Section III. Eligibility Information

1. Eligible Applicants

With this solicitation for the K12 application, a separate, companion FOA solicits applications for a required UM1 (PAR-21-293). A UM1 hub application without the required companion K12 application will not be reviewed. The required K12 application will only be awarded if the UM1 application is awarded. Initial and resubmission of K12 will be accepted concurrently or if the UM1 application is awarded.

The application must provide a specific plan describing the partnership between the UM1, the required K12 and any optional components. The applicant institution must be the UM1 applicant. The UM1 institution must have a strong and high-quality research program in the area(s) proposed under this K12 FOA and 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 the proposed program will complement other ongoing career development programs occurring at the applicant institution and 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 goal.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

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.

The applicant institution must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and 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.

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

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

• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. In order to ensure that the PD/PI has adequate time to devote to the training program, a UM1 PD(s)/PI(s) may not be a PD(s)/PI(s) on the K12 application or award.

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 SF 424 (R&R) 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.

2. Cost Sharing

3. Additional Information on Eligibility

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

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

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Only one K12 application will be awarded if the UM1 application is awarded. If the UM1 is awarded and the initial K12 is not, the K12 application may be resubmitted. If the UM1 (A0) application is not awarded, then the K12 (A0) will not be awarded.

NCATS solicits the submission of one set of companion applications. With this FOA for the K12 application, a separate, companion FOA seeks applications for a required UM1 (PAR-21-293: Clinical and Translational Science Award). The UM1 and initial K12 applications must be submitted concurrently; a K12 application without the required companion UM1 application will not be reviewed. The required K12 application will only be awarded if the UM1 application is awarded. Resubmission of a K12 will be allowed only if the UM1 application is awarded.

Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Program faculty should have experience in working in multidisciplinary teams. Programs are encouraged to build a diverse team of preceptors/mentors that includes, for example, faculty from underrepresented groups (see Notice of NIH's Interest in Diversity) and at different career stages (i.e., early-career as well as established faculty).

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 young 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

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.

Individuals from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity) are always encouraged to be appointed to the K12.

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 NIH research project grant [this does not include NIH small grants (R03), Exploratory/Developmental (R21) or SBIR, STTR (R43, R44 grants)] or equivalent non-PHS peer reviewed grants that are over $100,000 direct costs per year, 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 outyear 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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

SF424(R&R) Cover

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

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 Title (including the tag, e.g., 1/3 ), and 3) the Applicant Institution. Each site should submit an identical listing.

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

All instructions in the SF424 (R&R) 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). A plan must be provided for the appointment of an External Advisory Committee. The 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) applications from potential scholar candidates, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations concerning scholar appointments, evaluates ongoing research activities annually (including the interaction and integrated nature of the scholars' 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 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. If this attachment is not included, the application will be considered incomplete and will not be reviewed. Please name your file External_Advisory_Committee.pdf .

Scholar Selection and Appointment Process (3 page maximum). Define and justify the selection and appointment criteria for scholars. The applicant must provide information about the process that will be taken by the participating departments/interdepartmental programs to recruit grant eligible individuals. Where applicable in the application the applicant must explain how it will identify and recruit a diverse pool of potential candidates from a wide variety of institution types and backgrounds (e.g., individuals from underrepresented groups in the biomedical sciences, NIH's Interest in Diversity). Applicant must 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.

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

Sustainability Plan (1-page maximum). The application must 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. If this attachment is not included, the application will be considered incomplete and will not be reviewed. Please name your file Sustainability_Plan.pdf .

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. The applicant must 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. The applicant must 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). The application must 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 Interaction Plan (3-page maximum). The application must provide a specific plan describing the partnership between the UM1, the required K12 and any optional components. The application must describe the overarching goals of each component and the coordination, integration, synergy, and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or 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.

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.

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., postdoctoral, faculty ), and intended 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 SF424 (R&R) Application.

Applicants may designate a Training Director (TD) who will have responsibility for the day-to-day administration of the program. The Training Director may be one of the PD(s)/PI(s). The Training Director 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 Training Director 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 SF424 (R&R) Application.

PHS 398 Training Subaward Budget Attachment(s)

Follow all instructions provided in the SF424 (R&R) Application Guide.

Research and Related (R&R) Budget

Follow all instructions provided in the SF424 (R&R) 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.

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 FOA specifically instructs applicants to do so.

Follow all instructions provided in the SF424 (R&R) 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 participants, and other factors that contribute to the overall environment of the program.

For this FOA, 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 8C, Part III (New) and Table 8C, Part I and Part II (Renewal applications only)

Program Plan

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 next generation 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, e.g., from groups underrepresented in the biomedical sciences (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

The application must 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).

• Does the evidence-informed mentor training assessment move beyond the faculty s/preceptor’s participation satisfaction to self-reporting of perceived skills gained, self-reported changes in mentoring behaviors or self-reporting of effectiveness?
• Is there a way for scholars in the mentoring teams to corroborate mentor’s self-report of changes in mentoring behaviors?

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 Scholarsto 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 qualified and diverse scholars.

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).

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 his/her 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

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 features such as PD/PI salary, or tuition 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 SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. Each application of a collaborative set must be on-time. Considerations for late applications that are based on the institution or PD/PI apply only to his/her individual application.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The National Research Service Award (NRSA) policies apply to this program. 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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training 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.

Career Development Program and Environment

• Is there evidence of an adequate pool of potential scholars who could benefit from participating in research-focused career development program activities?
• Does the proposed program clearly outline obtainable and measurable objectives with respect to scholar outcomes (e.g., transition of scholars into research independence )?
• Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as clinical and translational scientists?
• Are the content and duration of any proposed didactic, career development , and research related activities of the program appropriate?
• Is the program plan appropriate for producing fully independent researchers and scientific leaders in the area of clinical and translational science by the end of the project period?
• Does the proposed program outline an effective strategy to provide and safeguard protected time for the scholars?
• Are appropriate timelines indicated for career progression and transition to research independence in clinical and translational science?
• Are the research facilities and research environment conducive to preparing scholars for research independence as clinical and translational scientists?
• Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
• Is the institutional commitment to the proposed program appropriate?
• Does the coordination and interaction plan adequately describe the coordination, integration, synergy, and mutual reinforcement of resources between the UM1 and the K12?
• Is the training in leadership and management (e.g., emotional intelligence, conflict resolution, negotiation, communication, self-advocacy, stress management and wellness, balancing competing priorities, etc .) appropriate?
• Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the career development, and related activities?
• Is the research plan likely to generate the publications and data that may help the scholars to establish their own fully independent research programs as clinical and translational scientists?
• Is there adequate documentation describing the responsibilities of the External Advisory Committee with regard to the provision of input, guidance, and oversight of the program?
• For institutions with other K12 programs, is there justification for an additional program and will there be synergistic relationships among the programs?

• If clinical trials may be proposed Scholar(s), are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are the plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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

• Do the PD/PI and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program?
• Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
• Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
• Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
• Does the leadership demonstrate a commitment to developing the next generation of clinical and translational scientists, such as leading recruitment efforts to enhance diversity, and fostering inclusive research environments including individuals from all backgrounds, (e.g., from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity) ?
• For applications designating multiple PD(s)/PI(s):
  • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
  • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

• With regard to the proposed leadership for the career development program, do the PD/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation of the proposed clinical trial (if applicable)?

Mentors

• Are sufficient numbers of experienced mentors with appropriate expertise, including clinical expertise, and funding available to support the number of scholars proposed in the application?

• Do the mentors have appropriate expertise and experience in clinical and translational science?
• Is there a plan for how multiple mentors will effectively coordinate their training and mentoring responsibilities?
• Is a plan in place for experienced mentors to provide guidance and mentorship to Junior Faculty who are serving as mentors?
• Are the quality and extent of the mentors roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?
• Do the scholars have mentors who are clinicians?
• Will the scholars have access to mentors with experience in working in multidisciplinary teams?
• Does the program include mentors with expertise in areas pertinent to clinical and translational science such as pre-clinical research, clinical research, clinical implementation, and public health in order to ensure that scholars transition into research independence and in the mentoring of scholars?
• Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research-focused career development program?
• If the program will support clinical trial research experience for the scholars, do the mentor(s) who will supervise the scholar(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the scholar(s) to meet the timelines?
• Do the preceptors/mentors demonstrate a commitment to training and mentoring, including of individuals from all backgrounds, e.g., from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity)?
• Will the participating faculty be trained to ensure the use of evidence-informed mentoring practices that promote the development of scholars from all backgrounds?
• Does the evidence-informed mentor training assessment move beyond the faculty s/preceptor’s participation satisfaction to self-reporting of perceived skills gained, self-reported changes in mentoring behaviors or self-reporting of effectiveness?

• Do the preceptors/mentors who will supervise the Scholar(s) have the expertise, experience, and ability to provide guidance in the organization, management and implementation of a clinical trial, ancillary, or feasibility study and help him/her to meet timelines?

Scholars

• Is a recruitment plan proposed with strategies likely to attract high quality scholars?
• Is there a competitive applicant pool of sufficient size and quality to ensure a successful career development program?
• Are there well-defined and well justified recruitment and selection strategies?

• Are the content, phasing, and proposed duration of the research-focused career development program activities appropriate for achieving scientific independence of the scholars?

• Are there plans to provide instruction in data management and statistics including those relevant to clinical trials (if applicable) to the prospective scholars?
• Are there plans to ensure that scholars proposing to lead clinical trials have the potential to organize, manage, and implement the proposed clinical trial, feasibility, or ancillary study?

Training Record

• Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Career Development in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide career development in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the scholars?

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific aspect of the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR career development in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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.

Will receive a written critique.

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

• 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

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

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

Section VI. Award Administration Information

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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).

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

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

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

Not Applicable.

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 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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,

• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
• 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.
• 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. 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, NIH will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application 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)
Email: [email protected]

Carol Kim, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Phone: 301-402-1744
E-mail: [email protected]

Zulema Eldridge
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-3066
Email: [email protected]

Section VIII. Other Information

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 45 CFR Part 75 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.