Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title

One-Year Administrative Supplements to NIMH-supported Research for FY2015 (Admin Supp)

Activity Code

Administrative Supplement

Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):

Administrative supplement requests must be submitted on paper for the following activity codes:

P01 Research Program Projects
P30 Center Core Grants
P50 Specialized Center
U19 Research Program – Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
UM1 Multi-Component Research Project Cooperative Agreements

Administrative supplement requests may be submitted electronically for the following activity codes:

DP1 NIH Director’s Pioneer Award (NDPA)
DP2 NIH Director’s New Innovator Awards
DP5 Early Independence Award

R01 Research Project Grant
R03 Small Grant Program
R21 Exploratory/Developmental Research Grant Award
R21/R33 Phased Innovation Award

R33 Exploratory/Developmental Grants Phase II
R34 Clinical Trial Planning Grant Program
R37 Method to Extend Research in Time (MERIT) Award

U01 Research Project – Cooperative Agreements

UH2 Exploratory/Developmental Cooperative Agreement Phase I
UH2/UH3 Phase Innovation Awards Cooperative Agreement
UH3 Exploratory/Developmental Cooperative Agreement Phase II

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PA-15-128

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.242

Funding Opportunity Purpose

The National Institute of Mental Health announces the availability of one-year administrative supplements to support on-going NIMH-supported research.  Investigators with active NIMH-supported research grants can request supplemental funding in FY2015 for continued research in one of the NIMH identified priority areas.  NIMH has identified specific areas of interest in accordance with its goal of accelerating mental health research as described in the Institute’s Strategic Plan.    

Key Dates
Posted Date

February 27, 2015

Open Date (Earliest Submission Date)

May 1, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

June 1, 2015 by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

September 2015

Expiration Date

June 2, 2015

Due Dates for E.O. 12372

Not Applicable

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.

Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The National Institute of Mental Health (NIMH) announces opportunities for investigators with active NIMH-supported research grants to request supplemental funding in FY2015. NIMH has identified specific areas of interest in accordance with its goal of accelerating mental health research as described in the Institute’s Strategic Plan.  Within the described priority areas, supplement requests can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project.

NIMH priority research areas to be considered for supplemental funding in FY2015:

  • Expanding the computational or analytical sophistication of existing basic systems-level neuroscience grants.  The intent of this administrative supplement is to support the addition of computational approaches for interpreting neural circuit function in the context of mental health-relevant behaviors, including analytical approaches for the detection and interpretation of neuronal interactions from single cells to networks to systems to complex mental health-relevant behaviors. Applicants for these supplements are encouraged to form new collaborations between behavioral neuroscientists, biostatisticians, and computational modelers.
  • Supplements to advance translation of basic neuroscience techniques and findings toward therapeutic development for mental disorders. Development and optimization of innovative cellular and molecular measures of neurobiological processes as assays that can be used to identify or validate novel targets or discover novel probes as leads for therapeutic discovery. 
  • Identifying genetic and environmental causes of mental illness
    • application of novel statistical/computational approaches to publicly available datasets particularly those datasets that include diverse ancestral backgrounds
    • Increased numbers of samples to be genomically characterized in order to improve power or replication efforts for novel gene discovery or gene x environment interaction models
    • Supplemental support will be provided to ongoing multi-scale genomic studies on postmortem brain collections and clinical populations to facilitate novel integrated analyses to elucidate molecular mechanisms underlying pathophysiology of psychiatric disorders.
  • Developing a risk calculator for the probability of a specified clinical event (given a specified set of antecedent measures). These supplements must employ a clinical database obtained in the course of the PD/PI's funded research, and other relevant clinical databases to which the investigator has access, in order to develop a risk calculator for the probability of a specified clinical event (given a specified set of antecedent measures). The focus of the calculator must be relevant to one or more mental disorders. The prediction may involve the probability of developing a disorder given antecedent risk factors, or of responding to a certain type of treatment for patients with current disorder.  Examples of such calculators might include, but are not limited to:  (1) probability of developing PTSD, depression, or other disorders within a certain time frame following a traumatic event; (2) probability of developing schizophrenia or bipolar disorder in a certain time period, given a defined set of risk factors; (3) probability of remitting from a major depressive episode in response to a specified treatment, given variables related to history, current clinical status, and one or more biomarkers.
  • Testing Potential Biomarkers:  Supplements are encouraged to leverage current NIMH investments to facilitate the initial testing of potential biomarkers that may have predictive value for disease onset, progression, remission, or treatment response.. As appropriate to the design and aims of the existing study, the supplemental request may focus on development of any of a variety of biomarker types (e.g., markers of disease risk, pathophysiological process, disease severity or progression, response to treatment).  Activities under this topic may include but are not limited to:
    • Testing innovative biomarkers measured during pregnancy that inform mechanisms of early neurodevelopment and/or predict risk trajectories for psychopathology. 
    • Biomarkers for risk and resilience related to suicidal ideation and suicide attempts. 
  • Supplements to Add, Harmonize, Standardize or Share Data and/or Use Other Available Data:
    • Support for adding Imaging, Clinical, and Other Measures to Ongoing Studies to Characterize Trajectories of Mental Illness across Time or Developmental Periods.  The intent is to add additional assessment point(s) to ongoing studies to characterize trajectories of developmental and disease processes that give rise to mental illness across the lifespan and/or to identify points of divergence in developmental trajectories.  Eligible studies should have available at least 3 assessment points by the end of the project period in order to define, analyze, and track trajectories.   
    • Supplements to support the incorporation of common measures and procedures (including common data elements) into studies that are conceptually-related but may use different methods, measures or patient populations or address distinct research questions; and/or develop and implement data sharing plans among funded NIMH investigators (NOT-MH-14-015).
    • Data use from publicly-available NIMH-supported data repositories.  NIMH supports several databases of clinical, imaging, and genetic data from NIH-supported clinical research.  The National Database for Autism Research (NDAR) currently holds data from over 43,000 individuals with Autism Spectrum Disorders (ASD), close to 40,000 family members of someone with ASD, and over 15,000 typically-developing controls.  Built on the NDAR platform, the National Database for Clinical Trials (NDCT) and the Research Domain Criteria Database (RDoCdb) also serve as data repositories and sources of publicly-shared data. The database of Genotypes and Phenotypes (dbGaP) was developed to archive and distribute the results of studies that have investigated the interaction of genotype and phenotype and contains phenotypic and genotypic data from thousands of subjects with Mental Disorders. Finally, the NIMH Repository and Genomics Resource Database (http://NIMHGenetics.org) also contains genomic and phenotypic data from many genetic studies of Mental Disorders.
  • Supplements to add suicide-relevant phenotype measures (particularly those in the Suicide Specialty Collection of the PhenX Toolkit) to ongoing translational or clinical studies involving samples that may have elevated risk for suicide, but which were not primarily designed to test hypotheses related to suicide. For example, individuals with bipolar disorder, trauma, or ADHD may have elevated risk for suicidal ideation and behavior. 
  • Supplements are encouraged for academic researchers and public health departments or community based organizations (CBOs) to jointly advance research on key gaps in the HIV care continuum. Special consideration will be afforded to projects that employ novel methods, and to projects conducted in metropolitan areas not previously targeted by the Center for Disease Control’s Enhanced Comprehensive HIV Prevention Planning (ECHPP) initiative. Possible focus areas include: a) studies of innovative interventions to increase the frequency of HIV testing in high risk populations; b) studies of novel approaches to improve linkage to care, retention in care, antiretroviral adherence, and/or viral suppression, and to decrease community viral load and AIDS-related mortality; c) studies of the feasibility and acceptability of enrolling, re-engaging, and retaining patients not successfully engaged in HIV care, for the purposes of future intervention trials; d) studies of strategies to increase HIV preventive behaviors after a negative HIV test, including PrEP knowledge, interest, readiness, and uptake; e) studies of the multi-level factors that may influence the impact and sustainability of evidence-based interventions for HIV prevention and treatment; and f) studies of modeling techniques to improve the targeting and understanding of the implementation of combination intervention approaches, with the use of novel modeling methods that include HIV-related outcomes (e.g., transmission events, attributable risk).
  • Mental Health Disparities and Global Mental Health:
    • Research on reducing racial and ethnic disparities in mental health care. Possible areas of focus include: a) subgroup analyses of existing data that enable investigators to examine clinical and functional differences in intervention outcomes, as well as mediators and moderators of main outcome variables, among diverse racial and ethnic groups; and b) research to examine factors related to the current use, benefits, safety, efficiencies and unmet needs for mental health care that may serve as targets for the reduction or elimination of disparities in mental health outcomes among racial and ethnic groups.
    • Advancing global mental health research. Research to increase the availability of valid mental health assessments for use in diverse low- and middle-income country contexts. Possible areas of focus include validation of a) brief screening tools for the detection of mental disorders in routine care settings or educational settings in low- and middle-income settings; b) measures of global functioning that can be used across cultural contexts; or c) measures of effective uptake of evidence-based treatments for mental disorders. Note that measures for validation must be generated, or in use, in the parent grant.
Section II. Award Information
Funding Instrument

The funding instrument will be the same as the parent award. 

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but must reflect the actual needs of the proposed project.

The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.

Award Project Period

The project and budget periods must be within the currently approved project period for the existing parent award.  Budgets are limited to one-year funds to be award in FY2015.

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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)

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.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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.
  • 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.  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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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.  

Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must prepare applications using current 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.

2. Content and Form of Application Submission

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 in the Application Guide (SF424 (R&R) Application 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 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.

Page Limitations

All page limitations described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions:

Supplement Applications, regardless of the parent grant's activity code, are limited to 1 page for Specific Aims and 5 pages for the Research Strategy.

Application Submission

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.

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 Form. Prepare applications using the SF424 (R&R) application forms associated with this announcement. 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.

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, to:

NIMH Referral Office
Telephone: 301-443-3367
Email: NIMHReferral@mail.nih.gov

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.

PHS 398 Research Plan (Research Plan)

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.

Specific Aims: Provide an overview of the aims of the supplement and how these aims are within scope of the approved and funded aims of the parent award.

Research Strategy:  The research strategy should address, in separate sections, the bulleted items below.

  • Scope of the overall project and the anticipated contribution of the requested supplement.
  • Description of the supplement's purpose; including research design/proposed scientific activities and methods and data analysis.  Description of the time-frame to complete the supplement, not to exceed one year.
  • Describe the relationship of the supplement request to the parent grant. Specifically, summarize how the activities proposed in the supplemental request fit within the scope/aims of the parent grant. Describe the progress on the parent grant
  • Identify and clearly state how the supplement request fits within one or more of the solicited topics identified above as areas of interest for NIMH.
  • Any supplemental data collection in on-going studies should clearly address the following:  study progress, including enrollment, to date; and the anticipated number of data points that can be captured with the proposed supplemental assessments.
  • As applicable, the supplement request must provide a strong rationale for the proposed research effort, clarifying the potential utility of the targeted biomarker(s), specific analyses needed to ready them for use in future research or the other scientific opportunity to be served by the additional data collection. The application must clearly describe how the additional data to be obtained will be combined with other information available within the project or from other sources so as to enable analyses that will contribute substantially to advancing the targeted biomarker development.
  • For supplements requesting to add assessments to clinical trials, the application should provide the rationale for the selection of suicide-related constructs and corresponding assessment instruments (e.g., measures of ideation, attempts), the time periods assessed (e.g., lifetime history, current), and the assessment schedule for administration (e.g., baseline, during intervention, post-intervention, follow up), taking into account the nature of the target population, participant burden, etc.  The application should also address provisions for clinical management when suicidal behavior is reported. See: http://www.nimh.nih.gov/health/topics/suicide-prevention/issues-to-consider-in-intervention-research-with-persons-at-high-risk-for-suicidality.shtml and http://ora.research.ucla.edu/OHRPP/Documents/Policy/8/Risk_of_Suicide.pdf
Project/Performance Site Locations (Project/Performance Sites)

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.
Senior/Key Personnel Form

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.
R&R Detailed Budget Form (for use with electronic submissions)

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 budget justification should include explain why any large unobligated balance is unavailable for the proposed work.

Budget for the Entire Proposed Period of Support (for use with paper-based submissions)

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 budget justification should include explain why any large unobligated balance is unavailable for the proposed work.

Other Project Information (for use with electronic submissions); Appendix (use with paper-based submissions)

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

IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions)

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.

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the Application Guide.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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. 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.

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.

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

Post Submission Materials

Not Applicable

Section V. Application Review Information
1. Criteria

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.  The following criteria will be considered:

  • Is the supplement responsive to the goals and scientific priorities listed in this FOA?
  • Will the supplement likely succeed in producing the anticipated contribution to the parent project?
  • Is the proposed scientific approach of the supplement of high quality?
  • Is the plan to accomplish the goals within the timeframe proposed appropriate and well described?
  • Are the proposed activities within scope of the parent grant?
  • Is there adequate progress of the parent grant that is appropriate to the current stage of the project?
  • Is there appropriate expertise in the proposed research team to conduct and achieve the supplement goals?

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 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.

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.

2. Review and Selection Process

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.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information
1. Award Notices

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.

2. Administrative and National Policy Requirements

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.

3. Reporting

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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding 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)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Please contact the Program Official associated with the Parent Grant to be supplemented.  To learn who the Program Official is, examine your eRA Commons account for the program official assignment and contact information. 

OR send an inquiry to the NIMH Referral Office atTelephone:  301-443-3367  
Email: NIMHReferral@mail.nih.gov

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Rebecca Claycamp, M.S., CRA
National Institute of Mental Health (NIMH)
Telephone: 301-402-7111
Email: rclaycam@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.

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