The National Center for Advancing Translational Sciences (NCATS) will award Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Institutional Research Training Grants for the Clinical and Translational Science Awards (CTSA) Program (T32) to eligible institutions to create, provide, and disseminate clinical and translational science training and career support programs that enhance postdoctoral research training of individuals with doctoral degrees (these include, but are not limited to, the following: D.M.D., DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND [Doctor of Naturopathy], DSW, PsyD, as well as a doctoral degree in nursing research) and help ensure a heterogenous pool of clinical and translational scientists trainees who are equipped with the knowledge, skills and abilities to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health and support meaningful translational science research projects that address demonstrable needs among stakeholder communities.

PAR-25-195: Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)

Posted Date: December 19, 2024 Open Date (Earliest Submission Date): January 13, 2025 Expiration Date: September 29, 2027

Updates:

• March 31, 2025: This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.
• April 4, 2024: Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.

Part 1. Overview Information

Participating Organization(s): National Institutes of Health (NIH) Components of Participating Organizations: National Center for Advancing Translational Sciences (NCATS)

Funding Opportunity Title: Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)

Activity Code: T32 Announcement Type: Reissue of PAR-21-338

Related Notices: See Notices of Special Interest associated with this funding opportunity.

Funding Opportunity Number (FON): PAR-25-195

Companion Funding Opportunity: None

Number of Applications: Only one application per UM1 applicant institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s): 93.350

Funding Opportunity Purpose: This is a limited competition. The National Center for Advancing Translational Sciences (NCATS) will award Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Institutional Research Training Grants for the Clinical and Translational Science Awards (CTSA) Program (T32) to eligible institutions to create, provide, and disseminate clinical and translational science training and career support programs that enhance postdoctoral research training of individuals with doctoral degrees (these include, but are not limited to, the following: D.M.D., DC, DO, DVM, OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND [Doctor of Naturopathy], DSW, PsyD, as well as a doctoral degree in nursing research) and help ensure a pool of clinical and translational scientists trainees are equipped with the knowledge, skills and abilities to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health and support meaningful translational science research projects that address demonstrable needs among stakeholder communities.

NCATS will not accept applications proposing combined predoctoral and postdoctoral training under this Notice of Funding Opportunity (NOFO).

Applications proposing predoctoral research training should apply to the Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Institutional Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (PAR-25-194).

Applicants interested in providing short-term research experiences should apply to the companion NCATS Clinical and Translational Science Award (CTSA) Program Research Education Grants Programs (R25) (PAR-25-197). A short-term research experience is one where the participant is full-time (40 hours per week) for a period of 10 to 15 weeks, or as specified by the sponsoring institution in accordance with its own policies.

The proposed institutional research training program may complement other ongoing research training and career development programs at the applicant institution, but must be clearly distinct from related programs currently receiving Federal support.

This NOFO does not allow appointed Trainees to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial on which the principal investigator is a mentor or co-mentor.

This NOFO is part of a required set of companion applications: the Clinical and Translational Science Award (UM1) and companion Institutional Career Development Award (K12). The remaining NOFOs in the suite are optional and include the Ruth L. Kirschstein National Research Service Award (NRSA) institutional training programs (T32 predoctoral and T32 postdoctoral), the Research Education Grant (R25), and the Specialized Innovation Program (RC2). These optional NOFOs are only available to CTSA Program UM1 applicants and award recipients. Applications to the companion NOFOs cannot be awarded until an award has been issued for the UM1 (see Section III. Eligibility Information of this NOFO and the respective NOFOs for more information).

Funding Opportunity Goal(s): The mission of the National Center for Advancing Translational Sciences (NCATS) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

Key Dates:

• Posted Date: December 19, 2024

• Open Date (Earliest Submission Date): January 13, 2025

• Application Due Dates:

  • New: May 28, 2025
  • Renewal / Resubmission / Revision (as allowed): May 28, 2025
  • AIDS - New/Renewal/Resubmission/Revision, as allowed: Not Applicable

• Scientific Merit Review:

  • New: June 2025
  • Renewal / Resubmission / Revision (as allowed): October 2025
  • AIDS - New/Renewal/Resubmission/Revision, as allowed: Not Applicable

• Advisory Council Review:

  • New: October 2025
  • Renewal / Resubmission / Revision (as allowed): January 2026
  • AIDS - New/Renewal/Resubmission/Revision, as allowed: Not Applicable

• Earliest Start Date:

  • New: December 2025
  • Renewal / Resubmission / Revision (as allowed): April 2026
  • AIDS - New/Renewal/Resubmission/Revision, as allowed: Not Applicable

• Application Due Dates: September 29, 2025

• Scientific Merit Review: March 2026

• Advisory Council Review: May 2026

• Earliest Start Date: July 2026

• Application Due Dates: January 28, 2026

• Scientific Merit Review: June 2026

• Advisory Council Review: October 2026

• Earliest Start Date: December 2026

• Application Due Dates: May 28, 2026

• Scientific Merit Review: October 2026

• Advisory Council Review: January 2027

• Earliest Start Date: April 2027

• Application Due Dates: September 28, 2026

• Scientific Merit Review: March 2027

• Advisory Council Review: May 2027

• Earliest Start Date: July 2027

• Application Due Dates: January 28, 2027

• Scientific Merit Review: June 2027

• Advisory Council Review: October 2027

• Earliest Start Date: December 2027

• Application Due Dates: May 28, 2027

• Scientific Merit Review: October 2027

• Advisory Council Review: January 2028

• Earliest Start Date: April 2028

• Application Due Dates: September 28, 2027

• Scientific Merit Review: March 2028

• Advisory Council Review: May 2028

• Earliest Start Date: July 2028

All applications are due by 5:00 PM local time of applicant organization. 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.

Expiration Date: September 29, 2027

Due Dates for E.O. 12372: Not Applicable

Required Application Instructions: It is critical that applicants follow the Training (T) Instructions in the How to Apply Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts. Conformance to all requirements (both in the How to Apply Application Guide, and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply Application Guide, as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

• Use the NIH ASSIST system to prepare, submit and track your application online.
• 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.
• Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Table of Contents

• Part 1. Overview Information
  • Key Dates
• Part 2. Full Text of Announcement
  • Section I. Funding Opportunity Description
  • Section II. Award Information
    • Other Award Budget 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

This is a limited competition. The overall purpose of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In order to accomplish this goal, NRSA training programs are designed to train individuals to conduct research and to prepare for research careers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

Purpose and Background Information

The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. Research training activities can be in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH mission.

Institutional NRSA programs allow the Training Program Director/Principal Investigator (Training PD/PI) to select the trainees and develop a program of coursework, research experiences, and technical and/or professional skills development appropriate for the selected trainees. Each program should provide high-quality research training and offer opportunities in addition to conducting mentored research. Trainees should develop the ability to work effectively in teams with colleagues from a variety of backgrounds, and to promote safe and supportive scientific research environments. The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with agency-approved support levels.

Program Objective

The goal of the Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Postdoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program is to equip trainees with the knowledge, skills and abilities (KSAs) to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health.

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), is transforming the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients.

Translation, translational research, and translational science are related but different.

• Translation turns observations in the laboratory, clinic, and community into diagnostics, therapeutics, medical procedures, and behavioral changes that improve people’s health.
• Translational research moves a project to the next step in the translational process.
• Translational science enables these projects to reach their goals faster and more efficiently. At NCATS, we define translational science as the field that generates scientific and operational innovations that overcome the long-standing barriers along the translational research pipeline to accelerate translational progress and enhance the impact of translational research. With its focus on improving the translational process, translational science ultimately leads to more treatments for all people more quickly. The NCATS Translational Science Principles characterize effective approaches for advancing translational progress. These principles are described on the NCATS website (https://ncats.nih.gov/about/about-translational-science/principles). These principles are intentionally broad and apply to research anywhere along the translational continuum. While they exemplify translational science approaches, they are not intended to be comprehensive.

The NCATS Clinical and Translational Science Awards (CTSA) Program is designed to develop innovative solutions that will improve the efficiency, quality and impact of the process for turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public. Sustaining a vibrant clinical and translational research enterprise requires a 21st century workforce that can advance clinical and translational science (CTS) that will, in turn, increase the efficiency and efficacy of translation, with the ultimate goal of getting more treatments to more patients more quickly.

Clinical and translational scientists will possess both deep scientific domain expertise and systems understanding, and their research is expected to be designed to produce discoveries that are simultaneously important for their discipline(s) and contribute to other disciplines, thus intentionally advancing the translational process as a whole. These characteristics will be required to successfully prepare trainees to transition into the many and varied productive career paths available to clinical and translational scientists within the translational science spectrum. Proposed training programs are expected to help trainees develop the following characteristics independent of their particular area(s) of expertise:

• Domain Expert: Possesses deep disciplinary knowledge and expertise within one or more of the domains of the translational science spectrum ranging from basic to clinical to public health research and domains in between.
• Boundary Crosser: Breaks down disciplinary silos and collaborates with others across research areas and professions to collectively advance the development of a medical intervention.
• Team Player: Practices a team science approach by leveraging the strengths and expertise and valuing the contributions of all players on the translational science team. Has the ability to work effectively with colleagues from a variety of backgrounds, and to promote safe and supportive scientific research and training environments.
• Process Innovator: Seeks to better understand the scientific and operational principles underlying the translational process and innovates to overcome bottlenecks and accelerate that process.
• Skilled Communicator: Communicates clearly with all stakeholders in the translational process across social, economic, and scientific backgrounds, including patients and community members.
• Systems Thinker: Evaluates the complex external forces, interactions, and relationships impacting the development of medical interventions, including patient needs and preferences, regulatory requirements, current standards of care, and market and business demands.
• Rigorous Researcher: Conducts research at the highest levels of rigor and transparency within their field of expertise, possesses strong statistical analysis skills, and designs research projects to maximize reproducibility.

Program Considerations

Applicants are expected to identify training needs and objectives (i.e., specific and measurable outcomes the program intends to achieve). Applicants are expected to develop plans to implement evidence-informed training and mentoring activities (i.e., approaches that are grounded in the literature and from evaluations of existing relevant training programs). The plans are to describe how the participating faculty and preceptors are trained to use evidence-informed mentoring practices that promote the development of trainees. The evidence-informed plans are to consider mentor training assessments that move beyond the faculty’s/preceptor’s participation satisfaction to self-reporting of perceived skills gained, self-reported changes in mentoring behaviors or self-reporting of effectiveness. The plan is expected to include a built-in planned strategy to assess and monitor how well the faculty mentor/preceptor promotes a safe and supportive research training environment. To the extent possible, the development plan is to include information on how trainees in mentoring dyads/teams are to corroborate mentor’s self-report of changes in mentoring behaviors.

Funded programs are expected to implement the following:

• Core Knowledge Expectations in Clinical and Translational Science Research: Ensure that by the end of the training period, trainees would have achieved sufficient breadth in clinical and translational science research areas to facilitate work that advances research along the translational continuum. These research areas include preclinical research, clinical research, implementation science, and population science/public health research. Trainees are expected to acquire knowledge in broad areas of research including, but not limited to: clinical research, regulatory science, biostatistics, epidemiology, telehealth and telemedicine, dissemination and implementation science research, bioinformatics, community engagement, training in translational team science, responsible conduct of research and rigorous research design, entrepreneurship, scientific communication, and leadership. It is expected that customized curricula will be personalized for trainees to achieve domain-specific KSAs depending on the trainee’s desired career role or focused area of research.

• Clinical and Translational Science Research is a Cross-Disciplinary Team-Based Endeavor: Ensure that trainees have mastered core competencies in their own discipline, while gaining knowledge of other disciplines and knowledge of the operational principles underlying at least two sectors of the translational science ecosystem. These competencies and knowledge will confer the trainee’s ability and capacity to effectively communicate, collaborate, and break down barriers across multidisciplinary teams and the translational process. Clinical and translational science research is a team-based endeavor that requires input from many different disciplines, sectors, and points of view to be successful. Programs should support partnerships that give trainees experience outside of their particular discipline, both within the academic domain and with stakeholders and sectors outside it, such as patients, non-profit organizations, regulatory agencies, and industry.

• Building on Institutional Strengths in Clinical and Translational Science Research: Each NRSA (T32) Training program is to be innovative in its research training and career development program efforts so to impart to trainees the KSAs required for high quality clinical and translational science research. To achieve this, programs are encouraged to build on the local strengths and demonstrated translational innovations of their companion CTSA Program hub (i.e., telehealth and telemedicine, rural health, community engagement, bioinformatics, dissemination and implementation, entrepreneurship, drug discovery, etc.) to effectively curate and foster the clinical and translational science researcher. In this spirit, programs should identify training strengths, needs and objectives (i.e., specific and measurable outcomes the program intends to achieve) that will lead to the creation of a community of clinical and translational science research trainees that extends beyond the training program and across multiple schools (i.e., nursing, dental, engineering) and departments at the institution. Building on institutional strengths can include approaches on how to expose trainees to a larger cadre of mentors with broad clinical expertise, experiences, resources, and backgrounds relevant to clinical and translational science and who can help the trainee transition to the next career phase.

• Understanding Career Opportunities: The career outcomes of individuals supported by the NRSA Postdoctoral Institutional Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program include both research-intensive careers in academia and industry and research-related careers in various sectors including academia, government, industry, and nonprofit. Training programs should make available structured, career development advising and learning opportunities (e.g., workshops, discussions, grant-writing, Individual Development Plans). Opportunities for trainees to gain direct experience with parts of the translational ecosystem outside academia are also important, such as research externships in industry, regulatory agencies, nonprofit patient-advocacy groups, or with other CTSA Program hubs and/or training programs with strengths different from their home hub. Through such opportunities, trainees are expected to obtain a working knowledge of various potential career paths that would make strong use of the clinical and translational science knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen career.

• Leadership and Management: In addition to the above referenced Fundamental Characteristics of a Translational Scientist, leadership is another essential characteristic of clinical and translational science scientists. Leadership and management training should be infused into the research-focused career development program activities of the institutional research training (T32) program in Clinical and Translational Science Awards (CTSA) Program so that trainees can develop professional and leadership skills (e.g., emotional intelligence, eliminating barriers to participation, imposter phenomenon) conflict resolution, job offer negotiation, laboratory management, balancing competing priorities) to be effective leaders in clinical and translational science.

This NOFO does not allow appointed Trainees to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

Applications Not Responsive to this NOFO

The following types of applications will be deemed nonresponsive and will not be reviewed:

• Applications that are not submitted concurrently with a UM1 application (PAR-21-293 or PAR-24-272 (Clinical and Translational Science Award)), or while the UM1 application is either in review, under consideration for funding, or has been awarded.
• Applications proposing combined predoctoral and postdoctoral training under this NOFO.
• Applications that propose short-term research experiences (experiences in which the participant is full-time (40 hours per week) for a period of 10 to 15 weeks, or as specified by the sponsoring institution in accordance with its own policies).
• Applications proposing predoctoral research training must apply to the Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Institutional Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (PAR-25-194). However, team-based training models that include partnerships with predoctoral trainees are allowed with the following caveats: 1) the T32 postdoctoral application includes stipend and other budget support for postdoctoral trainees only; and 2) all aspects of the training program, such as mentors, evaluation, descriptions of candidate pools, training program plan, and information collected and presented in data tables provide details specific for postdoctoral trainees only.

Application information, including Frequently Asked Questions and Technical Assistance Webinars, are found on https://ncats.nih.gov/research/research-activities/ctsa/applicant-information.

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

Section II. Award Information

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

Application Types Allowed:

• New
• Renewal
• Resubmission - Resubmission Applications for PAR-21-338 and this NOFO

The OER Glossary and the How to Apply Application Guide, provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial? Not Allowed: Only accepting applications that do not propose clinical trials. Note: Appointed Trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

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: Application budgets are not limited, but need to reflect the actual needs of the proposed project.

Application budgets are to reflect no more than 2 trainee slots Hub Tier G; 3 trainee slots for Hub Tier T; 4 trainee slots for Hub Tier C; and 5 trainee slots for Hub Tier A per budget period. NCATS will not award more than these noted slots to a NRSA T32 postdoctoral program under this NOFO. Hub tiers must be ascertained to determine the maximum budget that can be requested for the UM1 companion application. Please see Clinical and Translational Science Award (UM1 Clinical Trial Optional) (PAR-21-293 and PAR-24-272).

Budget tier requests (A, C, G, or T) of the optional T32 application submitted must be the same budget tier of the respective UM1.

Please note that slots awarded under this program cannot be increased through cost sharing. Voluntary committed cost share should not be used as a means for increasing the number of trainee slots beyond the expected Tier slot number caps. Application budgets should request NCATS funding support for all trainee slots requested using applicable NRSA funding levels.

Recipients are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines (NIH Grants Policy Statement - Institutional Research Training Grants). Funds may be used only for those expenses that are directly related to and necessary for the research training and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement, and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

Award Project Period: The project period duration may be up to 5 years.

Other Award Budget Information

• Stipends, Tuition, and Fees: Ruth L. Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research training experience. NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. 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.

• Trainee Travel: Travel for trainees to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable expense for postdoctoral trainees. Trainees must be appointed to the training grant at the time of the actual travel for this to be an allowable cost. NCATS will provide up to $1,500 per trainee to travel to scientific meetings. Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense for postdoctoral trainees.

• Training Related Expenses: NIH will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, mentor training activities, equipment, research supplies, and faculty/staff travel directly related to the research training program. The most recent levels of training related expenses 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.

• Indirect Costs: Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement. NCATS does not permit automatic carryover from one budget period to the next.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations: All Clinical and Translational Science Award (UM1 Clinical Trial Optional) (PAR-21-293, PAR-24-272) applicant organizations and active award recipients are eligible to apply under this NOFO.

Only the primary UM1 CTSA hub organization is eligible to apply. Partner/Partnering and/or Collaborator/Collaborating institutions are not eligible.

Postdoctoral T32 applications submitted in response to this NOFO are optional companion applications to the Clinical and Translational Science Award (UM1 Clinical Trial Optional) application. Such T32 applications may be submitted in response to this NOFO under one of the following scenarios:

• concurrently with the UM1
• while the UM1 application is under review consideration
• while the UM1 is under consideration for funding
• after the UM1 application is funded

Postdoctoral T32 applications will only be awarded if there is an awarded UM1 application from the applicant organization.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Foreign Organizations: 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.

Required Registrations:

• Applicant Organizations: Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide, to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

  • 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day-to-day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

The UM1 PD(s)/PI(s) may not be a PD(s)/PI(s) on the T32 application or award in order to ensure the PD(s)/PI(s) have adequate time to devote to the respective programs.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

Voluntary committed cost share will not be accepted and will not be considered in the review score for trainee NRSA stipends and fringe benefits, travel, training related expenses and/or tuition and fees. Any applicant identifying voluntary committed cost share in the budget sections of the application will be bound to the cost share commitment for the entire approved project period. All costs included in the budget section of the application must be allowable costs per the NOFO. Unallowable costs will be removed prior to award. Applicants should describe other institutional support available to enhance the training experience in the Facilities & Other Resources attachment and/or the Institutional Environment and Commitment to Training section of the application.

3. Additional Information on Eligibility

Number of Applications: Applicant organizations may NOT submit more than one application.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Only one T32 postdoctoral application per institution (normally identified by having a unique UEI number or NIH IPF number) is allowed.

This NOFO is part of a required set of companion applications: the Clinical and Translational Science Award (UM1) and companion Institutional Research Career Development (K12). The remaining NOFOs in the suite are optional and include the Ruth L. Kirschstein National Research Service Award (NRSA) institutional training programs (T32 predoctoral and T32 postdoctoral), the Research Education Grant (R25), and the Specialized Innovation Program (RC2). These optional NOFOs are only available to CTSA Program UM1 applicants and award recipients. Applications to the companion NOFOs cannot be awarded until an award has been issued for the UM1. Adhering to the submission eligibility below, a set must contain 1 application to the UM1 NOFO and 1 application to the K12 NOFO; it may also contain 1 application to the T32 predoc NOFO, 1 application to this T32 postdoc NOFO, 1 application to the R25 NOFO, and/or up to 2 applications for the RC2 NOFO.

Preceptors/Mentors: Programs are encouraged to build a team of preceptors/mentors that includes, for example, faculty at different career stages (i.e., junior as well as senior faculty).

Trainees: The applicant organization will select the trainees to be supported by the research training program and is responsible for establishing trainee eligibility and selection criteria that are consistent with applicable law.

The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement.

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit, or when trainees are appointed to approved, short-term training positions.

Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: D.M.D., DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Individuals in postgraduate clinical training, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Within the full-time training period, research trainees who are also training as clinicians (stage of residency or fellowship) must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training goals. At time of appointment, trainees with clinical degrees, must have completed residency if they have chosen not to subspecialize.

Trainees with PhDs should be early in their postdoctoral stage, with no more than 2 years since the date of their terminal degree. These institutional research training grants typically provide 2 years of full-time support to postdoctoral trainees to ensure they are prepared to apply clinical and translational science research principles to their area of study.

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) Instructions in the How to Apply - Application Guide except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations: All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission: The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

• SF424(R&R) Cover: All instructions in the How to Apply - Application Guide must be followed. Descriptive Title of Applicants Project: Use the format “CTSA Postdoctoral T32 at Name of Institution".

• Cover Letter Attachment: The Cover Letter is one pdf file only. Applications that are part of a collaborative set must include the following information: a listing of all the applications that are a part of the set of collaborative applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the NOFO number, 3) the Title of the application, and 4) the Applicant Institution. Each application that is part of the collaborative set should submit an identical listing.

• SF424(R&R) Project/Performance Site Locations: All instructions in the How to Apply - Application Guide must be followed.

• SF424 (R&R) Other Project Information: All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

  • Project Summary/Abstract. Provide an overview of the entire program. Include the mission, objectives, rationale and design of the research training program. Highlight key activities in the training plan that promote skills development and successful transitions into careers in the biomedical research workforce. Indicate the planned duration of appointments, the projected number of trainees and intended trainee outcomes.

• Other Attachments: All of the following attachments are required. Applications that do not contain the following attachments will be deemed incomplete and will not be reviewed.

  • An Internal Advisory Committee (3-page maximum). A plan must be provided for the appointment of an Internal Advisory Committee. The Internal Advisory Committee will be a group of scientists from the sponsoring department and other departments or institutions, as appropriate, with research interests relevant to clinical and translational science. The two major functions of the committee are to evaluate: 1) applications from potential trainee candidates, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations concerning trainee appointments, evaluates ongoing research activities annually (including the interaction and integrated nature of the trainees' research experience), and makes recommendations regarding their continuation. The committee may use institutional or outside consultants, if needed. In the plan provided, describe the composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information. Describe how the Internal Advisory Committee will evaluate the overall effectiveness of the program. Proposed Internal Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Please name your file “Internal_Advisory_Committee.pdf”.
  • Mentor/Trainee Assessment Plan (3-page maximum): The assessment plan is to describe how the program will monitor mentoring relationships. The plan should describe the approaches and tools that will be used to corroborate the mentors’ self-rated quality of mentoring with those perceived by their mentees. The plan should include a plan on how the Program leadership will monitor, address and intervene in instances of major discrepancies. A plan for removing faculty displaying unacceptable mentorship qualities from the training program should be described. The application may include blank surveys, rubrics, and/or forms used to (a) document and monitor the mentoring relationship progress and (b) determine whether the training and research environment is effective, safe, and supportive. Please name your file “Mentoring_Assessment.pdf”.
  • Trainee Selection and Appointment Process (3 page maximum). Define and justify the selection and appointment criteria for postdoctoral trainees. Provide information about the process used by the participating departments/interdepartmental programs to recruit training grant eligible individuals. Discuss whether a multifactorial candidate review process is used (i.e., a process that considers metrics beyond previous institution, GPA, and standardized test scores) that will allow a broad group of trainees who have taken advantage of the research opportunities available to them and are committed to contributing to the biomedical research enterprise the ability to participate in the training program. Please name the file “Trainee_Selection_Process.pdf”.
  • Trainee Retention Plan (3-page maximum). The applicant must provide a Trainee Retention Plan. Describe efforts to sustain the scientific interests as well as monitor the academic and research progress of all trainees within a program (i.e., retention) and to use evidence-informed practices for retention with the recognition that the variety of trainee backgrounds and experiences may necessitate the need to tailor retention approaches. Centralized institutional efforts alone will not satisfy the requirement to implement robust and successful mechanisms to retain all trainees (e.g., participating faculty are expected to be actively involved in trainee retention efforts). Please name the file “Retention_Plan.pdf”.
  • Sustainability Plan (1-page maximum). The application must provide a plan for supporting trainees whose appointments will be on-going at the end of the project period. Please name your file “Sustainability_Plan.pdf”.
  • Outcomes Data Collection and Storage Plan (2-page maximum). The applicant must provide an Outcomes Data Collection and Storage Plan to track the outcomes for all supported trainees for a minimum of 15 years beyond the trainee’s participation in the program. Programs are encouraged to make the aggregate outcome data available on the institution's website. If the applicant intends to make the data available, describe how the aggregate data will be de-identified before public posting. Include a strategy to ensure the secure storage and preservation of program data and outcomes. Describe how the data will be centralized, safeguarded, and retrievable during leadership changes. Please name your file “Data_Collection_Storage_Plan.pdf”.
  • Dissemination Plan (1-page maximum). The application must provide a specific Dissemination Plan to publish or present nationally any findings or materials developed under the auspices of the program. Examples of dissemination may include data or materials from successful training or mentoring interventions via web postings, presentations at scientific meetings, and/or workshops. Please name your file “Dissemination_Plan.pdf”.
  • Coordination and Integration Plan (3-page maximum). The application must provide a specific plan describing the partnership between the UM1, the required K12 and any optional companion application(s). Describe the overarching goals of each required and optional companion application and the coordination, integration, synergy, and mutual reinforcement of resources between them. Include a description of the roles of any shared partners and/or collaborators. Include a description of any proposed team-based or near-peer mentoring aspects, if applicable. Describe the integration of these activities with the UM1, K12, and the postdoctoral training supported under this T32, as well as any other optional companion applications, as well as with partners and collaborators. Please name your file “Coordination_Interaction_Plan.pdf”.

  The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

• SF424(R&R) Senior/Key Person Profile Expanded: Follow all instructions provided in the How to Apply - Application Guide.

  • Biographical sketch. Where applicable, personal statements should highlight prior experience with training and mentoring, promoting a safe and supportive scientific environment, and providing instruction in scientific rigor.

• PHS 398 Cover Page Supplement: Follow all instructions provided in the How to Apply - Application Guide.

• PHS 398 Training Subaward Budget Attachment(s): Follow all instructions provided in the How to Apply - Application Guide.

• Training Budget: Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications:

  • Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • As per the instructions, request actual amounts for tuition/fees and provide justification. The amounts may be adjusted at the time of award.
  • Tuition is only allowable if such charges are applied consistently to all individuals in a similar training status at the organization per the NIH GPS.
  • Budget tier requests (A, C, G, or T) of the optional T32 applications submitted must be the same budget tier of the respective UM1.
  • Funding tiers for any new or resubmitted T32 applications submitted within the UM1 7-year award project period will be tied to the awarded UM1 tier size (A, C, T or G). For example, if the UM1 was funded at a Tier G level then a new or resubmitted T32 postdoctoral application from the UM1 prime applicant institution must request an application budget that aligns with the Tier G level (2 postdoctoral trainee slots).
  • Within the budget section, include only items for trainees directly supported by direct NIH funding via this NOFO.

• PHS 398 Research Training Program Plan: The PHS 398 Research Training Program Plan Form is comprised of the following sections:

  • Training Program
  • Faculty, Trainees, and Training Record
  • Other Training Program Sections
  • Appendix - Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the NOFO specifically instructs applicants to do so.

  Follow all instructions provided in the How to Apply - Application Guide. Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of past participants, and other factors that contribute to the overall environment of the program.

  • Training Program:

    • Program Plan: The "Program Plan" attachment is required and must adhere to the NIH Table of Page Limits, as well as the organization and instructions provided below. For the Program Plan attachment, do not follow the organization and instructions provided in the SF424 (R&R) application guide; instead applicants must use the instructions below. For all other sections of the Training Program Plan, follow the instructions in the How to Apply - Application Guide. Start each section with the appropriate heading.
      • Mission and Objectives: The justification for the proposed research training program including, but not limited to, the relevant background and an overview of the current research training activities of the participating department(s) or unit(s); and The training mission (i.e., broad statement of purpose of the program), and objectives (i.e., specific measurable outcomes the program intends to achieve) that align with the overarching goals of the CTSA research training program described above and lead to the creation of a community of clinical and translational science research trainees.
      • Program Administration: The application should describe how the Training Program Director(s)/Principal Investigator(s) (PDs/PIs) will promote the success of the trainees and training program. Multiple PDs/PIs are encouraged, particularly when each brings a unique perspective and skill set that will enhance training, as described in the Eligible Individuals section. The application should expand on the information in the biosketch(es) to address how the PD/PI or PD/PI team has:
        • The scientific expertise, including a record of rigorous research, as well as the administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program.
        • The time to commit sufficient effort to ensure the program's success, given other professional obligations (applicants should indicate the program director's percent effort in the proposed program).
        • The planned strategy and administrative structure to oversee and monitor the program and ensure appropriate and timely trainee progress, along with evidence-informed mentor training and mentoring practices.
      • Program Faculty and Mentoring Oversight: The application must include information about the program faculty who will serve as preceptors/mentors and, if relevant, distinguish between faculty members who will serve as primary mentors and those who have other roles in the training program. In addition to the information specified in the Application Guide, describe:
        • How the program faculty have time to commit to training given their other professional obligations;
        • How the program faculty composition will ensure that trainees will gain the KSAs to advance clinical and translational science research areas into diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health;
        • How the program has a team of program faculty that includes faculty at a range of career stages and from a variety of scientific backgrounds;
        • How the program will provide mentoring oversight, including oversight of the effectiveness of the trainee/program faculty match;
        • How the program faculty are trained to ensure the use of evidence-informed training and mentoring practices that promote the development of trainees;
        • How the program faculty will provide supportive mentoring;
        • How the program faculty will be evaluated as teachers and mentors;
        • In programs where trainees will have multiple mentors, how the faculty will effectively coordinate training and mentorship responsibilities.
      • Proposed Training: In addition to the information specified in the Application Guide, describe:
        • How trainees will be instructed on data science principles that are relevant to their areas of research. Examples include statistics, computational science, bioinformatics, data sharing and access, data management, data security, and data privacy in human subject research.
        • Program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in the varied research career options available in the clinical and translational science research workforce. For example, programs should provide all trainees with instruction and training in oral and written presentations and in skills needed to apply for individual fellowship or other grant support.
        • How the proposed program will engage a range of potential employers to ensure the trainees will acquire the appropriate skills, knowledge, and steps needed to attain positions in the sectors of the biomedical research workforce that are of interest to them.
        • How the training program or institution will provide experiential learning opportunities (e.g., industry internships, shadowing, informational interviews, teaching opportunities) that allow trainees to develop the professional skills and networks necessary to transition into careers in the biomedical research workforce.
        • How the program will incorporate opportunities for near-peer mentoring experiences, where the mentored experience is turned into two-way learning opportunities for both participants, if applicable.
        • How the training plan is distinct from, but will share resources and synergize with, other NCATS-funded training or career development programs at the same organization (e.g., predoctoral or postdoctoral TL1/T32, KL2/K12). The application should expand upon, but not duplicate, information on overlap and synergies described in the Coordination and Interaction Plan. NCATS expects that the training program will be distinct with respect to the scientific research training area; however, collaborative activities such as the responsible conduct of research training, career and professional skills development, etc. are encouraged.
        • How the training program provides leadership training.
      • Training Program Evaluation: In addition to the information specified in the Application Guide, describe:
        • How the program will identify tools to assess program performance including evaluation of the curriculum, mentors, research training opportunities, and trainees.
        • How the program will be evaluated to determine its quality and effectiveness. This plan should include evaluation metrics as well as plans to obtain feedback to help identify weaknesses and to provide suggestions for improvements. The specified evaluation metrics should be tied to the goals of the training research program and is to track the career progress of trainees. How the proposed evaluation will assess the extent to which trainees find the training program to be safe and supportive of trainee development.
        • How the proposed evaluation will assess the trainee’s perception of a training program that encourages participation at all levels.
        • How the proposed evaluation will assess the trainee’s perceptions of effective mentoring and of a safe and supportive scientific and training environment.
        • A mechanism to monitor mentoring, including oversight of the effectiveness of the trainee/participating faculty match, and a plan for removing faculty displaying unacceptable mentorship qualities from the training program (applicants are to use the Mentor/Trainee Assessment Plan to provide details of the plan).
        • How the proposed evaluation will assess trainee’s key training milestones and achievements such as, but not limited to, program completion; first authored manuscripts, applications and successes of fellowship or career development awards; successful competition for positions in industry, academia, government or other research venues, etc.
      • Trainee Candidates: In addition to the information specified in the Application Guide, and through the narrative and summaries of the information presented in the Training Data Tables and the attachments, the application should describe:
        • A strong justification for the number of requested funded slots per year in the context of the training grant eligible pool, the size of the proposed program, and the number of participating faculty. For interdepartmental programs, describe the number of appointed individuals in the program from each scientific discipline.
        • The proposed training grant support structure, i.e., how many individuals (e.g., 4 per year), at what stage (e.g., first year postdoctoral), and for how long (e.g., for 2 years). Note: The CTSA postdoctoral T32 Programs should support individuals early in their postdoctoral stage (no more than 2 years since the date of their terminal degree).
      • Institutional Environment and Commitment to Training: The application should describe how the level of institutional and departmental commitment to research and training excellence will promote the productivity and progress of the trainees and the success of the training program. This includes providing a safe and supportive environment with procedures to ensure accountability and reporting of concerns. For institutions that have multiple NIH-funded training grants, the letter (see Letters of Support) should also explain what distinguishes the proposed program from existing ones at the same training level, how the programs will synergize and share resources when appropriate, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed program in addition to existing ones. The applicant should ensure the peer reviewed sections (budget section) of the application focus on the scholars/trainees to be supported by direct NIH funding via this funding opportunity. Descriptions of other institutional training programs should be included in the Institutional Environment and Commitment to Training and Facilities & Other Resources sections.

  • Faculty, Trainees, and Training Record Section:

    • Participating Faculty Biosketches: Program faculty are encouraged to provide a personal statement that describes their prior experience with:
      • Training, mentoring, and promoting a safe and supportive scientific environment.
      • Providing training in rigorous and unbiased experimental design, methodology, analysis, interpretation, and reporting of results.
      • Aiding and supporting trainees in identifying and transitioning into careers in the biomedical research workforce that are consistent with trainees' skills, interests, and values.
    • Letters of Support:
      • Institutional Support Letter: Include a signed letter on institutional letterhead from a President, Provost, Dean or key institutional leader that describes the activities and resources provided by the institution that will ensure the success of the planned training program and its trainees (not to exceed 10 pages). Institutional commitment to the following areas should be described in the letter:
        • Developing and promoting a culture in which the highest standards of scientific rigor, reproducibility and responsible conduct are advanced.
        • Ensuring sufficient resources and support will be available to the training faculty and trainees, for example, to permit early-stage faculty to participate in training and trainees to continue in training if their mentors experience a hiatus in research funding.
        • Supporting core facilities and technology resources and describing how they can be used to enhance training.
        • Providing adequate staff, facilities, and educational resources to the planned program.
        • Supporting the PD(s)/PI(s) and other key staff associated with the planned training program; ensuring faculty have protected time available to devote to mentoring, training and research; considering activities integral to excellent training (such as teaching and mentorship) in tenure and promotion decisions.
        • Promoting safe and supportive research environments at all levels (trainees, staff, faculty, and leadership);
        • Ensuring the research facilities and laboratory practices promote the safety of trainees; ensuring the research facilities are accessible to trainees with disabilities.
        • Ensuring that proper policies, procedures, and oversight are in place to prevent discrimination, harassment and other discriminatory practices and to appropriately respond to allegations of such discriminatory practices, including providing any notifications to NIH (NOT-OD-19-056) OCR (e.g., see NOT-OD-15-152) or to relevant offices in the grantee institution,
        • Providing the types and levels of support necessary for trainees to successfully complete the research training program.
        • Supporting evaluation of the training program and procedures for responding to evaluation findings. All information related to institutional support, as defined above, must be included within the 10-page limit of this letter.
    • Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

• PHS Assignment Request Form: All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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 How to Apply - 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. An NRSA appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

7. Other Submission Requirements and Information

• Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
• Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
• For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

• All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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 How to Apply - Application Guide.
• See more tips for avoiding common errors.
• Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NCATS, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Mandatory Disclosure: Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]

Post Submission Materials: 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. While any information in the application relevant to the program goals can be included as part of the review process, the race, ethnicity, or sex of trainee candidates, trainees, or faculty may not be used as factors in the evaluation of applications.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will equip the trainees with the skills, knowledge and experiences necessary to transition to successful careers in the biomedical research workforce, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed.)

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major biomedical research training impact.

• Training Program and Environment

  • Does the application provide a compelling rationale for the proposed research training program and propose appropriate training goals and objectives relevant to the rationale?
  • Will the courses, structured training activities, mentoring, and research experiences achieve the training program’s goals and objectives, and provide opportunities for trainees to acquire skill and expertise in transparent, rigorous, reproducible and relevant research methodologies and tools applicable to the goals of the training program?
  • Is there an effective mechanism to monitor mentoring and to promote the development, retention and success of all trainees throughout their training?
  • Will the proposed training program provide the trainees appropriate information regarding the breadth of careers in the biomedical research workforce for which their training may be useful, and appropriate learning opportunities that allow them to develop the professional skills and networks necessary to transition into those careers?
  • Does the research training environment have adequate and appropriate facilities to support the proposed research training program?
  • Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to promote the success of the program?
  • Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?
  • Specific to this NOFO:
    • Does the proposed program clearly outline obtainable and measurable objectives that align with the overarching goals of the CTSA research training program?
    • Does the program structure ensure that trainees will receive training in knowledge, skills and abilities relevant to clinical and translational science research?
    • Are the research facilities and research environment conducive to preparing trainees for successful careers as clinical and translational scientists?
    • Is the proposed training program likely to ensure trainees will be well exposed to Clinical and Translational Science (CTS) concepts and prepared for broad, research-related careers in translational science?
    • Does this training program have customized curricula that are personalized and nurture domain-specific knowledge, skills and abilities depending on the trainee’s desired career role or focused area of research?
    • Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate and timely trainee progress?
    • Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?
    • Does the program provide appropriate multidisciplinary research training opportunities?
    • Is there evidence that the proposed programmatic activities will unify a cohort of trainees and expand their expertise beyond what would occur in the absence of the program?
    • For multidisciplinary and/or multi-departmental programs, is it clear how the individual disciplinary and/or departmental components of the program are integrated and coordinated and how each will relate to an individual trainee's experience?
    • Will the trainees be provided with adequate and appropriate information regarding the wide variety of careers in the translational science research workforce for which their training may be useful?
    • Will the program engage with potential employers to ensure that the trainees acquire the appropriate skills, knowledge, and steps needed to attain positions in translational science research workforce sectors that are of interest to them?
    • Will the training program or institution provide experiential learning opportunities (e.g., industry internship, shadowing, informational interviews, grant writing) that allow trainees to develop the professional skills and networks necessary to transition into careers in translational science?
    • To what extent will the training program provide training in leadership and management (e.g., emotional intelligence, imposter phenomenon, conflict resolution, job offers negotiation, communication skills, self-advocacy, laboratory management, budgeting, hiring, stress management and wellness, balancing competing priorities)?
    • To what extent will the institutional and departmental commitment to research and training excellence promote the success of the CTS trainees and training program that includes, but not limited to, recognition and acknowledgment of all team members and a team science approach?
    • To what extent is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
    • To what extent is there adequate support of the PD(s)/PI(s) and other key staff, facilities, and educational resources associated with the training program?
    • To what extent is there evidence that a CTS trainee community is being created and nurtured in ways that permeates the broader learning community beyond the CTSA Program Hub?
    • To what extent are safe and supportive research training environments promoted at all levels of the research training environment (trainees, staff, faculty, and leadership)?
    • To what extent does the proposed program support high-quality, rigorous research training that will enable individuals to succeed at all levels of the research training environment?
    • To what extent are there resources and the expertise for evaluating the training outcomes of the program?

• Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

  • Do the PD(s)/PI(s) have the appropriate background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
  • Do the PD(s)/PI(s) plan to commit sufficient effort to promote the program’s success?
  • Have the PD(s)/PI(s) demonstrated a strong commitment to training future researchers?
  • Does the application describe how the PD(s)/PI(s) will receive appropriate training on effective mentoring practices to promote trainee success?
  • For applications designating multiple PDs/PIs:
    • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
    • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs?
  • Specific to this NOFO:
    • To what extent is there a planned strategy and administrative structure to oversee and monitor the program and to ensure appropriate and timely progress for the duration of each trainee's time in the program?
    • To what extent are the PD(s)/PI(s) currently funded and engaged in clinical and translational science?
    • To what extent does the leadership demonstrate a commitment to developing future clinical and translational scientists and fostering safe and supportive research environments?

• Preceptors/Mentors

  • Does the proposed program demonstrate the presence of a sufficient pool of preceptors/mentors with appropriate expertise and adequate resources available to support the training goals and objectives proposed in the application (including short-term training, if applicable)?
  • Is there a strong plan to ensure participating faculty receive appropriate training in the use of evidence-informed mentoring practices that promote the development of trainees?
  • Do participating faculty appropriately promote the trainees' career progression?
  • Specific to this NOFO:
    • Does the program faculty have the experience to train the trainees in the knowledge, skills, and abilities to advance clinical and translational science research areas into diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health?
    • Is selection of the program faculty based on a commitment to training and mentoring?
    • Do faculty have sufficient protected time available to devote to the training activities?
    • Do faculty have experience working as part of multidisciplinary teams?
    • Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate and timely trainee progress for the duration of the trainees' graduate careers?
    • For clinically oriented trainees, do these trainees have mentors who are clinicians?
    • Does the evidence-informed mentor training assessment move beyond the faculty’s/preceptor’s participation satisfaction to self-reporting of perceived skills gained, self-reported changes in mentoring behaviors or self-reporting of effectiveness?
    • Is there a way for trainees in the mentoring teams to corroborate mentor’s self-report of changes in mentoring behaviors?
    • Is there a plan to ensure that the participating faculty engage in activities that promote trainee career development (including but not limited to the utilization of Individual Development Plans), and fulfill the need of the trainees to obtain the skills, credentials and experiences to transition into independence and careers in the translational science?
    • Is there an effective mechanism to monitor mentoring, including oversight of the effectiveness of the trainee/participating faculty match, and a plan for removing participating faculty displaying unacceptable mentorship qualities from the training program?
    • Is there evidence that the program faculty and preceptors include faculty at a range of career stages and from a variety of scientific backgrounds?
    • Is there a plan for how multiple mentors will effectively coordinate their training and mentoring responsibilities?
    • Is there evidence that mentor training efforts extend beyond those involved in the training grant and impact the institution?
    • Does the program include mentors with expertise in areas pertinent to clinical and translational science such as pre-clinical research, clinical research, clinical implementation, and public health in order to form the intellectual and technical base for the mentoring of trainees?
    • Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
    • Do the preceptors/mentors demonstrate a commitment to effective mentoring and promoting positive and supportive scientific and career development environments?
    • Do the preceptors/mentors have a commitment to training and mentoring? For example, have they received training on how to effectively mentor individuals?
    • If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

• Trainees

  • Does the proposed program demonstrate the presence of a sufficient pool of potential trainees in appropriate disciplines and training stages to achieve the training goals and objectives (including short-term training, if applicable)? Do the recruitment strategies identify trainee candidates with the potential to strongly benefit from, and with proper training and support, succeed in the training program?
  • Does the program propose an appropriate multifactorial candidate review process to allow a broad group of research-oriented trainees the ability to participate in the training program (for example, a process that considers, consistent with applicable law, metrics beyond previous institution, GPA, and standardized test scores)?
  • Are there well-defined and justified selection and re-appointment criteria?
  • Specific to this NOFO:
    • Does the application provide a strong justification for the number of trainee positions requested?

• Training Record

  • How successful are the trainees (or, for new applications, recent graduates in similar training) in completing the program?
  • Does the application provide evidence that trainees (or, for new applications, other recent graduates in similar training) conducted rigorous research that, appropriate to the training stage of the proposed program, advanced scientific knowledge and/or technologies with increasing self-direction (such as peer-reviewed publications and other accomplishments appropriate to the field)?
  • How successful are the trainees (or, for new applications, recent graduates in similar training) in transitioning to careers in the biomedical research workforce that utilize their training and directly benefit the broader biomedical research enterprise?
  • If disparities are observed in outcomes for trainees (or, for new applications, recent graduates in similar training), has the program proposed adequate approaches to identify the causes and, where warranted, approaches to feasibly address them?
  • Does the program propose a rigorous evaluation plan to assess the effectiveness of the training program and the extent to which it is meeting its overall goals and objectives? Are effective mechanisms in place for obtaining feedback from current and former trainees, and appropriate plans to respond to trainee feedback?
  • Specific to this NOFO:
    • Does the plan include involvement of both internal and external faculty?
    • Does the program have a strategy to address the training outcomes of the overall program and the training records of the individual mentors?
    • Does the program evaluate that participation is promoted at all levels of the translational science research training environment (trainees, staff, faculty, and leadership)?
    • Does the program evaluate the research and training environment?
    • Does the program evaluation provide evidence that the PD(s)/PI(s) and team will be attentive and responsive to the evaluation findings?
    • To what extent does the institution or training program have an established record of successfully recruiting and retaining trainees?

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: Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
• Inclusion of Women, Minorities, and Individuals Across the Lifespan: Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
• Vertebrate Animals: Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
• Biohazards: Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
• Training in Methods for Enhancing Reproducibility: Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide training in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the trainees? For renewal applications, does the application document appropriate changes in the plan for Methods for Enhancing Reproducibility in response to feedback and to evolving issues related to the conduct of rigorous and reproducible research?
• 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.
• Training in the Responsible Conduct of Research: All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components:
  1. Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.);
  2. Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics?
  3. Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application?
  4. Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction?
  5. Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years? For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?
• Renewals: For Renewals, the committee will consider the progress made in the last funding period, including on the Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s)? Is the program achieving its training objectives? Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period (may not be applicable to short-term training)? Does the program continue to evolve and reflect changes in the research area in which the training occurs?
• Revisions: Not Applicable

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.

• 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).
• 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 NCATS 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.

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

The following will be considered in making funding decisions, consistent with applicable law:

• 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal 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 NOFO.
• All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
• Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.
• Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy Statement - Institutional Research Training Grants.
• The taxability of stipends is described in the NIH Grants Policy Statement. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement.
• As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement; and more details are in the Frequently Asked Questions. Officials at the recipient institution have the responsibility of explaining the terms of the payback requirements to all prospective trainees before appointment to the training grant. Additionally, all trainees recruited into the training program should be provided with information related to the career options that might be available when they complete the program. The suitability of such career options as methods to satisfy the NRSA service payback obligation should be discussed.

Successful recipients under this NOFO agree that:

• Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity. Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.
• Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.
• Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that: When recipients, subrecipients, or third-party entities have: * ongoing and consistent access to HHS owned or operated information or operational technology systems; and * receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award. Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information.

Inventions and Copyrights: Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

Cooperative Agreement Terms and Conditions of Award: Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Other Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant for 8 weeks or more. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.

A final RPPR, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

In carrying out its stewardship of human resource-related programs, NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

NCATS intends to conduct an overall evaluation of the program and it will be based on metrics that will include, but are not limited to, the following:

For programs involving postdoctorates and early career investigators:

• Subsequent participation in a formal research training or career development program in a Clinical and Translational Science field
• Subsequent participation in research or employment in a Clinical and Translational Science field
• Authorship of scientific publications in a Clinical and Translational Science field
• Subsequent independent research grant support from NIH or another source

Section VII. Agency Contacts

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

Application Submission Contacts:

• eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)
  • Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
  • Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
• General Grants Information (Questions regarding application processes and NIH grant resources)
  • Email: [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]

Scientific/Research Contacts:

• Jennie L Conroy, Ph.D. National Center for Advancing Translational Sciences (NCATS) Telephone: 301-594-8165 Email: [email protected]

Peer Review Contact(s):

• Victor Henriquez, Ph.D. National Center for Advancing Translational Sciences (NCATS) Telephone: 301-435-0813 Email: [email protected]

Financial/Grants Management Contacts:

• Katie Matthews National Center for Advancing Translational Sciences (NCATS) Telephone: 301-827-7060 Email: [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.

Authority and Regulations: Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.

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