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

Maximizing the Scientific Value of the NHLBI Biologic Specimen Repository: Scientific Opportunities (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

New

Related Notices

  • August 29, 2016 - This RFA has been reissued as RFA-HL-17-022.
  • February 3, 2012 - See Notice NOT-HL-12-010. The National Heart, Lung, and Blood Institute is publishing this Notice to remind potential applicants who plan to submit applications in response to this FOA that they are required to submit documentation confirming availability of biospecimens and data for the proposed research in the grant application.

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-004

Companion FOA

Not Applicable

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.839; 93.838

FOA Purpose

This Funding Opportunity Announcement (FOA), issued by the National Heart, Lung, and Blood Institute, solicits Exploratory/ Developmental Grant (R21) applications from Investigators at institutions/organizations that propose to conduct research in heart, lung, and blood diseases, and blood resources using existing biospecimens stored in the NHLBI Biologic Specimen Repository (Biorepository).

Key Dates
Posted Date
Open Date (Earliest Submission Date)

April 4, 2011

Letter of Intent Due Date

April 4, 2011; April 4, 2012

Application Due Date(s)

May 4, 2011; May 4, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

August 17, 2011; August 17 2012, by 5:00 PM local time of applicant organization.

Scientific Merit Review

November 2011; November 2012

Advisory Council Review

January 2012; January 2013

Earliest Start Date(s)

April 1, 2012; April 1, 2013

Expiration Date

August 18, 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

Program Objectives

The NHLBI is committed to maximizing the scientific value of biospecimen collections stored in the NHLBI Biologic Specimen Repository (NHLBI Biorepository) that are available to the wider scientific community through the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) website (https://biolincc.nhlbi.nih.gov). In addition, the NHLBI is committed to supporting Early Stage Investigators (ESI) whose field of research falls within the mission of the Institute and help them achieve their career goals (
http://www.nhlbi.nih.gov/funding/training/redbook/newinvest.htm). The objective of this FOA is to address both these commitments by providing Investigators with an opportunity to conduct exploratory research in heart, lung, and blood diseases, and blood resources using biospecimens currently stored in the NHLBI Biorepository and considering the ESI status of the PD/PI in the funding decision.

Background

The NHLBI Biorepository was established in 1975 and, during the first 25 years, several large plasma, serum, and whole blood biospecimen collections were acquired from NHLBI funded epidemiologic studies in transfusion medicine. The transfusion medicine biospecimen collections have provided many seminal contributions to transfusion safety. Biospecimens from the Transfusion-Transmitted Virus Study (TTVS), established in 1975, lead to the identification of the agent now known as hepatitis C virus (HCV). The TTVS biospecimens were used again in the mid-1990s in the development of more sensitive assays to detect HCV in blood donors and, recently, to investigate cytokine/chemokine changes that correlate with long-term outcomes of HCV infection. The Transfusion Safety Study (TSS) collection, established in the mid 1980s, was used by investigators to evaluate the transmission of HIV and other transfusion-associated viruses by blood donation components. A later collection, established in 2000, called the Retrovirus Epidemiology Donor Study Allogeneic Donor and Recipient Repository (RADAR), is a unique collection of biospecimens from transfused recipients and the blood donation components they received. This collection has been used to evaluate the transmission of parvovirus B19.

In more recent years, the NHLBI Biorepository acquired additional collections of biospecimens and associated clinical study data from several large clinical studies in heart, lung, and blood diseases. These studies collected a variety of material types including serum, plasma, whole blood, DNA and urine. The DNA biospecimens from A Case Control Etiologic Study of Sarcoidosis (ACCESS) have supported research in identifying gene polymorphisms in severe sarcoidosis phenotypes. Serum and urine from the Acute Respiratory Distress Syndrome Network (ARDSNet) studies have supported research in biomarkers of myocardial injury in ARDS. Cryopreserved umbilical cord blood units from the Cord Blood Transplantation Study (COBLT) have been used in studies aimed at optimizing the expansion of hematopoietic stem cells. DNA from the Hemochromatosis and Iron Overload Screening Study (HEIRS) was used to support research validating candidate modifying SNPs of Hemochromatosis. Plasma from the Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy (PEACE) collection has been used to support exploratory mechanistic studies related to venous thrombosis. The newly acquired Multicenter Hemophilia Cohort Study I and II has contributed to our understanding of the epidemiology and natural history of several blood-borne viral infections, especially HIV and HCV, as well as other conditions.

Biospecimen collections that may be accessed for this FOA must be from Open Study collections. As opposed to Proprietary Study collections, biospecimens and associated data from Open Study collections are available to all qualified scientific investigators irrespective of whether or not they participated in the original study that collected the biospecimens and data. Open Study biospecimens and associated data are available through the NHLBI BioLINCC web site at https://biolincc.nhlbi.nih.gov. As of September 2010, over 4 million biospecimens from 22 unique study protocols (4 heart disease; 6 lung disease; 3 blood disease; 9 blood resources/transfusion related) are available as Open Studies through the NHLBI BioLINCC web site and this number continues to increase as more collections and data are added to the inventory. Information on the number and material type of the biospecimens, the parent study protocol, the available study and/or biospecimen data, and any restrictions specified by the parent study informed consent is available on the website at https://biolincc.nhlbi.nih.gov.

Accessing the NHLBI Biorepository Biospecimen Collections

Investigators applying to this FOA must first identify appropriate biospecimens in Open Studies stored in the NHLBI Biorepository using the BioLINCC website . As for any grant application, documentation confirming availability of biospecimens and data for the proposed research will be provided to the investigator for inclusion in the grant application.. Grant applications that do not include documentation of biospecimen availability will not be reviewed and will be returned to the Iinvestigator. Information on obtaining this documentation is available on the BioLINCC web site (https://biolincc.nhlbi.nih.gov). In summary, interested applicants should follow the following steps:

1. Search for appropriate biospecimen material using the Open Studies link on the BioLINCC home page: https://biolincc.nhlbi.nih.gov.

2. From the selected study page, click on the request button. Enter your username and password. If you are not a registered BioLINCC user, the system will ask the user to register. Registered users will be asked to provide a brief description of the biospecimen requirements to initiate the search. The information required includes the number and material type of the biospecimens and the minimum and optimal volume required to perform the research.

3. BioLINCC staff will perform a preliminary search based on the information provided and contact the user regarding the availability of biospecimens or possible alternative study collections, if the requested biospecimens are not available.

4. If the requested biospecimens are available through BioLINCC, the user will be asked to provide a brief summary of their research aims to ensure the proposed research falls within the limits of the biospecimen collection’s informed consent document and, for this FOA, falls within the mission of the NHLBI.

5. Documentation indicating availability of biospecimens for the proposed research will be provided and the biospecimens will be placed on hold until the grant application is reviewed and approved for funding.

Of note, applicants may request a consultation with BioLINCC and NHLBI Biorepository staff prior to, or during, the biospecimen search to discuss which biospecimen material types and/or study collections may be appropriate for their proposed research.

Research Scope

Research in heart, lung, and blood diseases, or research in transfusion medicine, blood banking, and cellular therapies that uses biospecimens from existing NHLBI Biorepository Open Study collections is responsive to this announcement. Specific examples of research areas appropriate to this announcement include, but are not limited to:

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

NHLBI/DBDR intends to commit approximately $5 million to this program to fund up to 10-12 new grants in FY 2012 and up to 10-12 additional new grants in FY 2013.

Award Budget

Budgets for direct costs of up to $75,000 per year for a maximum of $150,000 direct costs over the two year period.

Award Project Period

2 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 (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project 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. Resubmission applications are not permitted in response to this FOA. Renewal applications are not permitted in response to this FOA.

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
6701 Rockledge Drive, Room 7214, MSC 7924
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 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.

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.

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.

Foreign Organizations

Not Applicable

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 NHLBI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Required Documentation: Applicants must include documentation that appropriate biospecimens are available from Open Study collections stored in the NHLBI Biorepository. Please follow the instructions under Section I. Funding Opportunity Description; Accessing the NHLBI Biorepository Biospecimen Collections (above) to obtain the documentation prior to submitting an application in response to this FOA.

Biospecimen Shipping Costs: The NHLBI Biorepository contract will support the retrieval, aliquoting, and packing of biospecimens. Applicants will be responsible for the cost of shipping biospecimens to their facility. Applicants should request an estimate for the cost of shipping biospecimens to their facility during the search process in BioLINCC.

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

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.

1. Criteria

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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? Do they have appropriate experience and training? 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 the NHLBI (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

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 NHLBI 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/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.

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)

Elizabeth Wagner, M.P.H.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9152, MSC 7950
Bethesda, MD 20892-7950
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0065
FAX: 301-480-0868
Email:wagnere@nhlbi.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Shelia Ortiz
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7144, MSC 7926
Bethesda, MD 20892-7926
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0166
FAX: 301-451-5462
Email:ortizsl@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.


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