CYSTIC FIBROSIS CORE CENTER Release Date: January 24, 2000 RFA: DK-00-013 National Institute of Diabetes and Digestive and Kidney Diseases http://www.niddk.nih.gov/ Letter of Intent Receipt Date: May 16, 2000 Application Receipt Date: June 16, 2000 PURPOSE Cystic Fibrosis (CF) Core Centers provide shared resources to enhance research ranging from elucidation of the molecular pathogenesis of CF to development of new therapies for this disorder. Biomedical research cores are intended to enhance the efficiency of research and foster collaborations at institutions with strong existing bases of research relevant to CF. In addition to biomedical research cores, Centers provide support for pilot and feasibility studies and an enhanced environment for research training. 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, Cystic Fibrosis Core Center, is related to the priority area of chronic diseases. Potential applicants may obtain a copy of "Healthy People 2010" at http://odphp.osophs.dhhs.gov/pubs/hp2000 ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and nonprofit 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 P30 grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. An outstanding interdisciplinary program of CF research consisting of at least $1,000,000 of peer-reviewed research projects must be in existence at the applicant organization. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) core center grant (P30). Except as otherwise stated in this announcement, awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The anticipated award date is April 1, 2001. Applicants from institutions which have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. FUNDS AVAILABLE The NIDDK intends to commit approximately $1.1 million in FY 2001 to fund one new or competitive continuation grant in response to this RFA. The receipt of one competing continuation application is anticipated, which will be in competition together with other applications received 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, excluding facilities and administrative(F&A)costs on consortium arrangements. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. 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. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. RESEARCH OBJECTIVES Cystic fibrosis is the most common fatal genetic disease in caucasians, affecting approximately one in 2500 newborns. Since the cloning of the CF gene and identification of its protein product as a cAMP-regulated chloride channel, there has been impressive progress in the molecular understanding of this disorder. CF Core Centers are part of an integrated program of CF-related research support within the NIDDK directed at further defining the molecular mechanisms underlying CF and translating information about the molecular basis of the disease into new treatments. Continued progress will depend on multidisciplinary collaborations among clinical and basic scientists. Core centers provide a focus for enhancing such collaborations. Centers promote efficient management of resources, interaction and collaboration among scientists in multiple disciplines, and a multifaceted approach to a common goal. The objective of the core center is facilitation of progress in research on CF with the ultimate goal of developing new therapies for this disorder. CF Core Centers are designed to enhance the efficiency and effectiveness of an established, ongoing program of research through provision of core resources, support of pilot and feasibility studies, and support of program enrichment activities. Thus, an outstanding existing program of biomedical research in the area of CF is an essential prerequisite for a CF Core Center. This research should be in the form of NIH-funded research projects (R01 or R29), program projects (P01), Specialized Centers of Research (P50), or other peer-reviewed research such as that supported by the Cystic Fibrosis Foundation. This established research program must be in existence at the time of submission of a CF Core Center application. A CF Core Center is composed of shared resources (cores) that enhance productivity or in other ways benefit a group of investigators pursuing a multifaceted approach to significant problems related to the pathogenesis and treatment of CF. The CF Core Center is intended to improve the quality and efficiency of research on CF by providing shared access to specialized technical resources and expertise. Examples of cores that would be considered responsive to this RFA include the following: electrophysiology, cell morphology, imaging, tissue culture, protein expression, mutagenesis, structural biology, transgenic, animal models, gene transfer, and clinical resources. Specific cores should be proposed based on the requirements of the investigators at the applicant institution. Two other types of activities may also be supported with center funding: a pilot and feasibility program and an enrichment program. The pilot and feasibility program provides modest support for initiatives by new investigators, established investigators entering CF research, or established CF investigators exploring a new research direction related to CF. The Center grant may also include limited funds for program enrichment such as, but not limited to, seminars, visiting scientists, consultants, and workshops. SPECIAL REQUIREMENTS Applicants must be willing to participate in an annual Centers Directors" meeting and are advised to include such travel in their budget request. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide For Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html 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 Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 16, 2000, 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 the title of the RFA in your letter of intent. 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 avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Blvd, Room 653 MSC 5452 Bethesda, MD 20892-5452 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) 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, email: GrantsInfo@nih.gov. Applicants should request a copy of "Administrative Guidelines for Cystic Fibrosis Core Centers." These guidelines contain important additional information on the format, content, and review of applications and review criteria. In addition, they include information on new formats and just- in-time policies. Prospective applicants may obtain guidelines from Dr. Catherine McKeon at the address listed under INQUIRIES. 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 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 sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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 time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Blvd, Room 653 MSC 5452 Bethesda, MD 20892-5452 Bethesda, MD 20817 (for express/courier service) Applications must be received at NIH by June 16, 2000. If an application is received after that date, it will be returned to the applicant without review. Supplemental documents containing significant revision or additions will not be accepted, unless applicants are notified by the Scientific Review Administrator. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be 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 the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewer will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Are the scientific and administrative abilities of the Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the Core Center appropriate? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of Institutional commitment to the program, including lines of accountability regarding management of the Core Center grant and a commitment to establish new positions as necessary? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o Scientific excellence of the Center"s research base which should have a central focus on cystic fibrosis. The integration of the research base into the goals of the Center and collaboration between Center investigators must be described, o Appropriateness, impact, relevance and uniqueness of the services provided by the cores. Renewal applications must demonstrate core usage, cost effectiveness and research progress, o For new applications, the pilot and feasibility program is judged on the basis of (1) scientific merit of the submitted projects and (2) the merit of the administrative process for selecting subsequent studies. In competing renewal applications, emphasis is placed on the program as a whole, including past research accomplishments, success in attaining research support and management of the program, o The appropriateness of the Core Center budgets for the core facilities, pilot and feasibility studies, and for enrichment and the proportion of funds devoted to each component in relation to the total Center program, o Adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: May 16, 2000 Application Receipt Date: June 16, 2000 Peer Review Date: November - December 2000 Council Review: January 2001 Earliest Anticipated Start Date: April 1, 2001 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. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Catherine McKeon, Ph.D. Division of Diabetes, Endocrinology and Metabolic DIseases NIDDK 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8810 FAX: (301) 480-3503 E-mail: Catherine_McKeon@nih.gov Address after March 31, 2000: 6707 Democracy Blvd, Rm 6103 - MSC 5460 Bethesda 20892-5460 Bethesda, MD 20817 (for express/courier service) Direct inquiries regarding fiscal matters to: Cheryl Chick Division of Extramural Activities NIDDK 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8825 FAX: (301) 480-3504 E-mail: chickc@extra.niddk.nih.gov Address after March 31, 2000: 6707 Democracy Blvd, Rm 606 - MSC 5456 Bethesda 20892-5456 Bethesda, MD 20817 (for express/courier service) AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. 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.


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