Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

Targeted Analyses of Jackson Heart Study Data (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • January 11, 2012 - See Notice NOT-HL-11-170. Notice of Changes to the Scored Review Criteria, Delayed Receipt Date, and Notice of Answers to Frequently Asked Questions.

Funding Opportunity Announcement (FOA) Number

RFA-HL-13-007

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.837, 93.847  

FOA Purpose

This FOA will fund external topical working groups to collaborate with Jackson Heart Study researchers to analyze the data collected to date.  The Jackson Heart Study is an observational cohort study of 5,301 community-dwelling African Americans from Jackson, MS.  At the time of these grant awards, the Study will have completed 3 clinical examinations between 2000-2012, with annual follow-up telephone interviews.  NHLBI expects to fund 5 analytical working groups, each focused on a topic of concern for the health of African Americans, each having particular relevance to cardiovascular and related diseases, including but not limited to the following topics: hypertension, diabetes and obesity, physical activity and nutrition, heart failure, and chronic kidney disease.  Funding under this FOA will not support the collection of additional data.

Key Dates
Posted Date

November 3, 2011

Open Date (Earliest Submission Date)

January 28, 2012

Letter of Intent Due Date

January 28, 2012

Application Due Date(s)

(Extended to March 9, 2012 per NOT-HL-11-170), Original Date February 28, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

July/August 2012

Advisory Council Review

October 2012

Earliest Start Date(s)

December 2012

Expiration Date

(Extended to March 10, 2012 per NOT-HL-11-170), Original Date March 1, 2012  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

The objective of this program is to use existing clinical examination, laboratory, and imaging data generated by the Jackson Heart Study to address important scientific questions on the risk factors for and natural history of cardiovascular and related diseases among African Americans.  This program aims to support research that will address questions involving hypertension, diabetes and obesity, physical activity and nutrition, heart failure, and chronic kidney disease.  Support for other topics will be considered if a strong case can be made for their inclusion.

Nature of the Research Opportunity

Research funded by this announcement shall address cardiovascular and related diseases, as well as the risk factors for these diseases, that contribute to the disproportionate burden of cardiovascular morbidity and mortality among African Americans, using data generated by the Jackson Heart Study.

The Jackson Heart Study (JHS) is a community-based observational cohort study of 5300 African American adults living in or near Jackson, Mississippi.  At the time of the grants to be awarded by this announcement, the JHS will have completed 3 examinations between 2000 and 2012.  Data from these examinations document extremely high levels of CVD risk factors in the JHS cohort: as of the second examination, 88% were either overweight or obese, 73% were hypertensive, and 29% had diabetes.  Since its inception, the JHS has sought to collect and analyze data on risk factors and cardiovascular disease etiology among this high risk population, in particular, data that can be used to address issues of disparities in cardiovascular disease burden between African Americans and Americans of other racial/ethnic backgrounds 

Because of the limited size of the Jackson research community, this announcement seeks to fund external topical working groups of established clinical researchers that will collaborate with Jackson researchers to better use the wealth of data collected to date. Each working group will focus on a topic of particular relevance to cardiovascular and related diseases in African Americans. Overlapping research topics will be coordinated between the focused working groups and the JHS Publications and Presentations Committee. Suggested topic areas include, but are not limited to the following: 1) hypertension, 2) diabetes and obesity, 3) physical activity and nutrition, 4) heart failure, and 5) chronic kidney disease. These topical focus areas were chosen as areas for which extensive data exists in the JHS but for which data have not yet been fully explored to address key research questions. Alternative topical areas of research may be considered if a strong case can be made for fruitful exploration using data from the Jackson Heart Study and if there is no other NHLBI-funded study that might be better used to examine the proposed alternative research topic.  Although genetic data are also available from the JHS cohort, and linkage with genetic data is not explicitly discouraged, funds offered by this announcement are not intended to be used for primary genetic analyses.

Funded applicants should have a strong record of clinical research and publication in the chosen topical area and proven capability in data management and statistical analysis, including the analysis of large epidemiologic data bases.

Background Information

Although cardiovascular disease (CVD) is the most frequent cause of mortality throughout the U.S, the southeastern region carries a particularly high burden of CVD.  Mississippi is one of the most severely affected states: in 2006, age-adjusted CVD mortality in Mississippi was 30% higher than the national average (347 vs. 261 per 100,000 persons) (1).  Mississippi’s population has the highest proportion of African Americans (37%) of any state in the nation other than the District of Columbia (2), and African Americans are disproportionately affected by cardiovascular disease (1).   In 2007, age-adjusted death rates due to CVD for African American males vs. white males were 406 vs. 294 per 100,000, and for African American females vs. white females were 287 vs. 206 per 100,000 (1).  National estimates of hypertension prevalence (1999-2002) was 41.4% for African Americans, compared to 28.1 % for whites; in addition, African Americans develop hypertension earlier in life than whites and have higher average blood pressures than whites.  African American adults are also more likely to be obese, i.e., BMI =30 kg/m2, than whites, especially so for black women, for whom a recent national survey estimated as having an obesity prevalence of 50%, compared to 33% of white women (3).  Extreme obesity, i.e., BMI=40 kg/m2, was also more prevalent among African American adults vs. white adults: 7% vs. 4% for men and 14% vs. 6% for women (3).  The age-adjusted estimate of diabetes prevalence was 12% for African Americans, compared with 7% for whites (1).  More African American adults (32%) than white adults (22%) reported no leisure-time physical activity (4).  Fewer African Americans adults (22%) compared to white adults (25%) reported following dietary guidelines concerning recommended servings of fruits and vegetables (5).  African Americans were less likely to consume DASH-type diets (Dietary Approaches to Stop Hypertension) although they are more likely to benefit in reducing in blood pressure when they follow a DASH-type diet (6).  Heart failure mortality figures differ between the two races:  2007 mortality data showed that any-mention death rate for heart failure per 100,000 was higher for African Americans vs. whites (men: 104 vs. 99 ; women: 82 vs. 77) (1).  Chronic kidney disease begins at an earlier age in African Americans and is more likely to progress to end-stage renal disease than in whites.  Although comprising only 13% of the U.S. populations, almost 28% of treated end-stage renal disease patients are African American (1).

The JHS is well-positioned to address these alarming disparities in CVD and associated risk factors among African Americans.  The JHS was designed to collect clinical, laboratory, imaging, genetic, and environmental information that can inform the scientific community about the determinants and development of cardiovascular and related diseases in this high risk population.  Details about the design of the study and its development can be found at:  http://jhs.jsums.edu/jhsinfo/.

The following is a partial list of the types of data collected by the JHS to date, some collected at each examination, some only at one or two examinations, and others on subsamples of the full cohort.  In addition, surveillance is conducted at all regional hospitals for cardiovascular events (CHD, stroke, heart failure) among all JHS participants, and death certificate and Medicare record linkage is available.

A more complete list of data components can be found at:   http://jhs.jsums.edu/jhsinfo/ForResearchers/StudyComponents/tabid/88/Default.aspx

Scientific knowledge to be achieved through research supported by the special program

The funded topical focused analysis groups will use the JHS data to better understand the risk factors for and etiology of cardiovascular and related diseases in African Americans, a subpopulation that may carry unique risks for cardiovascular disease compared to other Americans.  Comprehensive analyses of these data, which may include comparisons of these data with data from other observational cohorts, may serve to elucidate some of the differences in disease risk and trajectories observed in African Americans compared to other groups.  Careful study and characterization of the nature of these diseases in African Americans will contribute to better understanding of the basic biology of CVD and related diseases in persons of all backgrounds.  

Publications of the JHS to date may be found at: http://jhs.jsums.edu/jhsinfo/ForResearchers/Publications/JHSPublications/tabid/101/Default.aspx

Examples of research topics (not limited to these):

Objectives of this research program and programmatic structure

It is anticipated that each funded topical working group will collaborate with the JHS Administrative Coordinating Center and the JHS Data Coordinating Center on assurances of proper human subjects training and data security, appropriate and permissible use of the data as dictated by the JHS participant consent forms, appropriate means of data sharing and data transfer, and the archival of standard data manipulations and derived variable coding. 

Each funded topical working group is expected to collaborate with other JHS topical working groups and with the JHS Publications and Presentations (P&P) Committee on issues of cross-topic research overlap and in coordinating the allocation or sharing of manuscript topics across working groups.  With concurrence of the JHS Steering Committee, each funded working group will be expected to contribute at least one member to the JHS P&P Committee who will help to review manuscripts and manuscript proposals and participate in semi-monthly meetings of this committee.

Grantees should anticipate traveling to Jackson to meet with collaborators at least once per year during the grant period, and PIs should plan to lead regular teleconference meetings at least bimonthly to discuss ongoing analyses and manuscript preparations with collaborators at the grantee’s institution(s) and in Jackson; key co-investigators and pre-and postdoctoral trainees shall be eligible and encouraged to participate in these meetings.  The cost of travel, resource development, teleconferences, and administrative assistance should be included in the proposed research budget.

Awardees should demonstrate the capability to engage early-career investigators in the analysis of these data, including graduate students, post-doctoral students, and early-stage investigators at their own institutions and in the Jackson, MS, research community.  Involvement of early-stage investigators who come from diverse backgrounds that are underrepresented in the medical research community is especially encouraged.  Grant recipients are encouraged to provide opportunities for mentored career development experiences through a variety of additional funding mechanisms, including NHLBI Diversity Supplements (http://www.nhlbi.nih.gov/funding/training/guid-app.htm) and support from other federal and non-federal training and career development opportunities.   Additional opportunities at NHLBI may be found at:  http://www.nhlbi.nih.gov/training/index.htm.

References

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

NHLBI intends to fund five awards and intends to commit $5 million between fiscal year 2013 - FY 2017.

Beyond FY 2013, future year amounts will depend on annual appropriations.

Award Budget

Application budgets for each award are limited to an aggregate of $649,000 in direct costs over the duration of the project, not including consortium F & A costs.

Award Project Period

 3-5 years 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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 NHLBI staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
Fax: 301-480-0730
Email:nhlbichiefreviewbranch@nhlbi.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:  

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NHLBI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?     

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NHLBI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.


As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Council (NHLBAC). The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.  

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Jane Harman, DVM, PhD
Program in Prevention and Population Sciences
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-1290
Email: Jane.Harman@nih.gov

Cheryl Nelson, MS
Program in Prevention and Population Sciences
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0451
Email: Cheryl.Nelson1@nih.gov

Jean Olson, MD, MPH
Program in Prevention and Population Sciences
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0397
Email: Jean.Olson@nih.gov

Paul Sorlie, PhD
Program in Prevention and Population Sciences
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0456
Email: Paul.Sorlie@nih.gov

Peer Review Contact(s)

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Financial/Grants Management Contact(s)

Tracee Gilchrist
Grants Management Specialist
National Heart, Lung, and Blood Institute
National Institutes of Health
Telephone: 301-402-3843
Tracee.gilchrist@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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