Determination That ORTHO-CEPT (Desogestrel-Ethinyl Estradiol) 21- and 28-Day Oral Tablets, 0.15 Milligram/0.03 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 47118-47119 [2021-17990]
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47118
Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices
2013–D–1464 for ‘‘Bioequivalence
Studies With Pharmacokinetic
Endpoints for Drugs Submitted Under
an ANDA.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
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and Drug Administration, 10001 New
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0002. Send one self-addressed adhesive
VerDate Sep<11>2014
18:11 Aug 20, 2021
Jkt 253001
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
David Coppersmith, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673,
Silver Spring, MD 20993–0002, 301–
796–9193.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Bioequivalence Studies With
Pharmacokinetic Endpoints for Drugs
Submitted Under an ANDA.’’ The
revised draft guidance supersedes the
draft guidance ‘‘Bioequivalence Studies
With Pharmacokinetic Endpoints for
Drugs Submitted Under an ANDA,’’
which was announced in the Federal
Register on December 5, 2013 (78 FR
73199). FDA received nine comments
on the draft guidance, which were
considered before publication of this
revised draft guidance.
This revised draft guidance provides
recommendations to applicants
planning to include BE information in
ANDAs and ANDA supplements. In
addition, this guidance describes how to
meet the BE requirements set forth in
the FD&C Act and FDA regulations. This
guidance is generally applicable to
dosage forms intended for oral
administration and to non-orally
administered drug products in which
reliance on systemic exposure measures
is suitable for documenting BE (e.g.,
transdermal delivery systems and
certain rectal and nasal drug products).
This guidance will also be useful to
applicants planning BE studies intended
to be conducted during the postapproval period for changes to a drug
product approved in an ANDA. FDA
recommends that applicants consult this
revised draft guidance, in conjunction
with any relevant product-specific
guidances for industry, when
considering the appropriate BE study
and/or other studies for a proposed drug
product.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on
‘‘Bioequivalence Studies With
Pharmacokinetic Endpoints for Drugs
Submitted Under an ANDA.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
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it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: August 18, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–18073 Filed 8–20–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0292]
Determination That ORTHO-CEPT
(Desogestrel-Ethinyl Estradiol) 21- and
28-Day Oral Tablets, 0.15 Milligram/
0.03 Milligram, Were Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that ORTHO-CEPT
(desogestrel-ethinyl estradiol) 21- and
28-day oral tablets, 0.15 milligram (mg)/
0.03 mg, were not withdrawn from sale
for reasons of safety or effectiveness.
This 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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
E:\FR\FM\23AUN1.SGM
23AUN1
Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices
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 must be made prior to
approving 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.
ORTHO-CEPT (desogestrel-ethinyl
estradiol) 21- and 28-day oral tablets,
0.15 mg/0.03 mg, is the subject of NDA
020301, held by Janssen
Pharmaceuticals, Inc., and initially
approved on December 14, 1992.
ORTHO-CEPT is indicated for the
prevention of pregnancy in women who
elect to use oral contraceptives as a
method of contraception.
In a letter dated October 7, 2014,
Janssen Pharmaceuticals, Inc., notified
FDA that ORTHO-CEPT (desogestrelethinyl estradiol) 21- and 28-day oral
tablets, 0.15 mg/0.03 mg, were being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Arnall Golden Gregory LLP submitted
a citizen petition dated March 11, 2021
(Docket No. FDA–2021–P–0292), under
jbell on DSKJLSW7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:11 Aug 20, 2021
Jkt 253001
21 CFR 10.30, requesting that the
Agency determine whether ORTHOCEPT (desogestrel-ethinyl estradiol) oral
tablets, were 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 ORTHO-CEPT
(desogestrel-ethinyl estradiol) 21- and
28-day oral tablets, 0.15 mg/0.03 mg,
were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that ORTHOCEPT (desogestrel-ethinyl estradiol) 21and 28-day oral tablets, 0.15 mg/0.03
mg, were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of ORTHOCEPT (desogestrel-ethinyl estradiol) 21and 28-day oral tablets, 0.15 mg/0.03
mg, 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 ORTHO-CEPT
(desogestrel-ethinyl estradiol) 21- and
28-day oral tablets, 0.15 mg/0.03 mg, 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: August 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–17990 Filed 8–20–21; 8:45 am]
BILLING CODE 4164–01–P
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47119
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0906–XXXX]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: COVID–19
Provider Relief Programs Application
and Attestation Portal, and Claims
Reimbursement Submission Activities
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than October 22, 2021.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
COVID–19 Provider Relief Programs
Application and Attestation Portal, and
Claims Reimbursement Submission
Activities, OMB No. 0906–XXXX.
Abstract: HRSA administers the
Provider Relief Programs (which
includes the Provider Relief Fund (PRF),
the American Rescue Plan Act Rural
(ARPA–R) payments, the COVID–19
Coverage Assistance Fund (CAF), and
the COVID–19 Claims Reimbursement
to Health Care Providers and Facilities
for Testing, Treatment, and Vaccine
Administration for the Uninsured
(Uninsured Program or UIP). The
SUMMARY:
E:\FR\FM\23AUN1.SGM
23AUN1
]]>Agencies
[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Notices]
[Pages 47118-47119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17990]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0292]
Determination That ORTHO-CEPT (Desogestrel-Ethinyl Estradiol) 21-
and 28-Day Oral Tablets, 0.15 Milligram/0.03 Milligram, Were 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, Agency, or we) has
determined that ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and 28-
day oral tablets, 0.15 milligram (mg)/0.03 mg, were not withdrawn from
sale for reasons of safety or effectiveness. This 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: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
[email protected].
[[Page 47119]]
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 must be made prior to approving 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.
ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and 28-day oral
tablets, 0.15 mg/0.03 mg, is the subject of NDA 020301, held by Janssen
Pharmaceuticals, Inc., and initially approved on December 14, 1992.
ORTHO-CEPT is indicated for the prevention of pregnancy in women who
elect to use oral contraceptives as a method of contraception.
In a letter dated October 7, 2014, Janssen Pharmaceuticals, Inc.,
notified FDA that ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and
28-day oral tablets, 0.15 mg/0.03 mg, were being discontinued, and FDA
moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book.
Arnall Golden Gregory LLP submitted a citizen petition dated March
11, 2021 (Docket No. FDA-2021-P-0292), under 21 CFR 10.30, requesting
that the Agency determine whether ORTHO-CEPT (desogestrel-ethinyl
estradiol) oral tablets, were 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 ORTHO-CEPT (desogestrel-ethinyl estradiol) 21-
and 28-day oral tablets, 0.15 mg/0.03 mg, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that ORTHO-CEPT (desogestrel-
ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, were
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of ORTHO-CEPT
(desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/
0.03 mg, 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 ORTHO-CEPT
(desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/
0.03 mg, 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: August 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-17990 Filed 8-20-21; 8:45 am]
BILLING CODE 4164-01-P
