Determination That SPECTAZOLE (Econazole Nitrate) Topical Cream, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 46070-46071 [2017-21174]
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Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership: Caryn Cohen, Office of
Science, Center for Tobacco Products,
Food and Drug Administration, Center
for Tobacco Products, Document
Control Center, Building 71, Rm. G335,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 1–877–287–
1373 (choose Option 5), TPSAC@
fda.hhs.gov.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
Web site by using the following link:
https://www.fda.gov/
AdvisoryCommittees/default.htm.
FDA is
requesting nomination for voting
members on the Tobacco Products
Scientific Advisory Committee.
SUPPLEMENTARY INFORMATION:
I. General Description of the Committee
Duties
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner of Food and
Drugs (the Commissioner) or designee in
discharging responsibilities related to
the regulation of tobacco products. The
Committee reviews and evaluates safety,
dependence, and health issues relating
to tobacco products and provides
appropriate advice, information, and
recommendations to the Commissioner.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
II. Criteria for Voting Members
The Committee consists of 12
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
individuals knowledgeable in the fields
of medicine, medical ethics, science, or
technology involving the manufacture,
evaluation, or use of tobacco products.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The Committee includes
nine technically qualified voting
members, selected by the Commissioner
or designee. The nine voting members
include seven members who are
physicians, dentists, scientists, or health
care professionals practicing in the area
of oncology, pulmonology, cardiology,
toxicology, pharmacology, addiction, or
any other relevant specialty. The nine
voting members also include one
member who is an officer or employee
of a State or local government or of the
Federal Government, and one member
who is a representative of the general
public. Almost all non-Federal members
of this committee serve as Special
Government Employees. Members will
be invited to serve for terms of up to 4
years.
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16:49 Oct 02, 2017
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III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
´
´
complete resume or curriculum vitae for
each nominee and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21173 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–2530]
Determination That SPECTAZOLE
(Econazole Nitrate) Topical Cream, 1%,
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 SPECTAZOLE
(econazole nitrate) topical cream, 1%,
was 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:
Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
SUMMARY:
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Ave., Bldg. 51, Rm. 6222, Silver Spring,
MD 20993–0002, 301–796–4455.
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, a drug is
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.
SPECTAZOLE (econazole nitrate)
topical cream, 1%, is the subject of NDA
018751, held by Alvogen Malta
Operations Ltd., and initially approved
on December 23, 1982. SPECTAZOLE is
indicated for topical application in the
treatment of tinea pedis, tinea cruris,
and tinea corporis caused by
Trichophyton rubrum, Trichophyton
mentagrophytes, Trichophyton
tonsurans, Microsporum canis,
Microsporum audouini, Microsporum
gypseum, and Epidermophyton
floccosum; in the treatment of
cutaneous candidiasis; and in the
treatment of tinea versicolor.
SPECTAZOLE (econazole nitrate)
topical cream, 1%, is currently listed in
E:\FR\FM\03OCN1.SGM
03OCN1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lachman Consultant Services, Inc.
submitted a citizen petition dated April
21, 2017 (Docket No. FDA–2017–P–
2530), under 21 CFR 10.30, requesting
that the Agency determine whether
SPECTAZOLE (econazole nitrate)
topical cream, 1%, 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 SPECTAZOLE (econazole
nitrate) topical cream, 1%, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that SPECTAZOLE
(econazole nitrate) topical cream, 1%,
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
SPECTAZOLE (econazole nitrate)
topical cream, 1%, 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 SPECTAZOLE
(econazole nitrate) topical cream, 1%, 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: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21174 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
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16:49 Oct 02, 2017
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5739]
Formal Meetings Between the Food
and Drug Administration and
Abbreviated New Drug Application
Applicants of Complex Products Under
Generic Drug User Fee Act; 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 ‘‘Formal
Meetings Between FDA and ANDA
Applicants of Complex Products Under
GDUFA.’’ This draft guidance describes
an enhanced pathway for discussions
between FDA and a prospective
applicant preparing to submit (or an
applicant that has submitted) to FDA an
abbreviated new drug application
(ANDA) for a complex product.
Specifically, this draft guidance
provides information on requesting and
conducting product development
meetings, pre-submission meetings, and
mid-review-cycle meetings with FDA.
This draft guidance will assist
applicants in generating and submitting
a meeting request and the associated
meeting package to FDA for complex
products to be submitted under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) and as contemplated in the
commitments made by FDA in
connection with the reauthorization of
the Generic Drug User Fee Amendments
for Fiscal Years (FYs) 2018–2022
(GDUFA II).
DATES: Submit either electronic or
written comments on the draft guidance
by December 4, 2017 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.
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
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46071
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 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–
2017–D–5739 for ‘‘Formal Meetings
Between FDA and ANDA Applicants of
Complex Products Under GDUFA; Draft
Guidance for Industry; Availability.’’
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.
• 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
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46070-46071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21174]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-2530]
Determination That SPECTAZOLE (Econazole Nitrate) Topical Cream,
1%, 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 SPECTAZOLE (econazole nitrate) topical cream, 1%, was
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: 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.
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, a drug is 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.
SPECTAZOLE (econazole nitrate) topical cream, 1%, is the subject of
NDA 018751, held by Alvogen Malta Operations Ltd., and initially
approved on December 23, 1982. SPECTAZOLE is indicated for topical
application in the treatment of tinea pedis, tinea cruris, and tinea
corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes,
Trichophyton tonsurans, Microsporum canis, Microsporum audouini,
Microsporum gypseum, and Epidermophyton floccosum; in the treatment of
cutaneous candidiasis; and in the treatment of tinea versicolor.
SPECTAZOLE (econazole nitrate) topical cream, 1%, is currently
listed in
[[Page 46071]]
the ``Discontinued Drug Product List'' section of the Orange Book.
Lachman Consultant Services, Inc. submitted a citizen petition
dated April 21, 2017 (Docket No. FDA-2017-P-2530), under 21 CFR 10.30,
requesting that the Agency determine whether SPECTAZOLE (econazole
nitrate) topical cream, 1%, 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 SPECTAZOLE (econazole nitrate) topical cream,
1%, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
SPECTAZOLE (econazole nitrate) topical cream, 1%, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of SPECTAZOLE (econazole
nitrate) topical cream, 1%, 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 SPECTAZOLE (econazole
nitrate) topical cream, 1%, 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: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21174 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P
