Determination That BUSPAR (Buspirone Hydrochloride) Tablets, 10 Milligrams, 15 Milligrams, and 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 64310-64311 [2010-26214]
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Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices
Public Comment Period:
Comments must be received by
December 20, 2010.
ADDRESSES: Written comments may be
submitted to the NIOSH Docket Office,
identified by Docket Number NIOSH–
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FOR FURTHER INFORMATION CONTACT:
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(513) 841–4258, e-mail mailto:
sas2@cdc.gov, or Amy Feng, M.S.,
telephone (513) 841–4128, e-mail
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45226.
DATES:
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2010–26221 Filed 10–18–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–P–0234]
Determination That BUSPAR
(Buspirone Hydrochloride) Tablets, 10
Milligrams, 15 Milligrams, and 30
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
mstockstill on DSKH9S0YB1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that BUSPAR (buspirone hydrochloride)
Tablets, 10 milligrams (mg), 15 mg, and
30 mg, were not withdrawn from sale
SUMMARY:
VerDate Mar<15>2010
16:24 Oct 18, 2010
Jkt 223001
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:
Molly Flannery, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6237,
Silver Spring, MD 20993–0002, 301–
796–3543.
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,’’
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).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug. Under § 314.161(a)(2), FDA must
determine whether a listed drug was
withdrawn from sale for reasons of
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
safety or effectiveness whenever a listed
drug is voluntarily withdrawn from sale
and ANDAs that refer to the listed drug
have been approved. Section 314.161(d)
provides that if FDA determines that a
listed drug was withdrawn from sale for
reasons of safety or effectiveness, the
agency will initiate proceedings that
could result in the withdrawal of
approval of the ANDAs that refer to the
listed drug.
BUSPAR (buspirone hydrochloride)
Tablets, 10 mg, 15 mg, and 30 mg, are
the subject of NDA 18–731, held by
Bristol-Myers Squibb, and initially
approved on September 29, 1986 (10 mg
strength), and April 22, 1996 (15 mg and
30 mg strengths). BUSPAR is indicated
for the management of anxiety disorders
or the short-term relief of the symptoms
of anxiety. BUSPAR (buspirone
hydrochloride) Tablets, 10 mg, 15 mg,
and 30 mg, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. There are
approved ANDAs for buspirone
hydrochloride tablets, 10 mg, 15 mg,
and 30 mg; these ANDAs are listed in
the Orange Book and, following the
discontinuation of BUSPAR, one of
them was designated as the reference
listed drug to which new ANDAs
should refer.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated May
4, 2010 (Docket No. FDA–2010–P–
0234), under 21 CFR 10.30, requesting
that the agency determine whether
BUSPAR (buspirone hydrochloride)
Tablets, 15 mg and 30 mg, were
withdrawn from sale for reasons of
safety or effectiveness. Although the
citizen petition did not address the 10
mg strength, that strength has also been
discontinued. On our own initiative, we
have also determined whether that
strength was withdrawn for safety or
effectiveness reasons.
After considering the citizen petition
and reviewing agency records, FDA has
determined under § 314.161 that
BUSPAR (buspirone hydrochloride)
Tablets, 10 mg, 15 mg, and 30 mg, were
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that BUSPAR (buspirone
hydrochloride) Tablets, 10 mg, 15 mg,
and 30 mg, were withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of BUSPAR
(buspirone hydrochloride) Tablets, 10
mg, 15 mg, and 30 mg, from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events and have
found no information that would
indicate that this product was
E:\FR\FM\19OCN1.SGM
19OCN1
Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the agency will continue
to list BUSPAR (buspirone
hydrochloride) Tablets, 10 mg, 15 mg,
and 30 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. FDA
will not begin procedures to withdraw
approval of approved ANDAs that refer
to BUSPAR. Additional ANDAs for
buspirone hydrochloride tablets, 10 mg,
15 mg, and 30 mg, 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: October 13, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
mstockstill on DSKH9S0YB1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel, NIH Training
Grants.
Date: December 6, 2010.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Daniel R. Kenshalo, PhD,
Scientific Review Officer, Division of
16:24 Oct 18, 2010
Jkt 223001
Dated: October 13, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–26310 Filed 10–18–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Notice of Meeting; National
Commission on Children and Disasters
Administration for Children
and Families, Department of Health and
Human Services.
ACTION: Notice of Meeting.
AGENCY:
The meeting will be held on
Monday, November 15, 2010, from 9:30
a.m. to 3:30 p.m.
ADDRESSES: The meeting will be held at
the Administration for Children and
Families, 901 D Street, SW.,
Washington, DC 20024. To attend either
in person or via teleconference, please
register by 5 p.m., Eastern Time,
November 10, 2010. To register, please
e-mail Jacqueline.Officer@acf.hhs.gov
with ‘‘Meeting Registration’’ in the
subject line, or call (202) 205–9560.
Registration must include your name,
affiliation, and phone number. If you
require a sign language interpreter or
other special assistance, please call
Jacqueline Officer at (202) 205–9560 or
e-mail Jacqueline.Officer@acf.hhs.gov as
soon as possible and no later than 5
p.m. Eastern Time, November 1, 2010.
Agenda: The Commission will: (1)
Discuss a recommendation to establish
a National Resource Center on Children
and Disasters; (2) Discuss
implementation strategies for
recommendations published in the 2010
Report to the President and Congress;
and (3) Discuss potential issues for
future study and changes to
subcommittee structure.
Written comments may be submitted
electronically to
Juliana.Sadovich@acf.hhs.gov with
‘‘Public Comment’’ in the subject line.
The Commission recommends that you
include your name, mailing address and
an e-mail address or other contact
information in the body of your
comment. This ensures that you can be
DATES:
[FR Doc. 2010–26214 Filed 10–18–10; 8:45 am]
VerDate Mar<15>2010
Extramural Research, National Eye Institute,
National Institutes of Health, 5635 Fishers
Lane, Suite 1300, MSC 9300. 301–451–2020.
kenshalod@nei.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
64311
identified as the submitter of the
comment, and it allows the Commission
to contact you if further information on
the substance of the comment is needed
or if your comment cannot be read due
to technical difficulties. The
Commission’s policy is that the
Commission will not edit your
comment, and any identifying or contact
information provided in the body of a
comment will be included as part of the
comment placed in the official record.
The Commission will provide an
opportunity for public comments during
the public meeting on November 15,
2010. Those wishing to speak will be
limited to three minutes each; speakers
are encouraged to submit their remarks
in writing in advance to ensure their
comment is received in case there is
inadequate time for all comments to be
heard on November 15, 2010.
Additional Information: Contact
CAPT Juliana Sadovich, RN, PhD
Director, Office of Human Services
Emergency Preparedness and Response,
e-mail Juliana.Sadovich@acf.hhs.gov or
call (202) 401–9306.
SUPPLEMENTARY INFORMATION: The
National Commission on Children and
Disasters is an independent Commission
directed to conduct a comprehensive
study to examine and assess the needs
of children as they relate to preparation
for, response to, and recovery from all
hazards, building upon the evaluations
of other entities and avoiding
unnecessary duplication by reviewing
the findings, conclusions, and
recommendations of these entities. The
Commission submitted reports to the
President and the Congress on the
Commission’s independent and specific
findings, conclusions, and
recommendations to address the needs
of children as they relate to preparation
for, response to, and recovery from all
hazards, including major disasters and
emergencies.
Dated: October 13, 2010.
David A. Hansell,
Acting Assistant Secretary for Children and
Families.
[FR Doc. 2010–26231 Filed 10–18–10; 8:45 am]
BILLING CODE 4184–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Office of Liaison, Policy and Review
Meeting of the NTP Board of Scientific
Counselors
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health.
AGENCY:
E:\FR\FM\19OCN1.SGM
19OCN1
]]>Agencies
[Federal Register Volume 75, Number 201 (Tuesday, October 19, 2010)]
[Notices]
[Pages 64310-64311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26214]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-P-0234]
Determination That BUSPAR (Buspirone Hydrochloride) Tablets, 10
Milligrams, 15 Milligrams, and 30 Milligrams, Were 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
BUSPAR (buspirone hydrochloride) Tablets, 10 milligrams (mg), 15 mg,
and 30 mg, were 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: Molly Flannery, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6237, Silver Spring, MD 20993-0002, 301-
796-3543.
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,'' 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). Under Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)), the
agency must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug. Under Sec. 314.161(a)(2), FDA must determine
whether a listed drug was withdrawn from sale for reasons of safety or
effectiveness whenever a listed drug is voluntarily withdrawn from sale
and ANDAs that refer to the listed drug have been approved. Section
314.161(d) provides that if FDA determines that a listed drug was
withdrawn from sale for reasons of safety or effectiveness, the agency
will initiate proceedings that could result in the withdrawal of
approval of the ANDAs that refer to the listed drug.
BUSPAR (buspirone hydrochloride) Tablets, 10 mg, 15 mg, and 30 mg,
are the subject of NDA 18-731, held by Bristol-Myers Squibb, and
initially approved on September 29, 1986 (10 mg strength), and April
22, 1996 (15 mg and 30 mg strengths). BUSPAR is indicated for the
management of anxiety disorders or the short-term relief of the
symptoms of anxiety. BUSPAR (buspirone hydrochloride) Tablets, 10 mg,
15 mg, and 30 mg, are currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book. There are approved ANDAs for
buspirone hydrochloride tablets, 10 mg, 15 mg, and 30 mg; these ANDAs
are listed in the Orange Book and, following the discontinuation of
BUSPAR, one of them was designated as the reference listed drug to
which new ANDAs should refer.
Lachman Consultant Services, Inc., submitted a citizen petition
dated May 4, 2010 (Docket No. FDA-2010-P-0234), under 21 CFR 10.30,
requesting that the agency determine whether BUSPAR (buspirone
hydrochloride) Tablets, 15 mg and 30 mg, were withdrawn from sale for
reasons of safety or effectiveness. Although the citizen petition did
not address the 10 mg strength, that strength has also been
discontinued. On our own initiative, we have also determined whether
that strength was withdrawn for safety or effectiveness reasons.
After considering the citizen petition and reviewing agency
records, FDA has determined under Sec. 314.161 that BUSPAR (buspirone
hydrochloride) Tablets, 10 mg, 15 mg, and 30 mg, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that BUSPAR (buspirone
hydrochloride) Tablets, 10 mg, 15 mg, and 30 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of BUSPAR (buspirone
hydrochloride) Tablets, 10 mg, 15 mg, and 30 mg, from sale. We have
also independently evaluated relevant literature and data for possible
postmarketing adverse events and have found no information that would
indicate that this product was
[[Page 64311]]
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list BUSPAR (buspirone
hydrochloride) Tablets, 10 mg, 15 mg, and 30 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to BUSPAR. Additional ANDAs for buspirone
hydrochloride tablets, 10 mg, 15 mg, and 30 mg, 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: October 13, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-26214 Filed 10-18-10; 8:45 am]
BILLING CODE 4160-01-P
