and Human Services (HHS)
NOTICE OF LIMITED COMPETITION REQUEST FOR COMPETING APPLICATIONS: STRONG HEART STUDY RELEASE DATE: May 20, 2004 NOTICE: NOT-HL-04-107 National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) APPLICATION RECEIPT DATE: June 21, 2004 The NHLBI is requesting competing renewal applications from the five Strong Heart Study centers. These programs were originally awarded as a result of Request for Applications (RFA) and have been funded through competing renewal applications since the initial three-year funding. This re-competition will continue surveillance activities and associated data analyses for the original cohort of 4,549 participants and provide additional data collection and genetic analyses for the 3,600 family study participants. The goals of this solicitation are to (1) continue surveillance for morbid and mortal events in the original cohort for analyses related to baseline and later risk factor data, (2) collect additional phenotype data from the family study cohort for linkage and association studies, (3) genotype candidate genes for analysis with existing and new phenotype data, and (4) pursue significant linkage results with focused resequencing and genotyping to identify genes related to CVD and CVD risk factors. This RFA uses just-in-time concepts and non-modular budget. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm MECHANISM OF SUPPORT The Strong Heart Study uses the cooperative agreement (U01) administrative and funding mechanism of support. Under the cooperative agreement, the NIH assists, supports, and/or stimulates, and is substantially involved with recipients in conducting a study by facilitating performance of the effort in a "partner" role. Details of the responsibilities, relationships, and governance of a study funded under this cooperative agreement will be the same as in the current terms and conditions of the award. Organization, Operation, and Oversight, as well as Terms and Condition of award remain unchanged from the previous award. The total project period for an application submitted in response to this Notice may not exceed five (5) years. This program will end as of May 31, 2010. Renewal of the program is possible but should not be assumed. The anticipated award date for this solicitation is June 1, 2005. FUNDS AVAILABLE The NHLBI intends to commit a total of approximately $5.255 million in total costs for FY 2005 to fund five competitive continuation grants in response to this notice. The five applicants may request a project period of up to five years. Applicants are requested to submit applications with a budget for total costs (direct costs plus facilities and administrative (F&A) costs) for the five applications not to exceed a total of $27.9 million for the entire project period. Applicants may escalate costs at 3% per year for recurring costs. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001; updated 6/28/2002). Applications must have a Dunn and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. SUPPLEMENTARY INSTRUCTIONS: Only competing renewal applications from the currently funded five Strong Heart Study grantees will be considered. Please see http://apps.nhlbi.nih.gov/popstudies/Contacts.ASP?TrialNumber=1004 for a list of grantees. For the program, there must be a single Master Plan which describes the progress and plans for renewal for the three field centers and the data coordinating center and the central laboratory components of the study. The Master Plan is limited to 35 pages and replaces the Research Plan (sections a. through d.) in the PHS 398 for the three field center applications. Each of the other field center applications in the program will have the same Description (abstract) as the Master application, but will have unique Budget pages, Biosketches, Resources, and Checklist; the section "Research Plan" should be identical for the three field center applications. Separate applications of no more than 25 pages each will be accepted for the genetics center and for the cardiology center. For every application, Item 2 on the Face Page should be checked "Yes"; after "Number:" enter "NOT-HL-04-107" and after "Title:" enter "Competing Applications for the Strong Heart Study". 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 plus all five collated sets of appendix material must be sent to: Valerie Prenger, Ph.D. Chief, Review Branch National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, Room 7214 Bethesda, MD 20892-7924 Bethesda, MD 20817 (for express/ courier service) Telephone: 301-435-0270 FAX: 301-480-0730 APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgment of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI in accordance with the review criteria stated below. REVIEW CRITERIA Each application will be evaluated based on the progress and the proposed plans for each of five areas as normally applied to grant applications: (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)? (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? (6) Relationship with the American Indian Communities: Have formal approvals been obtained to allow the investigators to continue their research investigation within the communities? Is there evidence that the interests of American Indians are being served through input into the study and/or through communication of their perspectives? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. A complete copy of the updated Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research Amended, October, 2001 may be found at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. Guidelines on inclusion of children as participants in research may be found at http://grants.nih.gov/grants/funding/children/children.htm Sharing Research Data Applicants requesting $500,000 or more in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. See current policy for sharing data: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Factors that will be considered in making awards include: a) the scientific merit of the proposed studies; b) relevance to the overall programmatic balance and priorities of the NHLBI; and c) the availability of funds. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.837, 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. SCHEDULE Application Receipt Date: June 21, 2004 Peer Review: October-November 2004 Council Review: February, 2005 Start Date: June 1, 2005 INQUIRIES o Direct your questions about scientific/programmatic issues to: Richard R. Fabsitz, Ph.D. Leader, Genetic Epidemiology Scientific Research Group Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 8178 Bethesda, Maryland 20892-7934 For express mail use: 20817-8178 Telephone: (301) 435-0458 Fax: (301) 480-1667 e-mail: [email protected] o Direct your questions about peer review issues to: Valerie Prenger, Ph.D. Chief, Review Branch National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, Room 7214 Bethesda, MD 20892-7924 Bethesda, MD 20817 (for express/ courier service) Telephone: 301-435-0270 FAX: 301-480-0730 o Direct your questions about financial or grants management issues to: Ms Tanya McCoy Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Rockledge II, Room 7132, MSC 7926 6701 Rockledge Drive Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-0422 email: [email protected]
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