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. Notice of 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. Notice of Funding Opportunity Description

Purpose and Background Information

This is a limited competition.  The overall goal of the NIH Research Career Development programs 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. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

This NOFO encourages applications from organizations that propose well-designed, rigorous institutional research career development programs in the mission area(s) of the NIH. The applicant organization must have the requisite faculty, staff, potential scholars and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

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

The National Center for Advancing Translational Sciences (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 that will, in turn, increase the efficiency and efficacy of translation, with the ultimate goal of getting more treatments to more patients more quickly.

The purpose of this NOFO is to encourage institutions to propose creative and innovative institutional research career development programs designed to prepare a  pool of promising later stage postdoctoral fellows and junior faculty scholars who have made a commitment to independent clinical and translational science research careers, facilitating their timely transition (i.e., sectors including academia, industry, nonprofit and government), and continued engagement in research. This program provides support and protected time to scholars for an intensive, research career development experience under the guidance of an experienced mentorship team with expertise in clinical and translational science. The institutional research career development (K12) programs prepare scholars to transition into research independence in clinical and translational science and to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health. Institutional research career development (K12) programs are expected to be designed with a sustained period of protected time to enhance the scholar’s research-focused career development experiences as clinical and translational science researchers, both in their chosen areas and in research areas that includes: 1) pre-clinical research, 2) clinical research, 3) clinical implementation, and/or 4) public health. By understanding the scientific and operational principles underlying each step of the translational process, upon the completion of the institutional research career development program, the scholars will be prepared to launch into research independence. The scholars should be able to turn observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public while simultaneously poised to take on leadership roles in clinical and translational science.

Diversity at all levels - from fields of science to the regions in which it is conducted to the demographic backgrounds of scientists - contributes to excellence in mentored research career development environments and strengthens the research enterprise. This NOFO is intended to support outstanding mentored research career development programs and NCATS encourages program outreach efforts intended to foster diverse participation at all levels (e.g., see the Notice of NIH’s Interest in Diversity).

The NCATS at the 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. With its focus on improving the 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 objective of the institutional research career development (K12) programs component of the Clinical and Translational Science Awards (CTSA) Program is to prepare and provide protected time to scholars for an intensive mentored research career development experience that leads to full research independence and leadership positions in clinical and translational science. At the end of the research career development experience, the scholars should be well positioned with the knowledge, skills, and ability to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health.

Proposed institutional research career development (K12) programs are expected to nurture the scholars’ development of the following characteristics irrespective of their particular area(s) of expertise (Reference: Gilliland CT, et al. The Fundamental Characteristics of a Translational Scientist. ACS Pharmacol Transl Sci. 2019;2(3):213-216. doi:10.1021/acsptsci.9b00022):

• 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.
• 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.

Clinical and translational scientists exhibit both deep scientific domain expertise and systems understanding. Their research is designed to produce discoveries that are simultaneously important for their discipline(s) and complementary disciplines, thus advancing the translational process as a whole. These characteristics are required in order for scholars to successfully transition into research independence, and to effectively traverse and contribute to the advancement of the translational science spectrum.

Considerations

Applicants are expected to identify research career development needs and objectives (i.e., specific and measurable outcomes the program intends to achieve).

Funded programs are expected to implement the following:

Core Knowledge Expectations in Clinical and Translational Science Research: The institutional research career development (K12) program should be designed to ensure that by the end of the research career development training period, scholars are able to launch into independent research careers in clinical and translational science research areas, which include 1) pre-clinical research, 2) clinical research, 3) implementation science, and/or 4) population science/public health research. Scholars are expected to apply their cumulative experiential research training and knowledge in broad areas of research including, but not limited to: clinical and clinical trial research, regulatory science, biostatistics, epidemiology, health disparities, telehealth and telemedicine, dissemination and implementation science research, bioinformatics, community engagement and cultural competence, translational team science, entrepreneurship, scientific communication, project management, patents, Investigational New Drug (IND) filling process, FDA regulatory process, teaching pedagogy, leadership, and responsible conduct of research and rigorous research design.

The award may be used to support scholars with different levels of prior research training and at different stages in their mentored career development. For example, a scholar with limited experience in clinical and translational science may receive support in the career development experience that includes a designated period of didactic training followed by a period of closely mentored research experience. A scholar with previous research experience and training may not require extensive additional didactic preparation and may receive support in the form of career development experience that focuses on an intensive, mentored research experience in clinical and translational science.

Clinical and Translational Science Research is a Cross-Disciplinary Team-Based Endeavor: The institutional research career development (K12) programs are encouraged to be personalized so that scholars can further refine their domain-specific knowledge, skills and abilities (KSAs) and effectively transition to full research independence in clinical and translational science. Scholars are expected to carry out independent research in their disciplinary mastered competencies, while also gaining complementary knowledge of other disciplines and operational principles underlying at least two sectors of the translational science ecosystem to improve their capacity to effectively lead, 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 scholars scientific practice outside of their area(s) of expertise, both within the research academic domain and with stakeholders and with sectors outside it, such as patients, non-profit organizations, regulatory agencies, and industry.

Building on Institutional Strengths in Clinical and Translational Science Research: Each institutional research career development (K12) program is to be innovative in its research career development program efforts. The goal is for the scholars to improve their core competencies so that they can conduct high quality independent clinical and translational science research. To achieve this, research-focused career development programs are encouraged to build on the local strengths and demonstrated translational innovations of their companion CTSA Program hub (e.g., health disparities, telehealth and telemedicine, community engagement, bioinformatics, dissemination and implementation, entrepreneurship, etc.) to effectively curate and foster research independence of clinical and translational science scholars. In this spirit, programs should identify research-focused career development strengths, needs and objectives (e.g., specific and measurable outcomes the program intends to achieve) that will lead the scholar’s transition to fully independent research careers while creating a community of clinical and translational science research scholars that extends beyond the career development program. Building on institutional strengths can include approaches on how to expose scholars to a larger cadre of mentors with a broad  range of clinical expertise, experiences, resources, and backgrounds relevant to clinical and translational science and who can help the scholars launch into independent clinical and translational science research careers.

Diversity Contributes to Excellence: Diversity contributes to excellence in research training environments, is needed to address complex translational problems, and strengthens the clinical and translational science research enterprise. Consistent with existing NIH 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 scholar or faculty candidate as an eligibility or selection criteria, and (2) NIH does not use the race, ethnicity, or sex of prospective scholars, scholars, or faculty in the application review process or funding decisions.  However, programs are expected to demonstrate a commitment to promoting inclusive, safe and supportive scientific and training environments. Programs also should engage in outreach efforts intended to foster diverse participation.  Applicants and funded programs are encouraged to consult with their General Counsel to ensure all applicable laws and regulations are being followed in program design and implementation.

Optimizing Mentor Training: Effective mentoring is expected to increase self-efficacy, educational and career satisfaction, career advancement, and research productivity for individuals pursuing clinical and translational science research-focused careers. Institutional research career development (K12) programs are to describe how the participating faculty and preceptors are trained to use evidence-informed mentoring practices that launch scholars from all backgrounds, including scholars from groups underrepresented in the biomedical sciences (see Notice of NIH's Interest in Diversity) into independent research-focused careers. The evidence-informed mentor training assessments are expected to 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 application is to include a plan to assess and monitor how well the faculty mentor/preceptor promotes a safe, inclusive, and supportive research training environment and to make adjustments if needed. Scholars are to corroborate the self-report of changes in mentoring behaviors of each mentor in the mentoring team. Institutions are encouraged to develop strategies to recognize and reward outstanding mentors, including mentor awards, and to create opportunities where effective mentoring practices pervade the education and clinical and translational science research landscape of the institution.

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 career development (K12) program in Clinical and Translational Science Awards (CTSA) Program so that scholars can develop professional and leadership skills (e.g., emotional intelligence, implicit bias, imposter phenomenon, conflict resolution, job offers negotiation, laboratory management, balancing competing priorities) to be effective leaders in clinical and translational science.

Career Visibility and Enhancement: The career outcomes of scholars supported by the institutional research career development (K12) program in Clinical and Translational Science Awards (CTSA) Program include, but are not limited to, independent research-intensive careers in academia and industry. Research-focused career development programs must make available structured, career development advising and coaching which may include academic job search strategies, Individual Development Plans, workshops addressing diversity, equity and inclusion in the research workforce, mitigating microaggressions, grant-writing, and publishing aimed at increasing the competitiveness of the scholars to successfully transition, in a timely manner, to the next stage of their independent research career and become fully independent researchers. The career development activities should enhance the scholars’ scientific and professional network beyond the local institution.

NCATS seeks the submission of one set of companion applications. With this NOFO for the K12 application, a separate, companion NOFO seeks applications for a required UM1 (PAR-24-272: Clinical and Translational Science Award). While the institutional research career development K12 required companion application must be submitted concurrently with the initial UM1 application or resubmitted at any time the submitted UM1 new or resubmission application or award remains active, the K12 required companion application will only be awarded if the UM1 is awarded. (See Section III. Eligibility Information).

Note: This NOFO allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

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 the required UM1 (PAR-24-272: Clinical and Translational Science Award) application, or while the required UM1 application is either in review, under consideration for funding, or has been awarded.
• Applications that do not meet the criteria noted under the eligibility criteria (see Section III).
• Applications that do not submit all of the required attachments.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Note: This Notice of Funding Opportunity (NOFO) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

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

Section II. Award Information

Other Award Budget Information

NCATS will contribute up to $120,000 per year toward the salary of each K12 scholar. Note that the salary allowance will be commensurate with the actual number of person months committed applicable to their current salary and program-related activities. The $120,000 amount is exclusive of fringe benefits. In general, 9 person-months (75 percent of the K12 full-time effort) must be devoted to the K12 program, except for those in surgical specialties, which can have less than 9 person-months (75 percent), but no less than 6 person-months (50 percent), protected time for this program, if sufficiently justified and programmatically approved. Additional support may be requested for research-related activities detailed below. The total amount budgeted per scholar must not exceed $180,000 in direct costs per year.

Scholar Research and Development Support: The K budget must include funds to support K scholar research projects and career development activities. No less than $10,000 and up to $30,000 per individual Scholar must be provided for the following types of research-related expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) tuition and fees related to required career development courses and activities; (c) travel to scientific meetings or training that the institution determines to be necessary for the individual’s career development experience; and (d) statistical services including personnel and computer time. No more than $5,000 of the scholar research and development support funds per scholar may be pooled for program-wide activities only if such activities support the career development of all scholars. It is expected that the K12 Scholars will be working in a funded research environment and that support provided by the K12 grant will augment existing research support to the scholar. These expenses must be itemized in Section F of the R&R Budget.

The application must clearly indicate the number of scholar appointments proposed for each year. Candidates must have a full-time appointment at the applicant institution or a partnering institution. Scholar support is provided for a minimum of two years and a maximum of five years of consecutive funding for each scholar, consisting of 12-month appointments, provided their progress towards an independent clinical and translational science research career is on track and satisfactory. Applications must be able to show their ability to recruit scholars who can complete the entire two to five-year proposed program. Programs may not split funds for an awarded slot across two or more individuals.

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 applicant organizations and/or active award recipients for PAR-24-272 or PAR-21-293 Clinical and Translational Science Award (UM1 Clinical Trial Optional) 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.

The institutional research career development K12 required UM1 companion application must be submitted in accordance with the UM1 and K12 NOFOs application submission dates under the following scenario:

• Initial concurrent submission of both a UM1 application and a K12 application.

The K12 required companion application may be resubmitted in accordance with the applicable NOFO application submission dates under the following scenarios:

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

While the K12 required companion application must be submitted concurrently with the initial UM1 application or resubmitted at any time the submitted UM1 new or resubmission application or award remains active, the K12 required companion application will only be awarded if the UM1 is awarded.

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 Organizations) are not eligible to apply.

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the 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. The 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." The url for "Notice of NIH's Interest in Diversity" is https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html .

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 should be an established investigator (successfully competed for an R01 or R01-equivalent research grant) and must demonstrate effective mentoring of individuals at the same career stage as scholars who would be appointed to the award. 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 required companion K12 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.

3. Additional Information on Eligibility

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

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).

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 optional 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 this K12 NOFO; it may also contain 1 application to the T32 predoc NOFO, 1 application to T32, postdoc NOFO, 1 application to 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). Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, are encouraged to participate as preceptors/mentors. 

Program faculty should have a record of research training, including , former trainees who have established productive careers relevant to the NIH mission. Program faculty should have experience in working in multidisciplinary teams. 

Each scholar should have at least two mentors and at least one mentor should have a clinical background. The mentors should hold faculty positions, be supported by NIH or other competitively awarded grants, and be acknowledged experts in the area of clinical and translational science. Mentors must have an excellent track record for supporting and advancing the careers of junior clinical and translational scientists. Established, funded investigators, as mentors, will make available their expertise, guidance, and laboratory facilities to be utilized by scholars for research projects that will enhance their knowledge and skills. Mentors must have track records in mentoring and training. Mentors are expected to interact directly and consistently with the scholar in order to develop an individualized career development plan. No less than two mentors must be appointed to the scholar’s research-focused career interest and provide guidance for the development of each scholar. Mentors must be committed to continue their engagement throughout the scholar's total period of development under the award.

Scholars

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

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.

Scholars must have a research or health-professional doctoral degree or its equivalent.

Candidates should be later stage postdoctoral fellows or junior faculty who can take full advantage of and benefit from the described state-of-the-art research-focused career development program in clinical and translational science. Consistent with the type of mentoring and career development being provided by the CTSA Program, a K12 scholar candidate who is already in the process of applying for an independent mentored career development grant, Program Project Grants/Center Grants or equivalent grant is likely too senior for the K12 award.

Non-surgical specialties scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award. Surgical specialties can have less than 9 person-months (75% of full-time professional effort), but no less than 6 person-months (50%), protected time for this program, if sufficiently justified and programmatically approved.

Candidates must have a full-time appointment at the applicant institution or a partnering institution.

Selection Restrictions
At the time of appointment, scholars must not have a pending application for any other PHS mentored career development award (e.g., K07, K08, K22, K23, F99/K00) that duplicates any of the provisions of the K component. Former or current PDs/PIs on any major NIH research project grant (RPG; https://grants.nih.gov/grants/glossary.htm) [this does not include smaller NIH research grants and awards https://grants.nih.gov/grants/glossary.htm, or equivalent non-PHS peer reviewed grants  or project leaders on sub-projects of Program project (P01) or center grants (P50) are NOT eligible to participate as scholars.

Appointed scholars are encouraged to apply for individual mentored K awards (e.g., K07, K08, K22, K23) and independent awards (e.g., R01, R03, R15, R21, R34, or equivalent application from another Federal agency); if successful, scholars may be required to reduce effort on the mentored career award to a minimum of six-person months and hold concurrent support from their mentored career award and a competing PHS research grant on which they are the PD/PI or component lead or terminate the K12 appointment depending on Program requirements (See NOT-OD-08-065).

Scholars must be selected with the anticipated ability to complete the entire two to five-year proposed program. The selection committee must consider whether individuals who have pending NIH research grant applications with fundable scores that would require early K12 termination are appropriate for this award.  

Repeated selection of individuals who subsequently require early termination may affect out year funding.

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.

Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

SF424(R&R) Cover

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

Descriptive Title of Applicants Project: Use the format “CTSA K12 Program 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 a 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.

Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:

Other Attachments.

An External Advisory Committee (3-page maximum). Provide a plan for the appointment of an External Advisory Committee. The term ‘external’ here, means external to the career development program.  The K12 External 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) the candidate appointment process, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations concerning the strategies used for recruiting, selecting, evaluating, and retaining scholars consistent with applicable law and the alignment of the program outcomes with the NCATS CTSA K12 Research Career Development Program purpose. 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 (no less than annually), and other relevant information. Describe how the External Advisory Committee will evaluate the overall effectiveness of the program. Proposed External Advisory Committee members should be named in the application only if they have been invited to participate at the time the application is submitted. Renewal applications with External Advisory Committees should include the names of all committee members during the past project period.  Please name your file “External_Advisory_Committee.pdf”. If this attachment is not included, the application will be considered incomplete and will not be reviewed. 

Scholar Selection and Appointment Process (3 page maximum). Define and justify the selection and appointment criteria for scholars. Provide information about the process that will be taken by the participating departments/interdepartmental programs to select grant eligible individuals. Explain how it will ensure that the selection process will recruit scholars who can complete the entire two to five-year proposed program. Please name the file “Trainee_Selection_Process.pdf”. If this attachment is not included, the application will be considered incomplete and will not be reviewed.

1. Mentor/Scholar Assessment Plan (5-page maximum): The assessment plan is to describe how the program will monitor mentoring relationships. Describe the approaches and tools that will be used to support the mentors’ self-rated quality of mentoring with those perceived by their mentees. Include a description of how the Program leadership monitor, address and intervene in instances of major discrepancies. Describe a plan for removing faculty displaying unacceptable mentorship qualities from the training program. 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”. If this attachment is not included, the application will be considered incomplete and will not be reviewed. 

Sustainability Plan (1-page maximum). Provide a plan for supporting scholars whose appointments will be on-going at the end of the project period. Additionally, to plan for situations in which a Renewal application of the K12 and the UM1 are deemed to be non-competitive during peer review, renewal applications must include contingency plans for supporting current scholars so that they may complete their career development activities beyond the funding period. Please name your file “Sustainability_Plan.pdf”. If this attachment is not included, the application will be considered incomplete and will not be reviewed. 

Outcomes Data Collection and Storage Plan (2-page maximum). Funded programs are expected to track scholars for a minimum of 15 years beyond the scholar’s participation in the program. Provide a plan to track the outcomes for all supported scholars. Programs are encouraged to make the aggregate outcome data available on the grantee 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”. If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Dissemination Plan (1-page maximum). Provide a specific plan to disseminate 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”. If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Coordination and Integration Plan (3-page maximum). Provide a specific plan describing the partnership between the UM1, the required K12 and any optional applications. Describe the overarching goals of each application and the coordination, integration, synergy, and mutual reinforcement of resources between the application(s). 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, as well as any optional applications; as well as with partners and collaborators. Please name the file “Coordination_Interaction_Plan.pdf”. If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., predoctoral, postdoctoral, short-term faculty), and intended trainee/scholar outcomes.

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.

Applicants may designate personnel who are not also MPI but will have the responsibility for the day-to-day administration of the program. If such a person is proposed, they should be considered as other leadership, administrative, and management personnel (subject to the 6.0 total person months per annum) and listed as Senior/Key Personnel.  Note: This person should be an established scientist with the expertise, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary career development program of this scope. The day-to-day administrator will be expected to monitor, assess, and submit all documents and reports as required.

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.

Research and Related (R&R) 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. Also include proposed salary costs for planned scholars.
• Do not complete the section on Participant/Trainee Support Costs.
• Budget tier requests (no more than $700,000 Direct Costs for Hub Tier G; $900,000 Direct Costs for Hub Tier T; $1,000,000 Direct Costs for Hub Tier C; and $1,500,000 Direct Costs for Hub Tier A per budget period) of a the K12 application submitted in response to PAR-24-284 must be the same budget tier of the respective UM1. 

• Funding tiers for any new or resubmitted K12 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 K12 application from the UM1 prime applicant institution must request an application budget that aligns with the Tier G level. 

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.

For this NOFO, applicants should use the following Data Tables only (Data for scholars should be entered into the Postdoctoral sections of the Data Tables):

• Table 2 (New and Renewal applications)
• Table 3 (New and Renewal applications)
• Table 4 (New and Renewal applications)
• Table 8B, Part II (New) or Table 8B, Part I and Part II (Renewal applications only)

Information regarding the race, ethnicity, or sex of the applicant pool or scholars will not be used in the new or renewal application review process or funding decisions.

Training Program

Program Plan

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

Program Administration.

Describe the strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD(s)/PI(s) and Training Director. Relate these strengths to the proposed management of the career development program. Describe the respective roles of those in leadership positions and the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple PD(s)/PI(s), then the plan for Program Administration is expected to synergize with the “Multiple PD(s)/PI(s) Leadership Plan” section of the application. The program leadership is to demonstrate a commitment to developing the future clinical and translational science workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments. The PD(s)/PI(s) should have received evidence-informed training on how to effectively mentor individuals from all backgrounds, including individuals from  underrepresented groups(NIH's Interest in Diversity).

When an administrative coordinator position is planned, a description of the administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Institutions with existing K12 programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs.

Proposed Faculty

Include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of scholars proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Program Faculty lacking research training experience, describe a plan to ensure successful career development guidance by these individuals. Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation. The program faculty are to employ the highest standards of scientific rigor and impact those standards to the scholars. The program faculty are to receive evidence-informed training on how to effectively mentor individuals from all backgrounds, e.g., from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity).

Discuss whether mentor training assessments move beyond the faculty/preceptor’s self-reporting of gains in perceived skills, changes in mentoring behavior, or effectiveness of mentoring and whether there exists a process for scholars to corroborate mentors self-reporting outcomes.

Scholars

The application should describe plans for scheduling scholar appointments. Candidates must have a full-time appointment at the applicant institution or a partnering institution. Support is provided for a minimum of two years and a maximum of five years of consecutive funding for each scholar, consisting of 12-month appointments. If the event that a clinical trial may be proposed, discuss the potential of prospective Scholars to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

Support of scholars is renewable at the discretion of the PD/PI, contingent upon presentation of evidence of satisfactory progress as determined by the External Advisory Committee. The pool of potential scholars and criteria for selecting scholars must be described in the grant application. Institutions are encouraged to develop novel mechanisms for recruiting  scholars from diverse backgrounds.

Proposed Career Development

Describe how the research-focused career development program activities will ensure that scholar’s transition into research independence in clinical and translational science. In addition, describe proposed training in leadership and management (e.g., emotional intelligence, conflict resolution, negotiation, communication, self-advocacy, stress management and wellness, balancing competing priorities, etc.).

Programs should also describe the anticipated timeline by which scholars will develop a research project that will begin during the K12 support period that will be suitable for continuation beyond the K12 support period via an individual funding mechanism or independent NIH research funding (e.g., R01, R21, P50) or equivalent grants. Programs should also describe an administrative structure that facilitates successful adherence to this anticipated timeline, including potential corrective measures if milestones are not met.

Provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for any clinical trial, including any feasibility or ancillary study, proposed by scholar(s).

Proposed Training

In the event that a clinical trial may be proposed, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study, proposed Scholar(s).

Program Faculty.

If any mentors will supervise a Scholar proposing to either lead a clinical trial, or gain research experience in a clinical trial, provide documentation of their expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.

Scholar Candidates and Retention Plans.

If the event that a clinical trial may be proposed, discuss the potential of prospective Scholars to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

Institutional Environment and Commitment to the Program

The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program.

Programs are encouraged to rigorously enforce this protected time. Surgeon-scientists must devote a minimum of 50% full time professional effort to research and career development activities.

The application must include a signed letter, on institutional letterhead, that describes the applicant institution's commitment to the planned program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

This commitment may include potential additional administrative or financial support for individuals involved in the proposed career development program, or other commitments essential to a successful career development program.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the How to Apply - Application Guide.

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 Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed, with the following additional modifications:

Study Record: PHS Human Subjects and Clinical Trials Information

DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

Delayed Onset Study

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

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must complete a Delayed Onset Study.

If you check the “Anticipated Clinical Trial” box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the awarding component before any appointee begins independent clinical trial research.

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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. 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

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, or transgender status) of program candidates, scholars, or faculty may not, in and of themselves, 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 career development program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, 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 scientific impact.

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.

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 2.4.4 Disposition of Applications.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Prior Approval of Scholar Projects proposing to conduct research with Human Subjects and/or Live Vertebrate Animals: Recipient-selected projects that involve human subjects research require prior approval by NIH prior to initiation. The recipient institution will follow the process as described: https://ncats.nih.gov/research/research-activities/ctsa/ctsa-program-governance-guidelines/human-subjects-research   

Recipient-selected projects that involve live vertebrate animals research require prior approval by NIH prior to initiation. The recipient institution will follow the process as described: https://ncats.nih.gov/research/research-activities/ctsa/ctsa-program-governance-guidelines/prior-approval.

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. 

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 and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. Continuation support will not be provided until the required forms are submitted and accepted. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar 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.
• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more. Scholars with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS Form 6031-1) until the payback service obligation is satisfied.
• Description of EAC activities, per the RPPR Instructions (Section F.1 Changes in Approach and Reasons for Change). Appropriate reporting would include date/time the K12 EAC met and a summary of the EAC discussions applicable to program success, evaluation and improvement. 
• Progress reports (RPPRs) should provide information on all Scholars for the present grant years as instructed plus: 
  • Institutional title (Assistant Professor, Instructor, Fellow, etc.)

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement Section 8.6 Closeout. Evaluation results should be included as part of the final RPPR.

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

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

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

• Subsequent participation in a formal research training or career development program in clinical and translational science.
• Subsequent participation in research or employment in clinical and translational science.
• Authorship of scientific publications in clinical and translational science.
• 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]

Irina Krasnova, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-1737
Email: [email protected]
 

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

Zulema Eldridge
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-3066
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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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.