Determination That Amphetamine Sulfate, 5 and 10 Milligram Tablets, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 69088-69089 [2010-28358]
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Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices
Dated: November 1, 2010.
Christy Thomsen,
Director, Office of Communications and
Public Liaison, National Center for
Complementary and Alternative Medicine,
National Institutes of Health.
OMB No.: New Collection.
Description: This proposed
information collection activity is to
obtain information from participants in
two Strengthening Communities Fund
(SCF) programs: The Nonprofit Capacity
Building Program and the State, Local,
and Tribal Government Capacity
Building Program. Both programs are
designed to contribute to the economic
recovery as authorized in the American
Recovery and Reinvestment Act of 2009
(ARRA). The SCF evaluation is an
important opportunity to examine
outcomes achieved by the Strengthening
Communities Fund and progress toward
the objective of improving the capacity
of organizations served by program
grantees to address broad economic
recovery issues in their communities.
[FR Doc. 2010–28290 Filed 11–9–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Strengthening Communities
Fund (SCF) Evaluation.
The evaluation will be designed to
assess progress and measure increased
organizational capacity of each
participating organization. The purpose
of this request is to receive approval of
the data collection instruments that will
be used in this study.
A significant amount of information is
already being collected through
program-specific OMB-approved PPR
forms or is available through secondary
sources. Proposed surveys and phone
interviews are very brief to reduce the
burden on respondents.
Respondents: SCF grantees,and faithbased and Community Organizations
(FBCOs).
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
emcdonald on DSK2BSOYB1PROD with NOTICES
An on-line survey of SCF grantees .................................................................
Telephone interview of SCF grantees .............................................................
On-line survey of faith-based and community organizations (FBCOs) that
received capacity building services from the SCF grantees .......................
Estimated Total Annual Burden
Hours: 647
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
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1.50
21
126
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1
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500
[FR Doc. 2010–28304 Filed 11–9–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–P–0273]
Determination That Amphetamine
Sulfate, 5 and 10 Milligram Tablets,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) has determined
that Amphetamine sulfate, 5 and 10
milligram (mg) tablets, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Total burden
hours
1
1
Dated: November 4, 2010.
Robert Sargis,
Reports Clearance Officer.
ACTION:
Average
burden hours
per response
84
84
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
AGENCY:
Number of
responses per
respondent
applications (ANDAs) for Amphetamine
sulfate, 5 mg and 10 mg tablets, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522.
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\10NON1.SGM
10NON1
emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices
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.
Amphetamine sulfate, 5 mg and 10
mg tablets, is the subject of ANDA
083901 held by Lannett Company Inc.
(Lannett). Amphetamine sulfate is a
sympathomimetic amine indicated for
treatment of narcolepsy, attention
deficit disorder with hyperactivity, and
exogenous obesity, as described in the
labeling.
In a letter dated April 4, 1994, Lannett
notified FDA that Amphetamine sulfate,
5 mg and 10 mg tablets, had been
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Lachman Consultant Services
submitted a citizen petition dated June
12, 2009 (Docket No. FDA–2009–P–
0273), under 21 CFR 10.30, requesting
that the Agency determine whether
Amphetamine sulfate, 5 mg and 10 mg
tablets, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records, FDA has
determined under § 314.161 that
Amphetamine sulfate, 5 mg and 10 mg
tablets, was not withdrawn for reasons
of safety or effectiveness. The petitioner
has identified no data or other
information suggesting that
Amphetamine sulfate, 5 mg and 10 mg
tablets, was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
Amphetamine sulfate, 5 mg and 10 mg
tablets, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events and have
found no information that would
VerDate Mar<15>2010
18:25 Nov 09, 2010
Jkt 223001
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list Amphetamine sulfate, 5
mg and 10 mg tablets, 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 Amphetamine sulfate, 5 mg and 10
mg tablets, 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: November 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–28358 Filed 11–9–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0514]
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Tissue Adhesive With Adjunct Wound
Closure Device Intended for the
Topical Approximation of Skin;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Class II Special Controls Guidance
Document: Tissue Adhesive with
Adjunct Wound Closure Device
Intended for the Topical Approximation
of Skin.’’ This guidance document
describes a means by which tissue
adhesives with adjunct wound closure
devices intended for the topical
approximation of skin may comply with
the requirement of special controls for
class II devices. Elsewhere in this issue
of the Federal Register, FDA is
publishing a final rule to classify tissue
adhesive with adjunct wound closure
device intended for the topical
approximation of skin into class II
(special controls). This guidance
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
69089
document is immediately in effect as the
special control for tissue adhesive with
adjunct wound closure device intended
for approximation of skin, but it remains
subject to comment in accordance with
the agency’s good guidance practices
(GGPs).
DATES: Submit either electronic or
written comments on the guidance at
any time. General comments on agency
guidance are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Tissue Adhesive
with Adjunct Wound Closure Device
Intended for the Topical Approximation
of Skin’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your request, or fax your
request to 301–847–8149. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
George J. Mattamal, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1434, Silver Spring,
MD 20993–0002, 301–796–6396.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
classifying tissue adhesive with adjunct
wound closure device intended for the
topical approximation of skin into class
II (special controls), under section
513(f)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360c(f)(2)). This guidance document
will serve as the special control for the
tissue adhesive with adjunct wound
closure device intended for the topical
approximation of skin device. Section
513(f)(2) of the FD&C Act provides that
any person who submits a premarket
notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) for a device
that has not previously been classified
may, within 30 days after receiving an
order classifying the device in class III
E:\FR\FM\10NON1.SGM
10NON1
]]>Agencies
[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Notices]
[Pages 69088-69089]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28358]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-P-0273]
Determination That Amphetamine Sulfate, 5 and 10 Milligram
Tablets, 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
Amphetamine sulfate, 5 and 10 milligram (mg) tablets, was not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
Amphetamine sulfate, 5 mg and 10 mg tablets, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.
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.
[[Page 69089]]
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.
Amphetamine sulfate, 5 mg and 10 mg tablets, is the subject of ANDA
083901 held by Lannett Company Inc. (Lannett). Amphetamine sulfate is a
sympathomimetic amine indicated for treatment of narcolepsy, attention
deficit disorder with hyperactivity, and exogenous obesity, as
described in the labeling.
In a letter dated April 4, 1994, Lannett notified FDA that
Amphetamine sulfate, 5 mg and 10 mg tablets, had been discontinued, and
FDA moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book.
Lachman Consultant Services submitted a citizen petition dated June
12, 2009 (Docket No. FDA-2009-P-0273), under 21 CFR 10.30, requesting
that the Agency determine whether Amphetamine sulfate, 5 mg and 10 mg
tablets, was withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec. 314.161 that Amphetamine
sulfate, 5 mg and 10 mg tablets, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that Amphetamine sulfate, 5 mg and 10 mg
tablets, was withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
Amphetamine sulfate, 5 mg and 10 mg tablets, 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 withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list Amphetamine sulfate,
5 mg and 10 mg tablets, 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 Amphetamine sulfate, 5 mg and 10 mg
tablets, 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: November 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28358 Filed 11-9-10; 8:45 am]
BILLING CODE 4160-01-P
