Determination That TRIVARIS (Triamcinolone Acetonide) Injectable Suspension, 80 Milligrams/Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 35362-35363 [2016-12949]
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Federal Register / Vol. 81, No. 106 / Thursday, June 2, 2016 / Notices
In
compliance with 44 U.S.C. 3507, ACL
has submitted the following proposed
collection of information to OMB for
review and clearance. Grantees are
required by Congress to provide
information for use in program
monitoring and for Government
Performance and Results Act (GPRA)
purposes. This information collection
reports the number of active volunteers,
issues and inquiries received, other
SMP program outreach activities, and
the number of Medicare dollars
recovered, among other SMP
performance outcomes. This
information is used as the primary
method for monitoring the SMP
Projects. ACL estimates the burden of
this collection of information as follows:
Respondents: 54 SMP grantees at 23
hours per month (276 hours per year,
per grantee). Total Estimated Burden
Hours: 7,452 hours per year.
SUPPLEMENTARY INFORMATION:
Dated: May 25, 2016.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2016–12868 Filed 6–1–16; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Collaborating To Strengthen Food,
Drug, and Medical Device Safety
Systems; Notice of Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of conference.
The Food and Drug
Administration (FDA) Philadelphia
District Office, in co-sponsorship with
the Association of Food and Drug
Officials (AFDO), and the North Central
Association of Food and Drug Officials,
is announcing a conference entitled
‘‘Collaborating to Strengthen Food,
Drug, and Medical Device Safety
Systems.’’ This conference is intended
to provide information about FDA drug
and device regulation to the regulated
industry.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
The conference will be held on
June 25 to June 29, 2016. See
SUPPLEMENTARY INFORMATION for meeting
times.
ADDRESSES: The Omni William Penn
Hotel, 530 William Penn Pl., Pittsburgh,
PA 15219. Attendees are responsible for
their own accommodations.
DATES:
VerDate Sep<11>2014
18:30 Jun 01, 2016
Jkt 238001
FOR FURTHER INFORMATION CONTACT:
Randy Young, Association of Food and
Drug Officials, 2550 Kingston Rd., Suite
311, York, PA 17402, 717–757–2888,
FAX: 717–650–3650, ryoung@afdo.org.
SUPPLEMENTARY INFORMATION: FDA has
made education of the food, feed, drug,
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated products. The
conference helps to achieve objectives
set forth in section 406 of the Food and
Drug Administration Modernization Act
of 1997 (21 U.S.C. 393), which includes
working closely with stakeholders and
maximizing the availability and clarity
of information for stakeholders and the
public. The conference also is consistent
with the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub.
L. 104–121), as outreach activities by
government Agencies to small
businesses.
The conference helps fulfill the U.S.
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
conference will provide FDA-regulated
drug and device entities with
information on a number of topics
concerning FDA requirements related to
the production and marketing of drugs
and/or devices. Topics for discussion
include, but are not limited to the
following:
• FDA Program Alignment
• Recalls from the Perspective of the
District
• Inspection of Licensed Producers
under the Marijuana for Medical
Purposes Regulations (Health Canada)
• Foreign inspections
• Regulatory Intelligence
• FDA Inspections: Challenges and
Opportunities (Working Luncheon)
• Drug Shortages
• Drug Supply Chain Act: Wholesale
Drug Distributor and 3rd Party
Logistics Provider
• Medical Device Single Audit Program
• Compliance Questions Panel
The Conference Web site is: https://
afdo.org/conference. The meeting times
are as follows:
Date
June
June
June
June
June
25
26
27
28
29
Meeting time
.......
.......
.......
.......
.......
8
8
8
8
8
a.m.
a.m.
a.m.
a.m.
a.m.
to
to
to
to
to
5 p.m.
6 p.m.
5:30 p.m.
5 p.m.
11:30 a.m.
Registration: The AFDO registration
fees cover the cost of facilities,
materials, and breaks. Seats are limited
and registration will close after the
course is filled; therefore, please submit
your registration as soon as possible.
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Conference space will be filled in order
of receipt of registration; those accepted
will receive confirmation. Registration
at the site is not guaranteed but may be
possible on a space available basis on
the day of the conference, beginning at
7:30 a.m. The cost of registration
follows:
Category
Cost of
registration
Member ...................................
Non-Member ...........................
Additional Fee for Registration
Postmarked After June 1,
2016 ....................................
$475
575
100
To register, please complete and
submit an AFDO conference registration
form, available at https://pitt.afdo.org/
registration.html, along with a check,
money order payable to ‘‘AFDO’’; the
registrar will also accept Visa and
MasterCard credit cards. Please mail
your completed registration form and
payment to: AFDO, 2550 Kingston Rd.,
Suite 311, York, PA 17402. To register
online, please visit https://pitt.afdo.org/
registration.html (FDA has verified the
Web site address, but is not responsible
for subsequent changes to the Web site
after this document publishes in the
Federal Register.) For more information
on the conference, or for questions
about registration, please contact Randy
Young (see FOR FURTHER INFORMATION
CONTACT), email inquiries will also be
accepted at afdo@afdo.org, or visit
https://www.afdo.org.
If you need special accommodations
due to a disability, please contact Randy
Young (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
the conference.
Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12942 Filed 6–1–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–0378]
Determination That TRIVARIS
(Triamcinolone Acetonide) Injectable
Suspension, 80 Milligrams/Milliliters,
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
SUMMARY:
E:\FR\FM\02JNN1.SGM
02JNN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 106 / Thursday, June 2, 2016 / Notices
determined that TRIVARIS
(triamcinolone acetonide) injectable
suspension, 80 milligrams/milliliters
(mg/mL), was not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for triamcinolone
acetonide injectable suspension, 80 mg/
mL, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Linda Jong, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6288, Silver Spring,
MD 20993–0002, 301–796–3977.
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.
TRIVARIS (triamcinolone acetonide)
injectable suspension, 80 mg/mL, is the
subject of NDA 22–220, held by
VerDate Sep<11>2014
18:30 Jun 01, 2016
Jkt 238001
Allergan, and initially approved on June
16, 2008. TRIVARIS is indicated for
sympathetic ophthalmia, temporal
arteritis, uveitis, and ocular
inflammatory conditions unresponsive
to topical corticosteroids. TRIVARIS
(triamcinolone acetonide) injectable
suspension, 80 mg/mL, is currently
listed in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
The Weinberg Group submitted a
citizen petition dated January 28, 2016
(Docket No. FDA–2016–P–0378), under
21 CFR 10.30, requesting that the
Agency determine whether TRIVARIS
(triamcinolone acetonide) injectable
suspension, 80 mg/mL, 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 TRIVARIS (triamcinolone
acetonide) injectable suspension, 80 mg/
mL, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that TRIVARIS
(triamcinolone acetonide) injectable
suspension, 80 mg/mL, was withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
TRIVARIS (triamcinolone acetonide)
injectable suspension, 80 mg/mL, 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 TRIVARIS
(triamcinolone acetonide) injectable
suspension, 80 mg/mL, 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. ANDAs that refer
to TRIVARIS (triamcinolone acetonide)
injectable suspension, 80 mg/mL, 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.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
35363
Dated: May 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12949 Filed 6–1–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0055]
Voluntary Sodium Reduction Goals:
Target Mean and Upper Bound
Concentrations for Sodium in
Commercially Processed, Packaged,
and Prepared Foods; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance entitled ‘‘Voluntary Sodium
Reduction Goals: Target Mean and
Upper Bound Concentrations for
Sodium in Commercially Processed,
Packaged, and Prepared Foods.’’ The
draft guidance, when finalized, will
describe our views on voluntary shortterm and long-term goals for sodium
reduction in a variety of identified
categories of foods that are
commercially processed, packaged, or
prepared. These goals are intended to
address the excessive intake of sodium
in the current population and promote
improvements in public health.
DATES: 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 the draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on Issues 1 through 4 listed in section
IV of this document by August 31, 2016.
Submit either electronic or written
comments on Issues 5 through 8 listed
in section IV of this document by
October 31, 2016.
ADDRESSES: You may submit comments
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
E:\FR\FM\02JNN1.SGM
02JNN1
]]>Agencies
[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)]
[Notices]
[Pages 35362-35363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12949]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-P-0378]
Determination That TRIVARIS (Triamcinolone Acetonide) Injectable
Suspension, 80 Milligrams/Milliliters, 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
[[Page 35363]]
determined that TRIVARIS (triamcinolone acetonide) injectable
suspension, 80 milligrams/milliliters (mg/mL), was not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
triamcinolone acetonide injectable suspension, 80 mg/mL, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Linda Jong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6288, Silver Spring, MD 20993-0002, 301-796-3977.
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.
TRIVARIS (triamcinolone acetonide) injectable suspension, 80 mg/mL,
is the subject of NDA 22-220, held by Allergan, and initially approved
on June 16, 2008. TRIVARIS is indicated for sympathetic ophthalmia,
temporal arteritis, uveitis, and ocular inflammatory conditions
unresponsive to topical corticosteroids. TRIVARIS (triamcinolone
acetonide) injectable suspension, 80 mg/mL, is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
The Weinberg Group submitted a citizen petition dated January 28,
2016 (Docket No. FDA-2016-P-0378), under 21 CFR 10.30, requesting that
the Agency determine whether TRIVARIS (triamcinolone acetonide)
injectable suspension, 80 mg/mL, 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 TRIVARIS (triamcinolone acetonide) injectable
suspension, 80 mg/mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that TRIVARIS (triamcinolone acetonide)
injectable suspension, 80 mg/mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of TRIVARIS (triamcinolone acetonide)
injectable suspension, 80 mg/mL, 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 TRIVARIS
(triamcinolone acetonide) injectable suspension, 80 mg/mL, 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. ANDAs that refer to TRIVARIS
(triamcinolone acetonide) injectable suspension, 80 mg/mL, 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.
Dated: May 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12949 Filed 6-1-16; 8:45 am]
BILLING CODE 4164-01-P
