DIGESTIVE DISEASES RESEARCH DEVELOPMENT CENTERS Release Date: April 26, 2001 RFA: RFA-DK-01-030 November 27, 2006 (RFA-DK-06-018) - This RFA has been reissued as RFA-DK-06-018. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: September 26, 2001 Application Receipt Date: October 29, 2001 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Digestive Diseases Research Development Centers (DDRDCs). These Research Development Centers will support shared research resources, or cores, to be used by groups of NIDDK-funded investigators pursuing research that can be enhanced by the use of those shared resources, but who do not currently have access to a Silvio O. Conte Digestive Diseases Research Core Center. DDRDCs will enhance capabilities for conducting basic, clinical, and/or translational digestive diseases research relevant to the mission of the Division of Digestive Diseases and Nutrition (DDDN), NIDDK. The major purpose of this initiative is to increase the availability of core resources, with the goal of fostering research, collaborations, and new directions in digestive and liver disease research. 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. 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. Foreign institutions are not eligible for resource-related research project (R24) grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as DDRDC Directors and/or core directors. Each application for a DDRDC must propose to serve a minimum of six NIH Research Project (R01), Exploratory/Development (R21), MERIT (R37), and/or Program Project (P01) grants, with no less than 10 grant-years collectively remaining in the council-recommended project periods of those grants at the time of the start date for the DDRDC. A minimum of three of these grants must be supported by the NIDDK. This cohort of funded grants will be known collectively as the base grants for the DDRDC. Every grant counted in the base must have more than one year remaining in the council-recommended project period at the requested start date for the DDRDC. No other mechanism or source of support will be considered in determining eligibility. While only three NIDDK grants are required, it is anticipated that the composition of the base grant portfolio will strongly influence funding decisions by the NIDDK. Only one DDRDC will be awarded to any single applicant organization. Principal Investigators of the base grants, however, may be located at several affiliated, or closely aligned, institutions provided a clear plan of operation is provided describing administration structure and current interactions among the investigators. Each NIDDK base grant may only serve that purpose for one DDRDC. If well justified, supported core activities and core-related research may be located at sites and institutions other than that/those of the base grants and the DDRDC. This could be justified, for example, when the applicant institution is located in close proximity to a research institution with a well-established gnotobiotic animal facility, when it would not be logical or cost effective to duplicate the facility at the DDRDC institution. Each DDRDC will support one to three cores. Each core must be used by at least three of the base grants, and, in general, should serve as many base grants as possible. Direct costs requested on each DDRDC application may not exceed 25 percent of the annual direct costs awarded to the base grants at the anticipated start date for the DDRDC. Maximum allowable direct costs may not exceed $350,000 per year. MECHANISM OF SUPPORT DDRDCs will be supported by the resource-related research project grant (R24) mechanism. Each of the cores comprising a DDRDC should provide services, equipment, and/or other research resources to the base grants. Research related to the cores, in turn, will enhance the capabilities of those cores. The coordinated use of shared resources should increase the efficiency of digestive diseases research, facilitate the use of new technologies and the pursuit of new lines of investigation, and promote interdisciplinary and collaborative research. Up to five years of support may be requested. DDRDCs will be eligible for one competing renewal, making 10 years the maximum support period for a DDRDC. Former DDRDCs may apply, after a hiatus of at least two years, and in response to a Request for Applications, for a new DDRDC. Alternatively, former DDRDC awardees may wish to compete for a Silvio O. Conte Digestive Diseases Research Core Center (P30) grant. The latter compete for funding in response to periodic Requests for Applications. This RFA is a one-time solicitation. The anticipated award date is December, 2002. FUNDS AVAILABLE The NIDDK will commit $1.5 million in FY 2003 to fund 3 to 5 new R24 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 $350,000 per year, excluding facilities and administrative (F&A) costs on consortium arrangements. Although the financial plans of the NIDDK 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 applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Background The NIDDK recognizes that a critical mass of funded investigators is needed to provide the research base for a large core grant, such as a Silvio O. Conte Digestive Diseases Research Core Center, but that many sites around the country support smaller groups of NIDDK-funded investigators whose research would be enhanced, and could be extended, by the existence of shared core facilities. The DDRDC award is designed to allow groups of investigators already engaged in common thematic areas of digestive diseases research to benefit from shared research resources on a smaller scale than our P30 centers program. The use of such shared resources is expected to increase efficiency and cost-effectiveness by eliminating unnecessary duplication of effort and by supporting resources (e.g., costly equipment) that might be needed by, but not fully utilized by, any one research grant or investigator. Objectives and Scope The primary purpose of each DDRDC is to support shared research resources to enhance the capabilities of NIDDK-supported investigators who are pursuing research in areas of interest to the DDDN. A DDRDC will support cores and core-related research representing shared research resources and activities that can include services (e.g., cell isolations, patient recruitment, statistical support), equipment (e.g., confocal microscope, scanning electron microscope), or other resources (e.g., use of transgenic facilities, access to batch preparation of reagents, clinical research resources). The DDRDC must benefit the base grants that it serves and should increase efficiency, promote new research directions, and foster interactions and collaborations among the base grant researchers. Cores can also promote new research directions and innovative uses of technology by providing access to techniques, equipment, services, and expertise that might not otherwise be available. DDRDC cores may not be used to fund pilot projects, per se, but can help investigators validate novel hypotheses and generate sufficient preliminary data for the submission of a research project grant. It is anticipated that the proper use and management of the cores in the DDRDC will promote interactions, collaborations, and new projects that will in turn advance the field of digestive diseases research. Cores may also be used judiciously by investigators not directly supported by base grants, as long as the core usage provides opportunities for new investigators, for minority investigators, and for investigators wishing to become involved in the research base of the DDRDC. The proposed Director of the DDRDC must have a demonstrated ability to organize, administer, and direct the DDRDC, must be the Principal Investigator on one of the base grants, and may also serve as the head of a core. Research Topics The following are examples of the research supported by the NIDDK which would be eligible to apply for DDRDCs: pediatric liver disease, pediatric gastroenterology, celiac disease, inflammatory bowel disease, motility disorders/irritable bowel syndrome, diarrheal diseases, pancreatitis/pancreatic disease, peptic ulcer disease/Helicobacter pylori, gene therapy of liver or digestive disorders, gastroesophageal reflux disease/Barrett’s esophagus, and gastrointestinal aspects of AIDS. This list is neither inclusive, nor exclusive, and consultation with program staff is advisable to determine the programmatic suitability of a research focus for a DDRDC. 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 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 Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to 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 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. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained. 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. LETTER OF INTENT Prospective applicants are asked to submit, by September 26, 2001, 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-DK-01-030. 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 or e-mailed to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8885 FAX: (301) 480-3505 E-mail: fc15y@nih.gov APPLICATION PROCEDURES Applicants are strongly encouraged to call NIDDK program staff with any questions regarding the responsiveness of their proposed application to the goals of this RFA. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted only on or before the receipt date for this RFA, October 29, 2001. Application kits 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: . The application is also available at http://grants.nih.gov/grants/funding/phs398/phs398.html The title and number of this RFA, DK-01-030, must be typed in Section 2 on the face page of the application. The DDRDCs are intended to enhance the capabilities of NIDDK-supported investigators to pursue digestive diseases research. The manner in which the proposed DDRDC will do this must be evident from the information provided in the application. The following sections should replace the Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and the Research Design and Methods sections of the traditional Research Plan in form PHS 398 (Rev. 4/98): o General Description of the Base Grants. Each base grant should be described in no more than two pages, one page is preferred. The following must be provided for each base grant: the grant number, title, name of the PI, grantee organization, the project period end date, and the direct cost budget for the year on which the budget of the DDRDC application is based. In addition, the single page per grant must include a description providing an overview of the research goals and approaches used in the grant and the manner in which the DDRDC award will enhance, complement, or expedite the research activities of the research supported by the base grant. In addition, the specific ways in which the DDRDC will increase efficiency, promote new research directions, and foster collaborations should be described in the context of all the base grants in another section, not to exceed 4 pages. o Core Descriptions. These should not exceed 5 pages for any one core and should detail the purpose of the core, any anticipated core-related research, including the manner in which the research is expected to enhance the capabilities of the core, and must clearly delineate the space, facilities, resources, services, technical and professional expertise and support that the core will provide. If a fee-for-service is anticipated, this must be described. The specific manner in which each core will relate to base grants must also be described as well as how each base grant will benefit from the core. For each core, describe the degree of use by the relevant base grants, and the investigators supported by the base grants, keeping in mind that each core must be used by at least three of the base grants. It is not sufficient for a single investigator, holding three grants, to be the sole user of a core. Also, describe any anticipated use of the core facility by non-base grant investigators and the rationale for and extent of such use, if appropriate. o Operational Plan. This should not exceed the equivalent of 2 pages per core, and may be included as a sub-section of each of the core descriptions, or as an overarching plan for the operation of the DDRDC. The operational plan should describe arrangements required to manage the DDRDC, including the manner in which priority for core access and use is determined, the operational and administrative role of the director of each core, and plans for upgrades, enhancements, and modifications of core offerings as well as the plans for quality control. Any committee structure developed for managing the center should be described here, also. In exceptional circumstances, a core may be located at a site other than that of the DDRDC. For those applications proposing an offsite core, clear justification for this arrangement must be included. Budget The maximum direct costs requested may not exceed 25% of the direct costs for the base grants for the year in which the DDRDC would begin, up to a maximum of $350,000 per year in direct costs. The requested budget should include the costs of travel for the DDRDC Director to attend the yearly Digestive Diseases Centers Directors meeting in the budget. Other The RFA label available in the PHS 398 (rev. 4/98) 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 title of this RFA (Digestive Diseases Research Development Centers) and number (DK-01-030) 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 and appendices, 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 time of submission, two additional copies of the application and appendices must be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Applications must be received by October 29, 2001. 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 also 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to this 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 Criteria for scientific/technical review of DDRDC grant applications will include the following: o Approach: Is the research development center grant approach appropriate? The need for and suitability of the DDRDC approach will be assessed as well as whether this support will significantly enhance the capabilities of base grant investigators to pursue digestive diseases research. In addition, the likelihood that the DDRDC will increase efficiency, promote new research directions, facilitate interactions and collaborations among DK-funded investigators, and prove cost-effective will be evaluated. o Innovation: Is it likely that the proposed resources, in support of the base grants, will lead to fundamental advances within the field, to new discoveries, and/or to new technological, clinical, or scientific developments? The overall quality, scientific merit, and suitability of the activities to be supported as well as the likelihood that the cores will significantly enhance the research of the individual investigators will be evaluated. o Investigators: The capability and scientific credentials of the Director of the DDRDC, the core directors, and other participating investigators will be assessed. o Significance: Will the existence of the DDRDC grant significantly enhance the funded research, provide opportunities not otherwise available to the investigators, represent an appropriate cost savings/cost sharing advantage, and stimulate the development of new approaches? Are the operational plans and core structure appropriate? Is the organizational and administrative structure, oversight, and contingency plans for the management of the DDRDC adequate? o Environment: What is the nature and level of resource commitment from the applicant institution and from any other participating institutions? Do the proposed cores appear to complement or to enhance what is already available at the institution? The initial review group will also examine: the appropriateness of proposed project budget and duration. For applications requesting support for cores dealing with human subjects or animals, the initial review group will examine: the adequacy of plans to include both genders, minorities and their subgroups, and children, plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. The initial review group will make an overall recommendation to score (by assigning a priority score) or not to score the entire DDRDC application. Under some circumstances, it may be appropriate for the initial review group to recommend that one or more core(s) not be recommended for further consideration. Schedule Letter of Intent Receipt Date: September 26, 2001 Application Receipt Date: October 29, 2001 Peer Review Date: March, 2002 Council Review: May, 2002 Earliest Anticipated Start Date: December, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit as determined by peer review, o Availability of funds, o Programmatic priorities, o Geographic distribution. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic or review issues to: Judith Podskalny, Ph.D. Division of Digestive Diseases and Nutrition NIDDK 6707 Democracy Boulevard, Rm. 667 MSC 5450 Bethesda, MD 20892-5450 Telephone: (301) 594-8876 FAX: (301) 480-8300 E-mail: jp53s@nih.gov Direct inquiries regarding fiscal matters to: Teresa Farris Division of Extramural Activities NIDDK 6707 Democracy Boulevard, Rm. 728 MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-7682 FAX: (301) 480-3504 E-mail: tf102y@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are 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 NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.