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 Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute of Environmental Health Sciences (NIEHS)

.

Funding Opportunity Title

Competing Revisions to Existing NIH Grants and Cooperative Agreements (Clinical Trial Optional)

Activity Code

Competing Revision Notice of Special Interest (NOSI) published by NIH Institutes and Centers will specify the activity codes under which recipients can apply, which may include any of the following activity codes:

R01 Research Project Grant

P30 Center Core Grants

U54 Specialized Center- Cooperative Agreements
U01 Research Project – Cooperative Agreements

G12 Research Centers in Minority Institutions Award
P01 Research Program Projects
P20 Exploratory Grants
P30 Center Core Grants
P40 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material Resource Grants
P41 Biotechnology Resource Grants
P50 Specialized Center
P51 Primate Research Center Grants
P60 Comprehensive Center
P2C Resource-Related Research Multi-Component Projects and Centers

PM1 Program Project or Center with Complex Structure

PN2 Research Development Center
S06 Research-Related Programs
U10 Cooperative Clinical Research – Cooperative Agreements
U19 Research Program – Cooperative Agreements
U2C Resource-Related Research Multi-Component Projects & Centers

U41 Biotechnology Resource Cooperative Agreements
U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements
U45 Hazardous Waste Worker Health and Safety Training Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
U56 Exploratory Grants – Cooperative Agreements
UC2 High Impact Research and Research Infrastructure Cooperative Agreement Programs
UC3 Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Cooperative Agreement Program
UC7 National Biocontainment Laboratory Operation Cooperative Agreement
UG4 National Network of Libraries of Medicine

UH4 Hazmat Training at DOE Nuclear Weapons Complex

UL1 Linked Specialized Center Cooperative Agreement

UM2 Program Project or Center with Complex Structure Cooperative Agreement

C06 Research Facilities Construction Grant
D43 International Training Grants in Epidemiology
D71 International Training Program Planning Grant
DP1 NIH Director's Pioneer Award (NDPA)
DP2 NIH Director's New Innovator Awards
DP3 Type 1 Diabetes Targeted Research Award
DP4 NIH Director's Pathfinder Award- Multi-Yr Funding
DP5 Early Independence Award

DP7 NIH Director's Workforce Innovation Award
F05 International Research Fellowships
F30 Individual Predoctoral NRSA for MD/PhD Fellowships
F31 Predoctoral Individual National Research Service Grant Award
F32 Postdoctoral Individual National Research Service Award
F33 National Research Service Awards for Senior Fellows

F99/K00 Pre-doc to Post-doc Transition Award/ Post-doctoral Transition Award
G08 Resources Project Grant (NLM)
G13 Health Sciences Publication Support Awards (NLM)
G20 Grants for Repair, Renovation and Modernization of Existing Research Facilities
K01 Research Scientist Development Award - Research & Training
K02 Research Scientist Development Award – Research
K05 Research Scientist Award
K06 Research Career Awards
K07 Academic/Teacher Award (ATA)
K08 Clinical Investigator Award (CIA)
K12 Physician Scientist Award (Program) (PSA)
K18 Career Enhancement Award
K22 Career Transition Award
K23 Mentored Patient-Oriented Research Career Development Award
K24 Midcareer Investigator Award in Patient-Oriented Research
K25 Mentored Quantitative Research Career Development Award
K26 Midcareer Investigator Award in Biomedical and Behavioral Research

K38 Early Stage Mentored Research and Career Development
K43 International Research Career Development Award

K76 Emerging Leaders Career Development Award

K99/R00 Career Transition Award/Research Transition Award
KL2 Mentored Career Development Award
KM1 Institutional Career Enhancement Awards

OT1 Pre-Application for an Other Transaction Award

OT2 Research Project - Other Transaction Award

OT3 Other Transaction Multiple-Component Research Award

RC2 High Impact Research and Research Infrastructure Programs

RC3 Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Program

RC4 High Impact Research and Research Infrastructure Programs – Multi-Yr Funding

RM1 Research Project with Complex Structure
R00 Research Transition Award

R01 Research Project Grant
R03 Small Grant Program
R13 Support for Conferences and Scientific Meetings
R13/U13 Support for Conferences and Scientific Meetings
R15 Academic Research Enhancement Award (AREA)
R18 Research Demonstration and Disseminations Projects
R21 Exploratory/Developmental Research Grant Award
R21/R33 Phased Innovation Award
R24 Resource-Related Research Projects

R25 Education Projects
R33 Exploratory/Developmental Grants Phase II
R34 Clinical Trial Planning Grant Program
R35 Outstanding Investigator Award
R36 Dissertation Award
R37 Method to Extend Research in Time (MERIT) Award
R38 Mentored Research Pathway in Residency

R41 Small Business Technology Transfer (STTR) Grant - Phase I only
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track
R42 Small Business Technology Transfer (STTR) Grant - Phase II only
R43 Small Business Innovation Research (SBIR) Grant - Phase I only
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track
R44 Small Business Innovation Research (SBIR) Grant - Phase II only

R61/R33 Exploratory/Developmental Phased Award

RC1 NIH Challenge Grants and Partnerships Program – Phase I

RC2 High Impact Research and Research Infrastructure Programs

RC3 Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Program

RC4 High Impact Research and Research Infrastructure Programs – Multi-Yr Funding

RM1 Research Project with Complex Structure

S07 Biomedical Research Support Grants
S10 Biomedical Research Support Shared Instrumentation Grants
S11 Minority Biomedical Research Support Thematic Project Grants
S21 Research and Institutional Resources Health Disparities Endowment Grants – Capacity Building
SB1 Commercialization Readiness Program

SC1 Research-Enhancement Award
SC2 Pilot Research Project
SC3 Research Continuance Award
T14 Conferences
T15 Continuing Education Training Grants
T32 Institutional National Research Service Award (NRSA)
T34 MARC Undergraduate NRSA Institutional Grants
T35 National Research Service Award (NRSA) Short -Term Research Training
T36 MARC Ancillary Training Activities Grant
T37 Minority International Research Training Grants

T42 Educational Resource Center Training Grants
T90/R90 Interdisciplinary Research Training Award/Interdisciplinary Regular Research Training Award
TL1 Linked Training Award
U01 Research Project – Cooperative Agreements

U13 Conferences Cooperative Agreements
U18 Research Demonstration – Cooperative Agreements
U2R International Training Cooperative Agreement
U24 Resource-Related Research Projects – Cooperative Agreements U34 Clinical Planning Grant Cooperative Agreement

U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II
UB1 Commercialization Readiness Program - Cooperative Agreement

UC4 High Impact Research and Research Infrastructure - Cooperative Agreement Programs
UG1 Clinical Research Cooperative Agreements - Single Project

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

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

UM1 Multi-Component Research Project Cooperative Agreements

UP5 Cooperative Agreement

Announcement Type

New

Related Notices
  • April 3, 2020 - Notice of Specialist Interest (NOSI): Availability of Funds for Competitive Revision Applications to Conduct Research with a Focus in Chronic Disease and the Reduction of Health Disparities Within the Mission of NIDDK (R01, U01, U24, P30, U54). See Notice NOT-DK-20-012.
Funding Opportunity Announcement (FOA) Number

PA-20-163

Companion Funding Opportunity

None

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

93.847, 93.113   

Funding Opportunity Purpose

The National Institutes of Health (NIH) hereby notifies NIH award recipients that funds may be available for revision applications to support the expansion of existing projects and/or programs within the awarding IC identified in the competitive revision Notice of Special Interest (NOSI).

Only applications submitted in response to a NOSI published by an NIH Institute or Center will be allowed to apply to this FOA.    

Key Dates

 

Posted Date

April 3, 2020

Open Date (Earliest Submission Date)

Open dates may vary by awarding IC on an as-needed rolling basis.  See competitive revision NOSI published by an NIH Institute or Center for applicable Application Due Dates.

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

See the competitive revision NOSI for any applicable Application Due Dates.

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

See NOSI for scientific merit review information.

Advisory Council Review

See NOSI for council review information.

Earliest Start Date

See competitive revision NOSI for information on start dates associated with specific needs)

Expiration Date

April 3, 2023

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. 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 Institutes of Health (NIH) hereby notifies NIH award recipients that funds may be available for revision applications to support the expansion of existing projects and/or programs.

    Only applications submitted in response to a NOSI published by an NIH Institute or Center will be allowed to apply to this FOA.

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

    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. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    Competitive revision applications to active NIH parent awards.

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    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

    Specific budget limits may be specified in the competitive revision NOSI. Application budgets must be reasonable and must reflect the actual needs of the proposed project.

    Award Project Period

    The project and budget periods must be within the currently approved project period for the existing parent award. Unless otherwise instructed in the Competitive Revision NOSI, applicants may request up to two years of support. The parent award must have a minimum of two years remaining within the current project period at the time of application submission.   

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    All organizations administering an eligible parent award may apply for a competitive revision under this announcement unless otherwise stated in the terms and conditions of the parent award.

    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 competitive revisions 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.

    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. Since competitive revisionsare made to active grants and cooperative agreements, many of these registrations may already be in place. All registrations must be current and completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

    System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

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

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

    Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. 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.

    Eligible Individuals (Program Director/Principal Investigator)

    Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the competitive revision 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 competitive revisions to parent awards that include multiple PDs/PIs, the competitive revision 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 competitive revision 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 unless otherwise specified in the competitive revision NOSI.

    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 application 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.

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. Note: Grants.gov Workspace may not be used for multi-project applications. Multi-project applications must be submitted using NIH ASSIST or an institutional system-to-system solution

    2. Content and Form of Application Submission

    All applications must be submitted electronically using one of the submission methods listed in Part 1 of this FOA and must be in response to the competitive revision NOSI that refers to this FOA. All forms must be completed for the proposed new 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, as appropriate) except where instructed in this funding opportunity announcement or NOSI 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.

    Page Limitations

    All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits for the activity code of the parent award must be followed,  except where instructed in the NOSI to do otherwise.

    Application Submission

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

    SF424(R&R) Cover

    All instructions in the SF424 (R&R) Application Guide and competitive revision NOSI must be followed. 

    NOSI Special Instructions

    The NOSI number must be included in box 4b (Agency Routing Identifier) on the application face page to be considered under the revision NOSI and this FOA.

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide and applicable competitive revision NOSI must be followed. 

    SF424(R&R) Other Project Information

    All instructions in the SF424 (R&R) Application Guide and applicable competitive revision NOSI must be followed. 

    SF424(R&R) Senior/Key Person Profile

    All instructions in the SF424 (R&R) Application Guide and applicable competitive revision NOSI must be followed. 

    R&R Budget

    All instructions in the SF424 (R&R) Application Guide and applicable competitive revision NOSI must be followed.

    R&R Subaward Budget

    All instructions in the SF424 (R&R) Application Guide and applicable competitive revision NOSI must be followed.

    PHS 398 Cover Page Supplement

    All instructions in the SF424 (R&R) Application Guide and applicable competitive revision NOSI must be followed.

    PHS 398 Research Plan

    All instructions in the SF424 (R&R) Application Guide and applicable competitive revision NOSI must be followed, with the following additional instructions: 

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide and the competitive revision NOSI.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

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

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record:

    PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    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.
    • Project/Performance Site Location form: Include the primary site where the proposed   supplement activities will be performed. If a portion of the proposed supplement activities will     be performed at any other site(s), identify the locations in the fields provided.
    • Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this      supplement, or for whom additional funds are being requested through this supplement;     include a biographical sketch for each.
    • Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
    • R&R Other Project Information form: If applicable, attach PDF documents in the “Other Attachments” field indicating that the proposed research experience was approved by the       Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review      Board (IRB) at the grantee institution. Name the documents “IACUC Documentation.pdf”      and/or “IRB Documentation.pdf”. Adherence to the NIH policy for including women and    minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement.
    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. Unique Entity Identifier and System for Award Management (SAM)

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

    4. Submission Dates and Times

    As described in Part I. Overview Information, the NOSI will provide 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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

    Important reminders:
    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.

    Post Submission Materials

    Not Applicable

    Section V. Application Review Information
    1. Criteria

    The competitive revision NOSI will provide the applicable review criteria. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) as described in the NOSI, in accordance with NIH peer review policy and procedures, using the  review criteria provided in the NOSI. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    3. Anticipated Announcement and Award Dates

    See competitive revision NOSI for anticipated announcement and award dates.

    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.

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the 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).  

    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.

    All competitive revisions funded under this FOA will be subject to the same Administrative and National Policy Requirements as the parent award.

    Cooperative Agreement Terms and Conditions of Award

    Any competitive revisions awarded to Cooperative Agreements under this FOA 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 new 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.

    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 Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    For any scientific or research-related questions on this competitive revision notice please contact the Program Officer listed on NoA of the most recent parent award.

    Peer Review Contact(s)

    Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

    Financial/Grants Management Contact(s)

    For any financial or grants management questions on this competitive revision notice please contact the Grants Management Specialist or Grants Management Officer listed on the NoA of the most recent parent award.

    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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