Full Text DK-96-011 OBESITY/NUTRITION RESEARCH CENTERS NIH GUIDE, Volume 25, Number 18, June 7, 1996 RFA: DK-96-011 P.T. 04 Keywords: Obesity Metabolism Nutrition/Dietetics Biomedical Research, Multidiscipl National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: September 26, 1996 Application Receipt Date: October 29, 1996 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Obesity/Nutrition Research Centers (Core Centers P30) for conducting basic and clinical research on obesity and the related fields of energy metabolism, body composition, satiety, adipocyte metabolism, eating disorders, and weight management. The centers will be awarded in Fiscal Year 1997. The award of at least two Obesity/Nutrition Research Centers by NIDDK is anticipated. Two existing Centers are expected to submit competitive renewal applications. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention goals of "Healthy People 2000," a PHS-led national activity for setting priorities. This Request for Applications (RFA), Obesity/Nutrition Research Centers, 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. There must be in existence at the applicant's institution an ongoing program of excellence in biomedical basic and clinical research related to obesity, eating disorders, energy regulation and the nutritional sciences. The quality of the programs must be evident from the fact that they have been awarded support through peer review competition and predominantly from the NIH or other Federal agencies. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT Support of this program will be through the NIH core center grant (P30) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the 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. This RFA is a one-time solicitation. The receipt of two competing continuation application is anticipated, which will be in competition with other applications received in response to this RFA. The total requested project for an application submitted in response to this RFA may not exceed five years. Requests for support must be limited to no more than $700,000 in direct costs per year and $1,000,000 total costs per year. The anticipated award date is September 30, 1997. FUNDS AVAILABLE For FY 1997, up to $1,434,000 total costs will be committed to fund applications submitted in response to this RFA. It is anticipated that two awards will be made; however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objectives of the Core Center are to encourage a multidisciplinary approach to research in the nutritional sciences and to bring together, on a cooperative basis, clinical and basic science investigators in a manner that will enhance and extend the effectiveness of nutritional research being conducted in the field of obesity, eating disorders, and energy regulation. To accomplish the overall goal of these centers, there must be in existence at the applicant's institution an ongoing program of excellence in biomedical research related to the study of obesity. This research should be in the form of NIH-funded research projects (R01), FIRST Awards (R29), program projects (P01) or other peer-reviewed research from Federal and non-federal sources. The research base in the nutritional sciences need not be exclusively in obesity and can include a focus on eating disorders, energy metabolism, cell biology, or nutrient metabolism. It would be highly desirable that the Principal Investigator, as well as the applicant institution, have a commitment to the treatment and prevention of obesity. The availability of a clinic population with adequate representation of women and minorities that can be readily utilized by investigators will play a major role in attracting investigators to the field of obesity research and to serve as a resource in the design of pilot and feasibility projects. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. Applicants should consult with NIDDK staff concerning plans for the development of the Center and the organization of the application. The Obesity/Nutrition Research Centers are based on the core concept. Five or six cores are usually included in a Center. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in obesity and nutritional sciences research to accomplish the stated goals of the Center. Examples of such resources include cell culture and radioimmunoassay instrumentation facilities. Centers are encouraged to include a clinical component or core that deals with patients. This clinical component can exist as a stand-alone core or part of another core such as the administrative core. Besides leading to a better understanding of disease etiology and natural history of disease, such cores might provide biostatistics support, enhance clinical study design, enhance collaboration among researchers and recruitment of subjects for clinical studies, provide for epidemiological studies, or provide modest funding for tissue, DNA, or serum storage. In addition, a clinical or epidemiology core may more effectively address NIH policies concerning issues of women and ethnic minority participation in clinical studies. Two other types of activities may also be supported with Center funding: a pilot and feasibility (P/F) program and an enrichment program. The P/F program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to obesity and nutritional sciences research, and, occasionally, at investigators who wish to make a substantial change in the direction of their research. In addition, temporary salary support for one Named New Investigator in a specified area of research with a defined P/F study may be requested for up to 24 months, with subsequent individuals to be named by the Center Director and approved by the Center's External Advisory Board and the NIDDK. The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. 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 reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS Volume 23, Number 11, March 18, 1994. Investigators may also obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 26, 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 a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-E - MSC -6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. Additional information about Obesity/Nutrition Research Centers and suggestions that could be helpful to the applicant are given in "Administrative Guidelines for Obesity/Nutrition Research Centers" which may be requested from the NIDDK program staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, plus three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-E - MSC 6600 Bethesda, MD 20892-6600 Applications must be received by October 29, 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 previously reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed for completeness and responsiveness. Incomplete applications or non-responsive applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with NIH peer review procedures. Applications are unlikely to be reviewed by a site visit team; therefore, the written application must be complete to facilitate review without a site visit. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Advisory Council. 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 (such as how usage will be prioritized), facilities, and potential for contribution to ongoing research. Renewal applications must document the use, utility, quality control and cost effectiveness of each Core requested to continue as part of the Center. Progress will be judged in part on the list of publications arising from the cores. At least two users are required to establish a core. However, a greater number of users generally can be evaluated as more cost effective. o For new applications, the proposed management of the 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 The anticipated date of award is September 30, 1997. Applications will compete for available funds with all other applications submitted in response to this RFA and recommended for further consideration 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 Obesity/Nutrition Research Centers program. Schedule Letter of Intent Receipt Date: September 26, 1996 Application Receipt Date: October 29, 1996 Initial Review: March-April 1997 Second Level Review: May-June 1997 Anticipated Date of Award: September 1997 INQUIRIES Prospective applicants should request the pamphlet "Administrative Guidelines for Obesity/Nutrition Research Centers" from the program office listed below. Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct requests for the Administrative Guidelines and inquiries regarding programmatic issues to: Van S. Hubbard, M.D., Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8883 FAX: (301) 480-8300 Email: hubbardv@ep.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Mrs. Sharon Bourque Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-49H - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8846 FAX: (301) 480-3504 Email: bourques@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. 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. .
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