applications within a specific scoring range or vary the payline for different areas of science, e.g., basic science versus patient- oriented research. For these applications, an abbreviated revision in the form of a 3-5 page letter responding to the reviewers' criticisms could be sent to the IC and reviewed internally by staff with or without external advice. The primary objective of this initiative is to expedite the subsequent review of a group of applications that have already undergone initial and council review. (added 7/96) SUBMISSION OF ADDITIONAL INFORMATION FOR GRANT APPLICATION REVIEW: (pilot phase) -- Consistent with our goal of shortening the time line involved in the current peer review process, the NIH has developed a repertoire of tools that may be used alone or in combination to provide more information to reviewers as they consider applications. The primary goal is to minimize unnecessary delays in funding because of missing information that could easily be provided before or during the review meeting. The DRG plans to conduct pilot experiment in several study sections (CBY-1, CTY, ET-2, and one or more AIDS review groups) to test the concept of reviewers identifying applications as eligible to submit, at the PI's option, an abbreviated 3-5 page response providing supplemental information directly to the study section for review at the next meeting. Only those applications that the reviewers have identified as meritorious but which require limited additional information to potentially change the evaluation of scientific merit, would be eligible for this option. The status of the application would be delineated clearly in the Summary Statement. The Summary Statement and original application would be available to the reviewers at the next meeting. (added 7/96) ELECTRONIC REVIEW: (pilot experiment) -- The NIAID has developed a pilot experiment to test the feasibility of conducting electronic review, and the DRG is prepared to adapt some aspects of this model to review of applications in study sections. The idea is to provide an electronic platform for reviewers to interact prior to the review meeting. For example, a secure Internet access point could be provided that would allow each reviewer to independently upload directly his/her comments, score(s) and recommendation(s) regarding a specific grant application. Reviewers would have access to read and edit their own documents on the server to ensure accuracy but would not have access to any other reviewers' comments. This 'shielding' preserves independence of evaluations and scoring. After the first deadline, all reviewers' comments would be sealed and no longer could be edited or modified. At this time, the reviewers' comments and recommendations would be made available to the full committee to read. All members of the study section would be able to comment on any application or respond to the reviewers' critiques. This process of interactive dialogue would be allowed for a specified period of time, during which reviewers could also raise questions that might be related to the feasibility of the proposed project that they would want relayed to the applicant by the Scientific Review Administrator (SRA), and for which answers would be sought for discussion at the review meeting. In addition, reviewers could at any time indicate that they want to defer any further comment or discussion of a particular application until the actual review meeting. At the close of this second deadline, assigned reviewers would be allowed a third period of time to have access only to their original critiques and comments to change their written review and score in a manner reflective of the electronic discussion. Preliminary electronic interaction of reviewers could expedite review meetings, focus discussion on critical issues such as differences in reviews and 'gray area' applications. The benefit to applicants is the opportunity to address issues raised during the electronic review and allow them sufficient time to provide responses before meeting. (added 7/96) REVISED POLICY ON REVIEWER VOTING AND SCORING: (fully implemented) -- For many years, special reviewers recruited to supplement the expertise of chartered committees and evaluate particular areas of science have not been allowed to vote and score. In FY 1995 this amounted to 2600 reviewers, on average 4 to 5 per meeting. With an average of 12-18 appointed members per committee, this represents a substantial proportion of voices silent when the committee formalizes its recommendations. The revised policy makes it possible for any "fully participating reviewer" to vote and assign a score, whether a regular member of a chartered group or not. For this purpose, a "fully participating reviewer" is one who is formally assigned as a reviewer or discussant, or who is present, has reviewed and evaluated the application, and has participated in the deliberation on its scientific and technical merit at the review meeting. Allowing all such reviewers to vote and score has the potential for improving the quality of the review process, and in particular, the validity of the scores given to grant applications. In order to make the voting policy comply with the GSA regulations, special reviewers will serve as 'temporary members' for the meeting in which they participate. Another benefit of this change is that we will be able to include 'temporary members' when we track reviewers for participation of women and minority reviewers. This would more faithfully reflect the diversity of those who participate in peer review. This change in policy will be effective for all scientific peer review group meetings starting with the June 1996 review round. (added 7/96) INCREASING THE FLEXIBILITY OF APPOINTMENTS TO INITIAL REVIEW GROUPS: (under discussion)-- In addition to the changes in voting policy, strategies are being considered for improving the flexibility in making formal appointments for full membership on a review group. The primary goal in developing these strategies is to provide each Scientific Review Administrator (SRA) with additional tools for keeping pace with changes in science, while maintaining the ability to plan for future review meetings. (added 7/96) B. CONTRACTS STREAMLINING THE RESEARCH AND DEVELOPMENT (R&D) CONTRACT REVIEW PROCESS: (partial implementation) -- Recommendations for streamlining R&D contract review were developed following a Reinvention forum for Scientific Review Administrators. These include: limiting the number of pages in technical proposals, developing a common format for the preparation of proposals, and requiring input from the Scientific Review Administrator regarding the clarity of the statement of work, adequacy of the evaluation criteria, and the milestone dates pertaining to the initial peer review. These recommendations have been accepted in principle and implementation documents are in the process of being developed. (updated 7/96) EXPEDITED REVIEW OF R&D CONTRACT PROPOSALS: (partial implementation) -- The National Heart, Lung, and Blood Institute (NHLBI) has expedited review procedures for R&D contract proposals. The process is designed to improve the efficiency of the Special Emphasis Panel review meeting by reducing the workload of the reviewers and providing reviewers more time for discussion of the strengths and weaknesses of proposals having the highest probability of receiving an "acceptable" recommendation. These procedures are similar to the streamlined review process for grants, but all contract proposals are discussed by the Special Emphasis Panel, as required by the regulations for contract review. Other ICs are being encouraged to use these expedited review procedures. (updated 7/96) STREAMLINING SOURCE EVALUATION/SOURCE SELECTION PROCEDURES: (under development) -- The NCI is in the process of streamlining its two- tier source evaluation/selection procedures. The initial peer review group and the source evaluation group will be combined into one panel, which will be responsible for evaluating initial proposals, making recommendations concerning the competitive range, evaluating best and final offerors, and making selection recommendations. This will significantly reduce the amount of time between the initial technical evaluation and source selection, and will ultimately accelerate contract award by an average of 75 days. (added 7/96) C. COUNCIL REVIEW ELECTRONIC COUNCIL BOOK : (partial implementation) -- The NIA has developed an electronic Council book that is easy to search and readily available to program staff and Council members. Security is maintained using passwords that are changed after each Council meeting. Users can download or print Summary Statements thereby reducing the need to provide hard copy. The NIA effort is well received by its Council members, while it maintains flexibility to provide hard copies to members who did not want to be dependent on the electronic version. (added 7/96) ELECTRONIC REVIEW: (partial implementation) -- In February 1996 the NIAID expanded its experiment of streamlining its Advisory Council review by implementing a new electronic system to expedite the approval of applications with percentiles within the payline and having no special concerns, e.g., human subjects. Approval for these application may be obtained from its Advisory Council members electronically several weeks before the council meeting. A database contains the Summary Statements reviewed by a special Council subcommittee. Applications with concerns are reviewed by Council subcommittees in a closed session. On a NIH-wide level, many ICs have streamlined Council review by providing the Summary Statements to their members electronically prior to the meeting. Provisions are made for hard copies of the Summary Statements to be available to Council members if they wish. (updated 7/96) PROGRAM ANNOUNCEMENTS: (partial implementation) -- To encourage investigator-initiated research, the NIAID has decided to rely more heavily on program announcements (PA) and less on Requests for Applications (RFA) and Request for Proposals (RFP). The PAs are developed in conjunction with its Advisory Council and ad hoc consultants and identified as target areas of scientific opportunities. The paradigm shift represents a new means of stimulating investigator-initiated R01s. The PAs afford applicants all the benefits of investigators-initiated research, including multiple receipt dates, review by DRG, and a commitment to fund research in the stated scientific areas. The NIAID benefits from formulating its initiatives on a broad advisory base with the Council playing a proactive role to determine Institute priority. Thus meritorious applications with percentiles within the payline and possibly beyond it when necessary to build a desirable research portfolio. The Council will conduct an annual review of the Institute's PA to determine whether they succeeded in expanding a research area, should be modified, or should remain open for another year. (added 7/96) POST-AWARD PROCESSES GRANTS A number of post-award processes have been streamlined and reconfigured as part of the ERA initiative described above. Examples of processes conducted in an electronic medium are: streamlined non- competing award process (SNAP), EDISON, electronic trainee appointments, and electronic non-competing submission. (updated 7/96) INQUIRIES Dr. Wendy Baldwin Deputy Director for Extramural Research National Institutes of Health Building 1, Room 144 Bethesda, MD 20892-0162 Email: DDER@nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** PUBLIC HEALTH SERVICE POLICY RELATING TO DISTRIBUTION OF UNIQUE RESEARCH RESOURCES PRODUCED WITH PHS FUNDING NIH GUIDE, Volume 25, Number 23, July 12, 1996 P.T. 36; K.W. 1014006, 0780000 Public Health Service This announcement is a republication of the one last appearing in the NIH Guide for Grants and Contracts, Vol. 23, No. 26, July 15, 1994. Investigators conducting biomedical research frequently develop unique research resources. Categories of these resources include: synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA, as well as DNA sequences, mapping information, crystallographic coordinates, and spectroscopic data. Some specific examples are: specialized and/or genetically defined cell lines, including normal and diseased human cells; monoclonal antibodies; hybridoma cell lines; microbial cells and products; viruses and viral products; recombinant nucleic acid molecules; DNA probes; nucleic acid and protein sequences; certain types of animals such as transgenic mice; and intellectual property such as computer programs. The PHS provides the following statement of policy concerning unique research resources developed through PHS awards. A. Policy on Distribution of Research Resources The policy of the PHS is to make available to the public the results and accomplishments of the activities that it funds. Restricted availability of unique resources upon which further studies are dependent can impede the advancement of research and the delivery of medical care. Therefore, when these resources are developed with PHS funds and the associated research findings have been published or after they have been provided to the agencies under contract, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. This policy applies to PHS intramural investigators as well as extramural scientists funded by PHS grants, cooperative agreements, and contracts. Because of concern that some crystallographers are not making their coordinates available promptly (see Science, Vol. 245, p. 1179), one of the national advisory councils of the NIH and the executive committee of another institute recently adopted resolutions affirming the policy of the International Union of Crystallographers (IUCr) (Acta Cryst., A45: 658, 1989). The PHS has now adopted the IUCr policy that includes data from publications based on spectroscopic data such as nuclear magnetic resonance as well as crystallographic coordinates. The PHS encourages investigators who have such resources to consult the appropriate Program Administrators who may be of assistance in determining a suitable distribution mechanism. Such a mechanism should take into consideration all applicable Federal regulations including, but not limited to: those regarding human subjects, animal welfare, and use and handling of hazardous materials, where applicable. Investigators requesting materials should provide evidence of having the proper training, experience, and facilities to make use of the items they request. Program staff of the agencies will be available to assist in verification of credentials of requesters where such concern exists on the part of suppliers. Investigators who believe that they will be unable to implement this policy should promptly contact the appropriate PHS Program Administrator to discuss the circumstances, obtain information that might facilitate compliance with the policy, and reach an understanding in advance of the subsequent award. For research and development contracts, approval should be obtained from the PHS Contracting Officer before distribution of unique resources, unless the terms of the contract permit distribution without prior clearance of the Contracting Officer. In order to facilitate the availability of unique or novel biological materials and resources developed with PHS funds, investigators may distribute the materials through their own laboratory or institution or submit them, if appropriate, to entities such as the American Type Culture Collection or other repositories. In the case of unique biological information, such as DNA sequences or crystallographic coordinates, investigators are expected to submit them to the appropriate data banks because they otherwise are not truly accessible to the scientific community. When distributing unique resources, investigators are to include pertinent information on the nature, quality, or characterization of the materials. Investigators must exercise great care to ensure that resources involving human cells or tissues do not identify original donors or subjects, directly or through identifiers, such as codes linked to the donors or subjects. The goals of some programs, (e.g., the Human Genome Program) are such that applicants for certain projects may be required to provide plans for the sharing of data and materials. These plans will undergo review by program staff and the national advisory council prior to award. B. Distribution Costs Institutions and investigators may charge the requester, if necessary, for the reasonable cost of production of unique biological materials, and for packaging and shipping, Such costs may include labor, supplies, and other directly related expenses. Investigators should note, however, that such a charge accrues as general program income. This should not be an impediment to the distribution of materials, but investigators and institutions are advised that: a) for grants, the income is governed by 45 CFR Part 74 and it must be reported on the Financial Status Report. Questions regarding these policies and the treatment of income should be directed to the Grants Management Officer. b) for contracts, the income is governed by Federal Acquisition Regulations (FAR) 45.610-3. Contracting Officers must be contacted before generating any revenues from the distribution of materials. Any contract under which research resources would be sold require specific contract instructions. Existing contracts may require an amendment and specific approval of the Contracting Officer to render them allowable. C. Inventions and Commercialization Federal policy encourages the commercialization of the products of research developed as a consequence of Federal funding; therefore, the intent of this policy is to not discourage, impede, or prohibit the organization that develops unique research resources or intellectual property from commercializing the products. Investigators may make their materials available to others for commercial purposes with appropriate restrictions and licensing terms as they and their institution deem necessary. Institutions are reminded that some of these products may be inventions subject to the various laws and regulations applicable to patents and must be reported to the Extramural Inventions Reports Office of the NIH. The terms for licensing of unpatented research products, such as cell lines, monoclonal antibodies, and other materials and products, should generally be no more restrictive than would have been the case had they been patented---for example, only if there is full public disclosure of the invention/discovery, availability through a repository, and written agreement to end all fees and constraints after 17 years. When reporting is required, it should occur at the earliest possible time. (See 37 CFR 401 and NIH Guide for Grants and Contracts, Vol. 19, No. 6, February 9, 1990.) $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL INSTITUTE OF MENTAL HEALTH GENETICS INITIATIVE NIH Guide, Volume 25, Number 23, July 12, 1996 P.T. 34; K.W. 1002019, 0413001, 0715129 National Institute of Mental Health Given the major public health implications of identifying genes responsible for severe neuropsychiatric disorders, the National Institute of Mental Health (NIMH) has funded a Genetics Initiative to establish a national resource of demographic, clinical, diagnostic, and genetic data from individuals with bipolar (BP) disorder, schizophrenia (SZ), or Alzheimer disease (AD), in order to aid researchers in identifying etiologic factors responsible for these disorders. This notice announces the availability of clinical/diagnostic data and DNA samples to qualified investigators studying the genetics of SZ or BP. Files of demographic and diagnostic variables necessary for genetic analysis with accompanying documentation, access to DNA samples, a code manual listing additional clinical and demographic data, and pedigree drawings prepared using the CYRILLIC program, are available. Comparable data for the AD Genetics Initiative have been available to qualified investigators since July 1, 1995 (NIH Guide, Vol. 24, No. 23, June 23, 1995). Descriptive information on the BP, SZ, and AD samples are provided on the World Wide Web at http://www- srb.nimh.nih.gov/gi.html. Data being collected include a psychiatric assessment using the Diagnostic Interview for Genetic Studies (DIGS). The DIGS is a polydiagnostic interview that permits the determination of affective and schizophrenia core and spectrum illnesses in multiple diagnostic systems. A number of comorbid disorders are also evaluated in the DIGS, including alcohol and substance abuse disorders, and their chronological relationship to the onset of schizophrenic or affective spectrum illnesses is determined. The DIGS also includes sections to assess general and psychiatric medical history, demographic aspects, and additional clinical information on symptoms, suicidality, and course of illness. The diagnostic process in the NIMH SZ and BP Genetics Initiative includes a systematic and comprehensive examination of multiple sources of available information obtained from relatives, medical records, clinical notes and other diagnostic information, and direct interviews. Resolution of discrepancies that occur among these data sources are resolved by a final best-estimate diagnostic procedure that involves at least two senior clinicians. It is anticipated that subjects will be followed longitudinally to track potential changes in diagnoses, thus avoiding the false-positive diagnoses that are a major pitfall of genetic linkage studies. Schizophrenia Families with SZ and related spectrum disorders are identified via cooperative agreements to Columbia University, Harvard University, and Washington University. Data collection utilizes an agreed-upon protocol that includes uniform DIGS assessment, final best estimate diagnoses, and shared rules for extension of pedigrees through affected members. Pedigrees have been ascertained in which there are at least two affected individuals who are biologically related as first-degree relatives. In systematic ascertainment, an affected individual with DSM-III-R SZ or schizoaffective disorder - depressive type (SAD) is identified through systematic screening of patients within a clinical population. Then, if the affected individual initially identified has at least one living first-degree relative with SZ or SAD, the pedigree is targeted for further examination. The affected individual initially identified and each one of these relatives constitutes a pair. A pedigree is enrolled in the study if it contains at least one pair where one member is diagnosed with SZ and the other is diagnosed with SZ or SAD. Some nonsystematically ascertained pedigrees are enrolled at one site if all rules for systematic ascertainment are met and the pedigree contains at least one additional first- or second- degree relative with SZ, SAD, or schizotypal personality disorder (determined through direct interview). Nonsystematically ascertained pedigrees are recruited from a variety of sources, e.g., clinical referrals, media advertising, and local chapters of the Alliance for the Mentally Ill. Overall, approximately 88 percent of families have been systematically ascertained. Pedigrees are sequentially extended through first-degree relatives of specific individuals with specific diagnoses. Bipolar Disorder Families with BP disorder and related spectrum disorders are identified via cooperative agreements to Indiana University, Johns Hopkins University, and Washington University. A fourth site, the Clinical Neurogenetics Branch of the NIMH Intramural Research Program, participates but is not supported via the U01 grant mechanism. Data collection utilizes an agreed-upon protocol which includes uniform DIGS assessment, final best estimate diagnoses, and shared rules for extension of pedigrees through affected members. Pedigrees have been ascertained in which there are at least two affected individuals who are biologically related as first-degree relatives. Pedigrees are sequentially extended through first-degree relatives of specific individuals with specific diagnoses. Pedigrees in which both parents of the proband have SAB or BPI disorder are excluded. In systematic ascertainment, an affected individual with DSM-III-R bipolar I (BPI) disorder is identified through systematic screening of patients within a clinical population. Then, if the affected individual initially identified has at least one-living first degree relative with BPI disorder or schizoaffective disorder - bipolar type (SAB), the pedigree is targeted for further examination. A nonsystematically ascertained pedigree is enrolled in the study if it contains at least four affecteds. Two of these affecteds form a pair where one member is diagnosed with BPI disorder and the other is diagnosed with BPI disorder or SAB. These subjects may be first-degree relatives or they may be second-degree relatives who are connected through a subject with bipolar II (BPII) disorder as defined by the Research Diagnostic Criteria (RDC). Two additional ill family members with BPI disorder, SAB, BPII disorder, or recurrent unipolar depressive disorder as defined by the RDC are required. Pedigrees are recruited from a variety of sources, e.g., clinical referrals, media advertising, and local chapters of the Alliance for the Mentally Ill. Overall, approximately 60 percent of families have been systematically ascertained. Access to Data and DNA Clinical information and DNA will be distributed only to experienced and qualified investigators conducting research on the genetics of AD, SZ or BP at recognized biomedical research facilities. Interested investigators may request access to the data by sending a request to Debra Wynne, at the address listed under INQUIRIES. Investigators without funding under a peer-reviewed NIMH research grant application to analyze these data must purchase DNA samples from the NIMH Genetics Initiative Cell Repository at a cost of $50 per subject for a 50 microgram vial (DNA is shipped only in 50 microgram vials). Any and all data obtained by an experienced and qualified investigator cannot be transferred in any manner, with or without charge, to anyone not under the direct supervision of that investigator, without the expressed written permission of the NIMH. INQUIRIES Inquiries regarding these data and requests may be directed to: Debra Wynne, M.S.W. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18C-14 Rockville, MD 20857 Telephone: (301) 443-3527 FAX: (301) 443-6000 Email: dwynne1@nih.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HL-96-014 FULL-TEXT ************************************** SCOR IN NEUROBIOLOGY OF SLEEP AND SLEEP APNEA, AIRWAY BIOLOGY AND PATHOGENESIS OF CYSTIC FIBROSIS, AND ACUTE LUNG INJURY NIH Guide, Volume 25, Number 23, July 12, 1996 RFA AVAILABLE: HL-96-014 P.T. 34; K.W. 0715165, 0715187, 0715027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 13, 1996 Application Receipt Date: July 22, 1997 The National Heart, Lung, and Blood Institute (NHLBI) invites clinical center (P50) grant applications for Specialized Centers of Research in Neurobiology of Sleep and Sleep Apnea, Airway Biology and Pathogenesis of Cystic Fibrosis and Acute Lung Injury. The purpose of the award is to foster multidisciplinary basic and clinical research enabling basic science findings to be more rapidly applied to clinical problems. It is expected that results from these SCOR grants will have an impact on the prevention, diagnosis, and treatment of sleep apnea, cystic fibrosis, and acute lung injury. All applications received in response to the Neurobiology of Sleep and Sleep Apnea and Airway Biology and Pathogenesis of Cystic Fibrosis programs will be considered as new applications. Applications submitted by current SCOR groups must be sufficiently changed to meet the objectives of one of these programs. Applications received in response to the acute lung injury program may be either new or renewal applications. It is estimated a total of $14,000,000 will be available for the first year of support for the three programs and it is anticipated that 13 awards will be made. 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, Specialized Centers of Research in Neurobiology of Sleep and Sleep Apnea, Airway Biology and Pathogenesis of Cystic Fibrosis, and Acute Lung Injury, is related to the priority areas of diabetes and chronic disabling diseases, unintentional injury, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The 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. Suzanne Hurd, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0233 FAX: (301) 480-3547 Email: hurds@gwgate.nhlbi.nih.gov $$R1 END ************************************************************ $$P1 BEGIN PA-96-064 FULL-TEXT ************************************** MENTAL HEALTH RESEARCH IN EATING DISORDERS NIH Guide, Volume 25, Number 23, July 12, 1996 PA AVAILABLE: PA-96-064 P.T. 34; K.W. 0715095, 0715091, 0755030, 0785055, 1002030 National Institute of Mental Health National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases Office of Research on Women's Health PURPOSE The National Institute of Mental Health (NIMH), National Institute of Dental Research (NIDR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and Office of Research on Women's Health (ORWH) invite applications for studies relevant to the neuroscience, epidemiology, etiology, treatment, services research, and prevention of eating disorders (anorexia nervosa, bulimia nervosa, and binge eating disorder), and their comorbidity with other medical, dental/craniofacial, and psychiatric disorders. The purpose of this program announcement is to promote additional mental health research emphasis on the broad array of influences, including gender, on eating disorders and ingestive behaviors. Applications are requested under the following mechanisms: research project grant (R01), small grant (R03), and First Independent Research Support and Transition (FIRST) (R29) 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 PA, Mental Health Research in Eating Disorders is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Harold Goldstein, Ph.D. Clinical Director, Eating Disorders Program National Institute of Mental Health Parklawn Building, Room Number 10-85 Rockville, MD 20857 Telephone: (301) 443-4140 FAX: (301) 443-4045 Email: hg11p@nih.gov Susan Z. Yanovski, M.D. Division of Digestive Disease and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AN-18 Bethesda, MD 20892 Telephone: (301) 594-8882 FAX: (301) 480-8300 Email: yanovskis@ep.niddk.nih.gov Dr. Patricia S. Bryant Behavior, Pain, Oral Function, and Epidemiology Program National Institute of Dental Research Building 45, Room 4AN-24K Telephone: (301) 594-2095 FAX: (301) 480-8318 Email: BryantP@DE45.nidr.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-96-065 FULL-TEXT ************************************** NEURONAL CEROID LIPOFUSCINOSIS, INCLUDING BATTEN DISEASE NIH Guide, Volume 25, Number 23, July 12, 1996 PA AVAILABLE: PA-96-065 P.T. 34; K.W. 0715138 National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Neurological Disorders and Stroke announces the reissuance of a program announcement (PA) (originally published December 20, 1991) to notify the scientific community of its continued interest in the submission of research grant applications concerning neuronal ceroid lipofuscinosis. The support mechanisms for grants in this area will be the individual investigator-initiated research project grant (R01), First Independent Research Support and Transition (FIRST) (R29) Award, program project grant (P01) and clinical center grant (P50). 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, Neuronal Ceroid Lipofuscinosis, including Batten Disease, is related to the priority areas of chronic disabling conditions and maternal and child health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-11474-0 or Summary Report: Stock No.017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Judy A. Small, Ph.D. Division of Convulsive, Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 8CO4 - MSC 9165 Bethesda, MD 20892-9165 Telephone: (301) 496-5821 FAX: (301) 402-0887 Email: jsl34h@nih.gov $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Tue Jul 16 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-96-014 - V25(23) 07/12/96 Date: 16 Jul 1996 20:25:12 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 807 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4shmeo$gul@net.bio.net> NNTP-Posting-Host: net.bio.net SCOR IN NEUROBIOLOGY OF SLEEP AND SLEEP APNEA, AIRWAY BIOLOGY AND PATHOGENESIS OF CYSTIC FIBROSIS, AND ACUTE LUNG INJURY NIH GUIDE, Volume 25, Number 23, July 12, 1996 RFA: HL-96-014 P.T. 34; K.W. 0715165, 0715187, 0715027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 13, 1996 Application Receipt Date: July 22, 1997 PURPOSE The primary objective of the Specialized Centers of Research (SCORs) programs supported by the Division of Lung Diseases is to foster multi disciplinary basic and clinical research enabling basic science findings to be more rapidly applied to clinical problems. The basic and clinical research to be supported through this RFA will be related to one of the above three categories. It is expected that results from these SCOR grants will have an impact on the prevention, diagnosis, and treatment of sleep apnea, cystic fibrosis and acute lung injury. 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), SCORs in Neurobiology of Sleep and Sleep Apnea, Airway Biology and Pathogenesis of Cystic Fibrosis, and Acute Lung Injury, is related to the priority areas of diabetes and chronic disabling diseases, unintentional injury, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and nonprofit domestic institutions, public and private, such as universities, colleges, hospitals, and laboratories. This RFA is intended to support SCOR grants for basic and clinical investigations. Applications that include only basic or only clinical research will not be responsive to this announcement. In addition, clinical research projects focused on large epidemiologic studies or large clinical trials will be considered unresponsive to this RFA. Awards will not be made to foreign institutions. However, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. Women and minority investigators are encouraged to apply. The Principal Investigator should be an established research scientist with the ability to ensure quality control and the experience to administer effectively and integrate all components of the program. A minimum time commitment of 25 percent is expected for this individual. The Principal Investigator must also be the project leader of one of the component research projects. If, through peer review, this project is determined non-competitive, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. Project leaders must agree to commit at least 20 percent effort to each project for which they are responsible. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) specialized centers (P50) mechanism to support this research program. All applications received in response to the Neurobiology of Sleep and Sleep Apnea and Airway Biology and Pathogenesis of Cystic Fibrosis programs will be considered as new applications. Applications submitted by current SCOR groups must be sufficiently changed to meet the objectives of one of these programs. Applications received in response to the Acute Lung Injury program may be either new or renewal applications. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under the RFA. Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to diseases relevant to the mission of the NHLBI. It is essential, therefore, that all applications include both basic and clinical research projects. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. Each SCOR grant application and award must include research involving human patients/subjects, which is defined as research conducted with human patients/subjects or on material of human origin such as tissue or other specimens for which an investigator directly interacts with human patients/subjects. Support may be provided for human biomedical and behavioral studies of etiology, pathogenesis, prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders or conditions. Small population-based epidemiologic studies, where the research can be completed within five years, may also be proposed. In addition, basic research projects must be included that relate to the clinical focus. A SCOR may also contain one or more core units that support the research projects. Length of SCOR Programs Each NHLBI SCOR program is limited to 10 years of support. Exceptions to this policy will be made only if a thorough evaluation of needs and opportunities, conducted by a committee composed of non-federal experts, determines that there are extraordinarily important reasons to continue a specific SCOR program. Under this policy, a given SCOR grant is awarded for a five-year project period following an open competition. Only one five-year competing renewal is permitted, for a total of 10 years of support, unless the SCOR program is recommended for extension. The NHLBI comprehensive evaluation of the Neurobiology of Sleep and Sleep Apnea and Airway Biology and Pathogenesis of Cystic Fibrosis SCOR programs will be conducted during the second project period according to the following timetable: Program Announced: FY 1996 Project Period (First Competition): FY 1998 through FY 2003 Program Reannounced: FY 2001 Project Period (Second Competition): FY 2003 through FY 2008 Letter to SCOR Directors Regarding SCOR Evaluation Plans: FY 2005 (mid-way through year 02 of 2nd project period) SCOR Evaluation Meeting: FY 2005 (late in year 02 of 2nd project period) Notification of SCOR Directors of NHLBI Decision: FY 2006 (mid-way through year 03 of 2nd project period) This is the second competition for the Acute Lung Injury program and, therefore, will undergo a comprehensive evaluation during the second year of the upcoming project period. The evaluation will be conducted according to the following schedule: Program Announced: FY 1991 Project Period (First Competition): FY 1994 through FY 1998 Program Reannounced: FY 1996 Project Period (Second Competition): FY 1999 through FY 2003 Letter to SCOR Directors Regarding SCOR Evaluation Plans: FY 2000 (mid-way through year 02 of 2nd project period) SCOR Evaluation Meeting: FY 2000 (late in year 02 of 2nd project period) Notification of SCOR Directors of NHLBI Decision: FY 2001 (mid-way through year 03 of 2nd project period) The NHLBI does not limit the number of SCOR applications in a given SCOR program from one institution nor does it limit the number of applications in the three SCOR programs described in this announcement from one institution. However, there must be a different SCOR principal investigator for each application and each application must be self-contained and independent of the other(s). This does not preclude cooperation planned or possible among participants of SCORs after awards are made. Scientific overlap among applications will not be accepted. If more than one application in a given program is envisioned from an institution, the institution is encouraged to discuss its plans with the NHLBI SCOR program administrator. FUNDS AVAILABLE For new applications, the applicants may request up to $1,140,000 direct costs, not including indirect costs for collaborating institutions, in the first year, and for renewal applications, the applicants may request a 10 percent increase over the last year of the preceding project period or a total of $1,140,000, whichever is greater. An increase of no more than four percent may be requested in each additional year. Award of grants pursuant to this RFA is contingent upon availability of funds for this purpose. It is estimated that a total of $14,000,000 will be available for the first year of support for the three programs and it is anticipated that 13 awards will be made. Equipment is included in the budget limitation. However, requests for expensive special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requests require in-depth justification. Final decisions will depend on the nature of the justification and the Institute's fiscal situation. Consortium Arrangements If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. Such activities may be included in a SCOR grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact Mr. Ray Zimmerman, Grants Operations Branch, NHLBI, 301 435-0171. Applicants of SCOR grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. RESEARCH OBJECTIVES Background The SCOR program was initiated within the Division of Lung Diseases in 1971 as a "Pulmonary SCOR." Since then, several modifications and changes in program direction have been made. In the 1975 and 1980 competitions, the DLD SCOR program was announced in four disease categories: Chronic Airways Diseases, Fibrotic and Immunologic Lung Diseases, Pediatrics, and Pulmonary Vascular Diseases; in the 1985 competition the disease categories were: Chronic Diseases of the Airways, Occupational and Immunologic Lung Diseases, Respiratory Disorders of Neonates and Children, and Pulmonary Vascular Diseases. The SCOR program expanded in 1977 with the solicitation for applications in Adult Respiratory Failure. This program was reannounced in 1982 and 1987, with the latter competition resulting in four awards. As a result of a congressional mandate, two new SCOR programs, Cardiopulmonary Disorders During Sleep and Cystic Fibrosis, were announced in 1988, resulting in a total of five awards. In 1989, the DLD announced a SCOR competition in Chronic Diseases of the Airways, Occupational and Immunologic Lung Diseases, and Lung Biology and Disease in Infants and Children, following an evaluation of these programs. The Division made a total of 14 awards in FY 1992 in these three SCOR categories. An evaluation of the Pulmonary Vascular Diseases and Adult Respiratory Failure SCOR programs resulted in the recommendation to combine the two programs into a single new SCOR program in Acute Lung Injury. This new program was announced in 1991 along with renewal programs in Cardiopulmonary Disorders of Sleep and Cystic Fibrosis. In FY 1993, a total of seven awards were made for centers in Cardiopulmonary Disorders of Sleep and Cystic Fibrosis and six awards were made in FY 1994 for centers in Acute Lung Injury. In response to the new Institute policy that each SCOR program is limited to 10 years of support, unless a programmatic evaluation indicates that further support is warranted, the Division convened a committee, composed of Pulmonary Diseases Advisory Committee members and ad hoc consultants, to evaluate the SCOR programs in Occupational and Immunologic Lung Diseases, Lung Biology and Disease in Infants and Children, and Chronic Diseases of the Airways. The evaluation resulted in new SCOR programs being announced in 1994 for Pathobiology of Fibrotic Lung Disease, Pathobiology of Lung Development, and Cellular and Molecular Mechanisms of Asthma. Awards will be made in FY 97 for these three programs. An evaluation in 1995 by a group of consultants of the SCOR programs in Cardiopulmonary Disorders of Sleep and Cystic Fibrosis resulted in the recommendation that new SCOR programs be announced in Neurobiology of Sleep and Sleep Apnea and in Airway Biology and Pathogenesis of Cystic Fibrosis, two of the programs included in this RFA. The third program, Acute Lung Injury, is the renewal of a SCOR program begun in FY 1994. Justification for announcing a competition in the SCOR programs in Neurobiology of Sleep and Sleep Apnea, Airway Biology and Pathogenesis of Cystic Fibrosis, and Acute Lung Injury is based on the recommendations from the SCOR evaluation, on past accomplishments, which have been provided in reports from the Division and the Institute, and on opportunities for new research directions. Funding for the Cardiopulmonary Disorders of Sleep and Cystic Fibrosis centers expires on September 29, 1998 and for the Acute Lung Injury centers on November 30, 1998. Proposed Research Applications must be addressed to only one of the three disease categories identified below to be acceptable for this competition. A SCOR grant is a 5 year program, therefore, an applicant should submit a 5 year plan for all the projects. If a project can be completed in less than 5 years, it should not be included in the application. Examples of research topics of interest for each SCOR program under competition are listed below. These research topics are intended to provide a perspective of the scope of research that would meet the objectives of this program. It is not required that all or any of these topics be included; investigators are encouraged to consider other topics that are relevant to the goals of these programs. Neurobiology of Sleep and Sleep Apnea The objective of this SCOR program is to integrate the molecular, cellular and genetic approaches to sleep control with clinical investigations on the etiology and pathogenesis of sleep disorders, particularly sleep apnea. The research topics identified below are offered as examples that would be responsive to this announcement. Recent advances in the cellular and molecular neurobiology of sleep offer new opportunities to study the basic mechanisms of sleep and the consequences of disturbed sleep (e.g., sleepiness, hypoxia, and cardiovascular disease). Studies directed at understanding the fundamental neurophysiologic/pharmacologic, neuroanatomic, cellular and molecular nature of sleep regulation and homeostasis; interaction of CNS mechanisms involved in the regulation of sleep/wake states; and the relationship between putative sleep modulators and the pathogenesis of cardiopulmonary disturbances during sleep are areas that need further study. Genetic expression of neuromodulators and mediators during normal sleep and in sleep apnea is another area that requires more attention. For example, molecular approaches should be applied to determine what neurons express sleep promoting genes, whether sleep apnea causes changes in gene transcription, and to elucidate the regulatory signals involved in these genetic events. It is also important to determine how levels of sleep promoting compounds are genetically controlled in the sleep/wake cycle, and whether experimental alterations of specific genes alter sleep behavior. It is now known that homeostatic and circadian factors contribute to regulation of sleep and wakefulness. It is important to understand the interaction between biological clocks, chronobiology and sleep/wake behaviors at the cellular and molecular level, as well as determine how the neural circuits in the brain respond to input from the circadian pacemaker. Studies are also needed to investigate whether apoptosis and other neurodegenerative processes in sleep-related brain regions contribute to the respiratory disturbances. Pharmacologic agents, implants of genetically-engineered cells and gene transfer technologies need to be considered. Sleep disordered breathing and snoring have been implicated as risk factors for the development of hypertension, ischemic heart disease and cerebral infarction. It is important to examine the pathophysiology of sleep apnea in relation to cardiovascular diseases. There is also a need for more vigorous basic research directed towards understanding the autonomic nervous system, central cardiovascular control, and the neurophysiologic and neuropharmacologic mechanisms that regulate cardiovascular and circulatory adjustments during sleep. Epidemiologic studies have provided new insights into the prevalence of sleep apnea. Studies are needed to better define sleep apnea, identify possible sleep phenotypes and determine its predictors and antecedents, particularly in its early phases. One important question is what is the effect of sleep apnea in childhood on development of sleep disorders in later life? Evidence now suggests that the nature of sleep disturbances due to sleep apnea in children may be different than in adults. Attention should be given to the relationship between pathologic and physiologic abnormalities, gender specific factors and the impact of sleep apnea in children and the family. Better objective measures and standardized criteria for sleep apnea, including the associated morbidity and mortality should be investigated. Since excessive daytime sleepiness is a major clinical consequence of sleep apnea, it is important to focus on the basic neural mechanisms that produce sleepiness and design new approaches to evaluate daytime performance/alertness and sleepiness. Critical assessment of therapeutic approaches and development of new therapeutic strategies for sleep disorders, particularly pharmacologic approaches remain important goals of this SCOR program. Airway Biology and Pathogenesis of Cystic Fibrosis Despite dramatic advances in our understanding of the molecular and cellular basis of CF, our knowledge of the biology, structure and function of CFTR remains superficial. There is a critical need to begin to translate our current knowledge of CFTR into the broader aspects of airway biology, the pathogenesis of CF, and the development of new pharmacologic or gene therapies. The objective of the SCOR program is to utilize our current knowledge of CFTR as a focus of information, to promote advances in research on the pathogenesis of CF, the role of CFTR in airway biology, and the development of new treatment strategies. CF lung disease is characterized by chronic bacterial infections and inflammation that progressively destroy the lung. Yet it is not understood how a defect in CFTR leads to this bacterial colonization and inflammation. Information on how CF begins and progresses in the airway with respect to inflammation and/or infection is particularly important. Also critical is an understanding of the role of host defense mechanisms and inflammatory mediators in preventing or contributing to pathogenesis. How the loss of CFTR alters airway function is poorly understood. The airway surface fluid (ASF), believed to play a role both in fetal lung development and in adult pulmonary homeostasis and defense, may be critical in influencing lung function. Yet, our overall understanding of the mechanisms which generate and control ASF, and how CFTR affects it, is still lacking. ASF includes contributions from the submucosal glands; serous gland cells within the submucosal glands have been shown to contain large quantities of CFTR. Thus, an evaluation of the contribution of the submucosal glands versus the surface epithelium in normal fluid and electrolyte balance and in the pathogenesis of CF is needed. Developmental issues regarding fluid and electrolyte balance and information on stem or progenitor cells are also critical to our understanding of basic aspects of lung biology and would be helpful for therapeutic approaches. The role of CFTR plays in human airway epithelial function needs to be better defined. Critical to our understanding of how mutations in CFTR cause disease are structural biology studies both on mutant and wild-type CFTR. CFTR is known to function as a chloride channel and as a regulator of both sodium and chloride channels. Yet issues remain unresolved regarding the intramolecular and intermolecular interactions of different domains of CFTR, functional control of airway processes including ion transport, infection and inflammation, and consequences of mutations to the function of CFTR and the pathogenesis of CF. As potential sites of therapeutic targets designed to provide alternate pathways for fluid production in CF airways, it would be important to study alternate ion channels, uncover new receptors which control lung function and develop methods of overcoming aberrant processing of mutant CFTR. Despite the new information on the primary defect in CF, there are still no new therapies which correct the primary defect or activate alternative pathways to prevent airway disease. Thus, there is a critical need to translate the new knowledge regarding the pathogenesis of CF and the function of CFTR into new treatment strategies. Thus, the development of novel pharmacologic and gene therapies focusing on the primary consequences of CF (i.e., defective CFTR) would be important, such as the development of agents which correct defective CFTR or which interfere with bacterial colonization. Several barriers to persistent correction of defective CFTR function such as vector-induced inflammation and low efficiency of airway cell transduction, have been identified. Thus, new strategies to overcome these barriers and to prevent inflammation are needed. Identification of appropriate lung cell targets for gene transfer such as progenitor, surface and submucosal gland cells is needed. Development and use of animal models, tissues, and cells derived from the lung may be appropriate for certain studies, but, when feasible, human lung materials should be employed. When warranted, research involving human patients/subjects is preferable. Acute Lung Injury The pathogenesis of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) is thought to be related to an over-reaction of the inflammatory/immune system. In sepsis, a frequent predecessor to ARDS, a sequence of mediator responses has been clearly documented, and agents have been created that block the activity of the mediators. Although these agents are protective in animal models, clinically useful and specific therapies have not been found. This is in part because the inflammatory response has turned out to be much more complex than originally thought. Particularly important, now that many mediator systems have been identified, is to determine the interactions between the various systems. Promising areas for new insights may be found from studies of the relationship between inflammatory cell activation, surface adhesion molecules, and signal transduction; the interaction of oxidants with nuclear transcription factors; the mechanisms by which endotoxin increase intracellular oxidants; and the molecular mechanisms through which surfactant proteins modify nitrosation reactions remain to be characterized. The barrier and metabolic functions of the endothelium are disturbed during ALI and the molecular determinants of these processes need to be delineated. Similarly, progress has been made in the description of ion channels in the alveolar epithelium; however, the exact structure and function are unknown. The determinants of cell death and recovery need to be examined as do the factors that promote fibrosis as opposed to healing after tissue injury. Studies with knockout animals have shown that absence of adhesion molecules from birth does not alter the inflammatory response. However, the inflammatory system is redundant and these experiments do not prove that alterations in adhesion molecules are not important in human disease. ALI/ARDS is an acute and acquired disease. Models using inducible promoters would allow for manipulation of mediator levels throughout the course of the disease. Animal models are needed that accurately reflect human disease. In this regard, multidisciplinary studies that are directed towards understanding the integrated response of the entire organism to lung tissue injury may be particularly useful. Multiple Organ Dysfunction Syndrome (MODS), a frequent cause of death during ARDS, is particularly suited to whole animal studies where the integrated response of the whole organism can be studied. For example, the lung is known to produce large amounts of glutamine, an important gut nutrient. In sepsis, release of glutamine from the lung increases, but as ARDS develops, the release of glutamine from the lung drops precipitously, possibly affecting intestinal metabolism and viability, and furthering progression of MODS. Other interactions between the lung and other organs and their contribution to ARDS pathogenesis need to be elucidated in both animals and humans. Many questions remains about the progression and natural history of ALI/ARDS. There is a need to evaluate the role of inflammatory mediators in humans while controlling for confounding variables such as comorbidities, duration of disease, and physiologic variables. Other aspects of pathophysiology, including tissue oxygenation and metabolism, need to be investigated in patients as well as in the laboratory. Recently, two gene products of tumor necrosis factor (TNF) have been identified in humans, and the presence of homozygous TNFB2 gene as opposed to TNFB1 predicted the outcome of patients with sepsis. More needs to be done to evaluate possible genetic control of the response to tissue injury in humans. A clinical core is required to provide the following functions: enroll and characterize all ALI/ARDS patients; provide access to patients and patient samples for the research projects; and facilitate coordination within a SCOR center and among the ALI SCOR centers. SPECIAL REQUIREMENTS Special features of SCOR grants are: o They provide opportunities for investigators with mutual or complementary interests to engage in multidisciplinary research focusing on a specific respiratory disorder. o Inherent in the SCOR program is a special interaction between the SCOR director, the grantee institution and the Division of Lung Diseases. Funds are specifically allocated in a SCOR grant for investigators from different SCORs to meet and discuss problems of mutual interest and to participate in workshops addressing common research areas. o The Division's overall SCOR program and each SCOR grant undergo periodic evaluation. The progress reports are prepared for the information of the National Heart, Lung, and Blood Advisory Council, the Division of Lung Diseases staff, and ad hoc members of SCOR evaluation groups. Requirements of SCOR grants: o Research conducted at the individual centers must include both basic and clinical research to ensure that advances in the basic sciences are translated rapidly into clinical applications and that clinical needs will provide a direction for the basic research. Therefore, each SCOR grant application and award must include one or more research projects involving human patients/subjects. The basic research projects should clearly relate to the disease focus and contribute to elucidation of mechanisms underlying the disease, or to improved diagnosis or management of the disease. o Each component project requires a well-described hypothesis, preliminary data and a time-table for conducting the proposed investigations. o If core facilities are included, the relationship of each component project to each core should be described. o The principal investigator should be an established scientist with the ability to ensure quality control and the experience to administer effectively and integrate all components of the program. A minimum time commitment of 25 percent is expected for this individual. The principal investigator must also be the project leader of one of the component research projects. If, through peer review, this project is not recommended for further consideration, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. o Project leaders must agree to commit at least 20 percent effort to each project for which they are responsible. Investigators with minimal research experience, but promising credentials, may participate; however, it is expected that most of the project directors will be investigators with significant research experience. o Each SCOR must have a well-delineated organizational structure and administrative mechanism that foster interactions between investigators, accelerate the pace of research, and ensure a productive research effort. o If a project director transfers to another institution, support for the project will normally not be continued as a consortium. Because of the size and complexity of a SCOR, prospective applicants are urged to consult with the staff of the Division of Lung Diseases early in the preparation of the application (see INQUIRIES Section). To provide opportunity for such interactions, the time frame for implementation of this program includes an ample interval between the release of this RFA, June 1996 and the receipt date for applications, July 22, 1997. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 9, 1994 (F59 11146-11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 13, 1996, 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, it assists the NHLBI 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: Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Two Rockledge Centre, Suite 7093 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924 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 or may be obtained from the Office of Grants Information, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-0714 Email asknih@odrockm1.od.nih.gov. and from the NIH program administrator listed under INQUIRIES. Specific instructions for preparing a SCOR application are also available from the program contact listed under INQUIRIES. The RFA label included in grant application form PHS 398 (rev. 5/95) 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 or deliver 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) Send two additional copies of the application to Chief, Review Branch at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants (DRG); otherwise, the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by July 22, 1997. If an application is received after that date, it will be returned to the applicant without review. 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 Division of Research Grants will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NHLBI staff. Incomplete applications or applications deemed not responsive to the RFA 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 NHLBI in accordance with the review criteria stated below. Applicants should submit the highest quality applications possible to DRG as no site visits nor reverse site visits will be held. As part of the initial merit review, a streamlined process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score, and will also receive a second level of review by the National Heart, Lung, and Blood Advisory Council. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be notified. Factors to be considered in the evaluation of each application will be similar to those used in review of traditional research grant applications and, in addition, will include overall proposed interactions among basic and clinical research projects. Major factors to be considered in the evaluation of applications include: o Scientific merit of the proposed basic and clinical research projects including significance, importance, and appropriateness of the theme; innovation, originality, and feasibility of the approach; and adequacy of the experimental design. o Leadership, scientific stature, and commitment of the program director; competence of the investigators to accomplish the proposed research goals and their time commitment to the program; and the feasibility and strength of consortium arrangements. o Collaborative interaction among basic and clinical research components, the balance between them, and plans for transfer of potential findings from basic to clinical studies. o Adequacy of the environment for performance of the proposed research including clinical populations and/or specimens; laboratory facilities; proposed instrumentation; quality controls; administrative structure; institutional commitment; and, when needed, data management systems. o Appropriateness of the budget for the proposed program. AWARD CRITERIA The anticipated date of award is September 30, 1998 (FY 1998) for the Neurobiology of Sleep and Sleep Apnea and Airway Biology and Pathogenesis of Cystic Fibrosis programs and December 1, 1998 (FY 1999) for the Acute Lung Injury program. Awards will be made according to priority score, availability of funds, and programmatic priorities. INQUIRIES Written and telephone inquiries concerning the RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for supplemental instructions to: Suzanne Hurd, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10018, MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0233 FAX: (301) 480-3547 Email: hurds@gwgate.nhlbi.nih.gov Direct inquiries regarding fiscal matters to: Raymond Zimmerman Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: zimmermr@gwgate.nhlbi.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. 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 U.S.C. 2241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Jul 16 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-064 - V25(23) 07/12/96 Date: 16 Jul 1996 20:25:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 598 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4shmfl$h58@net.bio.net> NNTP-Posting-Host: net.bio.net MENTAL HEALTH RESEARCH IN EATING DISORDERS NIH GUIDE, Volume 25, Number 23, July 12, 1996 PA NUMBER: PA-96-064 P.T. 34; K.W. 0715095, 0715091, 0755030, 0785055, 1002030 National Institute of Mental Health National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases Office of Research on Women's Health PURPOSE The National Institute of Mental Health (NIMH), National Institute of Dental Research (NIDR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and Office of Research on Women's Health (ORWH) invite applications for studies relevant to the neuroscience, epidemiology, etiology, treatment, services research, and prevention of eating disorders (anorexia nervosa, bulimia nervosa, and binge eating disorder), and their comorbidity with other medical, dental/craniofacial, and psychiatric disorders. The purpose of this program announcement is to promote additional mental health research emphasis on the broad array of influences, including gender, on eating disorders and ingestive behaviors. 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, Mental Health Research in Eating Disorders is related to the priority area of mental health and mental disorders. 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 A variety of funding mechanisms are encouraged within this announcement, and eligibility and requirements for these funding mechanisms vary. Applicants are advised to contact NIMH, NIDR, or NIDDK program staff listed under INQUIRIES for additional information and specific application procedures. Applications may be submitted by foreign and domestic, for- profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for Small Grants (R03), Education projects (R25), or First Independent Research Support and Transition (FIRST) (R29) awards, Racial/ethnic minority individuals women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Applications are requested under the following mechanisms: research project grant (R01), small grant (R03), and FIRST award (R29). Applications to NIMH are also requested under the education projects (R25) mechanism. For additional information concerning Mental Health Education Projects, see the NIH Guide, Vol. 25, No. 14 (May 3, 1996). For research in method development, the small grant (R03) is a particularly appropriate mechanism; investigators may also choose to include method development as one component within research project grant (R01) applications. Support may be requested for a period of up to five years, except for small grants (R03), which are limited to two years. FIRST awards must be requested for five years. Annual noncompeting awards will be made subject to continued availability of funds and progress achieved. Because Education Projects, and FIRST awards have special eligibility requirements, dollar ceilings, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES, below) and to obtain the appropriate additional announcements for those grant mechanisms. An applicant planning to submit a new (Type 1) investigator- initiated grant application requesting $500,000 or more in direct costs for any year is advised that he or she must contact Institute program staff before submitting the application, i.e, as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in the cover letter that is sent with the application, the staff member and Institute who agreed to accept assignment of the application. Any application subject to this policy that does not contain the required information in the cover letter sent with the application will be returned to the applicant without review. For additional information concerning large grant applications, see the NIH Guide, Vol. 25, No. 14 (May 3, 1996). RESEARCH OBJECTIVES Summary Mental health disorders encompassing eating disorders and ingestive behaviors are an area of increasing public concern in the United States. Anorexia nervosa is a syndrome characterized by body weight severely below normal, body- image disturbance, and an intense fear of, and resistance to, weight gain. Bulimia nervosa is a syndrome characterized by repeated episodes of binge-eating followed by a variety of purging or other compensatory behaviors such as vomiting, laxative or diuretic use, excessive exercise, and/or fasting. Body weight, however, may remain in the normal range. Binge eating disorder is a recently identified syndrome in which there are repeated episodes of binge eating without subsequent regular purging behavior, typically resulting in body weight above normal limits. It is estimated that anorexia affects from .5 to 1 percent of teenage and young women, and bulimia from one to three percent. Women are 8 to 10 times more likely to suffer from anorexia or bulimia than men. Estimates of binge eating disorder range from about one to four percent of the population with women being about 1.5 times more likely to have this disorder than men. It has been estimated, on average, that 30 percent of enrollees in weight reduction programs suffer from binge eating disorder. Eating disorders, which may become chronic, frequently have serious psychological and medical consequences. Virtually all bodily systems are affected by starvation, and cardiac, gastrointestinal, and electrolyte disturbances are most common. Clinical depression and anxiety disorders commonly co-occur with eating disorders. Morbidity and mortality in anorexia nervosa are among the highest of any mental disorder. It has been estimated that some 10 percent of patients with anorexia nervosa will die from complications of the disorder. Eating disorders have a high degree of comorbidity with other psychiatric disorders, as well as with some medical disorders. In anorexia nervosa, affective disorders are most common, followed by anxiety disorders with obsessive compulsive disorder most prevalent. Among patients suffering from bulimia nervosa, high rates of affective disorder and anxiety disorders have been reported, as well as personality disorders and substance abuse. Binge eating disorder is associated with a higher degree of psychiatric comorbidity than is found in obese people who do not binge eat. Also, a "failure to thrive" syndrome, characterized by malnutrition, depression, and physical illness has been described in geriatric populations. Despite their high degree of comorbidity, eating disorders are distinct disorders; they do not transmute into other illnesses. Research Scope and Goals New research on the psychosocial and biological factors underlying eating disorders is needed to clarify issues of etiology and treatment. While a broad array of epidemiological, familial, biological, and treatment studies have identified promising leads, major questions in these areas remain unanswered. This program announcement emphasizes the need for research on eating disorders at all levels from fundamental studies of brain and behavior which identify basic mechanisms, to examinations of risk factors, to epidemiological and clinical investigations which help to successfully diagnose and treat the disorders. The overall goal is to establish a clearer understanding of the etiology, and treatment of these complex disorders, and ultimately, to prevent them. Eating Disorders research applications are welcome in the following broad areas: o Neuroscience and Behavioral Science o Epidemiology, including Comorbidity with Other Medical and Psychiatric Disorders and Genetic Studies o Behavioral Medicine o Treatment Studies o Services Research (NIMH only) 1. Neuroscience and Behavioral Science The regulation of energy and nutrient balance involves multiple complex systems in the brain and body. Integrative and interdisciplinary approaches will help us understand the genetic, immune, endocrine, neural, and behavioral determinants of energy balance, storage and body weight. Neural circuitry and neurophysiological research in animal models of ingestion have now advanced to where the important role of genetic and other molecular factors are rapidly being discovered. There is a pressing need to apply this knowledge to non-human primates and humans, and for the basic research approaches to be integrated with the development of new drugs in the clinical setting. Research in the following areas is encouraged: o Individual, family and community studies to clarify the contributions of personality, attitudes, and social dynamics to patterns of feeding, nutrition and body weight. o Basic studies of biochemical, neural, and psychological mechanisms of eating behavior, including taste and satiety. o The role of cognition and perception in eating behavior and eating disorders, and their interaction with social influences on the development of the body image. o Development of animal models of diagnostic or biological features of anorexia nervosa and bulimia nervosa. o Animal studies of metabolic efficiency, motivation, and behavior following changes in nutritive intake produced by peripheral, central, or environmental manipulations. o The influence of sex steroid hormones on changes in feeding patterns, their relation to gender differences in behavior and brain activity. o The interaction of feeding patterns with other major homeostatic systems including reproductive-cycle, circadian rhythms, sleep and wakefulness, and the regulation of stress. o The application of new molecular methods such as gene knockout technologies to specify the role of brain peptides, hormones, and cytokines, in disordered patterns of eating; and to identify genetic vulnerabilities and potential pharmacological interventions for weight gain or loss. o Studies of peripheral autonomic function in the development and maintenance of appetitive dysfunction or purging behaviors 2. Epidemiology and Comorbidity Research is needed to provide more accurate epidemiological data on anorexia nervosa and bulimia nervosa. Research in the following areas is encouraged: o Community-based epidemiologic surveys to identify prevalence and incidence of eating disorders and their comorbidity with medical (including diabetes mellitus), psychiatric, and substance abuse disorders. o Prospective epidemiological studies to identify biological (including genetic), psychological, and social factors contributing to the development and maintenance of eating disorders and their impact on the onset and course of these illnesses in both women and men. o Epidemiological study of high-risk populations, such as adolescent dieters and athletes, and children of eating- disordered parents. o Studies evaluating the epidemiology, clinical course, and response to treatment of subclasses of individuals currently identified as Eating Disorders Not Otherwise Specified (EDNOS) o Longitudinal studies for the early identification of infants and children at risk for developing eating disorders as well as follow up studies of individuals with eating disorders to identify the long-term course and outcome of these disorders and the impact of various types of treatment. o Epidemiological studies of high-risk families to examine the contribution and relationship of genetic traits, familial dynamics, individual personalities, and incidence of other mental disorders. o Studies evaluating understudied populations with eating disorders, including men and racial and ethnic minorities. o Refining dental indicators for early identification and referral. (Particular patterns of tooth erosion are, for example, characteristically seen in bulimia, although many dental practitioners may not be aware of this). o Effects of malnutrition from eating disorders on dental/oral conditions (e.g., periodontal diseases, aphthous ulcers, caries). 3. Behavioral Medicine Little is known about the prevention of eating disorders and studies are needed that increase understanding of the behavioral aspects of eating disorders. Such studies include the: o Examination of the link between behavioral and physiological processes underlying normal and abnormal eating. o Characterizations of normal and abnormal eating patterns under various cultural and occupational conditions, and as influenced by gender-specific attitudes and behaviors. o Study of comorbidity of eating disorders with physical illness. o Health promotion campaigns through dental offices to alert families/patients to dental consequences 4. Treatment Studies Treatment studies have suggested the efficacy of specific pharmacological and psychosocial interventions for some patients with eating disorders. While there is general agreement that a multidimensional treatment approach, including individual, group and/or family psychotherapy, psychopharmacotherapy, and behavioral interventions is necessary to treat most patients with eating disorders, few controlled clinical trials have been undertaken to evaluate these treatment modalities. Integrated treatment studies are particularly important to determine the efficacy of combined psychosocial and pharmacologic therapies and the active components of each of these treatments. Because of the serious physical health and mental health consequences of anorexia nervosa, bulimia nervosa, and binge-eating disorder, treatments for these disorders and intervention strategies to prevent their recurrence need to be developed and tested. Such treatments need to be studied across various stages of the life cycle and of the disorder. With the growing database of efficacious short-term treatments for some eating disordered patients, emphasis should be placed on longer-term trials aimed at maintaining or building upon the improvement obtained during acute treatment. Treatment studies should acknowledge the chronic nature of most eating disorders and assess outcome accordingly, including, but not limited to, a studied intervention's success and safety in maintaining healthy eating and activity habits, preventing relapse, and ameliorating other comorbid mental or physical health disorders. Controlled treatment studies are needed to: o Assess the efficacy of psychosocial treatments for eating disorders in a variety of treatment settings, to identify the active components of standardized individual, group, and family/couples therapies (using, for example, manualized cognitive-behavioral or behavioral, interpersonal, or psychodynamic approaches), and to explore new therapeutic techniques. o Determine the efficacy of pharmacological treatments for eating disorders. As with psychosocial interventions, this would include both short-term trials and longer-term continuation medication studies aimed at maintaining or building upon the gains of acute treatment, e.g. weight restoration in anorexia nervosa. o Determine the effects and contributions of integrated combination treatments, including the range of psychotherapies noted above and concurrent medication. o Aid in predicting and preventing relapse, long-term follow up studies to determine which factors contribute to maintenance of improvement/remission and to relapse or recurrence. o Evaluate the optimal interdigitation of treatment of eating disorders per se with the preceding, concurrent, or subsequent treatment of comorbid physical health or mental disorders. Examples of commonly occurring comorbidities include the medical consequences of starvation in anorexia nervosa and obesity in binge-eating disorder. o Determine the mechanisms involved in abnormal weight gain or loss side effects of commonly used treatments for major mental disorders. o Encourage dental participation in multi-disciplinary treatment for the eating disorder o Develop and test methods to reduce damage to teeth resulting from these disorders. 5. Services Research (NIMH only) Previous research suggests that while efficacious treatments exist for some forms of eating disorders, little is known about their effectiveness -- how they work in real world settings. Furthermore, little is known about improving the identification of affected individuals, including the development of valid screening tools and effective programs targeting high risk populations; access and pathways to treatment; and the cost-effectiveness of various forms of treatment. The following are examples of research issues that are covered under this announcement: o Assessment of effectiveness of proven treatments and interventions, including long-term follow-up and measurement of multiple outcome domains. o Development of valid, reliable screening instruments. o Studies of prevention interventions targeting care-givers of the at-risk population (i.e., teachers, coaches, parents) o Studies of screening and education programs to promote earlier identification and treatment of individuals with eating disorders as well as research on the implementation and cost-effectiveness of such programs targeting high risk populations. o Studies of the cost-effectiveness of various treatments including treatment combinations. o Studies of mechanisms for the effective transmission of knowledge and skills in the provision of psychotherapeutic modalities with established efficacy in the treatment of eating disorders to mental health practitioners and primary care providers. o Long-term follow-up studies to assess maintenance and relapse prevention strategies. o Assessment of treatment effectiveness in special populations, including racial/ethnic minorities, rural populations and difference age groups, in combination with gender-specific analysis. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Please note that R25 applications are received only once a year, on October 1. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach & 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 title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight mail service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. Review Criteria 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, particularly, but not exclusively, in the area of the proposed research; 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. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The quality of the proposed project (as determined by peer review), the availability of funds, and program priority will all be considered in making funding decisions. INQUIRIES Inquiries are encouraged. Institute staff welcome the opportunity to clarify any issues or questions from potential applicants. Please direct inquiries regarding programmatic issues to: Harold Goldstein, Ph.D. Clinical Director, Eating Disorders Program National Institute of Mental Health Parklawn Building, Room 10-85 Rockville, MD 20857 Telephone: (301) 443-4140 FAX: (301) 443-4045 Email: hg11p@nih.gov Susan Z. Yanovski, M.D. Division of Digestive Disease and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AN-18 Bethesda, MD 20892-660 Telephone: (301) 594-8882 FAX: (301) 480-8300 Email: yanovskis@ep.niddk.nih.gov Dr. Patricia S. Bryant Behavior, Pain, Oral Function, and Epidemiology Program National Institute of Dental Research Building 45, Room 4AN-24K Bethesda, MD 20892 Telephone: (301) 594-2095 FAX: (301) 480-8318 Email: BryantP@DE45.nidr.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Sharon Bourque Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AS-49H Bethesda MD 20892-6600 Telephone: (301) 594-8846 Email: bourques@ep.niddk.nih.gov Martin R. Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44A Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: Martin.Rubinstein@nih.gov The National Institute of Nursing Research (NINR) is not a co-sponsor of this program announcement, but it is interested in related research on eating disorders. For information concerning related research interests, contact: J. Taylor Harden, Ph.D., RN Division of Extramural Programs National Institute of Nursing Research Natcher Building 45, Room 3AN-12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5976 FAX: (301) 480-8260 Email: THarden@ep.ninr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 (NIMH), 93.121 (NIDR) and 93.848 (NIDDK). 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 66, and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Jul 16 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-065 - V25(23) 07/12/96 Date: 16 Jul 1996 20:26:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 271 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4shmga$h7c@net.bio.net> NNTP-Posting-Host: net.bio.net NEURONAL CEROID LIPOFUSCINOSIS, INCLUDING BATTEN DISEASE NIH GUIDE, Volume 25, Number 23, July 12, 1996 PA NUMBER: PA-96-065 P.T. 34; K.W. 0715138 National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Neurological Disorders and Stroke announces the reissuance of a program announcement (PA) (originally published December 20, 1991) to notify the scientific community of its continued interest in the submission of research grant applications concerning neuronal ceroid lipofuscinosis. 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, Neuronal Ceroid Lipofuscinosis, Including Batten Disease, is related to the priority areas of chronic disabling conditions and maternal and child health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-11474-0 or Summary Report: Stock No.017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions or organizations in foreign countries are not eligible for First Independent Research Support Transitions (FIRST) (R29) awards, program project grants (P01), or clinical center grants (P50). MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the individual investigator-initiated research project grant (R01), FIRST (R29) award, program project grant (P01), and clinical center grant (P50). RESEARCH OBJECTIVES The neuronal ceroid lipofuscinoses are a group of hereditary neurodegenerative diseases in children and adults in which there is a progressive loss of vision, seizures, and psychomotor degeneration. There are three major forms of the disease in children, and one in adults. The common mode of inheritance is autosomal recessive, and the general incidence in children is approximately 1.2 per 100,000 births. The three main forms of childhood NCL are delineated based on the age of onset, clinical course, and morphological observations. At least 15 atypical variants have been described. With the discovery of genes for two forms of the NCLs, infantile NCL and juvenile NCL, the question of the biochemical and genetic defects can now be addressed. Work also must continue to identify the gene defects for late infantile and adult onset NCL. Despite intensive research efforts, the biochemical defect(s) for the NCLs have not yet been identified. In the juvenile, late infantile, and adult forms there is storage of subunit c of mitochondrial ATP synthase. In the infantile form, there is storage of saposins A and D. There is an increase in dolichols in the urine and brain of the patients. There is also storage of other minor materials in all forms of the disease. NINDS encourages submission of quality research proposals to delineate the clinical and genetic types of the NCLs, to characterize the genetic and biochemical defects in INCL and JNCL, to identify and localize the gene(s) responsible for LINCL and adult onset NCL, and to develop measures for the prevention, early diagnosis and treatment of these disorders. Studies may encompass all aspects of the neurobiology of the NCLs by a variety of current and innovative experimental approaches and methods. Multidisciplinary approaches are encouraged. Areas of interest include, but are not limited to the following research disciplines. Genetic studies should focus on the determination of the gene defects for the INCL and JNCL genes. These should include studies to determine the function of the encoded protein, and should not be just a cataloging of the mutations. Information obtained in these studies should be helpful in understanding the normal metabolism of the protein, in addition to understanding its role in disease process in the NCLs. Studies to determine the chromosomal location and gene identification for LINCL, adult onset NCL and other atypical variants are encouraged. For cases where an animal has been determined to be a model for a specific variant of NCL, genetic studies to determine the defective gene would be appropriate. Biochemical studies should utilize state of the art techniques to identify and quantify the structural and mechanistic biochemical defects underlying the disease. Studies may employ either human or animal tissues. However, animal studies must clearly state relevance to the human diseases. Studies to elucidate the biochemical and genetic abnormalities of the NCLs can be done in appropriate animal models. Current. animal models available for study include sheep, dogs, and mice. It will be important to demonstrate how these animals mimic the human condition. In addition, with the discovery of the genes for the INCL and JNCL, recombinant technology can be used to generate animal models by creation of "knockout" and transgenic mice. Studies directed at therapeutic interventions may be included. These studies may involve pharmacological interventions, or may include gene therapy. 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 was reprinted in the Federal Register of March 28, 1994 (FR 59 14508-14513) to correct typesetting and errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18,1994, Volume 23, Number I 1. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (Rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. In addition, the PA title, ("Neuronal Ceroid Lipofuscinosis, PA-96-065) must be typed on line 2 of the face page of the application form and the yes box must be marked. Submit a signed typewritten original of the application, including the checklist, and five 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 courier or express service) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of all applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria 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, o particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and 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 Initial review group will also examine the provisions for the protection of human subjects and animal welfare and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other applications assigned to that Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review and availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged. Applicants for program project grants or centers should request, from the address below, a copy of the NINDS Guidelines: Program Project and Research Center Grants. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Judy A. Small, Ph.D. Division of Convulsive, Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 8CO4 7550 Wisconsin Avenue MSC 9165 Bethesda, MD 20892-9165 Telephone: (301) 496-5821 FAX: (301) 402-0887 Email: jsl34h@nih.gov Direct inquiries regarding fiscal matters to: King P. Bond, Jr. Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue MSC 9190 BETHESDA, MD 20892-9190 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: kb33s @nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.853 and 93.854. 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 103227, 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 Sun Jul 21 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 20 July 1996 Date: 22 Jul 1996 12:51:01 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 112 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4t0m35$19o@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 July 20, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: TIP60712 -- Media Tipsheet July 12, 1996 File size (bytes): 5392 STIS Filename: tip60712.txt Document Type: Program Guideline Title: Small Business Innovation Research Program Phase I -- Phase II Instruction Guide File size (bytes): 200936 STIS Filename: nsf96111.txt Title: NSF 96-114 CISE Research Infrastructure Program File size (bytes): 36779 STIS Filename: nsf96114.txt Title: NSF 96-115 Faculty Early Career Development (CAREER) Program Guidelines File size (bytes): 31222 STIS Filename: nsf96115.txt Document Type: Recruit Title: Social Science Administrator (Program Director) File size (bytes): 7507 STIS Filename: vex9624.txt Title: Supervisory Computer Specialist (Section Head) File size (bytes): 8757 STIS Filename: vgs9651.txt Document Type: SRS Data Brief Title: SDB 96-310 1994 Company Funding of U.S. Industrial R&D Rises as Federal Support Continues to Decline File size (bytes): 7416 STIS Filename: sdb96310.txt Also available: sdb96310.pdf Title: SDB 96-312 Graduate Enrollment in Science and Engineering Decreased by 1 Percent in 1994 File size (bytes): 4804 STIS Filename: sdb96312.txt Also available: sdb96312.pdf ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 94733 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113592 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 123228 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). 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 WAIS or Gopher: Do a word search on the filename as shown in the summary. 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" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Jul 22 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: IMPORTANT - BIOSCI Fundraising Update! Date: 23 Jul 1996 13:48:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 155 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199607200900.CAA17496@net.bio.net> NNTP-Posting-Host: net.bio.net BIOSCI is about halfway to its funding goal!! I'm interrupting the usual monthly posting of the BIOSCI miniFAQ to bring you up to date on BIOSCI fundraising progress, a topic of concern to your future use of this resource. Thank you in advance for taking the time to read this message carefully. Last year we announced that BIOSCI was going to adopt the U.S. Public Broadcasting System model to fund its operations after our DOE/NSF grant runs out later this year. Unlike PBS, we are not soliciting contributions from users; we are only selling ads on our Web pages solely to cover our operating costs. Our goal is to seek sponsorships until we build up an operating reserve of about $100,000 and then cease further promotions until we need to build the reserve back up. (The accountants among our readership will be familiar with the problem of deferred revenue which we can not safely utilize until ads have been displayed for a period of time.) We are only about halfway to our funding goal and need to raise further funds to avoid having to curtail services at net.bio.net. Fundraising is time-consuming, however, and we need your help as explained further below. Our operating costs consist of our network connection, phone lines, hardware maintenance (we will be getting newer and faster hardware soon!), plus 0.7 FTE of salaries covering UNIX systems admin, technical support, quality assurance, i.e., testing, of our system, and administrative costs (such as the time it takes to actually find/write/call potential sponsors and raise money!). Although the BIOSCI staff does get compensated for a portion of the work that they do, this project has always received a lot of free after-hours and "vacation" time labor, so we hope that no one will begrudge the time that we do charge to the project to serve you. All of the three part-time staff members, Dave Mack, Julie Lawrence, and myself, have full time day jobs and families in addition to working hard to keep this service running for all of you. Julie and Dave Mack are subcontractors for BIOSCI; my time that is charged to the project defrays a portion of my regular salary instead of adding to my income. Besides having to relocate the project, we were very busy this last year building new infrastructure such as our WWW hypermail interface to the system. This was released last December along with scores of WAIS indices for the newsgroups. Virtually everything is complete, although we do continue to find and fix bugs (many through your helpful feedback!). We are still having some problems with our WAIS indexing. The archives continue to grow rapidly. We are running over 100 indexes now versus three previously and any systems crashes cause greater havoc with the indexing than before! We are still working to fix this as fast as our resources permit and appreciate your patience, but we have been able to automate a lot of the infrastructure to reduce labor as compared to past requirements. We have also implemented new software to make moderation of BIOSCI/bionet newsgroups much easier and combat the growing problem of Internet junk mail and USENET "spamming." About 20% of our groups are now moderated, many of them by the BIOSCI staff! This, for example, made a major difference last year in the quality of content in our EMPLOYMENT/bionet.jobs.offered newsgroup which many commercial concerns and recruiting firms are using **without charge** to recruit candidates for positions in the biological sciences. We are also now in a position to have sponsors for individual newsgroups as you will have noticed if you have visited http://www.bio.net/ and clicked on "Access the BIOSCI/bionet newsgroups" recently. So, how can you help?? ---------------------- As noted above it can take a lot of time to contact potential sponsors if I have to do it all myself. Our request is quite simple. You can do two important things which will take very little time for you individually. First, please use our WWW system at http://www.bio.net/ to access the archives. You can now post or reply to messages via your Web browser. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. Our hope is to quickly raise several large corporate/institutional sponsors on our heavily-used WWW locations (some stats appended below), and then end this sponsorship campaign so that our resources can continue to be used for service provision, not fundraising. Many of our specialty newsgroup WWW archives are still used by small communities of scientists (and they haven't been heavily promoted yet). While these may be valuable niche markets to some advertisers, it will generate more labor and overhead having to find these sponsors, fairly price the locations, and deal with lots of smaller sponsorships than fewer mid-to large sponsors. We are striving to keep our operation as lean and efficient as possible since we are not trying to make careers out of running BIOSCI. We are trying if at all possible to avoid the administrative overhead entailed with processing lots of small payments to reach our fundraising goals. I'd like to thank all of you for your help in advance. In helping us, you are also helping yourselves, not only in keeping this resource available for all of the both large and small research communities that we serve, but also by alleviating the need for us to go back and compete with researchers for tight grant dollars! We promised NSF when we were awarded the BIOSCI grant that we would carry out this mission to make the service self-supporting. With your help, we will succeed in continuing BIOSCI's work into its second decade. Thank you very much! Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net A list of our prime WWW sponsorship locations follow. Please contact us for further details. ---------------------------------------------------------------------- The overall BIOSCI WWW pages are currently visited by users from close to 5500 unique computer hosts per week. Web servers only log the Internet computer/host name and frequently more than one individual can connect to us from a particular host. Main home page, http://www.bio.net, visited recently by about 2100 unique hosts per week Main Newsgroups archives page, http://www.bio.net/archives.html, visited recently by about 1200 Unique hosts per week BIO-JOURNALS archive page, http://www.bio.net/BIO-JOURNALS.html, visited recently by about 1000 unique hosts per week. EMPLOYMENT archive pages: http://www.bio.net:80/hypermail/EMPLOYMENT/ and monthly header pages, visited recently by about 800 unique hosts per week. Address database search page, http://www.bio.net/addrsearch.html, visited recently by about 450 unique hosts per week. Methods newsgroup archive pages, http://www.bio.net:80/hypermail/METHDS- REAGNTS/ and monthly header pages, visited recently by about 350 unique hosts per week. Ads can also be displayed on various combinations of other BIOSCI/bionet newsgroups. Please contact us at biosci-help@net.bio.net for details. ---------------------------------------------------------------------- From owner-sci-resources@net.bio.net Tue Jul 23 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 24, pt. 1of1, 19 July 1996 Date: 23 Jul 1996 17:05:30 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 513 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4t3pca$22t@net.bio.net> NNTP-Posting-Host: net.bio.net X-comment: RFAs described: DE-96-006, HL-96-020, PA-96-066 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.07.19 NIH GUIDE - Vol. 25, No. 24 - July 19, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 10/22/96 ************************************************* NATIONAL RESEARCH SERVICE AWARD - INSTITUTIONAL TRAINING (RFA DE-96-006) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R2 10/25/96 ************************************************* HOMING DETERMINANTS IN HEMATOPOIETIC STEM/PROGENITOR CELLS (RFA HL-96-020) National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases INDEX: HEART, LUNG, BLOOD; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P1 ********************************************************** RESEARCH ON THE HEMATOLOGIC ABNORMALITIES IN AIDS (PA-96-066) National Institute of Diabetes and Digestive and Kidney Diseases National Heart, Lung, and Blood Institute INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; HEART, LUNG, BLOOD THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. 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 GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & 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 $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 25, Number 24, July 19, 1996 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health (NIH), Office of Extramural Research (OER), Office for Protection from Research Risks (OPRR) is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1996 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and informal discussions. DATES: September 19-20, 1996 TOPIC: The 1996 Guide for the Care and Use of Laboratory Animals: The Era of Performance Based Standards LOCATION: Adams Park Hotel, 1550 Court Place, Denver, CO 80202, telephone (303) 893-3333, FAX (303) 623-0303 SPONSORS: University of Colorado Health Sciences Center, Denver, CO; University of Southern Colorado, Pueblo, CO CONTACT: Ms. Joann Bauer or Dr. James O. Stevens Continuing Medical Education Office University of Colorado Health Sciences Center 4200 East 9th Avenue, Campus Box C295 Denver, CO 80262 Telephone: (303) 372-9054 or (303) 270-4648 FAX: (303) 372-9065 REGISTRATION FEE: $175.00 INQUIRIES For further information concerning future NIH/OPRR Animal Welfare Education Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 - MSC 7507 Rockville, MD 20892-7507 Telephone: (301) 496-8101 x233 Email: RossD@od6100m1.od.nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 25, Number 24, July 19, 1996 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: DATES: July 25-26, 1996 TITLE: Protecting the Rights of Human Subjects in Research: Sharing the Benefits and Burdens of Research LOCATION: Alana Waikiki Hotel, 1956 Ala Moana Boulevard, Honolulu, HI 96815, telephone (808) 941-7275 SPONSORS: Kapi'olani Health Research Institute, Honolulu, HI; University of Hawaii, Honolulu, HI; Tripler Army Medical Center, Honolulu, HI REGISTRATION: Ms. Lora Young, Grants Assistant Kapi'olani Health Research Institute 1441 Kapi'olani Boulevard (18th Floor) Honolulu, HI 96814 Telephone: (808) 973-4759 FAX: (808) 973-8080 FEE: $120 DESCRIPTION: Topics to be discussed include: Protecting the Rights of Human Subjects: Today's Challenges; FDA Compliance Update; Report of Advisory Committee on Human Radiation Experiments; The IRB in Depth (Regulations; Policies and Procedures - What You Can and Cannot Review, Informed Consent, Expedited Reviews, Cooperative Agreements); Legal Issues in the Protection of Human Subjects (Access to Records: Hawaii Laws and Federal Regulations; Informed Consent; Liability Issues: The Institution Staff and Committee Members); Resolving Ethical Principles; Stressors for the IRB: Adverse Reaction Reporting Surviving Audits; The IRB's Obligation Regarding the Continuing Review of the Protocols; and Points for the IRB to Consider in Research Related to Human Genetics. DATES: September 26-27, 1996 TITLE: Role of the IRB in Collaborative Research LOCATION: Jumer's Castle Lodge, Peoria, IL SPONSORS: University of Illinois College of Medicine at Peoria, Peoria, IL; Meharry Medical College, Nashville, TN REGISTRATION: Ms. Nancy Hibser IRB/OPRR/FDA/Conference University of Illinois College of Medicine at Peoria One Illini Drive P.O. Box 1649 Peoria, IL 61656-1649 Telephone: (309) 671-8437 FAX: (309) 671-8513 REGISTRATION FEE: $125 ($135 after September 16, 1996) DESCRIPTION: The biomedical and behavioral research currently being conducted within academic institutions promises exciting advances in scientific knowledge, as well as unprecedented opportunities for the betterment of individual and society life. Increasingly, however, these dramatic achievements and opportunities are accompanied by scientific, ethical, regulatory, and legal intricacies, and dilemmas. Within the academic community, understanding these rapidly changing complexities is central to the Institutional Review Board's (IRB) ability to protect the rights and welfare of human research subjects while supporting scientific endeavor and its potential benefits to humankind. This conference is designed to examine a broad range of contemporary scientific, ethical, regulatory, and legal issues relating to biomedical, social behavioral, and anthropological research involving human subjects. Each of these issues will be discussed within the framework of the academic research environment, and presentations will focus on the unique challenges presented to (IRBs). Designed for both experienced and novice participants, the workshop will provide opportunities for greater depth and specificity on contemporary IRB issues. Along with sessions examining common IRB issues - including liability, informed consent, and deception - the conference will feature special focus sessions on issues related to historical perspectives, issues in mental health, the establishment, structure, and management of IRBs, computerized management information systems for the IRB office, FDA regulations for clinical trials, guidelines on inclusion of minorities and women, research involving special population, including children and elderly research subjects. Guest speakers will include representatives from OPRR: Mr. F. William Dommel, Jr., J.D., Dr. Kammal K. Mittal, and Ms. Darlene M. Ross; FDA: Dr. Gary L. Chadwick, Mr. Paul Goebel, Jr., Dr. Michael Norcross; NIMH: Dr. Andrea Baruchin. Distinguished members of the academic and clinical research community will also be present, including: Dr. Patricia Finn, St. Jude Children's Hospital at Memphis; Dr. Ernest Prentice, University of Nebraska; and co-host Dr. John Estrada, Meharry Medical College. The format will encourage audience participation and informational exchanges, with question and answer sessions throughout the program. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 - MSC 7507 Rockville, MD 20892-7507 Telephone: (301) 496-8101 x233 FAX: (301) 402-0527 Email: RossD@od6100m1.od.nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN DE-96-006 FULL-TEXT ************************************** NATIONAL RESEARCH SERVICE AWARD - INSTITUTIONAL TRAINING NIH GUIDE, Volume 25, Number 24, July 19, 1996 RFA AVAILABLE: DE-96-006 P.T. 44; K.W. 0720005, 0715148, 0785040, 0785035 National Institute of Dental Research Letter of Intent Receipt Date: September 13, 1996 Application Receipt Date: October 22, 1996 PURPOSE The National Institute of Dental Research (NIDR) invites new and competing applications proposing National Research Service Award (NRSA) Institutional Research Training Grant (T32) programs. The objectives are: (a) to develop highly qualified oral health research investigators, especially clinician scientists, by supporting postdoctoral training of individuals with a health professional degree who are committed to a research career in the basic biomedical, behavioral and clinical sciences pertaining to craniofacial, oral, and dental health and disease; (b) to provide re- training opportunities for mid-career scientists and clinical researchers to obtain expertise in particular basic or behavioral sciences relevant to the NIDR areas of research emphasis; and (c) to train pre- and early post-Ph.D. biomedical and behavioral scientists. In response to this RFA, the NIDR expects to make up to three new or competing continuation awards, each with two postdoctoral positions in the first year. The estimated total funding for all awards is $270,000 in the first year. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), NRSA - Institutional Training Awards, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). 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. James A. Lipton, D.D.S., Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-18J Bethesda, MD 20892-6402 Telephone: (301) 594-2618 or 594-7710 FAX: (301) 480-8318 Email: liptonj@de45.nidr.nih.gov $$R1 END ************************************************************ $$R2 BEGIN HL-96-020 FULL-TEXT ************************************** HOMING DETERMINANTS IN HEMATOPOIETIC STEM/PROGENITOR CELLS NIH GUIDE, Volume 25, Number 24, July 19, 1996 RFA AVAILABLE: HL-96-020 National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases P.T. 34; K.W. 1002004, 0710070 Letter of Intent Receipt Date: September 25, 1996 Application Receipt Date: October 25, 1996 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS FULL RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING RESPONSES TO THIS RFA. PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite research project grant (R01) applications for the purpose of delineating the function and regulation of homing determinants and their receptors (or ligands) that are involved in regulation of growth and differentiation of hematopoietic stem and progenitor cells. It is conceivable that the exquistive specificity of the hematopoietic homing process is determined by combinatorial "decision processes" involving multistep sequential engagement of overlapping regulatory, adhesion, and migratory events. However, this important process is poorly understood. The initiative will identify the cascade of interactive events in early phases of hematopoietic cell differentiation and its relation to engraftment. A major aspect of the program is to encourage research on the stem cell homing receptor or receptors and methods to manipulate receptor expression and binding. Such studies will undoubtedly have a major impact on our ability to identify the factors that are involved in such critical functions such as stem cell self-renewal, maintenance of progenitor cells, bone marrow and stem cell engraftment, and graft maintenance and rejection. Investigators are encouraged to consider other innovative approaches. It is anticipated that for fiscal year 1997, $1,500,000 total costs will be available for the first year of support for this initiative by the NHLBI. The NIDDK plans to allocate an additional $500,000 in total costs for the first year of support and plans to fund up to two applications. 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 initiative, Homing Determinants in Hematopoietic Stem and Progenitor Cells, is related to the priority areas of maternal and infant health and 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. Dr. Helena O. Mishoe Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10156 Bethesda, MD 20892-7950 Telephone: (301) 435-0050 FAX: (301) 480-0868 Email: hm31y@nih.gov Dr. David Badman Division of Kidney, Urology, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS-13C - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: badmand@ep.niddk.nih.gov $$R2 END ************************************************************ $$P1 BEGIN PA-96-066 FULL-TEXT ************************************** RESEARCH ON THE HEMATOLOGIC ABNORMALITIES IN AIDS NIH GUIDE, Volume 25, Number 24, July 19, 1996 PA AVAILABLE: PA-96-066 P.T. 34; K.W. 0715008, 0715032, 1002004, 0710070 National Institute of Diabetes and Digestive and Kidney Diseases National Heart, Lung, and Blood Institute PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases(NIDDK) and the National Heart, Lung, and Blood Institute (NHLBI) invite research project grant (R01) and FIRST (R29) award applications to support research addressing fundamental questions of hematologic abnormalities exhibited by humans infected by Human Immunodeficiency Viruses (HIV), the infectious agents of Human Acquired Immunodeficiency Syndrome (AIDS). Hematologic abnormalities in patients with the HIV infection are common. These abnormalities can significantly impact on the course of treatment for these patients. Fundamental progress has been made in understanding the molecular biology and clinical aspects of retroviral infection. It has become clear that further studies of retroviral-induced neoplasms of immunodeficiency states will continue to provide useful new information about the cellular and humoral basis of the immune responses, including the mechanisms leading to hematologic abnormalities that are seen following HIV infection. This program announcement is intended to solicit applications for support of studies on the cellular basis of these hematologic abnormalities. 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). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), the NIDDK Website (http://www.niddk.nih.gov), and by mail or email from the program official contacts 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, Room 6AS-19B MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: Ralph_Bain@nih.gov Helena O.Mishoe, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10156 Bethesda, MD 20892-7950 Telephone: (301) 435-0050 FAX: (301) 480-0868 Email: hm31y@nih.gov $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Tue Jul 23 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-066 - V25(24) 07/19/96 Date: 23 Jul 1996 17:06:21 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 328 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4t3pdt$259@net.bio.net> NNTP-Posting-Host: net.bio.net RESEARCH ON THE HEMATOLOGIC ABNORMALITIES IN AIDS NIH GUIDE, Volume 25, Number 24, July 19, 1996 PA NUMBER: PA-96-066 P.T. 34; K.W. 0715008, 0715032, 1002004, 0710070 National Institute of Diabetes and Digestive and Kidney Diseases National Heart, Lung, and Blood Institute PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Heart, Lung, and Blood Institute (NHLBI) invite grant applications for support of research addressing fundamental questions of hematologic abnormalities exhibited by humans infected by Human Immunodeficiency Viruses (HIV), the infectious agents of Human Acquired Immunodeficiency Syndrome (AIDS). Hematologic abnormalities in patients with the HIV infection are common. These abnormalities can significantly impact on the course of treatment for thesepatients. Fundamental progress has been made in the understanding of the molecular biology and clinical aspects of retroviral infection. It has become clear that further studies of retroviral-induced neoplasms of immunodeficiency states will continue to provide useful new information about the cellular and humoral basis of the immune responses, including the mechanisms leading to hematologic abnormalities which are seen following HIV infection. This announcement is intended to solicit applications for support of studies on the cellular basis of these hematologic abnormalities. 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 and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) award mechanisms. Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will vary also; however, the support of requests exceeding the NIDDK average grant size of $160,000 direct cost for R01 grants would be unusual and require ample justification. FIRST (R29) awards are limited to $350,000 direct cost over the five year period. RESEARCH OBJECTIVES The objective of this program announcement is to solicit proposals in which the hematologic abnormalities seen following HIV infection are examined at the cellular and molecular level. Particular encouragement is offered to investigators who are well-trained in the modern techniques of cell biology and molecular biology who currently may be pursuing other research interests. Investigators with interdisciplinary and collaborative arrangements already in place are encouraged to respond to this announcement. Applications should be focused on issues directly relevant to the understanding of the pathogenesis of cytopenia following HIV infection, and the role of hematopoietic precursor cells in the development of AIDS. Following is a description of the types of areas that may be appropriate to study. These descriptions are for illustrative purposes only and are not meant to be all inclusive or restrictive. Numerous hematologic abnormalities arise in individuals following HIV infection. Understanding how these abnormalities arise may be complicated by a variety of other infections, in addition to HIV, which usually are seen in these patients. Bone marrow dysplasia, anemia, thrombocytopenia, and leukopenia occur frequently in patients with HIV infection. Both ineffective hematopoiesis and peripheral destruction of blood cells may lead to cytopenia common in AIDS patients. The latter condition may be due to accelerated utilization and destruction of cells due to opportunistic infections, reticuloendothelial cell dysfunction, or to specific autoimmunity. Ineffective hematopoiesis in patients with AIDS has several potential causes which may include for example: (1)suppressive effects of infections; (2) the formation of circulating inhibitors; and (3) the effects of HIV on hematopoietic stem cells. The recent development of new technologies to make recombinant human hematopoietic growth factors has made it possible to correct some of the cytopenias associated with HIV infection and has also fostered studies of the role of growth factors in hematopoiesis, both in vitro and in vivo. Thrombocytopenia is seen in HIV infected patients with a high degree of incidence, and immune thrombocytic purpura has been recognized as a diagnostic category of the AIDS-Related Complex (ARC). The development of thrombopenia in HIV infections appears to be similar to that of other forms of idiopathic thrombocytopenic purpura. Antibody production against a 25,000 dayton protein of platelet membrane origin has been postulated to have a resemblance to an HIV precursor protein and may be involved in the formation of immune complexes which result in platelet destruction. Anemia is frequently present in HIV patients and its origin is unknown. The lack of reticulocyte response seen in these patients may be due to a hypoproliferative anemia or to ineffective hematopoiesis. Low erythropoietin levels and associated abnormalities seen in some AIDS patients may be a contributing factor to anemia. Neutropenia in AIDS patients is common. The recombinant human growth factor GM-CSF has been used in some clinical trials with AIDS patients and has been found to ameliorate the neutropenia of AIDS as well as that induced by treatment with zidovudine. Applications for support of clinical studies in humans are not requested at this time. In addition, the following studies would be considered unresponsive to this program announcement: (1) studies that do not emphasize the cellular and molecular basis of abnormal hematopoietic differentiation in AIDS; (2) general studies on hematopoiesis; and (3) phenomena associated with hematopoiesis in various disease states not related to AIDS. Program project grant applications (P01) are not suited to this program announcement. 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 20, 1994 (FR 59 1450814513) 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. ANIMAL WELFARE CONSIDERATIONS Investigators are encouraged to consider alternative methods and approaches in their research grant applications that do not require the use of whole animals, use alternative species such as nonmammals or invertebrates, reduce the number of animals required, and incorporate refinements to procedures that will result in the elimination or further minimization of pain and distress in animals. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The program announcement title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Potential R29 applicants should refer to the announcement on Just-in- Time Procedures for FIRST and Career Awards (NIH Guide for Grants and Contracts, Vol. 25, No. 10, March 29, 1996) for information on recent changes in guidelines for FIRST award format. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria 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, particularly, but not exclusively, in the area of the proposed research; 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. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. For Applications from Foreign Organizations: o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries that are not readily available in the United States or that provide augmentation of existing U.S. resources. AWARD CRITERIA Applications assigned on the basis of Public Health Service referral guidelines will compete for available funds with other approved applications assigned to the National Institute of Diabetes and Digestive and Kidney Diseases or the National Heart, Lung, and Blood Institute. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: 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-19B MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: Ralph_Bain@nih.gov Helena O. Mishoe, Ph.D. Division of Blood Diseases and Resources Nation Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10156 Bethesda, MD 20892-7950 Telephone: (301) 435-0050 FAX: (301) 480-0868 Email: hm31y@nih.gov Inquiries regarding fiscal matters may be directed to: Trude Hillard Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-44J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8859 Email: HillardT@ep.niddk.nih.gov Jane Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7174 Bethesda, MD 20892-7924 Telephone: (301) 435-0166 Email: davisj@gwgate.nhlbi.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 PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Jul 23 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-96-020 - V25(24) 07/19/96 Date: 23 Jul 1996 17:06:05 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 576 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4t3pdd$24l@net.bio.net> NNTP-Posting-Host: net.bio.net HOMING DETERMINANTS IN HEMATOPOIETIC STEM/PROGENITOR CELLS NIH GUIDE, Volume 25, Number 24, July 19, 1996 RFA: HL-96-020 National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases P.T. 34; K.W. 1002004, 0710070 Letter of Intent Receipt Date: September 25, 1996 Application Receipt Date: October 25, 1996 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The Cellular Hematology Scientific Research Group, Division of Blood Diseases and Resources, NHLBI, and the Hematology Program, Division of Kidney, Urology, and Hematologic Diseases, NIDDK, announces the availability of a Request of Applications (RFA) on the above subject. The purpose of this initiative is to encourage research aimed at delineating the function and regulation of homing determinants and their receptors (or ligands) that are involved in regulation of growth and differentiation of hematopoietic stem and progenitor cells. It is conceivable that the exquistive specificity of the hematopoietic homing process is determined by combinatorial "decision processes" involving multistep sequential engagement of overlapping regulatory, adhesion, and migratory events. However, this important process is poorly understood. The initiative will identify the cascade of interactive events in early phases of hematopoietic cell differentiation and its relation to engraftment. A major aspect of the program is to encourage research on the stem cell homing receptor or receptors and methods to manipulate receptor expression and binding. Such studies will undoubtedly have a major impact on our ability to identify the factors that are involved in such critical functions such as stem cell self-renewal, maintenance of progenitor cells, bone marrow and stem cell engraftment, and graft maintenance and rejection. 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 initiative, Homing Determinants in Hematopoietic Stem and Progenitor Cells, is related to the priority areas of maternal and infant health and 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 and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the federal government. Awards in response to this RFA will be made to foreign institutions only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. Minority individuals and women are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) mechanism of support. Newly independent investigators who may wish to consult with a program representative (see INQUIRIES section) are encouraged to apply. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. For this RFA, funds must be requested in $25,000 direct cost modules and a maximum of seven modules ($175,000 direct costs) per year may be requested. Any necessary escalation must be included within the number of modules being requested. Only limited budget information will be required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. 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, Other Support and Checklist information will be requested by NHLBI staff following the initial review. The APPLICATION PROCEDURES section of this RFA provides specific details of modifications to standard PHS 398 application kit instructions. Applicants, who will plan and execute their own research programs, are requested to furnish their own estimates of the time required to achieve the objectives of the proposed research project. Up to 4 years of support may be requested. At the end of the official award period, renewal applications may be submitted for peer review and competition for support through the regular grant program of the NHLBI and NIDDK. It is anticipated that support for the present program will begin August 1997. Administrative adjustments in project period or amount of support may be required at the time of the award. Since a variety of approaches would represent valid responses to this announcement, it is anticipated that there will be a range of costs among individual grants awarded. 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 It is anticipated that for fiscal year 1997, $1,500,000 total costs will be available for the first year of support for this initiative by the NHLBI. Award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose. It is anticipated that approximately five to six new grants will be awarded under this program. The NIDDK plans to allocate an additional $500,000 in total costs for the first year of support and plans to fund up to two applications. Applicants may request up to four years of support. The specific number to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Indirect costs will be awarded based on the negotiated rates. If collaborative arrangements involve subcontracts with other institutions, Ms. Jane R. Davis of the NHLBI Grants Operations Branch (telephone: (301) 435-0166) should be consulted regarding procedures to be followed. RESEARCH OBJECTIVES Background The production of blood cells, a process called hematopoiesis, takes place in the bone marrow. Hematopoiesis begins with the most primitive, pluripotent hematopoietic stem cell which is believed to be present as only one of every 100,000 nucleated bone marrow cells. The stem cell can either self-renew or differentiate into myeloid or lymphoid stem cells, which in turn can further differentiate and mature, ultimately giving rise to all the circulating blood cells. Each of these complex hematopoietic pathways is under the influence of one or more hematopoietic growth factors (colony stimulating factors) or cytokines that enhance cellular proliferation and maturation, or they exert negative or inhibitory effects on the process. Hemopoietic growth factors can be divided into two major groups (1): Those factors that are usually soluble and may reach hemopoietic cells via blood the stream. They tend to act on more differentiated cells, affecting their growth and maturation. They display little or no synergism with other growth factors. Examples of factors in this group are erythropoietin and G-CSF. There exists a second group of hemopoietic factors that can act on earlier, usually undifferentiated progenitor cells. The factors and their ligand are generally membrane-bound (2,3) and they constitute the molecular basis of cell- cell interaction (progenitor cell-stromal cells) (2). In addition these factors may not necessarily be "growth" factors since their actions are not typically stimulatory. They may also be involved in such critical functions stem cell self-renewal, stem cell engraftment, and graft maintenance or rejection. Although these functions may not belong strictly to the category of growth factors, stimulatory or inhibitory, their function may ultimately lead to one of the others. The factors moreover, are usually inactive by themselves and require the synergistic effect of other similar factors. Their interactions appear to form a cascade that leads to differentiation of cells that can later be subject to the effect of soluble, late-acting growth factors. Hence, it is owing to these membrane-associated factors that during early stages of development, the cell membrane is the arena of regulating interactions. Examples of these membrane-associated factors are the homing receptor-ligand (4) and the c-kit receptor and ligand (5). To this group should be added certain extracellular matrix components such as proteoglycans and fibronectin that could themselves be membrane-associated or interact with other membrane-associated factors (6). Whereas the soluble group of the growth factors and their respective ligands have been the subject of intensive and extensive studies and much of their clinical applications has been (or are being) defined, we are just beginning to learn the importance of the membrane-associated group and the cascade of their interactions. A major difficulty has been the availability of relatively purified stem cells or early progenitor cells, whose membrane is the area of action and interaction of these factors. These early progenitor cells are needed in relatively purified form and in quantities that can permit the application of modern cellular and molecular biological techniques. Such techniques are now gradually becoming available (7,8) and may help to reconstruct a cascade of interactive events in early phases of hemopoietic cell differentiation. The goals of this program are to identify this cascade of interactive events, its relation to engraftment, and its function in the maintenance of progenitor cells. A related goal is the development of methods such as amplification of purified progenitor cells. The ultimate goal is to identify the potentials of this cascade for exploitation in various clinical states and in particular in bone marrow transplantation. For example, a major aspect of this initiative is to encourage research on the stem cell homing receptor(s) and methods to manipulate receptor expression or receptor binding. Such studies may eventually be useful as a means for improving marrow and stem cell transplantation.These suggested approaches are intended as examples only. Investigators are encouraged to consider other innovative approaches. SPECIAL REQUIREMENTS Upon initiation of the program, the NHLBI and the NIDDK will sponsor annual meetings to encourage the exchange of information among investigators who participate in this program. In the preparation of the budget for the grant application, applicants should REQUEST ADDITIONAL TRAVEL FUNDS for one meeting each year to be held in Bethesda, Maryland. Applicants should also include a statement in the applications indicating their willingness to participate in such meetings. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 25, 1996, a letter 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. Such letters are requested only for the purpose of providing an indication of the number and scope of applications to be received; therefore, their receipt is usually not acknowledged. 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 the application. A faxed letter of intent may be used in place of a posted one. This letter of intent is to be sent to: Chief, Review Branch Division of Extramural Affairs, NHLBI National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: james_scheirer@nih.gov APPLICATION PROCEDURES Application Receipt Date: October 25, 1996 Applications are to be submitted on the research grant application form PHS 398 (rev. 5/95). Applications kits 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, email: ASKNIH@odrockm1.od.nih.gov. Use the conventional format for research grant applications and ensure that the points identified in the section on REVIEW CONSIDERATIONS are fulfilled. Budget Instructions The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398 (rev 5/95). It is not required nor will it be accepted at the time of application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget tables on Form page 5 of the PHS 398 (rev. 5/95). Only the requested total direct costs line for each year must be completed based on the number of $25,000 modules being requested. Applicants may not request a change in the amount of each module. A maximum of seven modules ($175,000)direct costs per year may be requested and each applicant may request up to four years of support for this RFA. Direct cost budgets will remain constant throughout the life of the project (i.e. the same number of modules requested for all budget periods). Any necessary escalation should be considered when determining the number of modules to be requested. However, in the event that the number of modules requested must change in any future year due to the nature of the research proposed, appropriate justification must be provided. Total Direct Costs for the entire Proposed Project Period should be shown in the box provided. BUDGET JUSTIFICATION - - Budget justifications should be provided under "Justifications" on Form Page 5 of the PHS 398. - List the names, role on the project and proposed percent effort for all project personnel (salaried or unsalaried)and provide a narrative justification for each person based on his/her role on the project. - Identify all consultants by name and organizational affiliation and describe the services to be performed. - Provide a general narrative justification for individual categories (equipment, supplies, etc.) required to complete the work proposed. More detailed justifications should be provided for high cost items. Any large one-time purchases, such as large equipment requests, must be accommodated within these limits. CONSORTIUM/CONTRACTUAL COSTS - If collaborations or subcontracts are involved that require transfer of funds from the grantee to other institutions, it is necessary to establish formal subcontract agreements with each collaborating institution. A letter of intent from each collaborating institution should be submitted with the application. Only the percentage of the consortium/contractual TOTAL COSTS (direct and indirect) relative to the total DIRECT COSTS of the overall project needs to be stated at this time. The following example should be used to indicate the percentage cost of the consortium, "The consortium agreement represents 27% of overall $175,000 direct costs requested in the first year.". A budget justification for the consortium should be provided as described in the "Budget Justification" section above (no Form Page 5 required for the consortium). Please indicate whether the consortium will be in place for the entire project period and identify any future year changes in the percentage relative to the parent grant. If there is a possibility for an award, the applicant will be requested to identify actual direct and indirect costs for all years of the consortium. Please note that total subc