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

Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) is sponsored by National Heart, Lung, and Blood Institute (NHLBI) / National Institutes of Health (NIH). This program provides supplemental funding to support NHLBI research projects during major life events for early-stage investigators and to promote diversity in health-related research.

Expired PA-20-272: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) 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 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 All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers listed above.

The following NIH Offices may co-fund applications assigned to those Coordination, Planning and Strategic Initiatives, Office of Disease Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Dietary Supplements ( ODS ) Office of Research on Women’s Health ( ORWH ) Funding Opportunity Title Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) Administrative Supplement Additional funds may be awarded as supplements to parent awards for all activity codes.

Notices of Special Interest associated with this funding opportunity April 25, 2025 - Notice of Participation of the Environmental influences on Child Health Outcomes (ECHO) Program in PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See Notice NOT-OD-25-099 March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. January 17, 2025 - Notice of Information: Administrative Supplements to Increase the Number of Training Slots in NIA-funded T32 Awards to Support Within-Scope Training of Music-Science Research. See Notice NOT-AG-24-092 .

January 15, 2025 - Notice to Extend the Expiration Date for PA-20-272 "Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)". See Notice NOT-OD-25-063 . May 22, 2024 - Childcare Costs for Ruth L.

Kirschstein National Research Service Award (NRSA) Individual Fellows and Institutional Research Training Awards. See Notice NOT-OD-24-116 March 27, 2024 - Notice of Information - Technical and Business Assistance (TABA) Funding May be Added to an SBIR/STTR Award by Administrative Supplement. See Notice NOT-OD-24-077 December 21, 2023 - Notice to Extend the Expiration Date for PA-20-272 .

See Notice NOT-OD-24-048 September 09, 2023 - Notice to Extend the Expiration Date for PA-20-272. See Notice NOT-OD-23-189 May 24, 2023 - Updated Notice of Information for HIV research priorities at the National Heart, Lung, and Blood Institute. See Notice NOT-HL-23-088 April 4, 2023 - NHLBI Notice of Availability of Frequently Asked Questions (FAQs) for NOT-HL-23-078 and NOT-HL-23-079 (CAROL Act).

See Notice NOT-HL-23-085 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 See Notices of Special Interest related to this Funding Opportunity June 30, 2022 - Notice of Pre-Application Webinar for NOT-CA-21-100 "Administrative Supplements to Participate in the NCI Early-stage Surgeon Scientist Program (ESSP)".

See Notice NOT-CA-22-100 April 6, 2022 - Emergency Award: Rapid Acceleration of Diagnostics Tribal Data Repository (RADx TDR) (U24 Clinical Trial Not Allowed). See Notice RFA-OD-22-011 December 23, 2021 - Notice of Special Interest (NOSI): Pain-Focused Administrative Supplements for NINDS Grants that are Not Focused on Pain Research.

See Notice NOT-NS-22-053 December 22, 2021 - Notice of Special Interest (NOSI): Availability of Administrative Supplements for Research on Pain, Pain Management, and Opioids in Aging.

See Notice NOT-AG-22-005 December 14, 2021 - Notice of NHLBI Participation in to NOT-OD-21-062, "Notice of Special Interest (NOSI): Administrative Supplement for Providing Technical and Business Assistance (TABA) Funding to SBIR/STTR Awardees (Admin Supp)". See Notice NOT-HL-21-046 November 23, 2021 - Notice of Special Interest: Administrative Supplements on High Priority Topic Areas for NCCIH Grants.

See Notice NOT-AT-22-002 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients.

See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel.

See Notice NOT-OD-21-109 September 21, 2021 Notice of Change to NOT-NS-20-038 "Notice of Special Interest: Administrative Supplement for the NINDS Research Education Program for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (Admin Supp)".

See Notice NOT-NS-22-027 August 25, 2021 - HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Advance the Study of Chronic Overlapping Pain Conditions (COPCs). See Notice NOT-NS-21-068 . November 17, 2020 - Notice of Clarification to NIEHS' Participation on PA-20-272.

See Notice NOT-ES-21-003 . June 30, 2020 - Notice of Requirement for Electronic Submission of all Administrative Supplements. See Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 989, 93. 350, 93.

393, 93. 394, 93. 395, 93.

396, 93. 399, 93. 867, 93.

172, 93. 233, 93. 837, 93.

838, 93. 839, 93. 840, 93.

866, 93. 273, 93. 855, 93.

846, 93. 286, 93. 847, 93.

113, 93. 142, 93. 143, 93.

859, 93. 242, 93. 307, 93.

853, 93. 361, 93. 879, 93.

351, 93. 313, 93.

310 Funding Opportunity Purpose National Institutes of Health (NIH) hereby notify Program Directors/Principal Investigators (PD(s)/PI(s)) 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 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. requests for administrative supplements may be submitted through this FOA, there is no guarantee that funds are available from the awarding IC or for All applicants are encouraged to discuss potential requests with the awarding IC.

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 https://grants. nih.

gov/grants/guide/admin_supp/index. htm . Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Due dates may vary by awarding IC.

See the awarding IC's web site or applicable Notice of Special Interest (NOSI) for appropriate Application Due Dates. Applicants may also contact their respective awarding IC. 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) Earliest start dates may vary by awarding IC. See the awarding IC's web site or applicable Notice of Special Interest (NOSI) for any applicable New Date September 30, 2025 per issuance of NOT-OD-25-063 .

(Original Expiration Date: January 24, 2025) 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 FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of the Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description Information for award authorities and regulations.

Section II. Award Information 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. Other: A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications.

Application Types Allowed Non-competing Administrative Supplements 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. 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.

Application budgets are limited to no more than the amount of the current parent award and must reflect the actual needs of the proposed 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 The project and budget periods must be within the currently approved project period for the existing parent award. described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

All organizations administering an eligible parent award may apply for a supplement under this announcement.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Institutions) This announcement is for supplements to existing projects.

To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are eligible Foreign components, as defined in the NIH Grants Policy Statement , 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.

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 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 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. 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.

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' 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 Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award.

Individuals are encouraged to work with their organizations to develop applications for support. For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.

Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more This FOA does not require cost sharing as defined in the NIH Grants 3.

Additional Information on Eligibility 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 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 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 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 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 a Notice of Special Interest (NOSI) to do otherwise. Administrative supplement requests must be submitted through Grants.

gov using electronic submission processes. Instructions for Electronic Application Submission through Grants. gov 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. Administrative supplement requests for multi-project activity codes must be submitted electronically using a single-project application form package. 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: Cover form: Select Revision in the Type of Application field.

Other Project Information form: If applicable to the supplement activities, 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. 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 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 forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.

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 Subjects and Clinical Trials Information form: This form is optional.

Given that the proposed supplement should not change the scope of the awarded parent project, it will typically not be needed. If new recruitment or use of an additional existing dataset or resource is proposed in the supplement application, Section 2 should be revised and new Inclusion Enrollment Reports created, as well as other required sections, as appropriate for supplemental activities.

Foreign (non-U.S.) institutions must follow policies Grants Policy Statemen t , 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 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 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) 5.

Intergovernmental Review This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Pre-award costs are allowable only as described in the NIH Grants Requirements and Information Applications must be submitted using the instructions 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 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 . 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 Section V. Application Review Information Administrative Supplements do not receive peer review. Instead, the administrative criteria described below, and/or in an applicable Notice of Special Interest (NOSI), will be considered in the administrative evaluation The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit.

The following general criteria NIH staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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 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 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, 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.

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.

NIH staff will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed. Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review.

Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above. 3. Anticipated Announcement and Award Dates Section VI.

Award Administration 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 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 .

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency.

The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www. hhs.

gov/civil-rights/for-providers/provider-obligations/index. html and http://www. hhs.

gov/ocr/civilrights/understanding/section1557/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