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 National Institute of Mental Health (NIMH) continues an administrative supplement program to provide funds to research projects to support advanced research experiences for exceptional individuals holding the MD/PhD degree who are early in their research careers. The goal of this program is to provide opportunities for individuals to continue to conduct research and to enhance their research skill set while completing clinical training, i.e., during the years of residency and clinical fellowship, and to contribute to the progress of the parent research grant. Support through this administrative supplement program is expected to enhance the scientific and professional development of the participating individuals, speed their transition to research independence as physician-scientists, and contribute to scientific knowledge that advances the mission of the NIMH.

Physician-scientists are believed to bring a unique perspective to research through the blend of clinical and research experiences they acquire during graduate and medical education, residency, and fellowship. Over the past three decades, there has been a steady decline in the number of physician-scientists actively pursuing research careers (Abrams et al., 2003). In psychiatry, the decline has been more striking than in other clinical specialties (Fenton, James, and Insel, 2004).

At the time they enter residency training, MD/PhDs have already received substantial research training while conducting dissertation research and have demonstrated a strong interest in and commitment to research. During clinical training, limited opportunities exist for these individuals to continue to develop research expertise, document their research productivity, and gain exposure to the rapidly evolving scientific landscape. The limited availability of options to support research effort during clinical training is a significant barrier to increasing the pipeline of outstanding MD/PhDs prepared to conduct innovative, NIMH-funded research. The 2008 National Advisory Mental Health Council Workgroup on Research Training recommended that the NIMH expand efforts to support research opportunities for MD/PhDs during residency and ensure flexibility of these opportunities so that MD/PhDs who are committed to research careers as physician-scientists may continue research during residency and transition efficiently and effectively to research independence.

The goal of this funding opportunity is to help MD/PhDs move more efficiently and effectively from the period of clinical training to the next stage of their research careers by supporting focused, protected research time during residency and/or clinical fellowship. The proposed research experience must be an integral part of the approved, ongoing research of the parent grant and must have the potential to contribute significantly to the candidate's research career. To ensure flexibility of research opportunities, the specific plan and scope of the research experience may vary depending on such factors as the year in residency, the nature of the parent grant, the candidate's technical skill set and goals, and the candidate's available effort.

Plans that primarily involve clinical interviewing and/or conducting laboratory sessions with research participants would be considered a low priority for this NIMH administrative supplement program.

An application is expected to reflect the individual needs of the candidate who is being nominated for support and will document:

• the quality of the proposed research plan and its appropriateness for the candidate's current career stage;
• the candidate's qualifications and potential as a physician-scientist conducting independent, mental health-related research;
• the alignment of the proposed research plan with the mission and strategic research priorities of the NIMH or, for AIDS-related applications, as exemplified in the research priorities of the most recent, annual Trans-NIH Plan for HIV-Related Research and the priorities of the NIMH Division of AIDS Research; and
• the commitment of the Program Director/Principal Investigator (PD/PI) and other faculty (if applicable) to provide appropriate guidance and supervision of the candidate's research experience and facilitate his/her successful transition to the next career stage.

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:

• 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)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 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 more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center. An applicant organization may not submit more than one MD/PhD administrative supplement application for a particular parent grant at one time. Each parent grant may support only one individual on an MD/PhD supplement at one time.

At the time of application, each candidate: 1) must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence; 2) must have graduated from a combined MD/PhD program or must have graduated from independent MD and PhD programs (in either order of completion) with time between the awarding of the two degrees not to exceed 10 years; 3) must currently be in good standing in an ACGME-accredited residency program or in good standing in a clinical fellowship program; 4) must be able to commit appropriate effort to the proposed research experience in any year; and 5) must not currently have support to obtain research experience from either federal or non-federal funds. Candidates during residency must commit no less than 1.8 person-months (15% of full-time professional effort) to the proposed research experience; at the time of award, such candidates must be in postgraduate year (PGY) 2 of residency or beyond. Candidates during fellowship must commit no less than 6 person-months (50% of full-time professional effort) to the proposed research experience.

MD/PhD candidates from underrepresented racial and ethnic groups as well as those with disabilities are always encouraged to apply for NIH support.

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:

• Research Strategy (Research Experience Plan): 5 pages
• Candidate Statement: 3 pages
• Applicant Eligibility Statement: 2 pages
• Letter from Research Residency Program (R25) PD/PI, if applicable: 1 page

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 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. The description of the proposed research experience plan should include:
• A summary or abstract of the funded grant or project.
• A plan and timeline for the research and career development experiences proposed for the candidate including milestones for progress. The plan should present evidence that the proposed experience is appropriate for the stage of the candidate's research development, and that it will significantly enhance the individual's research potential, while furthering the candidate's ability to pursue a mental health research career. Details regarding interactions of the PD/PI and the candidate are expected. The plan should be detailed, milestone-driven, and include the frequency of meetings with the mentor(s), topics to be discussed, and how progress will be monitored as well as seminar series, workshops, and conferences, as appropriate for the candidate's needs and goals. Appropriate milestones for progress might include submission of abstracts for scientific meetings or preparation and submission of manuscripts for publication, depending on the career stage of the candidate.
• A description of how the research and career development experiences will expand and foster the research capabilities of the candidate; how the proposed experiences relate to the specific research goals and objectives of the parent grant; and how the proposed research experiences relate to the mission and strategic research priorities of the NIMH or, for AIDS-related applications, as exemplified in the research priorities of the most recent, annual Trans-NIH Plan for HIV-Related Research and the priorities of the NIMH Division of AIDS Research
• Evidence of adequate mentoring experience and success. The PD/PI must document his/her experience and track record as a supervisor highlighting experience guiding MD/PhD-educated individuals and including a list of past mentees and their current positions. The PD/PI must describe how she/he will assist the candidate in achieving the objectives and goals described in the candidate's statement. If the PD/PI is a junior faculty member, it may be appropriate to include an experienced investigator as a co-mentor. The role(s) of any other contributing investigators should be described, and their biosketches must be included with the application.
• Evidence that the candidate will receive research career mentoring appropriate for his/her stage of training. Plans for successful transition to the next stage in the candidate's career path should be described. Regardless of the candidate's career stage, guidance in the preparation of grant applications for submission to NIMH is an expected component of the plan.

Proposed Research Experience: In all cases, the proposed research experience must be an integral part of the approved, ongoing research of the parent grant, and it must have the potential to contribute significantly to the research career development of the candidate. Applications for supplements must include a plan for the candidate to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge regarding the selected area of biomedical science. It must also provide evidence of a focus on enhancing the candidate's research capabilities and providing opportunities for the candidate's development as a productive researcher. In addition, the application must document that the PD(s)/PI(s) is both qualified and willing to provide appropriate mentorship. Applications are thus expected to describe: a) the candidate's supplemental research project, and b) a plan that is designed to enhance his/her research skills, scientific knowledge, and related professional skills including plans for subsequent funding applications that would help maintain the candidate's research momentum.

• 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. Include a Biographical Sketch for the candidate.
• Each Investigator's Biographical Sketch should document that individual's qualifications and experience to guide and mentor the candidate and specifically describe his/her role in the candidate's proposed research experience.
• Candidates for NIMH MD/PhD supplement support must have a profile in the eRA Commons, and the candidate's Commons Username should be entered on the Senior/Key Personnel form.
• The candidate's Biographical Sketch should include any source(s) of current research and/or career development funding.
• Budget forms (e.g., R&R Budget): Only include funds requested for the additional supplement activities. The NIMH will provide salary support for the candidate in addition to other justified expenses, such as travel and supplies, to enable the candidate to participate fully in the proposed research experience. The requested salary and fringe benefits must be in accordance with the salary structure of the grantee institution for individuals in comparable positions, consistent with the level of effort, and may generally not exceed $75,000 per year. Funds up to $5,000 annually may be requested for justified expenses (e.g., research supplies, technical support, and travel) for residents who are committing less than 50% effort in a given Post Graduate Year. In years where candidate residents commit 50% or more effort to the supplement, up to $10,000 annually may be requested. Funds up to $15,000 annually may be requested during clinical fellowship. No supplement funds may be used to purchase equipment. The amount requested should reflect the candidate's level of effort and should be well justified.
• 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.
• PHS Human Subjects and Clinical Trial Information: This form is optional. Given that the proposed supplement should not change the scope of the awarded parent project, it will typically not be needed. If new recruitment or use of an additional existing dataset or resource is proposed in the supplement application, Section 2.4 should be revised and new Inclusion Enrollment Reports created, as appropriate.

Other Attachments:

• Candidate Statement

The candidate must provide a signed statement outlining career stage-appropriate, short- and long-term research objectives and career goals. The candidate's statement is expected to summarize prior research experience and accomplishments, how the planned activities are related to and will facilitate achievement of his/her short- and long-term career goals, and how his/her research goals intersect with the mission and strategic priorities of the NIMH.

• Applicant Eligibility Statement

The application should include a signed statement from the PD/PI, the director of the residency or clinical fellowship program, the department chair, and an Authorized Signing Official for the institution certifying the candidate's eligibility for support under this program. The statement must include 1) certification that the candidate is a citizen or non-citizen national of the U.S. or has been lawfully admitted for permanent residence; 2) certification that the candidate is in good standing in a full-time, clinical fellowship program or an ACGME-accredited U.S. residency program; and 3) a description of the candidate's current support and plans for his/her future support during residency or clinical fellowship, as appropriate. In addition, the department chair and director of the residency or clinical fellowship program must document the institution's commitment to the research activities and associated time commitment proposed in the supplemental application and affirm that this commitment will not affect the candidate's board eligibility or prolong the period of residency or clinical fellowship, as appropriate.

• Letter from Research Residency Program (R25) PD/PI (if applicable)

If support is requested for a candidate during residency and the candidate is at an institution with an NIMH-supported research residency program (R25), then a signed letter must be included from the R25 PD/PI detailing why the current candidate cannot be supported on the research residency program.

• Letter from Another Institution where Research will be Conducted (if applicable)

If any of the research is to be conducted at a site other than the grantee institution, submit an appropriately signed letter from the institution where the research is to be conducted. This request must be signed by the candidate, PD/PI, and the appropriate Authorized Signing Official.

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. The NIMH will provide salary support for the candidate in addition to other justified expenses, such as travel and supplies, to enable the candidate to participate fully in the proposed research experience. The requested salary and fringe benefits must be in accordance with the salary structure of the grantee institution for individuals in comparable positions, consistent with the level of effort, and may generally not exceed $75,000 per year. Funds up to $5,000 annually may be requested for justified expenses (e.g., research supplies, technical support, and travel) for residents who are committing less than 50% effort in a given Post Graduate Year. In years where candidate residents commit 50% or more effort to the supplement, up to $10,000 annually may be requested. Funds up to $15,000 annually may be requested during clinical fellowship. No supplement funds may be used to purchase equipment. The amount requested should reflect the candidate's level of effort and should be well justified.
• 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. The description of the proposed research experience plan should include:

A summary or abstract of the funded grant or project.

A plan and timeline for the research and career development experiences proposed for the candidate including milestones for progress. The plan should present evidence that the proposed experience is appropriate for the stage of the candidate's research development, and that it will significantly enhance the individual's research potential, while furthering the candidate's ability to pursue a mental health research career. Details regarding interactions of the PD/PI and the candidate are expected. The plan should be detailed, milestone-driven, and include the frequency of meetings with the mentor(s), topics to be discussed, and how progress will be monitored as well as seminar series, workshops, and conferences, as appropriate for the candidate's needs and goals. Appropriate milestones for progress might include submission of abstracts for scientific meetings or preparation and submission of manuscripts for publication, depending on the career stage of the candidate.

A description of how the research and career development experiences will expand and foster the research capabilities of the candidate; how the proposed experiences relate to the specific research goals and objectives of the parent grant; and how the proposed research experiences relate to the mission and strategic research priorities of the NIMH or, for AIDS-related applications, as exemplified in the research priorities of the most recent, annual Trans-NIH Plan for HIV-Related Research and the priorities of the NIMH Division of AIDS Research

Evidence of adequate mentoring experience and success. The PD/PI must document his/her experience and track record as a supervisor highlighting experience guiding MD/PhD-educated individuals and including a list of past mentees and their current positions. The PD/PI must describe how she/he will assist the candidate in achieving the objectives and goals described in the candidate's statement. If the PD/PI is a junior faculty member, it may be appropriate to include an experienced investigator as a co-mentor. The role(s) of any other contributing investigators should be described, and their biosketches must be included with the application.

Evidence that the candidate will receive research career mentoring appropriate for his/her stage of training. Plans for successful transition to the next stage in the candidate's career path should be described. Regardless of the candidate's career stage, guidance in the preparation of grant applications for submission to NIMH is an expected component of the plan.

Proposed Research Experience: In all cases, the proposed research experience must be an integral part of the approved, ongoing research of the parent grant, and it must have the potential to contribute significantly to the research career development of the candidate. Applications for supplements must include a plan for the candidate to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge regarding the selected area of biomedical science. It must also provide evidence of a focus on enhancing the candidate's research capabilities and providing opportunities for the candidate's development as a productive researcher. In addition, the application must document that the PD(s)/PI(s) is both qualified and willing to provide appropriate mentorship. Applications are thus expected to describe: a) the candidate's supplemental research project, and b) a plan that is designed to enhance his/her research skills, scientific knowledge, and related professional skills including plans for subsequent funding applications that would help maintain the candidate's research momentum.

• Candidate Statement

The candidate must provide a signed statement outlining career stage-appropriate, short- and long-term research objectives and career goals. The candidate's statement is expected to summarize prior research experience and accomplishments, how the planned activities are related to and will facilitate achievement of his/her short- and long-term career goals, and how his/her research goals intersect with the mission and strategic priorities of the NIMH.

• Applicant Eligibility Statement

The application should include a signed statement from the PD/PI, the director of the residency or clinical fellowship program, the department chair, and an Authorized Signing Official for the institution certifying the candidate's eligibility for support under this program. The statement must include 1) certification that the candidate is a citizen or non-citizen national of the U.S. or has been lawfully admitted for permanent residence; 2) certification that the candidate is in good standing in a full-time, clinical fellowship program or an ACGME-accredited U.S. residency program; and 3) a description of the candidate's current support and plans for his/her future support during residency or clinical fellowship, as appropriate. In addition, the department chair and director of the residency or clinical fellowship program must document the institution's commitment to the research activities and associated time commitment proposed in the supplemental application and affirm that this commitment will not affect the candidate's board eligibility or prolong the period of residency or clinical fellowship, as appropriate.

• Letter from Research Residency Program (R25) PD/PI (if applicable)

If support is requested for a candidate during residency and the candidate is at an institution with an NIMH-supported research residency program (R25), then a signed letter must be included from the R25 PD/PI detailing why the current candidate cannot be supported on the research residency program.

• Letter from Another Institution where Research will be Conducted (if applicable)

If any of the research is to be conducted at a site other than the grantee institution, submit an appropriately signed letter from the institution where the research is to be conducted. This request must be signed by the candidate, PD/PI, and the appropriate Authorized Signing Official.

• 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.
• Sr/Key Personnel table: 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. Include a Biographical Sketch for the candidate.
• Each Investigator's Biographical Sketch should document that individual's qualifications and experience to guide and mentor the candidate and specifically describe his/her role in the candidate's proposed research experience.
• Candidates for NIMH MD/PhD supplement support must have a profile in the eRA Commons, and the candidate's Commons Username should be entered on the Senior/Key Personnel form.
• The candidate's Biographical Sketch should include any source(s) of current research and/or career development funding.
• PHS Human Subjects and Clinical Trial Information: This form is optional. Given that the proposed supplement should not change the scope of the awarded parent project, it will typically not be needed. If new recruitment or use of an additional existing dataset or resource is proposed in the supplement application, Section 2.4 should be revised and new Inclusion Enrollment Reports created, as appropriate.

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. The description of the proposed research experience plan should include:
• A summary or abstract of the funded grant or project.
• A plan and timeline for the research and career development experiences proposed for the candidate including milestones for progress. The plan should present evidence that the proposed experience is appropriate for the stage of the candidate's research development, and that it will significantly enhance the individual's research potential, while furthering the candidate's ability to pursue a mental health research career. Details regarding interactions of the PD/PI and the candidate are expected. The plan should be detailed, milestone-driven, and include the frequency of meetings with the mentor(s), topics to be discussed, and how progress will be monitored as well as seminar series, workshops, and conferences, as appropriate for the candidate's needs and goals. Appropriate milestones for progress might include submission of abstracts for scientific meetings or preparation and submission of manuscripts for publication, depending on the career stage of the candidate.
• A description of how the research and career development experiences will expand and foster the research capabilities of the candidate; how the proposed experiences relate to the specific research goals and objectives of the parent grant; and how the proposed research experiences relate to the mission and strategic research priorities of the NIMH or, for AIDS-related applications, as exemplified in the research priorities of the most recent, annual Trans-NIH Plan for HIV-Related Research and the priorities of the NIMH Division of AIDS Research
• Evidence of adequate mentoring experience and success. The PD/PI must document his/her experience and track record as a supervisor highlighting experience guiding MD/PhD-educated individuals and including a list of past mentees and their current positions. The PD/PI must describe how she/he will assist the candidate in achieving the objectives and goals described in the candidate's statement. If the PD/PI is a junior faculty member, it may be appropriate to include an experienced investigator as a co-mentor. The role(s) of any other contributing investigators should be described, and their biosketches must be included with the application.
• Evidence that the candidate will receive research career mentoring appropriate for his/her stage of training. Plans for successful transition to the next stage in the candidate's career path should be described. Regardless of the candidate's career stage, guidance in the preparation of grant applications for submission to NIMH is an expected component of the plan.

Proposed Research Experience: In all cases, the proposed research experience must be an integral part of the approved, ongoing research of the parent grant, and it must have the potential to contribute significantly to the research career development of the candidate. Applications for supplements must include a plan for the candidate to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge regarding the selected area of biomedical science. It must also provide evidence of a focus on enhancing the candidate's research capabilities and providing opportunities for the candidate's development as a productive researcher. In addition, the application must document that the PD(s)/PI(s) is both qualified and willing to provide appropriate mentorship. Applications are thus expected to describe: a) the candidate's supplemental research project, and b) a plan that is designed to enhance his/her research skills, scientific knowledge, and related professional skills including plans for subsequent funding applications that would help maintain the candidate's research momentum.

• 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. Include a Biographical Sketch for the candidate.
• Each Investigator's Biographical Sketch should document that individual's qualifications and experience to guide and mentor the candidate and specifically describe his/her role in the candidate's proposed research experience.
• Candidates for NIMH MD/PhD supplement support must have a profile in the eRA Commons, and the candidate's Commons Username should be entered on the Senior/Key Personnel form.
• The candidate's Biographical Sketch should include any source(s) of current research and/or career development funding.
• 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. The NIMH will provide salary support for the candidate in addition to other justified expenses, such as travel and supplies, to enable the candidate to participate fully in the proposed research experience. The requested salary and fringe benefits must be in accordance with the salary structure of the grantee institution for individuals in comparable positions, consistent with the level of effort, and may generally not exceed $75,000 per year. Funds up to $5,000 annually may be requested for justified expenses (e.g. research supplies, technical support, and travel) for residents who are committing less than 50% effort in a given Post Graduate Year. In years where candidate residents commit 50% or more effort to the supplement, up to $10,000 annually may be requested. Funds up to $15,000 annually may be requested during clinical fellowship. No supplement funds may be used to purchase equipment. The amount requested should reflect the candidate's level of effort and should be well justified.
• 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.
• Use the Appendix to include the following documents:
• Candidate Statement

The candidate must provide a signed statement outlining career stage-appropriate, short- and long-term research objectives and career goals. The candidate's statement is expected to summarize prior research experience and accomplishments, how the planned activities are related to and will facilitate achievement of his/her short- and long-term career goals, and how his/her research goals intersect with the mission and strategic priorities of the NIMH.

• Applicant Eligibility Statement

The application should include a signed statement from the PD/PI, the director of the residency or clinical fellowship program, the department chair, and an Authorized Signing Official for the institution certifying the candidate's eligibility for support under this program. The statement must include 1) certification that the candidate is a citizen or non-citizen national of the U.S. or has been lawfully admitted for permanent residence; 2) certification that the candidate is in good standing in a full-time, clinical fellowship program or an ACGME-accredited U.S. residency program; and 3) a description of the candidate's current support and plans for his/her future support during residency or clinical fellowship, as appropriate. In addition, the department chair and director of the residency or clinical fellowship program must document the institution's commitment to the research activities and associated time commitment proposed in the supplemental application and affirm that this commitment will not affect the candidate's board eligibility or prolong the period of residency or clinical fellowship, as appropriate.

• Letter from Research Residency Program (R25) PD/PI (if applicable)

If support is requested for a candidate during residency and the candidate is at an institution with an NIMH-supported research residency program (R25), then a signed letter must be included from the R25 PD/PI detailing why the current candidate cannot be supported on the research residency program.

• Letter from Another Institution where Research will be Conducted (if applicable)

If any of the research is to be conducted at a site other than the grantee institution, submit an appropriately signed letter from the institution where the research is to be conducted. This request must be signed by the candidate, PD/PI, and the appropriate Authorized Signing Official.

• PHS Human Subjects and Clinical Trial Information: This form is optional. Given that the proposed supplement should not change the scope of the awarded parent project, it will typically not be needed. If new recruitment or use of an additional existing dataset or resource is proposed in the supplement application, Section 2.4 should be revised and new Inclusion Enrollment Reports created, as appropriate.

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:

NIMH Referral Office
ATTN: MD/PhD Administrative Supplements Program
Division of Extramural Activities
6001 Executive Boulevard MSC 9607
Bethesda, MD 20892
Rockville, MD 20852 (FedEx)
[email protected]

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.

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 project to exert a sustained, powerful influence on the research field(s) involved?
• Based on the candidate's qualifications including career goals, prior research training, and research potential, does the candidate have high potential for an independent research career conducting NIMH-relevant research?
• Does the proposed research experience plan have scientific merit? Is it feasible within the context of residency and/or clinical fellowship? Will the proposed experience expand and foster the research capabilities, knowledge, and/or skills of the candidate?
• Are the proposed activities related to the funded (parent) grant and the mission and research priorities of the NIMH as exemplified in the NIMH Strategic Plan or, for AIDS-related applications, as exemplified in the research priorities of the most recent, annual Trans-NIH Plan for HIV-Related Research and the priorities of the NIMH Division of AIDS Research?
• Is there evidence that sufficient institutional commitment exists for the proposed research experience and that the proposed mentors have adequate mentoring experience that has led to successful outcomes?

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.

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 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.

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

See http://www.nimh.nih.gov/funding/training/contacts-for-research-training-and-career-development-programs.shtml

Not Applicable

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
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.