Determination That INVEGA (Paliperidone) Extended-Release Tablet, 12 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 66009-66010 [2013-26283]
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66009
Federal Register / Vol. 78, No. 213 / Monday, November 4, 2013 / Notices
testing results and behaviors and sexual
activities. Focus group discussions and
in-depth interviews will be used to
examine experiences of participants in
the RCT.
focus group discussion 1 hour and 30
minutes; and the in-depth interviews 1
hour and 15 minutes.
There is no cost to participants other
than their time.
The duration of the eligibility
screener is estimated to be 5 minutes;
the study registration process 5 minutes;
the baseline survey 15 minutes; the
reporting of home-test results 5 minutes;
the follow-up surveys 10 minutes; the
Number of
responses per
respondent
Number of
respondents
Average
hours per
response
Total
response
burden
(hours)
Type of respondent
Form name
Prospective Participant .....................
Enrolled participant ...........................
Enrolled participant ...........................
Enrolled participant ...........................
24,000
14,000
3,200
300
1
1
1
1
3/60
5/60
15/60
15/60
1,200
1,167
800
75
1,600
3
5/60
400
3,200
300
4
2
10/60
10/60
2,133
100
3,200
1
5/60
267
Enrolled participant ...........................
Enrolled participant ...........................
Eligibility Screener ............................
Study Registration ............................
Baseline Survey for RCT .................
Baseline Survey for HIV-positive
group.
Reporting of Home-test Results during study.
Follow-up Surveys for RCT ..............
Follow-up Surveys for HIV positive
group.
Reporting of Home-test Results at
completion of study.
Focus group discussion ...................
Individual in-depth interview guide ...
216
30
1
1
1.5
1.5
324
45
Total ...........................................
...........................................................
........................
........................
........................
6,511
Enrolled participant ...........................
Enrolled participant ...........................
Enrolled participant ...........................
Enrolled participants .........................
Leroy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–26277 Filed 11–1–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0775]
Determination That INVEGA
(Paliperidone) Extended-Release
Tablet, 12 Milligrams, 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) has determined
that INVEGA (paliperidone) extendedrelease tablet, 12 milligrams (mg), was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for paliperidone
extended-release tablet, 12 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Linda Jong, Center for Drug Evaluation
and Research, Food and Drug
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:07 Nov 01, 2013
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Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6224, Silver Spring,
MD 20993–0002, 301–796–3977.
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).
SUPPLEMENTARY INFORMATION:
PO 00000
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Fmt 4703
Sfmt 4703
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.
INVEGA (paliperidone) extendedrelease tablet, 12 mg, is the subject of
NDA 21–999, held by Janssen
Pharmaceuticals, Inc., and initially
approved on December 19, 2006.
INVEGA extended-release tablets are
indicated for the treatment of
schizophrenia and the treatment of
schizoaffective disorder as monotherapy
and as an adjunct to mood stabilizers
and/or antidepressants.
Janssen Pharmaceuticals, Inc., has
never marketed INVEGA (paliperidone)
extended-release tablet, 12 mg. In
previous instances (see, e.g., 72 FR
9763, 61 FR 25497), the Agency has
determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale. The other strengths of
INVEGA (paliperidone) that are
approved under NDA 21–999 are being
marketed.
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated June
25, 2013 (Docket No. FDA–2013–P–
0775), under 21 CFR 10.30, requesting
that the Agency determine whether
E:\FR\FM\04NON1.SGM
04NON1
66010
Federal Register / Vol. 78, No. 213 / Monday, November 4, 2013 / Notices
INVEGA (paliperidone) extendedrelease tablet, 12 mg, was discontinued
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 INVEGA (paliperidone)
extended-release tablet, 12 mg, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that INVEGA (paliperidone)
extended-release tablet, 12 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of INVEGA
(paliperidone) extended-release tablet,
12 mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events to
determine whether INVEGA
(paliperidone) extended-release tablet,
12 mg, was withdrawn for reasons of
safety or effectiveness. We have
reviewed the available information and
determined that the product was not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list INVEGA (paliperidone)
extended-release tablet, 12 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. ANDAs that refer
to INVEGA (paliperidone) extendedrelease tablet, 12 mg, 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: October 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–26283 Filed 11–1–13; 8:45 am]
TKELLEY on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1204]
Draft Risk Profile on Pathogens and
Filth in Spices; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
risk profile entitled ‘‘FDA Draft Risk
Profile: Pathogens and Filth in Spices’’
(draft risk profile). Our main objectives
were to: Describe the nature and extent
of the public health risk posed by
consumption of spices in the United
States by identifying the most
commonly occurring microbial hazards
and filth in spice; describe and evaluate
current mitigation and control options
designed to reduce the public health
risk posed by consumption of
contaminated spices in the United
States; identify potential additional
mitigation or control options designed
to reduce the public health risk posed
by the consumption of contaminated
spices in the United States; and identify
data gaps and research needs. The draft
risk profile is intended to provide
information for FDA risk managers to
use in regulatory decision making
related to the safety of spices in the U.S.
food supply. The information may also
be useful to stakeholders and interested
parties such as spice producers and
importers, spice and food
manufacturers, retail food
establishments, and consumers.
DATES: Submit either electronic or
written comments on the draft risk
profile by January 3, 2014.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments on the draft risk profile to
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Jane
Van Doren, Center for Food Safety and
Applied Nutrition (HFS–005), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2927.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
In response to recent outbreaks in the
United States of human illness
associated with consumption of certain
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spices, as well as other reports in the
literature and within FDA suggesting
that current pathogen control measures
in spices may not adequately protect
public health, we developed a draft risk
profile on pathogens and filth in spices
(Ref. 1). We initiated the draft risk
profile in response to a large outbreak of
Salmonella Rissen infections in 2008 to
2009 associated with the consumption
of ground white pepper in the United
States (id.). Subsequently, in 2009 to
2010, the United States had a larger
outbreak of Salmonella Montevideo
infections associated with consumption
of products containing black and red
pepper (id.). The objectives of the draft
risk profile are to: (1) Describe the
nature and extent of the public health
risk posed by consumption of spices in
the United States by identifying the
most commonly occurring microbial
hazards and filth in spice; (2) describe
and evaluate current mitigation and
control options designed to reduce the
public health risk posed by
consumption of contaminated spices in
the United States; (3) identify potential
additional mitigation and control
options; and (4) identify data gaps and
research needs.
Specific risk management questions
that are addressed include:
• What is known about the frequency
and levels of pathogen and/or filth
contamination of spices throughout the
food supply chain (e.g., on the farm, at
primary processing/manufacturing, at
intermediary processing (where spices
are used as ingredients in multicomponent products), at distribution
(including importation), at retail sale/
use, and at the consumer’s home)?
• What is known about the
differences in production and
contamination of imported and
domestic spices?
• What is known about the
effectiveness and practicality of
currently available and potential future
mitigations and control options to
prevent human illnesses associated with
contaminated spices (e.g., practices and/
or technologies to reduce or prevent
contamination, surveillance, inspection,
import strategies, or guidance)?
• What are the highest priority
research needs related to prevention or
reduction of contamination of spices
with pathogens or filth?
The draft risk profile has undergone
an independent external peer review,
and our response to the peer review is
available electronically on the FDA Web
site (Ref. 2).
For the purpose of the draft risk
profile, we consider ‘‘spice’’ to mean
any dried aromatic vegetable substances
in the whole, broken, or ground form,
E:\FR\FM\04NON1.SGM
04NON1
]]>Agencies
[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66009-66010]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26283]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0775]
Determination That INVEGA (Paliperidone) Extended-Release Tablet,
12 Milligrams, 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) has determined that
INVEGA (paliperidone) extended-release tablet, 12 milligrams (mg), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for paliperidone extended-release tablet, 12 mg,
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. 6224, 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.
INVEGA (paliperidone) extended-release tablet, 12 mg, is the
subject of NDA 21-999, held by Janssen Pharmaceuticals, Inc., and
initially approved on December 19, 2006. INVEGA extended-release
tablets are indicated for the treatment of schizophrenia and the
treatment of schizoaffective disorder as monotherapy and as an adjunct
to mood stabilizers and/or antidepressants.
Janssen Pharmaceuticals, Inc., has never marketed INVEGA
(paliperidone) extended-release tablet, 12 mg. In previous instances
(see, e.g., 72 FR 9763, 61 FR 25497), the Agency has determined that,
for purposes of Sec. Sec. 314.161 and 314.162, never marketing an
approved drug product is equivalent to withdrawing the drug from sale.
The other strengths of INVEGA (paliperidone) that are approved under
NDA 21-999 are being marketed.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
June 25, 2013 (Docket No. FDA-2013-P-0775), under 21 CFR 10.30,
requesting that the Agency determine whether
[[Page 66010]]
INVEGA (paliperidone) extended-release tablet, 12 mg, was discontinued
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 INVEGA (paliperidone) extended-release tablet,
12 mg, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
INVEGA (paliperidone) extended-release tablet, 12 mg, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of INVEGA (paliperidone)
extended-release tablet, 12 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events to determine whether INVEGA (paliperidone) extended-
release tablet, 12 mg, was withdrawn for reasons of safety or
effectiveness. We have reviewed the available information and
determined that the product was not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list INVEGA (paliperidone)
extended-release tablet, 12 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. ANDAs that refer to INVEGA (paliperidone) extended-
release tablet, 12 mg, 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: October 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26283 Filed 11-1-13; 8:45 am]
BILLING CODE 4160-01-P
