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 AGING (NIA)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title
Paul B. Beeson Emerging Leaders Career Development Award in Aging (K76 Clinical Trial Not Allowed)
Activity Code
K76 Emerging Leaders Career Development Award
Announcement Type
Reissue of RFA-AG-24-014
Reissue of RFA-AG-24-015
Related Notices
Funding Opportunity Number (FON)
PAR-27-112
Companion Notice of Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

The National Institute on Aging invites early-stage clinician-scientists to apply for the Beeson K76 award with the goal of advancing their research and leadership skills in their specialty and in the broader field of aging research.

Unlike other mentored K awards, candidates for this award must have received competitively awarded research support as a Program Director/Primary Investigator (PD/PI) at the faculty level or have otherwise leveraged faculty-level research support to develop an independent line of research. Candidates must show evidence of leadership in the clinical or research domain.

This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO applicants are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor.

Funding Opportunity Announcement Goal(s)

To encourage biomedical, social, and behavioral research and research training directed toward greater understanding of the aging process and the diseases, special problems, and needs of people as they age.

Key Dates

Posted Date
September 01, 2026
Open Date (Earliest Submission Date)
October 10, 2026
The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
November 10, 2026 November 12, 2026 * Not Applicable March 2027 May 2027 July 2027
June 12, 2027 * July 12, 2027 * Not Applicable November 2027 January 2028 April 2028
June 12, 2028 * July 12, 2028 * Not Applicable November 2028 January 2029 April 2029

All applications are due by 5:00 PM local time of applicant organization.

Applications 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.

Expiration Date
July 13, 2028
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the 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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall purpose of the NIH Research Career Development program is to help ensure that a pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Research Training and Career Development  website.

The goal of the NIH Emerging Leaders Career Development Award (K76) is to help develop a cadre of scientists prepared to take an active leadership role in transformative change that will lead to improved research or healthcare outcomes. This program supports basic or clinically trained faculty members who seek additional research, professional career and leadership skills essential for assuming a leadership role in an increasingly global biomedical workforce. NIH Emerging Leaders are early-stage investigators conducting research who have shown early signs of leadership and who will use this award to further develop the tools, skills and resources to have a significant impact as leaders in their field of expertise. These skills will prepare them to assume academic leadership roles and independent careers in an emerging discipline within their professional specialty.

Background 

The small number of individuals skilled in geriatrics, and the even smaller number pursuing research on aging, are inadequate to address the burgeoning needs of the rapidly growing aging population. A key goal of this initiative, therefore, is to foster the careers of emerging clinician-scientists who possess the skills necessary for academic leadership in aging and geriatrics. As a result, this award is intended to prepare early-stage investigators for academic research leadership, as well as provide mentoring in their scientific research area of interest. Its focus is on building a cadre of investigators and leaders to advance knowledge and skills in a new field, methodology, or approach, both through their own research and through their leadership, in the broader community of their specialty.

The Beeson Program

NIA uses the NIH Emerging Leaders Career Development Award to administer the Paul B. Beeson Emerging Leaders Career Development Award in Aging K76 program. The program is named after Dr. Paul B. Beeson, who profoundly influenced the career paths of many physicians, including several who now form the core leadership in geriatric medicine. Dr. Beeson was Chairman of Medicine at Emory and Yale Medical Schools, Nuffield Professor at Oxford University, and Professor and Distinguished VA Physician at the University of Washington. He chaired the first Institute of Medicine study on "Aging and Medical Education" in 1978. His leadership as an editor of the Cecil Textbook of Medicine greatly influenced medical education. From his research and patient care base, he grew increasingly interested in the process of aging, and this interest led to a commitment that included his editorship of the Journal of the American Geriatrics Society.

The aims of the program are as follows:

  • To provide support for career development and to advance the leadership skills of clinician scientists conducting clinically relevant basic, translational or clinical, and patient-oriented research (POR) in disciplines relevant to aging and geriatrics.
  • To deepen the commitment of research institutions to promote transformative academic research and leadership in aging and geriatric medicine by linking mentors to emerging scientists with a commitment to future leadership in aging research and policy.

Research Objectives 

This NOFO provides an opportunity for candidates to expand their research area of interest and pursue activities consistent with the expectation of future leadership in the candidate's chosen field related to aging or older adults. Awardees will be provided salary and research support for a sustained period of "protected time" (3 to 5 years) for career development and to advance the leadership skills of clinician-scientists. NIA welcomes applications in all fields of aging research, including basic, translational, genetic, biological, neuroscientific, clinical, behavioral, and social sciences research on aging. A current high-priority topic for NIA is research on Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD). 

The full range of research methods appropriate to completing the proposed investigation is encouraged, including basic and translational research and cell or computational models, provided that the application makes clear the eventual clinical relevance of the proposed work. It is expected that scholars will contribute significantly to the research and scientific literature associated with the field of aging research. Please note that the Beeson K76 program does not support independent clinical trials.

 

  

  

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

Section II. Award Information

Funding Instrument

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
New
Resubmission - Applications submitted to RFA-AG-24-014 or RFA-AG-24-015

The OER Glossary and the How to Apply - Application Guide provides details on these application types.

Clinical Trial?

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

Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.

Funds Available and Anticipated Number of Awards

NIA intends to commit $1,944,000 in FY 2027 - FY 2029 to fund approximately 8 general aging awards each year.

NIA intends to commit $972,000 in FY 2027 - FY 2029 to fund approximately 4 AD/ADRD awards each year.

Future year amounts are contingent upon annual appropriations.

Award Budget
Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period

The total project period may not exceed 5 years.

Other Award Budget Information

Salary

NIH will contribute up to the legislative limit per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. Salary must be within the overall direct cost limit of $225,000 (see NOT-OD-17-094).

The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap.

Other Program-Related Expenses

NIH will contribute support up to the overall direct cost limit of $225,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. These funds may be used for the following expenses: 

  • Tuition and fees related to career development;
  • Research-related expenses, such as supplies, equipment and technical personnel;
  • Travel to research meetings or training; and 
  • Statistical services, including personnel and computer time.

It is expected that recipients will use a portion of their research development funds to cover the costs of traveling to an annual domestic meeting for Beeson scholars.

Salaries for mentors, secretarial and administrative assistants, etc. are not allowed. 

Indirect Costs
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions - Includes all types

  • 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

  • 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

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 not allowed. 
Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with their mentor and organization to develop an application for support. Multiple PDs/PIs are not allowed.

Candidates for the K76 award must have Early-Stage Investigator status at the time of application submission. Applicants whose ESI status expired in 2025 or 2026 may also be eligible on a case-by-case basis. Note that possible exceptions do not apply to applicants who no longer have ESI status due to having received an R01 or equivalent – exceptions may only be granted to those whose ESI status timed out in 2025 or 2026. Contact NIATraining@mail.nih.gov with questions.

This initiative is targeted primarily towards individuals who have prior training in research coursework, methods, and resources related to aging. Candidates are expected to hold or have had prior competitively awarded research support, such as through small grant support from NIH, similar support from other federal agencies, or foundation funding as a PD/PI, at the faculty level.  

Individuals who have leveraged faculty-level research development support to advance an independent line of research and who can provide evidence that they possess the attributes of committed and skilled leaders in their respective fields are also welcome to apply. Prior evidence of leadership can be in either clinical duties or research activities that illustrate keen engagement and commitment to moving the applicant's field forward. Examples include organizing seminar series, conferences, or symposia at a national meeting; organizing workshops; or other activities where the candidates have played a leading role in enhancing their field's academic, medical/health, and research accomplishments and visibility.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Candidates for this award must have a clinical doctoral degree. Such degrees include, but are not limited to, the MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), and DVM. Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Individuals holding the PhD in a non-clinical discipline who are certified to perform clinical duties should contact the program contact concerning their eligibility. 

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Candidates for this award must have a clinical doctoral degree. Such degrees include, but are not limited to, the MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), and DVM. Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Individuals holding the PhD in a non-clinical discipline who are certified to perform clinical duties should contact the program contact concerning their eligibility. 

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

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. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, 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).

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources, either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

Level of Effort

At the time of award, the candidate must have a "full-time" appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program. 

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-18-156  and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

Mentor(s)


Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an established investigator in the area of the proposed aging and/or age-related diseases and conditions research and agree to commit time to supervise and guide the candidate during the period of the award. A part of that commitment is the intent to advance the candidate both as a researcher and as an emerging leader in the field. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate's research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate's career stage. Candidates proposing to gain experience in clinical trial research should include at least one mentor who can provide opportunities for hands-on training in clinical trial design, implementation, and analysis through their own line of research.
 


 

Institutional Environment

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, social science, or clinical research.

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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 Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

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.

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.

Other Project Information

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

SF424(R&R) Senior/Key Person Profile Expanded

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

IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (fellowship applicant) must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

R&R Budget

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

A central component of this award is an annual meeting for Beeson scholars and their mentors. Accordingly, recipients must attend the annual meeting. Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni, and mentors. The meetings are intended to spark collaboration and expose scholars to a wide range of exciting science on aging. Include funds in the budget to travel to an annual domestic meeting of Beeson scholars, alumni, and mentors.

PHS 398 Cover Page Supplement

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

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional Commitment to the Candidate
Other Research Plan Sections
Appendix

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

Candidate Section

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

Candidate Information and Goals for Career Development

Candidate's Background

  • Describe the candidate's background as an emerging leader: how the candidate has (a) prior or current competitive external funding for research at the faculty level; (b) lead-author peer-reviewed publications; and (c) leadership either in clinical duties, or in research activities. 
  • Provide evidence that the applicant has an area of research or clinical specialty or similar focus where they intend to show leadership in promulgating research important to the growth of knowledge within the specialty.
  • Describe how the candidate's background shows the potential for the candidate to become a productive investigator and a leader in their chosen field. 
  • Describe all of the candidate's professional responsibilities in the recipient institution and elsewhere and describe their relationship to the proposed activities on the career award.
  • Describe the candidate's commitment to a health-related research career with a focus on aging, including AD/ADRD and/or other geriatric conditions.
  • If a candidate is requesting more than five years of combined mentored career award support with earlier years obtained from other awards (such as K12s, KL2s, or K23s) and the additional years obtained from the Beeson award, the extra time beyond five years should be clearly justified.
     

Career Goals and Objectives

  • Describe the candidate's immediate, near term and long range career development goals, including plans for leadership development and enhancing the skill and capability to implement change.
  • Describe a systematic plan that: (1) shows a logical progression from prior and current research, and leadership experiences to the research, career development and leadership activities that will occur during the career award period and post award; (2) justifies the need for further career development to become an independent investigator and emerging leader; and (3) utilizes the relevant research and educational resources of the institution. 
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the candidate must demonstrate they will receive training in: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials. The candidate must also include plans to obtain hands-on research experience in clinical trial design, implementation, and analysis through a clinical trial led by their mentor(s). 

Candidate's Plan for Career Development/Training Activities During Award Period

  • The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful.
  • Describe the career development plan incorporating consideration of the candidate's goals and prior experience. Include details of the plans to obtain the necessary experience to facilitate further development as an academician and leader.
  • Describe career development activities consistent with the expectation of future leadership in the selected field(s).

Research Plan Section

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

Research Strategy

  • Provide a sound research project that is consistent with the candidate's level of research development and objectives of their career development plan. 
  • The research description should demonstrate not only the quality of the candidate's research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
  • For candidates proposing patient-oriented research, complementary laboratory research directly related to patient-oriented research may be proposed in the application, thereby providing an opportunity for a career development experience in translational research.

Training in the Responsible Conduct of Research

  • All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See How to Apply - Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

Plans and Statements of Mentor and Co-mentor(s)

  • The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program.   
  • The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. 
  • The application must include a statement from the mentor providing: 1) information on their research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; and 3) a plan for career progression for the candidate to move from the mentored stage of their career to independent research investigator status during the project period of the award.
  • Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meeting.
  • The mentor must agree to provide annual evaluations of the candidate's progress as required in the annual progress report.
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoring team must include a statement to document leadership of the clinical trial and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

Letters of Support from Collaborators, Contributors and Consultants

  • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. 
  • Advisory committee members (if applicable): The research expertise to be sought in the Advisory Committee should be described, but the members should not be named in the application. The names should be submitted as part of the just in time information. Advisory Committee members may be established faculty at either the candidate's institution or at another institution. Members should be chosen for their expertise in the research project proposed by the candidate.

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

  • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. 
  • Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
  • Describe the resources and facilities that will be available to the candidate. 

Institutional Commitment to the Candidate’s Research Career Development

  • The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award. 
  • Provide assurances that the candidate will be able to devote the required effort to activities under this award. The remaining effort should be devoted to activities related to the development of the candidate's career as an independent scientist. 
  • Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations, as applicable) to carry out the proposed research plan. 
  • Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.
  • Candidates who will be using resources associated with a Clinical and Translational Science Award (CTSA) during the course of their career development award should include a letter of agreement from the CTSA PD/PI as part of their application.

Other Plan(s):

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

  • A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or 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.

  • For NOFOs that do not allow independent clinical trials, do not complete Section 4 – Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

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.

Reference Letters

Candidates must carefully follow the How to Apply - Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov. 

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) using ASSIST or other electronic submission systems. 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 Section 7.9.1 Selected Items of Cost .

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 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 fieldof 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.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.36.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:
Reviewers should evaluate the candidate's potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

Overall Impact

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate's potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

 
  • Does the background of the candidate reveal potential to become a productive independent investigator prepared to take an active leadership role in transformative change leading to improved health-care outcomes?
  • Are the candidate's interactions with senior and junior scientists and trainees indicative of their ability to lead in their chosen field?
  • Is the candidate's academic, clinical (if relevant), and research record of high quality?
  • Is there likelihood that the award will contribute substantially to the academic and research career development of the candidate and the candidate's chosen field?
  • Do the reference letters on behalf of the candidate express her/his potential and commitment to the planned academic career program and the likelihood that the program will meet the candidate's career goals for research and leadership?

 
  • What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
  • Are the candidate's prior training and research experience appropriate for this award?
  • Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
  • Are there adequate plans for monitoring and evaluating the candidate's research and career development progress?
  • Is the proposed plan to enhance leadership skills of the candidate of high quality? 
  • If proposed, will the clinical trial experience contribute to the applicant's research career development?

 
  • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
  • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Are the proposed research question, design, and methodology of significant scientific and technical merit?
  • Is the research plan relevant to the candidate's research career objectives?
  • Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?
  • Is the plan for coupling the research with other planned activities, appropriate and adequate for providing the experience, knowledge, and skills necessary to achieve the research and leadership objectives of the award? 
  • If proposed, will the clinical trial experience contribute to the research project?

 
  • Are the mentor's research qualifications in the area of the proposed research appropriate?
  • Do(es) the mentor(s) adequately address the candidate's potential and their strengths and areas needing improvement?
  • Is there adequate description of the kind and extent of the mentor's proposed role in providing guidance and advice to the candidate?
  • Is there evidence of the mentor's, consultant's and/or collaborator's previous experience in fostering the development of independent investigators?
  • Is there evidence of the mentor's current research productivity and peer-reviewed support?
  • Is active/pending support for the proposed research project appropriate and adequate?
  • Are there adequate plans for monitoring and evaluating the career development recipient's progress toward independence and advancing leadership skills?
  • Are the combined expertise, roles and responsibilities of any involved co-mentors, consultants, and/or collaborators likely to enhance the candidate's career development?
  • Is the mentor's description of the elements of the research career development activities, including any formal course work and leadership guidance, adequate? 
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?

 
  • Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
  • Is the institutional commitment to the career development of the candidate appropriately strong?
  • Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate, adequate and appropriate?
  • Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator?
  • Are the quality of the scientific environment and relevance to the candidate’s professional academic and scientific development, including any unique features of the scientific environment beneficial to the candidate, of high quality?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

 

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.


 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research


 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.


 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.


 

For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.


 

For Renewals (as applicable), the committee will consider the progress made in the last funding period.


 

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.


Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 

All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate's career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow's instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019 and NOT-OD-22-055.


 

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).


 

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.


 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.


 

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.


2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) 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:

  • 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.
  • Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.

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

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. 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 the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 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.

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

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

  • ongoing and consistent access to HHS owned or operated information or operational technology systems; and
  • receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

  • Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
    • Identify:
      • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
    • Protect:
      • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
      • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
      • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
      • Regularly backup sensitive data and test backups.
    • Detect:
      • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
    • Respond:
      • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
      • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
    • Recover:
      • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

  • Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
  • Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
  • NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page . The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

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 Section 8.4.1 Reporting. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor's Report must include an annual evaluation statement of the candidate's progress. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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 200.301.

5. Evaluation

In carrying out its stewardship of human resource-related programs, NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

.

Application Submission Contacts

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Scientific/Research Contact(s)

NIA Training
Email: NIATraining@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

National Institute on Aging (NIA)
Email: NIA-NOFO-Grants@nih.gov
Please include the NOFO number in the subject line when emailing.

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.

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.