and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Heart, Lung, and Blood Institute (NHLBI) |
|
Funding Opportunity Title |
Basic Research in the Pathogenesis of HIV-Related Heart, Lung, and Blood (HLB) Diseases in Adults and Children (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-HL-14-024 |
Companion Funding Opportunity |
RFA-HL-14-029, R21 Exploratory/Developmental Grant |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.233, 93.837, 93.838, 93.839 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) invites basic research project grant (R01) applications to investigate the fundamental mechanisms underlying the pathogenesis of HIV-related heart, lung, and/or blood (HLB) diseases alone and in the context of antiretroviral therapy (ART). Investigations may be conducted on various primary cell types, biospecimens, computational models, and animal models, particularly those used for HIV research. The goal is to provide the critical basic science foundation and guide the design of new therapeutic approaches for HIV-related HLB conditions in adults and children. |
Posted Date |
October 23, 2013 |
Open Date (Earliest Submission Date) |
December 8, 2013 |
Letter of Intent Due Date(s) |
30 days before the application due date |
Application Due Date(s) |
January 8, 2014; May 8, 2014; September 9, 2014; January 8, 2015, and January 8, 2016 per NOT-HL-15-247 by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
January 8, 2014; May 8, 2014; September 9, 2014; and January 8, 2015, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
Scientific Merit Review |
February March 2014, June July 2014, October November 2014, and February March 2015 |
Advisory Council Review |
May 2014, September 2014, January 2015, and May 2015 |
Earliest Start Date |
July 2014, December 2014, April 2015, and July 2015 |
Expiration Date |
New Date January 9, 2016 per issuance of NOT-HL-15-247. (Originally January 9, 2015) |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (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.
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
The purpose of this funding opportunity announcement (FOA) is to encourage basic research to investigate the fundamental mechanisms of HIV-related heart, lung, and/or blood (HLB) diseases alone and in the context of antiretroviral therapy (ART). Investigations may be conducted on various primary cell types (e.g., hematopoietic stem cells and the surrounding niche), biospecimens, computational models, and animal models, particularly those used for HIV research. The use of HIV specimens in existing biorepositories and other human samples is highly encouraged, and their analyses should be directed towards basic research questions. The goal is to provide the critical basic science foundation and guide the design of new therapeutic approaches for HIV-related HLB conditions.
Each basic science application is strongly encouraged to use the multiple Program Director/Principal
Investigator (PD/PI) option (http://grants.nih.gov/grants/multi_pi/)
to provide strong leadership in basic research and expertise in HLB diseases
and HIV infection. It is intended that applications will be multi-disciplinary
and highly integrated. Inclusion of early stage investigators is highly
encouraged.
Widespread availability of effective antiretroviral therapy (ART) has changed the epidemiology of AIDS. HIV-infected patients on ART can expect to live for many decades, but now chronic diseases are increasingly replacing acute infections as important causes of morbidity and death. A growing body of evidence suggests that HIV may alter and/or accelerate the natural history of fundamental processes underlying atherosclerosis, pulmonary arterial hypertension (PAH), chronic obstructive pulmonary disease (COPD), pulmonary co-infections, anemia, coagulation, thrombotic disorders, and immune senescence.
However, the mechanisms by which HIV and ART may modify these processes have not been fully elucidated, primarily because of the multiple direct and indirect pathways by which HIV and ART induce cellular dysfunction. These pathways include direct infection, mitochondrial damage, altered high-density lipoprotein (HDL) and lipid metabolism, macrophage activation, inflammatory cytokine and viral protein secretion, and immune senescence. Other possible HIV contributing factors to these diseases include procoagulant changes, fibrinolytic effects, platelet and adhesion molecule activation, and monocyte/macrophage migration.
Advancing knowledge of which cell types are affected by HIV (and serve as reservoirs), as well as increased understanding of the vital interactions between HIV and the host cells is essential to elucidating the pathogenesis of HIV-related HLB diseases. For example, additional studies are needed to investigate how HIV-host interactions contribute to viral replication, inflammation, disordered lipid metabolism, immune deregulation and hyperactivation, endothelial dysfunction, coagulation changes, platelet activation, cytopenias perturbed redox balance, co-infections, and/or disruption of the host microbiome.
Basic research using animal, cellular, and computational models to study HIV-associated HLB disease progression allows for experiments that cannot be performed in patients. Examples include quantification of biomarkers and function at critical time points, identification of tissue pathology, in vivo manipulation of viral levels and associated disease risk, and evaluation of the impact of HIV on disease progression independent of other cofactors (e.g., smoking, alcohol, and diet). The use of basic research models will complement and extend the results of clinical studies.
In 2012, the NHLBI convened a Working Group on Advancing HIV/AIDS Research in Heart, Lung, and Blood Diseases. The group was comprised of a panel of basic and clinical experts charged with identifying research priorities in HIV-related HLB diseases. An executive summary from this Working Group is available on the NHLBI website (http://www.nhlbi.nih.gov/meetings/workshops/AIDSworking.htm).
The Working Group identified the following major basic research scientific gaps:
This FOA was developed to provide opportunities to address the recommendations from the Working Group, as well as to support other new areas of research in HIV-related HLB diseases.
This FOA invites investigators to conduct basic research to investigate the fundamental mechanisms of HIV-related HLB diseases alone and in the context of ART.
Basic Research. The primary goal of this FOA is to support research that will provide the critical basic science foundation to understand the mechanisms and pathogenesis underlying the development of HLB conditions in patients with HIV who are or are not receiving ART. A secondary goal is to enhance understanding of HLB disease processes in the general population. Basic research is defined as research that will answer fundamental mechanistic questions focused on the impact of HIV and ART on HLB disease progression, such as, but not limited to, alterations in metabolism, biomarkers, and tissue/cellular pathology. Investigations may be conducted on various cell types (e.g., hematopoietic stem cells as well as other cells involved in HLB diseases), biospecimens, computational models, and animal models, particularly those used for HIV research. The use of HIV specimens in existing biorepositories (e.g., NHLBI BioLINCC Biorepository https://biolincc.nhlbi.nih.gov/home/) and other human samples is highly encouraged, and their analyses should be directed towards basic research questions rather than epidemiological/clinical studies evaluating incidence, prevalence, risk assessment, and patterns/outcomes of care. Applications proposing to conduct clinical trials or epidemiological research will be deemed non-responsive to this announcement.
Study Design. Applications should propose statistically valid, hypothesis-driven, or hypothesis-generating, evidence-based projects aimed at elucidating cellular processes and molecular events that are altered by HIV and lead to the accelerated progression of HIV-related HLB diseases. Project aims should incorporate ART to the extent that is possible to reflect the pathophysiologic processes that might be at play in the treated HIV-infected population.
Leveraging Existing Research Infrastructure. Investigators are strongly encouraged to leverage existing clinical studies, biological specimens, or imaging banks whenever possible. Existing research infrastructure may include NHLBI-supported studies and repositories, programs primarily supported by other NIH Institutes, and other federal and non-federal programs. Investigators proposing to leverage resources from existing programs should follow the standard procedures for concept submission and review by the scientific committees of those programs. In the application, investigators should provide a letter of support from the leadership of the leveraged program confirming permission to use the infrastructure of the program. In addition, the investigator should provide a timeline highlighting when (s)he will be able to initiate and complete research, based on the required internal reviews of the programs.
Specific examples of existing research infrastructure that could be leveraged include (but are not limited to):
Investigator Expertise. Applicants are strongly encouraged to use a multiple Program Director/Principal Investigator (PD/PI) option (http://grants.nih.gov/grants/multi_pi/) to provide multi-disciplinary leadership and facilitate collaborations between HLB and HIV investigators. Other areas of expertise that may be represented include infectious diseases, immunology, cell biology, omics (e.g., genomics, proteomics, metabolomics, and metagenomics), molecular biology, physiology, and computational modeling. Early stage investigators are strongly encouraged to apply to gain exposure to HIV-related HLB research.
Research Topics That ARE Responsive to This FOA
Examples of research topics include, but are not limited to those listed below:
Research Topics That Are NOT Responsive to This FOA
Non-responsive applications will not be reviewed.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The NHLBI intends to commit $7,600,000 in FY 2014 to fund an estimated 10 awards and $9,120,000 in FY 2015 to fund an estimated 12 awards. |
Award Budget |
Application budgets are limited to a maximum of $499,999 direct costs in any year (excluding consortium F&A). Budgets need to reflect the actual needs of the proposed project. |
Award Project Period |
The scope of the proposed project should determine the project period. The maximum project period is 4 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.
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 Institutions) are
not 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.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
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 PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
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.
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.
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 NHLBI 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
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required 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.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: List each aim of the project and how it supports the Research Objectives of this RFA.
Research Strategy: Use this section to describe how this research project grant (R01) application will investigate the fundamental mechanisms of HIV-related HLB diseases in the context of ART, such as, but not limited to, alterations in metabolism, biomarkers, and tissue pathology using various cell types (e.g., hematopoietic stem cells and the surrounding niche), biospecimens, computational models, and animal models, particularly those used for AIDS research. The use of AIDS specimens in existing biorepositories and other human samples is highly encouraged, and their analyses should be directed towards basic research questions rather than clinical endpoints. The goal is to provide the critical basic science foundation for AIDS-related HLB conditions.
In the research strategy, include the following:
Letters of Support:
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.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
Applicants are responsible for viewing their application before the due date 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.
This initiative is not subject to intergovernmental review.
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.
Applications must be submitted electronically following the instructions described in the SF424 (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
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.
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 System for Award Management. 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, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
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.
Reviewers will provide an overall impact 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).
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 application specifically address an important basic science research question in HIV-related HLB diseases in either adults or children?
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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the application include plans for multi-disciplinary collaboration from HIV and HLB investigators? Is there a clear description of how the investigators will facilitate collaboration and communication among multi-disciplinary teams and integrate HIV and relevant HLB expertise? Early stage investigators are strongly encouraged to apply to this FOA to gain exposure to HIV-related HLB research. Does the application describe plans to integrate an early stage investigator into the research team?
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? Does the application leverage existing resources and/or programs
to enhance HIV-related HLB disease research? Has the investigator provided a
letter of support from the leadership of the leveraged program confirming
permission to use the infrastructure of the program? Have the investigators
provided a reasonable timeline of when they will be able to initiate and
complete research, based on the required internal reviews of the leveraged
programs?
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?
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 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 Guidelines
for the Review of Human Subjects.
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 Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable
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 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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group 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:
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.
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, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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
When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY: 301-451-5936
Email: [email protected]
Renee Wong, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-451-6808
Email: [email protected]
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: [email protected]
Howard Moore
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0166
Email: [email protected]
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.
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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