SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS RELEASE DATE: January 30, 2003 RFA: DK-03-013 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) LETTER OF INTENT RECEIPT DATE: June 11, 2003 APPLICATION RECEIPT DATE: July 11, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations: PURPOSE OF THIS RFA The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Silvio O. Conte Digestive Diseases Core Center grants. Three competing Digestive Diseases Core Center Grants (P30) will be awarded in fiscal year 2004. The Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs) 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. 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 the 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, functional bowel disorders, 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 imaging resources, transgenic animal, and membrane preparation facilities. Centers are encouraged to include a clinical component. This clinical component can exist as a stand-alone component 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, clinical components 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 component may more effectively address NIH policies concerning issues of women, children, 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 position 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. MECHANISM OF SUPPORT This RFA will use the NIH Core Center grant (P30) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is June 1, 2004 for one center and September 1, 2004 for two centers. This RFA uses just-in-time concepts as well as the non-modular budgeting format. The receipt of three competing continuation applications is anticipated. These will compete with all other applications received in response to this RFA. FUNDS AVAILABLE The NIDDK intends to commit approximately $3.5 in FY 2004 to fund 3 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $750,000 per year. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic Foreign institutions are not eligible to apply. For the purpose of this RFA, the NIDDK will not support more than one DDRCC center grant (P30) in an applicant institution. More details on the DDRCC program are available in the SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTER GUIDELINES available on the Internet at http://www.niddk.nih.gov/fund/other/centers.htm#digestive or from the program director listed under INQUIRIES, below. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS o The DDRCC Director, who is the Principal Investigator on the P30 application and Director of the Administrative Core, should be a scientist who can provide effective administrative and scientific leadership. The Director will be responsible for the organization and operation of the DDRCC and for communication with the NIDDK on scientific and operational matters. Center Directors are required, and their administrators strongly encouraged, to attend an annual 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. o Applications for DDRCC grants must propose a theme for the Center that is relevant to digestive diseases research and supported by the research projects comprising the research base for the DDRCC. The research base grants must be summarized in accordance with the DDRCC guidelines found at http://www.niddk.nih.gov/fund/other/centers.htm#digestive o 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. o Scientific personnel and institutional resources capable of supporting the research base must be available. In addition, the institution and pertinent departments must show a strong commitment to the Center's support. Such commitment may be provided as dedicated space, staff recruitment, salary support for investigators, dedicated equipment, or other financial support for the proposed Center. o Each core unit proposed for funding under the DDRCC must be utilized by a minimum of three federally funded research projects. A detailed description of each core unit proposed as part of the Center must be provided, with detailed budget and budget justification. A core director must be named for each core proposed. The description of each core unit proposed should include a rationale, indicating how it will support the research effort in a cost-effective manner. Facilities must be available for the primary needs of the DDRCC Program because funds for new construction are not available. o Promoting interdisciplinary collaboration among scientists working within a Center is a major goal of the DDRCC Program. Each Center application should describe how continuing and new interactions will be fostered and encouraged by the DDRCC. o Another goal of the DDRCC is to attract scientists to the field of digestive diseases research. Therefore, both a Pilot and Feasibility (PF) program as well as an Enrichment Program are available within the DDRCC program. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Judith Podskalny, Ph.D. Program Director Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 667 Bethesda, MD 20892-5450 Telephone: (301) 594-8876 Fax: (301) 480-3500 Email: jp53s@nih.gov o Direct your questions about peer 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 Blvd., Room 752 Bethesda, MD 20892-5452 Telephone: (301) 594-8897 Fax: (301) 480-3505 Email: fc15y@nih.gov o Direct your questions about financial or grants management matters to: Teresa Farris Marquette Senior Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 728 Bethesda, MD 20892-5456 Telephone: (301) 594-7682 Fax: (301) 480-3504 Email: tm275a@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed center o Name, address, and telephone number of the Principal Investigator o Names of other key personnel (Associate Directors, Core Directors) o Participating institutions o 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 plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should 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 Bethesda, MD 20892-5452 (Courier use Zip 20817) Telephone: (301) 594-8897 Fax: (301) 480-3505 Email: fc15y@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: The 'Silvio O. Conte Digestive Diseases Research Core Center' guidelines provide more detailed information on the Centers and on preparing the application. The guidelines are accessible at http://www.niddk.nih.gov/fund/other/centers.htm#digestive or from the program director listed under INQUIRIES. USING THE RFA LABEL: 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. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and 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 the time of submission, two additional copies of the application and all appendices must 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 Bethesda, MD 20892-5452 (Courier use Zip 20817) Telephone: (301) 594-8897 APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. 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 already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness to the RFA by the NIDDK. Incomplete and/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. No site visits are planned in the review of these applications; all information required for evaluation must be contained in the application. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which all applications will be discussed and assigned a priority score o Receive a second level review by the NIDDK National Advisory Council or Board. REVIEW CRITERIA All applications responding to this RFA will be evaluated according to the review criteria as outlined in the SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTER GUIDELINES available on the Internet at http://www.niddk.nih.gov/fund/other/centers.htm#digestive or from the program director listed under INQUIRIES, above. As part of the initial scientific review, which will result in an overall priority score for the P30 application, reviewers will rate each individual research core and, if requested, the clinical component. as well as the P/F program. The evaluation of the Enrichment program will be reflected in the score for the Administrative Core. The scores for each of these will appear in the summary statement. The review group will assign a descriptor, rather than a score, for the research base, the P/F program, and the Center Director. Review Criteria 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. 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 $150,000), and for enrichment in relation to the total Center program. Total requested Direct Costs are limited to $750,000 (including the P/F program). For competing continuation applications, total requested Direct Costs should not exceed the $750,000 cap. In addition to the criteria stated above, in accordance with NIH policy, all applications will be reviewed with respect to the following: o The adequacy of plans to include children, both genders, minorities, and their subgroups, as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget size and duration in relation to the proposed DDRCC. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 11, 2003 Application Receipt Date: July 11, 2003 Peer Review Date: November 2004 Council Review: January 2004 Earliest Anticipated Start Date: June 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o relevance to research areas of high programmatic interest to the Division of Digestive Diseases, NIDDK and research areas targeted by Congress; o availability of funds o geographic distribution REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-sponsored clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_ 2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH- defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the Human Embryonic Stem Cell Registry will be eligible for federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. Because P30 funds do not directly support research projects, the issues of minority/gender representation, inclusion of children as participants in research involving human subjects, required education on the protection of human subject participants, and the use of human embryonic stem cells will have been addressed at the individual project level (i.e., R01 level). However, the application must specifically address these issues for any P/F projects or cores as appropriate. 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. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 RFA 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.848, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the 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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