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

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

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



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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development program is to help ensure that a diverse population of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, clinical, behavioral and social (collectively termed “biomedical”) 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 Extramural Training Mechanisms website.

The goal of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) is to facilitate a timely transition of promising postdoctoral researchers from diverse backgrounds from their mentored postdoctoral research positions to independent, tenure-track or equivalent research-intensive faculty positions. The program is designed to support postdoctoral researchers who have demonstrated meaningful contributions and proposed compelling future plans to promote broad participation in the biomedical research workforce (such as activities that promote inclusive, supportive, and accessible biomedical research environments that support the success of trainees and scientists from all backgrounds, including individuals from underrepresented groups). The K99/R00 award is intended to help these postdoctoral researchers:

• Complete needed, mentored training.
• Transition in a timely manner to independent, tenure-track or equivalent faculty positions, and
• Be competitive for subsequent independent funding that will help advance the mission of the NIH.

Need for the Program

A broad portfolio – in terms of scientific areas, approaches, regions, organizations, and individual investigator experiences – is integral to NIH’s ability to fulfill its mission.   Advances in biomedical research depend upon a workforce composed of people trained in multiple disciplines and from a range of backgrounds who can provide the breadth of creativity, and individual interests, perspectives and experiences needed to identify and address important and complex scientific problems, engage with increasingly diverse patient populations, and effectively serve as mentors to trainees from increasingly diverse backgrounds who are pursuing biomedical research careers.  Research shows that teams with members from different backgrounds that utilize their members' unique experiences and perspectives better capitalize on innovative ideas and outperform homogeneous teams. There are many benefits that flow from an NIH-supported scientific workforce that leverages the talents of rigorous researchers from all backgrounds, including individuals from underrepresented groups: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of research, enhancing public trust, and increasing the likelihood that health disparities and the needs of underserved populations are addressed in biomedical research (for more information, see  Notice of NIH's Interest in Diversity ). However , expanding the population of academic investigators from nationally underrepresented backgrounds in the biomedical research workforce has remained an elusive goal (see  Policy Supporting Next Generation Researchers Initiative ). The NIH recognizes the need to promote broad participation in the scientific workforce through means consistent with applicable law, including by encouraging organizations to  eliminate barriers and enhance the participation of individuals from groups underrepresented in the biomedical research workforce. 

At the same time, individuals from certain groups and backgrounds often face organizational and environmental barriers that restrict their potential to advance their training and careers and are underrepresented in the biomedical research workforce. For example:

• Individuals from underrepresented racial and ethnic groups, including Black or African American, Hispanic or Latino, American Indian or Alaska Native, Native Hawaiian or other Pacific Islander comprise ~39 percent of the college age population, but earn only ~25 percent of bachelor’s degrees and ~17 percent of Ph.D. degrees in the life sciences (as per data from the Census Bureau, the National Center for Education Statistics, and the National Center for Science and Engineering Statistics). Additionally, increases in the numbers of biomedical Ph.Ds. awarded to scientists from these groups are not reflected in NIH funded K awardees or Research Project Grant investigators (Lauer and Bernard, 2023a, 2023b) and individuals from those groups comprise only ~10 percent of full-time faculty at all U.S. medical schools (as per data from the Association of American Medical Colleges).
• The representation of scientists with disabilities decreases from 19% for undergraduate students to 9% of doctoral students and fewer than 2% of NIH and NSF-funded principal investigators (NIH ACD WGD Subgroup on Individuals with Disabilities Report, 2022).
• Women have earned a majority of biomedical Ph.Ds. since 2008 ( NSF data ), but only approximately 1/3 of NIH-funded PD/PIs on Research Project Grants are women ( NIH Databook ).
• Socioeconomic background plays a significant role in shaping academic success.  Individuals from certain disadvantaged backgrounds, for example those from families from the lowest socioeconomic quintile, were 50% less likely than those from the highest socioeconomic quintile to enroll in postsecondary education, limiting subsequent access to doctoral education and faculty careers (see National Center for Education Statistics; Standlee, 2018).  Moreover, faculty are significantly more likely than the overall population of similarly aged adults to have a parent who holds a Ph.D. or graduate degree ( Morgan et al, 2022 ).

The transition from postdoctoral research training to independent faculty careers is a key time frame when individuals from underrepresented groups disproportionately exit the academic biomedical research career pathway (Gibbs et al, 2016; Meyers et al, 2018).   Supportive peer groups and strong mentoring networks are critical for successfully navigating the transition to faculty careers for postdoctoral researchers from all backgrounds; however, individuals from underrepresented groups often report challenges in accessing appropriate mentoring relationships and professional networks, which can result in a sense of isolation and a lower sense of belonging in the research environment (Noel et al, 2022).  Research has shown that postdoctoral scientists from underrepresented groups have reported  differences in the types of support that would increase their likelihood of pursuing academic research careers (including greater professional skills development opportunities) and distinct motivations for pursuing faculty careers relative to their peers from other groups ( Layton et al, 2016 ;  Lambert et al, 2020 ).  For example, many scientists from underrepresented groups report that, in addition to their research interests, the ability to engage in educational, mentoring, role modeling, outreach and recruitment activities that promote broad participation in the biomedical research workforce strongly motivate their pursuit of research and faculty careers ( Gibbs and Griffin, 2013 ;  Diekman et al, 2016 ;  Jackson et al, 2017 ;  Mendez et al, 2024 ).  At the same time, many scientists from these groups are also disproportionately asked to engage in such activities, and these contributions to the research environment are generally not appropriately recognized and rewarded which can impact career advancement ( Gewin 2020 ).

Importantly, access to high quality mentoring, robust professional networks, the ability to integrate personal and professional values, and opportunities for skills development through structured programs have been linked to enhanced trainee productivity, increased self-efficacy and strengthening an individual’s commitment to a research career ( The Science of Effective Mentoring in STEMM, 2019). Additionally, cohort-based models have been shown to be particularly effective at supporting postdoctoral scholars as they navigate the transition to faculty careers (see, e.g., Rybarczyk et al, 2016, Cresiski et al, 2022;   Advisory Committee to the NIH Director, 2023 ). Therefore, there remains a strong need to develop additional opportunities to address these challenges and promote additional cohort-based career development opportunities that support the transition to independence for postdoctoral scholars. 

Program Goal

The purpose of the Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) program is to support a cohort of early career, independent investigators from diverse backgrounds (for example, individuals from underrepresented groups) conducting research in NIH mission areas. The program has two components: an individual career transition award for postdoctoral scholars (K99/R00) and a research education cooperative agreement (UE5) awarded to organizations to provide these scholars with additional mentoring, networking and professional development activities to support their transition to and success in independent, tenure-track or equivalent research-intensive faculty careers. The MOSAIC program supports NIH’s efforts to develop a biomedical research workforce that will benefit from the full range of perspectives, experiences and backgrounds needed to advance discovery.

The goal of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) is to facilitate a timely transition of promising postdoctoral researchers from diverse backgrounds from their mentored postdoctoral research positions to independent, tenure-track or equivalent research-intensive faculty positions.  The program is designed to support postdoctoral researchers who have demonstrated meaningful contributions and proposed compelling future plans to promote broad participation in the biomedical research workforce (such as activities that promote inclusive, supportive, and accessible biomedical research environments that support the success of trainees and scientists from all backgrounds, including individuals from underrepresented groups.   

Program Considerations

Consistent with existing NIH practice and applicable law:

• An applicant organization  may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a prospective K99 candidate as an eligibility  criteria.
• NIH does not use the race, ethnicity, or sex of a candidate to establish program eligibility, as part of the application review process, or as a factor in making funding decisions.

General Considerations

• Pre-application consultation: Before beginning an application, candidates are strongly encouraged to visit:
  • The  MOSAIC program website for resources including recent applicant webinars and  answers to frequently asked questions .
  • The Table of IC-Specific Information, Requirements and Staff Contacts to learn more about specific IC interests, and identify a scientific/research contact with whom to discuss their application. After consulting these resources, candidates are strongly encouraged to reach out to the appropriate contacts as early as possible before the due date:
    • The Scientific/Research Contact can assess the alignment of the proposed research with the Institute or Center’s priority areas (please send a biosketch and specific aims page to facilitate this assessment).
    • The Peer Review Contact can answer questions about the review process and is the NIH point of contact between application submission and the release of the summary statement.
    • The Financial/Grants Management Contact can address budgetary questions.
• Two-phase award: The K99/R00 award will provide up to 5 years of support in two phases. The initial (K99) phase will provide support for up to 2 years of mentored postdoctoral career development. The second (R00) phase will provide up to 3 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position. The two award phases are intended to be continuous in time. Although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 award period.
• Fostering independence.  The K99/R00 award is intended to foster research independence of the candidate. Consequently, it is important the application clearly describe how the:
  • Research and career development activities in the K99 phase will help the candidate achieve research independence by the start of the R00 phase.
  • Candidate will separate scientifically from their mentor(s).
  • Mentor(s) will actively support the candidate’s transition to independence – for example, which aspects of the research, resources, and reagents developed in the K99 phase the candidate can take with them to the R00 phase, and how they will not compete with the candidate in the research area.  

Candidates.  For the purpose of this announcement, organizations are encouraged to recruit prospective candidates from groups underrepresented on the national basis.  In addition, because underrepresentation can vary from setting to setting, organizations should design a recruitment strategy to foster a diverse candidatepool  based on the organization’s local context as well as national needs.  Appropriate to the career stage, candidates should have demonstrated meaningful contributions toward promoting broad participation in the biomedical research workforce (for example, furthering inclusive, supportive, and accessible biomedical research environments), and propose well-developed plans for how those activities will be continued as an independent investigator.  Candidates whose statements are weak in this area are not the intended recipients of this award. Organizations should select candidates who, through their activities and individual experiences, can effectively serve as mentors to trainees from increasingly diverse backgrounds pursuing biomedical research careers.  Additionally:

• Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. The K99 is not intended to extend time in the postdoctoral lab while an individual is on the job market. If the candidate achieves independence (any faculty or non-mentored research position) before a K99 award is made, neither the K99 nor the R00 award will be made.
• The K99/R00 award is intended for individuals who require at least 12 months of mentored career development (K99 phase) before transitioning to the R00 award phase of the program. Consequently, the strongest candidates will require and propose a well-conceived plan for 1-2 years of substantive mentored career development that will help them become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs. An individual who cannot provide a compelling rationale for at least one year of additional mentored career development at the time of award is not a strong candidate for this award.
• Candidates must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent Resubmission application (See Section III – Eligibility for more information, including when extensions can be granted). Candidates are strongly encouraged to apply no later than the third year of their postdoctoral training to receive maximum benefit from the K99 phase of the award, and to facilitate a timely transition to independence. Because the program aims to support the career development of scholars early in their postdoctoral training, candidates who have not yet published a first-author manuscript during their postdoctoral training, but whose previous and current studies and future plans are likely to support a successful independent research career are encouraged to apply.

MOSAIC Cohort-based career development program:  In addition to the K99/R00 award, postdoctoral scholars who receive funding through the MOSAIC program will be assigned to organizations that will provide additional mentoring, networking, and skills development opportunities (MOSAIC UE5 institutionally focused research education awardees).  These organizations are listed on the MOSAIC website. Candidates are encouraged to explore the various organizations’ websites, their programs for scholars, and incorporate these activities as part of their career development plans.  The integrated program of research and mentoring is expected to provide awardees with the mentoring and professional networks that will prepare them to transition into, advance, and succeed in independent, tenure-track or equivalent research-intensive faculty positions.

Additional Information for Clinician Scientists: For the purposes of this program, clinician scientists include individuals with an MD, DO, DDS/DMD, DVM/VMD, or nurses with research doctoral degrees who devote the majority of their time to biomedical research. The K99/R00 is intended for those clinician scientists who already have substantial research training and are dedicated to initiating a strong, research-intensive career as clinician scientists. The K99/R00 program is designed to facilitate a timely transition of rigorous clinician scientists from mentored, research positions to independent, tenure-track or equivalent faculty positions, and to provide independent NIH research support during the transition. Individuals who need a longer period of mentored career development before they are prepared to begin the transition to research independence should consider the K08 or K23 program (see: K Kiosk).

Basic Experimental Studies with Humans (BESH):  All applications submitted to this Notice of Funding Opportunity must propose basic science experimental studies involving humans, otherwise referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants,” that fall within the NIH definition of a clinical trial and also meet the definition of basic research.

NIH defines basic research consistent with the definition of basic research in federal code, “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.” (32 CFR 272.3).

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

For the purposes of this NOFO, “specific application towards processes or products” refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.

Basic experimental studies in which participants are prospectively assigned to experimental conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena may submit under this NOFO.

Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate NOFO for the type of study.

Prospective studies with humans conducted with specific applications towards processes or products in mind, including FDA Phase 0 or 1 studies, mechanistic clinical trials (e.g., those that examine the mechanisms by which an intervention works or the processes that account for an intervention's effects on clinical outcome), and safety and efficacy studies should submit under the a 'Clinical Trials Required' or Clinical Trial Optional’ NOFO, but not under this NOFO.

Observational studies involving humans should submit under the ‘Clinical Trials Not Allowed’ NOFO.

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

The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.

The applicant institution will be the mentored phase (K99) institution. All institution/organization types listed above are eligible for both the mentored (K99) and independent (R00) phase, with the following exceptions: (1) Eligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase; and (2) Eligibility of organizations, other than institutions of higher education, for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH research (R01 or R01-equivalent) grants.

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 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.
  • 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 Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities, women and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support. See NOT-OD-22-019 “Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities.”

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).

Candidates for the K99/R00 award must have a clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD or equivalent doctoral degrees). Clinicians (including those with MD, DDS, DVM and other licensed health professionals) in a clinical faculty position that denotes independence in clinical responsibilities but not in research may also be eligible for the K99/R00 award.

Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If the candidate achieves independence (that is, any faculty or non-mentored research position) before a K99 award is made, neither the K99 award nor the R00 award will be issued. K99/R00 candidates must have no more than 4 years of postdoctoral research experience as of the relevant application due date regardless of whether it is a New or Resubmission application. Only time dedicated to research activities counts toward the 4-year limit. 

• Consistent with the NIH Extension Policy for Early Stage Investigator Status (ESI), NIH will approve an extension of one year for childbirth within the 4-year K99 eligibility window. Candidates who will be PD/PIs on a K99 application must provide the child’s date of birth in the extension request justification submitted to IC program officials and/or scientific/research contacts listed in the NOFO at least 12 weeks before submitting an application.
• Parental, medical, or other well-justified leave for personal or family situations is not included in the 4-year eligibility limit, nor is clinical training with no research involvement (for example, full-time residency training). 
• Part-time postdoctoral research training, related to personal or family situations or occurring during a research residency or fellowship, will be prorated accordingly. 
• In addition, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 4-year research training eligibility limit. 

Please refer to NIH Extension Policy for Eligibility Window for Pathway to Independence Awards (K99/R00).

Individuals are NOT eligible if they:

• Have currently or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
• Have more than 4 years of related postdoctoral research training at the time of initial application or resubmission; or
• Have been an independent PD/PI on NIH research grants (e.g. R01, R03, R21), NIH career development awards (e.g., K01, K07, K08, K23, K25), or other peer-reviewed NIH or non-NIH research grants over $100,000 direct costs per year, or Project Leaders on sub-projects of program project (P01) or center (P50) grants or the equivalent.

  
Ph.D. (or equivalent research doctorate degree) candidates in positions other than postdoctoral fellow positions: It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility from the relevant IC before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that their position complies with the intent of this eligibility requirement. If a potential candidate is in a position that is not clearly identifiable as a postdoctoral training position, candidate should provide the relevant NIH Institute or Center 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.
 
Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral positions: Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K99/R00 award, and should contact a Program Director at the relevant NIH Institute for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career awards (see K Kiosk) available for junior faculty development.
 
The following is provided as an aid to distinguish independent from non-independent positions: However, it is not sufficient merely to cite one or more of the following items to document eligibility.
 
Evidence for non-independence may include:

• The candidate’s research is entirely funded by another investigator’s grants.
• The candidate’s research is conducted entirely in another investigator’s assigned space.
• According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students.
• According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research grant application (e.g., R01).
• The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.

  
Conversely, evidence for independence, and therefore lack of eligibility, includes:

• The candidate has a full-time faculty position.
• The candidate received a start-up package for support of their independent research.
• The candidate has research space dedicated to their own research.
• The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire technical support or postdoctoral fellows.
• The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research grant.

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).

K99 Phase. 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

R00 Phase. Although candidates are required to devote no less than 75% of their full-time, 12-month professional effort to research (i.e., full-time for 9 person-months), the required 9 person-months of research effort need not be devoted exclusively to the R00-supported research.

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 active investigator in the area of the proposed research and be committed to the career development of the candidate, the direct supervision of the candidate’s research and supporting the candidate’s transition to independence. The mentor must document the availability of sufficient research support and appropriate facilities for the proposed project. Candidates are encouraged to identify more than one mentor, that is, 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. Candidates also are encouraged to propose a mentoring team that will provide additional guidance, typically focused on professional aspects of the candidate’s career development. Mentors are expected to promote inclusive, safe and supportive research environments (that is, institutional and departmental environments where trainees from all backgrounds feel integrated into and supported by the biomedical community).

The candidate must work with the mentor(s) in preparing the application.

The primary sponsor can be an independent investigator at any career stage, including an early-stage investigator. Regardless of career stage, the primary mentor must demonstrate a commitment to ensuring the candidate receives tailored career development that will facilitate their transition to independence. 

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

The applicant organization must have appropriate research and career development activities, as well faculty able to serve as mentors in biomedical, behavioral, or clinical research. The applicant organization should have a clear commitment to promoting safe, inclusive, supportive and accessible scientific research environments.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to 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 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.

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, with the following additional instructions:

 Other Attachments

Statement on Activities to Promote Broad Participation in Biomedical Research Workforce (Required; 1-page maximum): The application must include a statement from the candidate (i.e., the postdoctoral researcher) describing (a) past and present activities, and (b) future plans as a faculty member to promote broad participation in the biomedical workforce, that is those activities that further and foster inclusive, supportive, and accessible biomedical research environments that support trainees and scientists from all backgrounds, including individuals from underrepresented groups. Highlight activities relevant to addressing underrepresentation within the biomedical research workforce within the United States and territories. Examples can include, but are not limited to:

• Outreach activities to foster awareness of biomedical research training opportunities for potential trainees from all backgrounds.
• Contributions to targeted recruitment activities (such as those to individuals from underrepresented groups) intended to diversify applicant pools for training programs.
• Mentoring or leadership activities in relevant programs or organizations meant to create and sustain inclusive biomedical research and research training environments for scientists and trainees from diverse backgrounds.

Highlight the impact of past and present activities.

For future plans as a faculty member, describe activities that go beyond those considered a regular part of an individual's academic duties (for example, mentoring the trainees who are in the faculty member’s research group).  

Describe planned activities during the career award to develop or enhance skills in working effectively with researchers and trainees from a wide variety of backgrounds.

Candidates may discuss how aspects of their personal background and lived experiences have motivated their pursuit of the activities or informed their plans to promote broad participation in biomedical research (see also, Program Considerations in Section I). 

Please name the file “BP Activities Statement.pdf”. Applications lacking this attachment will not be reviewed. The filename provided for each document added to the section “Other Attachments” will be the name used for the bookmark in the electronic application in eRA Commons.

Project Summary/Abstract

Include a description of your current research and the research you propose to continue in the independent phase.

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

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

R&R Budget

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

K99 Phase: Provide itemized budget information for each budget period covered under the K99 phase.

R00 Phase: Itemized budget information is not required for the R00 phase; a total requested amount for each budget period is acceptable. However, some basic information must be completed in order for NIH to successfully process the budget form. For each budget period of the R00 phase:

• Select the appropriate Budget Type
• Provide the Budget Period Start Date and End Date
• In Section A: Senior/Key Persons provide an entry for the PD/PI, including the appropriate level of effort, $0 for Requested Salary and $0 for Fringe Benefits
• In Section F: Other Direct Costs add a line item titled ‘R00 Independent Phase’ and provide the total request for that period (up to $249,000)

At the time of transition to the R00 phase, the R00 applicant institution will submit a detailed budget for each budget period of the R00 project period that reflects the direct and indirect costs at the R00 applicant institution.

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 commitment to a career in a biomedical, behavioral, or clinical research field relevant to the mission of one of the participating NIH ICs. 
• Describe how this career development project will support the candidate's ability to develop into an independent investigator in the time period requested for the K99 phase.

• If applicable, describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial.
• If applicable, describe the candidate's prior efforts, interests and experience in clinical trials research.

Career Goals and Objectives​

• Describe the candidate's current and long-term research and career objectives. 
• Present a scientific history that:
  • Shows a logical progression from the candidate’s prior research and training experiences to the career development and research experiences proposed for the mentored phase of the award (K99) and subsequently to the independent phase of the award (R00), and
  • Justifies the need for further mentored career development to become an independent research investigator. 
• If currently supported by an institutional organizational training grant or career development award (such as a T32 or K12), or an individual fellowship award (such as provided through the Ruth L. Kirschstein NRSA program), describe the candidate’s current research training, career development or fellowship program.
• Describe how the candidate plans to separate scientifically from their mentor and advance to research independence.
• The candidate must demonstrate they have received training or will participate in courses such as: 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

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

• A systematic plan should be presented for obtaining the appropriate biomedical science background, research experience, and career development activities necessary to launch the stated independent research career. Describe current activities and how they relate to the candidate’s career development plans and career goals.
• Describe proposed activities, for example, those that will lead to new or enhanced research skills and knowledge such as the development of quantitative, computational, or other technical skills, as well as development of professional skills such as grant-writing, communication, leadership, and laboratory management. The career development plan must be specifically tailored to meet the needs of the candidate and the goal of achieving independence as a researcher.
• MOSAIC scholars are assigned to participate in the mentoring, networking and career development activities provided  by a MOSAIC Organizational Research Education Award (UE5).  Describe how these activities will be incorporated to enhance the candidate’s career development.
  • Visit the MOSAIC website to identify the current MOSAIC UE5 awardees.
  • Identify one of the organizations the candidate would like to be affiliated with, and explain the reasons for the affiliation.
  • Examine the UE5 awardee's program for MOSAIC K99/R00 scholars, and incorporate, as applicable, the activities offered into the candidate’s career development.
• Describe how the career development plan will promote the candidate’s success and transition to scientific independence.
  • Describe how the skills and knowledge obtained during the mentored phase will enhance research productivity and facilitate the development of new approaches and directions for investigation.
  • Justify the need for the award, particularly the mentored (K99) phase, and provide a convincing case that the proposed period of support (1-2 years as a mentored candidate followed by up to 3 years as an independent scientist) will substantially enhance their career or will allow the pursuit of a novel or promising approach to a particular research problem. Candidates should make clear why additional mentored career development is critical before transitioning to research independence and pursuit of the proposed independent phase research.
• The candidate must describe a plan, including a timeline with milestones, for evaluation of their progress during the mentored phase and for the transition to the independent phase.
• The candidate and K99-phase mentor (see below) must describe a specific plan for the transition to the independent phase.

Research Plan Section

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

Research Strategy

• The research plan must span both phases of the K99/R00 award. The candidate should clearly indicate the research planned for each phase. This narrative should describe what the candidate will accomplish during the mentored phase research that will enable the candidate to launch an independent research program, including:
  • What does the candidate still need to accomplish during the mentored phase to compete successfully once independence is achieved.
  • How the themes and/or topics of the research project are substantive and appropriate for long-term pursuit.
• The research plan should state the significance, innovation and approach of the proposed research during the K99 and R00 phases of the award. The research plan should provide a detailed rationale, experimental approach, and expected/alternative outcomes for the proposed studies. Although it is anticipated that candidates will be best able to describe their current and past research, the research plan for the R00 phase of the award should be described in sufficient detail for reviewers to evaluate the merit of this component of the application.
• Describe the relationship between the mentor’s research and the candidate’s proposed research. Describe how the candidate will gain independence from their mentor(s) and separate their scientific research program from that of the mentor(s).
• Applicants proposing a clinical trial, ancillary or feasibility study should describe the planned analyses and statistical approach and how the expected analytical approach is suited to the available resources, proposed study design, scope of the project, and methods used to assign trial participants and deliver interventions. 
• 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 the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials.

• Describe the timelines for the proposed clinical trial, feasibility study or ancillary clinical trial, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).
• Describe how the proposed clinical trial or ancillary clinical trial will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a feasibility study).

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 plans and statements should be tailored to the candidate and their specific areas of research and career development. 

• The application must include a statement from the primary mentor that provides:
  • Information on their research qualifications and applicable previous experience as a research supervisor;
  • A plan describing the nature of the supervision and mentoring that will occur during the proposed K99 award period, including how the candidate’s scientific and professional independence will be promoted;
  • A description of the elements of the planned career development activities, including any formal course-work;
  • A plan for transitioning the candidate from the mentored phase to the independent phase of the award and a description of how the mentor will help the candidate achieve scientific independence from their mentor(s);
  • A statement identifying the components of the proposed research that the K99 candidate can take when the candidate transitions to research independence and that can be part of their independent (R00) phase award; and
  • When appropriate, a statement affirming any resources and reagents that can be taken by the candidate to the independent phase of the award.
• The mentor should have sufficient independent research support to cover the costs of the proposed K99 research project in excess of the allowable costs of this award and should state that needed costs will be covered. If  funds are needed beyond what will be provided by the mentor, the source of additional funds should be identified and documented in a letter signed by the responsible individual.
• Similar information must be provided by all co-mentors. If more than one mentor is proposed, the respective areas of expertise, the responsibility of each, and the nature of the involvement with the candidate should be explicitly described. Co-mentors should describe clearly how they will coordinate with the primary mentor and the candidate to provide an integrated mentoring effort.
• The primary mentor must agree to write and provide annual evaluations of the candidate’s progress for the initial mentored phase as required in the annual progress report.
• The mentor must agree to assist the candidate in transitioning to an independent research position by guiding the candidate during the job search and negotiation process and by commenting on the R00 phase application.
• The mentor should describe how they will support the candidate’s:
  • Activities to promote broad participation in the biomedical research workforce;
  • Participation in the cohort activities provided by the MOSAIC Organizational Research Education Award to Promote Diversity (UE5).
• As applicable, mentors should describe their willingness to participate in activities provided by the MOSAIC UE5 Awardees aimed to acclimate mentors to program expectations and promote scholar success.
• The mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the candidate in the organization, management and implementation of the proposed clinical trial, ancillary clinical trial or feasibility study and help the candidate to meet timelines. 

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): Signed statements must be provided by each member of the proposed advisory committee.  These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.  Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches. 

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 (2 Pages Maximum)

• The sponsoring organization must document a research and career development program related to the candidate's area of interest able to support the proposed career development award.
• Describe how the organizational research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
• Describe any organizational career development resources and activities that will be available to contribute to the candidate’s career development (for example, an office of postdoctoral affairs, a seminar series for future faculty, etc.).
• Describe any organizational policies and practices that are expected to contribute to the candidate’s research and career development success, such as policies and procedures to support safe, inclusive, supportive, and accessible research training environments, and prevent discriminatory harassment and other discriminatory practices, as well as to appropriately respond to allegations of such discriminatory practices, including providing any required notifications to NIH (e.g., requesting a change of PD/PI status; see NOT-OD-15-152 and NOT-OD-18-172).
• Describe the resources and facilities that will be available to the candidate, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support. If applicable, include a description of the resources and facilities available at international sites.

Applicants should disregard the following warning message "The Description of Institutional Environment attachment on the PHS 398 Career Development Award Supplemental Form is limited to 1 page." This NOFO permits 2 pages for this attachment.

Institutional Commitment to the Candidate’s Research Career Development

• The sponsoring organization must provide a statement of commitment to the candidate's development into a productive, independent investigator, i.e. conducting the proposed mentored research and career development during the K99 phase and competing for, and transitioning to, a tenure-track (or equivalent) faculty position at an eligible organization. While the K99 phase sponsoring institution is not responsible for sponsoring the candidate during the R00 phase, it should be supportive of the candidate prior to initiation of the R00 phase.
• Provide assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.
• Provide assurance that the research facilities, resources, and training opportunities, including faculty capable of productive collaboration with the candidate, will be available for the candidate’s planned career development and research programs during the K99 award period.
• Provide assurance that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be available during the K99 award period.
• For individuals in postdoctoral positions with other titles although still in non-independent, mentored training positions, provide evidence of eligibility for the K99/R00 program.

Description of Candidate’s Contribution to Program Goals

The “Description of Candidate's Contribution to Program Goals” is not required for this NOFO and should not be included in the application.  

Other Plan(s):

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

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

• All applications 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.  See additional information on Writing a Data Management and Sharing Plan. 

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.

Section 1 - Basic Information

1.4 Clinical Trial Questionnaire

Applications to this NOFO must propose a study that falls within the NIH definition of a clinical trial and also meets the definition of basic research. Consequently, applicants must answer "yes" to the four questions on 1.4 Clinical Trial Questionnaire and complete the subsequent form fields accordingly.

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 SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. At least three, but no more than five, reference letters are required. The letters should be from individuals not directly involved in the application, but who are familiar with the candidate's qualifications, training, interests, and who can elaborate on the candidate’s potential to contribute to program goals.  The sponsor/co-sponsor(s) of the application cannot be counted toward the three required references. 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.

Applications must include a “Statement on Activities to Promote Broad Participation in Biomedical Research Workforce” as an Other Attachment on the SF424(R&R) Other Project Information form. Applications that fail to include this information will be considered incomplete and will be withdrawn without review.

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: Through this NOFO, NIH intends to fund promising postdoctoral candidates who have demonstrated activities and proposed compelling future plans to promote broad participation in the biomedical research workforce as they develop new skills and progress to research independence. Reviewers should evaluate:

• The candidate's statement describing their demonstrated activities and proposed  plans to promote broad participation in the biomedical research workforce (that is those activities that further and foster inclusive, supportive, and accessible biomedical research environments that support trainees and scientists from all backgrounds, including individuals from underrepresented groups), noting that candidates whose statements are weak in this area are not the intended recipients of this award.
• The candidate's potential for obtaining a tenure-track or equivalent faculty position and developing an independent research program that will make important contributions to the field.
• The likely value of the proposed K99 phase research and career development activities in facilitating the candidate’s transition to research independence, and the feasibility of the proposed research project as a vehicle for developing a successful, independent research program after transition to the R00 award phase.
• How the mentors will actively support and foster the candidate's transition to independence (such as providing the candidate the necessary material support to launch an independent career, and not competing with the candidate as they establish their research group).

Reviewers should also note that candidates are encouraged to apply early in their postdoctoral tenure to have sufficient time to develop their skills, knowledge and career plans during the mentored K99 phase of an award. Therefore, candidates should not necessarily be expected to already have first-authored publications from their postdoctoral work but should instead present evidence that their previous and current studies and future plans are likely to support a successful independent research career.

Reviewers should also note that while any of the candidate’s individual  experiences relevant to the program goals can be included as part of the review process, the candidate’s race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) may not, in and of themselves, be used as factors in the evaluation of applications.

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.

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.

The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through career development awards may be sufficient to support only small feasibility studies

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.

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, consistent with applicable law:

• 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

• Contributions to portfolio breadth.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. This request is not a Notice of Awards nor should it be construed to be an indicator of possible funding.

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

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

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

Awardees are expected to participate in career development activities and convenings coordinated by MOSAIC institutionally-focused research education awardees (UE5).  Awardees will provide updates on involvement with the MOSAIC UE5 grantee in section B.4 of the RPPR.

There will not be a formal Notice of Award (NoA) associated with the K99 phase of the award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural “K99” award, as well as expectations for the transition to the R00 phase of the award.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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. Data and Safety

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

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 Laws and Regulations Enforced by the HHS Office for Civil Rights website. 

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

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

Transition to the Independent Phase

Transition from the mentored phase to the independent phase is intended to be continuous in time and, except in unusual, extenuating circumstances, the awarding NIH Institute/Center will not extend the K99 phase beyond the 2-year limit. ICs may, at their discretion, make exceptions to this time limitation when individuals have been invited for faculty job interviews but final decisions have not yet been made by the potential R00 institution or, rarely, because of unusual, extenuating circumstances. To activate the independent phase of the grant, individuals must have been offered and accepted a tenure-track, full-time assistant professor position (or equivalent) by the end of the K99 project period.

An eligible R00 institution will have appropriate infrastructure to support the proposed research program and a history of external research funding. K99 recipients are free to apply for independent phase positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the independent phase of the award will not be activated. This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards. Eligibility of for-profit organizations for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH R01 or R01-equivalent research grants. PIs are encouraged to discuss job offers at for-profit organizations with NIH Program staff well in advance of accepting such an offer.

To avoid potential problems in activating the independent phase, recipients are strongly encouraged to contact their NIH program official as soon as plans to apply for and, assume an independent position develop, and not later than 6 months prior to the termination of the K99 phase of the award.

At that time, individuals should discuss plans for transition to, and application for, the R00 phase with their NIH program official. The application for the R00 phase of the award should be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase recipient organization.

The independent phase institution will submit an application on behalf of the candidate for the R00 award using the PHS 398 Application. The R00 application must include:

• A new face page signed by the R00 phase institutional representative;
• A new project description page (the project summary or abstract should be updated to reflect current plans for the R00 phase);
• Detailed budget pages for a non-modular budget;
• Biographical sketches for the PD/PI and any other Key Personnel;
• A new Resources page;
• A brief description of progress made during the K99 phase that will serve as the Final Progress Report for the K99 phase;
• An updated research plan (the specific aims should be updated to reflect current plans for the R00 phase and the updated research plan should be briefly described in less than 5 pages);
• Updated Protections for Human Subjects and Inclusion of Women, Minorities and Individuals across the Lifespan (as appropriate);
• Updated Authentication of Key Biological and/or Chemical Resources (as appropriate);
• Updated Vertebrate Animals (as appropriate);
• Updated Biohazards (as appropriate); and
• A new checklist.

These materials should be sent directly to the awarding Institute or Center (IC). The organization's Authorized Organizational Representative will email the application in PDF format to the Financial or Grants Management contact person of the awarding NIH Institute or Center listed in the Notice of Award. The R00 application will be evaluated by extramural Program staff of the awarding component for completeness and appropriateness to the program.

Two additional documents are included with the R00 application. A letter from the R00 Department or Division Chairman must be submitted that describes the R00 organization's commitment to the candidate and plans for their career development (see below). If not already provided, the final evaluation statement by the K99 phase mentor, must be provided.

In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring organization must provide protected research time (minimum of 9 person-months or 75% of the candidate’s full time professional effort) at least for the duration of the R00 award. The start-up package and other organizational support must be described in detail and must be comparable to that given to other faculty recently hired into tenure-track or equivalent faculty positions. Organizations must provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant; R00 funds may not be used to offset the typical startup package or to offset the usual organizational commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support.  The R00 sponsoring organization must describe the candidate’s academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the organization. The R00 phase organization must describe how the awardee’s ability to apply for and secure independent research grant (e.g., R01, NIGMS R35 ESI MIRA, etc.) support will be fostered and supported during the R00 phase of the award. The R00 phase organization must describe its commitment and activities taken to promote research environments are safe, inclusive, supportive, and accessible, and strategies it employs to promote the success of early-stage faculty.

The R00 award requires that a minimum of 9 person months (75% of the candidate’s full time professional effort) be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the R00 award period. NIH staff may review start-up packages and other commitments between the organization and candidate prior to activating the independent phase of the award. It is suggested that the applicant and/or the hiring organization discuss the organizational commitment with the relevant NIH institute Program Official prior to finalizing the offer.  NIH will not activate the independent phase if the organizational commitment is deemed inadequate. Recipients who are approved to transition will receive a Notice of Award reflecting the new R00 grant mechanism, the dollar amount, and the new recipient organization (if applicable).

The K99/R00 award is intended to facilitate successful transition to independence. Consequently, a requirement for activation of the R00 phase is successful completion of this transition. K99 recipients are encouraged (but not required) to apply for independent positions at departments and organizations different from where they conducted their mentored research. It is important for all recipients, but especially so for those who intend to stay at the mentored phase organization for the independent phase, to provide a plan by which they will separate from their mentor and advance to independence. Recipients are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of an NIH awarding component.

Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the R00 application.

Although the financial plans of the NIH Institute or Center provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Termination of the K99 award phase

If transition from the K99 phase at an extramural organization to the R00 phase occurs at the originally scheduled end date of the K99 award, then no specific steps to terminate the K99 award are necessary. If the transition at an extramural organization occurs prior to the scheduled end date, then a revised Notice of Award will be issued to terminate the K99 phase award.  Carry-over of unspent funds from a partially completed year in the K99 phase into the R00 phase may be permitted.

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 (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

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, NIH will assess the program’s overall outcomes, gauge its effectiveness in achieving its goals, 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:

• Aggregate number and demographic characteristics of applicants and awardees
• Successful transition of awardees to an independent tenure-track or equivalent faculty position
• Authorship of scientific publications during both mentored and independent career phases
• Subsequent independent research grant support from NIH or another source
• Subsequent participation in activities to promote broad participation in the biomedical research workforce

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Because of the difference in individual Institute and Center (IC) program requirements for this NOFO, prospective applicants MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

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: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Neeraj Agarwal
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8155
E-mail: [email protected]

Carol Shreffler, PhD
NIEHS - National Institute of Environmental Health Sciences
Phone:  984-287-3322 or 919-316-9591
Email:   [email protected]

Maria G. Carranza, Ph.D.
National Institute on Aging (NIA)
Email: [email protected]

Lanay M. Mudd, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: [email protected]

Alberto L Rivera-Rentas
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301-496-1804
E-mail: [email protected]

James Churchill, Ph.D.
National Institute of Mental Health (NIMH)
Phone: 301-443-3621
Email: [email protected]

Lindsey Nicole Friend
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: none
E-mail: [email protected]

Michelle Jones-London, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-451-7966
Email: [email protected]

Carolyn Joy Bondar, Ph.D.
ORWH - Office of Research on Women's Health
Phone: (301) 402-8770
E-mail: [email protected]

Dennis A. Twombly, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3371
Email: [email protected]

Gary Murray, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9940
Email: [email protected]

National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Ramesh Vemuri, Ph.D. 
National Institute on Aging (NIA)
Email: [email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: [email protected]

Alicia Graham
NIEHS - National Institute of Environmental Health Sciences
Phone:  984-287-4215
Email:    [email protected]

Jessi Perez 
National Institute on Aging (NIA)
Email: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Christopher Myers
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-0713
E-mail: [email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Phone: 301-443-3858
Email: [email protected]

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Chief Grants Management Officer 
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected] 

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.