Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement – Clinical Trial Optional)

Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement – Clinical Trial Optional) is sponsored by National Institutes of Health (multiple institutes including NIAID, NIAMS, NIDA, NIEHS, NIMHD). NIH is offering emergency competitive supplements to existing awards for research related to COVID‑19, including pandemic-related topics, through April 19, 2027.

PA-24-201: Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional) 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. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations NATIONAL INSTITUTES OF HEALTH ( NIH ) National Institute of Allergy and Infectious Diseases ( NIAID ) Participation Added May 7, 2024 ( NOT-AI-24-051 ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute on Minority Health and Health Disparities ( NIMHD ) Funding Opportunity Title Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional) Emergency Notices of Special Interest (NOSIs) issued by the respective ICs will specify the activity codes under which recipients can apply.

Notices of Special Interest associated with this funding opportunity 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. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93. 846, 93. 279, 93.

307, 93. 113, 93. 142, 93.

143, 93. 855 Funding Opportunity Purpose The National Institutes of Health (NIH) hereby notify the applicant community that funds may be available for applications based on a presidentially declared disaster under the Stafford Act, a public health emergency declared by the Secretary, HHS, or other local, regional or national disaster.

Applications in response to Emergency Notices of Special Interest (NOSIs) will be routed directly to the NIH awarding component signed on to the Emergency NOSI. Only applications submitted in response to an Emergency NOSI published by an IC will be allowed to apply to this NOFO. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) See the Emergency Notice of Special Interest (NOSI) for any applicable Application Due Dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) See Emergency Notice of Special Interest (NOSI) for information on start dates associated with specific needs.

Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced.

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

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

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of 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 The National Institutes of Health (NIH) hereby notify the applicant community that funds may be available for applications based on a presidentially declared disaster under the Stafford Act, a public health emergency declared by the Secretary, HHS, or other local, regional or national disaster.

Applications for Emergency Competitive Revisions will be routed directly to the NIH awarding component listed on the NoA of the most recent parent award. Only applications submitted in response to an Emergency Notice of Special Interest (NOSI) published by an IC will be allowed to apply to this NOFO. See Section VIII.

Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II.

Award Information The funding instrument will be the same as the parent award. Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Cooperative Agreement: A financial assistance 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 Revision applications to active NIH awards. The OER Glossary and the How to Apply - Application Guide provide details on these application types. Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project. The parent award must be active when the application is submitted.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this Notice of Funding Opportunity (NOFO). Section III. Eligibility Information All organizations administering an eligible parent award may apply for a supplement under this NOFO.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (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 Recognized) 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 (Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Since competitive revisions 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. Failure to complete registration in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2. 3.

9. 2 Electronically Submitted Applications for additional information. 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 award. Individuals are encouraged to work with their organizations to develop applications for support.

For competitive revisions to parent awards that include multiple PDs/PIs, the competitive revision application may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the recipient organization of the parent award. Do not use this competitive revision application to add, delete, or change the PDs/PIs listed on the parent award.

Visit the Multiple Program Director/Principal Investigator Policy in the How to Apply - Application Guide for more information. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other competitive revision applications currently under consideration by the awarding NIH Institute or Center. Section IV.

Application and Submission Information 1. Requesting an Application Package Applicants must prepare applications using current forms in accordance with the How to Apply - 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 NOFO.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission All applications must be submitted electronically using one of the submission methods listed in Part 1 of this NOFO and must be in response to an Emergency Notice of Special Interest (NOSI) that refers to this NOFO It is critical that applicants follow the instructions for their submission option and the How to Apply - Application Guide , as appropriate.

except where instructed in this NOFO 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.

All page limitations applicable to the parent award as described in the Application Guide and the How to Apply - Application Guide for the activity code of the parent award must be followed, with the following exceptions or additional requirements, except where instructed in a Notice of Special Interest (NOSI) to do otherwise. Instructions for Application Submission Instructions for Electronic Application Submission through Grants.

gov The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed. SF424 (R&R) Other Project Information All instructions in the How to Apply - Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed. All instructions in the How to Apply - Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed. All instructions in the How to Apply - Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

All instructions in the How to Apply - Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed, with the following additional instructions: Other Plan(s): Applicants must address a Data Management and Sharing (DMS) Plan based on the policy applicability and requirements of the parent award and are required to comply with the instructions for DMS Plans accordingly, as provided in the How to Apply - Application Guide and the Emergency Notice of Special Interest (NOSI).

If applicable (i.e., when the parent award is already subject to the DMS Policy and an awarded competing revision changes the parent award’s approved approach to data management and sharing), an updated DMS Plan must be provided to the NIH awarding IC prior to award. Appendix: Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide and applicable Emergency Guide Notice, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed.

Foreign (non-U.S.) Organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply - Application Guide . 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times 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 How to Apply - Application Guide . 5. Intergovernmental Review (E.

O. 12372) This initiative is not subject to intergovernmental review. 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 Section 7. 9. 1 Selected Items of Cost .

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.

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 How to Apply - Application Guide . See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the staff of the NIH awarding component and responsiveness by components of participating organizations , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. Post Submission Materials Section V.

Application Review Information Only the review criteria described below will be considered in the review process. For this particular announcement, note the following: NIH may issue Emergency Award Notices in support of disaster under the Stafford Act, announcing a public health emergency declared by the POTUS and/or the Secretary, HHS, or other local, regional or national disaster.

Additional information related to application review information will be included in the Emergency Notice of Special Interest (NOSI). Based on the circumstances of the declared public health emergency, applications for Emergency Awards may be routed directly to the NIH awarding component listed within an Emergency Award Guide Notice.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). In addition, each of the following criteria will be evaluated as applicable for the proposed application.

For emergency applications, NIH staff will consider the appropriateness of the proposed application in response to the Emergency Notice of Special Interest (NOSI).

Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items and their responsiveness to the immediate need to help address a specific, public health crisis in a timely manner in accordance with the associated Emergency Notice of Special Interest (NOSI) but will not give separate scores for these items.

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, the committee 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, the committee 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, Racial and Ethnic 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.

For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research.

Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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. 2.

Review and Selection Process Applications will be evaluated for scientific and technical merit by an appropriate internal review panel convened by staff of the NIH awarding component, in accordance with the stated review criteria and any additional considerations specified in the associated Emergency Notice of Special Interest (NOSI). 3.

Anticipated Announcement and Award Dates Please see related Emergency Notices of Special Interest (NOSIs) for anticipated announcement and award dates. Section VI. Award Administration Information 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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement . Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. ClinicalTrials.

gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials. gov Protocol Registration and Results System Information Website ( https://register.

clinicaltrials. gov ). NIH expects registration of all trials whether required under the law or not.

For more information, see http://grants. nih. gov/ClinicalTrials_fdaaa/ Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC.

To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants. nih.

gov/grants/policy/hs/data_safety. htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA.

For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities , including of note, but not limited to: Federalwide Standard Terms and Conditions for Research Grants Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment Acknowledgment of Federal Funding 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 NIH 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. Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency.

HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www. hhs.

gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index. html and https://www. lep.

gov . Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.

hhs. gov/ocr/civilrights/understanding/disability/index. html .

HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www. hhs.

gov/civil-rights/for-individuals/sex-discrimination/index. html ; https://www2. ed.

gov/about/offices/list/ocr/docs/shguide. html; and https://www. eeoc.

gov/eeoc/publications/upload/fs-sex. pdf . For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.

nih. gov/grants/policy/harassment. htm .

Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.

hhs. gov/conscience/conscience-protections/index. html and https://www.

hhs. gov/conscience/religious-freedom/index. html .

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 System for Award Management (SAM. gov) requirements.

SAM. gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM. gov) prior to making an award.

An applicant can review and comment on any information in the responsibility/qualification records available in SAM. gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.

gov, 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 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 Cooperative Agreements terms and conditions will be outlined in the Emergency Notice of Special Interest (NOSI). 3.

Data Management and Sharing Consistent with the 2023 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