Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-0874]</DEPDOC> <SUBJECT>Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> These Authorizations are revoked as of January 16, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> 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 <E T="02">SUPPLEMENTARY INFORMATION</E> section for electronic access to the Authorization. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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). </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> 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 <E T="04">Federal Register</E> 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 <E T="04">Federal Register</E> 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). <HD SOURCE="HD1">II. EUA Revocation Request</HD> 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 revoke the EUA for REGIOCIT. FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. <HD SOURCE="HD1">III. The Revocation</HD> 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. <HD SOURCE="HD1">IV. Electronic Access</HD> An electronic version of this document and the full text of the Authorization is available on the internet at:  <E T="03">https://www.regulations.gov/.</E> <GPH SPAN="3" DEEP="511"> <GID>EN21MY25.005</GID> </GPH> <GPH SPAN="3" DEEP="407"> <GID>EN21MY25.006</GID> </GPH> <SIG> <DATED>Dated: May 7, 2025.</DATED> <NAME>Grace R. Graham,</NAME> Deputy Commissioner for Policy, Legislation, and International Affairs. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-09065 Filed 5-20-25; 8:45 am]</FRDOC> </NOTICE>