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/archive/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) 435-0714, Email: GrantsInfo@nih.gov.
 
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: RRF@NIH.GOV

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: mccoyt@nhlbi.nih.gov


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