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 Center for Complementary and Integrative Health (NCCIH)

National Eye Institute (NEI)

National Human Genome Research Institute (NHGRI)

National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Drug Abuse ( NIDA )
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Office of Strategic Coordination ( Common Fund )
National Center for Advancing Translational Sciences (NCATS)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Aging ( NIA )
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Library of Medicine (NLM)
National Institute of Nursing Research (NINR)
Office of Research on Women's Health (ORWH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Dental and Craniofacial Research ( NIDCR )

Funding Opportunity Title

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

Activity Code

Emergency Notices of Special Interest (NOSIs) issued by the respective ICs will specify the activity codes under which recipients can apply.

Announcement Type

New

Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • March 17, 2023 - Notice to Extend the Expiration Date for PA-20-135. See Notice NOT-OD-23-104.
  • 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
  • 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 NOT-OD-21-181.
  • August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169
  • 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
  • November 25, 2020 - Limited Competition for Emergency Competitive Revisions For Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 from Skin and the Oral Cavity for Rapid Acceleration of Diagnostics Radical (RADx-rad). See Notice NOT-OD-21-035.
  • November 17, 2020 - Notice of Special Interest (NOSI): Promoting Health, Safety, and Recovery Training for COVID-19 Essential Workers and their Communities. See Notice NOT-ES-21-002.
  • August 6, 2020 - Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for Chemosensory Testing as a COVID-19 Screening Tool. See Notice NOT-OD-20-152.
  • August 6, 2020 - Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for Wastewater Surveillance Research for Public Health Response to Coronavirus Disease 2019 (COVID-19). See Notice NOT-OD-20-159.
  • July 30, 2020 - Notice of NIDCR's Participation in PA-20-135. See Notice NOT-DE-20-030.
  • July 24, 2020 - Notice of NHLBI Participation in NOT-OD-20-121 . See Notice NOT-HL-20-805.
  • July 24, 2020 - Notice of NHLBI Participation in NOT-OD-20-119 . See Notice NOT-HL-20-803.
  • July 24, 2020 - Notice of Expiration of NOT-HL-20-782. See Notice NOT-HL-20-800.
  • July 6, 2020 - Notice of NIAMS Participation in PA-20-135. See Notice NOT-AR-20-020.
  • July 6, 2020 - Notice of Special Interest (NOSI) regarding the Availability of Emergency Competitive Revisions for Select Research Activities related to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). See Notice NOT-AI-20-059.
  • June 19, 2020 - Notice of NEI's Participation in PA-20-135. See Notice NOT-EY-20-010.
  • June 12, 2020 Notice of Special Interest (NOSI): Emergency Competitive Revisions for Social, Ethical, and Behavioral Implications (SEBI) Research on COVID-19 Testing among Underserved and/or Vulnerable Populations. See Notice NOT-OD-20-119 .
  • June 8, 2020 - Notice of Participation of National Institute of Nursing Research (NINR) in PA-20-135. See Notice NOT-NR-20-005.
  • June 8, 2020 - Notice of NIMH Participation in PA-20-135. See Notice NOT-MH-20-064.
  • June 8, 2020 - Notice of NLM's Participation in PA-20-135. See Notice NOT-LM-20-012.
  • June 5, 2020 - Notice of ORWH Participation in PA-20-135. See Notice NOT-OD-20-111.
  • June 5, 2020 - Notice of NIDA Participation in PA-20-135. See Notice NOT-DA-20-061.
  • June 5, 2020 - Notice of NIDCD's Participation in PA-20-13. See Notice NOT-DC-20-010.
  • June 5, 2020 - Notice of NIA Participation in PA-20-135. See Notice NOT-AG-20-036.
  • May 21, 2020 - Reissue of Parent Announcements (PA-18-589, PA-18-590, PA-18-591, and PA-18-592) and the Urgent (PA-18-935) and Emergency (PA-20-135) Competitive Revision FOAs is Underway - Continue to use the Current Announcements and Forms Packages Until Reissuance. See Notice NOT-OD-20-110.
  • April 27, 2020 - Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions on Coronavirus Disease 2019 (COVID-19) for Currently Active NHLBI Phase I-III Clinical Trials. See Notice NOT-HL-20-782.
  • April 27, 2020 - Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for Research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). See Notice NOT-RM-20-015.
  • April 21, 2020 - Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions and Administrative Supplements to Clinical and Translational Science Award (CTSA) Program Awards to Address 2019 Novel Coronavirus Disease (COVID-19) Public Health Needs. See Notice NOT-TR-20-028.
  • April 14, 2020 - Notice of Common Fund’s Participation in PA-20-135. See Notice NOT-RM-20-016.
  • April 13, 2020 - Notice of Participation of NIAAA in PA-20-135. See Notice NOT-AA-20-007.
  • April 10, 2020 - Notice of Early Expiration of NOT-ES-20-015. See Notice NOT-ES-20-019.
  • April 10, 2020 - Notice of Early Expiration of "Notice of Special Interest (NOSI) regarding the NIEHS Worker Training Program Coronavirus and Infectious Disease Response Training (Admin Supp Clinical Trial Not Allowed)". See Notice NOT-ES-20-016.
  • April 10, 2020 - NIEHS Worker Training Program Coronavirus and Infectious Disease Response Training (Admin Supp Clinical Trial Not Allowed). See Notice NOT-ES-20-017.
  • April 10, 2020 - Notice of Special Interest (NOSI): Availability of Emergency Competitive Revision and Administrative Supplements on Biomedical Technologies for Coronavirus Disease 2019 (COVID-19). See Notice NOT-EB-20-008.
  • April 9, 2020 - Notice of Special Interest (NOSI) regarding the Availability of Emergency Competitive Revisions to Existing NIH Grants and Cooperative Agreements for Tissue Chips Research on the 2019 Novel Coronavirus. See Notice NOT-TR-20-017.
  • April 9, 2020 - Notice of Special Interest (NOSI): NIEHS Support for Understanding the Impact of Environmental Exposures on Coronavirus Disease 2019 (COVID-19). See Notice NOT-ES-20-015.
  • April 8, 2020 - Notice of NCATS' Participation in PA-20-135. See Notice NOT-TR-20-013.
  • March 26, 2020 - Notice of Special Interest: NIEHS Worker Training Program Coronavirus and Infectious Disease Response Training (Admin Supp Clinical Trial Not Allowed). See Notice NOT-ES-20-014.
  • March 25, 2020 - Notice of Early Expiration of "Notice of Special Interest (NOSI) regarding the Availability of Urgent Competitive Revisions for Research on the 2019 Novel Coronavirus (2019-nCoV)," NOT-AI-20-030. See Notice NOT-AI-20-040.
  • March 25, 2020 - Notice of Special Interest (NOSI) regarding the Availability of Emergency Competitive Revisions for Research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). See Notice NOT-AI-20-034.
  • March 18, 2020 - Notice of NIBIB's Participation in PA-20-135. See Notice NOT-EB-20-003.
Funding Opportunity Announcement (FOA) Number

PA-20-135

Companion Funding Opportunity

None

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

93.121, 93.213, 93.393, 93.394, 93.395, 93.396, 93.399, 93.172, 93.855, 93.865, 93.847, 93.113, 93.142, 93.143, 93.859, 93.307, 93.286, 93.350, 93.273, 93.310 , 93.866, 93.173, 93.879, 93.242, 93.361, 93.867, 93.846

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 FOA.

Key Dates

Posted Date
March 10, 2020
Open Date (Earliest Submission Date)

Open dates may vary by awarding IC. See Emergency Notice of Special Interest (NOSI) for applicable Application Due Dates.

Letter of Intent Due Date(s)

Not Applicable

Application 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)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

See Emergency Notice of Special Interest (NOSI) for information on start dates associated with specific needs.

Expiration Date

New Date June 10, 2023 per issuance of NOT-OD-23-104. (Original Expiration Date: March 10, 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 FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

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 FOA.

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

Section II. Award Information
Funding Instrument

The funding instrument will be the same as the parent award.

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

Revision applications to active NIH awards. The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The project and budget periods must be within the currently approved project period for the existing parent award. 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 FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Since competitive 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) 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. In the case of Emergency awards, if the applicant is unable to comply with the requirement to complete and maintain SAM registration at the time of application submission, contact the agency immediately.
  • o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the 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 competitive revision application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other application currently under consideration by the awarding NIH Institute or Center.

Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must prepare applications using current forms in accordance with the Application Guide.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

All applications must be submitted electronically using one of the submission methods listed in Part 1 of this FOA and must be in response to an Emergency Notice of Special Interest (NOSI) that refers to this FOA.

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 for review.

Page Limitations

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

Application Submission

Instructions for Electronic Application Submission through Grants.gov

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

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide and applicable Emergency Notice of Special Interest (NOSI) must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide and applicable Urgent 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 SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

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

7. Other Submission Requirements and Information

Applications must be submitted using the instructions specified above.

Applicants must complete all required registrations prior to submission. Section III. Eligibility Information contains information about registration.

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. Additional information may be found in the SF424 (R&R) 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

Not Applicable

Section V. Application Review Information
1. Criteria

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.

Overall Impact

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.

Emergency Applications

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.

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

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 review criteria 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
1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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, 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 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 FOA.

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 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. Reporting

Any special reporting requirements specific to the public health emergency 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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 emergency application notice please contact the Program Officer listed in the Emergency Notice of Special Interest (NOSI).

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

For any financial or grants management questions on this emergency application notice please contact the Grants Management Specialist or Grants Management Officer listed in the Emergency Notice of Special Interest (NOSI).

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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