Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application 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 (see NOT-MH-11-014) 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 MD/PhD-trained 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.

Background

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 [e.g., Abrams MT, Patchan KM, Boat TF (Eds). Research Training in Psychiatry Residency: Strategies for Reform. Washington, DC. The National Academies Press, 2003. (http://www.nap.edu/catalog.php?record_id=10823)]. In psychiatry, the decline has been more striking than in other clinical specialties (Fenton, W, James, R, Insel, T. Psychiatry residency training, the physician-scientist, and the future of psychiatry. Acad Psychiatry 2004; 28:263-266).

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 maintain currency with 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.

Program Details

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 to the NIMH Supplement Program to Enable Continuity of Research Experiences of MD/PhDs during Clinical Training 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.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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)
• Eligible Agencies of the Federal Government
• 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 parent award must have at least 12 months remaining at the anticipated time of award.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. 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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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. Eligible PD(s)/PI(s) must hold an active, NIMH-supported research project grant or cooperative agreement, or must hold an active DP1, DP2, or DP5 award in which the funded research is aligned with the mission and strategic priorities of the NIMH. Individuals are invited 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 a 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 are required to prepare applications according to the current application forms in accordance with the Application Guide.
For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this announcement, or use the eRA Commons streamlined submission process.

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

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

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

All page limitations 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

Electronic submission of request for administrative supplements is only available for single-project activity codes for which competing applications are submitted electronically. Visit the list of single-project Activity Codes Processed Electronically by eRA to determine if the single-project activity code of the parent award has transitioned to electronic submission. Submission of requests for administrative supplements for all other activity codes must use paper.

If the administrative supplement may be submitted electronically, then you may either (A) submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, (B) submit using the streamlined submission process of eRA Commons, or (C) submit using the paper-based PHS 398 Application forms and the PHS 398 Application Guide.

Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

Instructions for Submissions using Grants.gov/Apply for electronic-based submissions

For single project grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Component. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some components 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 components.

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

NIH now 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.

Include the Research Strategy and any other required documentation (described below) as a PDF file using the Add Other Attachments function. Budget information should be entered for the grantee institution in the fields provided. There is no template or form available for subaward information; instead, all subaward information should be included as a separate attachment showing the funds requested (by budget period) using the same categories provided for the grantee institution. Also include a budget justification for the subawardee institution in the same file.

Instructions for Submissions using the PHS 398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. 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, and two signed photocopies in one package to:

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

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.

All instructions in the Application Guide must be followed for all Research Plan sections applicable to the proposed supplement activities. 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.

Research Strategy: 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 M.D./Ph.D.-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. 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.

All instructions in the Application Guide must be followed, with the following additional instructions:

• 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.

All instructions in the Application Guide must be followed, with the following additional instructions:

• 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.

All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, 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 $10,000 annually may be requested for supplies and travel for the candidate in PGY2 and PGY3. Funds up to $20,000 annually may be requested for supplies and travel for the candidate in PGY4 and clinical fellowship. Funds for supplies and travel should be prorated to reflect the candidate's level of effort. No supplement funds may be used to purchase equipment. If less than 12 months of support is requested, the budget should be prorated accordingly.

A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, 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 $10,000 annually may be requested for supplies and travel for the candidate in PGY2 and PGY3. Funds up to $20,000 annually may be requested for supplies and travel for the candidate in PGY4 and clinical fellowship. Funds for supplies and travel should be prorated to reflect the candidate's level of effort. No supplement funds may be used to purchase equipment. If less than 12 months of support is requested, the budget should be prorated accordingly.

All instructions in the Application Guide must be followed, with the following additional instructions:

Other Attachments (for use with electronic submissions) or Appendix (for use with paper-based submissions):

IACUC Documentation and IRB

Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this information will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made.

Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted. When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities.

If applicable, include documentation 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.

Candidate Statement

The candidate must provide a signed statement, not to exceed 3 pages, 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, not to exceed 2 pages, 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; 3) a description of the candidate s current support and plans for his/her future support during residency or clinical fellowship, as appropriate; and 4) if applicable, a statement that the candidate has not received any current or previous PHS support. 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.

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications as described above. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their 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 before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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 Component 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 System for Award Management (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and/or responsiveness by the awarding Institute or Center. Applications that are incomplete and/or nonresponsive will not be reviewed.

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.

Protections for Human Subjects:

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.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

NIH Staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

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 Non-Competing Grant Progress Report, PHS 2590 or 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.

The NIMH MD/PhD administrative supplement provides support to help MD/PhDs move efficiently and effectively from the period of clinical training to the next stage of their research careers and is thus expected to speed their transition to research independence. Individuals supported by this program must notify the NIMH when they receive an NIH research grant (e.g., R01, R03, R21), NIH mentored career development award (e.g., K08, K23, K99), any other peer-reviewed NIH or non-NIH research grant over $100,000 direct costs per year, or become project leaders on sub-projects of program project (P01) or center (P50) grants. Given the intent of this supplement program, the NIMH may elect to terminate the supplement award at the time of such an award.

The Final Progress Report for the administrative supplement should provide specific information on the next step in the candidate's career path in addition to a description of the candidate's research accomplishments during the award period.

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

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)
Telephone 301-945-7573
TTY: 301-451-5936
Email: [email protected]

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 Parts 74 and 92.