Part 1. Overview Information

Key Dates

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.

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.

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



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 diverse 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 cultural and scientific backgrounds, and to promote inclusive 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 goalof 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 cultural and scientific backgrounds, and to promote inclusive, 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, cultural, 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 from all backgrounds, including individuals from underrepresented groups.  See  Notice of NIH’s Interest in Diversity. 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, inclusive, 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, health disparities, telehealth and telemedicine, dissemination and implementation science research, bioinformatics, community engagement and cultural competence, 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., health disparities, 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.

Diversity Contributes to Excellence:   Within the framework of the NRSA T32 Program’s commitment to excellence and projected need for investigators in particular areas of research, attention must be given to promoting a diverse research workforce—from the kinds of science to the regions in which the research is conducted to the academic backgrounds and perspectives of the people conducting it. Diversity contributes to excellence in research training environments,  and strengthens the clinical and translational science research enterprise. Programs are expected to demonstrate a commitment to promoting inclusive, safe and supportive scientific and training environments (https://grants.nih.gov/policy-and-compliance/policy-topics/harassment) and collectively expand the pool of clinical and translational science-trained professionals.  Programs are also expected to engage in outreach and recruitment activities to encourage individuals from diverse backgrounds, including individuals from underrepresented groups (for examples, see the Notice of NIH’s Interest in Diversity) to participate in the program.  Consistent with existing NIH/NCATS practices and applicable law: (1) Funded programs may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a trainee or faculty candidate as an eligibility or selection criteria, and (2) NIH/NCATS does not use the race, ethnicity, or sex of trainee candidates, trainees, or faculty in the application review process or funding decisions.   Applicants and award recipients are encouraged to consult with their General Counsel to ensure all applicable laws and regulations are being followed in program design and implementation.

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 including bias,, 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

Other Award Budget Information

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

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.

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.

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.

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. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.See, Notice of NIH's Interest in Diversity.

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

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.

Programs are encouraged to build a broadly diverse 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, inclusive, 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), including those from underrepresented groups. Applicants are encouraged to consult the NIH’s extramural diversity website to identify promising retention practices 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 the 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 the 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 the 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 an inclusive 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 from all backgrounds; 
• 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 inclusive and supportive of trainee development.
• How the proposed evaluation will assess the trainee’s perception of a training program that encourages diversity at all levels.
• How the proposed evaluation will assess the trainee’s perceptions of effective mentoring and of an inclusive, 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 an inclusive, 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 an inclusive 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 diversity and inclusion at all levels of the research training environment (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 fieldof 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.    

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

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 (including gender identity, sexual orientation, of transgender status) of trainee candidates, trainees, or faculty may not, in and of themselves, be used as factors in the evaluation of applications.

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.)

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.

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.

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.

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

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.

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:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. 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. 

Not Applicable

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.

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.

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.

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.

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]

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

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

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.

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.