[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Notices]
[Pages 41323-41325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1729]


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) (the Authorization) 
issued to Fresenius Kabi USA, LLC (Fresenius Kabi), for Fresenius 
Propoven 2% Emulsion. FDA revoked the Authorization on May 10, 2022, 
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 May 10, 2022.

ADDRESSES: Submit written requests for single copies of the revocation 
to the Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, 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 Authorizations may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) 
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 May 8, 2020, FDA issued an 
Authorization (EUA 050) to Fresenius Kabi for Fresenius Propoven 2% 
Emulsion, 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. 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 April 8, 2022, Fresenius Kabi 
requested revocation of, and on May 10, 2022, FDA revoked, the 
Authorization for the Fresenius Propoven 2% Emulsion. Because Fresenius 
Kabi notified FDA that it does not intend to offer the Fresenius 
Propoven 2% Emulsion in the United States anymore and requested FDA 
revoke the EUA for the Fresenius Propoven 2% Emulsion, FDA has 
determined that it is appropriate to protect the public health or 
safety to revoke this Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the 
revocation is available on the internet at https://www.regulations.gov/.

IV. 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 Fresenius Kabi's Fresenius Propoven 2% 
Emulsion. 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.

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    Dated: July 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14800 Filed 7-11-22; 8:45 am]
BILLING CODE 4164-01-P


