[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Pages 83021-83023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23637]
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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.
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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.
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Dated: September 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-23637 Filed 10-11-24; 8:45 am]
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