[Federal Register Volume 88, Number 109 (Wednesday, June 7, 2023)]
[Notices]
[Pages 37255-37257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12100]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2057]


Revocation of Emergency Use of a Drug 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) is announcing the 
revocation of the Emergency Use Authorization (EUA) issued to B. Braun 
Melsungen AG (B. Braun Melsungen) for Propofol-Lipuro 1% injectable 
emulsion (Propofol-Lipuro 1% emulsion). The EUA was issued on March 12, 
2021. B. Braun Melsungen informed FDA that the inventory of the 
Propofol-Lipuro 1% emulsion within the United States has been depleted 
and that B. Braun Melsungen does not intend to offer this product in 
the United States anymore. Because B. Braun Melsungen has notified FDA 
that it does not intend to offer the Propofol-Lipuro 1% emulsion in the 
United States anymore and requested FDA revoke the EUA for the 
Propofol-Lipuro 1% emulsion, FDA has determined that it is appropriate 
to protect the public health or safety to revoke this authorization. 
The revocation, which includes an explanation of the reasons for the 
revocation, is reprinted in this document.

DATES: The Authorization is revoked as of April 12, 2023.

ADDRESSES: Submit written requests for a single copy of the EUA 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: Johanna McLatchy, 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, 301-796-3200 (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. With this EUA authority, FDA can help ensure that medical 
countermeasures may be used in emergencies to diagnose, treat, or 
prevent serious or life-threatening diseases or conditions caused by 
biological, chemical, nuclear, or radiological agents when there are no 
adequate, approved, and available alternatives. On March 12, 2021, FDA

[[Page 37256]]

issued an Authorization (EUA 096) to B. Braun Melsungen for Propofol-
Lipuro 1% emulsion, subject to the terms of the Authorization. Notice 
of the issuance of the Authorization was published in the Federal 
Register on June 23, 2021 (86 FR 32938), as required by section 
564(h)(1) of the FD&C Act.

II. The Revocation

    Because B. Braun Melsungen has notified FDA that it does not intend 
to offer the Propofol-Lipuro 1% emulsion in the United States anymore 
and requested FDA revoke the EUA for the Propofol-Lipuro 1% emulsion, 
FDA has determined that it is appropriate to protect the public health 
or safety to revoke this authorization. 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.

III. 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/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products.
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    Dated: June 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12100 Filed 6-6-23; 8:45 am]
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