Determination That ELOXATIN (Oxaliplatin for Injection), 50 and 100 Milligrams Per Vial, Sterile Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 65968-65969 [E7-22973]
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65968
Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / Notices
Dated: November 16, 2007.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–22920 Filed 11–23–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–08–06AY]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Evaluation of the Spanish-Language
Campaign ‘‘Good Morning Arthritis,
Today You Will Not Defeat Us.’’—
New—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Arthritis affects nearly 43 million
Americans, or about one in every five
people, and is the leading cause of
disability among adults in the United
States. Limitations due to arthritis are
particularly burdensome when they
affect an individual’s mobility,
productivity, and ability to earn a living,
as well as psychological and social wellbeing. Because of the broad public
health impact of this disease, the
Centers for Disease Control and
Prevention (CDC) developed the
National Arthritis Action Plan in 1998
as a comprehensive approach to
reducing the burden of arthritis in the
United States.
Hispanics are currently the fastest
growing racial/ethnic group in the
United States. Although Hispanic
populations have a slightly lower
prevalence rate of self-reported, doctordiagnosed arthritis than the general
population, Hispanics with arthritis
report greater work limitations, and
higher rates of severe pain than do
Caucasian populations with arthritis.
CDC has developed a Spanish-language
campaign, Good Morning Arthritis,
Today you will not defeat us, to deliver
culturally appropriate public health
messages about the benefits of physical
activity as an arthritis management
strategy. Campaign materials include
print ads, 30 and 60 second radio ads
and public service announcements, and
desktop displays with brochures for
pharmacies, doctors’ offices, and
community centers. The campaign is
designed to reach Spanish speaking
adults with arthritis who are aged 45–
64, who have high school education or
less, and whose annual income is less
than $35,000. CDC plans to conduct the
campaign in four experimental markets.
CDC requests clearance to conduct an
evaluation of the campaign by collecting
information from Spanish-speaking
respondents in the four experimental
markets and two control markets. An
initial data collection will consist of
telephone interviews, and will be based
on a pre- and post-campaign evaluation
design. A follow-up telephone
interview, involving a subset of the
initial respondents, will be conducted
six months later. Results will be used to
guide the public health practice of the
36 CDC-funded state arthritis programs
and their partners.
There are no costs to respondents
other than their time. The estimated
annualized burden hours are 2,730.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Target Population of Hispanic Adults .............
Screener for Primary Pre- and Post Campaign Survey.
Primary Pre- and Post Campaign Survey .....
Screener for 6–Month Follow-up Survey .......
6–Month Follow-up Survey ............................
Dated: November 16, 2007.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–22930 Filed 11–23–07; 8:45 am]
mstockstill on PROD1PC66 with NOTICES
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006P–0291, 2006P–0299,
2006P–0298, 2006P–0309, and 2007P–0062]
Determination That ELOXATIN
(Oxaliplatin for Injection), 50 and 100
Milligrams Per Vial, Sterile Lyophilized
Powder for Injection, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Aug<31>2005
22:03 Nov 23, 2007
Jkt 214001
PO 00000
Notice.
Frm 00032
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per response (in
hours)
60,000
1
2/60
2,400
2,400
600
1
1
1
13/60
2/60
13/60
Number of
respondents
Type of respondents
SUMMARY: The Food and Drug
Administration (FDA) has determined
that ELOXATIN (oxaliplatin for
injection), 50 and 100 milligrams (mg)
per vial, sterile lyophilized powder for
injection, was not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for oxaliplatin
sterile lyophilized powder for injection,
50 and 100 mg/vial.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sadove, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
E:\FR\FM\26NON1.SGM
26NON1
Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / Notices
Lane, Rockville, MD 20857, 301–594–
2041.
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
sponsors 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. Sponsors of
ANDAs 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 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.
ELOXATIN (oxaliplatin for injection),
50 and 100 mg/vial, sterile lyophilized
powder for injection, is the subject of
approved NDA 21–492 held by SanofiAventis. Oxaliplatin sterile lyophilized
powder for injection, 50 and 100 mg/
vial, is a chemotherapeutic agent
indicated for adjuvant treatment of stage
III colon cancer patients who have
undergone complete resection of the
primary tumor. Sanofi-Aventis ceased
manufacturing ELOXATIN (oxaliplatin
for injection), 50 and 100 mg/vial,
sterile lyophilized powder for injection,
in June 2006.
FDA received five citizen petitions,
submitted under 21 CFR 10.30,
requesting that the agency determine
mstockstill on PROD1PC66 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
22:03 Nov 23, 2007
Jkt 214001
whether oxaliplatin sterile lyophilized
powder for injection, 50 and 100 mg/
vial, was withdrawn from sale for
reasons of safety or effectiveness. The
petitions were submitted as follows:
• Sicor Pharmaceuticals, Inc.,
submitted a citizen petition dated July
24, 2006 (Docket No. 2006P–0291/CP1).
• Rothwell, Figg, Ernst & Manbeck,
P.C., submitted a citizen petition dated
July 24, 2006 (Docket No. 2006P–0299/
CP1).
• AAC Consulting Group submitted a
citizen petition dated July 25, 2006
(Docket No. 2006P–0298/CP1).
• Frommer Lawrence & Haug LLP
submitted a citizen petition dated
August 4, 2006 (Docket No. 2006P–
0309/CP1).
• Regulus Pharmaceutical Consulting,
Inc., submitted a citizen petition dated
February 20, 2007 (Docket No. 2007P–
0062/CP1).
The agency has determined that
ELOXATIN (oxaliplatin for injection),
50 and 100 mg/vial, sterile lyophilized
powder for injection, was not
withdrawn from sale for reasons of
safety or effectiveness. The petitioners
have identified no data or other
information suggesting that oxaliplatin
sterile lyophilized powder for injection,
50 and 100 mg/vial, was 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.
After considering the citizen petitions
and reviewing agency records, FDA
determines that for the reasons outlined
previously, ELOXATIN (oxaliplatin for
injection), 50 and 100 mg/vial, sterile
lyophilized powder for injection, was
not withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list ELOXATIN
(oxaliplatin for injection), 50 and 100
mg/vial, sterile lyophilized powder for
injection, 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 ELOXATIN
(oxaliplatin for injection), 50 and 100
mg/vial, sterile lyophilized powder for
injection, 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
65969
advise ANDA applicants to submit such
labeling.
Dated: November 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–22973 Filed 11–23–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Questionnaire Cognitive
Interview and Pretesting (ARP/DCCPS/
NCI)
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title:
Questionnaire Cognitive Interview and
Pretesting. Type of Information
Collection Request: NEW. Need and Use
of Information Collection: The purpose
of the data collection is to conduct
cognitive interviews, focus groups, Pilot
household interviews, and experimental
research in laboratory and field settings,
both for applied questionnaire
evaluation and more basic research on
response errors in surveys. The most
common evaluation method is the
cognitive interview, in which a
questionnaire design specialist
interviews a volunteer participant. The
interviewer administers the draft survey
questions as written, but also probes the
participant in depth about
interpretations of questions, recall
processes used to answer them, and
adequacy of response categories to
express answers, while noting points of
confusion and errors in responding.
Interviews are generally conducted in
small rounds of 10–15 interviews. When
possible, cognitive interviews are
conducted in the survey’s intended
mode of administration. Cognitive
interviewing provides useful
information on questionnaire
performance at minimal cost and
respondent burden. Similar
methodology has been adopted by other
federal agencies, as well as by academic
and commercial survey organizations.
There are no costs to respondents other
than their time. The total estimated
annualized burden hours are 600.
E:\FR\FM\26NON1.SGM
26NON1
]]>Agencies
[Federal Register Volume 72, Number 226 (Monday, November 26, 2007)]
[Notices]
[Pages 65968-65969]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22973]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006P-0291, 2006P-0299, 2006P-0298, 2006P-0309, and 2007P-
0062]
Determination That ELOXATIN (Oxaliplatin for Injection), 50 and
100 Milligrams Per Vial, Sterile Lyophilized Powder for Injection, 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
ELOXATIN (oxaliplatin for injection), 50 and 100 milligrams (mg) per
vial, sterile lyophilized powder for injection, was not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
oxaliplatin sterile lyophilized powder for injection, 50 and 100 mg/
vial.
FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers
[[Page 65969]]
Lane, Rockville, MD 20857, 301-594-2041.
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
sponsors 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. Sponsors of ANDAs 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 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.
ELOXATIN (oxaliplatin for injection), 50 and 100 mg/vial, sterile
lyophilized powder for injection, is the subject of approved NDA 21-492
held by Sanofi-Aventis. Oxaliplatin sterile lyophilized powder for
injection, 50 and 100 mg/vial, is a chemotherapeutic agent indicated
for adjuvant treatment of stage III colon cancer patients who have
undergone complete resection of the primary tumor. Sanofi-Aventis
ceased manufacturing ELOXATIN (oxaliplatin for injection), 50 and 100
mg/vial, sterile lyophilized powder for injection, in June 2006.
FDA received five citizen petitions, submitted under 21 CFR 10.30,
requesting that the agency determine whether oxaliplatin sterile
lyophilized powder for injection, 50 and 100 mg/vial, was withdrawn
from sale for reasons of safety or effectiveness. The petitions were
submitted as follows:
Sicor Pharmaceuticals, Inc., submitted a citizen petition
dated July 24, 2006 (Docket No. 2006P-0291/CP1).
Rothwell, Figg, Ernst & Manbeck, P.C., submitted a citizen
petition dated July 24, 2006 (Docket No. 2006P-0299/CP1).
AAC Consulting Group submitted a citizen petition dated
July 25, 2006 (Docket No. 2006P-0298/CP1).
Frommer Lawrence & Haug LLP submitted a citizen petition
dated August 4, 2006 (Docket No. 2006P-0309/CP1).
Regulus Pharmaceutical Consulting, Inc., submitted a
citizen petition dated February 20, 2007 (Docket No. 2007P-0062/CP1).
The agency has determined that ELOXATIN (oxaliplatin for
injection), 50 and 100 mg/vial, sterile lyophilized powder for
injection, was not withdrawn from sale for reasons of safety or
effectiveness. The petitioners have identified no data or other
information suggesting that oxaliplatin sterile lyophilized powder for
injection, 50 and 100 mg/vial, was 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.
After considering the citizen petitions and reviewing agency
records, FDA determines that for the reasons outlined previously,
ELOXATIN (oxaliplatin for injection), 50 and 100 mg/vial, sterile
lyophilized powder for injection, was not withdrawn from sale for
reasons of safety or effectiveness. Accordingly, the agency will
continue to list ELOXATIN (oxaliplatin for injection), 50 and 100 mg/
vial, sterile lyophilized powder for injection, 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 ELOXATIN (oxaliplatin for
injection), 50 and 100 mg/vial, sterile lyophilized powder for
injection, 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: November 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22973 Filed 11-23-07; 8:45 am]
BILLING CODE 4160-01-S
