Full Text DK-94-019 CORE GRANTS FOR CLINICAL NUTRITION RESEARCH UNITS NIH GUIDE, Volume 23, Number 25, July 1, 1994 RFA: DK-94-019 P.T. 34 Keywords: Nutrition/Dietetics Obesity Biomedical Research, Multidiscipl National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 21, 1994 Application Receipt Date: November 22, 1994 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for funding of two Clinical Nutrition Research Unit (CNRU) grants to be competitively awarded in Fiscal Year 1996. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Core Grants for Clinical Nutrition Research Units, is related to the priority areas of nutrition, physical activity and fitness, heart disease and stroke, cancer, diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. There must be in existence at the applicant's institution an ongoing program of excellence in biomedical basic and clinical research related to the nutritional sciences, obesity, eating disorders and energy regulation. The quality of the programs must be evident from the fact that they have been awarded support through peer review competition. Minority individuals and women are encouraged to submit as principal investigators. Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) core center grant (P30). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. The receipt of two competing continuation applications is anticipated, which will be in competition with other applications received in response to this RFA. The anticipated awards will be for five years and will be contingent upon the availability of appropriated funds. Requests for support must be limited to no more than $700,000 in direct costs per year. It is anticipated that awards will average approximately $775,000 total costs for the first budget period. FUNDS AVAILABLE Approximately $1,550,000 (total costs) has been set-aside for grants awarded under this RFA. The NIDDK anticipates awarding two CNRU Grants in Fiscal Year 1996 on a competitive basis. RESEARCH OBJECTIVES The NIDDK-supported Clinical Nutrition Research Units (CNRUs) are part of an integrated program of nutrition and obesity-research support provided by the NIDDK. These centers have provided a focus for increasing collaboration and cost effectiveness among groups of successful investigators at institutions with established comprehensive nutritional sciences and obesity research bases. A CNRU, at a minimum, must comprise the following seven components and also include other sources of support such as NIH research project grants (R01), FIRST Awards (R29), Program Projects (P01), Individual Fellowships (F32), and Institutional National Research Service Awards (T32), or other Federal and non-federal sources: 1. Research with human subjects and populations; 2. Laboratory investigations; 3. Research training (funds to be derived from other sources*); 4. Shared facilities and research services; 5. Education programs for medical students, house staff, practicing physicians, and allied health personnel (funds to be derived from other sources*); 6. Research components of nutritional support services; and 7. Public information activities (funds to be derived from other sources*). * Funds to support these components may not be requested as part of an application in response to this RFA. The objectives of the CNRUs are to bring together investigators from relevant disciplines in a manner that will enhance and extend the effectiveness of research related to nutritional sciences, obesity and related disorders. A CNRU must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the CNRU is to bring together on a cooperative basis, clinical and basic science investigators in a manner that will enrich the effectiveness of nutrition and obesity research. An existing program of excellence in biomedical research in the area of nutritional sciences, obesity, and related disorders is required. This research should be in the form of NIH-funded research projects, program projects, or other peer-reviewed research that is in existence at the time of submission of a center application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. Applicants may consult with NIDDK staff concerning plans for the development of the center. The CNRUs are based on the core center concept. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in nutrition and obesity related areas to accomplish the stated goals of the center. Two other types of activities may also be supported with center funding--a pilot and feasibility program and an enrichment program. The pilot and feasibility program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators or established investigators in other research disciplines where their expertise may be applied to nutrition and obesity research. The center grant may also include limited funds for program enrichment such as seminars, visiting scientists, consultants, workshops, etc. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator should be included with the application. STUDY POPULATIONS 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 9, 1994 (FR 59 11146-11151) 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 Potential applicants are strongly encouraged to submit a letter of intent no later than October 21, 1994. The letter of intent is to include the names of the Principal Investigator/program director and principal collaborators, a descriptive title of the potential application, identification of the organization(s) involved, and reference to the RFA number "DK-94-019." 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 the review of applications. It allows NIDDK 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: Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 603 Bethesda, MD 20892 APPLICATION PROCEDURES Applications are to be submitted on the form PHS 398 (rev. 09/91) available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD, telephone (301) 710-0267. On item 2a of the face page of the application, applicants must enter: "RFA: Core Grants for Clinical Nutrition Research Units, RFA number DK-94-019." The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application to the extent that it may not reach the review committee in time for review. Applications must be received by November 22, 1994, the original and three copies of the application must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two additional copies of the application under separate cover must be sent to: Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 603 Bethesda, MD 20892 REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the Division of Research Grants (DRG) for completeness. Evaluation of responsiveness to the program requirements and criteria stated in this RFA is an NIDDK staff function. Incomplete 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 NIDDK in accordance with the review criteria stated below and in the CNRU Guidelines. 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 RFA. 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. It is essential that the written application be in a form to be reviewed on its own merit, since no site-visit is anticipated. The initial review group will review each application using the criteria stated below: A. Biomedical Research o The scientific excellence of the Center's research base (its strengths, breadth, and depth) as well as the relevance and interrelation of these separately funded projects to the central themes of the Center and the likelihood for meaningful collaboration among Center investigators. The existence of a base of established, independently sponsored biomedical research of high quality is a prerequisite for the establishment of a Center and is the most important component of the review. o The qualifications, experience, and commitment of the Center investigators responsible for the individual research projects and their willingness to interrelate with each other and contribute to the overall objectives of the Center. o The appropriateness and relevance of the proposed cores and their modes of operation, facilities, and potential for contribution to ongoing research. Renewal applications must include the use, utility, quality control, cost effectiveness, and demonstrated progress of any developmental research in the shared resources. o For new applications, the proposed management of the pilot/feasibility (P/F) program and the scientific and technical merit of the P/F projects for which funds are requested from the Center grant. In competitive renewal applications, emphasis is accorded to the program as a whole, including past track record and management of the program. B. Enrichment o Efficient and effective use and/or planned use of these limited funds, including the contribution of these activities to enhancing the objectives of the Center. C. Administration o The scientific and administrative leadership abilities of the proposed Center director and associate director and their commitment and ability to devote adequate time to the effective management of the program. o The administrative organization proposed for the following: a. Coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring. b. Establishment and maintenance of internal communication and cooperation among the Center investigators. c. Mechanism for selecting and replacing professional or technical personnel within the Center. d. Mechanism for reviewing and administering funds for the P/F program. e. Management capabilities, including fiscal administration, procurement, property and personnel management, planning, and budgeting. C. Budget o The appropriateness of the budgets for the proposed work to be done in core facilities, for P/F studies, and for enrichment in relation to the total Center program. D. Institutional Commitment o The institutional commitment to the program, including lines of accountability for management of the Center grant and the institution's contribution to the management capabilities of the Center. o The academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and schools within the institution. o The institutional commitment to new individuals responsible for conducting essential Center functions. o The institutional commitment to establishing new positions specifically to enhance the operation of the Center. Applications determined in the initial review process to have sufficient merit for further consideration will be given a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. AWARD CRITERIA Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by peer review. The following will be considered in making funding decisions: o Quality of the proposed center as determined by peer review. o Availability of funds. o Overall balance in the CNRU program. INQUIRIES Applicants should request a copy of "Guidelines for Clinical Nutrition Research Units". These guidelines contain important additional information of the format, content, and review criteria. These documents and information about programmatic issues may be obtained from: Van S. Hubbard, M.D., Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A18B Bethesda, MD 20892 Telephone: (301) 594-7573 FAX: (301) 594-7504 Inquiries regarding fiscal matters may be directed to: Ms. Trude McCain Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 653 Bethesda, MD 20892 Telephone: (301) 594-7543 Schedule Letter of Intent Receipt Date: October 21, 1994 Application Receipt Date: November 22, 1994 Initial Review: March-April 1995 Second Level Review: May-June 1995 Anticipated Date of Award: December 1, 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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