RFA-DK-02-007: OBESITY/NUTRITION RESEARCH CENTERS

Department of Health
and Human Services (HHS)

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OBESITY/NUTRITION RESEARCH CENTERS Release Date: October 2, 2001 RFA: RFA-DK-02-007 National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) Letter of Intent Receipt Date: June 17, 2002 Application Receipt Date: July 17, 2002 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Obesity/Nutrition Research Centers (Core Centers: P30) grants. The Obesity/Nutrition Research Centers (ONRC) grants 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 research base involving both basic and clinical research related to obesity. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This Request for Applications (RFA), Obesity/Nutrition Research Centers, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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 mechanism. Responsibility for the planning, direction, and execution of the proposed center will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under the NIH Grants Policy Statement. Applicants from institutions which 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. In such a case, 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 applications are anticipated, which will be in competition together with other applications received in response to this announcement. The total requested project period for applications submitted in response to this RFA may not exceed five years. Requests for support must be limited to no more than $750,000 in direct costs per year and $1,000,000 total costs per year. Future budget period escalations may not exceed a three percent increase over the previous budget period. The earliest anticipated award date is April 2003. FUNDS AVAILABLE For FY 2003, approximately $1,900,000 (total costs) has been set-aside for grants awarded under this RFA. NIDDK anticipates awarding two ONRC Grants in Fiscal Year 2003 on a competitive basis. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Two existing Centers are expected to submit competing renewal applications. To help meet the goals of NIDDK for managing the costs of biomedical research, first-time applicants must limit their requests to not more than $750,000 direct costs for the initial budget period. Competing applicants must limit their requests to not more than a 10% increase over their last year’s awarded budget, or $750,000, whichever is less. 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. A Core Center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. 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), program projects (P01) or other peer-reviewed research from Federal and non-federal sources this is already funded at the time of submission of a Center grant application. 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. Four to 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 biostatistics, imaging, biotechnology, and 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 children, 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. SPECIAL REQUIREMENTS At least 50 percent of the already funded research base in a new application must be supported by the NIDDK. In competing continuation applications the percent may be less than 50 percent due to, for example, a growing research base of investigators entering digestive diseases from other fields. The initial review group will determine the significance of the research base. Center Principal Investigators are required, and their administrators encouraged, to attend a once a year meeting to be held at a location to be determined by the NIDDK. Funds for travel to this meeting should be included in the budget for the Administrative Core of the Center. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contract on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate tot NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and /or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 are scientific and 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. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants an Contracts, June 5, 2000 (Revised August 25, 2000), and is available at the following URL address http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS in NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit, by June 17, 2002, 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 plan the review. The letter of intent is to be sent to: Francisco O. Calvo, Ph.D. Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 752, MSC 5452 Bethesda MD 20892-5452 (Courier use Zip 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 Email: fc15y@nih.gov APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. It is strongly recommended that applicants contact the NIDDK program staff listed under INQUIRIES below to obtain a copy of the current Administrative Guidelines for Obesity/Nutrition Research Centers. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 752, MSC 5452 Bethesda MD 20892-5452 (Courier use Zip 20817) Applications must be received by July 17, 2002. If an application is received after that date, it will be returned to the applicant without review. Supplemental documents containing significant revision or additions will not be accepted, unless applicants are notified by the Scientific Review Administrator. 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 CSR and responsiveness by NIDDK. Incomplete applications 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. 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 National Diabetes and Digestive and Kidney Diseases Advisory Council. REVIEW CRITERIA The initial review group will review each application using the criteria stated below and the OBESITY/NUTRITION RESEARCH CENTERS ADMINISTRATIVE GUIDELINES. The most important component of an ONRC is an ongoing, strong base of obesity and nutritional science related research. Specific review criteria for ONRC 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 ONRC 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 ONRCs 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. 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. Schedule Letter of Intent Receipt Date: June 17, 2002 Application Receipt Date: July 17, 2002 Peer Review Date: September/October 2002 Council Review: January 2003 Earliest Anticipated Start Date: April 2003 AWARD CRITERIA The earliest anticipated date of award is April 2003. 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, availability of funds, and geographic distribution. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. 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. Chief, Nutritional Sciences Branch Division of Digestive Diseases and Nutrition National Institutes of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Boulevard, Room 679, MSC 5450 Bethesda, MD 20892-5450 Phone: (301) 594-8883 Fax: (301) 480-8300 E-mail: vh16h@nih.gov Direct inquires regarding review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752, MSC 5452 Bethesda MD 20892-5452 (Courier use Zip 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 Email: fc15y@nih.gov Direct inquiries regarding fiscal matters to: Ms. Sharon T. Bourque Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases, NIDDK 6707 Democracy Boulevard, Room 719, MSC 5456 Bethesda, MD 20892-5456 Phone: (301) 594-8846 Fax: (301) 480-3504 E-mail: sb114m@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 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.

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