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

Molecular Imaging of the Lung- Phase 1 (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-036

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.838

FOA Purpose

This FOA, issued by the National Heart, Lung and Blood Institute (NHLBI), National Institute of Health, invites Research Project Grant (R01) applications to develop novel in vivo imaging reagents and technologies such as molecular probes that target pathways or cells involved in development and pathobiology of pulmonary diseases. In Phase I investigators will identify appropriate molecular targets with relevance to lung health and diseases, develop the appropriate molecular probes, in combination with innovative imaging approaches, and validate the developed probes in cells and in vivo animal models. NHLBI anticipates announcing a companion FOA for a Phase II that will be released at a later date, to support studies to extend molecular imaging methods to human studies for clinical applications in lung disease.  Both phases will be open competitions. The long-term goal is to use molecular imaging to facilitate early detection and diagnosis of lung disease, enable noninvasive monitoring of lung disease progression and prognosis, and accelerate progress in cell-specific drug delivery and therapies.

Key Dates
Posted Date

October 24, 2011

Open Date (Earliest Submission Date)

January 1, 2012

Letter of Intent Due Date

January 1, 2012

Application Due Date(s)

February 1, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September 2012

Expiration Date

February 2, 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

Research objectives

Molecular imaging is needed to enable in situ identification and tracking of lung cells, assess physiological cell functions, detect early pre-symptomatic disease pathophysiology, stratify disease severity, predict disease outcomes, and facilitate lung tissue-specific targeting of pharmacotherapies. Probe development with molecular cellular targets is the essential step for molecular imaging. This program aims to support the identification of target molecules for probe development, the chemical synthesis and production of the probes, and the demonstration of probe safety and performance in cell and animal models of lung disease, with the eventual goal of generating sufficient preclinical data to support FDA IND submission for initial testing in humans.

Background

Chronic and acute diseases of the lung (for example, asthma, bronchopulmonary dysplasia, interstitial lung disease, cystic fibrosis, chronic obstructive pulmonary disease, pulmonary hypertension, and acute lung injury) demonstrate molecular and cellular changes before structural and functional symptoms emerge. These changes start only in specific cell types within specific areas of the lung. Being able to study the early molecular changes in vivo will facilitate early interventional strategies to be developed and provide molecular information that enhances understanding of the pathobiology of lung diseases. The heterogeneous nature of lung diseases suggests that systematic measures, including lung function tests (FEV1) or blood biomarkers, may not capture important aspects of the underlying pulmonary disease process. Disease screening, early detection, clinical diagnoses, and measures of therapeutic effect are all likely to be improved by the ability to non-invasively measure local lung molecular and cellular characteristics.

High-resolution live imaging of specific molecules and cells with probes targeting small molecules, cytokines, peptides, cell surface markers, enzymes, and metabolic products that are associated with specific cell types or pathological conditions seem ideally suited for advancing our understanding of lung diseases.

Research Scope

The program for Molecular Imaging of the Lung is expected to be a two-stage program. Phase I, the subject of this FOA, will support innovative, hypothesis-driven, proof-of-principle projects to develop and validate novel imaging approaches, including target selection and validation, toxicology, probe development and production, and characterization of the probes in cells, pre-clinical animal models, or if appropriate, humans. Development of probes against molecular targets relevant to pulmonary disease and validation with in vivo models are expected at the end of Phase I. (Phase II, to be addressed in a future FOA, will be a related, but distinct program that further extends the in vivo molecular imaging technologies into preparation for early preliminary studies in humans).

It is expected that applications funded during Phase I will be aimed at potential human studies. Studies that do not have applicability beyond animal models would not be responsive. (Applicants will not be required to have been funded in Phase I to submit applications for Phase II). Investigators are expected to develop strategies for safe use of the proposed probes in human subjects, including toxicity studies in animals and methods for administration and delivery to the lung and to demonstrate the capability and feasibility of plans for obtaining INDs for future clinical studies.

In addition to developing molecular probes, this program will also encourage molecular imaging technology development, including improvement of resolution, reduction of imaging time, or effects of motion and reduction of the use of ionizing radiation for imaging. System integration and software development are also encouraged to integrate multi-modality data, allow real-time image processing, incorporate temporal analysis of serial studies, and process imaging data from different platforms, methods and image databases.

This program encourages multi-disciplinary collaborations among pulmonary biologists, chemists, imaging engineers and computational analysts throughout the processes, including probe design and synthesis, imaging system development and validation, and imaging data analysis and interpretation. The goal is to achieve functional cellular and molecular imaging in vivo and towards clinical applications in humans.

Specific Areas of Research Interest

In order to be responsive to this FOA, the proposed molecular probes and methods must have direct relevance to human lung health and diseases and be feasible for use in human subjects. Funding priority will be given to applicants developing probes that are closest to application to human studies. Applications for probes that have no potential application in humans are not appropriate for this FOA.

Examples of the probes are:

Nucleotide sequence-specific probes for localized assessment of gene expression.

Peptide-based probes to localize targets for specific therapeutic interventions.

Antibody-based probes of specific lung cell types.

Ligands for specific cell surface markers to monitor trafficking of inflammatory cells.

Probes for activated macrophages.

Indicators of local redox status to monitor oxidative stress.

Probes of fibrotic activity and scarring.

Probes for inflammation induced cytokines and chemokines.

Probes for apoptotic pulmonary cells.

Probes for monitoring enzymatic activity, such as matrix metalloproteinase-activated probes for imaging sites of pulmonary injury.

Probes for activation and alteration of signaling pathways.

Probes for epigenetic markers.

Probes for specific cell types that allow identification and tracking in vivo.

Probes that can be activated in situ.

Probe validation in animal models by comparing molecular imaging data with in vitro gene expression studies to establish correlations.

Imaging and data processing.

Single or multi-modality imaging system to detect and capture molecular activities.

Software to process, validate, analyze, quantify and interpret in vivo imaging data.

Optional Use of the NIH Imaging Probe Development Center (IPDC)

Chemical synthesis and production of probes can be a technical barrier for molecular imaging. The NIH Imaging Probe Development Center (IPDC, www.ipdc.nih.gov), currently a core chemistry resource for the NIH intramural program, will be available to assist in the development and investigation of novel imaging probes of the lung. IPDC maintains a library of novel imaging probes, nearly all of which are new compositions-of-matter that are not commercially available. These probes will be available to pulmonary investigators in this program to be tested in the lung and to develop the necessary delivery and detection methods. A list of available imaging probes already developed by IPDC will be provided upon request. Investigators who propose new probes for development will have the option to use IPDC as a chemistry resource for probe synthesis and development service.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

NHLBI intends to commit $2.8 million total costs in FY 2012 to fund up to 7 awards, with a total cost commitment of $8.4 million over the three year period.

Award Budget

Direct costs requested may not exceed $250,000.

Award Project Period

Maximum period of 3 years

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

The letter of intent should be sent to:

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NHLBI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

A letter of support must be included in the application to demonstrate that the applicants have access to a chemistry resource with sufficient expertise and capacity for the synthesis and development of their proposed probes (include in 2. Research Plan Attachments: 14. Letters of Support).

Investigators planning to use IPDC existing probes are strongly urged to provide documentation from the IPDC that all probes for the proposed research are available. This documentation must be in the form of a support letter from the IPDC included with the application (include in 2. Research Plan Attachments:,14. Letters of Support). To obtain the letter of support, the PI must contact the NHLBI scientific contact, Dr. Sara Lin (sara.lin@nih.gov), no later than December 1st, 2011.

Investigators planning to use IPDC service for new probe development must request a probe information form from Dr. Sara Lin (sara.lin@nih.gov). The PI must complete and return the form no later than December 1st, 2011. Based on information provided, IPDC will evaluate the technical feasibility and estimate cost. For requests that are within IPDC capacity, IPDC will provide a support letter to be included with the final grant application (include in 2. Research Plan Attachments:,14. Letters of Support).

The support letter will not affect the scientific merit review; it will only confirm that the PD(s)/PI(s) has appropriate chemistry resource for probe development should the application be deemed meritorious and competitive for funding.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.


As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will 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 l. 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’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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)

Qing "Sara" Lin, Ph.D.
Program Director
Lung Biology and Disease Branch
Division of Lung Diseases
National Heart, Lung & Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7952
Telephone: (301) 435-0222
Email: sara.lin@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

Financial/Grants Management Contact(s)

Gayle Jones
National Heart, Lung & Blood Institute (NHLBI)
Division of Extramural Research Activities
Office of Grants Management
Telephone: 301-435-0166
Email: jonesgt@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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