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

Identifying Heart, Lung, and Blood Disease-Causing Variants (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • January 20, 2012 - See Notice NOT-HL-12-104. NHLBI withdraws effective immediately, No applications will be accepted for the February 8, 2012 or February 8, 2013 due dates.
  • December 13, 2011 - See Notice NOT-HL-11-161. Correction regarding Foreign Applicants.

Funding Opportunity Announcement (FOA) Number

PAR-12-043

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.233, 93.837, 93.838, 93.839

FOA Purpose

The objective of this initiative is to stimulate research to identify heart, lung, and blood disease-causing rare variants using the extensive exome data generated by the American Recovery and Reinvestment Act of 2009 (ARRA) GO exome sequencing project (GO ESP), CHARGE-S, and related genomic data.

Key Dates
Posted Date

November 30, 2011

Open Date (Earliest Submission Date)

January 8, 2012  

Letter of Intent Due Date

January 8, 2012 and January 8, 2013  

Application Due Date(s)

February 8, 2012 and February 8, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2012 and June/July 2013

Advisory Council Review

October 2012 and October 2013

Earliest Start Date(s)

December 2012 and December 2013

Expiration Date

(Now Expired January 20, 2012 per NOT-HL-12-104), Original Date February 9, 2013

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 initiative is to stimulate research to identify heart, lung, and blood disease-causing rare or lower frequency variants using the extensive exome data generated by the American Recovery and Reinvestment Act of 2009 (ARRA) GO Exome Sequencing Project (GO ESP), CHARGE-S, and related genomic data.

PURPOSE and RATIONALE:

The NHLBI launched a large-scale sequencing effort to find new disease-causing genetic variations as part of the RFA-OD-09-004 Recovery Act Limited Competition for NIH Grants: Research and Research Infrastructure “Grand Opportunities” (RC2) (GO) effort.  The goal of the two-year project was to sequence the “exome”, the protein-coding regions in the human genome, in thousands of samples from NHLBI’s well-phenotyped populations.  This NHLBI GO Exome Sequencing Project (GO ESP) has sequenced 7,500 samples to discover all the variation in the exons and provide the largest exome dataset for investigators interested in identifying the variation involved in heart, lung, and blood diseases.  Generated genotype data is being made available through publically available databases.  More detailed sequencing data and the phenotype information for these samples is being made available to authorized users through the NCBI's database for genotypes and phenotypes, dbGaP, http://www.ncbi.nlm.nih.gov/sites/entrez?db=gap.  The resource will enable heart, lung and blood investigators, to focus on the variants, genes and pathways most likely involved in these complex diseases.

This new initiative would capture the momentum established by the GO ESP to move the identification of disease-causing variants further toward a reality.  Having discovered the variants in the 7,500 exomes, the next step involves the complicated process of establishing the variants of large effect but sufficient frequency to be important in the development and progression of heart, lung and blood diseases and disorders.

The primary phenotypes in GO ESP include early onset myocardial infarction (EOMI), extremes of low density lipoprotein (LDL), anthropometry (high BMI with and without type 2 diabetes), early onset ischemic stroke, extremes of blood pressure, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), pulmonary hypertension (PAH), acute lung injury (ALI), asthma and subclinical/quantitative traits.  The short time-frame for the GO ESP effort has allowed only limited replication.  For some of the phenotypes (e.g., COPD, asthma, PAH, ALI, or stroke) more exomes may be needed to increase sample-size prior to replication.  In others (e.g., EOMI or CF) the findings may be ready for replication with targeted sequencing or genotyping.

The objective of this new initiative is to encourage investigators to identify and fill in specific gaps in the GO ESP exome dataset(s) to maximize the usefulness of this newly established resource for the complex diseases important to NHLBI.  The effort will require multidisciplinary collaborations involving epidemiologists, population geneticists, statistical geneticists, laboratory genomics experts, and diseases experts.  Potential gaps might be related to ethnic diversity, phenotypes that need additional power, analysis of the data in different ways, further validation of findings, and replication or follow-up studies in well chosen cohorts.  The specific gaps and approaches to meet the needs will be provided by the applicants.

Background:

NHLBI has been leading the effort to employ genomics to identify disease-causing variants and genes to find new treatments and prevention strategies for heart, lung and blood diseases and disorders.  Through the GO ESP effort, about 7,500 samples from participants in NHLBI’s well-phenotyped populations will have their exomes sequenced.  The samples have come from the large cohorts focused on heart (ARIC, CHS, FHS, JHS, MESA, CARDIA) or lung (Asthma, CF, COPD, PAH, ALI) disease and the Women’s Health Initiative (WHI) as well as smaller well-phenotyped cohorts focused on early onset MI or stroke.  The sequencing was performed in high enough coverage to allow identification of the lower frequency or rare variants.  The available data will include the variation calls, the raw exome data (in the NCBI Sequence Read Archive) and the harmonized phenotype data.  The first data release containing about 1,000 exomes was made available in September, 2011.  Subsequent releases with the remaining data will be made available to the scientific community in batches through dbGaP in the next four to six months.  The GO ESP investigators deposited the SNP data with general allele frequency for the first 2,400 exomes into dbSNP at the end of February for inclusion in the June, 2011 release.  These data also are available through the GO ESP Exome Variant Server (EVS) (http://snp.gs.washington.edu/EVS/).  These SNP data can be used by all investigators; for instance, it has been a valuable resource to check sequencing results to verify the uniqueness of specific variations.  The remaining exome data will be deposited in dbSNP and the EVS.  Thus, the data from the 7,500 exomes will provide a valuable resource for all investigators through NCBI’s dbGaP, SRA and dbSNP and the GO ESP EVS.  NHLBI’s leadership is needed to direct future efforts toward identifying the disease-causing variants and genes involved in heart, lung, and blood diseases.

An additional large-scale sequencing effort to identify the variation responsible for the GWAS peaks was funded by NHLBI through ARRA.  These data are being generated in CHARGE-S and will include targeted sequencing of 3,000 samples related to specific phenotypes and 2,000 controls, exome sequencing of 1,400 samples and 1,000 controls, followed by low coverage whole genome sequencing of a portion of the exome sequenced samples.  The samples for CHARGE-S are from ARIC, FHS and CHS.  The CHARGE-S datasets also will be shared through the NCBI databases including SRA and dbGaP.    
 
The NHLBI has funded major genotyping efforts in the large, well-phenotyped cohorts through CARe and SHARe.  The genotyping and phenotyping information from these efforts are available to authorized users through dbGaP and can be used in conjunction with the exome data through imputation to provide in silica information in a greater number of individuals.

Other exome projects have been funded by NIH.  Many of these have produced less than 500 exomes or have used a lower coverage and may not be able to identify rare variants.  However, these data can be used to provide input into the diseases and disorders of importance to NHLBI.  A consortium with exome data has developed an exome chip for genotyping the less common variants in the exome.

The results of this new initiative would provide the necessary groundwork for identifying variants, genes and pathways for functional studies to be funded through investigator initiated R01 applications.
 
SELECTED RESEARCH EXAMPLES:

The goal of this initiative is to fill in the gaps in the GO ESP exome dataset and to encourage replication studies to maximize utilization of NHLBI’s investment.  Applications should be focused on these objectives and include disease investigators, genomic investigators, statisticians and biologists.  The use of specimens/data from cohorts without approval for dbGaP sharing will need to be justified.
 
Potential examples are provided below.  Investigators are not limited to the following:

Replication studies of the rare variants identified in the GO ESP dataset in samples selected for one of the GO ESP primary phenotypes: extremes of LDL cholesterol, extremes of blood pressure, presence of COPD, presence of CF, high BMI with or without type 2 diabetes (anthropometry).

Extension of the GO ESP dataset(s) to increase ethnic diversity to indentify rare variation involved in a specific heart, lung or blood disease or phenotype using sequencing or imputation followed by replication studies.

Extension of the GO ESP dataset(s) to increase power to indentify rare variation(s) involved in a specific heart, lung, or blood disease or phenotype using sequencing or imputation followed by replication studies. 

Identification and replication of variation that have significant, effective size in quantitative blood cell traits, hemostatic factors, inflammatory markers, peripheral artery disease and/or other phenotypes beyond the primary GO ESP phenotypes.

Analysis of GO ESP exome dataset(s) by biological pathway or by a population genetics approach to identify key variants involved in either heart, lung or blood diseases followed by replication studies.

ADDITIONAL CONSIDERATIONS:

The focus of this program announcement is on enhancing the GO ESP dataset(s) for the study of complex diseases related to heart, lung, and blood with the goal of improving prevention and treatment.  The NHLBI has released a separate initiative to use the exome sequencing capacity of the Mendelian Disorders Genome Centers to carry out studies to investigate the genetic basis of Mendelian or monogenic disorders that significantly affect heart, lung, and blood (HLB) systems:  http://grants1.nih.gov/grants/guide/pa-files/PAR-11-307.html.  Associated information for the FOA for the NHGRI Mendelian Disorders Genome Centers can be found at http://grants.nih.gov/grants/guide/rfa-files/RFA-HG-10-016.html.  Therefore, applications to study Mendelian or monogenic diseases are not appropriate to the current initiative.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

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.

Award Budget

Application budgets for this FOA should not exceed $1,515,000 in direct costs (not including indirect cost for collaborating institutions) per year.  Application budgets need to reflect the actual needs of the proposed project.  Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period is 4 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.

[Updated language per NOT-HL-11-161]

NEW LANGUAGE:
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

OLD LANGUAGE:

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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Annual Meeting of Grantees 

The Principal Investigators for each grant awarded under this program announcement, as well as other collaborators, should plan to attend annual NHLBI-sponsored meetings in Bethesda, MD.  All applicants should include a request for funds to support attendance at the annual meeting.  

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.

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 modification:

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, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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 CSR, NIH, 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 on the basis of established PHS referral guidelines 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. 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(s)/PI(s) 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)

Deborah Applebaum-Bowden, Ph.D.
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8202 (MSC 7940)
Bethesda, MD 20892-7940
Telephone: (301) 435-0513
Fax: (301) 435-1454
Email: applebad@nhlbi.nih.gov

Weiniu Gan, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 10164, MSC 7952
Bethesda, MD 20892-7952
Telephone: (301) 435-0202
Fax: (301) 480-3451
Email: ganw2@nhlbi.nih.gov

Pankaj Qasba, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 9154, MSC 7950
Bethesda, MD 20892-7950
Telephone: (301) 435-0050
(301) 480-0868
Email: qasbap@nhlbi.nih.gov

Jacques Rossouw, M.D.
Women's Health Initiative
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 9192, MSC 7913
Bethesda, MD 20892-7913
Telephone: (301) 402-2900
Fax: (301) 480-5158
Email: rossouwj@nhlbi.nih.gov

Phyliss Sholinsky, MS
Prevention and Population Sciences Program
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 10120, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0703
Fax: (301) 480-1864
Email: sholinsp@nhlbi.nih.gov

Peer Review Contact(s)
Financial/Grants Management Contact(s)

Mr. Anthony J Agresti
Office of Grants Management
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 7158, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0186
Fax: (301) 480-3310
Email: agrestia@nhlbi.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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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