NOTICE OF LIMITED COMPETITION REQUEST FOR COMPETING APPLICATIONS: NHLBI PROGRAMS FOR GENOMICS APPLICATION (PGAs) RELEASE DATE: July 16, 2003 NOTICE: NOT-HL-03-011 National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) APPLICATION RECEIPT DATE: October 16, 2003 The NHLBI is requesting competing renewal applications from the eleven NHLBI Programs for Genomic Application (PGAs) (http://www.nhlbi.nih.gov/resources/pga/index.htm). These programs were awarded as a result of Request for Applications (RFA) HL-99-024, Genomic Applications for Heart, Lung, and Blood Research (https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-99-024.html). This re-competition will continue the unique ongoing resources and education programs of the PGA for a one time renewal cycle. Four activities in the PGAs will be emphasized in the renewal period: production of resources and tools, education, biological validation of the PGA resources and tools, and increased interactions between the PGA Groups. The production aspect of the program should remain as the primary effort of the PGA. The education component should consist of hands on courses and tutorials, web-based resources/learning, national meeting symposia, and visiting investigator programs. Each PGA should have some of each educational activity. Biological validation of the resources and tools should be directed at helping the scientific community see the various opportunities for the application of these tools and resources. In addition, it will enable each PGA to examine their products in order to provide an optimal set of resources. Trans-PGA projects to produce resources, educational programs, or biological queries that could not be attempted by an individual PGA are encouraged, but should be included within the scope of the PGA. The relative levels of effort for these activities should be at least 50% for production of resources and tools, at least 10% for education, and no more than 15% for biological application to validate the PGA resources and tools. Activities that increase or sustain interactions between or among the PGA Groups can be added to any of these above efforts. Dissemination of the products of the PGAs will continue to be within the policies established by the PGA Coordinating Committee as approved by NHLBI. A timeline with milestones for data, resources, and information dissemination should be included. Plans for the maintenance and distribution of the products of the PGA beyond the support of this specific program should be addressed in the competing application. MECHANISM OF SUPPORT The PGAs use 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 original RFA (https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-99-024.html). The total project period for an application submitted in response to this Notice may not exceed four (4) years. This program will end as of July 31, 2008. No renewal of the program will occur. The anticipated award date is August 1, 2004. FUNDS AVAILABLE The NHLBI intends to commit up to approximately $32,000,000 in FY 2004 to fund up to 11 PGAs. An applicant may request a project period of up to 4 years and a budget for total costs (direct costs plus facilities and administrative (F&A) costs) of up to $2,900,000 per year, including F & A costs on consortium arrangements. SUBMITTING AN APPLICATION Applications are due October 16, 2003. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001; updated 6/28/2002). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Only competing renewal applications which were funded as part of RFA HL-99-024, Genomic Applications for Heart, Lung, and Blood Research will be considered. For each program, there must be a single Master Plan which describes the progress toward and the plan for production of resources and tools, education, biological validation of the resources and tools, and interactions among and between PGA groups. The Master Plan is limited to 50 pages and replaces the Research Plan (sections a. through d.) in the PHS 398. For programs consisting of more than one application, only one application must contain the Master Plan. Each of the other 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 specify "See the application from Dr. X (Principal Investigator for the Master Plan application) for the Research Plan." For every application, Item 2 on the Face Page should be checked "Yes"; after "Number:" enter "NOT-HL-03-011" and after "Title:" enter "Competing Applications for PGAs". 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: Anne P. Clark, 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 email: clarka@nhlbi.nih.gov 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: 1) Production of Resources and Tools. Have the tools, resources and/or data produced by the PGA been beneficial to the scientific community (as a whole or to a particular discipline)? Are the plans for continued production appropriate? Is there potential to provide the scientific community with a valuable resource? What is the significance and potential impact of accomplishments and planned work? Is the proportion of effort allotted for production of resources and tools adequate? 2) Education. Have the educational programs of the PGA been beneficial to the scientific community (either to the whole community or to a particular discipline)? Do the proposed plans for education include hands on courses and tutorials, web based learning, national meeting symposium, and investigator visiting programs? Are there plans for assessing the quality and benefit of the educational opportunities offered? Is the proportion of effort allotted for education adequate? 3) Biological validation of resources and tools. Are the proposed plans for biological validation consistent with the applicant=s resources and tools? Will the proposed plans enhance the applicant=s resources and tools? 4) Synergy and interaction. Is the overall synergy of the component parts of the program apparent? Is there an expressed willingness to interact both within and between programs? Is the infrastructure appropriate to allow and foster synergy and interaction both within and among PGAs? 5) Data, resources, and tool sharing and dissemination. Are the data, resource, and tools sharing plans adequate? Is the time line and milestone plan appropriate? Are plans for maintenance and distribution of the products of the PGA beyond the support of this specific program addressed and adequate? 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. CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001; updated 06/28/2002) will be assessed. 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 program as determined by peer review, the multi disciplinary nature of the proposed studies, and the quality of meeting the special requirements of the PGA Program; b) relevance to the overall programmatic balance and priorities of the NHLBI; and c) the availability of funds. SCHEDULE Application Receipt Date: October 16, 2003 Peer Review: February - March 2004 Council Review: May 13-14, 2004 Start Date: August 1, 2004 INQUIRIES o Direct your questions about scientific/programmatic issues to: Susan E. Old, Ph.D. Bioengineering and Genomic Applications, Scientific Research Group Leader Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Rockledge II, Room 9144 6701 Rockledge Drive Bethesda, MD 20892-7940 Telephone: (301) 435-1802 FAX: (301) 480-1335 email: olds@nhlbi.nih.gov o Direct your questions about peer review issues to: Anne P. Clark, 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 email: clarka@nhlbi.nih.gov o Direct your questions about financial or grants management issues to: Ms. Carol Lander Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Rockledge II, Room 7164, MSC 7926 6701 Rockledge Drive Bethesda, MD 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 email: landerc@nhlbi.nih.gov
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