Determination That KAPVAY (Clonidine Hydrochloride) Extended-Release Tablets, 0.2 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 7581-7582 [2012-3223]
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7581
Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
(3) The suspension decisionmaking
process, which shall afford the
contractor (and any specifically named
affiliates) an opportunity, following the
imposition of suspension, to submit, in
person, in writing, or through a
representative, information and
argument in opposition to the
suspension;
(4) Recommending to the CG whether
or not to solicit offers from, award
contracts to, or consent to subcontracts
with a contractor who is debarred,
suspended, or proposed for debarment;
and
(5) Recommending to the CG whether
or not to continue current contracts with
a contractor or subcontractor who is
debarred, suspended, or proposed for
debarment.
OGC will review for legal sufficiency:
(1) Referrals by AM to the debarment/
suspension official;
(2) Recommendations by AM to the
CG that GAO solicit offers from, award
contracts to, or consent to subcontracts
with a contractor who is debarred,
suspended, or proposed for debarment;
(3) Recommendations by AM to the
CG to terminate a current contract
because a contractor or subcontractor
was subsequently debarred, suspended,
or proposed for debarment; and
(4) Notices of proposed debarment,
notices of suspension, or any other
communication to a contractor
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, email your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above email address within 60days.
Proposed Project: Survey of Primary
Care Physicians on Oral Health for the
Office on Women’s Health (OWH), U.S.
Department of Health and Human
Services (HHS) (New)—OMB No. 0990–
NEW.
Abstract: The Office on Women’s
Health (OWH) at the Department of
Health and Human Services is
requesting OMB approval to conduct a
new, one time survey of primary care
physicians regarding oral health. This
survey will provide the agency with
information on oral health knowledge,
attitudes, and professional experience
among practicing physicians throughout
the U.S. The study will explore
physicians’ level of understanding of
oral disease and what constitutes health
for the oral cavity, oral health training
and support needs, current practices
and barriers to further involvement.
OWH is requesting two years of OMB
approval to enable sampling, screening,
and survey implementation.
regarding that contractor’s potential or
actual suspension or debarment.
Lynn H. Gibson,
General Counsel, U.S. Government
Accountability Office.
[FR Doc. 2012–3307 Filed 2–10–12; 8:45 am]
BILLING CODE 1610–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
AGENCY:
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Number
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondent
Form name
Medical Secretary .............................
Physician ...........................................
Screener ...........................................
Survey ..............................................
1,300
600
1
1
5/60
30/60
108
300
Total ...........................................
...........................................................
........................
........................
........................
408
Keith A. Tucker,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2012–3210 Filed 2–10–12; 8:45 am]
Food and Drug Administration
erowe on DSK2VPTVN1PROD with NOTICES
BILLING CODE 4150–33–P
[Docket No. FDA–2011–P–0292]
Determination That KAPVAY
(Clonidine Hydrochloride) ExtendedRelease Tablets, 0.2 Milligram, Was
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
14:46 Feb 10, 2012
Jkt 226001
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that KAPVAY (clonidine hydrochloride)
Extended-Release Tablets, 0.2 milligram
(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 clonidine
hydrochloride extended-release tablets,
0.2 mg, if all other requirements are met.
SUMMARY:
E:\FR\FM\13FEN1.SGM
13FEN1
7582
Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
erowe on DSK2VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Kristiana Brugger, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6262,
Silver Spring, MD 20993–0002, 301–
796–3601.
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 only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
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.
KAPVAY (clonidine hydrochloride)
Extended-Release Tablets, 0.2 mg, is the
subject of NDA 22–331, held by
Shionogi Pharma, Inc., and initially
approved on September 28, 2010.
KAPVAY is indicated for the treatment
of attention deficit hyperactivity
disorder as monotherapy or as
adjunctive therapy to stimulant
medications. Shionogi Pharma has
VerDate Mar<15>2010
14:46 Feb 10, 2012
Jkt 226001
never marketed KAPVAY (clonidine
hydrochloride) Extended-Release
Tablets, 0.2 mg. In previous instances
(see, e.g., 72 FR 9763, March 5, 2007; 61
FR 25497, May 21, 1996), 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.
Actavis, Inc. submitted a citizen
petition dated April 20, 2011 (Docket
No. FDA–2011–P–0292), under 21 CFR
10.30, requesting that the Agency
determine whether KAPVAY (clonidine
hydrochloride) Extended-Release
Tablets, 0.2 mg, 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 KAPVAY (clonidine
hydrochloride) Extended-Release
Tablets, 0.2 mg, was not withdrawn
from sale for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that KAPVAY (clonidine
hydrochloride) Extended-Release
Tablets, 0.2 mg, was withdrawn from
sale for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of KAPVAY
(clonidine hydrochloride) ExtendedRelease Tablets, 0.2 mg from sale. We
have found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, FDA will continue to list
KAPVAY (clonidine hydrochloride)
Extended-Release Tablets, 0.2 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 KAPVAY (clonidine hydrochloride)
Extended-Release Tablets, 0.2 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: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3223 Filed 2–10–12; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0291]
Determination That JENLOGA
(Clonidine Hydrochloride) ExtendedRelease Tablets, 0.1 Milligram and 0.2
Milligram, Were 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 JENLOGA (clonidine
hydrochloride) Extended-Release
Tablets, 0.1 milligram (mg) and 0.2 mg,
were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for clonidine
hydrochloride extended-release tablets,
0.1 mg and 0.2 mg, if all other
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Kristiana Brugger, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6262,
Silver Spring, MD 20993–0002, 301–
796–3601.
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 approved
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 only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
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,’’
SUMMARY:
E:\FR\FM\13FEN1.SGM
13FEN1
]]>Agencies
[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7581-7582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3223]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0292]
Determination That KAPVAY (Clonidine Hydrochloride) Extended-
Release Tablets, 0.2 Milligram, 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
KAPVAY (clonidine hydrochloride) Extended-Release Tablets, 0.2
milligram (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 clonidine hydrochloride extended-
release tablets, 0.2 mg, if all other requirements are met.
[[Page 7582]]
FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6262, Silver Spring, MD 20993-0002, 301-
796-3601.
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 only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
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.
KAPVAY (clonidine hydrochloride) Extended-Release Tablets, 0.2 mg,
is the subject of NDA 22-331, held by Shionogi Pharma, Inc., and
initially approved on September 28, 2010. KAPVAY is indicated for the
treatment of attention deficit hyperactivity disorder as monotherapy or
as adjunctive therapy to stimulant medications. Shionogi Pharma has
never marketed KAPVAY (clonidine hydrochloride) Extended-Release
Tablets, 0.2 mg. In previous instances (see, e.g., 72 FR 9763, March 5,
2007; 61 FR 25497, May 21, 1996), 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.
Actavis, Inc. submitted a citizen petition dated April 20, 2011
(Docket No. FDA-2011-P-0292), under 21 CFR 10.30, requesting that the
Agency determine whether KAPVAY (clonidine hydrochloride) Extended-
Release Tablets, 0.2 mg, 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 KAPVAY (clonidine hydrochloride)
Extended-Release Tablets, 0.2 mg, was not withdrawn from sale for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that KAPVAY (clonidine
hydrochloride) Extended-Release Tablets, 0.2 mg, was withdrawn from
sale for reasons of safety or effectiveness. We have carefully reviewed
our files for records concerning the withdrawal of KAPVAY (clonidine
hydrochloride) Extended-Release Tablets, 0.2 mg from sale. We have
found no information that would indicate that this product was
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, FDA will continue to list KAPVAY (clonidine
hydrochloride) Extended-Release Tablets, 0.2 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 KAPVAY (clonidine hydrochloride)
Extended-Release Tablets, 0.2 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: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3223 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P
