2025-19270: Revocation of Emergency Use of a Biological Product; Availability

Federal Register, Volume 90 Issue 189 (Thursday, October 2, 2025) [Federal Register Volume 90, Number 189 (Thursday, October 2, 2025)] [Notices] [Pages 47774-47776] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2025-19270] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2020-N-2305] Revocation of Emergency Use of a Biological Product; Availability

Agency

Food and Drug Administration, HHS.

Action

Notice. -----------------------------------------------------------------------

Summary

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (ASPR/HHS) for COVID-19 convalescent plasma. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.

Dates

The Authorization is revoked as of August 27, 2025.

Addresses

Submit written requests for single copies of the revocation to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993- 0002. Send one self-addressed adhesive label to assist the office in processing your requests. The revocation may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010 or emailing [email protected]. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocation.

For Further Information Contact

Andrew C. Harvan, Center for Biologics Evaluation and Research, Food and Drug Administration, 240-402-7911.

Supplementary Information

I. Background

Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. On August 23, 2020, FDA issued an EUA to ASPR/HHS for COVID-19 convalescent plasma, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on February 19, 2021 (86 FR 10290), as required by section 564(h)(1) of the FD&C Act. Subsequent updates to the Authorization were made available on FDA's website. The authorization of a biological product for emergency use under section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked when the criteria under section 564(c) of the FD&C Act for issuance of such authorization are no longer met (section 564(g)(2)(B) of the FD&C Act), or other circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the FD&C Act).

II. EUA Revocation Request

In a request received by FDA on August 13, 2025, ASPR/HHS requested revocation of the Authorization of COVID-19 convalescent plasma. On August 27, 2025, FDA revoked the Authorization. In determining that there are circumstances that make revocation of this EUA appropriate to protect the public health or safety, FDA also considered that, as of December 10, 2024, there is licensed COVID-19 convalescent plasma for the same use that is described in the EUA, that current use of COVID-19 convalescent plasma under the EUA is limited to a small number of patients, and that the supply of licensed COVID-19 convalescent plasma is expected to meet clinical need. Due to all of these circumstances, FDA has determined that revoking this EUA is appropriate to protect the public health or safety.

III. The Revocation

Having concluded that the criteria for revocation of the Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUA for COVID-19 convalescent plasma. The revocation in its entirety follows and provides explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act.

IV. Electronic Access

An electronic version of this document and the full text of the Authorization and revocation are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. BILLING CODE 4164-01-P [[Page 47775]] [GRAPHIC] [TIFF OMITTED] TN02OC25.001 [[Page 47776]] [GRAPHIC] [TIFF OMITTED] TN02OC25.002 Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-19270 Filed 10-1-25; 8:45 am] BILLING CODE 4164-01-C