Notice of Limited Competition Request for Competing Applications: Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN) Study

Notice Number: NOT-HL-05-102

Key Dates
Release Date: November 17, 2004
Application Receipt Date: January 7, 2005

Catalog of Federal Domestic Assistance Number(s)
93.837

Issued by
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)

The NHLBI is requesting competing renewal applications from three GOCADAN Study centers. This study was originally awarded as a single investigator-initiated application that was converted to a U01. It is requested that the application and subcontracts be split into three applications representing the investigators and primary institutions that served as the original grantee institution and its subcontractors. These three applications are expected to comprise a field center in Nome submitted by Norton Sound Health Corporation, a coordinating, cardiology and laboratory center in Washington DC submitted by MedStar Research Institute, and a genotyping laboratory and statistical genetics analysis center in San Antonio submitted by Southwest Foundation for Biomedical Research. This re-competition will continue data analyses related to linkage studies for the original cohort of 1,214 participants, provide additional data collection and phenotyping for the family study participants, and establish surveillance activities for cohort members.

The objectives of this solicitation are to (1) pursue significant linkage results with focused fine mapping, resequencing and/or genotyping to identify genes related to clinical CVD, pre-clinical CVD and CVD risk factors, and (2) collect additional relevant phenotype data from the family study cohort for additional linkage studies. This RFA uses just-in-time concepts and nonmodular 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 GOCADAN 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 June 30, 2010. Renewal of the program is possible but should not be assumed. The anticipated award date for this solicitation is September 30, 2005.

Funds Available

The NHLBI intends to commit a total of approximately $2.004 million in total costs for FY 2005 to fund three competitive continuation grants in response to this notice. The three 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 three applications not to exceed a total of $9.860 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. 11/2004). 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.dnb.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) 435-0714, E-mail: GrantsInfo@nih.gov.

Supplemental Instructions: Only competing renewal applications from the currently funded GOCADAN Study grantees and subcontractors will be considered. For the program, there must be a single Master Plan which describes the progress and plans for renewal for the field center and the coordinating/cardiology/laboratory center and a second application related to the genotyping and statistical genetics analysis center. The Master Plan is limited to 25 pages and replaces the Research Plan (sections a. through d.) in the PHS 398 for the field center application and the coordinating/cardiology/laboratory center. Both of the latter center applications will have the same Description (abstract) of the Master application, but will have unique Budget pages, Biosketches, Resources, and Checklist; the section "Research Plan" should be identical for the field center and coordinating/cardiology/laboratory center. A separate application of no more than 25 pages will be accepted for the genotyping and statistical genetics analysis center.

For every application, Item 2 on the Face Page should be checked "Yes"; after "Number:" enter "NOT-HL-05-102" and after "Title:" enter "Competing Applications for the GOCADAN 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 six 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 Alaska Native 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 Alaska Natives 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:

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 more than $500,000 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://grants2.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: January 7, 2005
Peer Review: March-May 2005
Council Review: August, 2005
Start Date: September 30, 2005

Inquiries

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 8164
Bethesda, Maryland 20892-7934
For express mail use: 20817-8178
Telephone: (301) 435-0458
Fax: (301) 480-1667
E-mail: RRF@NIH.GOV

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

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
E-mail: mccoyt@nhlbi.nih.gov


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