Determination That DIDREX (Benzphetamine Hydrochloride) Tablets, 25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 14444-14445 [2010-6593]
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Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices
and facilitating information exchange
among professionals and concerned
citizens. A number of vehicles are
employed to accomplish these activities,
including, but not limited to, Web site
hosting, discussions with customers
(e.g., phone, live chat, etc.), and
dissemination of publications (both
print and electronic).
The Customer Satisfaction Evaluation
was initiated in response to Executive
Order 12862 issued on September 11,
1993. The Order calls for putting
customers first and striving for a
customer-driven government that
matches or exceeds the best service
available in the private sector. To that
end, Information Gateway’s evaluation
is designed to better understand the
kind and quality of services customers
want, as well as customers’ level of
satisfaction with existing services. The
proposed data collection activities for
the evaluation include customer
satisfaction surveys, customer comment
cards, selected publication surveys, and
focus groups.
Respondents: Child Welfare
Information Gateway customers.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of responses per
respondent
Average
burden hours
per response
Total burden
hours
Instrument
Affected public
Customer Satisfaction Survey (Web
site, E-mail, Print, Live Chat, and
Phone).
Publication Survey ............................
Individuals/Households ....................
Private Sector ...................................
State, Local, or Tribal Governments
Individuals/ Households ...................
Private Sector ...................................
State, Local, or Tribal Governments
Individuals/Households ....................
Private Sector ...................................
State, Local, or Tribal Governments
Individuals/Households ....................
Private Sector ...................................
State, Local, or Tribal Governments
Private Sector ...................................
State, Local, or Tribal Governments
Private Sector ...................................
State, Local, or Tribal Governments
Private Sector ...................................
State, Local, or Tribal Governments
State, Local, or Tribal Governments
1000
216
221
88
17
14
300
41
67
229
30
28
12
12
12
12
12
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
0.078
0.078
0.078
0.052
0.052
0.052
0.014
0.014
0.014
0.014
0.014
0.014
1.0
1.0
1.0
1.0
1.0
78.00
16.84
17.24
4.58
0.88
0.73
4.20
0.57
0.94
3.21
0.42
.39
12.00
12.00
12.00
12.00
12.00
12
1
1.0
12.00
...........................................................
........................
........................
........................
200.00
Comment Card (General Web and
Conference versions).
Web site Tools Comment Card ........
General Focus Group Guide ............
User Input Focus Group Guide ........
User Needs Assessment Focus
Guide.
mstockstill on DSKH9S0YB1PROD with NOTICES
Total Estimated Annual Burden
Hours.
In compliance with the requirements
of Section 3506 (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)
VerDate Nov<24>2008
16:42 Mar 24, 2010
Jkt 220001
ways to minimize the burden of the
collection of information on
respondents, including through the use
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.
Dated: March 18, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–6469 Filed 3–24–10; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–P–0215] (formerly
Docket No. 2008P–0006)
Determination That DIDREX
(Benzphetamine Hydrochloride)
Tablets, 25 Milligrams, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that DIDREX (benzphetamine
hydrochloride (HCl)) Tablets, 25
milligrams (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
benzphetamine HCl 25 mg tablets, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Christine Bina, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6220,
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 (Public Law 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
E:\FR\FM\25MRN1.SGM
25MRN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices
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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn 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.
DIDREX (benzphetamine HCl)
Tablets, 25 mg, are the subject of
approved NDA 12–427 held by
Pharmacia and Upjohn Co., a subsidiary
of Pfizer Inc. Benzphetamine HCl 25-mg
tablets are indicated in the management
of exogenous obesity as a short-term (a
few weeks) adjunct in a regimen of
weight reduction based on caloric
restriction. NDA 12–427 was initially
approved in 1960. In 1973, under the
Drug Efficacy Study Implementation,
FDA concluded that benzphetamine HCl
25-mg tablets are effective for the
indications described in the Federal
Register document published on
February 12, 1973 (38 FR 4280). Pfizer
Inc. ceased manufacturing DIDREX
(benzphetamine HCL) Tablets, 25 mg,
prior to September 1992. FDA received
a citizen petition from Lachman
Consultant Services, Inc., dated January
2, 2008, submitted under 21 CFR 10.30.
The petition requests that the agency
determine whether DIDREX
(benzphetamine HCL) Tablets, 25 mg,
were withdrawn from sale for reasons of
safety or effectiveness.
VerDate Nov<24>2008
16:42 Mar 24, 2010
Jkt 220001
FDA has reviewed its records and
under § 314.161, has determined that
DIDREX (benzphetamine HCL) Tablets,
25 mg, were not withdrawn from sale
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that
DIDREX (benzphetamine HCL) Tablets,
25 mg were withdrawn from sale as a
result of safety or effectiveness
concerns. FDA’s independent
evaluation of relevant information has
uncovered no information that would
indicate this product was withdrawn for
reasons of safety or effectiveness. In
addition, DIDREX (benzphetamine HCL)
Tablets currently are being marketed in
a 50-mg scored tablet. The lower, 25-mg
strength of DIDREX (benzphetamine
HCL) Tablets is within the effective
dosing range (25 to 50 mg, 1 to 3 times
daily) and currently can be obtained by
breaking in half the scored 50-mg
strength tablet.
After considering the citizen petition
and reviewing agency records, FDA
determines that for the reasons outlined
previously, DIDREX (benzphetamine
HCL) Tablets, 25 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list DIDREX
(benzphetamine HCl) Tablets, 25 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 DIDREX (benzphetamine HCl)
Tablets, 25 mg, may be approved by the
agency as long as they meet all relevant
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that the labeling of this drug
product should be revised to meet
current standards, the agency will
advise ANDA applicants to submit such
labeling.
Dated: March 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6593 Filed 3–24–10; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
14445
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0260]
Guidance for Industry on Submitting a
Report for Multiple Facilities to the
Reportable Food Electronic Portal as
Established by the Food and Drug
Administration Amendments Act of
2007; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance document
entitled ‘‘Submitting a Report for
Multiple Facilities to the Reportable
Food Electronic Portal as Established by
the Food and Drug Administration
Amendments Act of 2007.’’ The
document provides guidance to the
industry in complying with the
Reportable Food Registry requirements
prescribed by the Food and Drug
Administration Amendments Act of
2007 (FDAAA), and more specifically,
this guidance provides information to
the industry on submitting a single
reportable food report to FDA covering
reportable food located at more than one
of a company’s facilities.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written comments
on the guidance to the Division of
Dockets Management (HFA—305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written requests for single
copies of the guidance to the Office of
Food Defense, Communication and
Emergency Response (HFS–005), Center
for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740. Send two self-addressed
adhesive labels to assist that office in
processing your request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Faye
Feldstein, Center for Food Safety and
Applied Nutrition (HFS–005), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–2428.
SUPPLEMENTARY INFORMATION:
Frm 00028
Fmt 4703
Sfmt 4703
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 75, Number 57 (Thursday, March 25, 2010)]
[Notices]
[Pages 14444-14445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-P-0215] (formerly Docket No. 2008P-0006)
Determination That DIDREX (Benzphetamine Hydrochloride) Tablets,
25 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
DIDREX (benzphetamine hydrochloride (HCl)) Tablets, 25 milligrams (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 benzphetamine HCl 25 mg tablets, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Christine Bina, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6220, 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 (Public Law 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
[[Page 14445]]
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 generally known as the ``Orange
Book.'' Under FDA regulations, drugs are withdrawn 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.
DIDREX (benzphetamine HCl) Tablets, 25 mg, are the subject of
approved NDA 12-427 held by Pharmacia and Upjohn Co., a subsidiary of
Pfizer Inc. Benzphetamine HCl 25-mg tablets are indicated in the
management of exogenous obesity as a short-term (a few weeks) adjunct
in a regimen of weight reduction based on caloric restriction. NDA 12-
427 was initially approved in 1960. In 1973, under the Drug Efficacy
Study Implementation, FDA concluded that benzphetamine HCl 25-mg
tablets are effective for the indications described in the Federal
Register document published on February 12, 1973 (38 FR 4280). Pfizer
Inc. ceased manufacturing DIDREX (benzphetamine HCL) Tablets, 25 mg,
prior to September 1992. FDA received a citizen petition from Lachman
Consultant Services, Inc., dated January 2, 2008, submitted under 21
CFR 10.30. The petition requests that the agency determine whether
DIDREX (benzphetamine HCL) Tablets, 25 mg, were withdrawn from sale for
reasons of safety or effectiveness.
FDA has reviewed its records and under Sec. 314.161, has
determined that DIDREX (benzphetamine HCL) Tablets, 25 mg, were not
withdrawn from sale for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
DIDREX (benzphetamine HCL) Tablets, 25 mg were withdrawn from sale as a
result of safety or effectiveness concerns. FDA's independent
evaluation of relevant information has uncovered no information that
would indicate this product was withdrawn for reasons of safety or
effectiveness. In addition, DIDREX (benzphetamine HCL) Tablets
currently are being marketed in a 50-mg scored tablet. The lower, 25-mg
strength of DIDREX (benzphetamine HCL) Tablets is within the effective
dosing range (25 to 50 mg, 1 to 3 times daily) and currently can be
obtained by breaking in half the scored 50-mg strength tablet.
After considering the citizen petition and reviewing agency
records, FDA determines that for the reasons outlined previously,
DIDREX (benzphetamine HCL) Tablets, 25 mg, were not withdrawn from sale
for reasons of safety or effectiveness. Accordingly, the agency will
continue to list DIDREX (benzphetamine HCl) Tablets, 25 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 DIDREX (benzphetamine
HCl) Tablets, 25 mg, may be approved by the agency as long as they meet
all relevant legal and regulatory requirements for the approval of
ANDAs. If FDA determines that the labeling of this drug product should
be revised to meet current standards, the agency will advise ANDA
applicants to submit such labeling.
Dated: March 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6593 Filed 3-24-10; 8:45 am]
BILLING CODE 4160-01-S
