[Federal Register Volume 90, Number 97 (Wednesday, May 21, 2025)]
[Notices]
[Pages 21782-21784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09065]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0874]
Revocation of Emergency Use of a Drug Product During the COVID-19
Pandemic; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Fresenius Medical Care North America
(Fresenius) for multiFiltrate PRO System and multiBic/multiPlus
solutions (EUA 048), and to Baxter Healthcare Corp. (Baxter) for
REGIOCIT (EUA 068). FDA revoked the Authorizations on January 16, 2025,
under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The
revocations, including an explanation of the reasons for the
revocations, are reprinted in this document.
DATES: These Authorizations are revoked as of January 16, 2025.
ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Executive Programs, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, 6th Floor, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request or
include a Fax number to which the Authorization may be sent. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
Authorization.
FOR FURTHER INFORMATION CONTACT: Commander Andrea Gormley, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 2nd Floor, Silver Spring, MD
20993-0002, 301-796-2210 (this is not a toll free number).
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 April 30, 2020, FDA issued an Authorization to Fresenius, for
multiFiltrate PRO System and multiBic/multiPlus solutions, subject to
the terms of the Authorization. Notice of the issuance of the
Authorization was published in the Federal Register on September 11,
2020 (85 FR 56231), as required by section 564(h)(1) of the FD&C Act.
On August 13, 2020, FDA issued an Authorization to Baxter, for
REGIOCIT, subject to the terms of the Authorization. Notice of the
issuance of the 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.
The authorization of a drug 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 January 14, 2025, Fresenius
requested revocation of, and on January 16, 2025, FDA revoked, the
Authorization for multiFiltrate PRO System and multiBic/multiPlus
solutions. Because Fresenius has informed FDA that it does not intend
to offer the multiFiltrate Pro System and multiBic/multiPlus solutions
under the EUA in the United States anymore, Fresenius requested FDA
revoke the EUA for multiFiltrate PRO System and multiBic/multiPlus
solutions. FDA has determined that it is appropriate to protect the
public health or safety to revoke this Authorization.
In a request received by FDA on January 14, 2025, Baxter requested
revocation of, and on January 16, 2025, FDA revoked, the Authorization
for REGIOCIT. Because Baxter has informed FDA that it does not intend
to offer this product under the EUA in the United States anymore,
Baxter requested FDA
[[Page 21783]]
revoke the EUA for REGIOCIT. FDA has determined that it is appropriate
to protect the public health or safety to revoke this Authorization.
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 multiFiltrate PROSystem and multiBic/multiPlus
solutions and revoked the EUA for REGIOCIT. These revocations in their
entirety follow and provide an 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 is available on the internet at: https://www.regulations.gov/.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN21MY25.005
[[Page 21784]]
[GRAPHIC] [TIFF OMITTED] TN21MY25.006
Dated: May 7, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09065 Filed 5-20-25; 8:45 am]
BILLING CODE 4164-01-C