National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
National Center for Complementary and Integrative Health (NCCIH)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
Applicants should carefully note which ICs participate in this announcement and view their respective areas of research interest and requirements at the Table of IC-Specific Information, Requirements and Staff Contacts website. ICs that do not participate in this announcement will not consider applications for funding. Consultation with NIH staff before submitting an application is strongly encouraged.
See Notices of Special Interest associated with this funding opportunity
The purpose of the Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) program is to support a cohort of early career, independent investigators from diverse backgrounds (for example, individuals from underrepresented groups) conducting research in NIH mission areas. The program has two components: an individual career transition award for postdoctoral scholars (K99/R00) and a research education cooperative agreement (UE5) awarded to organizations to provide these scholars with additional mentoring, networking and professional development activities to support their transition to and success in independent, tenure-track or equivalent research-intensive faculty careers. The MOSAIC program supports NIHs efforts to develop a biomedical research workforce that will benefit from the full range of perspectives, experiences and backgrounds needed to advance discovery.
The goal of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to facilitate a timely transition of promising postdoctoral researchers from diverse backgrounds from their mentored postdoctoral research positions to independent, tenure-track or equivalent research-intensive faculty positions. The program is designed to support postdoctoral researchers who have demonstrated meaningful contributions and proposed compelling future plans to promote broad participation in the biomedical research workforce, such as activities that promote inclusive, supportive, and accessible biomedical research environments that support the success of trainees and scientists from all backgrounds, including individuals from underrepresented groups.
This Notice of Funding Opportunity (NOFO) is designed specifically to support candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. Candidates not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must work with their institutions to apply to companion NOFO PAR-24-225.
Not Applicable
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 |
Not Applicable | Not Applicable | September 07, 2024 * | November 2024 | January 2025 | April 2025 |
October 12, 2024 * | November 12, 2024 * | January 07, 2025 * | March 2025 | May 2025 | July 2025 |
February 12, 2025 * | March 12, 2025 * | May 07, 2025 * | July 2025 | October 2025 | December 2025 |
June 12, 2025 * | July 12, 2025 * | September 07, 2025 * | November 2025 | January 2026 | April 2026 |
October 12, 2025 * | November 12, 2025 * | January 07, 2026 * | March 2026 | May 2026 | July 2026 |
February 12, 2026 * | March 12, 2026 * | May 07, 2026 * | July 2026 | October 2026 | December 2026 |
June 12, 2026 * | July 12, 2026 * | September 07, 2026 * | November 2026 | January 2027 | April 2027 |
October 12, 2026 * | November 12, 2026 * | January 07, 2027 * | March 2027 | May 2027 | July 2027 |
February 12, 2027 * | March 12, 2027 * | May 07, 2027 * | July 2027 | October 2027 | December 2027 |
June 12, 2027 * | July 12, 2027 * | September 07, 2027 * | November 2027 | January 2028 | April 2028 |
All applications are due by 5:00 PM local time of applicant organization.
Applications are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in theHow to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
The overall goal of the NIH Research Career Development program is to help ensure that a diverse population of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, clinical, behavioral and social (collectively termed biomedical) research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
The goal of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) is to facilitate a timely transition of promising postdoctoral researchers from diverse backgrounds from their mentored postdoctoral research positions to independent, tenure-track or equivalent research-intensive faculty positions. The program is designed to support postdoctoral researchers who have demonstrated meaningful contributions and proposed compelling future plans to promote broad participation in the biomedical research workforce (such as activities that promote inclusive, supportive, and accessible biomedical research environments that support the success of trainees and scientists from all backgrounds, including individuals from underrepresented groups). The K99/R00 award is intended to help these postdoctoral researchers:
A broad portfolio – in terms of scientific areas, approaches, regions, organizations, and individual investigator experiences – is integral to NIH#146;s ability to fulfill its mission. Advances in biomedical research depend upon a workforce composed of people trained in multiple disciplines and from a range of backgrounds who can provide the breadth of creativity, and individual interests, perspectives and experiences needed to identify and address important and complex scientific problems, engage with increasingly diverse patient populations, and effectively serve as mentors to trainees from increasingly diverse backgrounds who are pursuing biomedical research careers. Research shows that teams with members from different backgrounds that utilize their members' unique experiences and perspectives better capitalize on innovative ideas and outperform homogeneous teams. There are many benefits that flow from an NIH-supported scientific workforce that leverages the talents of rigorous researchers from all backgrounds, including individuals from underrepresented groups: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of research, enhancing public trust, and increasing the likelihood that health disparities and the needs of underserved populations are addressed in biomedical research (for more information, see Notice of NIH's Interest in Diversity ). However , expanding the population of academic investigators from nationally underrepresented backgrounds in the biomedical research workforce has remained an elusive goal (see Policy Supporting Next Generation Researchers Initiative ). The NIH recognizes the need to promote broad participation in the scientific workforce through means consistent with applicable law, including by encouraging organizations to eliminate barriers and enhance the participation of individuals from groups underrepresented in the biomedical research workforce.
At the same time, individuals from certain groups and backgrounds often face organizational and environmental barriers that restrict their potential to advance their training and careers and are underrepresented in the biomedical research workforce. For example:
The transition from postdoctoral research training to independent faculty careers is a key time frame when individuals from underrepresented groups disproportionately exit the academic biomedical research career pathway (Gibbs et al, 2016; Meyers et al, 2018). Supportive peer groups and strong mentoring networks are critical for successfully navigating the transition to faculty careers for postdoctoral researchers from all backgrounds; however, individuals from underrepresented groups often report challenges in accessing appropriate mentoring relationships and professional networks, which can result in a sense of isolation and a lower sense of belonging in the research environment (Noel et al, 2022). Research has shown that postdoctoral scientists from underrepresented groups have reported differences in the types of support that would increase their likelihood of pursuing academic research careers (including greater professional skills development opportunities) and distinct motivations for pursuing faculty careers relative to their peers from other groups ( Layton et al, 2016 ; Lambert et al, 2020 ). For example, many scientists from underrepresented groups report that, in addition to their research interests, the ability to engage in educational, mentoring, role modeling, outreach and recruitment activities that promote broad participation in the biomedical research workforce strongly motivate their pursuit of research and faculty careers ( Gibbs and Griffin, 2013 ; Diekman et al, 2016 ; Jackson et al, 2017 ; Mendez et al, 2024 ). At the same time, many scientists from these groups are also disproportionately asked to engage in such activities, and these contributions to the research environment are generally not appropriately recognized and rewarded which can impact career advancement ( Gewin 2020 ).
Importantly, access to high quality mentoring, robust professional networks, the ability to integrate personal and professional values, and opportunities for skills development through structured programs have been linked to enhanced trainee productivity, increased self-efficacy and strengthening an individuals commitment to a research career ( The Science of Effective Mentoring in STEMM, 2019). Additionally, cohort-based models have been shown to be particularly effective at supporting postdoctoral scholars as they navigate the transition to faculty careers (see, e.g., Rybarczyk et al, 2016, Cresiski et al, 2022; Advisory Committee to the NIH Director, 2023 ). Therefore, there remains a strong need to develop additional opportunities to address these challenges and promote additional cohort-based career development opportunities that support the transition to independence for postdoctoral scholars.
The purpose of the Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) program is to support a cohort of early career, independent investigators from diverse backgrounds (for example, individuals from underrepresented groups) conducting research in NIH mission areas. The program has two components: an individual career transition award for postdoctoral scholars (K99/R00) and a research education cooperative agreement (UE5) awarded to organizations to provide these scholars with additional mentoring, networking and professional development activities to support their transition to and success in independent, tenure-track or equivalent research-intensive faculty careers. The MOSAIC program supports NIHs efforts to develop a biomedical research workforce that will benefit from the full range of perspectives, experiences and backgrounds needed to advance discovery.
The goal of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) is to facilitate a timely transition of promising postdoctoral researchers from diverse backgrounds from their mentored postdoctoral research positions to independent, tenure-track or equivalent research-intensive faculty positions. The program is designed to support postdoctoral researchers who have demonstrated meaningful contributions and proposed compelling future plans to promote broad participation in the biomedical research workforce (such as activities that promote inclusive, supportive, and accessible biomedical research environments that support the success of trainees and scientists from all backgrounds, including individuals from underrepresented groups).
Consistent with existing NIH practice and applicable law:
General Considerations
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 organizations local context as well as national needs. Appropriate to the career stage, candidates should have demonstrated meaningful contributions toward promoting broad participation in the biomedical research workforce (for example, furthering inclusive, supportive, and accessible biomedical research environments), and propose well-developed plans for how those activities will be continued as an independent investigator. Candidates whose statements are weak in this area are not the intended recipients of this award. Organizations should select candidates who, through their activities and individual experiences, can effectively serve as mentors to trainees from increasingly diverse backgrounds pursuing biomedical research careers. Additionally:
MOSAIC Cohort-based career development program: In addition to the K99/R00 award, postdoctoral scholars who receive funding through the MOSAIC program will be assigned to organizations that will provide additional mentoring, networking, and skills development opportunities (MOSAIC UE5 institutionally focused research education awardees). These organizations are listed on the MOSAIC website. Candidates are encouraged to explore the various organizations websites, their programs for scholars, and incorporate these activities as part of their career development plans. The integrated program of research and mentoring is expected to provide awardees with the mentoring and professional networks that will prepare them to transition into, advance, and succeed in independent, tenure-track or equivalent research-intensive faculty positions.
Additional Information for Clinician Scientists: For the purposes of this program, clinician scientists include individuals with an MD, DO, DDS/DMD, DVM/VMD, or nurses with research doctoral degrees who devote the majority of their time to biomedical research. The K99/R00 is intended for those clinician scientists who already have substantial research training and are dedicated to initiating a strong, research-intensive career as clinician scientists. The K99/R00 program is designed to facilitate a timely transition of rigorous clinician scientists from mentored, research positions to independent, tenure-track or equivalent faculty positions, and to provide independent NIH research support during the transition. Individuals who need a longer period of mentored career development before they are prepared to begin the transition to research independence should consider the K08 or K23 program (see: K Kiosk).
Clinical Trial: This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. Candidates not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO (PAR-24-225).
NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).
NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
See Section VIII. Other Information for award authorities and regulations.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply - Application Guide provides details on these application types.
Required: Only accepting applications that propose an independent clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Mentored Phase (K99)
Salary and fringe benefits may be requested to the level provided by the awarding Institute or Center. Candidates should consult the
Intramural: Mentored candidates in the NIH intramural program will be supported by intramural funds provided by the NIH Institute/Center intramural laboratory in which they are conducting their research. Budget details for the mentored phase will be negotiated with the sponsoring intramural laboratory. Salary will be consistent with that offered scientists in similar, intramural NIH positions.
Extramural: Mentored candidates at an extramural sponsoring organization will be supported by NIH extramural funds. The requested salary must be consistent both with the established salary structure at the organization and with salaries actually provided by the organization from its own funds to other staff members with equivalent qualifications, rank, and responsibilities in the department concerned. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.
The total salary may not exceed the legislatively mandated salary cap.
Independent Phase (R00)
The total cost for the independent phase (R00) may not exceed $249,000 per year. This amount includes salary, fringe benefits, research costs, and applicable indirect costs. Indirect costs will be reimbursed at the extramural sponsoring organization's indirect cost rate. Indirect costs requested by consortium participants are included in the total cost limitation.
The participating NIH Institutes and Centers will provide research development support for the award recipient (see the Table of IC-Specific Information, Requirements and Staff Contacts). These funds may be used for the following expenses:
Research development costs must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.
Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
For the extramural K99 phase, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. For the R00 phase, indirect costs will be reimbursed at the extramural sponsoring institutions indirect cost rate.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
1. Eligible Applicants
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.
The applicant institution will be the mentored phase (K99) institution. All institution/organization types listed above are eligible for both the mentored (K99) and independent (R00) phase, with the following exceptions: (1) Eligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase; and (2) Eligibility of organizations, other than institutions of higher education, for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH research (R01 or R01-equivalent) grants.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities, women and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support. See NOT-OD-22-019 Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities.
Multiple PDs/PIs are not allowed.
By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
Candidates for the K99/R00 award must have a clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD or equivalent doctoral degrees). Clinicians (including those with MD, DDS, DVM and other licensed health professionals) in a clinical faculty position that denotes independence in clinical responsibilities but not in research may also be eligible for the K99/R00 award.
Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If the candidate achieves independence (that is, any faculty or non-mentored research position) before a K99 award is made, neither the K99 award nor the R00 award will be issued. K99/R00 candidates must have no more than 4 years of postdoctoral research experience as of the relevant application due date regardless of whether it is a New or Resubmission application. Only time dedicated to research activities counts toward the 4-year limit.
Please refer to NIH Extension Policy for Eligibility Window for Pathway to Independence Awards (K99/R00).
Individuals are NOT eligible if they:
Ph.D. (or equivalent research doctorate degree) candidates in positions other than postdoctoral fellow positions: It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility from the relevant IC before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that their position complies with the intent of this eligibility requirement. If a potential candidate is in a position that is not clearly identifiable as a postdoctoral training position, the candidate should provide the relevant NIH Institute or Center an official statement of the institutions policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postdoctoral training position.
Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral positions: Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K99/R00 award, and should contact a Program Director at the relevant NIH Institute for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career awards (see K Kiosk) available for junior faculty development.
The following is provided as an aid to distinguish independent from non-independent positions: However, it is not sufficient merely to cite one or more of the following items to document eligibility.
Evidence for non-independence may include:
Conversely, evidence for independence, and therefore lack of eligibility, includes:
2. Cost Sharing
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.
NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:
K99 Phase. At the time of award, the candidate must have a full-time appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.
Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.
After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-18-156 and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details
R00 Phase. Although candidates are required to devote no less than 75% of their full-time, 12-month professional effort to research (i.e., full-time for 9 person-months), the required 9 person-months of research effort need not be devoted exclusively to the R00-supported research.
Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed to the career development of the candidate, the direct supervision of the candidates research and supporting the candidates transition to independence. The mentor must document the availability of sufficient research support and appropriate facilities for the proposed project. Candidates are encouraged to identify more than one mentor, that is, a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidates research. Candidates also are encouraged to propose a mentoring team that will provide additional guidance, typically focused on professional aspects of the candidates career development. Mentors are expected to promote inclusive, safe and supportive research environments (that is, institutional and departmental environments where trainees from all backgrounds feel integrated into and supported by the biomedical community).
The candidate must work with the mentor(s) in preparing the application.
The primary sponsor can be an independent investigator at any career stage, including an early-stage investigator. Regardless of career stage, the primary mentor must demonstrate a commitment to ensuring the candidate receives tailored career development that will facilitate their transition to independence.
The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.
The applicant organization must have appropriate research and career development activities, as well faculty able to serve as mentors in biomedical, behavioral, or clinical research. The applicant organization should have a clear commitment to promoting safe, inclusive, supportive and accessible scientific research environments.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to access the online ASSIST system or to download application forms are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
Page Limitations
All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.
SF424(R&R) Cover
All instructions in the How to Apply - Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Other Attachments
Statement on Activities to Promote Broad Participation in Biomedical Research Workforce (Required; 1-page maximum): The application must include a statement from the candidate (i.e., the postdoctoral researcher) describing (a) past and present activities, and (b) future plans as a faculty member to promote broad participation in the biomedical workforce, that is those activities that further and foster inclusive, supportive, and accessible biomedical research environments that support trainees and scientists from all backgrounds, including individuals from underrepresented groups. Highlight activities relevant to addressing underrepresentation within the biomedical research workforce within the United States and territories. Examples can include, but are not limited to:
Highlight the impact of past and present activities.
For future plans as a faculty member, describe activities that go beyond those considered a regular part of an individual's academic duties (for example, mentoring the trainees who are in the faculty members research group).
Describe planned activities during the career award to develop or enhance skills in working effectively with researchers and trainees from a wide variety of backgrounds.
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 document added to the section Other Attachments will be the name used for the bookmark in the electronic application in eRA Commons.
Project Summary/Abstract
Include a description of your current research and the research you propose to continue in the independent phase.
SF424(R&R) Senior/Key Person Profile Expanded
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
K99 Phase: Provide itemized budget information for each budget period covered under the K99 phase.
R00 Phase: Itemized budget information is not required for the R00 phase; a total requested amount for each budget period is acceptable. However, some basic information must be completed in order for NIH to successfully process the budget form. For each budget period of the R00 phase:
At the time of transition to the R00 phase, the R00 applicant institution will submit a detailed budget for each budget period of the R00 project period that reflects the direct and indirect costs at the R00 applicant institution.
PHS 398 Cover Page Supplement
All instructions in the How to Apply - Application Guide must be followed.
PHS 398 Career Development Award Supplemental Form
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:
Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional
Commitment to the Candidate
Other Research Plan Sections
Appendix
All instructions in the How to Apply - Application Guide must be followed.
Candidate Section
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Candidate Information and Goals for Career Development
Candidates Background
Career Goals and Objectives
Candidates Plan for Career Development/Training Activities During Award Period
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Research Strategy
Training in the Responsible Conduct of Research
Mentor, Co-Mentor, Consultant, Collaborators Section
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Plans and Statements of Mentor and Co-mentor(s)
The plans and statements should be tailored to the candidate and their specific areas of research and career development.
Letters of Support from Collaborators, Contributors and Consultants
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Description of Institutional Environment (2 Pages Maximum)
Applicants should disregard the following warning message "The Description of Institutional Environment attachment on the PHS 398 Career Development Award Supplemental Form is limited to 1 page." This NOFO permits 2 pages for this attachment.
Institutional Commitment to the Candidates Research Career Development
Description of Candidates Contribution to Program Goals
The Description of Candidate's Contribution to Program Goals is not required for this NOFO and should not be included in the application.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the How to Apply - Application Guide must be followed.
PHS Assignment Request Form
All instructions in the How to Apply - Application Guide must be followed.
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. At least three, but no more than five, reference letters are required. The letters should be from individuals not directly involved in the application, but who are familiar with the candidate's qualifications, training, interests, and who can elaborate on the candidates potential to contribute to program goals. The sponsor/co-sponsor(s) of the application cannot be counted toward the three required references. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIHs electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.
5. Intergovernmental Review (E.O. 12372)
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH . Applications that are incomplete or non-compliant will not be reviewed.
Applications must include a Statement on Activities to Promote Broad Participation in Biomedical Research Workforce as an Other Attachment on the SF424(R&R) Other Project Information form. Applications that fail to include this information will be considered incomplete and will be withdrawn without review.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following: Through this NOFO, NIH intends to fund promising postdoctoral candidates who have demonstrated activities and proposed compelling future plans to promote broad participation in the biomedical research workforce as they develop new skills and progress to research independence. Reviewers should evaluate:
Reviewers should also note that candidates are encouraged to apply early in their postdoctoral tenure to have sufficient time to develop their skills, knowledge and career plans during the mentored K99 phase of an award. Therefore, candidates should not necessarily be expected to already have first-authored publications from their postdoctoral work but should instead present evidence that their previous and current studies and future plans are likely to support a successful independent research career.
Reviewers should also note that while any of the candidates individual
Overall Impact
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidates potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through career development awards may be sufficient to support only small feasibility studies.
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmission applications, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. Undue weight should not be given for simply responding to previous comments; instead, the content of the responses and how the application will be improved by any proposed changes should be considered.
Not Applicable.
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidates career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the candidate's instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019 and NOT-OD-22-055.
Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.
The following will be considered in making funding decisions, consistent with applicable law:
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.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. This request is not a Notice of Awards nor should it be construed to be an indicator of possible funding.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipients business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Awardees are expected to participate in career development activities and convenings coordinated by MOSAIC institutionally-focused research education awardees (UE5). Awardees will provide updates on involvement with the MOSAIC UE5 grantee in section B.4 of the RPPR.
There will not be a formal Notice of Award (NoA) associated with the K99 phase of the award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural K99 award, as well as expectations for the transition to the R00 phase of the award.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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:
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 investigators scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicants integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Transition from the mentored phase to the independent phase is intended to be continuous in time and, except in unusual, extenuating circumstances, the awarding NIH Institute/Center will not extend the K99 phase beyond the 2-year limit. ICs may, at their discretion, make exceptions to this time limitation when individuals have been invited for faculty job interviews but final decisions have not yet been made by the potential R00 institution or, rarely, because of unusual, extenuating circumstances. To activate the independent phase of the grant, individuals must have been offered and accepted a tenure-track, full-time assistant professor position (or equivalent) by the end of the K99 project period.
An eligible R00 institution will have appropriate infrastructure to support the proposed research program and a history of external research funding. K99 recipients are free to apply for independent phase positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the independent phase of the award will not be activated. This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards. Eligibility of for-profit organizations for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH R01 or R01-equivalent research grants. PIs are encouraged to discuss job offers at for-profit organizations with NIH Program staff well in advance of accepting such an offer.
To avoid potential problems in activating the independent phase, recipients are strongly encouraged to contact their NIH program official as soon as plans to apply for and, assume an independent position develop, and not later than 6 months prior to the termination of the K99 phase of the award.
At that time, individuals should discuss plans for transition to, and application for, the R00 phase with their NIH program official. The application for the R00 phase of the award should be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase recipient organization.
The independent phase institution will submit an application on behalf of the candidate for the R00 award using the PHS 398 Application. The R00 application must include:
These materials should be sent directly to the awarding Institute or Center (IC). The organization's Authorized Organizational Representative will email the application in PDF format to the Financial or Grants Management contact person of the awarding NIH Institute or Center listed in the Notice of Award. The R00 application will be evaluated by extramural Program staff of the awarding component for completeness and appropriateness to the program.
Two additional documents are included with the R00 application. A letter from the R00 Department or Division Chairman must be submitted that describes the R00 organization's commitment to the candidate and plans for their career development (see below). If not already provided, the final evaluation statement by the K99 phase mentor, must be provided.
In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring organization must provide protected research time (minimum of 9 person-months or 75% of the candidates full time professional effort) at least for the duration of the R00 award. The start-up package and other organizational support must be described in detail and must be comparable to that given to other faculty recently hired into tenure-track or equivalent faculty positions. Organizations must provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant; R00 funds may not be used to offset the typical startup package or to offset the usual organizational commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support. The R00 sponsoring organization must describe the candidates academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the organization. The R00 phase organization must describe how the awardees ability to apply for and secure independent research grant (e.g., R01, NIGMS R35 ESI MIRA, etc.) support will be fostered and supported during the R00 phase of the award. The R00 phase organization must describe its commitment and activities taken to promote research environments are safe, inclusive, supportive, and accessible, and strategies it employs to promote the success of early-stage faculty.
The R00 award requires that a minimum of 9 person months (75% of the candidates full time professional effort) be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the R00 award period. NIH staff may review start-up packages and other commitments between the organization and candidate prior to activating the independent phase of the award. It is suggested that the applicant and/or the hiring organization discuss the organizational commitment with the relevant NIH institute Program Official prior to finalizing the offer. NIH will not activate the independent phase if the organizational commitment is deemed inadequate. Recipients who are approved to transition will receive a Notice of Award reflecting the new R00 grant mechanism, the dollar amount, and the new recipient organization (if applicable).
The K99/R00 award is intended to facilitate successful transition to independence. Consequently, a requirement for activation of the R00 phase is successful completion of this transition. K99 recipients are encouraged (but not required) to apply for independent positions at departments and organizations different from where they conducted their mentored research. It is important for all recipients, but especially so for those who intend to stay at the mentored phase organization for the independent phase, to provide a plan by which they will separate from their mentor and advance to independence. Recipients are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of an NIH awarding component.
Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the R00 application.
Although the financial plans of the NIH Institute or Center provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
If transition from the K99 phase at an extramural organization to the R00 phase occurs at the originally scheduled end date of the K99 award, then no specific steps to terminate the K99 award are necessary. If the transition at an extramural organization occurs prior to the scheduled end date, then a revised Notice of Award will be issued to terminate the K99 phase award. Carry-over of unspent funds from a partially completed year in the K99 phase into the R00 phase may be permitted.
3. Data Management and Sharing
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
4. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentors Report must include an annual evaluation statement of the candidates progress.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.
The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.
5. Evaluation
In carrying out its stewardship of human resource-related programs, NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
Within ten years of making awards under this program, NIH will assess the programs overall outcomes, gauge its effectiveness in achieving its goals, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.
The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Because of the difference in individual Institute and Center (IC) program requirements for this NOFO, prospective applicants MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (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: support@grants.gov
Lanay M. Mudd, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: lanay.mudd@nih.gov
Alberto L Rivera Rentas
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301-496-1804
E-mail: riverara@mail.nih.gov
Michelle Jones-London, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-451-7966
Email: jonesmiche@ninds.nih.gov
Carol Shreffler, PhD
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-3322 or 919-316-9591
Email: shreffl1@niehs.nih.gov
Meryl Sufian, PhD
National Library of Medicine (NLM)
Telephone: 301-496-4671
Email: sufianm@mail.nih.gov
Lindsey Nicole Friend
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: none
E-mail: lindsey.friend@nih.gov
Heather Colley
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301.480.2332
E-mail: heather.colley@nih.gov
James Churchill, Ph.D.
National Institute of Mental Health (NIMH)
Phone: 301-443-3621
Email: James.Churchill@nih.gov
Robert C Rivers, Ph.D.
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: 301-443-8415
E-mail: riversrc@mail.nih.gov
Tina L Gatlin
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: 301.480.2280
E-mail: gatlincl@mail.nih.gov
Dorothy M Castille, PhD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-9411
E-mail: dorothy.castille@nih.gov
Wayne C. Wang, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0535
Email: Wayne.wang2@nih.gov
Maria G. Carranza, Ph.D.
National Institute on Aging (NIA)
Email: NIAtraining@nih.gov
Mary Elizabeth (Libbey) Bowen, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-841-5345
Email: libbey.bowen@nih.gov
Carolyn Joy Bondar, Ph.D.
ORWH - Office of Research on Women's Health
Phone: (301) 402-8770
E-mail: carolyn.bondar@nih.gov
Dennis A. Twombly, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3371
Email: dtwombly@mail.nih.gov
Gary Murray, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9940
Email: Gary.Murray@mail.nih.gov
National Institute of General Medical Sciences (NIGMS)
Email: NIGMSReview@mail.nih.gov
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: nindsreview.nih.gov@mail.nih.gov
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Email: ramesh.vemuri@nih.gov
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov
Christopher Myers
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-0713
E-mail: cm143g@nih.gov
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov
Alicia Graham
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-4215
Email: alicia.graham@nih.gov
Andrea Culhane
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: andrea.culhane@nih.gov
Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov
Deanna L Ingersoll
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301-435-7858
E-mail: deanna.ingersoll@nih.gov
Terri Jarosik
National Institute of Mental Health (NIMH)
Phone: 301-443-3858
Email: tjarosik@mail.nih.gov
Hubert Walters
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: 301-496-3258
E-mail: hubert.walters@nih.gov
Katie Ellis
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: 301-451-4791
E-mail: kellis@mail.nih.gov
Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: pg38h@nih.gov
Shaheed Michael Ziyout
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 301-827-8152
Email: shaheed.ziyout@nih.gov
Jessi Perez
National Institute on Aging (NIA)
Email: jessi.perez@nih.gov
Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@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
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