Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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 on Drug Abuse (NIDA)
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK ) - participation added for due dates on/after January 8, 2021 (see NOT-DK-21-002 )

Office of Research Infrastructure Programs (ORIP)

Special Note: Not all NIH Institutes and Centers participate in Parent Announcements. 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.

Funding Opportunity Title

Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Not Allowed)

Activity Code

K01 Research Scientist Development Award - Research & Training

Announcement Type

Reissue of PA-19-126

Related Notices

See Notices of Special Interest associated with this funding opportunity

December 20, 2023 - Notice of NCIs Participation in NIH Mentored Research Scientist Development Awards (Parent K01) Notices of Funding Opportunity. See Notice NOT-CA-24-020

September 27, 2023 - Update to NIDDK Policy on Combined Support Between and Institutional Career Development Award and an Individual Career Development Award. See Notice NOT-DK-23-025

March 2, 2023 - Notice to Extend the Expiration Date for All NIH Career Development Award (K) Parent Announcements. See Notice NOT-OD-23-096

NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

May 3, 2022 - Understanding the Basic Mechanisms of Immune-related Adverse Events (irAEs) in Cancer Immunotherapy. See Notice NOT-CA-22-063.

March 4, 2022 - NIDDK Notice of Continuation of Temporary Extension of Eligibility for the NIH Mentored Research Scientist Development Award (K01) Award During the COVID-19 Pandemic. See Notice NOT-DK-22-016.

See Notices of Special Interest related to this funding opportunity

October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.

September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.

August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170

April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109

See Notices of Special Interest related to this opportunity

  • May 20, 2021 - NIDDK Notice of Continuation of Temporary Extension of Eligibility for the NIH Mentored Research Scientist Development Award (K01) Award During the COVID-19 Pandemic. See Notice NOT-DK-21-019.
  • April 26, 2021 - Guidance Regarding Reduction of Effort for Surgeons on NIA Individual Mentored K Awards. See Notice NOT-AG-21-019.
  • November 17, 2020 - Temporary Extension of Eligibility for the NIDDK K01 Mentored Research Scientist Development Award During the COVID-19 Pandemic. See Notice NOT-DK-20-054.
  • November 10, 2020 - Notice of NIDDK Participation in PA-20-190 and PA-20-176. See Notice NOT-DK-21-002.
  • Funding Opportunity Announcement (FOA) Number

    PA-20-190

    Companion Funding Opportunity

    PA-20-176 - Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Required)

    PA-20-191 - Mentored Research Scientist Development Award (Parent K01 - Independent Basic Experimental Studies with Humans Required)

    Catalog of Federal Domestic Assistance (CFDA) Number(s)

    93.213; 93.172; 93.837, 93.838, 93.839, 93.840, 93.233; 93.866; 93.273; 93.855; 93.846; 93.286; 93.279; 93.173; 93.121; 93.242; 93.307; 93.361; 93.351, 93.398, 93.399, 93.393

    Funding Opportunity Purpose

    The purpose of the NIH Mentored Research Scientist Development Award (K01) is to provide support and protected time (three to five years) for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. Although all of the participating NIH Institutes and Centers (ICs) use this support mechanism to support career development experiences that lead to research independence, some ICs use the K01 award for individuals who propose to train in a new field or for individuals who have had a hiatus in their research career because of illness or pressing family circumstances..

    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. Applicants proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion FOA.

    Key Dates

    Posted Date

    May 6, 2020

    Open Date (Earliest Submission Date)

    May 12, 2020

    Letter of Intent Due Date(s)

    Not Applicable

    Application Due Date(s)

    Standard dates apply.

    The first standard application due date for this FOA is June 12, 2020.

    All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). 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.

    AIDS Application Due Date(s)

    Standard AIDS dates apply.

    The first AIDS application due date for this FOA is September 7, 2020.

    All applications are due 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 the listed date(s).

    Scientific Merit Review
    Advisory Council Review
    Earliest Start Date
    Expiration Date

    New Date May 8, 2024 (Original Date: May 8, 2023) per issuance of NOT-OD-23-096

    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

    It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

    3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


    4. Table of Contents

      Part 1. Overview Information
      Part 2. Full Text of the Announcement

      Section I. Funding Opportunity Description
      Section II. Award Information
      Section III. Eligibility Information
      Section IV. Application and Submission Information
      Section V. Application Review Information
      Section VI. Award Administration Information
      Section VII. Agency Contacts
      Section VIII. Other Information


      Part 2. Full Text of Announcement
      Section I. Funding Opportunity Description

      The overall goal of the NIH Research Career Development program is to help ensure that a diverse 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 Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of protected time (3-5 years) for intensive research career development, under the guidance of an experienced mentor, or sponsor in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that, through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.

      Although all of the participating NIH Institutes and Centers (ICs) use this mechanism to support career development experiences that lead to research independence, some ICs use the K01 award for individuals who propose to train in a new field or for individuals who have had a hiatus in their research career because of illness or pressing family circumstances. Other ICs utilize the K01 award to support research in other fields.

      Note: This Funding Opportunity Announcement (FOA) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study clinical trial. Under this FOA candidates are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Those proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion FOA (PA-20-176).

      Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this FOA, prospective candidates are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs.

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

      Section II. Award Information
      Funding Instrument

      Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

      Application Types Allowed

      New
      Resubmission
      Revision

      The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

      Clinical Trial?

      Not Allowed: Only accepting applications that do not propose a clinical trial.

      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?

      Funds Available and Anticipated Number of Awards

      The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

      Award Budget

      Award budgets are composed of salary and other program-related expenses, as described below.

      Award Project Period

      The total project period may not exceed 5 years.

      Other Award Budget Information

      Salary

      The participating NIH Institutes and Centers will provide salary and fringe benefits for the award recipient (see Table of IC-Specific Information, Requirements and Staff Contacts). Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094

      The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.

      Other Program-Related Expenses

      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 funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research-related expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.

      Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

      Indirect Costs

      Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

      NIH grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

      Section III. Eligibility Information
      1. Eligible Applicants
      Eligible Organizations

      Higher Education Institutions

      • Public/State Controlled Institutions of Higher Education
      • Private Institutions of Higher Education

      The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

      • Hispanic-serving Institutions
      • Historically Black Colleges and Universities (HBCUs)
      • Tribally Controlled Colleges and Universities (TCCUs)
      • Alaska Native and Native Hawaiian Serving Institutions
      • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

      Nonprofits Other Than Institutions of Higher Education

      • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
      • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

      For-Profit Organizations

      • Small Businesses
      • For-Profit Organizations (Other than Small Businesses)

      Governments

      • State Governments
      • County Governments
      • City or Township Governments
      • Special District Governments
      • Indian/Native American Tribal Governments (Federally Recognized)
      • Indian/Native American Tribal Governments (Other than Federally Recognized)
      • U.S. Territory or Possession

      Other

      • Independent School Districts
      • Public Housing Authorities/Indian Housing Authorities
      • Native American Tribal Organizations (other than Federally recognized tribal governments)
      • Faith-based or Community-based Organizations
      • Regional Organizations
      Foreign Institutions

      Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
      Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
      Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

      Required Registrations

      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.

      • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
      • System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
      • o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
      • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
      • Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

      Program Directors/Principal Investigators (PD(s)/PI(s))

      All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

      All PD(s)/PI(s) must be registered with ORCiD. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

      Eligible Individuals (Program Director/Principal Investigator)

      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.

      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).

      Current and former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), other major individual career development awards (e.g., DP5, K01, K07, K08, K22, K23, K25, K76, K99/R00), or Project Leads of program project (P01) or center grant (P50) sub-projects, or the equivalent are not eligible. Current and former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Planning Grant (R34/U34), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible, as do PD/PIs of Transition Scholar (K38) awards and individuals appointed to institutional K programs (K12, KL2).

      Candidates for the K01 award must have a research or health-professional doctoral degree.

      This funding opportunity may support individuals who propose to train in a new field or individuals who have had a hiatus in their research career because of illness or pressing family circumstances.

      2. Cost Sharing

      This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

      3. Additional Information on Eligibility
      Number of Applications

      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:

      • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
      • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
      • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

      Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

      Level of Effort

      At the time of award, the candidate must have a full-time appointment at the applicant institution. Candidates are required to commit a minimum of nine person months of effort (i.e., 75% of full-time professional effort) to their program of career development during the mentored phase. Candidates may engage in other duties as part of the 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.

      Mentor(s)

      Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed 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.

      Institutional Environment

      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, behavioral, or clinical research.

      Section IV. Application and Submission Information
      1. Requesting an Application Package

      The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. 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 Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

      Page Limitations

      All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

      Instructions for Application Submission

      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 SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

      SF424(R&R) Cover

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

      SF424(R&R) Project/Performance Site Locations

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

      Other Project Information

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

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

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

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

      R&R Budget

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

      PHS 398 Cover Page Supplement

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

      PHS 398 Career Development Award Supplemental Form

      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, with the following additional instructions:

      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

      • Describe the candidate's commitment to a health-related research career. Describe all the candidate's professional responsibilities in the grantee institution and elsewhere and describe their relationship to the proposed activities on the career award.
      • Describe prior training and how it relates to the objectives and long-term career plans of the candidate.
      • Describe the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experience.
      • Provide evidence of the candidate's potential to develop into an independent investigator. Usually this is evident from publications, prior research interests and experience, and reference letters.

      Career Goals and Objectives

      • Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent investigator.

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

      • The candidate and the mentor(s) are jointly responsible for the preparation of the career development plan. A career development timeline is often helpful.
      • The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals.
      • Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person-months (75% full-time professional effort) commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.

      Research Plan Section

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

      Research Strategy

      • A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate the quality of the candidate’s research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
      • The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
      • If the applicant is proposing to gain experience in a clinical trial, ancillary clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

      Training in the Responsible Conduct of Research

      • All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

      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)

      • The candidate must name a primary mentor who, together with the candidate, is responsible for planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
      • The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
      • Include a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the career development program and related career development activities.
      • The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate’s research, publications, and progression towards independence.
      • Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
      • The primary mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
      • If the candidate is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or co-mentor of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

      Letters of Support from Collaborators, Contributors and Consultants

      • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants do not need to provide their biographical sketches unless also listed as senior/key personnel. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
      • Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.

      Environmental and Institutional Commitment to the Candidate

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

      Description of Institutional Environment

      • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
      • Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
      • Describe the resources and facilities that will be available to the candidate.,

      Institutional Commitment to the Candidate’s Research Career Development

      • The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
      • Provide assurances that the candidate will be able to devote the required effort to activities under this award.The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.
      • Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
      • Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

      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.

      PHS Human Subjects and Clinical Trials Information

      When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

      o do not complete Section 4 Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

      Delayed Onset Study

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

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

      PHS Assignment Request Form

      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.

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

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

      4. Submission Dates and Times

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

      Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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.

      5. Intergovernmental Review (E.O. 12372)

      This initiative is not subject to intergovernmental review.

      6. Funding Restrictions

      All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

      Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

      7. Other Submission Requirements and Information

      Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

      Important reminders:

      All PD(s)/PI(s) 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.

      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 (SAM). 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.

      Section V. Application Review Information
      1. Criteria

      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 developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

      Overall Impact

      Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

      Scored Review Criteria

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

      Candidate

      • Does the candidate have the potential to develop as an independent and productive researcher?
      • Are the candidate's prior training and research experience appropriate for this award?
      • Is the candidate’s academic, clinical (if relevant), and research record of high quality?
      • Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research?
      • Do the reference letters address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent investigator?

      Career Development Plan/Career Goals and Objectives

      • What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
      • Are the candidate's prior training and research experience appropriate for this award?
      • Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
      • Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?
      • If proposed, will the clinical trial experience contribute to the applicant’s research career development?

      Research Plan

      • Is the prior research that serves as the key support for the proposed project rigorous?
      • Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support of the proposed project?
      • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
      • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
      • Are the proposed research question, design, and methodology of significant scientific and technical merit?
      • Is the research plan relevant to the candidate’s research career objectives?
      • Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?
      • If proposed, will the clinical trial experience contribute to the proposed research project?

      Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

      • Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
      • Does the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement?
      • Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate?
      • Is the mentor’s description of the elements of the research career development activities, including formal course work adequate?
      • Is there evidence of the mentor s, consultant s, and/or collaborator s previous experience in fostering the development of independent investigators?
      • Is there evidence of the mentor's current research productivity and peer-reviewed support?
      • Is active/pending support for the proposed research project appropriate and adequate?
      • Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
      • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?

      Environment & Institutional Commitment to the Candidate

      • Is there clear commitment of the sponsoring institution to ensure that a minimum of 9 person-months (75% of the candidate’s full-time professional effort) will be devoted directly to the research and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
      • Is the institutional commitment to the career development of the candidate appropriately strong?
      • Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
      • Is the environment for the candidate’s scientific and professional development of high quality?
      • Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator?
      Additional Review Criteria

      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.

      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 across the lifespan (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.

      Renewals

      Not applicable

      Revisions

      For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

      Additional Review Considerations

      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.

      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).

      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).

      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.

      2. Review and Selection Process

      Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

      As part of the scientific peer review, all applications:

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

      Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

      • Scientific and technical merit of the proposed project as determined by scientific peer review.
      • Availability of funds.
      • Relevance of the proposed project to program priorities.
      3. Anticipated Announcement and Award Dates

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

      Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

      Section VI. Award Administration Information
      1. Award Notices

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

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

      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, Grantees, 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 the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

      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.

      3. Reporting

      When multiple years are involved, awardees 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. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

      A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

      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.

      4. Evaluation

      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.

      Section VII. Agency Contacts

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

      Because of the difference in individual Institute and Center (IC) program requirements for this FOA, prospective applications 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.

      Application Submission Contacts

      eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post submission issues)
      Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

      Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

      GrantsInfo (Questions regarding application instructions, 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

      Scientific/Research Contact(s)

      See Table of IC-Specific Information, Requirements and Staff Contacts

      Peer Review Contact(s)

      Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

      Financial/Grants Management Contact(s)

      See Table of IC-Specific Information, Requirements and Staff Contacts

      Section VIII. Other Information

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

      Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of fellowship and career development awards are encouraged to apply for an extramural LRP award.

      Authority and Regulations

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

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