Revocation of Authorization of Emergency Use of a Medical Device During COVID-19; Availability, 28849-28851 [2021-11384]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Notices]
[Pages 28849-28851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11384]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0455]


Revocation of Authorization of Emergency Use of a Medical Device 
During COVID-19; 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 Battelle Memorial Institute for the Battelle Critical Care 
Decontamination System. FDA revoked the Authorization on April 30, 
2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as 
requested by Battelle Memorial Institute on April 2, 2021. The 
revocation, which includes an explanation of the reasons for the 
revocation, is reprinted in this document.

DATES: The Authorization for the Battelle Critical Care Decontamination 
System is revoked as of April 30, 2021.

ADDRESSES: Submit written requests for a single copy 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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 240-402-8155 (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. On March 28, 2020, FDA issued the Authorization to Battelle 
Memorial Institute for the Battelle Critical Care Decontamination 
System. Notice of the issuance of the Authorization was published in 
the Federal Register on June 5, 2020 (85 FR 34638), as required by 
section 564(h)(1) of the FD&C Act. The authorization of a device 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

[[Page 28850]]

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 for a Medical Device During COVID-19

    On April 2, 2021, Battelle Memorial Institute requested the 
revocation of, and on April 30, 2021, FDA revoked, the Authorization 
for the Battelle Critical Care Decontamination System. Because Battelle 
Memorial Institute notified FDA that it has ceased operations and 
associated activities and requests withdrawal of the Authorization, 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 
revocations are available on the internet at https://www.regulations.gov/ and https://www.fda.gov/media/148132/download.

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 the Battelle Critical Care Decontamination 
System. 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: May 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11384 Filed 5-27-21; 8:45 am]
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