Determination That SANOREX (Mazindol) Tablets 1 and 2 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 40582-40583 [E8-15998]
Download as PDF
<![CDATA[
40582
Federal Register / Vol. 73, No. 136 / Tuesday, July 15, 2008 / Notices
websites for ordinary business purposes,
including advertising their goods or
services and to facilitate communication
with the public. Accordingly, any costs
franchisors would incur specifically as
a result of electronic disclosure under
part 436 appear to be minimal.
As set forth in the 2005 Notices, staff
estimates that the non-labor burden
incurred by franchisors under part 436
will differ based on the length of the
disclosure document and the number of
disclosure documents produced. Staff
estimates that 2,000 franchisors (80% of
total franchisors covered by the Rule)
will print and mail 100 disclosure
documents at $35 each. Thus, these
franchisors will each incur $3,500 in
printing and mailing costs. Staff
estimates that the remaining 20% of
covered franchisors (500) will transmit
50% of their 100 disclosure documents
electronically, at $5 per electronic
disclosure. Thus, these franchisors will
each incur $2,000 in distribution costs
(($250 for electronic disclosure [$5 for
electronic disclosure x 50 disclosure
documents]) + ($1,750 for printing and
mailing [$35 for printing and mailing x
50 disclosure documents])).
Accordingly, the cumulative annual
non-labor costs for part 436 of the
amended Rule is approximately
$8,000,000 (($3,500 printing and
mailing costs x 2,000 franchisors =
$7,000,000) + ($250 electronic
distribution costs + $1,750 printing and
mailing costs) x 500 franchisors =
$1,000,000)).
William Blumenthal
General Counsel
[FR Doc. E8–16092 Filed 7–15–08: 8:45 am]
[BILLING CODE 6750–01–S]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
National Institute for Occupational
Safety and Health (NIOSH) Advisory
Board on Radiation and Worker Health
(ABRWH orAdvisory Board)
mstockstill on PROD1PC66 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention announces the
following committee meeting:
Name: Advisory Board on Radiation and
Worker Health, National Institute for
Occupational Safety and Health.
Audio Conference Call Time And Date: 11
a.m.–4 p.m., EDT, Tuesday, August 5, 2008.
Place: Audio Conference Call via FTS
Conferencing. The USA toll free dial in
VerDate Aug<31>2005
15:01 Jul 14, 2008
Jkt 214001
number is 1–866–659–0537 with a pass code
of 9933701.
Status: Open to the public, but without a
public comment period.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation Program
Act of 2000 to advise the President on a
variety of policy and technical functions
required to implement and effectively
manage the new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines which
have been promulgated by the Department of
Health and Human Services (HHS) as a final
rule, advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule, advice
on the scientific validity and quality of dose
estimation and reconstruction efforts being
performed for purposes of the compensation
program, and advice on petitions to add
classes of workers to the Special Exposure
Cohort (SEC). In December 2000, the
President delegated responsibility for
funding, staffing, and operating the Advisory
Board to HHS, which subsequently delegated
this authority to the CDC. NIOSH implements
this responsibility for CDC. The charter was
issued on August 3, 2001, renewed at
appropriate intervals, most recently, August
3, 2007, and will expire on August 3, 2009.
Purpose: This Advisory Board is charged
with (a) Providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b) providing
advice to the Secretary, HHS, on the
scientific validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advising the Secretary on
whether there is a class of employees at any
Department of Energy facility who were
exposed to radiation but for whom it is not
feasible to estimate their radiation dose, and
on whether there is reasonable likelihood
that such radiation doses may have
endangered the health of members of this
class.
Matters to be Discussed: The agenda for the
conference call includes: Special Exposure
Cohort (SEC) Petition Status Updates;
Updates from the Subcommittee on Dose
Reconstruction and Work Groups; Update on
selection of the Board’s contractor; Future
Plans; and Status of transcripts and minutes.
The agenda is subject to change as
priorities dictate.
Because there is not a public comment
period, written comments may be submitted.
Any written comments received will be
included in the official record of the meeting
and should be submitted to the contact
person below well in advance of the meeting.
Contact Person for More Information:
Zaida Burgos, Committee Management
Specialist, NIOSH, CDC, 1600 Clifton Road,
Atlanta, Georgia 30033, Telephone (404)
498–2548 e-mail: zab6@cdc.gov.
Toll Free 1–800–CDC-INFO, e-mail
ocas@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
PO 00000
Frm 00104
Fmt 4703
Sfmt 4703
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: July 8, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–16065 Filed 7–14–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–P–0326]
Determination That SANOREX
(Mazindol) Tablets 1 and 2 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) is announcing its
determination that SANOREX
(mazindol) Tablets, 1 and 2 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 mazindol
tablets if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Carol E. Drew, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306
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
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.
E:\FR\FM\15JYN1.SGM
15JYN1
mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 73, No. 136 / Tuesday, July 15, 2008 / 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).
Regulations also provide that the agency
must make a determination as to
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
(§ 314.161(a)(1) (21 CFR 314.161(a)(1))).
FDA may not approve an ANDA that
does not refer to a listed drug.
On August 20, 2007, AAIPharma
submitted a citizen petition (Docket No.
2007P–0326/CP1) to FDA under 21 CFR
10.30. The petition requests that the
agency determine whether SANOREX
(mazindol) Tablets, 1 and 2 mg (NDA
17–247), manufactured by Novartis
Pharmaceuticals Corp. (Novartis), were
withdrawn from sale for reasons of
safety or effectiveness. SANOREX is
approved for the management of
exogenous obesity as a short term
adjunct in a regimen of weight
reduction based on caloric restriction in
certain patients. SANOREX Tablets
were approved on June 14, 1973.
SANOREX Tablets were discontinued in
1999, and the drug product was moved
from the prescription drug product list
to the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
FDA has reviewed its records and,
under § 314.161, has determined that
SANOREX Tablets, 1 and 2 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. The petitioner
identified no data or other information
suggesting that SANOREX Tablets, 1
and 2 mg, were withdrawn for reasons
of safety or effectiveness. FDA has
independently evaluated relevant
literature and data for possible
postmarketing adverse events and has
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 SANOREX
Tablets 1 and 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
VerDate Aug<31>2005
15:01 Jul 14, 2008
Jkt 214001
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to SANOREX
(mazindol) Tablets, 1 and 2 mg, may be
approved by the agency if all other legal
and regulatory requirements for the
approval of ANDAs are met. 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: July 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15998 Filed 7–14–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
40583
Submit written requests for
single copies of these documents to the
Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 240–276–3151. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
documents.
Submit written comments concerning
these documents to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.reguations.gov. Identify comments
with the docket number found in
brackets in the heading of this
document.
ADDRESSES:
For
information regarding Study Group 1:
Ginette Y. Michaud, Chairperson,
GHTF, Study Group 1, Office of Device
Evaluation, Center for Devices and
Radiological Health (HFZ–480), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3700.
For information regarding Study
Group 3: Kimberly Trautman, GHTF,
Study Group 3, Office of Compliance,
Center for Devices and Radiological
Health (HFZ–340), Food and Drug
Administration, 2094 Gaither Rd.,
Rockville, MD 20850, 240–276–0296.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2008–N–0356]
Global Harmonization Task Force,
Study Groups 1 and 3; Proposed and
Final Documents; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of final and proposed
documents that have been prepared by
Study Groups 1 and 3 of the Global
Harmonization Task Force (GHTF),
respectively. These documents
represent a harmonized proposal and
recommendation from the GHTF Study
Groups that may be used by
governments developing and updating
their regulatory requirements for
medical devices. These documents are
intended to provide information only
and do not describe FDA’s current
regulatory requirements; elements of
these documents may not be consistent
with current U.S. regulatory
requirements. In particular, FDA seeks
comments on the advantages and
disadvantages of the approaches in the
GHTF documents, particularly where
they are not consistent with current
practices for the manufacturer of
products distributed within the United
States.
DATES: Submit written or electronic
comments on these documents by
October 14, 2008. After October 14,
2008, written comments or electronic
comments may be submitted at any time
to the contact persons listed in this
document.
PO 00000
Frm 00105
Fmt 4703
Sfmt 4703
I. Background
FDA has participated in a number of
activities to promote the international
harmonization of regulatory
requirements. In September 1992, a
meeting was held in Nice, France by
senior regulatory officials to evaluate
international harmonization. This
meeting led to the development of the
organization now known as the GHTF to
facilitate harmonization. Subsequent
meetings have been held in various
locations throughout the world.
The GHTF is a voluntary group of
representatives from national medical
device regulatory authorities and the
regulated industry. Since its inception,
the GHTF has been comprised of
representatives from five founding
members grouped into three
geographical areas: Europe, Asia-Pacific,
and North America, each of which
actively regulates medical devices using
their own unique regulatory framework.
The objective of the GHTF is to
encourage convergence at the global
E:\FR\FM\15JYN1.SGM
15JYN1
]]>Agencies
[Federal Register Volume 73, Number 136 (Tuesday, July 15, 2008)]
[Notices]
[Pages 40582-40583]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15998]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-P-0326]
Determination That SANOREX (Mazindol) Tablets 1 and 2 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) is announcing its
determination that SANOREX (mazindol) Tablets, 1 and 2 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 mazindol tablets if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306 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 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 40583]]
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). Regulations also provide that the
agency must make a determination as to 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 (Sec.
314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that
does not refer to a listed drug.
On August 20, 2007, AAIPharma submitted a citizen petition (Docket
No. 2007P-0326/CP1) to FDA under 21 CFR 10.30. The petition requests
that the agency determine whether SANOREX (mazindol) Tablets, 1 and 2
mg (NDA 17-247), manufactured by Novartis Pharmaceuticals Corp.
(Novartis), were withdrawn from sale for reasons of safety or
effectiveness. SANOREX is approved for the management of exogenous
obesity as a short term adjunct in a regimen of weight reduction based
on caloric restriction in certain patients. SANOREX Tablets were
approved on June 14, 1973. SANOREX Tablets were discontinued in 1999,
and the drug product was moved from the prescription drug product list
to the ``Discontinued Drug Product List'' section of the Orange Book.
FDA has reviewed its records and, under Sec. 314.161, has
determined that SANOREX Tablets, 1 and 2 mg, were not withdrawn from
sale for reasons of safety or effectiveness. The petitioner identified
no data or other information suggesting that SANOREX Tablets, 1 and 2
mg, were withdrawn for reasons of safety or effectiveness. FDA has
independently evaluated relevant literature and data for possible
postmarketing adverse events and has 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
SANOREX Tablets 1 and 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 SANOREX (mazindol) Tablets, 1 and 2
mg, may be approved by the agency if all other legal and regulatory
requirements for the approval of ANDAs are met. 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: July 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15998 Filed 7-14-08; 8:45 am]
BILLING CODE 4160-01-S
