It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award 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

The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve human health by leading the development and accelerating the clinical application of biomedical technologies. The NIBIB believes that interdisciplinary research teams, particularly involving basic and clinical investigators, are the best approach to translating biomedical technology to the clinical environment.

The National Center for Advancing Translational Sciences (NCATS) supports clinical and translational research, creating and sharing the expertise, tools and training needed to develop and disseminate effective treatments in patients. To meet the particular training and career development needs of translational science, NCATS encourages innovative research training and career guidance through its programs which impart knowledge, skills, and attributes that are unique to translational scientists. NCATS supports research to identify and test promising translational innovations and develop, demonstrate, and disseminate advances across the translational science spectrum.

The NCATS Clinical and Translational Science Award (CTSA) program supports a national network of academic research institutions that work together to improve translational research. One of the overarching goals of the program is to promote team science, and the development of a well-trained and skilled translational research workforce. The program is envisioned to be an integrated research and training environment for clinical and translational sciences that aims to dramatically improve efficiency and quality across the translational research spectrum.

The NCATS and the NIBIB are dedicated to promoting team science and supporting translational research. This administrative supplement has been developed to encourage the formation of teams (hereafter referred to as the research team) comprised of a quantitative researcher with a background in engineering or the computational or physical sciences, (hereafter "the NIBIB Translational Research Scholar"), and a KL2-supported clinician-scientist (hereafter "the partnering clinician-scientist"). The supplement will support the research training and career development of the NIBIB Translational Research Scholar as well as the research efforts of the research team to facilitate the development of new biomedical technologies and to apply them to important biomedical challenges or clinical disease.

The intent of this supplement is to support the career development of an NIBIB Translational Research Scholar to successfully conduct translational research projects and to accelerate his/her progress to research independence. This supplement will provide support towards salary, research associated costs, and travel for the NIBIB Translational Research Scholar. The NIBIB Translational Research Scholar is expected to devote a minimum of 9 person-months (75% of full-time professional effort) to conduct his/her research project. The proposed candidate should have significant experience in the biomedical field and currently hold the position of tenure- or research-track assistant professor or a similar level faculty position. The NIBIB Translational Research Scholar candidate must not already be appointed to the KL2 at the time of the application, but will be appointed to the KL2 program, if the supplement is awarded.

The partnering clinician-scientist candidate should have demonstrated interest in conducting translational research, particularly research that involves quantitative approaches or novel biomedical technologies, and be committed to an academic research career. They should hold a doctorate clinical professional degree, such as an M.D. or M.D./Ph.D. or equivalent degree. The partnering clinician-scientist candidate may already be appointed to the KL2 at the time of the application, or the application must confirm that he/she will be appointed to the KL2 program, if the supplement is awarded.

The PD/PI of the active CTSA KL2 program will recruit and nominate scholars for this supplement. Funding provided through this supplement is contingent upon having a research team in place comprised of a NIBIB Translational Research Scholar and partnering clinician-scientist. The translational research project conducted by the research team is expected to lead to a significant scientific or technological discovery/development relevant to the NIBIB's research mission. The research plan should be closely aligned with one or more of the Scientific Program Areas supported by the NIBIB. The research plan should be conceived jointly between the NIBIB Translational Research Scholar and the partnering clinician-scientist and involve comparable contributions to the project from both candidates.

The application should identify mentors from the basic and clinical sciences who have experience in the area of the proposed research and will provide guidance to the research team. Letters of support are required for all mentors. The application should also include letters of reference for each member of the research team from investigators who are familiar with their education and research capabilities.

Applications must also include a signed letter from the sponsoring institution that describes the commitment to the proposed research program. A letter of support should be provided by the KL2 program director(s) that describes their acceptance and support for the proposed research project and the partnering clinician-scientist's and the NIBIB Translational Research Scholar's appointment to the KL2 program. Letters of support from relevant department chairs and facility director(s) should also be provided as described in Section IV. 2 Content and Form of Application Submission.

The NIBIB Translational Research Scholar may lead an independent clinical trial within the scope of this supplement. For this Funding Opportunity Announcement, NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this FOA for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial applications that NIBIB supports.

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

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

All organizations administering an eligible parent award may apply for a supplement under this announcement.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

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 not 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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. 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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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.

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit up to two applications.

By the time of the award, institutions must have an active CTSA KL2 program with at least two years remaining on their parent project award period.

By the time of award, eligible candidates must be citizens or non-citizen nationals of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status.

Current and former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50), other career development awards (K awards), or the equivalent are not eligible to participate as the NIBIB Translational Research Scholar or clinician-scientist partner required by this FOA. Current and former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), except for NIBIB Trailblazer (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

To be eligible to be considered for support through this supplement, the NIBIB Translational Research Scholar candidate must have identified an existing or proposed partnering clinician-scientist candidate, and in close collaboration with him/her, have developed a novel research proposal that is relevant to NIBIB's scientific mission and that will be undertaken jointly by the research team, if the supplement is awarded. Potential applicants are strongly encouraged to contact the Scientific/Research Contact listed in this FOA before preparing the application, to ascertain that the proposed research falls under one or more of NIBIB's Scientific Program Areas and hence is eligible to be supported under this supplement.

The NIBIB Translational Research Scholar candidate must have a doctoral degree or equivalent in engineering or the computational or physical sciences (PhD, DSc, etc.) and hold the position of tenure- or research-track assistant professor or similar faculty position. The candidate should have professional accomplishments consistent with their career status. Ideally, the NIBIB Translational Research Scholar candidate should have a demonstrated interest or experience in pursuing translational research. The NIBIB Translational Research Scholar candidate cannot be appointed to the KL2 program at the time of application but will be appointed to the program if the supplement is funded.

The partnering clinician-scientist candidate must hold an M.D. or M.D./Ph.D. or an equivalent professional degree (i.e. DO, DDS, DMD, OD, DC, PharmD, ND) and have a demonstrated interest in conducting translational research. Ideally, this might include a familiarity with quantitative approaches, translation of biomedical technologies, and past collaborations with quantitative researchers. The partnering clinician-scientist candidate should be appointed to an actively funded KL2 program at the time of the application with the appointment ending no sooner than the support period requested for the supplement. Alternatively, the institutional commitment letter should confirm plans to appoint the partnering clinician-scientist canddaite to the KL2 for the duration of this supplement request, if the supplement is funded.

Both research team candidates must have faculty appointments at the CTSA institution (including partner institutions. The CTSA Program hub must have at least 2 years remaining on the award at the time of the supplement award.

Applicants must prepare applications using current forms in accordance with the Application Guide.

Buttons to access the online ASSIST system or to download application forms 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.

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

PHS 398 Research Training Program Plan Form:

Program Plan: 12 pages

Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes. Administrative supplement requests for multi-project activity codes must be submitted using the paper submission process. See Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.

Instructions for Electronic Application Submission through Grants.gov

Use the "Apply" button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

• R&R Cover form: Select "Revision" in the "Type of Application" field.
• Research Plan form: At a minimum, the Program Plan and Letters of Support attachments should be completed and must include a summary or abstract of the funded parent award or project. Describe in detail, the CTSA Network Resources and Optional Modules that will support the proposed project. Other sections should also be included if they are being changed by the proposed supplement activities.

Program Plan

• Background: Include a summary or abstract of the funded parent award project. Provide the rationale for the proposed supplement program and its alignment with the NIBIB's mission.
• Research Program Plan

The proposed plan should align with the mission of the NIBIB and the NCATS CTSA program. Specifically, the research plan must fall strictly under one or more of the Scientific Program Areas supported by the NIBIB. Describe the specific aims of the proposed research. Include a description of how both members of the research team will collaborate and contribute to the proposed project. Describe the roles of any additional collaborators. Describe how the proposed project will contribute to the research team's career goals and path to independence. Present a timeline for activities and potential publications and grant applications for future individual and/or team research support.

• Career Development Plan

Career development plans should be detailed for both candidates (as applicable). Describe key activities of both candidates in the research team during the supplement, including mentored team science activities and technical training to enhance skills and proficiency in conducting translational research. Didactic coursework, if proposed, should be strongly justified. Describe how these proposed activities will enhance both candidate's translational science skills and prepare them for independent research careers.

• Mentoring Faculty

Provide information about the program faculty who will be involved in the supplement activities, including the complementary expertise and experiences, active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stages. If any co-mentor is not located at the sponsoring institution, describe the frequency and type of communication that will be used to engage the scholar.

• Institutional Environment and Commitment to Training

Include a signed letter, on institutional letterhead, that describes the applicant institution's commitment to the proposed research project. The letter should provide assurance that the NIBIB Translational Research Scholar candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the supplement project. The letter should describe the partnering clinician-scientist candidate's and NIBIB Translational Research Scholar candidate's appointment to the KL2 program and confirm that the partnering clinician-scientist candidate will be appointed through the duration of the requested supplement. If the partnering clinician-scientist candidate is not appointed to the KL2 program at the time of application, the letter should confirm that they will be supported by the KL2 throughout the support period requested, if the supplement is funded. The letter must also identify the laboratories, centers, and other specialized institutional facilities that will be made available to the research team for the research project.

Letters of Support: Attach appropriate letters from both mentors from the basic and clinical sciences, investigators familiar with the proposed research team, the KL2 program director(s), relevant department chairs and faculty directors(s) confirming their roles in the proposed supplement program as described in Part 2 Section I. Letters of support from the clinical and basic science mentors should address their history of mentoring clinical and non-clinical researchers, their knowledge of the NIBIB Translational Research Scholar candidate and partnering clinician-scientist candidate, and their proposed interactions with both candidates. The mentors' letters of support should address whether the research team is newly formed or an ongoing collaboration. If the partnership is an ongoing collaboration a detailed description of the project accomplishments should be provided.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Vertebrate Animals: Complete this section if the scholars will design and conduct their own independent vertebrate animal research and indicate that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) at the grantee institution.

• Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.

R&R Other Project Information form: If applicable, attach PDF documents in the "Other Attachments" field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents "IACUC Documentation.pdf" and/or "IRB Documentation.pdf". Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects' involvement is planned for the supplement.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User's Guide for submitting through this system is available, with the following additional guidance:

• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the "Add Other Attachments" function to include the following PDF documents:
• Research Strategy including a summary or abstract of the funded parent award or project.

Program Plan

o Background: Include a summary or abstract of the funded parent award project. Provide the rationale for the proposed supplement program and its alignment with the NIBIB's mission.

o The proposed plan should align with the mission of the NIBIB and the NCATS CTSA KL2 Career Development program. Specifically, the research plan must fall strictly under one or more of the Scientific Program Areas supported by the NIBIB. Describe the specific aims of the proposed research. Include a description of how both members of the research team will collaborate and contribute to the proposed project. Describe the roles of any additional collaborators. Describe how the proposed project will contribute to the research team's career goals and path to independence. Present a timeline for activities and potential publications and grant applications for future individual and/or team research support.

o Career Development Plan

Career development plans should be detailed for both candidates (as applicable). Describe key activities of both candidates in the research team during the supplement, including mentored team science activities and technical training to enhance skills and proficiency in conducting translational research. Didactic coursework, if proposed, should be strongly justified. Describe how these proposed activities will enhance both candidate's translation science skills and prepare them for independent research careers.

o Mentoring Faculty

Provide information about the program faculty who will be involved in the supplement activities, including the complementary expertise and experiences, active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stages. If any co-mentor is not located at the sponsoring institution, describe the frequency and type of communication that will be used to engage the scholar.

o Institutional Environment and Commitment to Training

Include a signed letter, on institutional letterhead, that describes the applicant institution's commitment to the proposed research project. The letter should provide assurance that the NIBIB Translational Research Scholar candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the supplement project. The letter should describe the partnering clinician-scientist candidate's and NIBIB Translational Research Scholar candidate's appointment to the KL2 program and confirm that the partnering clinician-scientist candidate will be appointed through the duration of the requested supplement. If the partnering clinician-scientist candidate is not appointed to the KL2 program at the time of application, the letter should confirm that they will be supported by the KL2 throughout the support period requested, if the supplement is funded. The letter must also identify the laboratories, centers, and other specialized institutional facilities that will be made available to the research team for the research project.

Letters of Support: Attach appropriate letters from both mentors from the basic and clinical sciences, investigators familiar with the proposed research team, the KL2 program director(s), relevant department chairs and faculty directors(s) confirming their roles in the proposed supplement program as described in Part 2 Section I. Letters of support from the clinical and basic science mentors should address their history of mentoring clinical and non-clinical researchers, their knowledge of the NIBIB Translational Research Scholar candidate and partnering clinician-scientist candidate, and their proposed interactions with both candidates. The mentors' letters of support should address whether the research team is newly formed or an ongoing collaboration. If the partnership is an ongoing collaboration a detailed description of the project accomplishments should be provided.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Vertebrate Animals: Complete this section if the scholars will design and conduct their own independent vertebrate animal research and indicate that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) at the grantee institution.

If applicable, attach documents indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects' involvement is planned for the supplement component.

Instructions for Paper-based Submissions using the PHS 398 Application Forms

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application, with the following additional guidance:

Checklist: Select "Revision" in the "Type of Application" field.

Face Page (Form Page 1): On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.

Research Plan: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.

Program Plan

• Background: Include a summary or abstract of the funded parent award project. Provide the rationale for the proposed supplement program and its alignment with the NIBIB's mission.
• The proposed plan should align with the mission of the NIBIB and the NCATS CTSA KL2 Career Development program. Specifically, the research plan must fall strictly under one or more of the Scientific Program Areas supported by the NIBIB. Describe the specific aims of the proposed research. Include a description of how both members of the research team will collaborate and contribute to the proposed project. Describe the roles of any additional. Describe how the proposed project will contribute to the research team's career goals and path to independence. Present a timeline for activities and potential publications and grant applications for future individual and/or team research support.
• Career Development Plan

Career development plans should be detailed for both candidates (as applicable). Describe key activities of both candidates in the research team during the supplement, including mentored team science activities and technical training to enhance skills and proficiency in conducting translational research. Didactic coursework, if proposed, should be strongly justified. Describe how these proposed activities will enhance both candidate's translation science skills and prepare them for independent research careers.

• Mentoring Faculty

Provide information about the program faculty who will be involved in the supplement activities, including the complementary expertise and experiences, active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stages. If any co-mentor is not located at the sponsoring institution, describe the frequency and type of communication that will be used to engage the scholar.

• Institutional Environment and Commitment to Training

Include a signed letter, on institutional letterhead, that describes the applicant institution's commitment to the proposed research project. The letter should provide assurance that the NIBIB Translational Research Scholar candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the supplement project. The letter should describe the partnering clinician-scientist candidate's and NIBIB Translational Research Scholar candidate's appointment to the KL2 program and confirm that the partnering clinician-scientist candidate will be appointed through the duration of the requested supplement. If the partnering clinician-scientist candidate is not appointed to the KL2 program at the time of application, the letter should confirm that they will be supported by the KL2 throughout the support period requested, if the supplement is funded. The letter must also identify the laboratories, centers, and other specialized institutional facilities that will be made available to the research team for the research project.

Letters of Support: Attach appropriate letters from both mentors from the basic and clinical sciences, investigators familiar with the proposed research team, the KL2 program director(s), relevant department chairs and faculty directors(s) confirming their roles in the proposed supplement program as described in Part 2 Section I. Letters of support from the clinical and basic science mentors should address their history of mentoring clinical and non-clinical researchers, their knowledge of the NIBIB Translational Research Scholar candidate and partnering clinician-scientist candidate, and their proposed interactions with both candidates. The mentors' letters of support should address whether the research team is newly formed or an ongoing collaboration. If the partnership is an ongoing collaboration a detailed description of the project accomplishments should be provided.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Vertebrate Animals: Complete this section if the scholars will design and conduct their own independent vertebrate animal research and indicate that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) at the grantee institution.

• Project/Performance Sites section (Form Page 2): Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel section (Form Page 2): List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget for Entire Proposed Project Period (Form Page 5): A proposed budget should be submitted using the PHS 398 budget forms and should only include funds requested for the additional supplement activities.
• If applicable, attach documentation in the Appendix section indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects' involvement is planned for the supplement component.

The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:

ZEYNEP ERIM

6707 Democracy Boulevard

Room 236

Bethesda, MD 20892

Telephone: 301-451-4797

Email: [email protected]

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.

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit electronic 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.

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

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted using the instructions specified above.

Applicants must complete all required registrations prior to submission. Section III. Eligibility Information contains information about registration.

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

Important reminders:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(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 (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Not Applicable

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award's overall impact within the original scope of award:

• Will the administrative supplement increase or preserve the likelihood for the research team candidates to maintain a strong research program?
• Will the administrative supplement increase the research team candidates' clinical and translational research skills?
• Will the administrative supplement help the research team candidates build independent research programs and successful research careers?
• Will the administrative supplement leverage the research team candidates' unique skills?
• Is there a comparable and significant contribution to the project development and execution from both research team candidates?
• Are the career development plans appropriate when considered in the context of prior training/research training?
• Will the career development plans substantially contribute to the scientific development of the research team candidates?
• Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
• Could the proposed research lead to a significant scientific or technological development, future awards, or first in human clinical trials?
• Do the proposed mentors have experience in the area of the proposed research?
• Do the mentors have a history of mentoring researchers at comparable career stages and with similar research interests?
• Is there clear institutional commitment and support for both candidates to conduct the proposed research, including funds to support the salary of the partnering clinician-scientist and access to appropriate facilities?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, NIH staff 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 six categories of research that are exempt under 45 CFR Part 46, NIH staff 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.

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 children 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.

NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

NIH staff will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Not Applicable

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee's business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution's current F&A rate; i.e., the rate in effect when the new funding is provided.

For this Funding Opportunity Announcement, NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this FOA for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial applications that NIBIB supports.

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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general 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/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. 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. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required in the NIH Grants Policy Statement.

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.

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

Other Reporting Requirements

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the KL2 training grant. Grantees 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.

Prior Approval of Research Supplement Projects

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH's Instructions for Preparing the Human Subjects Section of the Research Plan.

The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Zeynep Erim, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4797
Email: [email protected]

Not Applicable

Ruthann McAndrew
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8521
Email: [email protected]

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 45 CFR Part 75.