Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug Applications and Two Abbreviated New Drug Applications, 96004-96005 [2016-31625]
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96004
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a revised guidance for industry entitled
‘‘Listing of Ingredients in Tobacco
Products.’’ We are issuing this guidance
consistent with our good guidance
practices regulation (21 CFR 10.115).
The revised guidance document is
intended to assist persons making
tobacco product ingredient submissions
to FDA as required by the Tobacco
Control Act.
The Tobacco Control Act (Pub. L.
111–31), enacted on June 22, 2009,
amends the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) and
provides FDA with the authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health. Among its
many provisions, the Tobacco Control
Act added section 904 to the FD&C Act
(21 U.S.C. 387d), establishing
requirements for tobacco product
ingredient submissions.
The revised guidance discusses
tobacco products that are newly deemed
subject to chapter IX of the FD&C Act.
Cigarettes, cigarette tobacco, roll-yourown tobacco (RYO), and smokeless
tobacco were immediately covered by
FDA’s tobacco product authorities in
chapter IX of the FD&C Act, including
section 904, when the Tobacco Control
Act went into effect. As for other types
of tobacco products, section 901(b) of
the FD&C Act (21 U.S.C. 387a) grants
FDA authority to deem those products
subject to chapter IX of the FD&C Act.
Under that authority, FDA issued a rule
deeming all other products that meet the
statutory definition of ‘‘tobacco
product’’, set forth in section 201(rr) of
the FD&C Act (21 U.S.C. 321(rr)), except
for accessories of those products, as
subject to chapter IX of the FD&C Act
(81 FR 28974). FDA published the final
rule on May 10, 2016 and it became
effective on August 8, 2016. As a result,
manufacturers or importers (or their
agents) of tobacco products subject to
the deeming rule are now required to
comply with chapter IX of the FD&C
Act, including the ingredient listing
requirements in section 904(a)(1).
Section 904(a)(1) of the FD&C Act
requires each tobacco product
manufacturer or importer, or agent
thereof, to submit a listing of all
ingredients, including tobacco,
substances, compounds, and additives
that are added by the manufacturer to
the tobacco, paper, filter, or other part
of each tobacco product by brand and by
quantity in each brand and subbrand.
For cigarettes, cigarette tobacco, RYO,
and smokeless tobacco products on the
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18:41 Dec 28, 2016
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market as of June 22, 2009, the list of
ingredients had to be submitted by
December 22, 2009. For cigarettes,
cigarette tobacco, RYO, and smokeless
tobacco products not on the market as
of June 22, 2009, section 904(c)(1)
requires that the list of ingredients be
submitted at least 90 days prior to
delivery for introduction into interstate
commerce. Section 904(c) of the FD&C
Act also requires submission of
information whenever any additive, or
the quantity of any additive, is changed.
As described in the preamble to the
final deeming rule, for products other
than cigarettes, cigarette tobacco, RYO,
and smokeless tobacco that are on the
market as of August 8, 2016, FDA does
not intend to enforce the section
904(a)(1) ingredient listing submission
requirement until 6 months from the
effective date of the rule or 12 months
from the effective date for small-scale
tobacco product manufacturers.
However, in the revised guidance, FDA
is announcing an additional 6-month
compliance policy for newly deemed
tobacco products on the market as of
August 8, 2016. Under this policy, FDA
will not enforce the ingredient listing
submission requirement until August 8,
2017, for businesses that are not
considered small-scale tobacco product
manufactures, and February 8, 2018, for
small-scale tobacco product
manufacturers. Manufacturers of
tobacco products introduced into
interstate commerce after August 8,
2016, must submit the ingredient
information required by section
904(a)(1) at least 90 days before the
product is delivered for introduction
into interstate commerce, as with
cigarettes, cigarette tobacco, RYO, and
smokeless tobacco first marketed after
June 22, 2009 (section 904(c)(1) of the
FD&C Act).
II. Significance of Guidance
FDA is issuing this revised guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ingredient listing. 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 it satisfies the requirements
of the applicable statutes and
regulations.
III. Paperwork Reduction Act of 1995
This revised guidance also refers to
previously approved collections of
information found in FDA regulations.
The revised draft guidance includes
information and recommendations for
how to provide ingredient listing
submissions. The collections of
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Fmt 4703
Sfmt 4703
information in section 904(a)(1) of the
FD&C Act have been approved under
OMB control number 0910–0650.
IV. Electronic Access
Persons with access to the Internet
may obtain an electronic version of the
revised guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
default.htm.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31587 Filed 12–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0002]
Abbott Laboratories, et al.; Withdrawal
of Approval of Four New Drug
Applications and Two Abbreviated
New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of four new drug applications
(NDAs) and two abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
DATES:
Effective Date: January 30, 2017.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
holders of the applications listed in the
table have informed FDA that these drug
products are no longer marketed and
have requested that FDA withdraw
approval of the applications pursuant to
the process in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
E:\FR\FM\29DEN1.SGM
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Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
96005
Application No.
Drug
Applicant
NDA 019080 ........................
ProSom (estazolam) Tablets, 1 milligram (mg) and 2
mg.
Fentanyl Oralet (fentanyl citrate) Troche/Lozenge,
Equivalent to (EQ) 0.1 mg base, EQ 0.2 mg base,
EQ 0.3 mg base, and EQ 0.4 mg base.
Niravam (alprazolam) Orally Disintegrating Tablets,
0.25 mg, 0.5 mg, 1 mg, and 2 mg.
Methyltestosterone Tablets USP, 10 mg ........................
Abbott Laboratories, 200 Abbott Park Rd., Abbott Park,
IL 60064.
Cephalon, Inc., 41 Moores Rd., Frazer, PA 19355.
NDA 020195 ........................
NDA 021726 ........................
ANDA 084287 ......................
ANDA 084310 ......................
NDA 205208 ........................
Methyltestosterone Tablets USP, 25 mg ........................
Desvenlafaxine Fumarate Extended-Release Tablets,
EQ 50 mg base and EQ 100 mg base.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and under
authority delegated to the Director,
Center for Drug Evaluation and
Research, by the Commissioner,
approval of the applications listed in the
table, and all amendments and
supplements thereto, is hereby
withdrawn, effective January 30, 2017.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the FD&C Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in
the table that are in inventory on the
date that this notice becomes effective
(see the DATES section) may continue to
be dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
UCB, Inc., 1950 Lake Park Dr., Building 2100, Smyrna,
GA 30080.
Impax Laboratories, Inc., 31047 Genstar Rd., Hayward,
CA 94544.
Do.
Teva Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
sets forth FDA’s policy regarding
compounding and repackaging of
radiopharmaceuticals for human use by
entities that are registered with FDA as
outsourcing facilities. This guidance
describes how FDA intends to apply
section 503B of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) to
radiopharmaceuticals compounded by
outsourcing facilities, and it describes
the conditions under which FDA does
not intend to take action for violations
of certain provisions of the FD&C Act
when an outsourcing facility repackages
radiopharmaceuticals.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 27,
2017. Submit either electronic or
written comments concerning the
collection of information proposed in
the draft guidance by February 27, 2017.
[FR Doc. 2016–31625 Filed 12–28–16; 8:45 am]
ADDRESSES:
BILLING CODE 4164–01–P
as follows:
DATES:
You may submit comments
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4317]
Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing
Facilities; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing
Facilities.’’ Specifically, this guidance
SUMMARY:
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
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
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
PO 00000
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–D–4317 for ‘‘Compounding and
Repackaging of Radiopharmaceuticals
by Outsourcing Facilities.’’ 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 Division of Dockets
Management 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
E:\FR\FM\29DEN1.SGM
29DEN1
]]>Agencies
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96004-96005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31625]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0002]
Abbott Laboratories, et al.; Withdrawal of Approval of Four New
Drug Applications and Two Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of four new drug applications (NDAs) and two abbreviated new drug
applications (ANDAs) from multiple applicants. The holders of the
applications notified the Agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.
DATES: Effective Date: January 30, 2017.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table have informed FDA that these drug products are no longer
marketed and have requested that FDA withdraw approval of the
applications pursuant to the process in Sec. 314.150(c) (21 CFR
314.150(c)). The applicants have also, by their requests, waived their
opportunity for a hearing. Withdrawal of approval of an application or
abbreviated application under Sec. 314.150(c) is without prejudice to
refiling.
[[Page 96005]]
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 019080.................. ProSom (estazolam) Abbott Laboratories,
Tablets, 1 200 Abbott Park
milligram (mg) and Rd., Abbott Park,
2 mg. IL 60064.
NDA 020195.................. Fentanyl Oralet Cephalon, Inc., 41
(fentanyl citrate) Moores Rd., Frazer,
Troche/Lozenge, PA 19355.
Equivalent to (EQ)
0.1 mg base, EQ 0.2
mg base, EQ 0.3 mg
base, and EQ 0.4 mg
base.
NDA 021726.................. Niravam (alprazolam) UCB, Inc., 1950 Lake
Orally Park Dr., Building
Disintegrating 2100, Smyrna, GA
Tablets, 0.25 mg, 30080.
0.5 mg, 1 mg, and 2
mg.
ANDA 084287................. Methyltestosterone Impax Laboratories,
Tablets USP, 10 mg. Inc., 31047 Genstar
Rd., Hayward, CA
94544.
ANDA 084310................. Methyltestosterone Do.
Tablets USP, 25 mg.
NDA 205208.................. Desvenlafaxine Teva Pharmaceuticals
Fumarate Extended- USA, Inc., 425
Release Tablets, EQ Privet Rd.,
50 mg base and EQ Horsham, PA 19044.
100 mg base.
------------------------------------------------------------------------
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn, effective
January 30, 2017. Introduction or delivery for introduction into
interstate commerce of products without approved new drug applications
violates section 301(a) and (d) of the FD&C Act (21 U.S.C. 331(a) and
(d)). Drug products that are listed in the table that are in inventory
on the date that this notice becomes effective (see the DATES section)
may continue to be dispensed until the inventories have been depleted
or the drug products have reached their expiration dates or otherwise
become violative, whichever occurs first.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31625 Filed 12-28-16; 8:45 am]
BILLING CODE 4164-01-P
