CLINICAL NUTRITION RESEARCH UNIT CORE CENTERS Release Date: May 1, 1998 RFA: DK-98-013 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: September 23, 1998 Application Receipt Date: November 10, 1998 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for funding of eight Clinical Nutrition Research Unit (CNRU) grants to be competitively awarded (three in September 1999 (FY 1999), four in FY 2000, and one in FY 2001). Six existing CNRUs are expected to submit competitive renewal applications. The Clinical Nutrition Research Units grants are core centers (P30) that provide a focus for increasing collaboration and improving the cost-effectiveness of supported research among groups of successful investigators at institutions with an established, comprehensive federally supported nutritional sciences and obesity-related research base. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Clinical Nutrition Research Unit Core 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 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 such as research project grants (R01), program project grants (P01), Mentored Clinical Scientist Development Awards (K08), cooperative agreements, and contracts, or through other Federal Agencies or non-federal groups. It is required that at least fifty percent of the nutritional sciences and obesity-related research comprising the research base be supported by Federal Agencies. 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 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. The receipt of six competing continuation applications is anticipated. These applications will be in competition together 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 $800,000 total costs for the first budget period. Future budget period escalations may not exceed a 3 percent increase over the previous budget period. FUNDS AVAILABLE Approximately $6,525,000 (total costs) has been set-aside for grants awarded under this RFA. NIDDK anticipates awarding three CNRU Grants in FY 1999, four in FY 2000 and one in FY 2001, on a competitive basis. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Applicants must limit their requests to not more than $700,000 direct costs for the initial budget period. 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 NIDDK-supported CNRUs are part of an integrated program of nutrition and obesity-research support provided by NIDDK. These centers have provided a focus for increasing collaboration and cost effectiveness among groups of successful investigators at institutions with established comprehensive federally supported nutritional sciences and obesity research base. 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 should consult with NIDDK staff concerning plans for the development of the center. A CNRU should be comprised the following components and include other sources of support such as an NIH research project grant (R01), NIH Program Project (P01), NIH Individual Fellowship (F32), and the NIH Institutional National Research Service Award (T32) or other Federal and non-federal sources: Required Components 1. Research with human subjects and populations, 2. Basic laboratory investigations, 3. Research training (funds to be derived from other sources*), 4. Shared facilities and research services, Encouraged Components (The presence of these components demonstrate the institutional commitment and the recognition of the clinical nutritional sciences and obesity within the Institution(s)). 5. Education programs emphasizing the nutritional sciences and obesity and related conditions or disorders 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 announcement. 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. It is appropriate and may be beneficial to have one or more central themes around which core center research investigations are focused. A clinical component or core that deals with patients is often helpful. This clinical component can exist as a stand-alone core or as a 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, foster collaboration among researchers, aid in recruitment of subjects for clinical studies, support epidemiological studies in areas of nutritional sciences and obesity, or provide modest funding for tissue, DNA, or serum storage. In addition, a clinical or epidemiology core may more effectively address NIH policies concerning the participation of women, children, and ethnic minority populations 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 and at investigators established in other research disciplines with expertise that may be applied to nutritional sciences and obesity 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. Subsequent individuals for this slot will 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there is scientific or ethical reasons not to include them. This applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by September 23, 1998, 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 this RFA. 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 to avoid conflicts of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8886 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant applications form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Phone (301) 710-0267, FAX: (301) 480- 0525, Email: asknih@od.nih.gov. Forms are also available on the NIH Website at http://grants.nih.gov/grants/forms.htm Administrative Guidelines for Clinical Nutrition Research Unit Core Centers may be requested from the NIDDK program staff listed under INQUIRIES below. 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: CENTER FOR SCIENTIFIC REVIEW 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 also be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F, MSC 6600 Bethesda, MD 20892-6600 Applications must be received by November 10, 1998. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) 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 CSR 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 by the CSR and responsiveness by the NIDDK. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and are 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 Diseases Advisory Council. The most important component of a CNRU is an ongoing, strong base of nutritional sciences and obesity-related research. Specific review criteria for CNRU Core Centers are: o The scientific excellence of the Center"s research base (its strengths, its breadth and depth) as well as the relevance and interrelation of these separately funded research projects to the central theme(s) or focus of the Center and the likelihood for meaningful collaborations among Center investigators. The existence of a base of established, independently supported biomedical research of high quality is a prerequisite for the establishment of a CNRU Core Center and is the most important component of the review. (The results of previous peer reviews of its content will weigh heavily in the assessment of the application"s overall strength as a potential recipient of an award.) 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 CNRU Core 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. Competing continuation 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 by the list of publications arising from the cores. At least two users are required to establish a core (Pilot and Feasibility projects do not count as a user for this purpose.) However, a greater number of users will be considered to be more cost effective. o For all applications, a description of current or proposed P/F studies should be submitted for evaluation as part of the review of the P/F program. In general for new applications, the proposed P/F projects will be examined to assess the eligibility of the P/F applicant and the adequacy of the selection process by which the individual studies were selected. For competitive renewal applications emphasis is accorded to the program as a whole, including past track record and management of the program. Applicants should refer to the Administrative Guidelines for CNRUs for specific details regarding the P/F program and its review. o A Named New Investigator, if requested, will be considered separately. 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 Core Center, (d) Mechanism for reviewing the use of and administering funds for the P/F program, (e) Management capabilities that include fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities, o The institutional commitment to the program, including lines of accountability regarding 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 institutions, o Efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities in enhancing the objectives of the Center, o The appropriateness of the budgets for the proposed and approved work to be done in Core facilities, for P/F studies (these are restricted funds) and for enrichment in relation to the total Center program. As part of the scientific and technical merit evaluation of the research plan, reviews will be instructed to address adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research, or justification for exclusion. Also, for competing continuation applications, the budget reductions instituted in accordance with NIDDK administrative policy are taken into consideration. Ongoing Center grants have incurred negotiated budget reductions averaging approximately 10 to 20 percent per year in addition to the budget reductions recommended by the Initial Review Group as indicated in the summary statements. The applicant should address how these cuts affected their Center. AWARD CRITERIA The earliest anticipated date of award is September 1999 for three centers, December 1999 for four centers and December 2000 for one center. Applications recommended by the National Diabetes and Digestive and Kidney Diseases Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, program needs and balance, and availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. It is strongly suggested that the pamphlet "Administrative Guidelines for Clinical Nutrition Research Unit Core Centers" be obtained before an application is prepared. Inquiries regarding programmatic issues and requests for the Administrative Guidelines may be directed 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, Room 6AN-18F - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8883 FAX: (301) 480-8300 Email: hubbardv@extra.niddk.nih.gov Direct inquiries regarding fiscal matters to: Mrs. Sharon Bourque Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-49H - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8846 FAX: (301) 480-3504 Email: bourques@extra.niddk.nih.gov Schedule Letter of Intent Receipt Date: September 23, 1998 Application Receipt Date: November 10, 1998 Initial Review: March/April 1999 Second Level Review: May 1999 Anticipated FY 1999 Dates of Award: September 1999 Award dates for FY 2000 and FY 2001 may be obtained by contacting program staff listed above. 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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