Full Text DK-94-021 SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA: DK-94-021 P.T. 04 Keywords: Digestive Diseases & Disorders Etiology Pathophysiology Treatment, Medical+ National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 18, 1994 Application Receipt Date: November 15, 1994 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 (P30s) in Fiscal Year 1996. At least one of these awards will be to a center with a research emphasis on the etiology, pathology, and treatment of inflammatory bowel disease. 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 Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (not foreign) 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. 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, cooperative agreements, and contracts or through other Federal agencies or non-federal groups. It is required that at least fifty percent of the digestive diseases-related research being conducted at the 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 dates will be December 1995 for three center grants and January 1996 for the other grant. 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 four 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 1996, up to $3,265,000 in total costs will be committed to fund applications submitted in response to this RFA. It is anticipated that four awards will be made with an average size of approximately $750,000 per year, total costs; 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 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. 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 digestive diseases centers to accomplish the stated goals of the Center. Examples of such resources include electron microscope, tissue culture, and radioimmunoassay 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 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 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, but 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 significance of the research base will be determined by the initial review group. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by October 18, 1994, 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 subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), available in the office of sponsored research of most academic or research institutions and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 710-0267. 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 application form must be affixed to the bottom of the face page. 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 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by November 15, 1994. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement 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. Such applications must not only include an introduction addressing the previous critique, but also be responsive to this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the DRG for completeness. Incomplete 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. If the application is not responsive to the RFA, NIDDK staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. If the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted to withdraw applications from further competition if they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. 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. Following this review, the applications will be given a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council unless not recommended for further consideration by the initial review group. The most important component of a DDRCC is an ongoing, strong base of digestive disease-related research. Specific review criteria for Digestive Diseases 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 collaboration 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 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 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 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 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 application, total requested Direct Costs should not exceed the $700,000 cap or be 10% greater that the amount recommended in the last funding period, whichever is lower. Also in competing continuation applications, consideration must be taken for reductions instituted in FY 87 in accordance with NIDDK administrative policy. Ongoing Center grants incurred negotiated budget reductions averaging approximately 20 to 25 percent per year in addition to the Initial Review Group recommended reductions indicated in the summary statements. Applicants should address how these cuts affected their Center. AWARD CRITERIA The anticipated date of award is December 1995 for three center grants and January 1996 for one additional center grant. 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 Written and telephone inquiries concerning this RFA are encouraged. 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: Dr. Judith M. Podskalny Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A15 Bethesda, MD 20892 Telephone: (301) 594-7539 FAX: (301) 594-7504 Inquiries regarding fiscal matters may be directed to: Ms. Nancy Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 637A Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 Schedule Letter of Intent Receipt Date: October 18, 1994 Application Receipt Date: November 15, 1994 Initial Review: March 1995 Second Level Review: May 1995 Anticipated Date of Awards: December 1995 and January 1996 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 Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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