Global Implementation of the Veterinary Medicinal Products Guidelines, 61504-61505 [2010-24905]
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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was withdrawn from sale for reasons of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withdrawn from sale for reasons of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withdrawn from sale for reasons of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
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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
Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
international standards, as an
instrumental and essential prerequisite
to the establishment and effective
implementation of adequate and
appropriate legislation covering all
aspects of products for veterinary use,
including registration, quality control,
distribution, monitoring of quantities
and final use.
• Develop and improve international
and regional cooperation in the
establishment and enforcement of
legislation to harmonize the regulatory
framework between OIE Member States
so as to assist countries in need to
effectively institute and maintain such
mechanisms.
• Encourage countries to allocate
appropriate human and financial
resources to veterinary services and
laboratories to correctly implement the
OIE standards and guidelines related to
veterinary products and their control.
• Enhance capacities of national focal
points for OIE on matters related to
veterinary products according to the
suggested terms of reference and
encourage his/her participation in
training sessions and appropriate
international gatherings and meetings.
• Promote the responsible and
prudent use of veterinary medicinal
products, in particular of antimicrobials
used in veterinary medicine, and the
monitoring of the quantities used and
potential existence or development of
antimicrobial resistance in diseasecausing organisms affecting both
humans and animals.
• Actively encourage the recognition
and application of the international
recommendations, guidelines and tools
developed by the OIE and adopted by
the World Assembly of Delegates on
veterinary products.
C. Eligibility Information
The following organizations/
institutions are eligible to apply: The
OIE.
II. Award Information/Funds Available
mstockstill on DSKH9S0YB1PROD with NOTICES
A. Award Amount
FDA anticipates providing one award
of $565,000 (total costs including
indirect costs) in fiscal year (FY) 2010
in support of this project. Subject to the
availability of funds and successful
performance, 1 additional year of
support up to $565,000 per year will be
available.
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. 2010–24905 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Listing of Members of the
National Institutes of Health’s Senior
Executive Service 2010 Performance
Review Board (PRB)
The National Institutes of Health
(NIH) announces the persons who will
serve on the National Institutes of
Health’s Senior Executive Service 2010
Performance Review Board. This action
is being taken in accordance with Title
5, U.S.C., 4314(c)(4), which requires that
members of performance review boards
be appointed in a manner to ensure
consistency, stability, and objectivity in
performance appraisals and requires
that notice of the appointment of an
individual to serve as a member be
published in the Federal Register.
The following persons will serve on
the NIH Performance Review Board,
which oversees the evaluation of
performance appraisals of NIH Senior
Executive Service (SES) members:
Ms. Colleen Barros (Chair), Dr. Michael
Gottesman, Ms. Lenora Johnson, Ms.
Robin Kawazoe, Dr. Sally Rockey, Dr.
Lawrence Tabak, Dr. Samir Zakhari.
For further information about the NIH
Performance Review Board, contact the
Office of Human Resources, Workforce
Relations Division, National Institutes of
Health, Building 31, Room B3C07,
Bethesda, Maryland 20892, telephone
301–402–9203 (not a toll-free number).
Dated: September 27, 2010.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2010–24929 Filed 10–4–10; 8:45 am]
BILLING CODE 4140–01–P
The support will be 1 year with the
possibility of an additional year of
noncompetitive support. Continuation
beyond the first year will be based on
satisfactory performance during the
18:36 Oct 04, 2010
Jkt 223001
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC)—Health Disparities
Subcommittee (HDS)
Correction: This notice was published
in the Federal Register on September 1,
2010, Volume 75, Number 169, page
53703. A quorum of the subcommittee’s
membership was not able to participate;
therefore, the meeting was adjourned.
The subcommittee will reconvene as
follows:
Time and Date: 2 p.m.–3 p.m.,
October 21, 2010.
Place: Teleconference.
Status: Open to the public.
Teleconference access limited only by
the availability of telephone ports. The
public is welcome to participate during
the public comment period, which is
tentatively scheduled from 2:45 p.m. to
2:50 p.m. To participate in the
teleconference please dial (877) 394–
7734 and enter conference code
9363147.
Purpose: The Subcommittee will
provide recommendations for
consideration to the ACD on strategic
and other broad issues facing CDC.
Matters To Be Discussed: Policy brief
on health equity and social
determinants of health; update on
collaboration with the CDC Health
Equity Workgroup; CDC Director’s
Annual Health Disparity Report; and
briefing on the realignment of the CDC
Office of Minority Health and Health
Disparities. Agenda items are subject to
change as priorities dictate.
Contact Person for More Information:
Walter W. Williams, M.D., M.P.H.,
Designated Federal Officer, HDS, ACD,
CDC, 1600 Clifton Road, NE., M/S E–67,
Atlanta, Georgia 30333. Telephone (404)
498–2310, E-mail: https://
www1@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 other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: September 29, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
B. Length of Support
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[FR Doc. 2010–24911 Filed 10–4–10; 8:45 am]
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Agencies
[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61504-61505]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24905]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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 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
[[Page 61505]]
international standards, as an instrumental and essential prerequisite
to the establishment and effective implementation of adequate and
appropriate legislation covering all aspects of products for veterinary
use, including registration, quality control, distribution, monitoring
of quantities and final use.
Develop and improve international and regional cooperation
in the establishment and enforcement of legislation to harmonize the
regulatory framework between OIE Member States so as to assist
countries in need to effectively institute and maintain such
mechanisms.
Encourage countries to allocate appropriate human and
financial resources to veterinary services and laboratories to
correctly implement the OIE standards and guidelines related to
veterinary products and their control.
Enhance capacities of national focal points for OIE on
matters related to veterinary products according to the suggested terms
of reference and encourage his/her participation in training sessions
and appropriate international gatherings and meetings.
Promote the responsible and prudent use of veterinary
medicinal products, in particular of antimicrobials used in veterinary
medicine, and the monitoring of the quantities used and potential
existence or development of antimicrobial resistance in disease-causing
organisms affecting both humans and animals.
Actively encourage the recognition and application of the
international recommendations, guidelines and tools developed by the
OIE and adopted by the World Assembly of Delegates on veterinary
products.
C. Eligibility Information
The following organizations/institutions are eligible to apply: The
OIE.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing one award of $565,000 (total costs
including indirect costs) in fiscal year (FY) 2010 in support of this
project. Subject to the availability of funds and successful
performance, 1 additional year of support up to $565,000 per year will
be available.
B. Length of Support
The support will be 1 year with the possibility of an additional
year of noncompetitive support. Continuation beyond the first year will
be based on satisfactory performance during the preceding year, receipt
of a non-competing continuation application and available Federal FY
appropriations.
Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24905 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S