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

Management of HIV-Related Lung Disease and Cardiovascular Co-Morbidity (R34)

Activity Code

R34 Clinical Trial Planning Grant Program

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-034

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 invites clinical trials planning grant (R34) applications to support the initial organization, protocol development, and necessary preliminary studies critical for the design of robust Phase II and III clinical trials in HIV-infected populations with lung disease alone or with cardiovascular co-morbidity. The focus of the clinical trials designed in this program will be on optimizing intervention strategies for HIV-related lung disease, with or without co-morbid cardiovascular disease, to reduce morbidity and mortality associated with these conditions.

Key Dates
Posted Date

November 17, 2011

Open Date (Earliest Submission Date)

February 15, 2012

Letter of Intent Due Date

February 15, 2012

Application Due Date(s)

March 15, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June, 2012

Advisory Council Review

August, 2012

Earliest Start Date(s)

September, 2012

Expiration Date

March 16, 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

Clinical trials are needed to develop optimal intervention strategies for HIV-related lung disease, with or without co-morbid cardiovascular disease, to reduce morbidity and mortality associated with these conditions. The goal of this program is to support the initial organization, protocol development, and necessary preliminary studies, including small pilot studies needed for designing robust phase II and III clinical trials in HIV-infected populations with lung disease, alone or with cardiovascular co-morbidity. The primary questions that this initiative will address are whether early detection and prompt, appropriate management of lung disease or lung disease coupled with cardiovascular disease can reduce deaths and illness from these conditions and improve quality of life.

Although the scientific literature may provide the rationale for conducting a clinical trial, investigators often lack critical information about the intervention, the plausible outcome, or recruitment necessary to complete design of the trial. Preparatory pilot studies can fill this information gap, thereby improving trial design and knowledge of trial feasibility.

Applications must demonstrate that the proposed R34 pilot studies will yield information that is both necessary and sufficient to permit the design of a clinical trial. Applicants should describe the planned full-scale trial in sufficient detail to establish the significance of the trial and to provide a context for the proposed R34 award activities.

Applicants are encouraged to provide strong evidence of their qualifications and ability to conduct clinical trials and basic mechanistic research, including availability of appropriate institutional resources, experienced investigative team members, previous investigative experience in related studies, and potential availability of suitable patient populations.

R34 awardees may prepare and submit an application for a full clinical trial during the final year of the R34 award period. Please note that an R34 award does not guarantee or imply that the NHLBI will accept for review or fund a subsequent full clinical trial application.

One application may contain more than one protocol for a clinical trial, if the trials may be run concurrently, i.e., they do not compete for resources or could co-enroll participants.

The NHLBI anticipates that the R34 award period will yield competitive investigator-initiated clinical trial grant applications and robust and successful clinical trials. The products of a successful R34 award period are the data necessary to design and carry out a well-executed clinical trial, a decision that a trial is not feasible or justified, or evidence that additional studies must be completed before proceeding to a full trial.

BACKGROUND

Despite the significant burden presented by pulmonary and cardiovascular diseases in HIV infected individuals, uncertainty exists about optimum treatment regimens and management. Even though good evidence-based treatments exist for many heart and lung conditions when they occur in the general population, these treatment options may not represent optimal management in the setting of HIV infection.

Large existing AIDS cohorts and study infrastructure represent important opportunities to move this research forward. These patient cohorts are available through studies supported by the NHLBI, National institute of Allergy and Infectious Diseases (NIAID), and National Institute of Alcohol Abuse and Alcoholism (NIAAA) - Veterans Aging Cohort Study (VACS), but inclusion of pulmonary research in current on-going trials is relatively rare.

This initiative would promote new collaborations among investigators with pulmonary expertise, cardiovascular expertise (if appropriate for the project), infectious diseases/HIV expertise, and biostatisticians expert in designing, coordinating, and investigators expert in designing, coordinating, and conducting clinical trials in HIV -infected populations. The studies should be designed to utilize, existing well-characterized cohorts since this could greatly reduce costs. Multi-site studies are likely to be necessary since the cohort size needed to power these studies may be too large for one site to handle. It is anticipated that most of the proposed clinical investigations will involve the use of currently marketed and indicated or repurposed therapeutic agents, alone or in combination. However, Phase II and III clinical trials of investigational agents under an IND are allowable under this FOA.

Studies in Veterans Administration (VA)/NIAAA-supported, NIAID-supported, and NHLBI-supported cohorts have reported high rates of lung and cardiovascular abnormalities in HIV-infected cohorts occurring at a younger age than in the general population. For example, in an analysis of pulmonary diseases in the VACS over 33,000 HIV-infected persons (65% on antiretroviral therapy) compared to more than 66,000 uninfected persons (adjusted for age sex, race, ethnicity, and site) the reported disease rates - pneumonia 20.3 per 1000 person years vs. 5.8, chronic obstructive pulmonary disease (COPD) 20.3 per 1000 person-years vs.17.5, lung cancer 2.3 per 1000 person years vs. 1.3, pulmonary hypertension 1.2 per 1000 person years vs. 0.8, and pulmonary fibrosis 0.9 per 1000 person years vs. 0.8 - were all significantly increased (p<0.001) . Lung conditions, such as COPD and pulmonary hypertension appear to be important health problems and may be under diagnosed in HIV-infected patients.

Cardiovascular data from the VACS of over 81,000 HIV positive and negative individuals (followed from 2003 to 2008) showed that HIV infection doubled the risk of myocardial infarction after accounting for traditional risk factors and also that greater risk correlated with lower CD4 counts and or higher viral loads. (Freiberg abstract data presented at Conference on Retroviruses and Opportunistic Infections (CROI) Boston 2/27/11-3/02/11). In a smaller study of more than 8,400 veterans participating in VACS, HIV-infected veterans were found to have an increased risk of heart failure (hazard ratio 1.81) compared to non-infected veterans.

A pulmonary study published in 2010 using data from the VA electronic database of over 33,000 HIV-infected subjects (median age 45 years) reported that COPD is the most common non-infectious disease in HIV-infected patients, with 16% carrying a baseline or incident diagnosis of COPD, based on ICD codes. Considerably higher rates have been observed in ongoing prospective studies of HIV-infected cohorts, in which pulmonary function testing is performed. As with risk of MI, risk of COPD and other lung diseases also correlate with lower CD4 counts and or higher viral loads.

Lung disease and cardiovascular disease often occur as co-morbid conditions. In the general population COPD is an independent risk factor for cardiovascular disease and for other lung diseases including lung cancer and pneumonia, which are already elevated in the HIV-infected population and associated with a higher risk of mortality than in the general population.

Lung and cardiovascular diseases, normally more prevalent in older populations, are now starting to have an increasing impact on HIV-infected populations in the US and other industrialized nations where effective antiretroviral therapy has increased the average age of the HIV-infected population.

The aging effect is compounded in HIV-infected populations because cardiovascular and lung complications are occurring in younger age groups.

The CDC estimates (based on 2007-2008 data) that HIV prevalence is over 800,000 in the US, with more than 40,000 new cases each year. CDC predicts that by 2015 one half of the HIV-infected population will be over age 50. We need to intensify our efforts to address the problem of HIV-associated lung diseases now.

RESEARCH SCOPE

The NHLBI anticipates that the Management of HIV-related Lung Disease and Cardiovascular Co-morbidity R34 program will result in well-crafted, highly competitive clinical trial grant applications that will lead to robust and successful clinical trials. This planning grant program will allow investigators or groups of investigators to develop competitive phase II or III clinical trials of intervention strategies for HIV-related lung disease, or lung disease with co-morbid cardiovascular disease to improve management and long term outcomes and to reduce morbidity and mortality.

During the planning period investigators can assemble a research team, consisting of a data coordinating center and clinical sites, that might be single centers or have several collaborating ancillary sites, define and prioritize research questions, collect information on the feasibility of the therapies to be tested and patient availability needed for timely recruitment, and develop a protocol(s). Applications will need to demonstrate a sufficiently important scientific question(s) and existence of sufficient clinical trials infrastructure to merit proceeding to the design of a clinical trial(s). Evaluation of applications in response to this FOA, will also take into consideration the significance and potential impact of the full-scale clinical trial(s).

Each R34 application will be required to propose one, or if appropriate, more than one clinical trial protocol(s) that addresses the central issue of identifying treatment strategies in HIV-related lung disease and, if appropriate, treatment(s) aimed at the cardiopulmonary co-morbidities that can reduce morbidity and mortality.

Investigators will be expected to utilize existing cohorts, to use efficient and innovative trial designs, and to have multidisciplinary teams that combine state-of-the-art clinical trial expertise and biostatistics with expertise in pulmonary disease, cardiovascular disease, including cardiopulmonary imaging, immunology, and infectious diseases especially HIV and co-infections. Collaborations among pulmonologists, cardiologists (if there is a cardiovascular component) and infectious disease specialists are required and inclusion of basic scientists with expertise in these disciplines is strongly encouraged.

Since the program requires strong leadership in several clinical sciences it is well suited to multiple PD(s)/PI(s). Applicants are strongly encouraged to utilize the multiple PD(s)/PI(s) mechanism and to consider having a pulmonologist as one of the PD(s)/PI(s). Applicants are encouraged to assemble teams of 3 to 5 clinical centers that will work together to develop an application.

Studies designed from the outset to accommodate bedside-to-bench-to-bedside research are highly desirable. Resources are scarce and data and specimens associated with these clinical cohorts might be used to fill some of the many gaps that remain both in understanding pathogenesis and in improving treatment of lung and cardiovascular disease in HIV-infected persons. Applicants are encouraged to collaborate with basic researchers during this planning period to design the planned trial(s) to collect specimens for future (or maybe concurrent) basic investigations and to jump start the process by identifying hypotheses that might be tested and by collecting preliminary data. Planning ahead in this manner may permit the investigators to design studies that can collect scientifically meaningful samples without compromising the main study.

It is anticipated that NHLBI will convene annual R34 investigator meetings (1-2 days each) in the Washington DC metropolitan area on specific high priority areas related to this FOA. Such meetings will provide an opportunity for investigators to discuss progress of their research and facilitate successful completion of R34 project goals.  Applicants should include travel costs in their applications for up to three investigators to attend these annual meetings. If the R34 application needs to have a Data and Safety Monitoring Board (DSMB), then funds associated with running the DSMB should be budgeted for in the application.

Examples of research activities that might be appropriate in R34 grants include but are not limited to the following:

SELECTED RESEARCH EXAMPLES related to Management of HIV-related Lung Disease and Cardiovascular Co-morbidity may include, but are not limited to those listed below:

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.

Future year amounts will depend on annual appropriations.

The NHLBI intends to commit $2.0 million total costs in FY 2012 to fund up to four awards, with a total cost commitment of $4.0 million over the two-year period.

Award Budget

Application budgets are limited to a maximum of $400,000 direct costs in any year, but need to reflect actual needs of the proposed project.

Award Project Period

The scope of the proposed project is up to a maximum of two years, FY2012 and FY2013.

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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not 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 modification:

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 modification:

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

Post Submission Materials

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

         Applicants may submit a two-page data update, including any figures, as a pdf file. The data update must be countersigned by the Institutional Official in the Office of Sponsored Research and must be received by NHLBI by Monday, May 7, 2012. It should be e-mailed to the SRO. Check the eRA Commons for the SRO assignment. Please contact the assigned SRO for further updates concerning this.

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? Does the planned full-scale trial address a significant public health concern?

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? What is the quality of the pulmonary expertise? What is the quality of the expertise in the clinical management of HIV-infection? What is the quality of the expertise and leadership in the design, coordination, and conduct of clinical trials? If the project contains a cardiac component, what is the quality of the expertise in cardiology? If basic research is included in the application, what is the quality of basic research expertise?

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? Are the proposed pilot studies both necessary and sufficient to permit the design of a full-scale clinical trial?

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NHLBI,,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 be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NHLBI Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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)

Hannah H. Peavy, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0222
Email:peavyh@nhlbi.nih.gov

Cheryl L. McDonald, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0560
Email:McDonaldc@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)

Mr. Andre Walker
National Heart, Lung, and Blood Institute (NHLBI))
Office of Grants Management
6701 Rockledge Drive, Room 7146
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: 301-435-0166
Fax: 301-451-5462
Email: walkera@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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NIH Funding Opportunities and Notices



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