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

Early-Phase Clinical Trials for Blood Cell Therapies (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-11-204

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

FOA Purpose

This FOA issued by the National Heart, Lung, and Blood Institute, National Institutes of Health, encourages Research Project Grant (R01) applications from institutions and organizations for the purpose of supporting early-phase clinical trials—i.e., first-in-human, phase I, or phase II trials—to evaluate innovative and novel cell therapies to treat blood diseases and/or to improve the outcome of hematopoietic stem cell transplantations.

Key Dates
Posted Date

April 20, 2011

Open Date (Earliest Submission Date)

September 5, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

October 5, 2011 (first receipt date)
October 5, 2012 (second receipt date), by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

January 7, 2012 and January 7, 2013 by 5:00 PM local time of applicant organization.

Scientific Merit Review

February/March  2012 (first review date)
February/March 2013 (second review date)

Advisory Council Review

May 2012 and May 2013

Earliest Start Date(s)

July 2012 and July 2013

Expiration Date

January 8, 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

Nature of the research opportunity

This FOA issued by the National Heart, Lung, and Blood Institute, National Institutes of Health, encourages Research Project Grant (R01) applications from institutions and organizations proposing to conduct early-phase clinical trials—i.e., first-in-human, phase I, or phase II trials—to evaluate innovative and novel cell therapies to treat blood diseases and/or to improve the outcome of hematopoietic stem cell transplantations.  To promote this endeavor, applications that include clinical protocols and investigators will be encouraged to apply for dedicated NHLBI cell therapy resources to help them in the planning and/or conduct of the clinical trial.

Background

Accelerating hematopoietic stem cell transplant recovery and avoiding toxicities are key issues essential to expanding transplant use and treatments for benign hematological diseases (e.g., aplastic anemia, sickle cell disease, and thalassemia). Preclinical studies have provided new strategies but to advance the field, the relevant scientific and medical questions must be addressed through clinical investigation. Early clinical studies—first-in-human, phase I, or phase II trials--are required to address these scientific and mechanistic questions and to move the field forward. 

A number of issues have been seen as roadblocks hindering the clinical development of new cell therapies.  Investigators with preclinical findings have found that the standard NIH grant mechanism for hypothesis-driven basic research may not be suitable for clinical questions.   Also standing study sections may not include clinical expertise relevant to new cell therapies.  And basic research investigators may lack the clinical trial expertise needed to address regulatory issues, early-phase clinical trial design, trial management, or statistical issues.

This FOA provides a specific opportunityfor the submission of early-phase clinical trials for novel cell therapies to treat blood diseases and/or to improve the outcome of hematopoietic stem cell transplantation.    

Basic researchers that may lack clinical experience are strongly encouraged to ask for assistance from three NHLBI resource programs: the Production Assistance for Cellular Therapies or PACT, the Gene Therapy Resource Program or GTRP, and/or the Science Moving towards Research Translation and Therapy or SMARTT.  In addition to furnishing important key clinical-grade resources such as cells, vectors, or biologics, the coordinating centers of these programs can provide cell regulatory support, as well as data collection and statistical support related to the use of these resources in early phase clinical trials.

Investigators planning trials and developing clinical protocols for cell therapy applications to this FOA are encouraged to consult the coordinating centers at these resource programs (links to each resource program listed below) as well as the NHLBI program staff listed in this announcement (see Scientific/Research Contact(s) in Section VII. Agency Contacts.

PACT (http://www.pactgroup.net/) is an ongoing NHLBI cell processing resource program that has been producing clinical-grade cell products for over five years.  PACT facilities have been recently expanded from 3 to 5 cell production facilities.  Investigators without expertise in the scale up or production of clinical-grade cell products can consult PACT experts regarding cell production protocols and proposed clinical cell therapy trials.   Investigators planning clinical studies can submit applications and, if approved, obtain cells required for pre-IND studies as well as GMP-grade cells for clinical trials.  The PACT coordinating center can also provide regulatory support, data collection support, and statistical support related to its cell products.  If PACT centers cannot produce a specific cell product or the desired cell type cannot be shipped to the trial site, other cell processing facilities may be used.

Cell therapy trials that include gene transfer studies should consult GTRP (http://www.gtrp.org/).  This resource program provides: (1) large- and small-scale viral and non-viral vectors for preclinical studies and performs immunology testing, (2) clinical-grade adeno-associated virus (AAV) vectors for use in clinical studies and GMP process-comparable AAV vectors for use in pharm/tox studies, (3) clinical-grade lentiviral vectors for use in clinical studies and GMP process-comparable lentivirus vectors for use in pharm/tox studies.  In addition, GTRP can perform (4)  toxicology testing and bio-distribution studies of vectors in large and small animal models as a prerequisite for use in clinical studies and its coordinating center can provide (5) regulatory support.

Clinical-grade biologics, non-biologics, and small molecules can be furnished by the SMARTT program (http://www.nhlbi.nih.gov/new/SMARTT.htm).   Pre-clinical and clinical development requires materials manufactured using standard operating procedures and carefully controlled conditions to comply with Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP).  SMARTT provides resources through four facilities: (1) a production facility for biologic therapeutics, (2) a production facility for non-biologic and small-molecule therapeutics, (3) pharmacology and toxicology center, and (4) a coordinating center.

Investigators are encouraged to work with the staff at the coordinating centers for these three resource programs to create an appropriate preclinical and clinical development plan to support the submission of a well designed study protocol.  Consistent with the trial proposed, information on the following should be included: 1) preliminary data on the use of the proposed cell type, 2) safety and efficacy data, 3) potency assay data, 3) monitoring for immune reactions, 4) data supporting trial feasibility, 5) the suitability and availability of the proposed patient population, and 6) a data and safety monitoring plan including identification of specific personnel to monitor adverse events, and proposed stopping rules.  The proposed clinical protocol and consent forms are submitted in the appendix of the application. Information on the protocol must also be provided in the research strategy section of the application including an overview of the state of the science, current status and relevance of the trial, a discussion of the specific protocol, and the approach to data collection and analysis. In the Research Strategy section, a protocol should include sections on the hypothesis, specific aims, background, eligibility criteria, treatment plan, primary and secondary outcomes, study design with accrual targets based on the statistical power of the study, number of accrual sites required based on patient availability, timeline including site start-up, patient accrual, follow up, data collection and analysis, and the data and safety monitoring plan. Certification of IRB approval for the proposed clinical protocol will not be required prior to review or prior to award.  However, protocols submitted need to be well developed with the necessary regulatory and other approvals in place so the clinical trial can be initiated after award. Applicants will be expected to complete the requirements for regulatory filing, e.g., an Investigational New Drug (IND) application or Biologics License Application (BLA), prior to award and the status of discussions with the FDA should be documented in the application.  Applicants need not have their clinical protocols reviewed by a Scientific Review Committee – also knows as a Protocol Review Committee – at their institution prior to submission, however, since approval by this Committee is needed prior to award, the clinical protocol should be well developed at the time of application submission.

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

Preclinical research studies have provided advances that should be explored to determine their clinical applicability.  For example, preclinical studies indicate that to increase cord blood use, insufficient cell numbers may be expanded using notch ligands.  Preclinical data also indicate that cord blood engraftment can be improved using prostaglandin PGE2 or dipeptidylpeptidase-IV inhibitors. Other studies suggest that virus-specific cytotoxic T-cells may treat opportunistic infections and regulatory T-cells may control graft versus host disease or GVHD.  Another example is the use of mesenchymal cells that may suppress immune responses to control GVHD or may also be useful as an adjunct to promote stem cell engraftment.  Before these results might find clinical application, early clinical studies are required to address scientific and mechanistic questions and move the field forward.  Depending on the stage of development, first-in-human or a Phase I trial may be needed or the clinical project may be appropriate for a Phase II study.

Objectives

The objective of this FOA is to accelerate translation of new preclinical stem cell and cell therapy research advances into new cell therapies to treat blood diseases and/or to improve the outcome of hematopoietic stem cell transplantations. These first-in-human, phase I, phase II, or phase I/II clinical trials will investigate new cell therapy methods and could include testing new cell types, differentiation protocols, or other strategies.

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

This initiative seeks applications that consider new cell therapies for blood diseases and cell therapies adjunct to hematopoietic stem cell transplantation. Applications using minimally manipulated cell therapy products (see FDA Guidance documents on minimally manipulated products at: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/default.htm) should consider PA-10-067 (Parent R01) or other FOAs as appropriate.

Examples of research topics

Appropriate ideas include but are not limited to the following topics:

One area of potential overlap within hematopoietic stem cell transplantation will be cell therapies for the treatment of malignancies.  NIH referral guidelines will be used to determine which applications are appropriate for NHLBI and which are appropriate for other NIH Institutes, e.g., the National Cancer Institute.  The above list provides examples of early-phase cell therapy trials applications appropriate for NHBLI.  However, prior to preparing or submitting an application to this announcement, potential applicants are strongly urged to first discuss their clinical trial application with the NHLBI program staff listed in this announcement (see Scientific/Research Contact(s) in Section VII. Agency Contacts

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 are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

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

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.

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.

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, with the following modifications:

Include in the appendix the complete proposed clinical protocol and the informed consent forms.   

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, 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/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

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 Center for Scientific Review (CSR), 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 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/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 301-435-0714
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)

John Thomas, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge II, Suite 350
Bethesda, MD  20892-7950 (Express zip code 20817)
Telephone: 301-435-0065
Email: ThomasJ@nhlbi.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Mr. Kevin Heath
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Rockledge II,  Suite 7044
Bethesda, MD  20892-7926 (Express zip code 20817)
Telephone: 301-435-0166
Email: heathkj@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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