Revocation of Authorization of Emergency Use of Becton, Dickinson and Company Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site); Availability, 68625-68626 [2023-21995]
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Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices
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Dated: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–21989 Filed 10–3–23; 8:45 am]
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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.
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 selfaddressed 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).
SUMMARY:
68625
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/.
SUPPLEMENTARY INFORMATION:
IV. The Revocation
I. Background
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
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 AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
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04OCN1
68626
Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices
for revocation, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164–01–P
U.S. FOOD & DRUG
Al:IMINIST!a.MIO.M
July 11, 2023
Matthew Trachtenberg, MSE
Director Regulatory Mairs
Becton, Dickinson and Co,
l Becton Drive
Franklin Lakes, NJ 07417
Re: Revocation ofEUAZ10465
Dear Matthew Trachtenberg:
this letter is in response to the request from .Becton, l)ickihson and Co. ("BD"), in an email
received June 12, 2023, that the U.S ..Food and Drug Adminisu·ation (FDA) withdraw the EUA
for the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) issued on July 22,
2021. BD indicated that they have discontinued the sale ofthe authorized product and requested
that the litJA be withdrawn. FDA understands that, M of the date of this letter, there are no
viable BI> Vac,rtainer Plus Citrate Plasma Tubes (UK Manuracturing Site) ren1.aining in
distribution in the United States.
•
The authorization of a device for emergency iise under section 564 of'th:e Federal Food, Drug,
and Cosmetic Act (the Act) (21 tJ.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,
be revoked when circttmstances make such revocation appropriate to protect the public health or
safety (section 564(g)(2)(C) of the Act). Because BD has requested that FDA withdraw the EUA
for the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), FDA has determined
that it is appropriate, to protect the publki health or safety, to revoke this. authorization,
Acc<)tdingly, FDA hereby revokes EUA210465 for the BDVacutainer Plus Citrate Pla.<;ma
tubes (UK Manufacturing Site), pursuant to section 564(g)(2)(C) ofthe Act. As ofthe date of
this letter, the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) are 110 longer
authorized for emergency use by FDA.
Notice of this revocation will be published in the Federal Register, pursua11t to section 564(h)(l)
ofth.e Act.
•
Sincerely,
Jeffrey E. Shuren, M.D., J.D.
Director
Dated: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–21995 Filed 10–3–23; 8:45 am]
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lotter on DSK11XQN23PROD with NOTICES1
Center for Devices and Radiological Health
Food and Drug Admillistration
]]>Agencies
[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]
-----------------------------------------------------------------------
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 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.
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
