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 Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Office of Strategic Coordination (Common Fund)

All applications to this notice of funding opportunity should fall within the mission of the Institutes/Centers listed above. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Dietary Supplements (ODS)

Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

NIH Administrative Supplements to Recover Losses due to Hurricanes Fiona and Ian Under the Consolidated Appropriations Act, 2023 (Admin Supp Clinical Trial Optional)

Activity Code

Administrative Supplement

Additional funds may be awarded as supplements to parent awards for all activity codes.

Announcement Type

New

Related Notices

NOT-OD-20-128 June 30, 2020- Notice of Requirement for Electronic Submission of all Administrative Supplements

NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

Notice of Funding Opportunity (NOFO) Number

PA-23-134

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.661

Funding Opportunity Purpose

The purpose of this funding opportunity is for investigators and institutions impacted by Hurricanes Fiona and Ian with active NIH grants to request:

1) a 24-month extension of the current budget period, with 12-months of funding at the same funding level as the current year of the grant and/or

2) a one-time administrative supplement of up to $150,000 in direct costs (excluding consortium facilities and administrative costs) to replace lost and/or damaged research resources; and/or

3) up to $250,000 to replace a single item of equipment so long as that request is accompanied by well-documented support for the need to replace that item of equipment; and/or

4) minor alternation and renovation to research facilities up to $500,000.

Supplement requests will be routed to the appropriate NIH Institutes and Centers for consideration.

The number of awards issued will depend on the number of applicants received and funneled through the review process.

Benefits of this opportunity are restricted to applicants located in a county or parish where a major disaster has been declared under the Stafford Act as a result of Hurricanes Fiona and Ian.

Grants at NIH-supported institutions impacted by Hurricanes Fiona and Ian will be eligible for both the funded extension and/or administrative supplements. If a grant has relocated or relocates prior to the award of the funded extension, the funded extension may be withdrawn.

Applications submitted in response to this announcement will be considered for funding only with funds appropriated from the Consolidated Appropriations Act, 2023 (Public Law 117-328). This opportunity does not preclude additional requests for administrative supplements on other NIH grant programs or for these mechanisms. Institutes and Centers will still consider such requests on a case-by-case basis.

These funds cannot duplicate nor overlap with reimbursement provided by FEMA, under a contract for insurance, or by self-insurance. Self-insurance is a formal plan, pursuant to law or regulation, in which amounts are set aside in a fund to cover losses of specified types and amounts, typically by a commercial insurance company. Appropriated funds are precluded from expenses that are or can be reimbursed by the formal self-insurance plan.

This opportunity applies to awards active at the time of the hurricanes.

Key Dates
Posted Date

March 17, 2023

Open Date (Earliest Submission Date)

March 17, 2023

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Applications will be accepted on a rolling basis, beginning March 17, 2023

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

Not Applicable

Expiration Date

September 30, 2023

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, as appropriate) except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of 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. Notice of Funding Opportunity Description

Applications submitted in response to this announcement will be considered for funding only with funds appropriated from the Consolidated Appropriations Act, 2023 (Public Law 117-328).

This funding opportunity is for those investigators and institutions impacted by Hurricanes Fiona and Ian and with NIH grants active at the time of the storms. Benefits of this opportunity are restricted to applicants located in a county or parish where a major disaster has been declared under the Stafford Act as a result of Hurricanes Fiona and Ian.

Two options are available:

1) Funded Extension: Recipients may request a funded extension at the same funding level as the current year of the grant. The active grant can have multiple future years still committed, e.g., it need not be in the final year. For those approved for funding, the extension will be funded as a 24-month extension of the current budget period; however, the funding provided will be equivalent to 12 months of support based on the funding level of the current budget period.

2) One-time Administrative Supplements: Recipients may request

a) up to $150,000 in direct costs (excluding consortium F&A costs) to replace lost and/or damaged research resources such as small pieces of equipment or their repair, supplies, reagents, animals, etc.; and/or

b) up to $250,000 to replace a single item of equipment so long as that request is accompanied by well-documented support for the need to replace that item of equipment; and/or

c) minor alternation and renovation (A&R) to research facilities up to $500,000.

Excluded from the one-time supplement options are salaries, training costs, travel and recurring supplies (only replacement supplies can be requested).

Grants at NIH-supported institutions impacted by Hurricanes Fiona and Ian will be eligible for the funded extension option and/or the administrative supplement options. If a grant has relocated or relocates prior to the award of the additional support, the additional support may be withdrawn.

This funding opportunity includes training and training-related programs at otherwise eligible institutions. Such programs include individual research career development awards (Ks), individual fellowships (Fs), institutional training and scientist development grants (Ts, Ds, K12s/KL2) and Education grants (R25s). Since the options available for these programs are very program-specific, contact the Program Official Contact identified in your Notice of Award before considering submitting an administrative supplement request. In all cases involving training and training-related programs, as part of any supplement request a justification must address how the training and/or educational plan has been disrupted. All costs requested must be costs that are allowable on the parent grant.

This opportunity does not preclude additional requests for administrative supplements on other NIH grant programs or for these mechanisms. Institutes and Centers will still consider such requests on a case-by-case basis.

Funds provided by NIH through these supplements cannot duplicate nor overlap with reimbursement provided by FEMA, under a contract for insurance, or by self-insurance.

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 NOFO.

Application Types Allowed

Non-competing Administrative Supplements

Clinical Trial?

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

Administrative supplement applications may not propose changes to the overall human subjects or clinical trial designation of the award.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon funds received by the NIH from the Consolidated Appropriations Act, 2023 (Public Law 117-328), and the submission of a sufficient number of meritorious applications.

The NIH intends to commit up to $25 million; awards will be made in FY23-FY24.

Award Budget

This funding mechanism provides for the following options:

1) Funded Extension: Recipients may request a funded extension at the same funding level as the current year of the grant. The active grant can have multiple future years still committed, e.g., it need not be in the final year. For those approved for funding, the extension will be funded as a 24-month extension of the current budget period; however, the funding provided will be equivalent to 12 months of support based on the funding level of the current budget period.

2) One-time Administrative Supplements: Recipients may request

a) up to $150,000 in direct costs (excluding consortium F&A costs) to replace lost and/or damaged research resources such as small pieces of equipment or their repair, supplies, reagents, animals, etc.; and/or;

b) up to $250,000 to replace a single item of equipment so long as that request is accompanied by well-documented support for the need to replace that item of equipment; and/or

c) minor alternation and renovation (A&R) to research facilities up to $500,000 (see Sec. 10.8.2, Alteration and Renovation Projects Under Non-Construction Grants, of the NIH Grant Policy Statement.).

Excluded from the one-time supplement options are salaries, training costs, travel and recurring supplies (only replacement supplies can be requested).

If both a funded extension and one-time administrative supplement(s) are approved and awarded, the funds requested in the supplement may not duplicate any costs requested in the funded extension.

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

1. For the funded extension option, the application will request 24 months of additional time.

2. For the one-time administrative supplement and minor A&R options, the project and budget period must be within the currently approved project period for the existing award if at least 24 months remain. An extension of the current project period may be requested if less than 24 months remain in the current period.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Eligibility is limited to institutions located in a county or parish where a major disaster has been declared under the Stafford Act as a result of Hurricanes Fiona and Ian.

  • Applicants should first assess the impact of the hurricanes on a particular project, including time lost and the additional work necessary to restore the project in order to address the approved aims and objective. Recipients will need to wait until after such an assessment has been completed before applying.

This announcement is for supplements to existing projects. To be eligible, the parent award must be active, and the award must have been active at the time of the hurricanes. Applications will be considered from parent awards currently in a no-cost extension, only if the extension was requested due to the impacts of Hurricanes Fiona and Ian. Applicants must provide a justification demonstrating the reason the award was extended.

IMPORTANT: The research proposed by the NIH recipient 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 not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

  • 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.
    • 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.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH 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 NOFO 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.

Since applications 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 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. Applicants are encouraged to contact the administrative office for instructions if you plan to use an institutional system-to-system solution.

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 for their submission option (SF424 (R&R) Application Guide, as appropriate) except where instructed in this notice of funding opportunity announcement to do otherwise. Conformance to documented requirements is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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, with the following exceptions or additional requirements, and/or except where instructed in a Notice of Special Interest (NOSI) to do otherwise:

Application Submission

Administrative supplement requests must be submitted through Grants.gov using electronic submission processes.

Instructions for Electronic Application Submission

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:

  • SF424 R&R Cover form: Select Revision in the Type of Application field. The "Descriptive Title of the Applicant's Project" must match the title of the currently funded grant.
  • 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 recipient 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.
  • Project/Performance Site Location(s) 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 Person Profile (Expanded) 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.
  • Research Plan form (e.g., PHS 398 Research Plan form, PHS 398 Research Training Program Plan): At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
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

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit electronic applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Applicants are responsible for viewing their electronic application before the due date in the eRA Commons to ensure accurate and successful submission.

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

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.

This funding opportunity is for those investigators and institutions impacted by Hurricanes Fiona and Ian, with NIH grants active at the time of the storm. Eligibility is limited to institutions located in a county or parish where a major disaster has been declared under the Stafford Act as a result of Hurricanes Fiona and Ian. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement with the exceptions noted below.

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

For the Funded Extension Option, funds are restricted to the same level of funding as the current year of the grants. All costs must be allowable under the terms and conditions of the parent award.

For the one-time administrative supplements option:

a) Funds are restricted to up to $150,000 in direct costs (excluding consortium F&A costs) to replace lost and/or damaged research resources such as small pieces of equipment or their repair, supplies, reagents, animals, etc.; and/or;

b) Recipients may request up to $250,000 to replace a single item of equipment so long as that request is accompanied by well-documented support for the need to replace that item of equipment; and/or

c) minor alternation and renovation (A&R) to research facilities up to $500,000 (see Sec. 10.8.2, Alteration and Renovation Projects Under Non-Construction Grants, of the NIH Grant Policy Statement.).

Excluded from the one-time supplement options are salaries, training costs, travel and recurring supplies (only replacement supplies can be requested).

If both a funded extension and one-time administrative supplement(s) are approved and awarded, the costs requested in the supplement may not duplicate any costs requested in the funded extension.

Funds will be restricted so that they cannot duplicate costs reimbursed by FEMA, under a contract for insurance or self-insurance. If during the period of the award a claim is paid which provides such duplication, the recipient will be required to pay back the funds to the NIH.

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. Failure to register in the eRA 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

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:

  • Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
  • Will the administrative supplement increase or preserve the likelihood that the fellowship will enhance the candidate's potential for, and commitment to, a productive, independent scientific research career in a health-related field?
  • Will the administrative supplement increase or preserve the likelihood for the candidate to maintain a strong research program?
  • Will the administrative supplement increase or preserve the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved?
  • Will the administrative supplement increase or preserve the potential benefit of the instrument requested for the overall research community and its potential impact on NIH-funded research?

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 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 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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.

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) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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 recipient’s business official.

Recipients 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 NOFO 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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Any supplements will be subject to the same data management and sharing requirements as the parent award.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301

Funds awarded for supplements will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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: https://www.era.nih.gov/need-help (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: 301-637-3015

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 administrative supplement notice please contact the Program Officer listed on the 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

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. and 2 CFR Part 200

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