Part 1. Overview Information

Key Dates

It is critical that applicant organizations follow the Fellowship (F) 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. Applicant organizations and fellowship candidates must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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



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

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 (Lorsch, Tabak and Bertagnolli, 2024). 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 independent 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.D.s awarded to scientists from these groups are not reflected in NIH funded K awardees or Research Project Grant investigators (Lauer and Bernard, 2024a, 2024b) 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 lack of diversity is also observed among those pursuing biomedical careers in government agencies, industry, and nonprofit organizations (NIH Workforce Demographics, 2021; NSF NCSES Table 9-19, 2019; Measuring Diversity in the Biotech Industry, 2022). 
• 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.D.s 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).

NIH aims to enhance support for trainees and scholars from diverse backgrounds through critical career transition points as they progress towards positions in a range of careers in the biomedical research workforce that utilize their scientific training. 

Graduate education and postdoctoral training are often challenging for trainees from all backgrounds, and they are accompanied by significant changes in career interests and knowledge about career opportunities (Graduate STEM Education for the 21st Century, 2018). Additionally, there are often unique, additional challenges faced by trainees from underrepresented groups. For example, graduate students from underrepresented groups, especially underrepresented women, report lower levels of belonging in their research groups and departments, less confidence in their abilities as an independent researcher, and distinct career interest profiles when compared to their counterparts from well-represented racial and ethnic backgrounds and these differences were not explained by research productivity (Gibbs et al, 2014; Gibbs et al., 2015). Moreover, research has also 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, and opportunities for skills development through structured formalized 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 career transitions of graduate students and postdoctoral scholars.

Program Goal

The purpose of the Advancing Research Careers (ARC) Predoctoral to Postdoctoral Transition Award to Promote Broad Participation (F99/K00) program is to facilitate the transition of promising, late-stage graduate students from diverse backgrounds into mentored postdoctoral research positions. This two-phase award will provide support for late-stage graduate students pursuing research related to the mission areas of participating NIH Institutes, Centers, and Offices (ICOs) to complete their doctoral research training (F99 phase), and to transition into and succeed in postdoctoral biomedical research and career development opportunities (K00 phase). The program also is designed to support predoctoral researchers who, appropriate to their career stage, have demonstrated contributions and propose meaningful 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. It is anticipated that successful completion of this phased award program will position ARC scholars to advance in impactful careers in the biomedical research workforce that typically require postdoctoral training (for example, academic research and teaching at a range of organization types, industry or government research).

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 F99 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.

Pre-application consultation: Before beginning an application, candidates are strongly encouraged to visit the ARC program website for resources including recent applicant webinars and answers to frequently asked questions. After consulting these resources, candidates are strongly encouraged to reach out to the appropriate contacts (see Section VII below) 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 F99/K00 award will provide up to 5 years of support in two phases:

• The initial phase (F99) will provide 1-2 years of support to complete Ph.D. research training. The ARC F99/K00 award is intended for individuals who require at least 12 months of predoctoral research training (F99 phase) before transitioning to the K00 award phase of the program. During the F99 phase, students are expected to complete their doctoral degree, identify postdoctoral research mentor(s) distinct from their predoctoral sponsor(s), and work with these mentors to develop a postdoctoral research project.
• The second phase (K00) will provide up to 3 years of support for mentored postdoctoral research and career development. A K00 award will be made only to a candidate who has successfully completed the F99-supported training, secured an appropriate postdoctoral position, and provided a strong research and career development plan that will occur in a supportive research environment. A separate application for the K00 phase will be submitted to the awarding IC no later than 3 months prior to the proposed activation date of the K00 award (see Section VI.2). This application should be prepared in collaboration with the K00 mentor(s) and demonstrate how the K00 will further facilitate achievement of a career in the biomedical research workforce (e.g., academic research and teaching, industry or government research, and research-related careers that typically benefit from postdoctoral research experience).

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 candidate pool based on the organization’s local context as well as national needs. Appropriate to the career stage, candidates should have demonstrated contributions toward promoting broad participation in the biomedical research workforce (for example, furthering inclusive, supportive, and accessible biomedical research environments), and propose meaningful plans for how those activities will be continued as a postdoctoral scholar. 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, will be well positioned to serve as mentors to trainees from increasingly diverse backgrounds pursuing biomedical research careers.  

Graduate students developing an application for the ARC F99/K00 award are expected to propose an individualized research training plan for their final 1-2 years of predoctoral research training and a broad outline for up to 3 years of mentored postdoctoral research and career development activities that will prepare them for impactful careers in the biomedical research workforce. The strongest candidates will propose a well-conceived plan for 1-2 years of substantive research training that will help them become competitive candidates for postdoctoral research positions. An individual who cannot provide a compelling rationale for at least one year of additional mentored predoctoral research training at the time of award is not a strong candidate for this award.

The candidate's research interests should be related to the mission area(s) of one or more of the participating NIH ICOs. Candidates whose research interests are outside these areas are encouraged to explore other NIH F99/K00 opportunities.

ARC Cohort-based career development program:  In addition to the F99/K00 award, individuals who receive funding through the ARC program will be assigned to organizations that will provide additional mentoring, networking, and skills development opportunities (ARC UE5 awardees). These organizations are listed on the ARC Website. Candidates are encouraged to explore the various organizations’ programs for ARC scholars and incorporate these activities as part of their research training plans. ARC UE5 awardees will also engage the primary research sponsor(s) of the F99 fellows/K00 scholars to enhance mentoring relationships and to promote the career development of the scholars. This integrated program of research and mentoring is expected to provide ARC F99 fellows/K00 scholars with the mentoring and professional networks that will prepare them to identify a postdoctoral mentor, transition into and succeed in a postdoctoral research laboratory, and ultimately transition into an impactful career within the biomedical research workforce that typically requires postdoctoral training (e.g., academic research and teaching at a range of organization types, industry or government research).

ICO Specific Research Interests

The specific NIH Institute and Center research training areas supported through this NOFO include the following:

• NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS' research mission is aimed at understanding the principles, mechanisms, and processes that underlie living organisms, often using research models. NIGMS also supports research in specific clinical areas that affect multiple organs, particularly those related to injury and critical illness: sepsis, trauma, burn, wound healing, anesthesiology, and clinical pharmacology. NIGMS does not support research that is relevant to the diseases, organ systems, or stages of life within the mission areas of other NIH ICOs. To ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in training future scientists, enhancing the diversity of the scientific workforce, and developing research capacity throughout the country. NIGMS will only accept non-AIDS related applications through this NOFO. Through this NOFO, NIGMS aims to build the pool of well-trained researchers with rigorous basic science training.
• NEI will accept applications for funding that are responsive to programmatic priority areas for research within vision and ophthalmology as detailed in the NEI strategic plan.
• NIBIB welcomes applications from predoctoral researchers seeking research training in scientific program areas relevant to NIBIB. In general, NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, candidates may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Before preparing an application, prospective candidates are encouraged to contact the NIBIB F99/K00 Scientific Program Contact in order to verify eligibility and determine if the application is appropriate for an F99/K00 award through NIBIB.
• NLM supports career development in data science research and clinical, public health, translational, and personal health informatics; and bioinformatics. NLM defines informatics as the intersection of computer, information, biomedical and behavioral sciences with one or more application domains. Application domains of interest include health care delivery, basic biomedical research, clinical and translational research, public health, health equity, and other related areas.
• NICHD supports research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. The NICHD's broad and diverse research portfolio includes research related to conception and pregnancy; typical and atypical development in childhood; childhood trauma, injury, and critical illness; the transition from adolescence to adulthood; reproductive health; rehabilitation; intellectual, developmental, and physical disabilities; and population dynamics across the lifespan. Before preparing an application, prospective candidates are encouraged to contact the NICHD F99/K00 Scientific Program Contact to verify eligibility and determine if the application is appropriate for a F99/K00 award through NICHD.
• NCCIH's mission is to determine, through rigorous scientific investigation, the fundamental science, usefulness, and safety of complementary and integrative health approaches and their roles in improving health and health care. NCCIH seeks to expand the knowledge base about how complementary health approaches exert their effects, and describe how these approaches improve resilience, restore health, and manage symptoms in a whole person health framework. Examples of complementary approaches include therapies or interventions with nutritional or natural product components (e.g. dietary supplements, microbial-based therapies, and chemical space derived from plants, fungi, marine organisms, or animals), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, devices related to these approaches), and/or a combination of psychological and physical input (e.g., yoga, tai chi, music or dance therapies, some forms of art therapies). NCCIH will use the ARC F99/K00 program to support promising late-stage predoctoral investigators who are seeking to transition to postdoctoral opportunities in complementary and integrative research and have the potential to become future creative, innovative, and independent researchers in areas of NCCIH’s interests and priorities. The F99 and K00 phases may can include dissertation or postdoctoral research, respectively, consisting of well-defined secondary data analyses, observational and/or qualitative, or basic and/or mechanistic research projects. Before the application receipt date, candidates are strongly encouraged to discuss their proposed research interest with an NCCIH Program Officer in the specific scientific area and/or intervention that is closely related to the proposed project to confirm its relevance to NCCIH's mission and research priorities. Candidates interested in natural products research are encouraged to review NCCIH's Natural Product Integrity Policy.
• The mission of the Tribal Health Research Office (THRO) is to improve Native health, enhance capacity for health research in Native communities, and promote opportunities for the next generation of American Indian and Alaska Native (AI/AN) researchers. THRO supports research and training of candidates invested in addressing critical health issues prioritized by Tribal and AI/AN populations. THRO does not have grant-making authority or administer grants, however THRO can co-fund grants deemed scientifically meritorious after review by one of the institutes or centers (ICs) participating in this announcement.

Note: This Notice of Funding Opportunity (NOFO) does not allow candidates to propose to lead an independent clinical trial but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

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

Section II. Award Information

Other Award Budget Information

ALLOWABLE COSTS F99 PHASE: Stipends are provided as a subsistence allowance to help defray living expenses during the research training experience. The stipend level for F99 predoctoral fellows is the same as for the F31 Ruth L. Kirschstein National Research Service Award (NRSA) fellows. See https://researchtraining.nih.gov/resources/policy-notices for more information.

ALLOWABLE COSTS K00 PHASE: The requested salary must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the organization and with salaries provided by the organization from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. The maximum salary NIH will contribute is the level-four Kirschstein-NRSA postdoctoral stipend level in effect when NIH issues the grant award (see current levels posted at http://grants.nih.gov/training/nrsa.htm). The recipient organization may supplement the NIH contribution up to a level that is consistent with the organization's salary scale.   Fringe benefits are provided in addition to salary and should be in accordance with organizational policy. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Confirmation of salary may be required prior to the issuance of an award.   For effort directly committed to the K00 award, salary supplementation is allowable, but must be from non-Federal sources (including organization sources). Non-Federal or organizational supplementation of salary must not require extra duties or responsibilities that would interfere with the goals of the K00 award. For effort not directly committed to the K00 award, K00 award recipients may devote effort, with compensation, on Federal or non-Federal sources as the Program Director/Principal Investigator (PD/PI) or in another role (e.g., co-Investigator), as long the specific aims of the other supporting grant(s) differ from those of the K00 award.

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)

Governments

• Eligible Agencies of the Federal Government

• 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

F99 Eligibility: Domestic institution/organization types listed above that grant Ph.D. or equivalent research degrees (e.g., Dr.P.H., Sc.D.) are eligible to submit an application. More than one F99 application per institution/organization is allowed.

K00 Eligibility: Domestic institution/organization types listed above, including Federal laboratories, are eligible to submit K00 transition phase applications on behalf of F99 awardees. There is no limit on the number of K00 awardees that an organization may sponsor. Note that if the F99 awardee accepts a postdoctoral position in the NIH intramural research program or another federal agency, the postdoctoral phase (K00) will not be awarded, as federal employees are not eligible for NIH extramural grants. The postdoctoral phase will then be supported directly by the federal agency offering the postdoctoral position, but these postdoctoral scholars are invited to continue to participate in the ARC UE5 mentoring, networking and skills development opportunities.

Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

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

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

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 applicant organizations should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

• System for Award Management (SAM) Applicant organizations 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 Applicant organizations 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 individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

• 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).
• Multiple PDs/PIs are not allowed.
• The candidate must have a baccalaureate degree and be currently enrolled as a student in a mentored, biomedical Ph.D. or equivalent research degree program (e.g., Dr.P.H., Sc.D.) at a domestic organization, and should propose research relevant to the mission area of one or more participating NIH Institutes, Centers or Offices.
• By the time of award, the candidate must be at the dissertation research stage of training and is expected to require 1–2 years to complete their Ph.D. dissertation research training (F99 phase) before transitioning to mentored postdoctoral research training (K00 phase).
• This F99/K00 award may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional degree (e.g., D.C., D.M.D., D.N.P., D.O., D.P.M., D.V.M., N.D., O.D., Au.D.). Students matriculated in a dual-degree clinician scientist training programs (e.g., M.D./Ph.D., D.O./Ph.D., D.D.S./Ph.D., or D.V.M./Ph.D.) are not eligible for the ARC F99/K00 program.
• If an individual begins a postdoctoral position or completes all Ph.D. dissertation requirements before an F99 award is made, neither the F99 award nor the K00 award will be issued.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.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).

Each candidate may submit one fellowship application at a time: An individual may not have two or more competing NIH individual fellowship applications pending review concurrently. A candidate for an ARC F99/K00 award may not simultaneously submit or have an application pending for any other PHS fellowship award (e.g., F31 or any other PHS award that duplicates any of the provisions of the F99/K00 award).

Individuals may not exceed the aggregate limit of support shown above in the Award Project Period (see Section II. Award Information).

F99 awardees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring organization in accordance with its own policies. K00 awardees are required to have a full-time appointment at the applicant organization, and to commit a minimum of 9 person months (or 75% of their full-time professional effort at the applicant organization) to their career development and research training. K00 awardees may engage in other duties (e.g., other research, training, clinical and teaching activities) as part of the remaining 25% effort not covered by the award, as long as such duties do not interfere with or detract from the proposed career development program.

F99 Sponsor(s) The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the candidate’s research training and to direct supervision of their research. The primary sponsor must document the availability of sufficient research funds and facilities for the proposed research training. The primary sponsor can be an independent investigator at any career stage, including an early-stage investigator. Regardless of career stage, the primary sponsor must demonstrate a commitment to ensuring the candidate receives tailored training that will facilitate their skills development and career advancement. 

Candidates are encouraged to identify more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for their training program. When there is a sponsor team, one individual must be identified as the primary sponsor, and will be expected to coordinate the candidate’s overall F99 training. The candidate must work with the sponsor(s) in preparing the application. Candidates are not required to identify a sponsor for the K00 phase at time of the initial F99/K00 application.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicant organizations and fellowship candidates follow the Fellowship (F) 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.

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.

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

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

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

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 predoctoral researcher) describing (a) past and present activities, and (b) plans 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.

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

As applicable, 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 “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

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

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

Biographical Sketch:

Candidate: In the "Personal Statement" section, candidates should follow the instructions for "Applicants for dissertation research awards."  

The PHS Fellowship Supplemental Form is comprised of the following sections:

• Candidate Section
• Research Training Plan Section
• Commitment to Candidate, Mentoring, and Training Environment Section
• Other Research Training Plan Section
• Additional Information Section
• Budget Section
• Appendix

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

Candidate Section

Candidate's Goals, Preparedness, and Potential

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

A. Overall Training Goals

Describe short- and long-term career goals that are integrated into a systematic plan that:

• Shows a logical progression from prior research and training experiences to the research training and career development that will occur during the F99 and K00 phases, and then to an impactful career in the biomedical research workforce; 
• Specifically addresses how completion of postdoctoral training will help the candidate achieve the career goals; and
• Justifies the need for further research training during both phases. 

B. Candidate’s Preparedness

• In this section, candidates may also provide an example of a challenge that they faced in research and have overcome using creativity and persistence. 

Research Training Plan Section

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

Training Activities and Timeline

• In the context of the training plan, briefly describe the applicant organization’s graduate program in which the candidate is enrolled, including the required milestones and usual timing, the number of courses, teaching commitments, clinical requirements, qualifying exams, etc. Describe the progress at the time of the application and the frequency and methods by which the program formally monitors and evaluates a student’s progress.
• The plan and timeline should span the entire award period, including the F99 and K00 phases. Provide a broad overview of the desired K00 phase scientific and professional activities.   
• For each of the F99/K00 phases, discuss how the proposed research training plan will facilitate transition to the next career stage.
• For each phase, identify the skills, theories, conceptual approaches, etc., to be learned or enhanced during the award, including, as applicable, expertise in rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation. Explain how the plan will complement existing strengths as well as promote additional skill development. Describe plans during the F99 phase training that provide preparation for the K00 research.
• ARC scholars are assigned to participate in the mentoring, networking and career development activities provided by an ARC Organizational Research Education Award (UE5). Describe how these activities will be incorporated to enhance the candidate’s career development.
  • Visit the ARC Website to identify the current ARC 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 ARC F99/K09 scholars, and incorporate, as applicable, the activities offered into the Training Activities and Timeline.
• Potential mentor(s) for the K00 phase do not need to be identified, but a plan for identifying a mentor(s) should be included, and an appropriate set of qualifications and mentor attributes should be described, as well as features of the postdoctoral scientific environment that would benefit the proposed research and career development.

Research Training Project Specific Aims

All candidates must use these two Specific Aims:

• Specific Aim 1: The Dissertation Research Project: Provide a concise description of the overall dissertation research project, what has been accomplished to date (preliminary data may be included), and the research to be completed in the F99 phase.
• Specific Aim 2: The Postdoctoral Research Direction: Identify a broad research direction the candidate intends to pursue for the K00 phase.

Research Training Project Strategy

• Specific Aim 1: The Dissertation Research Project: Follow directions for Scientific Rationale and Approach in the SF424 (R&R) Application Guide, with the following additions:
  • Scientific Foundation and Rationale: Describe how the proposed F99 research training project is related to the candidate's next steps for the K00 phase.
  • Approach: Describe progress to date on the dissertation research project, including the approaches used, important research outcomes, and methodologies learned.
• Specific Aim 2: The Postdoctoral Research Direction. Use the following instructions:
  • Scientific Foundation and Rationale: Describe the broad postdoctoral research direction to be pursued during the mentored K00 phase. The postdoctoral research direction does not have to be a continuation of the predoctoral research direction but should have a relationship to the candidate’s career goals. For this section:
    • Describe the rationale for the research training project, including the area of research and why this area of research is interesting and important.
    • Describe how achieving the proposed research training project goals will advance biomedical research in the candidate’s chosen field. 
  • Approach: Provide a general description of how the K00 research project might be conducted, including potential experimental approaches and methodologies. 

Commitment to Candidate, Mentoring, and Training Environment Section

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

Sponsor(s) Commitment

C. Commitment to the Candidate’s Research Training Plan 

The sponsor should confirm that the candidate has 1–2 years from time of award before completion of their Ph.D. (include month and year of anticipated graduation).

This section should also address the following:

• How the sponsor(s) promote(s) the development of trainee skills in approaches to rigorous experimental design, methods of data collection, data analysis, interpretation, and reporting as well as ethically sound and responsible scientific research.
• How the sponsor(s) will support the candidate’s timely transition to the K00 phase.
• How the sponsor will support the candidate’s:
  • Activities to promote broad participation in the biomedical research workforce;
  • Participation in the cohort activities provided by the ARC Institutionally-Focused Research Education Award to Promote Diversity (UE5).

If the candidate is proposing to gain experience in a clinical trial as part of their research training, the sponsor or co-sponsor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the candidate in any proposed clinical trials research experience. The individual receiving support for the clinical trial (i.e., the sponsor/primary mentor or a co-sponsor) is the responsible individual of record for oversight of the trial though fellows can take part in all components of a clinical trial. 

Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the fellow can gain experience in all these components in conjunction with the mentor or individual leading the trial.

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.

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.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

• Do not provide an NCT# in Section 1, item 1.5. See instruction for Sponsor(s), Collaborator(s), and Consultant(s) above.
• Do not complete Section 4 - Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described, but will not start immediately (i.e., delayed start). 

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

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

Applicant organizations must carefully follow the How to Apply - Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Reference Letter link and not through Grants.gov. As applicable, the letter can discuss the candidate's demonstrated contributions to promoting broad participation in the biomedical research enterprise.

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. Applicant organizations 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). Applicant organizations 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.

Applicant organizations 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. The F99/K00 award may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award. 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.

Applicant organizations 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) and sponsor(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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. 

Applicant organizations 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 NOFO, note the following: Through this NOFO, NIH intends to fund promising late-stage graduate students who have demonstrated activities and proposed meaningful plans to promote broad participation in the biomedical research workforce as they develop new skills and progress toward postdoctoral research and career development. Reviewers should:

• Assess whether the candidate has documented clear needs for the proposed research training in the F99 phase, and the degree to which the research training project, training plan, sponsor(s), and environment will satisfy those needs. Reviewers should note that candidates are not necessarily expected to already have a first-authored publication from their graduate work but should instead show that their studies and plans are likely to support a successful transition to postdoctoral research training.
• Evaluate the K00 research direction and career development activities considering that candidates usually do not know where they will be conducting their postdoctoral research at the time of application. Thus, the K00 research direction is expected to be a broad description of a scientific area of interest the candidate rather than a detailed experimental plan, and it should be reviewed in this context. 
• Evaluate the candidate's statement describing their activities and 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.
• Assess the candidate’s potential for pursuing an impactful career in the biomedical research workforce after completing the two-phase award (e.g., academic research and teaching, industry or government research, and research-related careers that typically require postdoctoral training).    

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.  

Score the overall merits of the application. Use the three review criteria areas defined below to evaluate the proposed fellowship application.

Evaluate the overall merit of the application considering the three review criteria area defined below. For each criteria area, provide a score and comments addressing the elements listed.

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 will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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 NIH Institute or Center Advisory Committee. 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.
• Appropriate career stage of F99 candidate. 

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 organization as described in the NIH Grants Policy Statement. This request is not a Notice of Award nor should 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations must ensure that protocols are reviewed by their IRB or independent ethics committee (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.

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

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.

Transition to the Postdoctoral Career Development K00 Phase

The F99/K00 award is intended to facilitate successful transition to the postdoctoral career stage. Consequently, a requirement for initiation of the K00 phase is successful completion of the Ph.D. degree. Candidates are encouraged to apply for postdoctoral positions in distinct environments from where they conducted their doctoral research to enhance the breadth of their scientific training and career development. It is important that all candidates, but especially candidates who intend to stay at the predoctoral phase organization for the postdoctoral phase, provide a plan by which they will separate scientifically from their Ph.D. sponsor(s). 
 
The transition from the predoctoral phase to the postdoctoral phase is intended to be continuous in time and, except in unusual circumstances, the NIH will not extend the F99 phase. Transition from the predoctoral (F99) phase to the postdoctoral (K00) phase is not automatic. To activate the K00 phase of the grant, individuals must have been offered and accepted a full-time postdoctoral position. Upon starting the K00 phase of the award, the F99 phase of the award is terminated. 
 
Prospective candidates are strongly encouraged to contact their Program Official as soon as a plan to assume a postdoctoral position develops, and not later than 6 months prior to the proposed start date of the K00 award to discuss plans for transition to, and application for, the K00 phase. 
 
The application for the K00 phase should be submitted no later than 3 months prior to the proposed activation date of the K00 award by the K00 phase recipient organization. The organization's Authorized Organizational Representative (AOR) will email the application in PDF format to the Financial or Grants Management contact of the awarding NIH Institute or Center listed in the Notice of Award. The K00 application will be evaluated by ARC program and grants management staff of the awarding NIH Institute or Center for completeness and responsiveness to the program. 
 
An eligible K00 recipient organization must have appropriate infrastructure and research funding to support the proposed research program. Foreign institutions are not eligible. Candidates may apply for postdoctoral positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the postdoctoral 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. F99 fellows who accept a postdoctoral position in the IRP will be required to submit a final progress report and a final evaluation statement by the primary F99 mentor instead of a K00 application. Eligibility of for-profit organizations for the K00 phase depends on the nature of the appointment, and the ability of the postdoctoral fellow to conduct mentored postdoctoral research and freely disseminate findings, including through peer-reviewed publications and data sharing. Candidates are encouraged to discuss job offers at for-profit organizations with NIH Program staff well in advance of accepting such an offer. Candidates awarded the F99 and who are conducting postdoctoral training outside an academic institution will be encouraged to continue to participate in the mentoring, networking and career development activities sponsored by the ARC UE5. 
 
Candidates who are approved to transition to the postdoctoral phase (K00) will receive a Notice of Award reflecting the new K00 activity code, the dollar amount, and the new grantee organization (if applicable). Candidates who are not approved to transition will receive written notification from the NIH awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the K00 application. 
 
Instructions for the K00 Transition Award 
F99 awardees wishing to submit a K00 transition application must follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise, as described below: 

The K00 Transition Application will include the following components:

• A new Cover Page Supplement Form signed by the K00 phase Authorized Organizational Representative;
• Updated K00 Project Summary/Abstract, Project Narrative, Bibliography & References Cited, Facilities & Other Resources, and Equipment sections;
• Other Attachments:
  • A final progress report for the F99 phase;
  • A final evaluation statement by the F99 primary sponsor;
• Project/Performance Site Primary Location Form
• Biographical sketches for candidate and K00 mentor(s).
  • Candidates should use the Non-Fellowship Biosketch format (as such, Section D Scholastic Performance is not required).
  • The mentor(s) personal statement(s) should include a description of their mentoring and training philosophy, including commitment to diversity and inclusion in the research training environments;
• R&R Budget Form for a non-modular budget: K00 budgets consist of salary and fringe benefits, other program related expenses, and indirect costs, as described in Part 2, Section II. Award Information of this NOFO. Other costs are not allowed;

Updated PHS Career Development Award Supplemental Form, which should include:

• Candidate Section
  • In addition to the K application instructions, describe the candidate’s current and long-term research and career objectives.
  • Describe how the research and training experiences in the K00 phase of the award, combined with all previous research and training experiences, will provide the tools, skills and knowledge necessary to subsequently pursue an impactful career within the biomedical research workforce.
  • Describe how the candidate plans to separate scientifically from their F99 and K00 sponsors.
  • Provide a timeline with milestones for the research and career development experiences proposed.
• Research Plan Section
  •  Updated Specific Aims and Research Strategy should be described in less than 6 pages. These should reflect current plans for the K00 phase, and may differ from what was originally proposed as the Postdoctoral Research Direction in the F99/K00 application.
  • Training in the Responsible Conduct of Research
• Mentor, Co-Mentor, Consultant, Collaborators Section that includes a plan for fostering the candidate’s transition to the next stage of their career development. Candidates are encouraged to identify more than one mentor, i.e., a mentor team, if this is deemed advantageous for their training program. The role of each mentor, co-mentor, consultant and collaborator (as applicable) in the K00 and commitment to the candidate should be clearly described. When there is a mentor team, one individual must be identified as the primary mentor, and will be expected to coordinate the candidate’s overall K00 training. The primary mentor can be an independent investigator at any career stage, including an early-stage investigator. The mentor(s) should describe previous experience as a mentor. For all postdoctoral individuals mentored over the last 10 years, provide information on their time spent in the lab, their present employing organizations, and their present position titles or occupations. For early-career investigators, this may also include postdoctoral students that were mentored while the mentor was a senior postdoc or in a non-faculty position. Regardless of career stage, the mentor(s) should demonstrate a commitment to ensure the fellow receives tailored training that will facilitate their skills development and career advancement, describe their mentoring philosophies to support postdoctoral student success, and describe how any previous mentoring experience will support the success of the proposed project. Expand on efforts by the mentor/co-mentor to enhance diversity and promote inclusion through an environment that promotes the success of individuals with a wide variety of backgrounds and perspectives. The mentor should discuss the availability of adequate resources and research support available for the K00 project.
  • If the candidate is proposing to gain experience in a clinical trial as part of their research career development, the mentor or co-mentor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the candidate in any proposed clinical trials research experience.
• Environment and Institutional Commitment to Candidate Section
  • Description of Institutional Environment 
  • Institutional Commitment to Candidate’s Research Career Development :
    • Provide a statement of commitment to the candidate and their career goals, i.e., conducting the proposed mentored research and career development activities during the K00 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 in the biomedical research workforce.
    • Provide assurance that the research facilities, resources, and training opportunities will be available for the candidate’s planned career development and research programs during the K00 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 K00 award period.
    • Describe efforts by the organization to enhance diversity and promote inclusion through an environment that promotes the success of individuals with a wide variety of backgrounds and perspectives (i.e., organizational and departmental environments in which trainees from all backgrounds feel integrated into and supported by the biomedical community).
    • The organizational commitment must be dated and signed by the person who is authorized to commit the organization to the agreements and assurances listed above. In most cases, this will be the dean or the chair of the department.
• Other Research Plan Sections (as appropriate), including:
  • Vertebrate Animals;
  • Select Agent Research;
  • Resource Sharing Plans;
  • Authentication of Key Biological and/or Chemical Resources; and
  • Biohazards
• Human Subjects and Clinical Trials Information (as appropriate);

Termination of the F99 award phase 
If the transition from the F99 phase to the K00 phase at an extramural organization occurs prior to the scheduled end date of the F99 award phase, then a revised Notice of Award will be issued to terminate the F99 award phase. 

Institutional Allowances: Carry-over of unspent funds from a partially completed year in the F99 phase into the K00 phase is not permitted. 

Leave Policies 
ARC awardees follow the policies as outlined in the NIH Grants Policy Statement 11.3.16 Leave.

The taxability of stipends is described in the NIH Grants Policy Statement. 

Fellowships funded primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required. More details, including exceptions for fellows training at NIH are provided in the NIH Grants Policy Statement.

K00 Phase Awardees must complete the "Inventions and Patents" section when submitting the Research Performance Progress Report (RPPR). 

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 report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year.

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. 

Other Fellowship Reporting Requirements:

• Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award. 

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.

In carrying out stewardship of grant programs, NIGMS will periodically evaluate this program, employing the representative measures identified below, using information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes. 

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

For the F99 phase (graduate students):

• Successful completion of a STEM graduate program
• Subsequent participation in a formal research training or career development program in a STEM field
• Subsequent employment in a STEM field
• Authorship of scientific publications in a STEM field
• Transition to the K00 phase 

For the K00 phase (postdoctorates):

• Subsequent participation in a formal research training or career development program in a STEM field (e.g., K99/R00 award)
• Subsequent employment in a STEM field
• Authorship of scientific publications in a STEM field

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [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]

Laurie Stepanek, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Lameese D. Akacem, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Sekai Chideya-Chihota, MD, MPH
National Center for Complementary and Integrative Health (NCCIH)
Phone: 240-552-2994
Email: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Neeraj Agarwal
NEI - National Eye Institute
Phone: 301-435-8155
E-mail: [email protected]

Edwin C Clayton
NEI - National Eye Institute 
Phone: (301) 480-9350
E-mail: [email protected]

Sheila Caldwell, PhD
Tribal Health Research Office
Phone: 301-480-3527
email: [email protected]

Meryl Sufian, PhD
National Library of Medicine (NLM)
Telephone: 301-496-4671
Email: [email protected]

Joseph Gindhart, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: [email protected]

Dave Gutekunst, PhD
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: (240) 789-0004
E-mail: [email protected]

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

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

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

Karen Robinson Smith
NEI - National Eye Institute
Phone: 301-435-8178
E-mail: [email protected]

Andrea Culhane
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: [email protected] 

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

Mutema Nyankale
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: (301) 827-6317
E-mail: [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 fellowship 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 63A and 2 CFR Part 200.