Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Advancing Translational Sciences (NCATS)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS)
Office of Research on Women’s Health (ORWH)
Office of Strategic Coordination (Common Fund)

Funding Opportunity Title

Administrative Supplements to Existing NIH Grants and Cooperative Agreements(Parent Admin Supp)

Activity Code

Administrative Supplement

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

R01 Research Project Grant
R03 Small Grant Program
R21 Exploratory/Developmental Research Grant Award
R33 Exploratory/Developmental Grants Phase II
P01 Research Program Projects
P20 Exploratory Grants
P30 Center Core Grants
P50 Specialized Center
P60 Comprehensive Center
U01 Research Project Cooperative Agreements
U19 Research Program Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
UM1 Multi-Component Research Project Cooperative Agreements
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
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I and Phase II
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
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I and Phase II
R44 Small Business Innovation Research (SBIR) Grant - Phase II only
C06 Research Facilities Construction Grant
D43 International Research Training Grants
D71 International Research Training 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/UP5 Early Independence Award/Cooperative Agreement
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
F34 MARC (NRSA) Faculty Fellowship
G08 Resources Project Grant (NLM)
G12 Research Centers in Minority Institutions Award
G13 Health Sciences Publication Support Awards (NLM)
G20 Grants for Repair, Renovation and Modernization of Existing Research Facilities (NCRR)
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)
K14 Minority School Faculty Development Awards
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
K99/R00 Career Transition Award/Research Transition Award
KL2 Mentored Career Development Award
KM1 Institutional Career Enhancement Awards
P40 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material Resource Grants
P41 Biotechnology Resource Grants
P51 Primate Research Center Grants
PN1 Concept Development Award
PN2 Research Development Center
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
U18 Research Demonstration Cooperative Agreements
R21/R33 Phased Innovation Award
R24 Resource-Related Research Projects
R25 Education Projects
R30 Preventive Health Service Venereal Disease Research, Demonstration, and Public Information and Education Grants
R34 Clinical Trial Planning Grant Program
R36 Dissertation Award
R37 Method to Extend Research in Time (MERIT) Award
R49 Injury Control Research and Demonstration Projects and Injury Prevention Research Centers
S06 Research-Related Programs
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
S22 Research and Student Resources Health Disparities Endowment Grants Educational Programs
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
T90/R90 Interdisciplinary Research Training Award/Interdisciplinary Regular Research Training Award
TL1 Linked Training Award
U10 Cooperative Clinical Research Cooperative Agreements
U24 Resource-Related Research Projects Cooperative Agreements
U34 Clinical Planning Grant Cooperative Agreement
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
U56 Exploratory Grants Cooperative Agreements
U84 Cooperative Agreements for Fetal Alcohol Syndrome Prevention Research Programs
U90 Cooperative Agreements for Special Projects of National Significance (SPNS)
UC7 National Biocontainment Laboratory Operation Cooperative Agreement
U2R International Research Training Cooperative Agreements
UC4 High Impact Research and Research Infrastructure - Cooperative Agreement Programs
UH2 Exploratory/Developmental Cooperative Agreement Phase I
UH2/UH3 Phase Innovation Awards Cooperative Agreement
UH3 Exploratory/Developmental Cooperative Agreement Phase II
UL1 Linked Specialized Center Cooperative Agreement

Announcement Type

New

Related Notices
  • January 30, 2014 - See Notice NOT-OD-14-044. Updated Electronic Application Forms (FORMS-C) Now Available for Administrative Supplement (non-competing Type 3), Successor-in-Interest (Type 6), and Change of Grantee Organization (Type 7) Applications.
  • January 30, 2014 - This PA has been reissued as PA-14-077.
  • January 28, 2013 - See Notice NOT-OD-13-031. Notice of an Extension of Expiration Date.
  • July 18, 2012 - See Notice NOT-AT-12-005. Notice to Update Submission and Review Dates of NCCAM's Administrative Supplements.
  • June 22, 2012 - Addendum: Administrative Supplements to Existing NIH Grants and Cooperative Agreements, and Research Supplements to Promote Diversity in Health-Related Research. See Notice NOT-OD-12-117.
Funding Opportunity Announcement (FOA) Number

PA-12-100

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

Available CFDAs may vary by awarding IC. See the awarding IC's web site for any applicable CFDA information.

Funding Opportunity Purpose

The National Institutes of Health (NIH) hereby notify Principal Investigators holding specific types of NIH research grants, listed in the full Funding Opportunity Announcement (FOA) that funds may be available for administrative supplements to meet increased costs that are within the scope of the approved award, but that were unforeseen when the new or renewal application or grant progress report for non-competing continuation support was submitted. Applications for administrative supplements are considered prior approval requests (as described in Section 8.1.2.11 of the NIH Grants Policy Statement) and will be routed directly to the Grants Management Officer of the parent award.

Although requests for administrative supplements may be submitted through this FOA, there is no guarantee that funds are available from the awarding IC or for any specific grant. All applicants are encouraged to discuss potential requests with the awarding IC. Additionally, prior to submission, applicants must review the awarding IC's web site to ensure they meet the IC's requirements. A list of those web sites is available at http://grants.nih.gov/grants/guide/admin_supp/index.htm.

Key Dates
Posted Date

February 8, 2012

Open Date (Earliest Submission Date)

Open dates may vary by awarding IC. See the awarding IC's web site for any applicable Application Due Dates

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Due dates may vary by awarding IC. See the awarding IC's web site for any applicable Application Due Dates.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date(s)

Earliest start dates may vary by awarding IC. See the awarding IC's web site for any applicable Application Due Dates.

Expiration Date

(Extended to January 31, 2014 per NOT-OD-13-031), Originally January 31, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF 424 (R&R) Application Guide or PHS398 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

Section II. Award Information
Funding Instrument

Grant

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 generally limited to no more than the amount of the most recent parent award, and must reflect actual needs of the proposed project. Note that ICs may further limit application budgets for specific activity codes or programs. See the awarding IC's web site for any additional budget limitations.

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 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.

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

Below are the general eligibility requirements for administrative supplement, but please review the awarding IC's web site for any additional 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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 must complete the following registrations as described in the Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 invited to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PD(s)/PI(s), the supplement may be requested by any or all of the PD(s)/PI(s) (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 PD(s)/PI(s) listed on the parent award. Visit the Multiple Program Director(s)/Principal Investigator(s) 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

In general, applicant organizations may submit more than one administrative supplement request per award, provided that each is sufficiently distinct from any other administrative supplement request currently under consideration by the awarding NIH Institute or Center. However, please see the awarding IC's web site for any applicable restrictions on the number of applications that will be accepted for consideration. A list of those web sites is available at http://grants.nih.gov/grants/guide/admin_supp/index.htm.

Since applications in response to this announcement will only receive administrative review by the awarding Institute or Center, and will not receive a peer review, the NIH policy on resubmissions will not apply. However, applications not accepted by the Institute or Center for review, or not funded by the Institute or Center, should not be submitted again without either responding to any written concerns or contacting the awarding Institute or Center for instructions.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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 PHS398 Application Guide, as appropriate, and any instructions provided by the awarding IC) 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 based on the parent award's activity code and project components, with the following exceptions or additional requirements:

Application Submission

Prior to submission, applicants must review the awarding IC's web site to ensure they meet the IC's requirements and all applicants are encouraged to discuss potential requests with the awarding IC.

The process for submitting an application varies depending on whether the activity code of the parent award requires electronic submission (as of the submission date of the supplement application). Visit the list of Activity Codes Processed Electronically by eRA to determine if the activity code of the parent award has transitioned to electronic submission.

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

For grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically through grants.gov. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Administrative supplement requests submitted through this method should be marked as a "Revision" in Field 8 (Type of Application) on the R&R Cover Page. 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 the 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. All applications eligible for electronic submission through Grants.gov may also be submitted through the streamlined system. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A user’s guide for this system is available at http://era.nih.gov/commons/user_guide.cfm.

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 PHS398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS398 research grant application forms and instructions for preparing a research grant application. The grantee institution, on behalf of the PD(s)/PI(s) 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:

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.

PHS398 Research Plan Component (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.

PHS398 Career Development Award Supplemental Form

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.

PHS398 Research Training Program Form

All instructions in the Application Guide must be followed for all Research Training Program Plan sections applicable to the proposed supplement activities. At a minimum, the Program Plan section should be completed and must include a summary or abstract of the funded parent award or project.

PHS398 Fellowship Supplemental Form

All instructions in the Application Guide must be followed for all Research Training Plan, Additional Information, and Sponsor(s) and Co-Sponsor(s) 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. Additionally, the Budget section should only include additional funds requests for the proposed supplement activities.

Project/Performance Site Locations (Project/Performance Sites)

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

List the PD(s)/PI(s) 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. Follow all instructions in the Application Guide.

Budget Forms (for use with electronic submissions through Grants.gov)

R&R Detailed Budget Form

Budgets for all NIH research (R-series) and career development (K-series) applications 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.

PHS 398 Training Budget Form

Budgets for all NIH Training (T-series and D-series) applications should be submitted using the R&R Training Budget and R&R Detailed Budget forms (as appropriate), and should only include funds requested for the additional supplement activities.

SF424 Budget Information Construction Programs Form

Budgets for all NIH construction (C06) applications should be submitted using the SF424 Budget Information Construction Programs form and should only include funds requested for the additional supplement activities.

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

A proposed budget should be submitted using the PHS398 budget forms, in accordance with the PHS398 Application Guide, and should only include funds requested for the additional supplement activities.

Other Project Information Component (for applications submitted electronically); Appendix (for applications submitted on paper)

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.

Foreign Institutions

Foreign (non-US) 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 in advance of the deadline 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 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 PHS398 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.

See the awarding IC's web site for any additional funding restrictions. A list of those web sites is available at http://grants.nih.gov/grants/guide/admin_supp/index.htm.

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.

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 Central Contractor Registration (CCR). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

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

See the awarding IC's web site for any additional submission requirements. A list of those web sites is available at http://grants.nih.gov/grants/guide/admin_supp/index.htm.

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, as applicable:

In addition, each of the following criteria will be evaluated if they will be impacted by the proposed activities.

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, NIH staff 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 Human Subjects Protection and Inclusion Guidelines.

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

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 PHS Non-Competing Grant Progress Report, Form 2590, 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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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

Peer Review Contact(s)

Not Applicable.

Financial/Grants Management Contact(s)

For any financial or grants management questions on this administrative supplement 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 Parts 74 and 92.


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NIH Funding Opportunities and Notices



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