Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Mucosal Environment and HIV Prevention (MEHP) (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

RFA-AI-13-012

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.855, 93.856, 93.865      

Funding Opportunity Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, encourages grant applications from institutions/organizations that address the goals and objectives of this funding opportunity announcement (FOA). The Mucosal Environment and HIV Prevention (MEHP) FOA is intended to support innovative proof-of-concept/feasibility non-vaccine biomedical prevention (nBP) research needed to support and advance the development of safer and more effective microbicides, Pre-Exposure Prophylaxis (PrEP), and Multipurpose Prevention Technologies (MPT).  It will achieve this by supporting a better understanding of prevention candidates and strategy interaction with the micro- and macro-environments of the genital (male and female) and gastrointestinal (GI) mucosa. The MEHP FOA addresses the following 3 underserved emerging areas of Program interest: role of the microbiome in transmission/acquisition of HIV and candidate safety and efficacy, tissue responses to prevention agents, and the effect of genital secretions and hormones on susceptibility to HIV infection:

The MEHP is intended to support innovative basic research efforts, which may or may not involve an active pharmaceutical ingredients (APIs), formulation/excipient and/or device currently under development.  The MEHP FOA is not intended to support the preclinical or clinical development of new nBP candidates or their delivery systems. The MEHP concept has been previously released as PA-12-106, and applicants are urged to read this FOA carefully, since there are differences from the PA that could alter responsiveness.

Key Dates
Posted Date

March 7, 2013

Open Date (Earliest Submission Date)

June 25, 2013

Letter of Intent Due Date(s)

June 25, 2013

Application Due Date(s)

July 25, 2013, 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)

July 25, 2013, by 5:00 PM local time of the applicant organization

Scientific Merit Review

December, 2013

Advisory Council Review

January, 2014

Earliest Start Date

June, 2014

Expiration Date

July 26, 2013

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.

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


Purpose and Research Objectives

The purpose of this FOA is to stimulate research to better understand and optimize the interaction of genital (female and male) and gastrointestinal (GI) tract mucosa with non-vaccine biomedical prevention (nBP) candidates and strategies with the long-term goal of enhancing the safety and efficacy of HIV prevention interventions. For the purposes of this FOA, nBP will include topical microbicides, pre-exposure prophylaxis (PrEP) and Multipurpose Prevention Technology (MPT) candidates and strategies. The MEHP FOA is designed to support the use of active pharmaceutical ingredients (APIs), delivery vehicles and prevention strategies under development as tools to assess changes in mucosal target cells and tissues that might alter product/strategy safety and/or lead to increased or decreased susceptibility to HIV acquisition/transmission.  The FOA is not designed to develop new prevention APIs or delivery devices.  MPTs, for the purpose of this FOA, will be limited to those that incorporate established anti-HIV strategies with a contraceptive or inhibitor of a sexually transmitted infection (STI). The MEHP FOA will not support vaccine or behavioral and social science interventions to prevent HIV infection.

Depending on the tissue type and anatomical location, the male and female genital and GI tracts are covered by an epithelium consisting of single to multiple layers of cells that are histologically unique and, depending on site, are bathed in mucous. The composition of the mucosal tissues is controlled by a wide variety of endogenous and exogenous factors. These tracts have different commensal flora, unique innate and adaptive immune response mechanisms, immune cell compositions, and, in the case of the female genital tract, tissue and cellular structure and functions that are hormonally regulated. Numerous studies have shown that APIs, delivery vehicles and formulations/excipients can induce changes in the mucosa, such as loosening of epithelial tight and adherent junctions, alterations of innate and/or adaptive immune mediators (i.e. inflammation), and immune cell content (i.e. homing and trafficking). Sexually transmitted infections (STI) associated with HIV acquisition in the absence of gross evidence of toxicity or damage to the tissues also can modulate genital and GI tract mucosal susceptibility to HIV transmission/ acquisition. Although not all mucosal changes induced by prevention candidates or strategies have been linked directly to alterations in HIV acquisition/transmission, these changes represent modifications of the physical and active barriers to HIV infection that, under the right circumstances, could positively or negatively modulate susceptibility to HIV infection.

As opposed to the creation of more potent strategies to inhibit HIV transmission/acquisition by combining multiple APIs and/or creating prevention packages composed of multiple prevention strategies (i.e. PrEP + microbicide, etc.), the long-term objective of the MEHP FOA is to develop more effective prevention interventions by understanding and optimizing the interaction of the prevention strategy and its components with the HIV target mucosa. The knowledge gained can then serve as a first step toward the creation of "mucosal friendly" prevention strategies, incorporating modulation of delivery strategies and/or formulation/excipient interactions as an active component of the HIV prevention strategy.

Applicants are encouraged to develop applications that are focused on understanding the impact of nBP APIs, delivery vehicles, formulations/excipients and/or contraceptives on the genital and GI mucosa and HIV target cells. APIs selected as tools to evaluate mucosa responses should be chemically defined entities with known anti-HIV activity such as small chemical compounds, including licensed and unlicensed antiretrovirals and/or protein/peptide-based compounds that are being developed as nBP agents. If an MPT strategy is investigated, those incorporating contraceptives should use contraceptives that are in clinical development or currently licensed for contraceptive use. Hormonal or non-hormonal contraceptives investigated as part of an MPT strategy may be used in either HIV-negative or -positive women, and should be used at concentrations relevant to their contraceptive regimes. Topical (vaginal, rectal and/or penile) or systemic (implantable devices, injection, oral or transdermal) delivery of APIs, hormones, and/or excipients may be used. The influence of race, ethnicity, genital tissue maturation and mucosal injury/ sexual trauma as modifiers of the mucosal environment in the genital and GI tracts, and their relationship to HIV susceptibility and nBP candidate/strategy efficacy are of interest.

It is not the purpose of this FOA to develop new prevention candidates or strategies, but to use existing candidates and strategies as tools to probe the HIV target mucosae to develop a knowledge base that will lead to the creation of novel "mucosal friendly" prevention strategies. Thus, applications that are focused solely on prevention candidate development and individual specific aims in meritorious applications focusing solely on candidate development will not be funded.

Specific Areas of Research Interest

This FOA is designed to stimulate and support the innovative research needed to understand the interaction of nBP strategies with the mucosal micro- and macro-environments of the male and female genital and GI tracts. It is expected that this research will be the basis for creation of future prevention candidates and strategies that will incorporate optimized mucosal interactions as a critical part of the HIV prevention strategy. This FOA addresses 3 areas of interest required to develop the knowledge base to support the rational design of these more "mucosal friendly" prevention strategies:

Responsive Areas of Research

All examples of responsive areas assume that the identified activities are being conducted in the context of understanding the interaction of an API, delivery system and/or formulation/excipient within the male and/or female genital or GI mucosa.  These studies may be carried out with human secretions, cells and /or tissues and animal models of HIV transmission and acquisition.  Responsive studies include, but are not limited to:

Non-responsive Areas of Research

Applications focusing on the following areas will not be considered responsive and will not be reviewed:

Section II. Award Information
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 following NIH components intend to commit the following amounts in FY 2014:

NIAID/DAIDS intends to commit $3,500,000 to fund 4 to 8 awards.

NICHD/CPR/DBS intends to commit $2,400,000 to fund 4 to 6 awards.

Award Budget

Application budgets are limited to a direct cost of $400,000 per year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum 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.

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

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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(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.   

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 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:

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:

Peter R. Jackson, PhD
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
MSC 7616, Room 3133
6700-B Rockledge Drive
Bethesda, MD 20892-7616
For FedEx, use Zip 20817-7616
Telephone: 301-496-8426
Fax: 301-480-2408
Email: pj8v@nih.gov

Page Limitations

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

Required and Optional Components

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.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

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

All applications must contain a detailed, non-modular budget.

Applicants should ignore the following warning that will be generated for applications requesting budgets of $250,000 or less per year:  “The direct cost requests of $250K or less each year (on the 424 R&R Budget page section F-K) must be in modules of $25K, using the PHS 398 Modular Budget Form and not the R&R Budget Form. Incorrect applications may be delayed in the peer review process or rejected.”

PHS 398 Cover Letter

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

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-U.S.) 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 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.

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 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 components of participating organizations, NIH. 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.

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.

For this particular announcement, note the following:

The R01-based MEHP program is intended to support innovative research that can contribute significantly to our understanding of the genital and GI mucosal environments and their role in safety and efficacy of nBP strategies. Accordingly, the potential of a MEHP application to significantly advance our knowledge of mucosal nBP interactions is the focus of this program. Although, preliminary data can play a significant role in providing a justification or rationale for the proposed experimental approaches and projected impact, the types of research needed to achieve the objectives of the MEHP program may preclude the preexistence of extensive preliminary data. Thus, judgments regarding potential success for the proposed research may require reliance upon relational and/or inferential data to establish research impact/success rather than preliminary experimental data directly supporting application objectives.

Overall Impact

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).

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? Is the proposed research relevant to understanding the impact of nBP on prevention strategy efficacy and safety, and does the research have the potential to provide new knowledge that may be used to generate new targets/strategies for improving nBP safety and efficacy in future studies?   

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?   

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? Are the APIs and formulations/excipients used to study genital and GI mucosal responses used as tools to aid in the understanding of how the mucosa can ultimately be manipulated to enhance safety and efficacy of an nBP strategy?   

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 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 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 National Institute of Allergy and Infectious Diseases, 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council and National Advisory Child Health and Human Development Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’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.

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 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Jim A. Turpin, Ph.D
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-2732
Email: jturpin@niaid.nih.gov

Patricia Reichelderfer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435.6991
Email: jturpin@niaid.nih.gov

Peer Review Contact(s)

Lakshmi Ramachandra, M.Sc., Ph.D.
National Institutes of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-5658
Email: ramachandral@niaid.nih.gov

Financial/Grants Management Contact(s)

Ann Devine
National Institutes of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-5601
Email: adevine@niaid.nih.gov

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@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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