Notice2023-21995
Revocation of Authorization of Emergency Use of Becton, Dickinson and Company Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site); Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 4, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 191 (Wednesday, October 4, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68625-68626]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21995]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
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.
BILLING CODE 4164-01-P
[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
</pre></body>
</html>Indexed from Federal Register on October 4, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.