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 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Broadly neutralizing antibodies (bNAbs) were initially selected for their potency and breadth of neutralization against a representative panel of pseudoviruses. Since then, bNAbs have been engineered to enhance their potency, breadth of neutralization, pharmacokinetics (PK), and manufacturability. Clinical trials have established that bNAb administrations are safe, and they can prevent infection and maintain viral suppression in individuals with bNAb sensitive viruses. However, they have not demonstrated sufficient killing of HIV-infected cells to significantly reduce the HIV reservoir or increase the proportion of individuals able to maintain viral suppression off antiretroviral therapy once bNAb levels have waned. The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) and other funding organizations have supported research to identify biologics that more effectively kill HIV- and other virus-infected cells, including molecules with Fc modifications and engineered antibodies and antibody-like molecules. However, few of these enhanced biologics have been tested in people with HIV. Two DAIDS/NIH sponsored workshops in 2022 identified the lack of funding for late-stage development and investigational new drug (IND)-enabling studies as a significant impediment to advancing these agents to the clinic.

Research Objectives and Scope

The purpose of this Notice of Funding Opportunity (NOFO) announcement is to support the late-stage engineering and preclinical development of innovative biological products that safely and specifically engage the immune system to kill HIV-infected cells. Products of interest include but are not limited to bNAbs, their derivatives, and other soluble, antibody-like molecules that tag HIV-infected cells and recruit immune cells to specifically kill HIV-infected cells.

Applications must include:

• Preclinical work to advance late-stage development of biologics engineered to kill HIV-infected cells.
• IND-enabling, preclinical studies according to Good Laboratory Practice using product from the engineering run of product scale-up following FDA defined current Good Manufacturing Practice (cGMP), such as:
  • Tissue cross reactivity studies and possibly a binding study against an array of human membrane bound and secreted proteins to identify the appropriate species for the toxicology studies
  • Toxicology studies to evaluate animal PK and to identify the no observed adverse effect level and potential safety concerns
  • Confirmatory proof-of-concept studies with human samples or in an appropriate animal model, and
  • Continued assay development to comply with FDA guidance. 
• Milestones for transitioning from the UG3 phase to the UH3 phase.

Applications proposing any of the following will be considered non-responsive and will not be reviewed:

• Research focused on new antibody discovery
• Research focused on new Fc modifications to enhance killing
• Research using toxin conjugated or radioactive antibodies
• Research focused on vaccines
• Scale-up and cGMP manufacture of the biologic to be used in the UH3 phase
• Clinical trials

Applications missing the following information will be considered non-responsive and will not be reviewed:

• Applications without plans for IND-enabling, preclinical studies to be conducted according to Good Laboratory Practice using product from the engineering run of product scale-up following FDA defined cGMP
• Applications without a private sector entity
• Applications without a milestone section
• Applications without preliminary data demonstrating the specificity of the biologic’s binding to HIV-infected cells and demonstrating its capacity to engage human immune cells to kill HIV-infected cells

Private sector entities: Projects can be led by either academic or private sector entities. The advancement of laboratory-scale product candidates to cGMP material ready for human clinical trials is a critical goal of this program. To facilitate these activities, each application must include at least one private sector entity with commitment to contribute materially and intellectually to the overall goals and objectives of the project. For the purpose of this NOFO, the term “private sector” comprises large and small for-profit pharmaceutical, biotechnology, and bioengineering companies. Companies providing only fee-for-service type activities or access to materials or services without intellectual involvement in the proposed research may be included in the application but will not meet the criteria for being considered a private sector entity for the purpose of satisfying these requirements.

Steering Committee (SC): The contact PD/PI for each award will form a SC with the PDs/PIs, key personnel, and a NIAID Project Scientist. The purpose of the SC is to coordinate and facilitate research activities supported by their award; facilitate compliance with the data- and other resource-sharing policies; and promote research efficiency. NIH staff may appoint other subject matter experts as non-voting members of the SC to provide additional expertise and perspective.

Scientific Advisory Board (SAB): Each awardee will also be required to form a SAB to be comprised of independent experts in the field that will meet annually to review progress of the award and make recommendations for the coming year to the PD(s)/PI(s) and SC. Potential SAB members should NOT be named in the application or contacted prior to any awards being made.

Phased Innovation Awards

Due to the high-risk, high-impact nature of the research, this funding opportunity will use the UG3/UH3 phased exploratory/development cooperative agreement award mechanism.   Applicants may request up to five years of support. The number of years for each phase may vary depending on stage of research at time of application submission. The UG3 phase portion can be anywhere from one to three years for hypothesis- and milestone-driven basic technology research, assay development, generation of a pre-IND development plan consistent with FDA guidance, and completion of a meeting with the FDA in a meeting appropriate for the stage of product development (see https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otat-interact-meeting). The UH3 portion can be anywhere from two to four years for the pre-IND studies and additional activities as appropriate, such as expanded assay development, optimization, proof of concept validation with human samples, and usability testing. The total duration of the UG3 and UH3 phases cannot exceed five years. Proposed milestones will be reviewed and negotiated prior to award.

Before the end of the UG3 phase, awardees must submit a UH3 transition package, including a detailed progress report describing advancement toward the milestones, a description of how the completed work justifies continuation with the originally proposed UH3 studies, documentation that a meeting has been held with the FDA, and demonstration that an appropriate quality and quantity of the biologic has been procured for the UH3 phase. Note this cooperative agreement does not support manufacturing of the study agent to be tested in the UH3 phase. The UH3 transition package will be evaluated by NIH Program staff. Awards selected for continued funding will be transitioned to an UH3 award without the need to submit a new application. Transition to the UH3 phase is neither automatic nor guaranteed; UH3 funding decisions will be based on successful completion of transition milestones, meeting the above requirements, Program priorities, and availability of funds. It is expected that approximately one-half of the projects supported during the UG3 Phase will continue into the UH3 Phase.

NIH's Interest in Diversity

Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. NIH encourages applicants to include a diverse group of scientists in their research programs, including individuals from underrepresented backgrounds (see  NOT-OD-20-031, Notice of NIH’s Interest in Diversity and  NOT-OD-22-019, Reminder: Notice of NIH’s Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities).

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 Institutions) are not eligible to apply.

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 SF424 (R&R) Application Guide.

2. Cost Sharing

This NOFO 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.

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. 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.

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:

J. Bruce Sundstrom, Ph.D.
Telephone: 240-669-5045
Email: sundstromj@mail.nih.gov

Page Limitations

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

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.

R&R Subaward Budget

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:

Research Strategy:  Provide a brief overview of the research plan to support the feasibility of the approach that will lead to successful completion of the project. Describe the unique features of the proposed work, and how the work will address potential challenges to killing HIV-infected cells in humans, including, but not limited to, the heterogeneity of target viral determinants and the low level of target presentation on the surface of infected cells. Propose a research strategy with clearly defined methods and criteria to evaluate success. Describe the overall objectives and strategies to guide the development of candidate products including for example, plans for IND-enabling, preclinical studies to be conducted according to Good Laboratory Practice using product from the engineering run of product scale-up following FDA defined cGMP. Include a summary of critical properties, optimal and minimally acceptable attributes, and targets for development of the product.

Applicants must submit a single application that includes both the UG3 and UH3 phases. For each phase (UG3 and UH3), describe the planned research approach and explain how this approach will enable the successful achievement of the aims. Do not repeat information or experimental details in the UH3 section that are already described in the UG3 section. Discuss how the unique composition of the research team will ensure successful completion of the project.

Milestones (required): Applicants must include a section entitled Milestones and provide milestones for BOTH the UG3 and UH3 phases of the award within the research strategy.

Within this section, describe the suitability of the chosen milestones to achieve the goals for transition to the UH3 phase and to complete the goals for the UH3 phase. The milestones should be specific, scientifically rigorous, and not simply a restatement of the Specific Aims. They should address critical points of the proposed program and describe research outcomes by providing quantifiable measures for success within the UG3 and UH3 phases of the award, for example, the confirmation of efficacy in animal models or demonstration of feasibility to manufacture the desired biologic.

In a clearly labeled section, indicate the sequence, timeline, and location of milestones to illustrate the project schedule and the relationships between individual tasks in the project and the timeline for each task. Descriptions of the milestones must include GO/NO-GO statements to support critical parameters of the milestone that will determine whether the research should move forward or cease due to product development failures. Milestones must include a meeting with the FDA and procurement of sufficient cGMP material for the UH3 phase. Milestones may be indicated in a chart. Applicants may choose to use a Gantt chart or equivalent for this purpose.

Private Sector Entities (required): Applicants must include a private sector entity. In a separate section entitled Private Sector Entities, describe the role of the private sector entity in terms of scientific input, contribution and involvement in strategic planning and development process that supports their participation and fulfils a critical role in the development team. Describe the range of activities and processes that will be provided to the proposed project. Discuss how the facilities, resources and equipment provided by the private sector entity will facilitate the successful outcome described in the proposed project. Applications derived solely from industry should describe the advantages that an industry-only partnership brings to the application. Applications proposing an academic partner should describe the role the academic partner plays in implementing the proposed research.

Letters of Support: Provide letters of support documenting consensus with any potential partners regarding intellectual property, and other legal matters that may arise during the period of the award, as applicable. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) 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 SF424 (R&R) 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.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. 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. Overview Information 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 SF424 (R&R) 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.

7. 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 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 SF424 (R&R) 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 the National Institute of Allergy and Infectious Diseases (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.

For this particular announcement, note the following:

The UG3/UH3 phased exploratory/development cooperative agreement award mechanism supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An UG3/UH3 cooperative agreement application will need preliminary data showing the specificity of the biologic’s binding to HIV-infected cells and demonstrating its capacity to engage human immune cells to kill HIV-infected cells. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Reviewers will assign a single impact score for the entire application, which includes both the UG3 and UH3 phases.

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.

Transition Milestones

Are the proposed timelines for both the UG3 and UH3 phases of the project and the transition milestones well-defined with specific, scientifically rigorous, feasible, and measurable benchmarks? How likely are the milestones to foster success in the achievement of transition between phases and reaching the goals of the project? Are the proposed GO/NO-GO decision criteria appropriate for the overall advancement of the project?

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.

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: General and 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:

• Federal-wide 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that 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.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, 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 45 CFR Part 75.205 and 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 (DHHS) 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 the NIH as defined below. 

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

• Planning, directing, and executing the proposed research;
• Communication with the NIH Program Official regarding the status of ongoing research, changes in personnel, changes in research plans, etc.;
• Convening the Steering Committee (SC) within three months of the initial competing award and holding monthly SC meetings for the remainder of the competitive segment;
• Defining the responsibilities and governing processes of the SC
• Establishing the Scientific Advisory Board (SAB) within six months of the initial competing award start date in consultation with the NIAID Program Official(s) and Project Scientist. The SAB will review progress and make recommendations for the upcoming year on an annual basis;
• Organizing an annual meeting, including the SAB, 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 DHHS, PHS, and NIH policies. 

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

• Reviewing data generated under the award and using those data to prepare internal reports on the activities of the study;
• Facilitating access to resources and information that otherwise might not be available to the recipient;
• Advising on the management and technical performance of the program, and coordinating with other appropriate NIH staff to provide advice or assistance to the recipient on specific scientific or technical issues;
• Participating in the annual SAB meeting, the monthly SC meetings, and other meetings as appropriate,
• Participating in the review and approval of changes in research activities and resource allocation;
• The role of NIAID will be to facilitate and not direct the activities. It is anticipated that decisions on all activities will be reached by consensus or SC majority vote and that appropriate NIAID Program staff as non-voting members will be given the opportunity to offer input. The NIAID Project Scientist will not participate as a co-author on any publications resulting from the research.
• Additionally, an agency program official 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:

• Steering Committee: The SC will be comprised of the PD/PI(s), Key Personnel, and the NIAID Project Scientist. The SC should meet by monthly conference calls, supplemented as necessary by face-to-face meetings. Each member of the SC will have one vote. The NIAID Project Scientist will not have voting membership. The Program Officer(s) and NIH grants management staff may attend the meetings as observers. If the SC consists of an even number of voting members, then a process for resolving tied votes must be in place. The PD/PI(s) and other investigators will be required to accept and implement decisions of the SC. The SC may recommend redirection of scientific activities due to changes in priorities or lack of productivity. Changes in scope of the proposed scientific agenda must be approved by the NIAID Program Official and the designated Grants Management Official. Specific responsibilities of the SC may be negotiated among the members over the project period.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 (currently 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 45 CFR Part 75 and 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: 301-480-7075

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

Stephen Smiley, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3071
Email: stephen.smiley@nih.gov 

Yan Zhou, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-485-9785
Email:  zhouy16@niaid.nih.gov 

J. Bruce Sundstrom, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5054
Email:  sundstromj@niaid.nih.gov  

Mark Hodor
National Institute of Allergy and Infectious Diseases (NIAID 
Telephone:  240-669-5712
Email:  mark.hodor@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 45 CFR Part 75 and 2 CFR Part 200.