Part 1. Overview Information

Key Dates

The following table includes NIH standard due dates marked with an asterisk.

Application Due Dates			Review and Award Cycles
New	Renewal / Resubmission / Revision (as allowed)	AIDS - New/Renewal/Resubmission/Revision, as allowed	Scientific Merit Review	Advisory Council Review	Earliest Start Date
June 13, 2024	Not Applicable	September 07, 2024 *	November 2024	January 2025	April 2025
October 11, 2024	Not Applicable	January 07, 2025 *	March 2025	May 2025	July 2025
February 13, 2025	Not Applicable	May 07, 2025 *	July 2025	October 2025	December 2025
June 13, 2025	Not Applicable	September 07, 2025 *	November 2025	January 2026	April 2026
October 10, 2025	Not Applicable	January 07, 2026 *	March 2026	May 2026	July 2026
February 13, 2026	Not Applicable	May 07, 2026 *	July 2026	October 2026	December 2026
June 15, 2026	Not Applicable	September 07, 2026 *	November 2026	January 2027	April 2027
October 14, 2026	Not Applicable	January 07, 2027 *	March 2027	May 2027	July 2027
February 11, 2027	Not Applicable	May 07, 2027 *	July 2027	October 2027	December 2027

All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Other Award Budget Information
Section III. Eligibility Information
Section IV. Application and Submission Information
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

Background

The National Institutes of Health (NIH) recognizes the need to diversify the scientific workforce by enhancing the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences (collectively termed "biomedical") research workforce. Individuals from all backgrounds deserve an equitable opportunity to engage in the biomedical research enterprise, to pursue their scientific interests, and further their careers. Moreover, diversity at all levels from the kinds of science to the regions in which it is conducted to the backgrounds of the people conducting it is integral to scientific excellence and strengthens the research enterprise. There are many benefits that flow from a diverse NIH-supported scientific workforce, including 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. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from a variety of backgrounds and life experiences bring different perspectives, creativity, and individual interests to address complex scientific problems. NIH strives to ensure that future generations of researchers will be drawn from the entire pool of talented individuals, bringing different aptitudes, perspectives, interests, and experiences to address complex scientific problems.

Need for the Program

Promoting diversity in the extramural scientific workforce is critical to the success of the NIH mission and is consistent with the mandates of the 21st Century Cures Act. While scientific workforce diversity supports and is integral to the NIH mission, expanding the pool of scientists from nationally underrepresented backgrounds in the biomedical research workforce has remained an elusive goal (see Policy Supporting Next Generation Researchers Initiative). NIH has a longstanding commitment to training future biomedical scientists and supporting the training of students from diverse backgrounds, for example individuals from groups underrepresented in biomedical research, through a variety of fellowships, career development awards, and institutional training and student development programs. Despite recent advances, individuals from certain groups and backgrounds remain underrepresented in the biomedical sciences research workforce as described in the Notice of NIH's Interest in Diversity.

The severity of the underrepresentation of these groups increases throughout the training stages. For example, individuals from certain racial and ethnic groups, including Black or African American, Hispanic or Latino, American Indian or Alaska Native, Native Hawaiian or other Pacific Islander comprise ~38 percent of the college age population, but earn only ~23 percent of bachelor’s degrees and ~16 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, while the United States has seen a significant increase in the number of Ph.D. degrees in the biomedical sciences earned by scientists from historically underrepresented racial and ethnic groups, corresponding increases in the ranks of the faculty in basic science departments (Gibbs, et al., eLife 2016) or NIH-funded investigators (Hoppe et al, 2019; Lauer and Bernard, 2023) have not occurred. The representation of scientists with disabilities in the scientific workforce decreases throughout academic career paths (i.e., from undergraduate to academic leadership), despite the increasing prevalence of disabilities during the active years of research careers (ACD WGD Subgroup on Individuals with Disabilities Report, 2022). Similarly, women have earned a majority of biomedical Ph.Ds. since 2008 (NSF data), but only approximately 1/3 of NIH-funded principal investigators are women (NIH Databook). 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). NIH aims to enhance support for trainees and scholars from diverse backgrounds through critical career transition points as they progress towards positions in the range of biomedical careers 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 historically underrepresented racial and ethnic 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 differences that were not explained by research productivity (Gibbs et al, 2014; Gibbs et al., 2015). Moreover, postdoctoral researchers from underrepresented and well-represented racial and ethnic backgrounds report differences in the types of support that would increase their likelihood of pursuing academic research careers (Lambert et al, 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). Therefore, there remains a strong need to develop additional opportunities to address these challenges, supporting the career progression of graduate students and postdoctoral researchers from diverse backgrounds, for example those from underrepresented groups.

Program Goal

The ARC Program is part of NIH’s efforts to promote diversity within the biomedical research workforce and is designed as a structured program to enhance participation of trainees from diverse backgrounds, for example individuals from underrepresented groups (see Notice of NIH’s Interest in Diversity), as they transition from predoctoral research training to postdoctoral research and career development activities. ARC has two components: an institutionally-focused research education cooperative agreement (UE5) and an individual predoctoral career transition award (F99/K00) to enhance diversity. The overarching goal of the ARC F99/K00 award is to foster the development of individuals from diverse backgrounds who have demonstrated an interest in and potential for pursuing impactful careers in the biomedical research workforce that typically require postdoctoral training (e.g., academic research and teaching at a range of institution types, industry or government research).

Program Considerations

The F99/K00 award will provide up to 5 years of support:

• 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. Consequently, 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. 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).

ARC F99 fellows/K00 scholars will be expected to participate in additional mentoring, networking, and professional development activities coordinated by the institutionally-focused research education grant awardees (ARC UE5). ARC UE5 grantees 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. The 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 institution types, industry or government research).

Candidates (i.e., 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 candidate's research interests should be related to the mission area(s) of one or more of the participating NIH ICOs. Candidates are strongly encouraged to reach out to the relevant Scientific/Research Contact(s) listed below to discuss the appropriateness of their application. Candidates whose research interests are outside these areas are encouraged to explore other NIH F99/K00 opportunities.

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. For more information see https://www.nigms.nih.gov/about-nigms/who-we-are/overview. 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 strategic plan found at www.nei.nih.gov.

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 a F99/K00 award through NIBIB.

NLM supports research career development in data science and clinical, public health, and translational informatics, biomedical informatics, and personal health informatics. 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 and other related areas.

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. A list of NCCIH Program Officials can be found at https://www.nccih.nih.gov/about/der-program-directors.

Candidates interested in natural products research are encouraged to review NCCIH's Natural Product Integrity Policy.

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

Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.

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)

Governments

• Eligible Agencies of the Federal Government

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

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 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 Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with their sponsor and organization to develop an application for support. This individual will be referred to as the candidate for the remainder of the NOFO. Individuals from diverse backgrounds, for example underrepresented racial and ethnic groups and individuals with disabilities, are always encouraged to apply for NIH support (See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities). For the purpose of this NOFO, NIH encourages institutions to recruit prospective candidates from groups identified as underrepresented in the biomedical sciences (e.g., see Notice of NIH’s Interest in Diversity).

Multiple PDs/PIs are not allowed.

By the time of award, the candidate 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).

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 institution, 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.

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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.

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 institution in accordance with its own policies.

K00 awardees are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9 person months (or 75% of their full-time professional effort at the applicant institution) 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 applicants 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 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 SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

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

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

SF424(R&R) Other Project Information

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

Other Attachments:

Diversity Statement (1-page maximum): The application must include a diversity statement from the candidate for the F99/K00 award. The Diversity Statement should include a description of the candidate’s commitment to diversity in the biomedical sciences, and any past or present leadership, mentoring and outreach activities to enhance participation of groups underrepresented in the biomedical research enterprise, for example underrepresented racial/ethnic groups, persons with disabilities, students from disadvantaged backgrounds, women, and other groups as described in the NIH Notice of Interest in Diversity. Describe planned activities during the award to develop or enhance skills in working effectively with scientists from diverse backgrounds and to promote inclusive and equitable scientific biomedical research environments, and any planned activities to promote diversity in the biomedical sciences. Please name the file Diversity Statement.pdf .

Applications lacking a Diversity Statement will be considered incomplete and will not be reviewed.

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

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

Biographical Sketch:

Candidate: In the "Personal Statement" section, candidates should follow the instructions for "Applicants for dissertation research awards." In addition, specifically address how completion of postdoctoral training will help the candidate achieve their career goals. In this section, candidates may also:

• Describe experiences that contributed to their professional development and form the foundation for the training proposed.
• Include activities that demonstrate their passion and commitment to a scientific career.
• Provide an example of a challenge that they faced in research and have overcome using creativity and persistence.

Candidates should not complete Section D Scholastic Performance.

Sponsor and Co-Sponsor(s): In the "Personal Statement" section, the sponsor and any co-sponsors should include a statement describing their mentoring and training philosophy, including commitment to diversity and inclusion in their training environments. Do not duplicate information described elsewhere in the application.

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

• Fellowship Applicant
• Research Training Plan
• Sponsor(s), Collaborator(s), and Consultant(s);
• Institutional Environment & Commitment to Training
• Other Research Training Plan Sections
• Additional Information
• Budget
• Appendix

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

Fellowship Candidate Section

Applicant’s Background and Goals for Fellowship Training:

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

Note Applicant in this section refers to the candidate (i.e., the graduate student who is developing the fellowship application).

A. Doctoral Dissertation and Research Experience

• Follow instructions for Advanced graduate students.

B. Training Goals and Objectives

• 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; and
  • justifies the need for further research training during both phases.
• 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.
• Describe how the activities provided by the ARC Institutionally-Focused Research Education Award (UE5) will be integrated into career development activities available at the candidate's home institution to create synergies. Information on the ARC UE5 programs will be found on the ARC program website. (Note: NIH expects that information about UE5 awards will be available by the third receipt date. For applications prior to this receipt date, consult the ARC UE5 Notice of Funding Opportunity and describe a plan for integrating the skills development and mentoring activities into the Training Goals and Objectives).
• 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.
• For each phase, discuss how the proposed research training plan will facilitate transition to the next career stage.

C. Activities Planned Under this Award

• The plan and timeline should span the entire award period, i.e., both the F99 and K00 phases. Provide a broad overview of the desired K00 phase scientific and professional activities (these plans can change when a postdoctoral position is selected).

Research Training Plan

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

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 Strategy:

• Specific Aim 1: The Dissertation Research Project: Follow directions for Significance and Approach in the SF424 (R&R) Application Guide, with the following additions:
  • Significance: Describe how the proposed F99 research 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
  • Significance: Describe the broad postdoctoral research direction to be pursued during the mentored K00 phase. Explain the background and significance of the research direction, and how this work can advance or address unanswered questions in biomedical research. The postdoctoral research direction does not have to be a continuation of the predoctoral research direction but should have a relationship to the desired career goals.
  • Approach: Provide a general description of how the K00 research project might be conducted, including potential experimental approaches and methodologies.

Sponsor(s), Collaborator(s), and Consultant(s)

All instructions in the SF424 (R&R) Application Guide must be followed, with the exception of the "Sponsor and Co-Sponsor Statements" section.

Sponsor and Co-Sponsor Statements:

DO NOT follow the SF424 (R&R) Application Guide instructions for this section. Instead, follow the instructions below.

Who must complete the Sponsor and Co-Sponsor Statement attachment: The Sponsor and Co-Sponsor Statement attachment is required. The sponsor and each cosponsor must provide statements as described below.

Format: Follow the page limits for Sponsor and Co-Sponsor Statements in the NIH Table of Page Limits. The Sponsor and Co-Sponsor Statements can be integrated or written separately, but must be appended together and uploaded as a single PDF file. See NIH's Format Attachments page. Use of hyperlinks and URLs is not allowed unless specified in the Notice of Funding Opportunity.

Content: Complete these items as comprehensively as possible so that the reviewers can make a meaningful evaluation of the mentoring environment.

Create a heading at the top of the first page titled Sponsor and Co-Sponsor Statements. Organize each statement in the specified order and use the instructions below. Start each section with the appropriate section heading:

A. Research Support Available

B. Sponsor s/Co-sponsor’s Previous Predoctoral Trainees and Mentoring Philosophy

C. Training Plan, Environment, Research Facilities

D. Number of Trainees to be Supervised During the Fellowship

E. Candidate's Readiness and Potential Benefit from the Research Training Plan

F. Clinical Trial (if applicable)

Each F99 sponsor and co-sponsor statement must address all the following sections (A-F).

A. Research Support Available

In a table, list all current and pending research and research training support specifically available to the candidate for this training experience, including institutional support. Include funding source, complete identifying number, title of the research or training program, name of the PD/PI, start and end dates, and the amount of the award. If the sponsor’s research support will end prior to the end of the proposed training period, the sponsor should describe a contingency plan for how the fellow’s research will be supported.

The role of the sponsor/co-sponsor in the Research Training Plan should be described. If one or more co-sponsors are proposed, this plan should describe the role of each sponsor and how they will communicate and coordinate their efforts to mentor the candidate effectively.

B. Sponsor s/Co-sponsor’s Previous Predoctoral Trainees and Mentoring Philosophy

For all predoctoral individuals sponsored in 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 sponsors, this may also include predoctoral students that were mentored while the sponsor was a postdoc or in a non-faculty position. Regardless of career stage, the sponsor/co-sponsor should describe how their mentoring philosophy and any relevant previous mentoring experience will contribute to the success of the candidate's development.

The application should describe how the sponsor uses evidence-informed training and mentoring practices that promote the development of trainees from all backgrounds, including those from groups underrepresented in the biomedical sciences (see Notice of NIH's Interest in Diversity). Simply citing past trainees accomplishments is not sufficient evidence of effective training and mentoring.

C. Training Plan, Environment, Research Facilities

The candidate’s Research Training Plan should be individualized for the candidate, keeping in mind the candidate’s strengths and any areas of development. The information contained in this section should augment, but not duplicate, information provided in the Description of Institutional Environment and Commitment to Training sections. This section should address the following:

• How the Research Training Plan has been individualized and optimized for the fellowship candidate's career goals. Specifically, describe the skills and techniques that the candidate will learn. Include items such as classes, seminars, credentials, opportunities for interaction with other groups and scientists, and any professional skills development opportunities. Specifically relate these to the candidate’s K00 research direction and career goals;
• How the sponsor(s) will support the candidate’s timely transition to the K00 phase and how the candidate’s research and career development progress will be monitored and evaluated throughout the F99 phase (e.g., by use of an Individual Development Plan);
• How the sponsor(s) have sufficient time to commit to the individualized Research Training Plan given their other professional obligations;
• The sponsor(s) commitment to mentoring and promoting inclusive, safe, and supportive research training environments;
• How the sponsor(s) promote the use of highest standards of practice to ensure the safety of all individuals in the research environment;
• How the sponsor(s) conduct rigorous and unbiased experimental design, methodology, analysis, interpretation, and reporting of results as well as ethically sound and responsible scientific research.
• How the sponsor(s) promote the development of trainee skills in approaches to rigorous experimental design, methods of data collection, data analysis, interpretation, and reporting.
• How the sponsor(s) provide appropriate and adequate opportunities for trainees to present and publish research findings, and meet scientists within the community at national conferences and meetings;
• How the candidate will be able to complete the research component of the Research Training Plan given the research environment and available research facilities and equipment; and
• The sponsor’s willingness to participate in events organized by the ARC Institutionally Focused Research Education Award to Promote Diversity (UE5) to enhance mentoring relationships and to promote the career development of the scholars.

D. Number of Trainees to be Supervised During the Fellowship

Indicate how many trainees (e.g., postbaccalaureate, predoctoral, and postdoctoral) the Sponsor/Co-sponsor is expected to supervise during the award period.

E. Candidate's Readiness and Potential Benefit from the Research Training Plan

Evaluate the readiness of the candidate to undertake the proposed research training and the capacity to benefit from the fellowship. Sponsor(s) are encouraged to comment on qualities that go beyond academic and institutional backgrounds, such as determination, persistence, integrity, and creativity. Explain how the fellowship candidate has the potential to strongly benefit from, and with proper training and support, succeed in the research training environment and reach the proposed goals.

F. Clinical Trial (if applicable)

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 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 sponsor or individual leading the trial.

Include a statement/attestation that the sponsor will be responsible for the clinical trial. Describe how the sponsor will provide this oversight (be careful not to overstate the fellow’s responsibilities). Include details on the specific roles/responsibilities of the fellow and sponsor, keeping in mind that the terms of a fellowship award do not permit the fellow to lead a clinical trial.

Institutional Environment and Commitment to Training Section

Description of Institutional Environment and Commitment to Training:

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

• Follow instructions for F30 and F31 applications: Educational Information
• Describe how the institutional environment supports the candidate’s Research Training Plan. Describe any institutional career development resources and activities that will be available to contribute to the candidate’s career development (e.g., an office of graduate education, a career development seminar series or course, etc.). Detail the institutional commitment to promoting the following:
  • A culture in which the highest standards of safety, scientific rigor, reproducibility, and responsible conduct of research are advanced; and
  • Research training environments that value diversity, equity, and inclusion, and accessibility at all levels (trainees, staff, leadership).
• 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).
• Include the name of the individual providing this information at the end of the description. This information is typically provided by the director of the graduate program or the department chair.

Description of Candidate’s Contribution to Program Goals: The sponsoring institution must provide a document on institutional letterhead that explains, consistent with applicable law, how the candidate’s participation will further the goals of the fellowship program to promote diversity in health-related research. See the Notice of NIH's Interest in Diversity.

The "Description of Candidate’s Contribution to Program Goals attachment must be dated and signed by an institutional official. In most cases, this will be the dean or the chairman of the department. The signature must appear over the signer's name and title at the end of the statement.

See instructions in the SF424 (R&R) Application Guide.

Appendix

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

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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Three 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/cosponsor(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 Reference Letter and not through Grants.gov.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

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

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

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

Important reminders:

All PD(s)/PI(s) 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 SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

Reviewers should assess the candidate’s potential for pursuing an impactful career in the biomedical research workforce (e.g., academic research and teaching, industry or government research, and research-related careers that typically require postdoctoral training). A fellowship application has a research project that is integrated with a training plan. Reviewers should emphasize the candidate’s needs for the proposed research training, and the degree to which the research project, training plan, sponsor(s), and environment will satisfy those needs. The reviewers should also evaluate the research and career development plans for the K00 phase, emphasizing the need for the proposed career development. Because the candidates usually do not know where they will be doing their postdoctoral research at the time of application, the K00 research proposals are expected to be broad descriptions of a scientific area of potential interest to each candidate rather than a detailed experimental plan, and they should be reviewed in this context. Reviewers should assess the candidate’s commitment to and proposed plans for advancing and promoting diversity in the biomedical research enterprise. F99 sponsors do not need to be established investigators with long track records of mentoring graduate students and postdoctoral researchers, but should demonstrate a compelling commitment to excellence in mentoring and have a strong plan for the scientific and career development of the candidate.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, an impactful career in the biomedical research workforce, in consideration of the scored and additional review criteria.

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

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 policy and procedures, 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 his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

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

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 (IRB) or Independent Ethics Committee (IEC) Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690)) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that 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.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 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 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 institution 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 institution'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 K00 application will be evaluated by ARC program and grants management staff of the awarding component for completeness and responsiveness to the program.

An eligible K00 institution 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 of 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 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 institutional 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 II, Section II of this funding opportunity announcement. 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: The 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.
• Description of Institutional Environment section
• Institutional Commitment to Candidate’s Research Career Development Section:
• 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 institution 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., institutional and departmental environments in which trainees from all backgrounds feel integrated into and supported by the biomedical community).
• The institutional commitment must be dated and signed by the person who is authorized to commit the institution to the agreements and assurances listed above. In most cases, this will be the dean or the chairman 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 institution 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 phase award. 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.

F99 Phase 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

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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 45 CFR Part 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Joseph Gindhart, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: joe.gindhart@nih.gov

Laurie Stepanek, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: laurie.stepanek@nih.gov

Lameese D. Akacem, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: lameese.akacem@nih.gov

Sekai Chideya-Chihota, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 240-552-2994
Email: sekai.chideya@nih.gov

David Joseph Gutekunst
NIBIB - National Institute of Biomedical Imaging and Bioengineering
Phone: (301) 402-5069
E-mail: dave.gutekunst@nih.gov

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov

Neeraj Agarwal
NEI - National Eye Institute
Phone: 301-435-8155
E-mail: agarwalnee@nei.nih.gov

Meryl Sufian, PhD
NLM - National Library of Medicine
Phone: 301.496.4671
E-mail: sufianm@mail.nih.gov

Joanna Kubler-Kielb, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6916
Email: kielbj@mail.nih.gov

National Institute of General Medical Sciences (NIGMS)
Email: NIGMSReview@mail.nih.gov

Manana Sukhareva
NIBIB - National Institute of Biomedical Imaging and Bioengineering
Phone: 301-451-3397
E-mail: sukharem@mail.nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Justin Rosenzweig
National Institute of General Medical Sciences (NIGMS)
Email: justin.rosenzweig@nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Mutema Nyankale
NIBIB - National Institute of Biomedical Imaging and Bioengineering
Phone: (301) 827-6317
E-mail: nyankalem@mail.nih.gov

Karen Robinson smith
NEI - National Eye Institute
Phone: 301-435-8178
E-mail: kyr@nei.nih.gov

Samantha J Tempchin
NLM - National Library of Medicine
Phone: 301-496-4222
E-mail: samantha.tempchin@mail.nih.gov

Section VIII. Other Information

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

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of 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 45 CFR Part 75 and 2 CFR Part 200.