RFA-DK-98-016: SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS

Department of Health
and Human Services (HHS)

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SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS Release Date: April 17, 1998 RFA: DK-98-016 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 13, 1998 Application Receipt Date: November 13, 1998 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Silvio O. Conte Digestive Diseases Core Center grants. The NIDDK anticipates the award of four competitive Digestive Diseases Core Center Grants (P30) in Fiscal Year 2000. The Silvio O. Conte Digestive Diseases Research Core Centers are part of an integrated program of digestive diseases-related research support provided by the NIDDK. The Centers currently funded in this program have provided a focus for increasing collaboration and improving the cost-effectiveness of supported research among groups of successful investigators at institutions with an established, comprehensive digestive diseases 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), Digestive Diseases Research Core Centers, is related to the priority area of 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. Foreign institutions are not eligible for core center (P30) grants. Minority individuals and women are encouraged to submit as Principal Investigators. Applicant institutions must have an adequate base of established programs of high quality in laboratory and/or clinical digestive diseases-related research. The quality of the programs must be evident from the fact that support has been awarded through peer reviewed competition, such as NIDDK research project grants (R01), program project grants (P01), First Independent Research Support and Transition (FIRST) (R29) awards, 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 50 percent of the digestive diseases-related research being conducted at a new applicant institution be supported by the NIDDK. MECHANISM OF SUPPORT Support of this program will be through the NIH core center (P30) award. Responsibility for the planning, direction, and execution of the proposed center will be solely that of the applicant. This RFA is a one-time solicitation. The receipt of four competing continuation applications is anticipated. These applications will compete for four awards along with other applications received in response to this RFA. The total project period for each application submitted in response to the present RFA may not exceed five years. The earliest possible award date will be December 1999. Applicants must limit their requests to not more than $700,000 direct costs for the initial budget period. Included in this $700,000 may be a maximum of $100,000 for a pilot and feasibility program. Future budget period escalations may not exceed a three percent increase over the previous budget period. 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 at the National Center for Research Resources or a Principal Investigator must be included with the application. FUNDS AVAILABLE For FY 2000, up to $3,225,000 in total costs will be committed to fund four applications submitted in response to this RFA. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. First-time applicants must limit their requests to not more than $700,000 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 $700,000, 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 objective of the Core Centers is to bring together investigators from relevant disciplines to enhance and extend the effectiveness of research related to digestive diseases and their complications. A Core Center 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 Core Center is to bring together clinical and basic science investigators in a manner that will enrich the effectiveness of digestive diseases research. An existing program of excellence in biomedical research in the area of digestive diseases and disorders is required. This research must be in the form of NIH funded research projects, program projects, or other peer reviewed research that is already funded at the time of submission of a Center grant application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. The Core Center must have a central focus of research investigation. The central focus must be a digestive disease, group of diseases or functional studies relating to digestive diseases, at least half of the research must relate to this central focus. Examples of a gastrointestinal disease-related central focus of research investigation include (but are not restricted to) inflammatory bowel disease, peptic ulcer disease, pancreatic disease, liver disease, pediatric gastrointestinal disease, and AIDS in gastrointestinal disease. Examples of functional studies as the central focus include (but are not restricted to) gastrointestinal motility, gastrointestinal hormones, or gene therapy for digestive diseases. Applicants should consult with NIDDK staff concerning plans for the development of the Center and the organization of the application. Silvio O. Conte Digestive Diseases Research Core Centers are based on the core concept. Three 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 a center to accomplish the stated goals of the Center. Examples of such resources include electron microscope, transgenic animal, and membrane preparation 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 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 digestive diseases, 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 population 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 digestive disease research, and, occasionally, at investigators already working in digestive diseases 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. 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. 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 significance of the research base will be determined by the initial review group. INCLUSION OF WOMEN, MINORITIES, AND CHILDREN 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 also 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 policy 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 October 13, 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. 5/98) 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, telephone (301) 710-0267, fax: (301) 480-0525 Email: ASKNIH@OD.NIH.GOV Administrative Guidelines for Silvio O. Conte Digestive Diseases Research Core Centers may be requested from the NIDDK program staff listed under INQUIRIES below. The RFA label available in the PHS 398 (rev. 5/98) 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 13, 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 CSR and responsiveness by NHLBI. 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 DDRCC is an ongoing, strong base of digestive disease-related research. Specific review criteria for Digestive Diseases Research 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 Digestive Diseases Research 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 Digestive Diseases 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. However, a greater number of users will be considered to be more cost effective. o for all applications, four 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. Applicants should refer to the Administrative Guidelines for DDRCCs for specific details regarding the P/F program and its review by the IRG. o the 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 are capped at $100,000), and for enrichment in relation to the total Center program. Total requested Direct Costs are limited to $700,000 (including the P/F program). For competing continuation applications, total requested Direct Costs should not exceed the $700,000 cap or be 10% greater than the amount recommended in the last funding period, whichever is lower. 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. As part of the scientific and technical merit evaluation of the research plan, reviewers will be instructed to address the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. AWARD CRITERIA The earliest anticipated date of award is December 1999 for three centers and January 2000 for one center. Applications recommended for further consideration 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 Silvio O. Conte Digestive Diseases Research Core Centers" be obtained before an application is prepared. Inquiries regarding programmatic issues and requests for the Administrative Guidelines may be directed to: Judith M. Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-12E, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8876 FAX: (301) 480-8300 Email: jp53s@nih.gov Direct inquiries regarding fiscal matters to: Mr. George Tucker Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-49B, MSC 6600 Bethesda MD 20892-6600 Telephone: (301) 594-8853 FAX: (301) 480-3504 Email: tuckerg@niddk.ep.nih.gov Schedule Letter of Intent Receipt Date: October 13, 1998 Application Receipt Date: November 13, 1998 Initial Review: March 1999 Second Level Review: May 1999 Anticipated Date of Award: December 1999 and January 2000 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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