Part 1. Overview Information

Key Dates

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 Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Other Award Budget Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Research Plan Section
Section V. Application Review Information
Overall Impact
Section VI. Award Administration Information
1. Award Notices
Activation of the K22 Award
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development program is to help ensure that a diverse 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 objective of this K22 award is to support mentored, postdoctoral researchers in transitioning to their first non-mentored, tenure-track or equivalent faculty position by providing three years of protected research time and grant support in the form of a non-mentored career development award. Candidates should be postdoctoral researchers who are preparing to transition to a tenure-track or equivalent faculty position; however, the intended faculty institution will typically NOT be known at the time of the initial K22 application. This NOFO will use the term “submitting institution” to refer to the candidate’s current institution where they hold a mentored research position, and will use the term “transition institution” to refer to the institution where the candidate will eventually begin a faculty position.

The candidate and the submitting institution will work together to submit an initial K22 application. Successful candidates will receive an Approval Letter from NIA and will be considered K22 selectees. To activate the K22 award, within 12 months of receiving the Approval Letter, the selectee must secure a full-time, tenure-track or equivalent assistant professor position at their desired transition institution. The candidate will then work with the transition institution to submit a transition application to NIA detailing the faculty position. The K22 award will be issued to the transition institution only if NIA approves the transition application. The three-year funding support is to allow the individual to establish an independent research program at the transition institution and prepare an application for independent research grant support, such as a Research Project Grant (R01).

NIA is committed to building and developing the scientific workforce in aging. Retention of researchers from the postdoctoral to the faculty phase is key to maintaining a robust aging research field and is the goal of the K99/R00 programs and this K22 program. Unlike the K99/R00, which requires one to two years of additional mentored, postdoctoral research before beginning a faculty position, the K22 is designed to facilitate the rapid transition of postdoctoral researchers who are prepared for independence into tenure-track or equivalent faculty positions in NIA priority research areas. Potential candidates are encouraged to learn more about NIA’s research interests by visiting the NIA Strategic Directions and AD+ADRD Research Implementation Milestones.

While K22 selectees are encouraged to explore faculty positions beyond their current institution, the transition institution can be the same as the initial submitting institution, except when the initial submitting institution is a federal agency, as tenure-track or equivalent positions within the federal government will not be considered eligible.

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

Section II. Award Information

Other Award Budget Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Private (profit or non-profit) or public institutions, including the NIH intramural programs and other federal laboratories, are eligible to submit K22 applications. For an intramural fellow to activate the K22 award, the candidate must transition to a tenure-track or equivalent faculty position at an extramural institution. NIH intramural laboratories and other agencies of the Federal Government are not eligible to be the transition institution.

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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. 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.
  • 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.

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.

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 organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. Multiple PDs/PIs are not allowed.

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).

Doctoral degree and postdoctoral experience: Applications will only be considered from candidates that have earned a terminal research doctorate or clinical degree (including PhD, MD, DO, DC, ND, DDS, DMD, DMV, ScD, DNS, PharmD, or equivalent) or combined research doctorate/clinical degrees. As of the relevant application due date, K22 applicants must have no more than 8 years of overall research experience post terminal degree. Extensions to this 8-year limit will be considered for exceptional circumstances – please contact NIATraining@mail.nih.gov to be considered.

Current position: Individuals are not eligible to apply for the K22 award, or to receive the K22 approval letter, if they currently hold or have held an independent research faculty position, or its equivalent, in academia, industry or elsewhere. It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions. If a potential candidate is in a position that is not clearly identifiable as a postdoctoral training position, the candidate should submit an official statement of the institution’s policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postdoctoral training position. Clinical faculty members who do not hold an independent research faculty position may be eligible for the K22 award, but are encouraged to email NIATraining@mail.nih.gov to obtain confirmation of their eligibility before they begin to prepare their applications.

The requirement of a mentored, non-independent research position applies at the time of application, up through receipt of the K22 approval letter. If a candidate achieves independence (any faculty or non-mentored research position) before the K22 approval letter is issued, this letter will not be issued and the K22 will not be awarded.

Previous awards: Individuals are not eligible to apply for the K22, or to receive the K22 approval letter, if they currently hold or have held another individual NIH career development award (e.g., K01, K08, K18, K23, K25, K99/R00). Individuals are not eligible to apply for the K22 if they currently are or have been the PD/PI on a major NIH research grant (such as R01, R29, or DP2), or an equivalent NIH or non-NIH award. Individuals are not eligible to apply for the K22 if they currently are or have been a subproject leader on an NIH multicomponent grant or cooperative agreement (e.g., P01, P50, U19), or an equivalent NIH or non-NIH award. The previous awards requirement applies at the time of application, up through receipt of the K22 approval letter. If a candidate receives any of the above-mentioned awards before the K22 approval letter is issued, this letter will not be issued and the K22 will not be awarded. Individuals who hold or have held small research grants from the NIH (e.g., R03, R21), or equivalent non-NIH awards, remain eligible for the K22.

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

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).

At the time of award, the candidate must have a “full-time” appointment at the transition  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.

The transition institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to collaborate with the applicant.

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. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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.

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 SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

Project Summary/Abstract

Include a description of your current research and the research you propose during the K22 award period.

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

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

R&R Budget

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

As the transition institution is not typically known at the time of initial application, exact salary and fringe benefit rates are also not known. Applicants are encouraged to request the maximum salary amount and fringe benefits concordant with policies at the submitting institution. Salary and fringe benefits will be updated in the Transition Application.

PHS 398 Cover Page Supplement

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

Candidate Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of the NIA.

Career Goals and Objectives​

• Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) articulates how the research and career development activities proposed will enable the candidate to achieve independent research funding and build a research program that is independent from the postdoctoral mentor’s research and relevant to NIA research priorities.

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

• The candidate must present a sound, individually tailored career development plan with a goal of successfully competing for independent research funding, achieving separation from the postdoctoral mentor, and building a research program relevant to NIA research priorities. 
• The plan must clearly articulate the biomedical, behavioral, or clinical science background, research expertise, and professional skills critical to launch the stated research program, and must describe in general terms activities that would be planned at the transition institution to enhance these skills, expertise, and knowledge. 
• It is critical the candidate proposes, in general terms, ample activities that will strengthen the skills of the candidate, including but not limited to research, grant writing, communication, leadership, mentoring research trainees, laboratory management, and teamwork. ? Provide a timeline and plan for applying for independent research funding (for instance, an NIH R01 or similar NIH or non-NIH grant) prior to the end of the second year of K22 support. 
• Provide a plan for separating from the postdoctoral mentor. 
• An overall career development timeline, including a publication plan, is highly advisable. 
• The candidate must make a convincing case for how the proposed period of support will enhance their career and serve NIA’s mission.

Research Plan Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy

• A well-developed research project fitting the candidate’s research background and level must be presented. The project must be in line with the mission of NIA.
• While the research project will not be expected to be as detailed as an investigator-initiated research grant, such as the R01, it should demonstrate the scientific merit of the candidate’s research activities and training.
• The research plan must span both the period from approval to award and the award period itself. The narrative should describe what the candidate will accomplish during any remaining postdoctoral period that will enable the transition into the independent research program.
• The research plan must be sufficiently distinct from the postdoctoral mentor’s research area as to lead to an independent line of research for the candidate.
• The research plan must be well-integrated with the career development plan, specifically with the candidate’s timeline for applying for independent research funding.

• If proposing an ancillary clinical trial, provide a brief description of its relationship to the larger clinical trial.
• If proposing a feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials.

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 SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

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

• Not Applicable. The NIA K22 is not a mentored award. To avoid application submission error messages, the candidate should include a document that simply reads "Not Applicable?

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. 
• Current and/or past mentors should not submit letters of support, since this is not a mentored award. Instead, current and/or past mentors and co-mentors should submit only letters of reference into eRA Commons."

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Description of Institutional Environment

• As the transition institution will not yet be determined at the time of the initial K22 application, describe resources available to the candidate at the submitting institution which will support the candidate’s transition to a faculty position. For instance, interview coaching or preparation programs, sources of career advice, and research resources important for sustaining the candidate’s research project during the approval period prior to transition to a faculty position. 
• Describe, in general terms, any specialized facilities or resources that will be required at the transition (faculty) institution to foster the candidate’s independent research development. 

Institutional Commitment to the Candidate’s Research Career Development

• The department chair or similar institutional official at the submitting (postdoctoral) institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to their pursuit of an independent faculty position.
• This statement must describe the institution’s support of the candidate pursuing faculty positions at outside institutions. This may include preparation for the faculty job market, protected time for faculty interviews, and resources necessary to sustain the candidate’s research program during their faculty job search.
• It should be clear that this institutional commitment to the candidate is not contingent upon receipt of this career award.

Other Plan(s):

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) 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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

• 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 SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

Reference Letters

Candidates must carefully follow the SF424 (R&R) 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 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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 SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:
Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the mission of the NIA, 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 aging 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  lth-related field an aging-related field, taking into consideration the criteria below in determining the overall impact score.

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.

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

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

2. Review and Selection Process

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

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

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.

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

There will not be a formal Notice of Award (NoA) associated with the K22 until the candidate has received an offer of employment at an academic institution and is approved by the NIA. The NIA will initially notify candidates who have successfully competed for funding with a Letter of Approval. Selected candidates will then have up to 12 months from the date of the letter to accept an appointment in a domestic academic institution that has offered a position at the tenure-track faculty level, or its equivalent (e.g., Assistant Professor, Assistant Member, Laboratory Head, Principal Investigator, etc.), at which the candidate is expected to establish their own independent research program, prepare applications for regular (non-career development) research project funding and act as a PI(s)/PD(s) on such independent research projects. See “Activation of the K22 Award” below for more details.

Following review of the Transition Application, a formal notification in the form of a Notice of Award (NoA) will be provided to the transition organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.
 

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 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.”

Activation of the K22 Award

Activation of the K22 award is not automatic. If the candidate receives a fundable overall impact score after the review of the K22 application, they will be notified in writing by receiving an Approval Letter. The candidate will then have a period of up to 12 months to identify a suitable position as a tenure-track or equivalent assistant professor at a domestic academic institution and negotiate an acceptable start-up package. In order to activate the K22 award, the transition institution must submit a Transition Application using form PHS 2590 to the NIA for funding consideration. Please send the material directly to the NIA Training Office (niatraining@mail.nih.gov) along with the program officer and grants management specialist specified in the Approval Letter.

Faculty position requirements. The transition institution must have offered a full-time, tenure-track assistant professor position, or its equivalent at institutions or departments that do not follow a tenure-track. This offer should include a salary and start-up package comparable to that of other new faculty who do not hold career development awards. K22 funds may not be used to offset the startup package, and the position may not be contingent on transfer of the K22 award. The transition institution must demonstrate a commitment to the candidate by providing a minimum of nine person-months (75% full time professional effort) protected research time, as well as space and resources needed to conduct the proposed research project and apply for independent research funding.

Transition application contents. The transition application must include:

• Form PHS 2590, including:
  • Face Page
  • Detailed budget pages for all project years
  • Budget justification
  • Progress report summary describing any research progress since the initial K22 application
• Offer letter or letter from Department Chair or similar at the transition institution, describing:
  • Candidate’s status as a tenure-track assistant professor or the equivalent for institutions or departments that do not have a tenure track
  • Position duties and responsibilities of the candidate, including the percent of effort committed to research and career development.
  • Candidate’s salary and fringe benefits
  • Candidate’s start-up funding
  • Laboratory space available to the candidate
  • Any other specific resources or facilities committed by the transition institution
• Statement of institutional environment and commitment at the transition institution, including:
  • Description of available research facilities
  • Description of the relevance of the institutional environment for the candidate’s research and career development
  • Description of the institution’s commitment to fostering the career development of the candidate, including their pursuit of independent research funding
• The following items from the initial K22 application, updated as appropriate:
  • Specific aims page
  • Research strategy
  • Career Development plan (with a focus on a timeline for submitting an independent research grant, and a plan for separation from the postdoctoral advisor towards research independence)
  • Data Management and Sharing Plan
• Other Support format page
• Protocol certifications for human subjects or vertebrate animal research (as appropriate)

To avoid potential problems activating the K22 award, applicants are strongly encouraged to discuss the faculty position and institutional commitment with the NIA program official specified in the Approval Letter prior to submission of the transition application. NIA will not issue the K22 award if the faculty position does not meet the above requirements, or the institutional commitment is deemed inadequate. Applicants who are approved will receive a Notice of Award for the K22 award.

Applicants are encouraged (but not required) to apply for independent positions at departments and institutions different from where they conducted their postdoctoral research. It is important for all applicants, but especially so for applicants who intend to stay at their postdoctoral institution for the K22 award period, to provide a plan by which they will separate from their postdoctoral advisor and advance to independence. 

3. Data Management and Sharing

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

4. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

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

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.

Within ten years of making awards under this program, NIA will assess the program’s overall outcomes and consider whether there is a continuing need for the program.  Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program. 

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

• Subsequent participation in research or employment in a STEM field
• Authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

Section VII. Agency Contacts

.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

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

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Jamie Lahvic, Ph.D.
National Institute on Aging (NIA)
Email: NIATraining@mail.nih.gov

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: ramesh.vemuri@nih.gov

Jessi Perez
National Institute on Aging (NIA)
Telephone: 301-402-7739
Email: jessi.perez@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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.