Timothy Baxter; Final Order Announcing Termination Date of Debarment, 14861 [2024-04166]
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Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2022–E–2087]
[Docket No. FDA–2021–N–0028]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TEMBEXA
Timothy Baxter; Final Order
Announcing Termination Date of
Debarment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) announcing that the debarment of
Timothy Baxter will terminate on
October 26, 2025.
DATES: This order is applicable February
29, 2024.
ADDRESSES: Submit comments
electronically at https://
www.regulations.gov. Written comments
may be submitted to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy,
Compliance, and Enforcement, Office of
Regulatory Affairs, Food and Drug
Administration, at 240–402–8743 or
debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In a
Federal Register notice dated February
27, 2023 (88 FR 12369), FDA issued an
order debarring Dr. Timothy Baxter
pursuant to section 306(b)(2)(B)(i)(I) of
the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) for a period of 5 years
from providing services in any capacity
to a person with an approved or
pending drug product application under
section 505, 512, or 802 of the FD&C Act
(21 U.S.C. 355, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262). Through mutual
agreement of the parties, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(d) of the FD&C Act and under
authority delegated to the Assistant
Commissioner, issues this order
announcing that Dr. Baxter’s period of
debarment will now terminate on
October 26, 2025.
Dated: February 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04166 Filed 2–28–24; 8:45 am]
BILLING CODE 4164–01–P
16:39 Feb 28, 2024
Jkt 262001
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
AGENCY:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for TEMBEXA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by April 29, 2024.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 27, 2024. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
April 29, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
PO 00000
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14861
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–E–2087 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; TEMBEXA.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
E:\FR\FM\29FEN1.SGM
29FEN1
]]>Agencies
[Federal Register Volume 89, Number 41 (Thursday, February 29, 2024)]
[Notices]
[Page 14861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04166]
[[Page 14861]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0028]
Timothy Baxter; Final Order Announcing Termination Date of
Debarment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
announcing that the debarment of Timothy Baxter will terminate on
October 26, 2025.
DATES: This order is applicable February 29, 2024.
ADDRESSES: Submit comments electronically at https://www.regulations.gov. Written comments may be submitted to the Dockets
Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, at 240-402-8743 or
[email protected].
SUPPLEMENTARY INFORMATION: In a Federal Register notice dated February
27, 2023 (88 FR 12369), FDA issued an order debarring Dr. Timothy
Baxter pursuant to section 306(b)(2)(B)(i)(I) of the FD&C Act (21
U.S.C. 335a(b)(2)(B)(i)(I)) for a period of 5 years from providing
services in any capacity to a person with an approved or pending drug
product application under section 505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under section 351 of the Public Health
Service Act (42 U.S.C. 262). Through mutual agreement of the parties,
the Assistant Commissioner, Office of Human and Animal Food Operations,
under section 306(d) of the FD&C Act and under authority delegated to
the Assistant Commissioner, issues this order announcing that Dr.
Baxter's period of debarment will now terminate on October 26, 2025.
Dated: February 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04166 Filed 2-28-24; 8:45 am]
BILLING CODE 4164-01-P
