Determination That AVACLYR (Acyclovir Ophthalmic Ointment), 3 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 27436-27437 [2021-10593]
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Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Notices
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Dated: May 17, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–10680 Filed 5–19–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0226]
Determination That AVACLYR
(Acyclovir Ophthalmic Ointment), 3
Percent, Was Not Withdrawn From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 AVACLYR (acyclovir
SUMMARY:
VerDate Sep<11>2014
17:36 May 19, 2021
Jkt 253001
ophthalmic ointment), 3 percent, was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for acyclovir
ophthalmic ointment, 3 percent, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6222, Silver Spring,
MD 20993–0002, 301–796–4455,
Nisha.Shah@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which 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.
AVACLYR (acyclovir ophthalmic
ointment), 3 percent, is the subject of
NDA 202408, held by Fera
Pharmaceuticals, LLC, and initially
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
approved on March 29, 2019. AVACLYR
is indicated for the treatment of acute
herpetic keratitis (dendritic ulcers) in
patients with herpes simplex (HSV–1
and HSV–2) virus.
In a letter dated August 21, 2019, Fera
Pharmaceuticals, LLC notified FDA that
AVACLYR (acyclovir ophthalmic
ointment), 3 percent, was being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Cumulus Pharmaceutical LLC
submitted a citizen petition dated
February 23, 2021, (Docket No. FDA–
2021–P–0226), under 21 CFR 10.30,
requesting that the Agency determine
whether AVACLYR (acyclovir
ophthalmic ointment), 3 percent, 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 AVACLYR (acyclovir
ophthalmic ointment), 3 percent, was
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that AVACLYR (acyclovir
ophthalmic ointment), 3 percent, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
AVACLYR (acyclovir ophthalmic
ointment), 3 percent, from sale. We have
also independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list AVACLYR (acyclovir
ophthalmic ointment), 3 percent, 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. Any ANDAs
referencing AVACLYR (acyclovir
ophthalmic ointment), 3 percent, may
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.
E:\FR\FM\20MYN1.SGM
20MYN1
Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Notices
Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10593 Filed 5–19–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0166]
International Council for
Harmonisation Q12: Implementation
Considerations for Food and Drug
Administration-Regulated Products;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘ICH
Q12: Implementation Considerations for
FDA-Regulated Products.’’ The
International Council for Harmonisation
(ICH) guidance for industry entitled
‘‘Q12 Technical and Regulatory
Considerations for Pharmaceutical
Product Lifecycle Management’’ and its
Annexes (ICH Q12, May 2021) provide
a framework to facilitate the
management of postapproval chemistry,
manufacturing, and controls (CMC)
changes in a more predictable and
efficient manner. ICH Q12 includes
regulatory tools and enablers with
associated guiding principles that
should enhance industry’s ability to
manage postapproval changes and
increase transparency between industry
and regulatory authorities, supporting
innovation and continual improvement.
This guidance complements ICH Q12 by
clarifying how its tools and enablers can
be implemented within the U.S.
regulatory system. This draft guidance is
not final nor is it in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by July 19, 2021 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
VerDate Sep<11>2014
17:36 May 19, 2021
Jkt 253001
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
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–
2021–D–0166 for ‘‘ICH Q12:
Implementation Considerations for
FDA-Regulated Products.’’ Received
comments 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
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Frm 00074
Fmt 4703
Sfmt 4703
27437
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
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
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
Division of Drug Information, Center for
Drug Evaluation and Research (CDER),
Food and Drug Administration, 10001
New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD
20993–0002; Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002; or Office of Policy, Center for
Devices and Radiological Health
(CDRH), 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 requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Ashley Boam, CDER, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 4192, Silver Spring,
MD 20993–0002, 301–796–6341;
Stephen Ripley, CBER, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911; or
Andrew Yeatts, CDRH, Food and Drug
Administration, 10903 New Hampshire
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27436-27437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0226]
Determination That AVACLYR (Acyclovir Ophthalmic Ointment), 3
Percent, 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 AVACLYR (acyclovir ophthalmic ointment), 3 percent, was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for acyclovir ophthalmic ointment, 3 percent, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455,
[email protected].
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
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.
AVACLYR (acyclovir ophthalmic ointment), 3 percent, is the subject
of NDA 202408, held by Fera Pharmaceuticals, LLC, and initially
approved on March 29, 2019. AVACLYR is indicated for the treatment of
acute herpetic keratitis (dendritic ulcers) in patients with herpes
simplex (HSV-1 and HSV-2) virus.
In a letter dated August 21, 2019, Fera Pharmaceuticals, LLC
notified FDA that AVACLYR (acyclovir ophthalmic ointment), 3 percent,
was being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Cumulus Pharmaceutical LLC submitted a citizen petition dated
February 23, 2021, (Docket No. FDA-2021-P-0226), under 21 CFR 10.30,
requesting that the Agency determine whether AVACLYR (acyclovir
ophthalmic ointment), 3 percent, 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 AVACLYR (acyclovir ophthalmic ointment), 3
percent, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
AVACLYR (acyclovir ophthalmic ointment), 3 percent, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of AVACLYR (acyclovir
ophthalmic ointment), 3 percent, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that this drug product was not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list AVACLYR (acyclovir
ophthalmic ointment), 3 percent, 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. Any ANDAs referencing AVACLYR (acyclovir ophthalmic
ointment), 3 percent, may 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.
[[Page 27437]]
Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10593 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P
