NIDA Avant-Garde Program for HIV and Substance Use Disorder Research (DP1 Clinical Trial Optional) PAR-25-261

NIDA Avant-Garde Program for HIV and Substance Use Disorder Research (DP1 Clinical Trial Optional) PAR-25-261 is sponsored by National Institute on Drug Abuse (NIDA), NIH. This funding opportunity supports innovative research at the intersection of HIV and substance use disorders.

Expired PAR-25-261: NIDA Avant-Garde Program for HIV and Substance Use Disorder Research (DP1 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Drug Abuse ( NIDA ) Funding Opportunity Title NIDA Avant-Garde Program for HIV and Substance Use Disorder Research (DP1 Clinical Trial Optional) DP1 NIH Director’s Pioneer Award (NDPA) Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity NIH Director's New Innovator Awards See Section III. 3.

Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose The National Institute on Drug Abuse (NIDA) Avant-Garde Award Program for HIV Research supports exceptionally creative scientists, who propose high-impact studies that open new areas of HIV research in the context of substance use and Substance Use Disorders (SUD) and/or lead to new avenues for prevention and treatment of HIV in people with SUD.

The term “avant-garde” refers to highly innovative ideas and/or approaches that have the potential to be transformative.

Accordingly, applications responding to this notice of funding opportunity (NOFO) must propose pioneering research that aligns with the NIH HIV/AIDS Research Priorities as described in NOT-OD-20-018 and is substantially different from what is currently being pursued by the principal investigator or others in the field.

In essence, this funding opportunity supports innovative basic, clinical and translational research that may lead to improved therapies or preventive interventions for HIV in people with SUD.

Some examples of research studies include developing creative strategies to prevent HIV transmission in high-risk substance using populations, to improve outcomes of HIV and HIV-related Comorbidities, and to achieve functional or sterilizing cure of HIV. Funding Opportunity Goal(s) To support basic, clinical, translational, and implementation research in the field of substance use.

To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcomes, including HIV/AIDS.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

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

Part 1. Overview Information 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 The term “avant-garde” is used to describe highly innovative approaches and ideas that have the potential to be transformative.

The National Institute on Drug Abuse (NIDA) Avant-Garde Award Program for HIV and Substance Use Disorder (SUD) Research is therefore designed to support exceptionally creative scientists who propose cutting edge high risk and high reward and possibly transformative approaches to major challenges in biomedical and behavioral research on HIV in the context of substance use and/or SUDs.

Applications responding to this notice of funding opportunity (NOFO) must propose projects that align with the high priority HIV/AIDS research areas as described in NOT-OD-20-018 .

Areas of interest include innovative basic, clinical or translational research that may lead to improved preventive interventions or therapies; creative strategies to prevent HIV transmission; novel approaches to improve outcomes of HIV and HIV-related Comorbidities; innovative ideas to improve health outcomes of people with SUD and are living with HIV; and cutting-edge approaches to eradicating HIV.

The award is intended to support high-impact studies that open new areas of HIV research and/or lead to new avenues for treatment and prevention of HIV among people with SUD. Applications responding to this NOFO should clearly define the nexus with substance use.

Examples of relevant studies include research using populations and/or samples from people with SUD; studies using in vitro systems and/or animal models that test the effects of addictive substances on HIV pathogenesis, disease progression, persistence or treatment responses; and studies to develop interventions or treatments tailored to or with the potential for significant benefit for people with substance use and/or SUD.

The purpose of this program is to support visionary concepts and approaches to research on HIV. Therefore, proposed research cannot be an expansion of ongoing funded project, it must rather reflect ideas and approaches that are substantially different from those being pursued by the investigator or others in the field.

This announcement defines biomedical and behavioral research broadly, with the emphasis on creativity and potential impact rather than a particular discipline or research area. The award is meant to support individuals who intend to pursue research directions relevant to the NOFO that are not readily supported by other NIH research grant activity codes.

Here is additional guidance on consideration of substance use in the Avant-Garde (DP1) research projects. NIDA requires the applications to explain ‘how’ and ‘why’ substance use is considered in the research project by either addressing aspects of substance use in research and analysis as applicable in the individual research projects or by making clear the implications of the research for people using drugs or with a SUD.

The research plan must clearly explain: Why substance use is relevant and/or significant to the proposed HIV research problem? How will the research plan or methodology address substance use?

For applications that include intervention or implementation studies, as well as observational studies that are concerned with HIV epidemiology or etiology, the study design needs to assess outcomes relevant to substance use in the context of HIV, or the implication of outcomes to people who use drugs or have a SUD.

For basic research studies, the methodologies must incorporate testing the role of substance use in the proposed biological mechanisms, and/or consider the implications of biological mechanisms related to substance use or exposure. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the availability of funds. Application budgets are limited to $700,000 in direct costs per year.

The maximum project period allowed is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information All organizations administering an eligible parent award may apply for a supplement under this NOFO.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (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 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 registration; 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.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . For the purpose of this NOFO, multiple PD(s)/PI(s) are not allowed . The Project Director/Principal Investigator (PD/PI) is the only individual who can be listed on the SF424 form.

NIH intramural investigators are not eligible for support under this program. Investigators at all career levels who meet the eligibility criteria and are currently engaged in research are eligible to submit applications.

The research proposed need not be in a conventional biomedical or behavioral discipline; if the individual’s experience is in non-biological areas, however, he/she must demonstrate a commitment to exploring topics of biomedical or behavioral relevance to HIV and substance use and SUDs. DP1 awardees are required to commit a large portion (at least 35% or 4.

2 person months) of their research effort to activities supported by the Avant-Garde Award program. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility 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 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. 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: Email: [email protected] All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide must be followed. Agency Routing Identifier : Enter “N/A”.

Type of Application: Must be “New”. Proposed Project: Start date: April 1st Total Federal Funds Requested: Enter $3,500,000. Total Non-Federal Funds: Enter $0.

Total Federal & Non-Federal Funds: Enter $3,500,000. (See note below.) Estimated Program Income: Enter $0.

Note: The Budget Request is entered only in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total - $3.

5 million - should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds". Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request. A detailed budget is not requested and will not be accepted.

Cover Letter: Provide names and affiliations of significant collaborators for the Avant-Garde Award project. Biosketches of collaborators are not allowed. Provision of names here is only to help exclude conflicts during reviewer assignment.

Information regarding any collaborators may be included in the Essay. 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.

Project Summary/Abstract: Attach an abstract describing the goals of the project and relevance to HIV and SUD research. Provide text only – no figures, animations, or web links are allowed. Project Narrative: In 2-3 sentences, written in plain language, describe how the proposed research can positively impact HIV treatment or prevention among people with SUDs.

Bibliography & References Cited: Do not use. Reference citations cannot be attached here but may be included in the essay. Other Attachments: Do not use.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. Profile – Project Director/Principal Investigator Field – Attach Biographical Sketch: Attach the PD(s)/PI(s) biographical sketch using the sample format on the Biographical Sketch Format Page shown in the Application Guide, omitting Section A (Personal Statement) and Section D (Research Support).

No biographical sketches of potential collaborators or other key personnel are to be submitted and will not be accepted. Current and Pending Support : Attach a list of Current and Pending Support from all sources, including current year total costs and percent effort devoted to each project. Profile – Senior Key Person 1: DO NOT USE.

Submit information only for PD/PI. Information on collaborators or other key personnel is not required but may be included in the Essay (in the Research Strategy attachment). Research and Related Senior/Key Person Profile (Expanded) - Additional Senior/Key Person Profiles(s): DO NOT USE.

Only the PD/PI may serve as senior/key personnel. Research and Related Senior/Key Person Profile (Expanded) - Additional Biographical Sketch(es): DO NOT USE. Only the PD/PI may submit a Biographical Sketch.

All instructions in the How to Apply - Application Guide must be followed. Do not provide budget forms. All instructions in the How to Apply - Application Guide must be followed.

Do not provide budget forms. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Specific Aims: Do not use.

Research Strategy: Upload the Essay here. Describe the applicant’s innovative vision for, and the significance of, the HIV biomedical or behavioral problem to be addressed, and the applicant's qualifications to engage in groundbreaking research. The essay should describe the individual's view of the major challenges in HIV biomedical or behavioral research to which he/she can make seminal contributions.

No detailed scientific plan should be provided since the Research Strategy is expected to evolve during the tenure of the grant. The essay should include the following sections in the order given with the headings as shown below: Project title : The project title must be included at the beginning of the essay.

Statement of research effort commitment: A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 35% or 4. 2 person months of his/her research effort to the project supported by the NIDA Avant-Garde Award Program for HIV and Substance Use Disorder Research. Applications without such a statement will be considered incomplete and will be returned without review.

Project description: What is the scientific problem or challenge that will be addressed, and why is this important? What are the pioneering, and possibly high-risk, approaches that, if successful, might lead to groundbreaking or paradigm-shifting results, and how might these results benefit people who use substances? If the initial strategy/approach does not work out as planned, what alternative strategies/approaches might be employed?

Evidence of Innovation: What concrete evidence can you provide for your claim of innovation in the project?

For example, qualities common to many highly innovative people include an interest in, and the ability to integrate, diverse sources of information; an inclination to challenge paradigms and take intellectual risks; persistence in the face of failure; an ability to be flexible and a willingness to take a new view of a vexing problem; an ability to attract the right collaborators; and the energy and concentration necessary to plan and execute effective strategies for accomplishing goals.

How the planned research differs from your past or current work (required): Describe how the proposed ideas and approaches represent a new and distinct direction for your research, or the work of others in the field.

Compatibility with the goal of the Avant-Garde Award Program for HIV Research: Why is the planned research uniquely suited to the stated goal of the Avant-Garde Award Program for HIV Research, rather than a traditional grant mechanism? How will the planned research move the field forward in a truly transformative way that would benefit people who use drugs (PWUD)? Information on collaborations may be included in the essay.

Literature references are not required, but, if included, must fit within the page limit. Figures and illustrations may be included, but must also fit within the page limit. Do not include links to websites to provide further information.

Letters of Support: Provide letters of support from significant collaborators for the Avant-Garde Award project. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide .

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

No Appendix materials are allowed.

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.

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 (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the SF424 (R&R) 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. 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 . 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 NIH. Applications that are incomplete or non-compliant will not be reviewed. Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award.

See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4. 1.

35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] . Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Letters of reference are an important aspect of the application.

Applicants must arrange to have three (and no more than three) letters of reference submitted on their behalf. Applications that are missing letters of reference will be considered incomplete and will not be reviewed. Late letters will not be accepted.

Applicants are responsible for monitoring the submission of their letters to ensure that three letters have been submitted prior to the submission deadline. Applicants are encouraged to check the status of their letters in their Commons accounts. Letters may be submitted beginning July 15 and must be submitted no later than 5:00 p.

m.

(local time of applicant organization), August 15, 2025 To submit a letter of reference, the referee will need the following information: Funding Opportunity Number (NOFO) for this announcement: The applicant's eRA Commons User Name (Note: Referees do not need to be registered in the Commons and do not need their own Commons User Name – only the Commons User Name of the applicant is required); The applicant's first and last name (note – the name must match exactly the applicant's name in the Commons); The URL to the letter submission page: ( https://public.

era. nih. gov/commons/public/reference/submitReferenceLetter.

era ). The letter of reference submission deadline: – The deadline for receipt of letters is 5:00 p. m.

(local time of the referee) on August 15, 2025 Letters of reference are confidential. Applicants will not have access to the letters. Email confirmations will be sent to both the applicant and the referee.

The confirmation sent to the applicant will include the referee’s name and the date and time the letter was submitted. The confirmation sent to the referee will include the referee and applicant’s names, a confirmation number, and the date and time the letter was submitted. Note: Since email can be unreliable, it is the applicant’s responsibility to check the status of his/her letters of reference periodically in the Commons.

Applicants are strongly encouraged