Part 1. Overview Information

Key Dates

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) 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. NRSA fellowships support the training of pre-and postdoctoral scientists, dual-degree investigators, and senior researchers. More information about NRSA programs may be found at the NIH Research Training and Career Development website.

Note: 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.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome (DS). Graduate students recognized by their institutions as having high potential and strong interest in pursuing careers as independent researchers in a Down syndrome (DS)-related field, and then to facilitate their successful transition to postdoctoral positions. The objective of the INCLUDE Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) is to identify and encourage graduate students with a strong interest in pursuing careers as independent researchers in a Down syndrome (DS)-related field to assist with their successful transition to postdoctoral positions.

The F99/K00 award is intended for individuals who require 1-2 years to complete their Ph.D. dissertation research training (F99 phase) before transitioning to mentored postdoctoral research training (K00 phase). Consequently, applicants are expected to propose an individualized research training plan for the next 1-2 years of dissertation research training and a plan for 3-4 years of mentored postdoctoral research and career development activities that will prepare them for independent research careers in a DS-related field.

The F99/K00 award is meant to provide up to 6 years of support in two phases. The initial (F99) phase will provide support for 1-2 years of dissertation research (final experiments, dissertation preparation, and selection of a postdoctoral mentor). The second (K00) phase will provide up to 4 years of mentored postdoctoral research and career development support, contingent upon successful completion of the doctoral degree requirements and securing a DS-related postdoctoral position at a new institution. The two award phases are intended to be continuous in time meaning gaps are not permitted between the completion of the PhD requirements and the start of the K00 phase. A K00 award will be made only to a PD/PI who has successfully completed the F99-supported training, secured a DS-related postdoctoral appointment, and provided INCLUDE with a strong research and career development plan.

A list of Funding Priorities by Institute and Center is available on the INCLUDE website. Applications in response to this Funding Opportunity Announcement (FOA) should be aligned with at least one of the three components of the overall NIH INCLUDE Project Research Plan:

Component 1: Targeted, high risk-high reward, basic science studies in areas highly relevant to Down syndrome

Component 2: Assembly of a large cohort of individuals with Down syndrome across the lifespan to perform deep phenotyping and study co-existing conditions

Component 3: Inclusive clinical trials of existing and future treatments and interventions for co-occurring conditions in individuals with Down syndrome

Applicants planning to submit applications in response to this FOA are strongly encouraged to contact the scientific contacts for this announcement prior to submission to be advised on appropriateness of the intended research plans for this program, competitiveness of a potential application, and alignment with program priorities of the INCLUDE initiative. The INCLUDE website has a list of contacts for each participating NIH Institute and Center. Please contact the Scientific Contact listed for additional questions. Additional resources and answers to frequently asked questions can also be found here: FAQ for F99/K00.

Projects that propose to recruit subjects with DS are encouraged to promote enrollment of research subjects in the DS patient registry supported by NIH, DS-Connect . For other data and biospecimens collected from human genetic or non-genetic studies, recipients are encouraged to use biorepositories designated by INCLUDE staff that meet requirements for broad sharing. An NIH resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing. For those projects that will generate clinical data, it is expected that any required data sharing will include the INCLUDE Data Coordinating Center (DCC).

Note: The four years of K00 support of this award will not preclude the recipients from applying for other mentored career development (K) awards such as K99/R00. Awardees who can justify the need for additional mentored career development training beyond the four years of the K00 may apply for additional mentored career development awards.

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

Section II. Award Information

Other Award Budget Information

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

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• None

• None

F99 Eligibility: Domestic institution/organization types listed above that grant PhD or equivalent research degrees (e.g., Dr.P.H., Sc.D.) are eligible to submit an application. More than one F99 application per institution is allowed.

K00 Eligibility: Domestic institution/organization types listed above, including Federal laboratories, are eligible to submit K00 transition phase applications on behalf of F99 awardees. There is no limit on the number of K00 recipients that an organization may sponsor. Note that if the F99 recipient accepts a postdoctoral position in the NIH intramural research program, the postdoctoral phase will be supported directly by NIH intramural funds and the K00 will not be awarded, since NIH intramural scientists are not eligible for NIH extramural grant awards.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

• Unique Entity Identifier (UEI) A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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).

The applicant must have a baccalaureate degree and be currently enrolled as a graduate student in the third or fourth year of a mentored PhD or equivalent research degree program (e.g., DrPH, ScD) in the biomedical, behavioral, or clinical sciences at a domestic institution. F99 eligibility is determined from the date of enrollment as a graduate student at the PhD institution and includes the time spent earning a MS degree unless there was a major change in research area and a change in research mentor. The applicant must be at the dissertation research stage of training at the time of award, and must show evidence of high academic performance in previous coursework and research experiences, as well as a commitment to a career as an independent research scientist in the field of Down syndrome research.

Exceptions:

If a 2nd-year student is expected to graduate within 2 years, an exception may be requested. Applicants may check with the Program Official prior to the selection of the nominee.

If a 5th-year student took a documented and extended Leave of Absence, an exception may be requested. Applicants may check with the Program Official prior to the selection of the nominee. Any requests for exceptions should be explained in Section IV. Institutional Environment and Commitment to Training Section.

Potential candidates are encouraged to discuss their individual situation with the INCLUDE Scientific Program Contact prior to seeking institutional nomination.

The F99/K00 award may not be used to support studies leading to the MD, DDS, or other clinical, health-professional degree (e.g., DC, DMD, DNP, DO, DPM, DVM, ND, OD, AuD). Students matriculated in a dual-degree program (e.g. MD/PhD, DO/PhD, DDS/PhD, or DVM/PhD) are not eligible for the F99/K00 program.

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

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, per 2.3.7.4 Submission of Resubmission Application. 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.

At the time of award, individuals 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.

The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the candidate’s research training and to direct supervision of their research. The primary sponsor must document the availability of sufficient research funds and facilities for 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.

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

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

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

Other Project Information

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

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

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.

Fellowship Applicant Section

Applicant’s Background and Goals for Fellowship Training

This section should address both the F99 phase and the K00 phase.

Doctoral Dissertation and Research Experience

Include a description of how the combination of past research experiences and the F99/K00 plans contribute to achieving the long-term career goals of the candidate.

Training Goals and Objectives

Describe the long-term career goal and explain how the F99/K00 will enable the attainment of that goal. For each phase, describe how the proposed research training and career development plan will enhance the applicant's knowledge, technical expertise, and professional skills and advance the applicant's progression towards becoming a productive and independent research in a DS-related field, keeping in mind existing strengths as well as any gaps in existing skills. If the K00 research direction is markedly different from the F99 research area, describe efforts and/or plans during the F99 phase training that provide preparation for the K00 research. Include a strategy for identifying a K00 mentor.

Identify the skills, theories, conceptual approaches, etc., to be learned or enhanced during the award, including, as applicable, expertise in rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation, as applicable.

If the applicant proposes work in cohort-building or clinical trials administered by their research mentor, describe community engagement skills and strategies that will be learned or enhanced as part of fellowship training.

Activities Planned Under This Award

Describe the scientific and professional development activities planned for each phase and explain how the activities will facilitate the transition to each subsequent career stage. Include a timeline with scientific, professional development, and career milestones.

Research Training Plan

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

Specific Aims:

Explain the importance of the problem or critical barrier to progress that the proposed project addresses and provide an overview of the specific aims of the project. All applicants must use the following two Specific Aims:

• Specific Aim 1: The Dissertation (F99) phase
• Specific Aim 2: The Postdoctoral research (K00) phase

Research Strategy:

Applicants should individually address the Significance and Approach for each Specific Aim.

Specific Aim 1: Dissertation (F99) Phase

Significance

• Provide an overview of the dissertation research, including the scientific question being addressed and its potential impact on the dissertation research field.
• Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
• Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

Approach

The Approach for Aim 1 should be organized into two sections:

• A progress report on the dissertation research project thus far, including the approaches used, research outcomes obtained, and important methodologies learned;
• A detailed research proposal for the work to be completed in the F99 phase, including experimental design that encompasses rigor and reproducibility, anticipated results, potential problems, alternative strategies, and potential follow-up studies.

Specific Aim 2: Postdoctoral Research (K00) Phase

Significance

• Explain the significance of the K00 research direction. Describe a specific scientific question or observation that will be investigated. Explain how this question or observation is related to the applicant’s research interests and how this work will help advance this Down syndrome (DS)-related field,
• Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
• Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

Approach

• Provide a general description of how the research will be conducted, including approaches and methodologies to be used, anticipated results, challenges that might arise and how to address them.
• Explain the importance of the problem or critical barrier to progress that the proposed project addresses.
• Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
• Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.?
• 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 Fellowship (F) version of the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• Follow the instructions for Sections A through E. Additionally, in Section E the sponsor(s) should provide an assessment of the applicant’s qualifications and potential for transitioning to the postdoctoral phase (K00) and becoming a productive, independent researcher.
• The Sponsor should also describe the roles and responsibilities that both they and the fellow are undertaking, including contributions to the research plan, the portion of the research ideas and plan that originated with the candidate, and the relationship between the proposed research plan and funded or unfunded research projects previously devised by the sponsor.
• 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. The individual receiving support for the clinical trial (i.e., the sponsor/primary mentor or a co-sponsor) is the responsible individual of record for oversight of the trial though fellows can take part in all components of a clinical trial. Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the fellow can gain experience in all these components in conjunction with the mentor or individual leading the trial.

Institutional Environment and Commitment to Training Section

Description of Institutional Environment and Commitment to Training

In addition to the content described in the SF424 (R&R) Application Guide, institutions must include the Educational Information below. .

Educational Information

• 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 in a neuroscience-relevant field (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 from time of award before completion of their PhD (include month and year of anticipated graduation) or any reasons for exceptions.
• 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.

Appendix

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

• A fellowship application must have a research project that is integrated with the training plan. The review will emphasize the applicant’s potential for a productive career, the applicant’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. The review will also evaluate the research and career development plans for the?K00 phase, emphasizing the need for the career development and the potential to lead to a productive, independent Down syndrome research career.

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.

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

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA .

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the appropriate NIH Institute or Center. 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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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

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

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

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

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Transition to the Postdoctoral Career Development K00 Phase

The F99/K00 award is intended to facilitate successful transition to the postdoctoral career stage. Consequently, a requirement for initiation of the K00 phase is successful completion of the Ph.D. degree. 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. Except in unusual circumstances, the F99 phase will not be extended. Transition from the predoctoral (F99) phase to the postdoctoral (K00) phase is not automatic. To activate the K00 phase of the grant, individuals must have been offered and accepted a full-time postdoctoral position to carry out neuroscience-focused research. Upon starting the K00 phase of the award, the F99 phase of the award will be 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 6 months prior to the proposed start date of the K00 award. At that time, individuals should discuss plans for transition to, and application for, the K00 phase with their NIH program official.

The K00 postdoctoral phase institution must submit the materials on behalf of the candidate for the K00 award, no later than 3 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 Scientific/Research Contacts listed in Section VII. The K00 application will be evaluated by program staff for completeness and responsiveness to the program.

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 postdoctoral positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the postdoctoral phase of the award will not be activated. This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards. F99 fellows who accept a postdoctoral position in the IRP will be required to submit a final progress report and a final evaluation statement by the primary F99 mentor instead of a K00 application.

Applicants who are approved to transition will receive a Notice of Award reflecting the new K00 activity code, the dollar amount, and the new grantee organization (if applicable). Candidates who are not approved to transition will receive written notification from the NIH awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the K00 application.

Awards pursuant to this funding opportunity are contingent upon the availability of funds.

3. Data Management and Sharing

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

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

Instructions for the K00 Transition Award

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

The K00 Transition Application will include the following components:

• A new cover page 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 K00 Project Summary and Abstract, Project Narrative, Bibliography & References Cited, Facilities & Other Resources, and Equipment sections;
• Biographical sketches
• Mentor’s personal statement should include a description of their past and current mentoring and training philosophy, including commitment to diversity and inclusion in their training environments;
• Detailed budget pages for a non-modular budget: K00 budgets consist of salary and fringe benefits, other program related expenses, and indirect costs, as described in Part II, Section II of this funding opportunity announcement. Other costs are not allowed;
• Updated sections of the PHS Career Development Award Supplemental Form, which should include:
• A new Candidate Section
  • In addition to the K application instructions, describe the applicant's current and long-term research and career objectives.
  • Present a scientific history that shows a logical progression from the applicant's prior research and training experiences (including the F99 phase) to the training and research experiences proposed for the K00 phase of the award, which will ultimately lead to an independent research career.
  • Describe how the applicant plans to separate scientifically from his/her F99 and K00 sponsors.
  • Timeline with milestones for the research and career development experiences proposed.
  • Describe how the research training in the K00 phase of the award, combined with all previous research training and experiences, will provide the tools, skills and knowledge necessary to subsequently pursue an independent research career.
• 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 6 pages;
• A new Mentor, Co-Mentor, Consultant, Collaborators Section that includes a plan for fostering the candidate’s research career independence and transitioning the candidate to the next stage of his/her career by the end of the project award period. The mentor(s) should describe previous experience as a mentor, including the career levels of mentees (e.g., graduate students, career development awardees, postdoctoral students), number of individuals mentored, and their career outcomes. The role of each mentor, co-mentor, consultant and collaborator (as applicable) in the K00 and commitment to the candidate should be clearly described. Expand on efforts by the mentor/co-mentor to enhance diversity and promote inclusion through an environment that promotes the success of individuals with a wide variety of backgrounds and perspectives. It is acceptable to take a position with a mentor that has limited training experience, but in this case the candidate should integrate a co-mentor with a strong, successful track record as a mentor into his/her research training;
  • 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 Environment and Institutional Commitment to the Candidate Section:

• Provide a statement of commitment to the applicant and his/her career goal of developing into a productive, independent neuroscience-focused research investigator, i.e., conducting the proposed mentored neuroscience research and career development activities during the K00 phase.
• Provide assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of his/her research program. The remaining effort should be devoted to activities related to the development of the candidate's career as an independent scientist.
• Provide assurance that the research facilities, resources, and training opportunities will be available for the applicant's planned career development and research programs during the K00 award period.
• Provide assurance that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be available during the K00 award period.
• Describe efforts by the institution to enhance diversity and promote inclusion through an environment that promotes the success of individuals with a wide variety of backgrounds and perspectives (i.e. institutional and departmental environments in which trainees from all backgrounds feel integrated into and supported by the biomedical community).
• Updated Protections for Human Subjects and Inclusion of Women, Minorities and Individuals Across the Lifespan (as appropriate);
• Updated Other Research Plan Sections (as appropriate), including:
  • Vertebrate Animals;
  • Select Agent Research;
  • Resource Sharing Plans;
  • Data Management and Sharing Plan
  • Authentication of Key Biological and/or Chemical Resources; and
  • Updated Biohazards
  • Responsible Conduct of Research.

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

F99 Phase:

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

K00 Phase:

Recipients must complete the "Inventions and Patents" section when submitting the K00 Research Performance Progress Report (RPPR).

4. Reporting

When multiple years are involved, recipients 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.

NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Other Fellowship Reporting Requirements:

• Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.
• At the conclusion of a fellowship, the fellow must submit a Termination Notice (PHS 416-7) via pdf through email to the NIH within 30 days of termination.

5. 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 candidates.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Sujata Bardhan, M.S., Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-0471
Email: [email protected]

Anissa F Brown, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-594-5006
E-mail: [email protected]

Marie Mancini, Ph.D.
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-5032
E-mail: [email protected]

Neeraj Agarwal
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8155
E-mail: [email protected]

Charlene A Schramm, PhD
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: (301) 435-0510
E-mail: [email protected]

Laurie Ryan, Ph.D.
NATIONAL INSTITUTE ON AGING (NIA)
Division of Neuroscience
Phone: 301.496.9350
E-mail: [email protected]

Center for Scientific Review (CSR)

Email [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: [email protected]

Erik Edgerton
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-7760
E-mail: [email protected]

Karen Robinsonsmith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: [email protected]

Fatu Kamara
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-435-7916
E-mail: [email protected]

Jessica Perez
NATIONAL INSTITUTE ON AGING (NIA)
Phone: 301 496-1472
E-mail: [email protected]

Section VIII. Other Information

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

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 45 CFR Part 75 and 2 CFR Part 200.