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

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

Funding Opportunity Title

NHGRI Predoctoral to Postdoctoral Transition Award for a Diverse Genomics Workforce (F99/K00)

Activity Code

F99/K00  Pre-doc to Post-doc Transition Award/Post-doctoral Transition Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-21-143

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.172 

Funding Opportunity Purpose

 The purpose of the NHGRI Predoctoral to Postdoctoral Transition Award for a Diverse Genomics Workforce (F99/K00) is to support a defined pathway across career stages for talented graduate students from diverse backgrounds, including those from groups underrepresented in biomedical, clinical, behavioral and social sciences.  This two-phased award will facilitate completion of a doctoral dissertation (F99) and transition to a strong postdoctoral research position (K00) focused on the scientific, medical, ethical, social and/or legal areas of genomics research.  It is anticipated that successful completion of this phased award program will provide students sufficient scientific and career development activities to set them on the path to becoming independent genomics researchers.

This Funding Opportunity Announcement (FOA) does not allow applicants to propose to lead an independent clinical trial, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.

Key Dates
Posted Date

March 25, 2021

Open Date (Earliest Submission Date)

July 8, 2021

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

August 8, 2021; December 8, 2021; April 8, 2022; August 8, 2022; December 8, 2022; April 8, 2023; August 8, 2023; December 8, 2023; April 8, 2024

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).

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review
Advisory Council Review

Not Applicable for Fellowships

Earliest Start Date
Expiration Date

April 9 2024

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Fellowship (F) 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
    Purpose

    The purpose of the National Human Genome Research Institute (NHGRI) Predoctoral to Postdoctoral Transition Award (F99/K00) is to provide a structured pathway for outstanding graduate students from diverse backgrounds, including those from groups underrepresented in the biomedical, clinical, behavioral and social sciences on a national basis (see Notice of NIH's Interest in Diversity), to transition to postdoctoral research positions focused on the scientific, medical, ethical, social and/or legal areas of genomics research. NHGRI encourages genomics research training and career development to prepare a workforce that can contribute to the realization of NHGRI’s Mission and Strategic Vision. As highlighted in NHGRI’s Strategic Vision, NHGRI is committed to promoting the diversity of the genomics research workforce and supporting opportunities for individuals from diverse backgrounds, including those from groups underrepresented in biomedical research, to bring their inquiry, experiences and perspectives to research, discovery, and the improvement of human health.  For purposes of this FOA, the term “genomics” encompasses issues and activities related to basic science, medical, ethical, social or legal areas of genomics research.

    Background

    Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

    Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.  In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. Accordingly, the NHGRI, and NIH more broadly, continue to encourage institutions to diversify their student and faculty populations and to enhance the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences.

    In 2012, the NIH Advisory Committee to the Director, through its Working Group on Diversity in the Biomedical Research Workforce, identified key transition points at which nationally underrepresented groups (URGs) leave the research workforce pathway. One critical juncture is the predoctoral to postdoctoral transition.  It has been reported that many individuals from URGs progressively lose interest in research intensive careers during graduate training (Gibbs et al., 2014Underrepresented racial/ethnic groups comprised 30% of the US population in the 2010 Census. From the NSF Survey of Graduate Students and Postdoctorates in Science and Engineering and Survey of Earned Doctorates, as of the fall 2018, around 70,000 U.S. citizens and permanent residents were enrolled in U.S. graduate school programs in the biological and biomedical sciences fields, of which 18.2% were from underrepresented racial or ethnic groups.  Of the more than 6,400 U.S. citizens and permanent residents who received Ph.D. or equivalent doctoral degrees in 2018, 12.7% percentage were from underrepresented racial or ethnic groups.  Within this data, around 2150 students were enrolled in graduate programs in genetics/genomics, of which 12.9% were URG students; and URG genetics/genomics students who earned their Ph.D. that same year was only 9.4%.  Thus, the predoctoral to postdoctoral transition continues to be a transition point where biological and biomedical sciences students from underrepresented groups leave the research enterprise, with the subfield of genetics/genomics having less URG representation overall.

    Quality mentoring, especially through structured formalized programs, has been linked to enhanced trainee productivity, increased self-efficacy and strengthening an individual’s commitment to a research career (Pfund et al., 2016; Chemers et al., 2011). Mentorship can be particularly crucial for enabling individuals from underrepresented groups to navigate a research career pathway, and there is need for more equitable access to quality mentorship (Pfund et al., 2018).

    Overview of this F99/K00 Transition Opportunity

    The NHGRI F99/K00 award is intended for individuals who have demonstrated a strong interest in a genomics research career.  The award will provide up to 5 years of support for individualized mentorship over the transition from predoctoral student to postdoctoral researcher through two continuous phases.  The first phase (F99) will provide support for 1-2 years of PhD dissertation research training. During this phase, students are expected to complete their doctoral degree, identify postdoctoral research mentor(s) distinct from their primary dissertation advisor(s), and work with these mentors to develop a postdoctoral research project in a field directly related to the NHGRI Mission and NHGRI funding opportunities.  The second phase (K00) will provide support for 2-3 years of mentored postdoctoral research and career development.  F99/K00 applicants are not required to identify postdoctoral research mentors at the time of application. K00 awards will be made only to PD/PIs who have successfully completed doctoral degree requirements and their F99 research training programs, attained postdoctoral positions, and, provided NHGRI with a strong research training and career development plan for the K00 stage of the award.  The research training and career development plan for the K00 should be prepared in collaboration with the K00 mentorship team, and demonstrate how the K00 will further facilitate achievement of an independent genomics research career.

    The expected outcome of the F99/K00 program is enhanced participation of individuals from diverse backgrounds in the NHGRI research workforce who can bring their unique experiences, perspectives and innovation to addressing human disease or the ethical, legal or social implications of genomics research. Other desired program outcomes include completion of doctoral degree programs, transition to genomics postdoctoral research positions, and achievement of subsequent research funding, such as NHGRI individual career development awards and research project grants.

    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

    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 independent clinical trials.

    Note: Applicants may propose to gain experience in a clinical trial led by a sponsor/co-sponsor as part of their research training.

     

    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

    For the F99 phase, award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below.

    For the K00 phase, award budgets are composed of salaries and fringe benefits, research and career development support, and indirect costs, as described below.

    Award Project Period

    For the F99/K00 award, individuals may receive up to 5 years combined support for both phases, which includes up to 2 years in the F99 fellowship phase and up to 3 years in the K00 career development phase.

    Other Award Budget Information
    Stipends

    ALLOWABLE COSTS: F99 PHASE

    Stipends are provided as a subsistence allowance to help defray living expenses during the research training experience. NHGRI will contribute to the F99 stipend at the same level as set for the F31 Ruth L. Kirschstein National Research Service Award (NRSA).  Refer to the NIH Guide Notice on NRSA budgetary levels for more information.

    ALLOWABLE COSTS: K00 PHASE

    NHGRI will contribute up to $60,000 toward the salary of the career award recipient.  The total salary must be based on a full-time staff appointment.  The 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.  Confirmation of salary may be required prior to the issuance of an award. Fringe benefits, based on the sponsoring institution's rate and the percent of effort, are provided in addition to salary.

    The recipient institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale.  For effort directly committed to the K00 award, salary supplementation is allowable, but must be from non-Federal sources (including institutional sources).  Non-Federal or institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the goals of the K00 award.  For effort not directly committed to the K00 award, K00 award recipients may devote effort, with compensation, on Federal or non-Federal sources as the Program Director/Principal Investigator (PD/PI) or in another role (e.g., co-Investigator), as long the specific aims of the other supporting grant(s) differ from those of the K00 award.

    Tuition and Fees

    ALLOWABLE COSTS: F99 PHASE

    NHGRI will contribute to the combined cost of tuition and fees at the same level as set for the F31 Ruth L. Kirschstein National Research Service Award (NRSA).  Refer to the NIH Guide Notice on NRSA budgetary levels for more information.

    Institutional Allowance (F99)/Other Program Related Expenses (K00)

    ALLOWABLE COSTS: F99 PHASE

    The applicant should request an institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. The annual institutional allowance level for the F99 phase is the same as that provided for the F31 NRSA awards. Refer to the NIH Guide Notice on NRSA budgetary levels for more information. An additional $1,500 per year is allowed to defray the travel costs to attend the NHGRI Research Training and Career Development Annual Meeting.

    ALLOWABLE COSTS: K00 PHASE

    NHGRI will provide up to $20,000 per year towards the research development support for the award recipient, which 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. An additional $1,500 per year is allowed to defray the travel costs to attend the NHGRI Research Training and Career Development Annual Meeting.

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

    Indirect Costs

    ALLOWABLE COSTS: F99 PHASE

    NIH does not separately reimburse indirect costs (also known as Facilities & Administrative [F&A] Costs) for fellowships. Costs for administering the F99 awards are part of the Institutional Allowance.  See https://researchtraining.nih.gov/resources/policy-notices.

    ALLOWABLE COSTS: K00 PHASE

    Indirect Costs are reimbursed at 8% of modified total direct costs.

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

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this 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)

    F99 Eligibility: All domestic PhD-granting institution/organization types listed above are eligible to submit an application. Multiple applications from an institution are allowed.

    K00 Eligibility: All domestic institution/organization types listed above are eligible to submit K00 transition phase applications on behalf of F99 awardees.

    Before submitting a fellowship application, the candidate must identify a sponsoring institution. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. The training should occur in an environment that has appropriate human and technical resources and is demonstrably committed to training in the field(s) proposed by the applicant. All institutions with the appropriate resources and commitment are encouraged to apply.

    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.
    • ·    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 applicant fellow 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 their sponsor 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).

    Fostering diversity 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 (NOT-OD-20-031).

    Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation—requires superior intellect, creativity, and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds, including those from underrepresented groups, who will help to further NIH's mission.

    Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all.

    For the purpose of this announcement, institutions are encouraged to  diversify their student populations by recruiting potential participants from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

    A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report (Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. 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. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm)..

    B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at https://www.nsf.gov/statistics/2017/nsf17310/static/data/ tab7-5.pdf.

    C. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:

    1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);

    2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/foster-care);

    3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);

    4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);

    5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);

    6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).

    7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas  (qualifying zipcodes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.

    Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.ed.gov/https://nces.ed.gov/programs/coe/indicator_tva.asphttps://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.

    D. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/).

    The applicant must have a baccalaureate degree and be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, DrPH, DSW, PharmD, ScD), in the biomedical, behavioral, or clinical sciences at a domestic institution.

    At the time of award, the applicant is expected to require no more than 2 years to complete their doctoral training (F99 phase) before transitioning to mentored postdoctoral research training (K00 phase). Applicants conducting dissertation research in scientific, medical, ethical, social and/or legal areas of genomics research are encouraged to apply.

    Individuals who are currently being supported under the F31 are eligible to apply for this program; however, they must give up the F31 if they decide to accept the F99 award. Individuals who receive F99/K00 support remain eligible and are encouraged to apply for subsequent individual career development awards (e.g. K01, K08) and Pathway to Independence awards (K99/R00) provided they meet program eligibility requirements.  

    Students matriculated in a dual-degree program (e.g. MD/PhD, DO/PhD, DDS/PhD, or DVM/PhD) who seek support for both dissertation research training and clinical training are not eligible for this program. Such students may apply for the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral MD/PhD or Other Dual-Doctoral Degree Fellowship (Parent F30) to support both dissertation research training and clinical training.

    If an applicant begins a postdoctoral position or completes all PhD dissertation requirements before an F99 award is made, neither the F99 award nor the K00 award will be issued.

    Potential candidates are strongly encouraged to discuss their eligibility with the NHGRI Scientific Program contact in advance of application.

    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

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

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

     Each candidate may submit one fellowship application at a time: An individual may not have two or more competing NIH individual fellowship applications pending review concurrently. A candidate for an NHGRI F99/K00 Award may not simultaneously submit or have an application pending for any other PHS fellowship.  

    0

    Level of Effort

    F99 awardees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.

    K00 awardees are required to have a full-time appointment at the K00 applicant institution, and to commit a minimum of 9 person months (or 75% of their full-time professional effort at the applicant institution) to their career development and research training. K00 awardees may engage in other duties (e.g., other research, training, clinical and teaching activities) as part of the remaining 25% effort not covered by the award, as long as such duties do not interfere with or detract from the proposed career development program.

    Sponsor

    Before submitting the application, the applicant must identify an F99 sponsor(s) who will supervise the proposed mentored training experience. Applicants conducting F99 research in fields outside genomics research or planning to switch to a new genomics research area in the K00 phase are expected to include an F99 co-sponsor or consultant with relevant genomics research expertise and a strong mentorship record. Applicants are encouraged to identify more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for their training program. When there is a sponsor team, one individual must be identified as the primary sponsor, and will be expected to coordinate the applicant’s overall F99 training. The applicant must work with the sponsor(s) in preparing the application.

    Applicants are not required to identify a mentor for the K00 phase at time of the initial F99/K00 application.

    The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the candidate’s research training and to direct supervision of his/her research. The primary sponsor must document the availability of sufficient research funds and facilities for high-quality research training. The primary sponsor, or a member of the sponsor team, should have a successful track record of mentorship. The candidate must work with the primary sponsor(s) in preparing the application.

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

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this 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 Fellowship (F) 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

    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.

    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 (fellowship applicant) must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

    PHS Fellowship Supplemental Form

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

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

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

    Fellowship Applicant Section

    Applicant’s Background and Goals for Fellowship Training

    This section should address both phases of the F99/K00.

    Summarize all research and scientific experiences in chronological order.

    Describe short- and long-term career goals and explain how the overall training goals of the F99/K00 will enable the applicant to become a productive and independent genomics researcher. For each phase, describe how the proposed research training plan will enhance the applicant's knowledge, technical expertise, and professional skills, keeping in mind existing strengths as well as any gaps in existing skills. Explain how the activities in each phase will facilitate the transition to each subsequent career stage. Include a timeline with scientific, professional development, and career milestones that spans the entire award period.

    Although not required, it is encouraged that the F99 phase include genomics research. Thus, for those individuals who are entering the field of genomics research in their K00 phase, this will represent a significant research redirection. Such individuals are expected to describe their efforts and/or training plans during both F99 and K00 phases that provide preparation for the K00 research and, later, as an independent genomics scientist.

    Although it is not required to select a K00 mentor in the application, proposing one with an extensive research experience and mentoring history of junior scientists is desirable. For those applicants who do not plan to propose a postdoctoral mentor, strategies and plans for identifying a K00 mentor should be included in the application.

    Research Training Plan

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

    Specific Aims: All applicants must use these two Specific Aims:

    Specific Aim 1: The Dissertation Research Project.

    Provide a detailed description of the research to be completed in the F99 phase.

    Specific Aim 2: The Postdoctoral Research Direction.

    Identify the research direction to be pursued for the K00 phase.

     

    Research Strategy

    Applicants are expected to articulate a thoughtful description of their F99-phase dissertation research project. The Research Strategy should offer a clearly stated rationale and hypothesis, go beyond just experimental details, and provide perspective about the work's expected outcomes and significance. Applicants are also expected to articulate, in broad strokes, the future research direction for the K00 phase, and describe what is needed to develop their career through to the postdoctoral phase in light of the applicant's long-term career goal. Specific features of the postdoctoral scientific environment that would benefit the proposed research and research training should be described.

    Approach: Address the science and the career development activities for both phases of the F99/K00. Describe the specific skills and techniques that the applicant intends to learn as well as any planned, non-research activities (e.g. those relating to professional development) during the award period. The applicant must provide a timeline for the proposed dissertation research training and related activities for the F99 phase. The research direction to be pursued for postdoctoral studies should be described and how it relates to or expands the applicant's PhD research and a genomics research career trajectory.

    Specific Aim 1 (F99):

    • Describe the overall goal, rationale, hypotheses, and approaches of the dissertation research project;
    • Describe progress made thus far;
    • Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project;
    • Highlight skills and techniques already obtained that contribute to the long-term career goal;
    • Provide a detailed description of the research to be completed in the F99 phase, including rigorous experimental design, anticipated results, interpretation of results, and potential follow-up studies;
    • Detail how the rigorous experimental design will achieve robust and unbiased results;
    • Highlight new technical and professional skills to be learned;
    • Provide a timeline for the science and career development activities and milestones to be completed in the F99 phase that will facilitate transition to the K00 phase.

    Specific Aim 2 (K00):

    • Identify the broad research direction to be pursued for the K00 phase and explain the rationale for pursuing this direction;
    • The postdoctoral research plan does not have to be a continuation or within scope of the predoctoral research but must have direct relevance to NHGRI research areas;
    • The research direction described for the K00 phase (not a detailed research proposal) should include technical and career development skills to be acquired;
    • Potential mentor(s) do not need to be identified, but a plan for identifying a mentor(s) should be included, and an appropriate set of qualifications and mentor attributes should be described.

    If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, describe the relationship of the proposed research project to the clinical trial.

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

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

    The Sponsor and any Co-Sponsor(s) should describe their qualifications to train a predoctoral student who seeks mentored training in a research area relevant to the goals of this NHGRI F99/K00 program. If a team of sponsors is proposed, this plan should describe the role of each sponsor and how they will communicate and coordinate their efforts to mentor the applicant effectively.

    The training plan for the F99 phase should be individualized for the applicant, keeping in mind the applicant's strengths and any gaps in needed skills, and should be designed to enhance research training. The F99 training plan should be coordinated with the applicant's Research Strategy and the goals and activities identified in the Applicant section. Training in professional development skills, e.g. grant-writing and presentation skills, is strongly encouraged. The Sponsor should also describe their contribution to the research plan, the portion of the research ideas and plan that originated with the applicant, and the relationship between the proposed research plan and funded or unfunded research projects previously devised by the sponsor.

    The plan should describe how the Sponsor will facilitate the transition to the next stage of the applicant’s career and how the applicant's research and career development progress will be monitored and evaluated throughout the F99 phase.

    The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computing resources, subject populations) should be described for the F99 phase.

    The Sponsor and any Co-Sponsor(s) for the fellowship phase are expected to provide an assessment of the applicant's qualifications and potential for transitioning to the postdoctoral phase (K00) and pursuing a career as a productive, independent researcher.

    If the anticipated K00 research field is outside of the primary F99 Sponsor's expertise, discuss plans to provide the candidate with a foundation for the K00 research direction. This may be through interactions with Co-Sponsors, collaborators, consultants and other career development activities.

    If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, the sponsor or co-sponsor must include a statement to document leadership of the clinical trial including source of funding, NCT#, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

    Institutional Environment and Commitment to Training Section

    Description of Institutional Environment and Commitment to Training

    • Describe the institution's graduate program in which the applicant is enrolled. This description should include the structure of the program, the required milestones and their usual timing, the number of courses, any teaching commitments or qualifying exams, and the average time to degree over the past 10 years.
    • Describe the progress/status of the applicant in relation to the program's timeline, and the frequency and method by which the program formally monitors and evaluates a student's progress.
    • Confirm that the applicant is in a PhD program (include month and year of entry into the PhD program) and has reached the dissertation phase (include month and year of transition to dissertation phase).
    • Confirm that the applicant has 1-2 years left before completion of their PhD (include month and year of anticipated graduation).
    • Provide the name of the primary sponsor or mentor and an affirmation of the institution's commitment to the applicant's training and research career goals.
    • Include the name of the individual providing this information at the end of the description. This information is typically provided by the director of the graduate program or the department chair.

     

    Description of Candidate’s Contribution to Program Goals

    The sponsoring institution must provide a document on institutional letterhead that explains how the candidate’s participation will further the goals of the fellowship. 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.  

    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.

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

    Delayed Onset Study

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

    All instructions in the 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

    Applicants 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 Reference Letter 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). 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. The National Research Service Award (NRSA) policies apply to this program.  A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

    Pre-award costs are generally not allowable for Fellowships.

    7. Other Submission Requirements and Information

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

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

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

    Important reminders:
    All PD(s)/PI(s) and sponsor(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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.

     

    Post Submission Materials

    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

    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:

    • A F99/R00 application has a research project that is integrated with the training plan. The review will emphasize the candidate’s potential for a productive career, the candidate’s need for the proposed training, and the degree to which the research project and training plan, the sponsor(s), and the environment will satisfy those needs.
    Overall Impact

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.

    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.

     

    Fellowship Applicant

    • ·      Are the applicant’s academic record and research experience of high quality?
    • ·      Does the applicant have the potential to develop into an independent and productive researcher who will contribute significantly to the genomics research field?
    • ·      Does the candidate demonstrate commitment to a genomics research career in the future?
    • ·      Does the applicant demonstrate potential for successful transition to a strong postdoctoral position in genomics research (K00 phase)?

    Sponsors, Collaborators, and Consultants

    • ·      Are the F99 sponsor(s’) research qualifications (including recent publications) and track record of mentoring individuals at a similar stage appropriate for the needs of the candidate?
    • ·      Is there evidence of a match between the research interests of the applicant and the sponsor(s)? Do the sponsor(s) demonstrate an understanding of the applicant’s training needs as well as the ability and commitment to assist in meeting these needs?
    • ·      Is there evidence of adequate research funds to support the applicant’s proposed research project and training for the duration of the research component of the fellowship?
    • ·      If a team of sponsors is proposed, is the team structure well justified for the mentored training plan, and are the roles of the individual members appropriate and clearly defined?
    • ·      Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed project?
    • ·      If a K00 sponsor has been identified, do their research qualifications (including recent publications) and track record of mentoring individuals at a similar stage appropriate for the needs of the candidate? If a K00 sponsor has not been identified, does the application include an adequate a plan for identifying a mentor(s) including an appropriate description of qualifications and mentor attributes?
    • ·      If the applicant is proposing to gain experience in a clinical trial as part of applicant’s research training, is there evidence of the appropriate expertise, experience, resources, and ability on the part of the sponsor(s) to guide the applicant during the clinical trial research experience?

    Research Training Plan

    • ·      Is the F99 proposed research project of high scientific quality, and is it well integrated with the proposed research training plan?
    • Is the prior research that serves as the key support for the proposed project rigorous?
    • Has the applicant included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project
    • ·      Based on the sponsor’s description of their active research program, is the applicant’s proposed research project sufficiently distinct from the sponsor’s funded research for the applicant’s career stage?
    • ·      Is the F99 research project consistent with the applicant’s stage of research development?
    • ·      Is the proposed time frame feasible to accomplish the proposed F99 training?
    • ·      Is the F99 training plan well-reasoned, and likely to provide an effective research training experience and ease the transition to the K00 phase??
    • ·      If proposed, will the clinical trial experience contribute to the proposed project and/or the applicant’s research training?

    Training Potential

    • ·      Are the proposed research project and training plan likely to provide the applicant with the requisite individualized and mentored experiences in order to obtain appropriate skills for a genomics research career?
    • ·      Does the training plan take advantage of the candidate’s strengths and address gaps in needed skills?  Does the training plan document a clear need for, and value of, the proposed training?
    • ·      Does the proposed training have the potential to serve as a sound foundation that will clearly enhance the candidate’s ability to develop into a productive researcher?
    • ·      Are adequate plans described for monitoring and evaluating the applicant's research and career development progress throughout the F99 training period?
    • ·      Have the applicant and sponsor(s) outlined appropriate milestones in terms of research achievements, professional and career skills for transition to the career development phase of the award?

    Institutional Environment & Commitment to Training

    • ·      Are the research facilities, resources (e.g., equipment, laboratory space, computer time, subject populations) and training opportunities (e.g. seminars, workshops, professional development opportunities) adequate and appropriate? 
    • ·      Is the institutional environment for the candidate’s scientific and clinical development of high quality?
    • ·      Is there appropriate institutional commitment to fostering the candidate’s mentored training?
    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 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.

    Renewals

    Not Allowed

    Revisions

    Not Allowed

    Additional Review Considerations

    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 sponsor(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.

    Applications from Foreign Organizations

    Not Applicable.

    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.

    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), convened by NHGRI 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 committee 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, the following will be considered by NHGRI 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.
    • Geographic distribution of awarding institutions.
    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.

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

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    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.    

    Transition to the Postdoctoral Career Development K00 Phase

    The F99/K00 award is intended to facilitate successful transition to the postdoctoral career stage. Consequently, a requirement for initiation of the K00 phase is successful completion of the Ph.D. degree. Applicants are encouraged to apply for postdoctoral positions at departments and institutions different from where they conducted their doctoral research. It is important for all applicants, but especially so for applicants who intend to stay at the predoctoral phase institution for the postdoctoral phase, to provide a plan by which they will separate scientifically from their Ph.D. sponsor. The transition from the predoctoral phase to the postdoctoral phase is intended to be continuous in time and, except in unusual circumstances, NHGRI will not extend the F99 phase. Transition from the predoctoral (F99) phase to the postdoctoral (K00) phase is not automatic. To activate the K00 phase of the grant, individuals must have been offered and accepted a postdoctoral appointment to carry out genomics research. Upon starting the K00 phase of the award, the F99 phase of the award is terminated.

    Prospective applicants are strongly encouraged to contact their Program Official as soon as a plan to assume a postdoctoral position develops, and not later than 4 months prior to the end of the F99 phase of the award. At that time, individuals should discuss plans for transition to, and application for, the K00 phase with their NIH program official. The application for the K00 phase of the award should be submitted no later than 2 months prior to the proposed start date of the K00 award by the K00 phase grantee organization.

    An eligible K00 institution must have appropriate infrastructure to support the proposed research program and a history of external research funding. Foreign institutions are not eligible. Applicants may apply for genomics-focused postdoctoral positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the postdoctoral phase of the award will not be activated. This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards.

    Instructions for the K00 Transition Award

    F99 awardees wishing to submit a K00 transition application must follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise, as described here.

    The K00 Transition Application will include the following components:

    • A new face page signed by the K00 phase institutional representative;
    • A Final Progress Report for the F99 phase;
    • A final evaluation statement by the F99 primary sponsor;
    • Updated Project Summary and Abstract, Project Narrative, Bibliography & References Cited, Facilities & Other Resources, and Equipment sections;
    • Biographical sketches for candidate and K00 sponsor(s)
    • Detailed budget pages for a non-modular budget: K00 budgets consist of salary and fringe benefits, tuition and fees, other program related expenses, and indirect costs, as described in Part II, Section II of this funding opportunity announcement. Other costs are not allowed;
    • Updated sections of the PHS Career Development Award Supplemental Form, which should include:
    • A new Candidate Section. If applicable, include a discussion of non-research activities, such as clinical activities or clinical specialty training to be conducted at no more than 25% effort;
    • An updated Research Plan Section: The Specific Aims should be updated to reflect current plans for the K00 phase and the updated Research Strategy should be described in less than 5 pages;
    • A new Mentor, Co-Mentor, Consultant, Collaborators Section that includes a plan for transitioning the candidate to the next stage of his/her career by the end of the project award period. The mentor should discuss resources and research support available for the K00 project. The mentor should describe previous experience as a mentor, including type of mentoring (e.g., graduate students, career development awardees, postdoctoral students), number of persons mentored, and career outcomes. If the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should be included. For candidates transitioning to genomics research, discuss plans to provide a strong foundation in research design, methods and analytic techniques for the research area, and the relationship of the research training to dental, oral, and craniofacial health and disease. If the candidate is proposing to gain experience in a clinical trial as part of his or her research training, the mentor or co-mentor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the candidate in any proposed clinical trials research experience;
    • An updated Description of Institutional Environment;
    • An Institutional Commitment to Candidate’s Research Career Development;
    • Updated Protections for Human Subjects, Inclusion of Individuals Across the Lifespan, and Inclusion of Women and Minorities (as appropriate);
    • Updated Other Research Plan Sections (as appropriate), including:

    o   Vertebrate Animals;

    o   Select Agent Research;

    o   Resource Sharing; and

    o   Authentication of Key Biological and/or Chemical Resources

    • Updated Plan for Training in the Responsible Conduct of Research, and a new checklist

    The K00 postdoctoral phase institution must submit the materials on behalf of the applicant for the K00 award, no later than 2 months prior to the proposed start date of the K00 Award. The institution's Authorized Organizational Representative will email the application (in PDF format) to the NHGRI Scientific/Research Contact listed in Section VII. The K00 application will be evaluated by NHGRI program staff for completeness and responsiveness to the program.

    Applicants who are approved to transition will receive a Notice of Award reflecting the new K00 grant mechanism, the dollar amount, and the new recipient organization (if applicable). Applicants 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 K00 application.

    Although the financial plans of NHGRI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

    Termination of the F99 award phase

    F99/K00 leave policies will be in accordance with NRSA fellowships leave policies as described in the NIH Grants Policy Statement.

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

     
    Inventions and Copyrights

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

     

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year.

    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. 

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

     

    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.

    Within ten years of making awards under this program, NIH will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program.  Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program. 

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

    For the F99 phase:

    • Successful completion of a graduate program
    • Successful transition to a strong postdoctoral research position in the genomics field
    • Research products, such as scientific publications

    For the K00 phase:

    • Subsequent participation in research in a genomics field
    • Transition to an independent research career in the genomics field, such as a tenure-track research faculty positions
    • Subsequent independent research grant support from NIH, NHGRI, or another source
    • Research products, such as scientific publications in a genomics field
    Section VII. Agency Contacts

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

    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)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    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)

    Tina Gatlin, Ph.D.
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-480-2280
    Email: gatlincl@nih.gov

    Peer Review Contact(s)

    Rudy Pozzatti, Ph.D.
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-402-8739
    Email: Rudy.Pozzatti@nih.gov

    Financial/Grants Management Contact(s)

    Deanna Ingersoll
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-435-7858
    Email: Deanna.Ingersoll@nih.gov

    Section VIII. Other Information

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

    Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of fellowship 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 63A and 45 CFR Part 75.

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