[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68625-68626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21995]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4180]


Revocation of Authorization of Emergency Use of Becton, Dickinson 
and Company Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing 
Site); 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 Becton, Dickinson and Co., for the BD Vacutainer Plus Citrate 
Plasma Tubes (UK Manufacturing Site). FDA revoked this Authorization 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested 
by the Authorization holder. The revocation, which includes an 
explanation of the reasons for revocation, is reprinted in this 
document.

DATES: The Authorization for the Becton, Dickinson and Co., BD 
Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) is revoked 
as of July 11, 2023.

ADDRESSES: Submit a written request for a single copy of the revocation 
to the Office of Policy, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, 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: Kim Sapsford-Medintz, Office of 
Product Evaluation and Quality, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (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, radiological, or nuclear agent or 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 July 22, 2021, FDA 
issued the Authorization to Becton, Dickinson and Co., for the BD 
Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), subject 
to the terms of the Authorization. Notice of the issuance of this 
Authorization was published in the Federal Register on October 28, 2021 
(86 FR 59738), 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 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 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. Authorization Revocation Request

    In a request received by FDA on June 12, 2023, Becton, Dickinson 
and Co. requested the withdrawal of, and on July 11, 2023, FDA revoked 
the Authorization for the Becton, Dickinson and Co.'s BD Vacutainer 
Plus Citrate Plasma Tubes (UK Manufacturing Site). Because Becton, 
Dickinson and Co., notified FDA that they have discontinued the sale of 
the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) and 
requested FDA withdraw the EUA for the Becton, Dickinson and Co.'s BD 
Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), 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 of Becton, Dickinson and Co.'s BD Vacutainer Plus 
Citrate Plasma Tubes (UK Manufacturing Site). The revocation in its 
entirety follows and provides an explanation of the reasons

[[Page 68626]]

for revocation, as required by section 564(h)(1) of the FD&C Act.
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[GRAPHIC] [TIFF OMITTED] TN04OC23.020


    Dated: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21995 Filed 10-3-23; 8:45 am]
BILLING CODE 4164-01-C