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

Anchoring Metabolomic Changes to Phenotype (P20)

Activity Code

P20 Exploratory Grants

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-009

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    

FOA Purpose

This FOA issued by the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, encourages applications from institutions or organizations that propose metabolomic phenotyping of existing cohorts to gain mechanistic understanding of the molecular determinants contributing to cardiovascular and lung disease phenotypes to help in predicting disease susceptibility, diagnosis, risk stratification, assessing response to therapy and assessing prognosis. The FOA proposes a multidisciplinary and integrated program with two interacting components, a metabolomic component and a mechanistic component, each informing the other in an iterative manner.

Key Dates
Posted Date

April 5, 2011

Letter of Intent Due Date

May 17, 2011

Application Due Date(s)

June 17, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November-December 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

April 1, 2012

Expiration Date

June 18, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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 FOA is to facilitate the capture of molecular information that is most proximal to a cardiovascular or lung disease phenotype of interest and use that to gain mechanistic understanding of the pathways and mediators involved in the expression of the phenotype.

Given the complex nature of cardiovascular and lung diseases, evaluation with more comprehensive high-throughput analytical methodologies coupled with mechanistic studies is necessary to help provide needed insights into biochemical and physiological underpinnings of the disease process and to gain comprehensive understanding of the expressed phenotype. This initiative proposes a multidisciplinary and integrated program with two interacting components, the metabolomic component and the mechanistic component, each of which informs the other in an iterative manner. The initiative also proposes an administrative core to facilitate coordination, integration, interaction and leveraging of resources among the programs.

 The metabolomic component would be focused on facilitating targeted metabolomic phenotyping studies on existing cohorts, population-based and family studies, intervention studies and other appropriate clinical studies. These cohorts should have associated with them high-quality clinical data and plasma and/or urine samples, bronchoalveolar lavage or exhaled breath condensates. The goals of the targeted metabolomic component include, but are not limited to:

The mechanistic component would begin in the second year of the program. The focus of this component is to help understand if the metabolites identified in metabolomic component contribute to the development and expression of the phenotype. The goal here is to define the role of metabolites, the functional pathways that they represent and the molecular mechanisms that contribute to the observed phenotype that can additionally lead to the identification of novel targets for intervention and/or novel biomarkers. The main goals of this component include, but are not limited to:

Pertinent Background Information

Design of effective intervention and preventive strategies depend to a great extent on a comprehensive understanding of the underlying mechanisms involved in the disease process. Functional approaches such as metabolomics can help facilitate this process.  Metabolites participate in almost all aspects of cellular function. Furthermore, metabolites measure chemical phenotypes that are the net result of genomic, transcriptomic and proteomic variability and therefore provide the most integrated profile of biologic status and are robust tools for discerning mechanisms of action. Changes in specific metabolites can be used as diagnostic markers as well as to reveal deregulated pathways. This can then direct mechanistic studies to identify causative relationships between changes in metabolite levels and disease. Recent technological and computational advances have enabled the measurement of a large number of metabolites and a ‘metabolome-wide’ type approach is now feasible in large epidemiologic studies. Further, given that the number of metabolites is smaller than the number of genes, transcripts or proteins, processing complexity in metabolomics is greatly reduced while still remaining amenable to high-throughput analysis. By providing access to a portion of the biomolecular space not currently covered by other profiling approaches metabolomic phenotyping offers a unique opportunity for not only the discovery of novel biomarkers but also for the mechanistic understanding of the pathways operative in cardiovascular and lung disease. This offers novel avenues for predicting disease susceptibility, diagnosis, risk stratification, and assessing response to therapy as well as prognosis.

Objectives of This Research Program

The overall goal of this research program is to bring together multidisciplinary and integrative teams to help gain a better understanding of the molecular mechanisms that underlie many of the cardiovascular and lung disease phenotypes. To facilitate this goal, a bedside-to-bench-to-bedside approach is envisioned wherein metabolomic information of an expressed cardiovascular or lung disease phenotype would be used to guide mechanistic studies in animal models. A multicomponent application is to be submitted, consisting of a metabolomic center and an administrative core. Emerging mechanistic information from the animal models would in turn help refine the initial metabolomic phenotyping efforts and the validity of the metabolite information tested through experimental modulation of the phenotype to help assess its clinical utility.

The metabolomic component should include pilot studies to assess metabolite stability and variability over time and this should be completed by the end of the first year of the program as should any quality control issues related to the metabolomics platforms. The mechanistic component would typically begin in the second year of the program when the above have been completed.

The specific objectives of this program are (1) the identification of distinct metabolites and metabolomic profiles for specific cardiovascular and lung phenotypes, (2) identification of

candidate pathways and genes responsible for the generation of the distinct metabolites and metabolomic profiles of specific phenotypes, and (3) identification of (a) novel and potential targets for intervention and (b) novel biomarkers.

Applicants must propose a multidisciplinary team structure ensuring effective coordination and integration between the metabolomic and mechanistic components of the program. The team should include metabolomics experts, investigators familiar with all aspects of the parent studies from which samples are being used, experts in basic science and pathway analysis and experts in biostatistics and bioinformatics. Only projects that propose studies based on existing resources will be considered responsive.

Steering Committee and External Scientific Advisory Panel

Steering Committee Functions.  The Steering Committee is the operational group responsible for coordination of the activities of all components of the program. The Steering Committee will identify scientific and policy issues that need to be addressed by all components of the program, develop recommendations, and coordinate the dissemination of data, assay protocols, bioinformatic tools and other materials with the wider scientific community. The Steering Committee membership will include the Principal Investigator and Co-Investigator of each of the programs. The Steering Committee may add additional members if technology development, data generation, coordination, standardization or integration activities will benefit from such an expansion. The Steering Committee may also establish additional subcommittees or workgroups for specific tasks.

The Steering Committee will:

1. Convene at least once per year. The purpose of these meetings is to assess scientific progress, identify new research opportunities, establish priorities, consider policy recommendations, and discuss strategies. One of the meetings will be in conjunction with the annual meeting of the External Scientific Advisory Panel in Bethesda.

2. Plan, organize and facilitate the annual workshop in partnership with the administrative core.

3. Establish a chair, or workgroups for specific tasks.

4. Hold monthly conference calls of the full committee and any workgroups as needed.

5. Serve as a venue for coordination on improving the state-of-the-art for all program activities by reporting progress, disseminating best practices, and collectively evaluating new procedures, resources, and technologies.

6. Address recommendations made by the External Scientific Panel.

External Scientific Advisory Panel (ESP):  An External Advisory Panel consisting of NHLBI appointed non-federal scientists, not affiliated with the awarded programs, will be established. This Panel is advisory to the NHLBI and will help assess progress, evaluate whether goals are being met, identify strengths and weaknesses, and make recommendations to the NHLBI regarding the program’s success. The External Advisory Panel will meet on an annual basis in conjunction with the Steering Committee meeting in Bethesda.

Administrative Core  

All applications must include a description of an administrative core that will be reviewed independently. One of the meritorious applications will be selected to serve the additional function of the administrative core. The administrative core will  help facilitate the coordination, integration and interaction among the different metabolomic and mechanistic components across the program. The core will also help mediate contacts between the programs and NHLBI staff to allow for efficient interactions, consultations and oversight functions. The core will also be charged with disseminating results across multiple venues. Additionally, the core will coordinate the meeting of the annual External Scientific Panel.  The Administrative Core will coordinate meetings, conference calls, distribute minutes, and serve a range of functions common to the Programs. This includes the fiscal responsibility for the travel of the External Advisory Panel (6-8 members).The center will also establish an intranet web site to compile and manage a range of information that will be generated by the Programs and other information that the Steering Committee determines necessary to be compiled and maintained.

A workshop, facilitated through the administrative core, focused on biostatistic and bioinformatic issues and tools developed and under development should be held annually at the end of each year to facilitate leveraging of resources across the program as well as to get feedback from the broader scientific community.

Examples of responsive research include, but are not limited to:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NHLBI intends to commit approximately $26 million in total costs over a 5-year period to fund 3-5 new grants in response to this FOA.

Award Budget

Each budget year may not exceed the following direct cost thresholds: Year One and Year Five $450,000. Years Two, Three and Four $750,000. Additionally, applicants may request up to $130,000 in direct costs for an Administrative Core, for each of the five years.

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed five 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.

Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration:  See instructional documents in the NIH Guide Publishing System for the text to insert.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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.

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. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must 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

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed. 

Research Plan

All instructions in the PHS398 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 PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.

Projects outside the scope of this FOA will not be considered responsive and include (a) studies not addressing cardiovascular or lung disease phenotypes; (b) studies not using resources from existing cohorts, population-based and family studies, intervention studies and other appropriate clinical studies; (c) applications focused on either the metabolomic component alone or the mechanistic component alone; (d) applications not proposing a multidisciplinary team structure to ensure effective coordination and integration between the metabolomic and mechanistic components of the program; and (e) applications not including a plan for an administrative core.

Additional requirements for submitting an application:

Research Program (Specific Aims, 1 page; Research Strategy 12 pages):  The research plan should follow the instructions in the PHS 398 application form and should include specific aims, a rationale (i.e., scientific justification for the proposed research), metabolomic and mechanistic study designs (including a sound statistical plan, and timetable).  A Principal Investigator of the research program should not be the PD/PI of the administrative core.

Administrative Core (Specific Aims, 1 page; Research Strategy 6 pages):   This application should generally follow the instructions in PHS 398 and include aims, approach, facilities, experience, methods, and expected structure.

Budget Selected Items of Cost:

No money will be allowed for new mass spectrometry platforms.

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 - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program 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 program proposed).

Scored Review Criteria - Overall

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 program that by its nature is not innovative may be essential to advance a field.

Significance

Does the program address an important problem or a critical barrier to progress in the field? If the aims of the program 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 program? 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 program? 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 program 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 - Overall

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 program 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 - Overall

As applicable for the program 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.

Administrative Core: Reviewers will consider the plan for the administrative core independently and will not factor the plan into the determination of the scientific merit or the primary impact score. Each plan will receive a separate impact score which is separate from the primary impact score of the scientific application. The following review criteria will be used.

APPROACH:

Are the proposed activities appropriate for facilitating coordination and communication among awardees? Are state of the art coordinating strategies proposed?

INVESTIGATOR:

Is the applicant well suited or experienced in carrying out coordinating functions? Does the applicant have prior experience in performing coordinating functions? Is the administrative core team appropriate?

ENVIRONMENT:

Is there evidence of institutional support?  Are the facilities appropriate to conducting the business of the administrative core?

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 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 Councill. 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

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)

Pothur Srinivas, Ph.D., MPH
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 10184 (Express Mail Zip: 20817)
Telephone: 301-402-3712
Fax: 301-480-1336
Email:srinivap@mail.nih.gov

Weiniu Gan, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Diseases
National Institutes of Health
6701 Rockledge Drive, Room 10184 (Express Mail Zip: 20817)
Telephone: 301-435-0202
Fax: 301-480-3451
Email:ganw2@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
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health
6701 Rockledge Drive, Room 7167
Bethesda, MD 20892-7926 (Express Mail Zip: 20817)
Telephone: 301-435-0159
Fax: 301-480-1948
Email:stantonk@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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