89 FR 199 pgs. 83021-83023 - Revocation of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability
Type: NOTICEVolume: 89Number: 199Pages: 83021 - 83023
Pages: 83021, 83022, 83023Docket number: [Docket No. FDA-2021-N-0335]
FR document: [FR Doc. 2024-23637 Filed 10-11-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0335]
Revocation of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Janssen Biotech, Inc. (Janssen), for the Janssen COVID-19 Vaccine. FDA revoked the Authorization on June 1, 2023, 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 June 1, 2023.
ADDRESSES:
Submit written requests for a single copy of the revocation to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorization.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 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 February 27, 2021, FDA issued an Authorization (EUA 27205) to Janssen for the Janssen COVID-19 Vaccine, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on May 27, 2021 (86 FR 28608), 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 May 22, 2023, Janssen requested withdrawal of, and on June 1, 2023, FDA revoked, the Authorization for the Janssen COVID-19 Vaccine. Janssen notified FDA that the last lots of the Janssen COVID-19 Vaccine purchased by the U.S. Government have expired, that there is no demand for new lots of the Janssen COVID-19 Vaccine in the United States, and that it does not intend to update the strain composition of this vaccine to address emerging variants. Based on FDA's understanding that Janssen does not intend to offer the Janssen COVID-19 Vaccine in the United States under the EUA anymore and Janssen's request that FDA revoke the EUA for the Janssen COVID-19 Vaccine, FDA has determined that it is appropriate to revoke this Authorization 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 the Janssen COVID-19 Vaccine. Although FDA revoked the Authorization for the Janssen COVID-19 Vaccine on June 1, 2023, as was publicly announced on the Agency's website, publication of notice of this revocation in the Federal Register was inadvertently delayed. The revocation in its entirety follows and provides 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 Authorizations 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
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[Federal Register graphic "EN15OC24.037" is not available. Please view the graphic in the PDF version of this document.]
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Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-23637 Filed 10-11-24; 8:45 am]
BILLING CODE 4164-01-C