FDA - Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19

Notice Number: NOT-FD-20-019

Key Dates
Release Date: March 26, 2020

Related Announcements
None

Issued by
FOOD AND DRUG ADMINISTRATION (FDA)

Purpose

The FDA is deeply concerned for the health and safety of people involved in FDA grant funded activities, and about the effects on the public’s health from Coronavirus Disease 2019 (COVID-19). Due to the potential exceptional impact of the declared public health emergency, we want to assure our recipient community that FDA will be doing our part to help you continue your work.

The purpose of this Notice is to alert the community of administrative flexibilities that will apply to FDA applicants and recipients. Therefore, working with the Office of Management and Budget (OMB) and the Department of Health and Human Services (HHS), FDA has identified the following short-term administrative flexibilities to assist our applicants with managing administrative, financial management and audit requirements under the Uniform Guidance “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards” – which are implemented in HHS regulation at 45 CFR Part 75– without compromising their accountability requirements.

These flexibilities are applicable to FDA applicants and recipients where the entity is conducting FDA grant funded activities related to or affected by COVID-19. Affected entities are those that have been closed, or business activities have been hindered due to COVID-19 precautionary measures and/or illnesses. Entities that are affected will be asked to provide documentation to FDA describing the effects, and how long their facility and FDA grant funded activities was and/or will be affected.

The following requirements detail flexibilities that FDA is offering during this Public Health Emergency:


Cost Related Flexibilities/Expenditure of Award Funds

Reminder: Recipients should not assume additional funds will be available should the charging of cancellation or other fees result in a shortage of funds to eventually carry out the event or travel. Recipients must maintain appropriate records and cost documentation as required by 2 CFR § 200.302 -Financial management and 2 CFR § 200.333 -Retention requirement of records to substantiate the charging of any salaries and other project activities costs related to interruption of operations or services.

Salaries:

FDA understands that many recipient organization's staff may be unable to work as a result of or related to the effects of COVID-19. If a recipient organization’s policy (recipients' policy of paying salaries under unexpected or extraordinary circumstances) allows for the charging of salaries and benefits during periods when no work is performed due to the effect of COVID-19, regardless of the funding source, including Federal and non-Federal, then such charges to FDA grant awards will be allowable.

FDA may request documentation to confirm the requirements of institutional policies.

Travel:

Non-refundable costs associated with grant-related travel that has been cancelled due to COVID-19 may be charged to the FDA award if they would have otherwise been allowable.

Conference Registration Fees:

Non-refundable registration fees for conferences, symposiums or seminars that have been cancelled due to COVID19 may be charged to the FDA award if they would have otherwise been allowable (e.g. necessary to accomplish program objectives).

FDA-Supported Meetings and Conferences:

Scientific meetings, conferences and workshops supported by FDA funding may be delayed or cancelled due to COVID-19. Non-refundable costs associated with FDA supported meetings and conferences affected by COVID-19 may be charged to the FDA award if they would have otherwise been allowable.


Extension of Post-Award Financial and Other Reporting

If your institution is unable to complete and submit financial (FFR) and Research Progress Performance Reports (RPPR) by the scheduled due date, due to the effects of COVID-19, please be sure to contact the assigned grants management and/or program official to let them know the reports will be late. FDA will accept these late reports but will delay issuing grant awards until the reports are received and accepted.

Any additional/separate guidance provided by the Grants Management and/or Program Official to the recipient related to a specific award and/or grant program shall supersede the extension of reporting flexibilities outlined in this Notice.


Extension of Closeout
  • FDA will allow recipients that are affected by COVID-19 to delay submission of any final financial, performance, and other reports required by the terms and conditions of award for the closeout of expired projects, provided that proper notice about the reporting delay is given by the recipient to the agency. This delay may not exceed one year


Extension of Single Audit Submission

  • Per 45 CFR 75.501, institutions expending $750,000 or more in Federal funding in a Fiscal Year (FY) are required to submit an annual Single Audit report.
  • FDA will allow recipients directly affected by COVID-19 to delay the completion and submission of the Single Audit report for up to 6 months beyond the normal due date.
  • The delayed completion and submission would still qualify the recipient as a “low-risk auditee” under the criteria of 45 CFR 75.520.
  • Recipients and subrecipients should maintain documentation of the reason for the delayed filing.


As this Public Health Emergency continues, recipients may identify additional cost-related or other flexibilities that are needed. FDA will consider such requests on a case-by-case basis. Contact your assigned Grants Management Specialist and Program Official to provide a detailed justification outlining the effect of COVID-19 and the flexibility required. FDA will consider such requests in line with the Federal cost principles, FDA policy, and need to support the project. This is a rapidly evolving situation, and FDA will continue to provide updated guidance and information as it becomes available.

Inquiries

Please direct all inquiries to:

Questions concerning specific awards should be directed to the assigned Grants Management Specialist and Program Official? listed on the Notice of Award and in eRA Commons.

Questions concerning this Notice may be directed to:

Food and Drug Administration (FDA)
Office of Acquisitions and Grants Services (OAGS)
Grants Management Branch
Email: OAGSGrantsPolicy@fda.hhs.gov