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)
National Human Genome Research Institute (NHGRI)

Funding Opportunity Title

Life After Linkage: The Future of Family Studies (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • May 3, 2011 - See Notice NOT-HL-11-144 Frequently Asked Questions (FAQs) and a Correction regarding Foreign Applicants.

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-007

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.837, 93.838, 93.839, 93.233, 93.172

FOA Purpose

This FOA issued by NHLBI and NHGRI solicits applications which integrate novel molecular data with existing genotype and phenotype data in families to identify and characterize genes influencing complex disorders. Applications for this program should have previously examined families with some genotyping and phenotypes available. Proposals may utilize focused ascertainment from families, for example, using risk profile, extreme phenotypes or families contributing heavily to genomic signals. The program may support the addition of targeted or whole genome sequencing, exon sequencing, copy number variants (CNVs), expression profiling, metabolomics, epigenomics, and/or novel biomarkers. This may require additional sample collection and/or reconsent. Applications should include a strong analytic component focused on bioinformatics and integration of multiple data types.

Key Dates
Posted Date

April 8, 2011

Open Date (Earliest Submission Date)

May 15, 2011

Letter of Intent Due Date

May 16, 2011

Application Due Date(s)

June 15, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

April 1, 2012

Expiration Date

June 16, 2011

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 purpose of this program is to utilize existing family studies to identify and characterize rare variants and common variants of small effect contributing to complex disease. The addition of next generation sequencing technology, gene expression profiling, metabolomics, novel biomarkers, epigenetic patterns, and/or CNVs will be used to localize and identify rare and functional variation in families from a diversity of populations with extant genotyping and phenotyping.

Nature of the Research Opportunity

Studies participating in this program are required to have previously collected and examined families with evidence for genetic effects on the traits of interest, genotypes, existing phenotypes/clinical data and assessment of environmental exposures available. Proposals must focus on heart, lung, blood and sleep (HLBS) disorders influenced by multiple genetic variants and environmental factors; this FOA does not support studies of Mendelian disorders attributed largely to a single genetic variant or handful of variants. Families from diverse populations that may differ in allele frequencies, linkage disequilibrium (LD) structure and may be segregating ethnic-specific variants are particularly encouraged. Proposals may utilize randomly-ascertained families or those identified through focused ascertainment such as by risk profile, extreme phenotypes, or those families contributing heavily to linkage signals. The program would support the addition of targeted sequencing, exon sequencing, copy number variants (CNVs), expression profiling, metabolomics, epigenomics, and/or deep phenotypes (such as in-depth analyses of available biospecimens or images) to linkage studies with extant genotyping and phenotyping. This may require additional sample collection and/or reconsent. Studies should include a strong analytic component focused on bioinformatics and integration of additional novel measures with extant genotyping and phenotyping. Studies should also provide assurance that they will take advantage of the efficiencies of new genomic technologies that become available during the grant period.

Pertinent Background Information

Many common human disorders are known to cluster in families. The field of human genetics has historically taken advantage of this fact and extensively used family studies (including twins) to investigate the genetics of complex disease. These studies have relied heavily on the concepts of heritability and differential transmission of disease susceptibility alleles. With the advent of Genome Wide Association Studies (GWAS), research has shifted away from family studies, because ascertainment and recruitment can be difficult and GWAS can be readily employed in existing population-based studies. However, GWAS has not begun to explain the heritability of disease risk factors and phenotypes. It has been postulated that much of the missing heritability lies in rare alleles, structural variants or gene by gene and gene by environment interactions. Family studies are ideally suited for discovery and characterization of rare alleles. Thus we are proposing to leverage our existing family studies to look for rare alleles and alleles of small effect that may be contributing to common, complex disease. This will be accomplished by overlaying state of the art molecular measures such as next generation sequencing, gene expression, metabolomics, deep phenotyping (such as in-depth analyses of available biospecimens or images), methylation and/or CNV measures on existing measures in families. New molecular data can be integrated with previously collected genotype, phenotype and environmental data from family studies to fully interrogate the families and provide a resource for gene discovery and characterization of complex disease.

Families offer advantages for discovering rarer variants and interrogating sequence data. First, hidden population stratification and heterogeneity does not pose an analytic challenge as it does in population based samples. Second, analysis of rare alleles is not problematic. In GWAS, rare alleles are generally excluded from analysis because one cannot determine if the allele is truly rare or due to a genotype calling error. In family studies transmission can be used to distinguish true rare allels from genotyping errors. Family studies also enable assessment of inherited methylation patterns and CNVs versus de novo mutations, as well as possible quantification of shared environmental and parent-of-origin effects. Addition of next generation sequencing and other molecular markers will leverage existing genetic information to enable assessment of both nucleotide and structural variation contributing to the heritability of common, complex disorders.

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

The program will contribute to ongoing efforts to characterize the genetic underpinnings of common, complex diseases. In addition, it will build upon existing gene discovery efforts in families from both GWAS and linkage analysis. The program will focus on approaches to identify rare variants, variants of small effect size, epigenetic factors and gene by gene and gene by environment interactions.

Addition of expression profiling and/or analysis of methylation patterns in families can add information on biological pathways and heritable epigenetic changes to genetic discovery. Discovery of novel genes and biological pathways which may act to predispose disease in families will add to our understanding of the etiology of complex diseases. Additional molecular mining of families with well measured and defined environmental exposures will enable assessment of gene by environment interactions, thus identifying factors that may modify genetic risk. Including families from populations of diverse genetic and geographic origin will allow studies of gene-environment interaction on different genetic and environmental backgrounds, as well as investigation of differing patterns of allele frequencies and LD. Identification of modifiable genetic risk can have direct clinical applications and potential public health ramifications.

Objectives of this research program and programmatic structure

The objective of this program is to utilize next generation molecular methods to deeply interrogate the genetics of complex disease in existing family studies with a focus on HLBS diseases and risk factors. Next generation sequencing technology, gene expression profiling, metabolomics, and analysis of epigenetic patterns, novel biomarkers and/or CNVs will be used to localize and identify rare and functional variants in families with existing genotype and phenotype data.

This initiative will support the utilization of currently available phenotypic data related to complex HBLS disorders to implement novel strategies for gene identification and characterization.

Grantees funded under this FOA should plan to attend semiannual investigator meetings and bimonthly conference calls for the purpose of sharing information on the resources, methodologies, analytic approach, as well as preliminary findings resulting from this FOA. Key co-investigators and pre- and postdoctoral trainees are also eligible to attend these meetings. PIs are encouraged to include investigators and trainees who are members of under-represented minority groups where appropriate. The cost of attending semiannual investigator meetings and any related travel, resource development, and conference calls should be included in the proposed research budget.

Interaction among the participating investigators will be required over the five-year period to accomplish the program aims. A Steering Committee, comprising each PI, a Co-PI from each study, and NIH Scientific staff will identify issues that have broad applicability across the program. Initial recommendations regarding program level organization, consistency across studies in areas which would benefit from a coordinated research effort will be made by the Steering Committee. Applicants should budget to attend meetings to be held twice a year. There is no plan to fund a separate Program Coordinating Center to organize Steering Committee meetings. Therefore, the task of organizing Steering Committee calls and in person meetings will rotate among funded studies. Each study will be asked to assume this role for a one year period. Each applicant should budget for the cost of organizing monthly Steering Committee teleconference calls and in person meetings twice yearly for a period of one year. Applicants must include the costs associated with facilitating the Program Coordinating center activities in their first year estimated budget.

Types of research and experimental approaches that are being sought to achieve the objectives

Participating studies in this program are required to have previously collected and examined families with genotypes, phenotypes/clinical measures and assessment of environmental exposures. Applications must focus on common, complex HBLS disorders that have a significant effect on public health; this FOA does not support studies of Mendelian disorders. Family structure can be sibships, twin, nuclear families (parents and offspring) or pedigrees. Proposals may utilize focused ascertainment from these families, such as risk profile, extreme phenotypes, or families contributing heavily to linkage peaks. The program would support a variety of approaches, including but not limited to the addition of dense genotyping, targeted sequencing, exon sequencing, CNVs, expression profiling, metabolomics, epigenomics, and/or deep phenotyping (such as in-depth analyses of available biospecimens or images). This may require additional sample collection and reconsent. For example collection of samples for gene expression profiling or fresh blood samples for assessment of CNVs or novel biomarkers will be permitted if only cell lines are available. In addition, participating studies may choose to collect fibroblasts or keratinocytes and bank them for later molecular profiling. Participating studies should make provisions for reconsent (if necessary), data and sample sharing, and return of results to participants where appropriate. In addition, samples should be banked for future cellular and molecular profiling whenever possible. Studies should use the most efficiencient technologies available to lower the costs of the genetic and/or genomic studies. Studies should include a strong analytic component focused on bioinformatics and integration of multiple data types as well as development of novel analytic strategies for use with family based data. Analytic approaches must integrate pre-existing genotype and phenotype data with the new molecular data generated from this FOA.

The program will consist of a collaboration of R01s with a Program Coordinating Center. The Program Coordinating Center functions will be shared by the awardees. Investigator meetings will be held twice yearly to facilitate collaboration. Analysis workshops will be held twice yearly in concert with the investigator meetings to facilitate development and sharing of new analytic methodology. Data and results will be shared widely with the scientific community.

Examples of research topics include but are not limited to those listed below:

Responsiveness to this FOA

Applications should focus on phenotypes relevant to HLBS disorders. Applications that require recruitment of the entire family sample or de novo collection of all phenotypic and/or medical data will be considered non-responsive and returned to the applicant. Collection of limited deep phenotyping information in family members found in initial years of this FOA to carry rare variants with potential phenotypic implications will be considered for support within this grant period if strongly justified scientifically and as time and fiscal constraints allow. Limited expansion of existing families (sampling from newly identified members) will be considered for support if strongly justified and fiscal constraints allow.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

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 NHLBI intends to commit $26.8 million over 5 years to fund 5-7 grants. The NHGRI intends to commit $5 million over 5 years to the program.

Award Budget

Direct costs should not exceed $350,000 in year 1 and $3.5 million for the 5-year period.

Award Project Period

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations 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 Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 PDs/PIs, visit the Multiple Program Director/Principal Investigator 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.

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 IC 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:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

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 (Express Mail Zip: 20817)
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 application submission. 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/PIs 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/PI 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 the NHLBI, and NHGRI, , NIH. Applications that are incomplete and/or non-responsive will not be reviewed.

Additional requirements for submitting an application (Research Strategy, unless otherwise stated):

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/PIs, 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/PI, 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 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:

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 Appropriate IC Advisory Councils. 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 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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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 301-710-0267
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)

Cashell E. Jaquish, Ph.D.
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Suite 10018, MSC 7936
Bethesda, MD 20892-7934
Telephone: (301) 435-0447
FAX: (301) 480-1455
Email: jaquishc@nhlbi.nih.gov

George J. Papanicolaou, Ph.D.
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Suite 10018, MSC 7936
Bethesda, MD 20892-7934
Telephone: 301-435-0453
FAX: 301-480-1455
Email: gjp@nhlbi.nih.gov

Weiniu Gan, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Suite 10164, MSC 7952
Bethesda, Maryland 20892-7952
Telephone: (301) 435-0202
Email: ganw2@nhlbi.nih.gov

Pankaj Qasba, Ph.D.
Program Director, Blood Diseases Branch
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
National Institues of Health
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
Telephone: 301-435-0050
Fax: 301-480-0867
E-mail: qasbap@nhlbi.nih.gov

Ebony B. Bookman, Ph.D.
Office of Population Genomics
Office of the Director
National Human Genome Research Institute
530 Davis Drive Room 3130 MSC K3-02
Morrisville, NC 27560
Telephone: (919) 541-0367
FAX: (919) 541-2843
Email: bookmane@nhlbi.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)

Kimberly Stanton
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7167, MSC 7926
Bethesda, MD 20892-7926 (Express Mail Zip: 20817)
Telephone: 301-435-0159
Fax: 301-451-5462
Email: kimberly.stanton@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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NIH Funding Opportunities and Notices



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