Determination That ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 78111-78112 [2022-27647]
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Federal Register / Vol. 87, No. 244 / Wednesday, December 21, 2022 / Notices
amend the standard of identity for
canned tuna. The new expiration date of
the permit will be either the effective
date of a final rule amending the
standard of identity for canned tuna that
may result from the petition or 30 days
after denial of the petition.
In the Federal Register of March 5,
2021 (86 FR 12954), we issued a notice
announcing that we were amending the
temporary permit issued to StarKist Co.
to allow the test product to be
manufactured at three additional plants:
Tropical Canning (Thailand) Public Co.,
LTD., 1/1 M.2 T.Thungyai, Hatyai,
Songkhla 90110, Thailand; ISA Value
Co., Ltd., 44/4 Moo1, Petchkasem Road,
Yaicha, Sampran, Nakornpathom 73110,
Thailand; and Tri-Marine (Solomon
Islands), Soltuna Ltd., 1 Tuna Dr., Noro,
Western Province, Solomon Islands, and
to increase the amount of test product
to 213,500,000 pounds (96,841,971
kilograms).
In the Federal Register of December
28, 2021 (86 FR 73789), we issued a
notice announcing that we were
amending the temporary permit issued
to StarKist Co. to increase the amount of
test product to be market tested to
217,900,000 pounds (98,837,777
kilograms) in retail cans of various sizes
and to allow the test product to be
manufactured at one additional plant:
Socie´te´ De Conserverie en Afrique (SCA
S.A.), Nouveau Quai de Peche-Mole 10–
BP 782, Dakar, Senegal.
Under our regulations at 21 CFR
130.17(f), we are amending the
temporary permit issued to StarKist Co.
to allow the test product to be
manufactured at one additional plant:
RD Foods Americas, 48 S Franklin
Turnpike, Suite 204, Ramsey, NJ 07446
USA. All other conditions and terms of
this permit remain the same.
Dated: December 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27710 Filed 12–20–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
lotter on DSK11XQN23PROD with NOTICES1
[Docket No. FDA–2020–D–1140]
Enforcement Policy Regarding Federal
Veterinarian-Client-Patient
Relationship Requirements To
Facilitate Veterinary Telemedicine
During the COVID–19 Outbreak;
Withdrawal of Guidance
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
19:56 Dec 20, 2022
Jkt 259001
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA or Agency) is
announcing the withdrawal of the
guidance document entitled
‘‘Enforcement Policy Regarding Federal
VCPR Requirements to Facilitate
Veterinary Telemedicine During the
COVID–19 Outbreak,’’ which was issued
in March 2020. FDA is withdrawing this
guidance document in recognition that
the conditions that created the need for
the enforcement policy have evolved,
such that the policy is no longer needed.
DATES: The withdrawal date is February
21, 2023.
FOR FURTHER INFORMATION CONTACT:
William Flynn, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5704,
AskCVM@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
As part of FDA’s commitment to
providing timely guidance to support
continuity and response efforts to the
Coronavirus Disease 2019 (COVID–19) 1
pandemic, in March 2020, the Agency
published the guidance document GFI
#269, ‘‘Enforcement Policy Regarding
Federal VCPR Requirements to
Facilitate Veterinary Telemedicine
During the COVID–19 Outbreak,’’
recognizing the vital role veterinarians
play in protecting public health. In
accordance with the process announced
by the Agency in the Federal Register
on March 25, 2020 (85 FR 16949) for
making COVID–19-related guidances
available to the public, the notice of
availability for the guidance published
on May 12, 2020 (85 FR 28010).
When the COVID–19 public health
emergency began in January 2020, FDA
understood that veterinarians might face
challenges affecting their ability to make
on-premises examination of their
patients. Given that the Federal
veterinarian-client-patient relationship
(VCPR) definition (21 CFR 530.3(i))
requires animal examination and/or
medically appropriate and timely visits
to the premises where the animal(s) are
kept, the Federal VCPR definition
cannot be met solely through
telemedicine. To facilitate veterinarians’
ability to utilize telemedicine to address
animal health needs during the COVID–
19 outbreak, FDA published GFI #269,
stating that it intended to temporarily
suspend enforcement of a portion of the
Federal VCPR requirements.
1 The virus has been named ‘‘SARS–CoV–2’’ and
the disease it causes has been named ‘‘Coronavirus
Disease 2019’’ (COVID–19).
PO 00000
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78111
Specifically, FDA generally intended
not to enforce the animal examination
and premises visit VCPR requirements
relevant to FDA regulations governing
Extralabel Drug Use in Animals (21 CFR
part 530) and Veterinary Feed Directive
Drugs (21 CFR 558.6).
FDA stated in the guidance that, given
the temporary nature of this policy, we
planned to reassess it periodically and
provide revision or withdrawal of this
guidance as necessary. The Agency
acknowledges that the public health
emergency declared by the Secretary of
Health and Human Services for the
COVID–19 pandemic continues to exist.
However, the conditions that created the
need for the temporary enforcement
policy outlined in GFI #269 have
evolved, such that the policy is no
longer needed. After careful review of
current industry practices with regard to
on-premises animal examination and
comments submitted to the public
docket associated with the guidance, the
Agency has determined the guidance
document should be withdrawn.
Therefore, in accordance with 21 CFR
10.115(k), FDA is withdrawing the
‘‘Enforcement Policy Regarding Federal
VCPR Requirements to Facilitate
Veterinary Telemedicine During the
COVID–19 Outbreak’’ guidance in its
entirety.
II. Withdrawal Date
The withdrawal date for the guidance
document discussed in this document is
February 21, 2023.
Dated: December 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27673 Filed 12–20–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–P–0614]
Determination That ZYBAN (Bupropion
Hydrochloride) Tablets, Extended
Release, 150 Milligrams, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that ZYBAN (Bupropion
Hydrochloride) Tablets, Extended
Release, 150 Milligrams, was not
withdrawn from sale for reasons of
safety or effectiveness. This
SUMMARY:
E:\FR\FM\21DEN1.SGM
21DEN1
lotter on DSK11XQN23PROD with NOTICES1
78112
Federal Register / Vol. 87, No. 244 / Wednesday, December 21, 2022 / Notices
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Michelle Weiner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208,
Silver Spring, MD 20993–0002, 240–
402–0374, Michelle.Weiner@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but it must be made prior to
FDA’s approval of an ANDA that refers
to the listed drug (§ 314.161 (21 CFR
314.161)). FDA may not approve an
ANDA that does not refer to a listed
drug.
ZYBAN (Bupropion Hydrochloride)
Tablets, Extended Release, 150
Milligrams, is the subject of NDA
020711, held by GlaxoSmithKline LLC,
VerDate Sep<11>2014
19:56 Dec 20, 2022
Jkt 259001
and initially approved on May 14, 1997.
ZYBAN is indicated as an aid to
smoking cessation treatment.
ZYBAN (Bupropion Hydrochloride)
Tablets, Extended Release, 150
Milligrams, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Yichang Humanwell Pharmaceutical
Co., Ltd. submitted a citizen petition
dated April 18, 2022 (Docket No. FDA–
2022–P–0614), under 21 CFR 10.30,
requesting that the Agency determine
whether ZYBAN (Bupropion
Hydrochloride) Tablets, Extended
Release, 150 Milligrams, was withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ZYBAN (Bupropion
Hydrochloride) Tablets, Extended
Release, 150 Milligrams, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that this drug product was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of ZYBAN
(Bupropion Hydrochloride) Tablets,
Extended Release, 150 Milligrams, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list ZYBAN (Bupropion
Hydrochloride) Tablets, Extended
Release, 150 Milligrams, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
Dated: December 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27647 Filed 12–20–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Healthy Start
Evaluation and Capacity Building
Support, OMB No. 0906–xxxx—New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this Notice has
closed.
SUMMARY:
Comments on this ICR must be
received no later than January 20, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the acting HRSA
Information Collection Clearance Officer
at paperwork@hrsa.gov or call 301–594–
4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Healthy Start Evaluation and Capacity
Building Support, OMB No. 0906–
xxxx—New.
Abstract: The National Healthy Start
Program, authorized by 42 U.S.C. 254c–
8 (section 330H of the Public Health
Service Act) and funded through HRSA,
has the goal of reducing disparities in
DATES:
E:\FR\FM\21DEN1.SGM
21DEN1
]]>Agencies
[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Pages 78111-78112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27647]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-0614]
Determination That ZYBAN (Bupropion Hydrochloride) Tablets,
Extended Release, 150 Milligrams, Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that ZYBAN (Bupropion Hydrochloride) Tablets, Extended
Release, 150 Milligrams, was not withdrawn from sale for reasons of
safety or effectiveness. This
[[Page 78112]]
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Michelle Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-
402-0374, [email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but it must be made prior to FDA's approval of an ANDA that refers to
the listed drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve
an ANDA that does not refer to a listed drug.
ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150
Milligrams, is the subject of NDA 020711, held by GlaxoSmithKline LLC,
and initially approved on May 14, 1997. ZYBAN is indicated as an aid to
smoking cessation treatment.
ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150
Milligrams, is currently listed in the ``Discontinued Drug Product
List'' section of the Orange Book.
Yichang Humanwell Pharmaceutical Co., Ltd. submitted a citizen
petition dated April 18, 2022 (Docket No. FDA-2022-P-0614), under 21
CFR 10.30, requesting that the Agency determine whether ZYBAN
(Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams,
was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that ZYBAN (Bupropion Hydrochloride) Tablets,
Extended Release, 150 Milligrams, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that this drug product was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of ZYBAN (Bupropion Hydrochloride)
Tablets, Extended Release, 150 Milligrams, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that this drug product was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list ZYBAN (Bupropion
Hydrochloride) Tablets, Extended Release, 150 Milligrams, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. FDA will not begin procedures to withdraw
approval of approved ANDAs that refer to this drug product. Additional
ANDAs for this drug product may also be approved by the Agency as long
as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: December 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27647 Filed 12-20-22; 8:45 am]
BILLING CODE 4164-01-P
