Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
New
See Notices of Special Interest associated with this funding opportunity
None
93.853
The purpose of the NINDS Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to support a cohort of new and talented, independent investigators from diverse backgrounds (e.g. see NOT-OD-20-031, Notice of NIH’s Interest in Diversity) conducting AD/ADRD research. The program is designed to facilitate a timely transition of eligible postdoctoral researchers from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees establish independent research programs in the AD/ADRD field.
This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experiences in a clinical trial led by a mentor or co-mentor.
Not Applicable
Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
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.
Standard AIDS dates by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.
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.
Standard dates apply
Standard dates apply
Standard dates apply
Not Applicable
The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
The objective of the NIH Pathway to Independence Award (K99/R00) is to help outstanding postdoctoral researchers complete needed, mentored training and transition in a timely manner to independent, tenure-track or equivalent faculty positions. The K99/R00 award is intended to foster the development of a creative, independent research program that will be competitive for subsequent independent funding and that will help advance the mission of the NIH. Applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission. The K99/R00 award is intended for individuals who require at least 12 months of mentored research training and career development (K99 phase) before transitioning to the R00 award phase of the program. Consequently, the strongest applicants will require, and will propose, a well-conceived plan for 1 2 years of substantive mentored research training and career development that will help them become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs. An individual who cannot provide a compelling rationale for at least one year of additional mentored research training at the time of award is not a strong candidate for this award.
Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (any faculty or non-mentored research position) before a K99 award is made, neither the K99, nor the R00 award, will be made. The K99/R00 award will provide up to 5 years of support in two phases. The initial (K99) phase will provide support for up to 2 years of mentored postdoctoral research training and career development. The second (R00) phase will provide up to 3 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position. The two award phases are intended to be continuous in time. Therefore, although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 award period.
Background Information
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 biological, clinical, behavioral, and social sciences (collectively termed "biomedical") research workforce. 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 contributes to excellence in research training environments and strengthens the research enterprise. While the proportion of graduates from underrepresented groups in biomedical programs is increasing slightly, the representation of these groups in later career stages remains small (see http://www.nsf.gov/statistics/wmpd/).
The National Alzheimer's Project Act (NAPA), enacted into public law in January 2011, is a detailed plan that directs activities, drives the development of recommendations, and monitors progress on Alzheimer's disease (AD) and AD-related dementias (ADRD). To provide a living framework for NAPA, the U.S. Department of Health and Human Services (HHS) proposed the National Plan to Address Alzheimer’s Disease in 2012, which is organized into five strategic goals. Goal 1 of the National Plan is to prevent and effectively treat (delay onset, slow progression of) AD/ADRD by 2025. To achieve this ambitious goal, the National Plan has recognized a critical need to increase the number of health professionals and researchers, including those from underrepresented groups, who are trained to meet the expanding demand for cognitive impairment and dementia diagnosis, care, and research.
Purpose
The specific purpose of this Funding Opportunity Announcement (FOA) is to assist eligible postdoctoral researchers from diverse backgrounds with their transition to tenure-track or equivalent faculty positions and establishment of independent research programs in the field of AD/ADRD. The NINDS AD/ADRD K99/R00 program is intended to foster the development of a creative, independent researcher that will be competitive for subsequent independent funding and that will help advance the mission of the NIH and AD/ADRD research areas in particular. It is expected that the proposed research be rigorously designed, executed, analyzed, and interpreted (https://grants.nih.gov/policy/reproducibility/index.htm).
Applications appropriate for this FOA may propose biomedical research across the spectrum of AD/ADRD, including AD, Lewy body dementia, vascular contributions to cognitive impairment and dementia, frontotemporal dementia, and mixed dementias, especially mixed with cerebrovascular disease or Lewy bodies. The pre-symptomatic, early symptomatic, and dementia stages of these diseases and syndromes can be addressed. Applications may include, but are not limited to, the following research areas:
Program Considerations
Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. The K99 is not intended to extend time in the postdoctoral lab while an individual is on the job market. Individuals who are applying or interviewing for tenure track (or equivalent) faculty positions at research-intensive institutions are not the intended candidates for the AD/ADRD K99/R00 Transition Award. If an applicant achieves independence (any faculty or non-mentored research position) before a K99 award is made, neither the K99, nor the R00 award, will be made.
The K99/R00 award will provide up to 5 years of support in two phases. The initial (K99) phase will provide support for up to 2 years of mentored postdoctoral research training and career development. The second (R00) phase will provide up to 3 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position. The two award phases are intended to be continuous in time. Although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 award period.
Additional Information for Physician-Scientists: For the purposes of this program, physician-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 physician-scientists who already have substantial research training and are dedicated to initiating a strong, research-intensive career as physician-scientists. The K99/R00 program is designed to facilitate a timely transition of outstanding physician-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).
Applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission application. Candidates are strongly encouraged to apply no later than the third year of their postdoctoral training to ensure awardees receive maximum benefit from both the K99 phase of the award and to facilitate a timely transition to independence.
The K99/R00 award is intended for individuals who require at least 12 months of mentored research training and career development (K99 phase) before transitioning to the R00 award phase of the program. Consequently, the strongest applicants will require and propose a well-conceived plan for 1 2 years of substantive mentored research training and career development that will help them become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs. An individual who cannot provide a compelling rationale for at least one year of additional mentored research training at the time of award is not a strong candidate for this award (e.g., individuals who are actively applying or interviewing for independent positions at research-intensive institutions). If an applicant achieves independence (any faculty or non-mentored research position) before a K99 award is made, neither the K99, nor the R00 award, will be made.
Pre-Submission Consultation
Applicants are strongly encouraged to consult with NIH scientific/research staff as early as possible before the due date when planning an application. Early contact provides an opportunity for NIH scientific/research staff to provide guidance on program scope and appropriateness of the proposed research and training for potential funding in response to this FOA.
Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.
Need help determining whether you are doing a clinical trial?
NINDS intends to fund an estimate of 3 awards, corresponding to a total of $450,000, in fiscal year 2022. Future year amounts will depend on annual appropriations and the submission of a sufficient number of meritorious applications.
Mentored Phase (K99)
NINDS will provide up to $75,000 per year for salary support, plus fringe, and up to $20,000 for research support costs. For applicants with medical degrees who are licensed to practice, NINDS will provide up to $125,000 per year for salary support. Applicants must commit a minimum of 9 person months effort to the K99/R00 research during both phases of the award (Note: Neurosurgeons must commit a minimum of 6 person months effort to the K99/R00 research during both phases of the award). Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094
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 institution/organization will be supported by NIH extramural funds. The requested salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution 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 NIH contribution to salary may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
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 institution's indirect cost rate.
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. Expenses may include (a) tuition and fees related to career development activities; (b) supplies, equipment and technical personnel; (c) statistical services including personnel and computer time; and (d) expenses to attend relevant scientific meetings.
Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
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
Governments
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.
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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
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.
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 are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.
K99/R00 applicants 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. Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.
Parental, medical, or other well-justified leave for personal or family situations of generally less than 12 months duration is not included in the 4-year eligibility limit, nor is clinical training with no research involvement (e.g., full-time residency training). NIH will approve an extension of one year for childbirth within the 4 year K99 eligibility window. Applicants who will be PD/PIs on a K99 application must provide the child’s date of birth in the extension request justification submitted to IC program officials and/or scientific/research contacts listed in the FOA at least 12 weeks before submitting an application. Part-time postdoctoral research training, related to personal or family situations or occurring during a research residency or fellowship, will be pro-rated accordingly. In addition, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 4-year research training eligibility limit. Only time dedicated to research activities counts toward the 4-year limit.
Additional clarifications are provided under Frequently Asked Questions.
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). Potential candidates are encouraged to discuss their individual situation with an NIH Institute or Center Scientific Program Contact listed in Section VII before applying. K99/R00 applicants 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. Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.
Enhancing Diversity
The overarching goal of this program is to enhance the diversity of independent investigators conducting research on AD/ADRD. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student, post-doctorate, and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical sciences (see NOT-OD-20-031, Notice of NIH’s Interest in Diversity).
For the purpose of this announcement, institutions are encouraged to identify candidates who will enhance diversity on a national basis. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program. A clear commitment to enhancing diversity in the biomedical research workforce is required from the institutional environment letter.
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 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 his or her position complies with the intent of this eligibility requirement. If a potential applicant is in a position that is not clearly identifiable as a postdoctoral training position, candidate should provide the relevant NIH Institute or Center an official statement of the institution’s policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postdoctoral training position.
Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral positions: Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K99/R00 award, and should contact a Program Director at the relevant NIH Institute for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career awards (see K Kiosk) available for junior faculty development.
The following is provided as an aid to distinguish independent from non-independent positions: However, it is not sufficient merely to cite one or more of the following items to document eligibility.
Evidence for non-independence may include:
Conversely, evidence for independence, and therefore lack of eligibility, includes:
Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:
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-09-036 for more details.
R00 Phase. Although candidates are required to devote no less than 75% of their full-time, 12-month professional effort to research (i.e., full-time for 9 person-months), the required 9 person-months of research effort need not be devoted exclusively to the R00-supported research.
Mentor(s)
Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience in the field of AD/ADRD. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
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. For this FOA, the composition of the mentoring team should reflect knowledge and experience requisite for guiding the applicant's career development in the AD/ADRD field.
The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical or clinical research in the field of AD/ADRD. The applicant institution should have a clear commitment to enhancing diversity in the biomedical research workforce and promoting inclusive and supportive scientific research environments, as described in the Institutional Environment Letter.
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Project Summary/Abstract
Include a description of your current research and the research you propose to continue in the independent phase.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:
Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional
Commitment to the Candidate
Other Research Plan Sections
Appendix
All instructions in the SF424 (R&R) Application Guide must be followed.
Candidate Section
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate Information and Goals for Career Development
Candidate’s Background
Career Goals and Objectives?
Candidate’s Plan for Career Development/Training Activities During Award Period
Research Plan Section
All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Plans and Statements of Mentor and Co-mentor(s)
Letters of Support from Collaborators, Contributors and Consultants
Environmental and Institutional Commitment to the Candidate
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Description of Institutional Environment (2 pages maximum)
Institutional Commitment to the Candidate’s Research Career Development
Description of Candidate’s Contribution to Program Goals: The sponsoring institution must provide a document on institutional letterhead that explains 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 NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
Reference Letters
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.
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
Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
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.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number 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. Any instructions provided here are in addition to the instructions in the policy.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
Reviewers should evaluate the candidate's potential for obtaining a tenure-track or equivalent faculty position and developing an independent research program that will make important contributions to the AD/ADRD research field. Reviewers should consider in their evaluation the likely value of the proposed K99 phase research and career development in facilitating transition to research independence, and the feasibility of the proposed research project as a vehicle for developing a successful, independent research program after transition to the R00 award phase.
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Candidate
Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring
Research Plan
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
Protections for Human Subjects
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.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
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.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
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.
Resubmissions
For Resubmissions, 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.
Revisions
Not applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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.
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Training in the Responsible Conduct of Research
All applications for support under this FOA 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 candidate’s 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 fellow’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.
Select Agent Research
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).
Authentication of Key Biological and/or Chemical Resources:
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.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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:
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.
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.
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.
Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
There will not be a formal Notice of Award (NoA) associated with the K99 phase of the award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural K99 award, as well as expectations for the transition to the R00 phase of the award.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 FOA.
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 theFederal 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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Transition to the Independent Phase
Transition from the mentored phase to the independent phase is intended to be continuous in time and, except in unusual, extenuating circumstances, the awarding NIH Institute/Center will not extend the K99 phase beyond the 2-year limit. ICs may, at their discretion, make exceptions to this time limitation when individuals have been invited for faculty job interviews but final decisions have not yet been made by the potential R00 institution or, rarely, because of unusual, extenuating circumstances. To activate the independent phase of the grant, individuals must have been offered and accepted a tenure-track, full-time assistant professor position (or equivalent) by the end of the K99 project period.
An eligible R00 institution will have appropriate infrastructure to support the proposed research program and a history of external research funding. Applicants 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, applicants 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 original application plus one copy (preferably in PDF format) are to be mailed (or e-mailed) 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 institution’s commitment to the candidate and plans for his/her 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 institution must provide protected research time (minimum of 9 person-months or 75% of the candidate’s full time professional effort) at least for the duration of the R00 award. The start-up package and other institutional 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. Institutions 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 institutional commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support. The R00 sponsoring institution must describe the candidate’s academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the institution. The R00 phase institution must describe how the awardee’s ability to apply for and secure independent research grant (R01) support will be fostered and supported during the R00 phase of the award.
The R00 award requires that a minimum of 9 person-months (75% of the candidate’s full time professional effort) be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the R00 award period. NIH staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent phase of the award. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the relevant NIH institute Program Official prior to finalizing the offer. NIH will not activate the independent phase if the institutional commitment is deemed inadequate. Applicants 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. Applicants are encouraged (but not required) to apply for independent positions at departments and institutions different from where they conducted their mentored research. It is important for all applicants, but especially so for applicants who intend to stay at the mentored phase institution for the independent phase, to provide a plan by which they will separate from their mentor and advance to independence. Awardees are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of an NIH awarding component.
Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the R00 application.
Although the financial plans of the NIH Institute or Center provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
Termination of the K99 award phase
If transition from the K99 phase at an extramural institution 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 institution 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.
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.
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.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
In carrying out its stewardship of human resource-related programs, the 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, NINDS will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity in the AD/ADRD field, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NINDS 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.
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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Amelie Gubitz, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Lauren Ullrich, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Jamie Lahvic, Ph.D.
National Institute on Aging (NIA)
Email: [email protected]
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]
Chief, Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Jessi Perez
National Institute on Aging (NIA)
Telephone: 301-402-7739
Email:[email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.