Determination That AZDONE (Hydrocodone Bitartrate and Aspirin) Tablet, 5 Milligrams/500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 61503-61504 [2010-24902]
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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
• As appropriate, explore with the
WHO, the possibility of expanding this
information hub to other WHO Regions.
C. Eligibility Information
The following organizations/
institutions are eligible to apply: the
PAHO.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing one award
of $904,000 (total costs including
indirect costs) in FY 2010 in support of
this project.
B. Length of Support
The support will be 1 year with the
possibility of an additional 3 years of
noncompetitive support. Continuation
beyond the first year will be based on
satisfactory performance during the
preceding year, receipt of a noncompeting continuation application and
available Federal FY appropriations.
Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–24906 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0494]
Cooperative Agreement With the World
Health Organization for a Plan to
Develop a Global Integrated Food
Safety Information Platform
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces its
intention to accept and consider a single
source application for awarding a
cooperative agreement to the World
Health Organization (WHO),
Department of Food Safety and
Zoonoses, to develop a plan for a global
integrated food safety information
system or platform in partnership with
the WHO Secretariat and the Member
States.
FOR FURTHER INFORMATION CONTACT:
Management Contact: Katherine C.
Bond, Office of International
Programs, Office of the
Commissioner, Food and Drug
Administration, White Oak Bldg.
32, rm. 3300, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–8318, FAX: 301–
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:36 Oct 04, 2010
Jkt 223001
595–5058, email:
Katherine.Bond@fda.hhs.gov.
Grants Contact: Kimberly Pendleton,
Division of Acquisition and Grants
(HFA–500), Food and Drug
Administration, 5630 Fishers Lane,
rm. 2104, Rockville, MD 20857,
301–827–9363, FAX: 301–827–
7101, email:
kimberly.pendleton@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
contact Kimberly Pendleton.
61503
C. Eligibility Information
The following organizations/
institutions are eligible to apply: The
WHO.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing one award
of $395,500 (total costs including
indirect costs) in fiscal year (FY) 2010
in support of this project.
B. Length of Support
I. Funding Opportunity Description
The total project period for an
application submitted in response to
this funding opportunity may not
exceed 1 year.
RFA–FD–10–009
Catalog of Federal Domestic Assistance
Number(s): 93.103 https://www.cfda.gov
Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
A. Background
[FR Doc. 2010–24904 Filed 10–4–10; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–S
FDA announces its intention to accept
and consider a single source application
for awarding a cooperative agreement to
the WHO, Department of Food Safety
and Zoonoses to develop a plan for a
global integrated food safety information
system or platform in partnership with
the WHO Secretariat and the Member
States. This project represents a
collaborative agreement between WHO
and FDA in support of global solutions
to address food safety problems; global
sharing of comparable food safety data
and information; and improved global
capacity for detection of and response to
food safety threats through preventative
controls, data and surveillance and riskbased approaches.
B. Research Objectives
• Outreach to parties who have
information needs and information to
share to ascertain their interests and to
cultivate their support;
• Engagement of all relevant parties
in defining the goals and designing the
system to maximize utilization and
sustainability;
• A timeline for development, design,
pilot-testing, implementation and
maintenance of a global integrated
information platform;
• A business plan that delineates the
commitment, support and resources of
the WHO Secretariat and relevant
stakeholders essential to ensure full
implementation and long-term
sustainability; and
• A clear articulation of the benefits,
measurable outputs and impacts that
would result from a WHO global
integrated information platform to the
global community, Member States and
other relevant parties and stakeholders.
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–P–0338]
Determination That AZDONE
(Hydrocodone Bitartrate and Aspirin)
Tablet, 5 Milligrams/500 Milligrams,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that AZDONE (hydrocodone bitartrate
and aspirin) Tablet, 5 milligrams (mg)/
500 mg, was not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for hydrocodone
bitartrate and aspirin tablet, 5 mg/500
mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Deborah Livornese, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306,
Silver Spring, MD 20993–0002, 301–
796–0719.
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
SUMMARY:
E:\FR\FM\05OCN1.SGM
05OCN1
mstockstill on DSKH9S0YB1PROD with NOTICES
61504
Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
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.
AZDONE (hydrocodone bitartrate and
aspirin) Tablet, 5 mg/500 mg, is the
subject of ANDA 89–420, held by
Schwarz Pharma, Inc., and initially
approved on January 25, 1988. AZDONE
is indicated for the relief of moderate to
moderately severe pain. AZDONE
(hydrocodone bitartrate and aspirin)
Tablet, 5 mg/500 mg is currently listed
in the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated June
23, 2010 (Docket No. FDA–2010–P–
0338), under 21 CFR 10.30, requesting
that the Agency determine whether
AZDONE (hydrocodone bitartrate and
aspirin) Tablet, 5 mg/500 mg, 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
AZDONE (hydrocodone bitartrate and
aspirin) Tablet, 5 mg/500 mg was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
VerDate Mar<15>2010
18:36 Oct 04, 2010
Jkt 223001
identified no data or other information
suggesting that AZDONE (hydrocodone
bitartrate and aspirin) Tablet, 5 mg/500
mg, was withdrawn for reasons of safety
or effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of AZDONE
(hydrocodone bitartrate and aspirin)
Tablet, 5 mg/500 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
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
Agency will continue to list AZDONE
(hydrocodone bitartrate and aspirin)
Tablet, 5 mg/500 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 AZDONE (hydrocodone bitartrate and
aspirin) Tablet, 5 mg/500 mg, 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: September 29, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–24902 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0497]
Global Implementation of the
Veterinary Medicinal Products
Guidelines
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces its
intention to accept and consider a single
source application for a cooperative
agreement to the World Organization for
Animal Health (OIE). The OIE is the
intergovernmental organization
responsible for improving animal health
worldwide and is recognized by the
World Trade Organization (WTO) as a
reference for international sanitary
SUMMARY:
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
rules, with 175 Member Countries and
Territories. The purpose of this
agreement is to continue outreach that
began in fiscal year (FY) 2009 to expand
capacity building to support OIE’s
services and activities that are needed to
carry out OIE’s Veterinary International
Conference on Harmonization (VICH)
Global Outreach to disseminate and
implement VICH guidelines at the
country level.
FOR FURTHER INFORMATION CONTACT:
Program Contact: Merton V. Smith,
Center for Veterinary Medicine
(HFV–1), Food and Drug
Administration, 7519 Standish Pl.,
rm. 177, Rockville, MD 20855, 240–
276–9025, FAX: 240–276–9030,
email: Merton.Smith@fda.hhs.gov.
Management Contact: Katherine C.
Bond, Office of the Commissioner,
Food and Drug Administration,
White Oak Bldg. 32, rm. 3300,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–8318,
FAX: 301–595–5058, email:
Katherine.Bond@fda.hhs.gov.
Grants Contact: Kimberly Pendleton,
Division of Acquisition and Grants
(HFA–500), Food and Drug
Administration, 5630 Fishers Lane,
rm. 2104, Rockville, MD 20857,
301–827–9363, FAX: 301–827–
7101, email:
kimberly.pendleton@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
contact Kimberly Pendleton.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA–FD–10–010
Catalog of Federal Domestic Assistance
Number(s): 93.103 https://www.cfda.gov
A. Background
FDA announces its intention to accept
and consider a single source application
for award of a cooperative agreement to
the OIE in support of international
technical capacity building activities
that help to assure that U.S. imports of
veterinary medicinal products are safe,
effective, and of high quality and that
food from treated animals is safe and
wholesome; to assist foreign regulators
in developing and using rigorous safety
standards; to develop and foster
mutually beneficial regulatory
partnerships; and to leverage resources
for capacity building through
appropriate training and other activities.
B. Research Objectives
• Promote and enhance in OIE
Members good veterinary governance,
which includes the compliance of
Veterinary Services with OIE
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61503-61504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24902]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-P-0338]
Determination That AZDONE (Hydrocodone Bitartrate and Aspirin)
Tablet, 5 Milligrams/500 Milligrams, 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
AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 milligrams (mg)/
500 mg, was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for hydrocodone bitartrate and aspirin
tablet, 5 mg/500 mg, if all other legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT: Deborah Livornese, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002, 301-
796-0719.
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
[[Page 61504]]
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.
AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, is
the subject of ANDA 89-420, held by Schwarz Pharma, Inc., and initially
approved on January 25, 1988. AZDONE is indicated for the relief of
moderate to moderately severe pain. AZDONE (hydrocodone bitartrate and
aspirin) Tablet, 5 mg/500 mg is currently listed in the ``Discontinued
Drug Product List'' section of the Orange Book.
Lachman Consultant Services, Inc., submitted a citizen petition
dated June 23, 2010 (Docket No. FDA-2010-P-0338), under 21 CFR 10.30,
requesting that the Agency determine whether AZDONE (hydrocodone
bitartrate and aspirin) Tablet, 5 mg/500 mg, 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 AZDONE
(hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that AZDONE
(hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, was withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of AZDONE (hydrocodone
bitartrate and aspirin) Tablet, 5 mg/500 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 withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the Agency will continue to list
AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 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 AZDONE (hydrocodone
bitartrate and aspirin) Tablet, 5 mg/500 mg, 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: September 29, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-24902 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S
