Part 1. Overview Information

Key Dates

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.

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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



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

Background

Globally, per the UNAIDS HIV and AIDS statistics, children account for approximately 4% of all people living with HIV, 10% of new annual HIV infections, and 13% of all AIDS-related deaths. To facilitate the global response to end pediatric HIV and AIDS, the discovery, development and delivery of safe and effective prophylactic interventions against HIV remain a key priority to target the HIV pandemic, especially to prevent new infections in neonates, infants, and pre-adolescents. Advances in the field of translational immunology and vaccinology, including efforts directed at bridging preventable life-threatening pediatric infections are reinstating the role of early life immunization as an effective global health approach to abate pediatric HIV infection and to potentially provide lifelong immunity.

Early life presents a distinct immune landscape for the development and maturation of protective immunity to HIV as reported by the elicitation of early, potent, and polyclonal cross neutralizing responses for a streamlined path to generate and mature HIV neutralization breadth. Moreover, high magnitude, breadth and durability of functional antibody responses to multiple prophylactic vaccines provide a proof of principle to mount comparable or higher immunity in early life than in adults and further affirms an advantage to target HIV prevention in a pediatric setting. However, hypo-responsiveness or limited immunogenicity of HIV vaccine candidates and the transient durability of the elicited immune responses in early life remain significant challenges against effective pediatric immunization. Additionally, a significant gap remains to mechanistically understand how immune ontogeny and functionality in early life, as it transitions from neonatal to adult functional capacity, in the context of HIV preventive interventions, could be harnessed to elicit broad and durable protective immunity to HIV. Therefore, an in-depth understanding of the key components and pathways of the immune ontogeny and functionality in early life is necessary for tailoring the trajectories of immune mechanisms towards eliciting and maintaining pediatric immunity to HIV. This funding opportunity will solicit and support basic and applied research applications addressing unique immunologic features and molecular regulators in early life for developing and maintaining broad, durable, and protective immunity against pediatric HIV infection.

A primary goal of HIV prevention research is to elicit bNAbs to combat high antigenic diversity of HIV, given the ability of passive bNAb immunization to provide sterilizing protection in preclinical models and also the feasibility to protect against neutralization-sensitive HIV isolates in clinical testing (HVTN 704/HPTN 085: NCT02716675; HVTN 703/HPTN 081: NCT02568215). Safety, tolerability and short-term protective levels of bNAbs are also noted in a clinical trial testing anti-HIV monoclonal antibodies in HIV?exposed uninfected infants (IMPAACT P1112: NCT02256631). Additionally, the elicitation of HIV bNAb precursors, with substantial frequencies in blood and lymph nodes consistently across vaccine recipients, was recently reported in the first-in-human test of the germline-targeting immunization strategy (IAVI G001; NCT03547245). Moreover, an ongoing phase 1 clinical trial is evaluating the safety and immune responses to an adjuvanted protein vaccine, based on bNAb lineage prime immunogen, in healthy HIV-exposed and uninfected infants (HVTN 135; NCT04607408).

Early life, with developmentally sensitive immune trajectory, presents an opportunity to evaluate HIV bNAbs based immunization strategies, as a key HIV prevention modality. However, the mechanisms underpinning the development pathways to induce bNAbs through immunization strategies in early life remain a gap area in pediatric vaccinology. Deciphering and engaging unique features of pediatric immunity for identifying immune networks that distinguish between tolerogenic vs. immunogenic response to HIV prevention measures in early life are critical to 1) develop strategies to overcome immune evasion mechanisms that present barriers for induction of bNAbs to HIV; and 2) define and accelerate the kinetics of B-cell pathways for the elicitation of bNAbs. Considering that early life presents a bimodal mode of transmission of HIV, there is a need to test if both active and passive immunization strategies can prime immunity in infancy to protect from HIV transmission via breastmilk followed by pre-adolescent boosting to mature protective and durable response to HIV at the time of sexual debut. The goal of this funding opportunity is to promote research on deciphering the mechanisms for developing and maintaining immunity to HIV in early life that will provide further foundational information to improve immune health and efficacy of HIV preventive strategies in this vulnerable population.

Research Objectives and Scope

The scientific objective of this notice of funding opportunity (NOFO) is to support hypothesis-driven basic and applied research to investigate and advance the mechanistic understanding on how immune ontogeny and functionality in early life could be harnessed in the context of HIV prophylactic vaccines and bNAbs to protect against acquisition of HIV infection. The initiative focus is on neonates, infants, and pre-adolescents age groups (from birth to less than 12 years of age) considering that the unique and less pre-programmed immune landscape of early life may present an advantage to target HIV prevention strategies for elicitation of anti-HIV immune responses.

Applications may include basic and applied research using human samples and/or nonhuman primate (NHP) animal model. Though clinical trials are not allowed, the use of samples from clinical studies (from birth to less than 12 years of age) funded through other mechanisms and/or collaborations with groups performing clinical trials are highly encouraged. Studies in NHP animal model (from birth to less than 4 years of age) with HIV, SIV, and/or SHIV are allowed. Research programs are encouraged to include multidisciplinary teams to interrogate immunological and virological challenges of developing safe and effective HIV vaccines and bNAbs, and further insights on the dynamics and drivers of developing immune functionality in early life.

Key areas of the research focus include: 1) evaluation of pediatric HIV immunization strategies to identify prime components and pathways of immune ontogeny and functionality for the development of early and poly-specific bNAb lineages; and 2) determination of the biodistribution and efficacy of prophylactic bNAbs in the evolving pediatric immune landscape.

Additional examples of research topics include, but are not limited to:

• Mechanisms for establishing and maintaining immunity to HIV in early life, including active and passive immunization strategies in pediatric populations exposed- or unexposed- to HIV.
• Role of maternal influence, through breastfeeding, on immune ontogeny and clinical outcomes to HIV prophylactic measures in early life, including maternal determinants e.g., HIV infection status, antiretroviral therapy initiation, bNAbs treatment, inflammatory milieu, microbiota, and antibodies profile.
• Developmental pathways of bNAbs to HIV during pediatric immune maturation.
• Longitudinal imaging of pediatric immune cell dynamics and functionality in response to HIV immunization strategies.
• Mechanisms of elicitation of tissue-specific and/or mucosal immunity to HIV in the context of early life host microbiota and evolving immune landscape.
• Impact of vaccine adjuvants as immunopotentiators for improving pediatric immunity to HIV.
• Molecular regulators of pediatric HIV immunity based on systems-level identification of biomarkers of safety and efficacy of immunization with HIV prophylactic vaccines and bNAbs.

Applications proposing the following studies or topic areas will be considered non-responsive and will not be reviewed:

• Clinical Trials.
• Studies on human age groups 12 years or older.
• Studies based on HIV infected pediatric populations or cohorts with other immunodeficiencies or genetic diseases.
• HIV cure or treatment interventions.
• Strategies evaluating non-immune mechanisms of developing and maintaining immunity to HIV in early life.
• Vaccines and bNAbs for targets other than HIV.
• Use of animal models other than NHPs.
• Animal model development.
• Vaccines or bNAb platform development.
• Epidemiological studies.

Steering Committee (SC): The contact Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) for each award will form a SC, comprised of the PD(s)/PI(s), Key Personnel, and the NIH Project Scientist, to serve as the governing board of the MIEL Program. The SC will coordinate and facilitate the progress of research activities supported by the award; facilitate compliance with the data- and other resource-sharing policies; identify scientific opportunities, emerging needs and challenges; promote scientific collaboration and exchange of scientific findings among the awardees; and promote research efficiency. 

External Scientific Advisory Board (ESAB): The contact PD(s)/PI(s) for each award, in consultation with the NIH Project Scientist, will be required to form an ESAB to be comprised of 4-5 independent experts in the field. The ESAB will meet annually to review the current status of the research progress of the award related to stated goals or outcomes, address any concerns about the direction of the research, and provide recommendations to the SC members on the focus of the next year of research.

The ESAB members should NOT be named in the application or contacted prior to any awards being made.

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

Section II. Award Information

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

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)

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. 

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 NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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.

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 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&nbnbsp;except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Samita Andreansky, Ph.D.
Telephone: 240-669-2915
Email: samita.andreansky@nih.gov 

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

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.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply - Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

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

Specific Aims:

List the broad, long-range objectives and goals of the proposed project.     

Research Strategy:

Provide an overview of the scientific gap and the hypothesis to be addressed, and how the proposed research supports defining the mechanisms for establishing, developing and maintaining immunity to HIV in early life. Describe the overall objectives, significance, innovation, and the rationale for using the proposed approach of the research.

Elucidate how the proposed research on HIV prophylactic vaccines or bNAbs will advance knowledge of mechanisms for developing and maintaining immunity to HIV in early life (from birth to less than 12 years of age). Include preliminary safety and immunogenicity data for the proposed HIV vaccines and bNAbs. Propose a research strategy with clearly defined methods and criteria to support the capability with the proposed study design and to evaluate success based on specific and scientifically rigorous research outcome criteria.

For research based on the analysis of pediatric clinical samples, clearly describe the rationale and approach for selection of cohort(s), the age range, sample sources and assessments methods with respect to the specific aims and the overall goals of the project. Include descriptions of the studies from which the specimens are obtained. Provide documentation of access to specimens including descriptions of the types and quantities of specimens to be accessed.

If the research project uses pediatric NHPs, describe and justify the use of preclinical model (relevance to the human immune system) and age (from birth to less than 4 years of age) selection criteria. Explain how the results from the preclinical animal model will guide the mechanistic insights on HIV bNAb-based active and passive immunization strategies in early life, and will inform the design and assessment of the pediatric clinical studies.

In a Project Management Plan section, provide a plan with clearly defined timelines and milestones that include key features of the feasibility of the proposed research based on the approach and data collection to be monitored and evaluated. Applicants may choose to use a Gantt chart or equivalent for this purpose.

Discuss how members of the multidisciplinary research team and proposed collaborations will contribute to the successful completion of the project.     

Letters of Support:

Include letters of support, to document availability and/or and timeline to acquire, reagent(s), samples (e.g., clinical samples), specialized assays, NHPs and any critical intellectual contribution(s) that will be needed to complete the studies.   

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): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• All applicants funded through this NOFO are required to share their data publicly through ImmPort or other public portals approved by NIAID. Plan will include a summary of how the applicant will manage data submission and interactions with ImmPort or other proposed portals.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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

All instructions in the How to Apply - Application Guide must be followed.

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 NIAID, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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.

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.

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.

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.

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 policies and practices, 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 will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Serving as the lead for scientific and administrative oversight for the proposed research, including planning, directing, and executing the proposed research.
• Ensuring adherence to the timelines and milestones within the Project Management Plan. In the case where the milestones are not met, PD(s)/PI(s) will be responsible for setting and implementing corrective plans that will be negotiated with and approved by NIAID.
• Defining the responsibilities and governing processes of the SC. Convening the SC within three months of the award and holding monthly SC meetings.
• Holding an annual meeting, including the ESAB, SC, and NIH Program representatives, to review progress, plan research activities, and update priorities.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Monitoring the management of research activities, providing oversight of technical performance of the program, and coordinating with other appropriate NIH staff to provide assistance to the recipient on specific scientific or technical issues.
• Advising the recipient on the development and modification of milestone plans to ensure that proposed project activities and timelines are appropriately achieved.
• Coordinating review and recommend approval of any changes required in the project timelines and milestones to ensure projects are compliant with NIH, HHS, and other relevant policies.
• Advising in the selection of and facilitating access to NIAID-supported resources and services related to the goals of the project.
• Assisting with prioritization of resources and implementation of data and resource sharing plans.
• Providing advice on scientific, operational, or administrative activities to facilitate progress and implementation of collaboration(s) related to the overall goals and objectives of the program.
• Participating in the annual ESAB meeting, the monthly SC meetings, and other meetings as appropriate, to review research progress and data for use in the preparation of internal reports on the activities of the project.
• An agency program official or IC program director, other than the NIH Project Scientist, will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Establishing a SC consisting of PD(s)/PI(s), Key Personnel, and the NIAID Project Scientist. The PD(s)/PI(s) will be responsible for facilitating the governing processes and meetings of the SC. The selection of the SC chair will be based on the committee members voting. Each member of the SC will have one vote. The NIH Project Scientist will participate in the SC meetings to review research progress and data on the activities of the project though will not have voting membership. The NIH staff may appoint other subject matter experts as non-voting members of the SC to provide additional expertise and perspective. The Program Officer and NIH grants management staff may attend the meetings as observers. The SC may recommend redirection of scientific activities due to changes in priorities or lack of productivity. The PD(s)/PI(s) and the Key Personnel will be required to accept and implement decisions of the SC. Changes in scope of the proposed scientific agenda must follow the standard prior approval process as outlined in the NIH Grants Policy Statement.
• Coordinating an ESAB, comprised of 4-5 independent experts to provide feedback on the project focus and progress.
• Negotiating and finalizing annual milestones and timelines prior to issuance of an award. This process is a collaboration between the PD/PI and the NIAID Program Officer and Project Scientist.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Anjali Singh, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-507-4924
Email: anjalisingh@niaid.nih.gov 

Samita Andreansky, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2915
Email: samita.andreansky@nih.gov  

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: adevine@niaid.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.

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 2 CFR Part 200.