RFA-AI-27-019-Full-Announcement.html

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)

Funding Opportunity Title

Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of

RFA-AI-18-010

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-AI-27-019

Companion Funding Opportunity

None

Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.855

Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to support the establishment or continuation of longitudinal infant cohorts to determine and compare how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures. The goal of this research is to understand how these exposures influence immune responses to subsequent influenza infections and/or vaccines and provide key information to facilitate design of durable, broadly protective influenza vaccines.

Funding Opportunity Goal(s)

To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials. To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas. Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research.

Key Dates

Posted Date

February 10, 2026

Open Date (Earliest Submission Date)

May 04, 2026

June 04, 2026

June 04, 2026

Not Applicable

March 2027

All applications are due 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.

Due Dates for E.O. 12372

Not Applicable

Expiration Date

June 05, 2026

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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 Key Dates Part 2. Full Text of Announcement Section I. Notice of 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. Notice of Funding Opportunity Description

Purpose The purpose of this notice of funding opportunity (NOFO) is to support the establishment or continuation of longitudinal infant cohorts to determine and compare how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures. Research supported under this program will define and characterize immunity acquired upon initial exposure to influenza antigens from natural infections and/or vaccinations and examine how these exposures influence immune responses to subsequent influenza infections and/or vaccines. The goal of this research is to provide key information to facilitate design of durable, broadly protective influenza vaccines.

Background Seasonal influenza outbreaks occur annually and cause significant worldwide morbidity and mortality, particularly in vulnerable populations such as infants, young children, and the elderly. An even greater threat to the general population is the ever-present and unpredictable emergence of a novel viral strain for which humans may have limited to no pre-existing immunity. Because influenza viruses exhibit frequent antigenic change, influenza vaccines are developed against the strains predicted to circulate in the upcoming influenza season and novel strains that have the potential to widely infect humans. Therefore, annual vaccination remains the cornerstone for the control of influenza. Seasonal influenza vaccines typically contain two strains of influenza A (H1N1 and H3N2) virus and one or more influenza B viruses formulated as trivalent or quadrivalent vaccines, respectively. Currently available influenza vaccines provide suboptimal protection against seasonal influenza and provide limited protection against newly emerging strains. Numerous factors can significantly reduce vaccine effectiveness to circulating strains and contribute to waning immunity. A major advancement in influenza control would be the development of a vaccine that confers broad, robust, and durable protection against many or most seasonal strains of influenza, as well as novel strains that could cause significant morbidity and mortality in humans.

Humans encounter numerous influenza strains and may receive numerous vaccinations throughout their lifetime. Immune responses to these exposures are determined by the genetics of the infecting viruses and intrinsic factors, including host genetics, exposure and vaccination history, age, the presence or absence of chronic illnesses, and immune status. Additionally, one's initial infection with an influenza virus impacts immunity, including antibody responses, to subsequent infections with new strains. This concept of "original antigenic sin" was proposed in 1960 by Thomas Francis, Jr. to describe the impact of pre-existing immunological memory from an initial influenza encounter upon exposure to a different influenza virus. Recent epidemiologic evidence suggests that exposure during early childhood elicits a lifelong immunologic "imprint" that impacts the response to subsequent novel strains, including providing protection against novel hemagglutinin (HA) subtypes from the same phylogenetic group as the original infecting virus. Immunological "imprinting" has important implications for public health because it may also negatively influence responses to subsequent influenza infections and vaccinations. A better understanding of “imprinting” could allow it potentially to be harnessed for future vaccine design that provides infants with a broader immune landscape and protection from subsequent infections.

Understanding how infants' immune responses are altered or expanded by their encounter with subsequent influenza infections and/or vaccinations will be critical to define the breadth of immunological coverage that can be achieved with an effective universal influenza vaccine. Detailed immunological studies of clinical samples from infants will provide new insights into the mechanisms by which immunity is acquired following initial exposure to influenza via infection or vaccination and help define which influenza antigen/epitope-associated responses result in more broad-based immunity. This initiative is intended to support the establishment or continuation of focused, multi-disciplinary, prospective studies of longitudinal infant cohorts and immunological research studies to address critical knowledge gaps.

Research Objectives and Scope Despite early exposure to natural influenza infections or vaccinations, influenza infections continue to occur throughout life. Numerous studies have shown that one's initial exposure to influenza impacts immunity to subsequent exposures with different influenza strains. However, the impact of initial influenza infections and/or vaccinations on immunity to subsequent influenza exposures is not well understood. This initiative responds to the need for increased investments in clinical and basic research in well-characterized infant cohorts by exploring the impact of birth year, initial and subsequent vaccinations, and natural infections on influenza immunity. Recent innovations in the study of human immunology coupled with other advanced technologies can be leveraged to determine the critical immune components required for generation, maintenance, and evolution of broadly protective immunity against influenza in humans. Specifically, this research initiative will support the establishment or continuation of infant cohorts coupled with immunological analyses to determine how initial natural influenza exposure and/or primary influenza vaccination shape infant and childhood immune responses to subsequent influenza infections and/or vaccines. The findings from this research will help to advance the design of a universal influenza vaccine.

This initiative will support a synergistic and cross-disciplinary effort to generate, coordinate, and integrate data from human clinical samples to address critical questions in influenza immune "imprinting" research. The study findings will be made available to the public as rapidly as possible. The clinical data and biological samples collected from the cohort(s) are expected to be available for sharing and use by the scientific community to continue research in this important field, as appropriate and consistent with achieving the goals of the program.

This NOFO requires applicants to establish or continue prospective cohort(s) of infants that will be followed prior to and after:

Infant enrollment ideally should occur between birth and prior to initial influenza exposure. These cohorts are expected to be followed for at least three influenza seasons, with desired capabilities to follow for longer periods, to understand the impact of initial and subsequent influenza infections and/or vaccinations on the breadth and quality of influenza-specific humoral and T cell-mediated immune responses, as well as innate immune responses triggered by influenza vaccines or natural infections.

This program supports inclusion of domestic prospective cohorts and appropriate international cohorts, especially from countries where infection or vaccination rates complement those seen in the U.S. Inclusion of relevant international cohorts facilitates recruitment and retention of additional participants, allowing for experimental and statistical validation of research results and strengthening clinical applications.

Inclusion of pregnant women and post-partum mothers in the prospective cohorts is strongly encouraged. Pregnant women should be followed at least through the last trimester of pregnancy and post-partum mothers followed through infant weaning. Each mother's influenza exposure history (i.e., vaccine and natural infection) and circulating influenza-specific antibody responses should be captured during pregnancy, immediately post-partum, and through weaning in order to examine the effects of maternal influenza exposure and circulating maternal anti-influenza antibodies on infant immune responses to influenza vaccines or natural infection.

Areas of research must address both topics listed below (identified as 1 and 2):

1. Determination of the effect of repeated exposures to infections and/or vaccinations on the maintenance and evolution of influenza-specific humoral and T cell-mediated immunity in infants/young children.

Within this topic, examples of areas of research include:

2. Comparison of immune mechanisms/components elicited by influenza vaccination versus natural infection.

Within this topic, examples of areas of research include:

The approach taken to establish, maintain, and characterize the cohort, including determination of the type of experimental and clinical data and biological samples to collect, should provide the greatest degree of innovation possible to advance our understanding of rational universal influenza vaccine design for this vulnerable population.

Program Infrastructure and Support Administration and Leadership Team The Administration and Leadership Team, led by the Program Director(s)/Principal Investigator(s) [PD(s)/PI(s)], will be responsible for organizing, coordinating, and providing oversight for the implementation and execution of activities that facilitate progress and completion of the research project. This team will serve as the administrative oversight, coordination, and communications hub for the entire study. The Administration and Leadership Team will also work with the Data Stewardship and Analysis Team to develop efficient and statistically powered study designs and provide support for the preliminary and final data analyses for the research.

Data Stewardship and Analysis Team The Data Stewardship and Analysis Team will be responsible for the range of activities related to data including: collection, management, analyses, quality assurance and standards, and development of statistically powered study designs for the study. The Data Stewardship and Analysis Team will also implement processes and procedures for receipt, storage, retrieval, and inventory of biological specimens, harmonization of specimens to clinical and experimental data (including metadata), tracking and monitoring of biological specimen use, storage, and/or distribution, and executing data sharing agreements among recipients of these awards, and for sharing of data/meta-data with the broader research community including public repositories recommended by NIAID program staff. Team members will work with key personnel to develop efficient study designs and statistical calculations and provide support for the preliminary and final data analyses for the study.

Clinical Research Support Team The Clinical Research Support Team will be responsible for leading and coordinating the activities associated with human subjects’ research across the study, including for example, multi-site coordination, pre-study community outreach, tracking and monitoring enrollment, recruitment, maintenance, and status of regulatory documents with data collection and reporting, and compliance with human subjects’ research data and quality procedures. This team will serve as the process and procedure hub for the interaction among the clinical sites and other functional work areas.

External Advisory Committee (EAC) An External Advisory Committee will be established post-award by NIAID to review progress and to provide recommendations to investigators as part of the annual programmatic meeting. The EAC membership will consist of scientific experts in the fields of infant and child health, immunology, and influenza virology. Following establishment, the EAC will meet annually to review the progress of the recipient projects and make recommendations to the PDs/PIs regarding direction of the research program on an ongoing basis and in consultation with NIAID staff. Note that new applicants should not contact, recruit, or name potential EAC members until application review activities are completed. For a renewal application, applicants should provide the names of current and former members but should not recruit or name new members until application review activities are completed.

Annual Programmatic Meetings In the first year of the award, a kick-off meeting will be held to articulate and establish the major roles and functions of the program. Beginning in year 02 of the award and annually thereafter, a program meeting will be held to facilitate collaborations, provide progress reporting, seek new research directions and ideas, and update NIAID. These meetings will be attended by the PD(s)/PI(s), key personnel, EAC members, the NIAID Project Scientist, other NIAID personnel, and other relevant interest holders.

Opportunity Fund In consultation with NIAID, each recipient will develop and manage an Opportunity Fund that is intended to support research in new or emerging research, promote sharing of resources and expertise, and other collaborative activities consistent with the research objectives of the award. The recipient will be responsible for developing the specific processes necessary for solicitation, review, selection, and implementation of small pilot projects awarded through the Opportunity Fund. These small projects may include for example, collaborative pilot/feasibility projects among recipients, early-stage investigator or trainee research projects, or other activities that further the collaborative objectives and goals among the recipients.

Applications proposing any of the following topic areas will be considered nonresponsive and will not be reviewed:

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

New

Renewal

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAID intends to commit $9.6 million in FY 2027 to fund 2-4 awards.

Award Budget

Application budgets are not expected to exceed $3 million in direct costs per year and 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 must be five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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 their organization to develop an application for 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 How to Apply-Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For this specific NOFO, the Research Strategy section is limited to 30 pages.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Within the Biosketch under Personal Statement, describe how all Key Personnel demonstrate strong administrative, technical, and management expertise in areas critical to the success of the application, including experience working productively in team collaborative environments. Demonstrate how specific expertise supports the multi-disciplinary approach to guarantee a successful, integrated effort towards the goals of the research project.

R&R or Modular Budget All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed research, and indicate how these goals will be accomplished based on the proposed studies. Concisely describe the hypothesis or hypotheses to be tested. Indicate how the outcomes from the proposed hypotheses coalesce to support the overall goals and objectives of the research.

Research Strategy:

In separate sections within the Research Strategy, using the suggested titles below, include the following:

Administrative Plan:

Data Stewardship and Analysis Plan:

Without duplicating information included in the Data Management and Sharing Plan (DMSP), describe the following:

Clinical Management Plan:

Without duplicating information included in the PHS Human Subjects and Clinical Trials Information Section or Research Strategy, describe the following:

Opportunity Fund:

Describe the following:

The strategic approach to the Opportunity Fund and how it will support the research objectives of the award, including management of the processes and procedures for solicitation, review, selection, prioritization, development, and implementation of activities related to the use of the Opportunity Fund.

Project Benchmarks and Timelines:

Describe the following:

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Section 2 - Study Population Characteristics

2.2 Eligibility Criteria

Describe the planned selection process, accounting for infants before and after initial influenza vaccination and infants before and after initial documented clinical diagnosis of influenza, and how the plan accounts for the inherent complexities of the inclusion and exclusion process.

2.3 Age Limits

Describe the approach to enrolling age-appropriate infants for at least three influenza season cycles and how it will promote success of the overall program.

2.4 Inclusion of Women and Minorities

As applicable, discuss the complexities surrounding the enrollment of children, pregnant women, and fetuses to achieve varied representation.

2.5 Recruitment and Retention Plan

Describe how subjects for enrollment will be identified to enable implementation of the inclusion and exclusion criteria, and detail the verification process (e.g., medical record, clinical diagnostic tests) for conditions requiring verification (i.e., vaccination, influenza assay) through at least three influenza season cycles.

2.7 Study Timeline

If applicable, address the timeline for the planned enrollment process with respect to the required conditions of the subject pool.

Section 3 - Protection and Monitoring Plans

3.1 Protection of Human Subjects

3.1.1 Risks to Human Subjects

3.1.1.a Human Subjects Involvement, Characteristics, and Design Describe the power analyses with respect to exposure, vaccination, and age-matched control subjects; and describe how the cohort will achieve adequate sample/subject size to support the successful completion of the goals and objectives of the proposed research project.

3.1.2 Adequacy of Protection Against Risks

3.1.2.a. Informed Consent and Assent Describe the unique consent and assent procedures to ensure protections for the diverse sample of human subjects (e.g., pregnant women/fetus, neonates, young infants, children) necessary to achieve success of the overall program.

Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form All instructions in the How to Apply- Application Guide must be followed.

Foreign Organizations Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times Part I. contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

6. 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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 scored review…