Withdrawal of Approval of Part of a New Animal Drug Application; Tiamulin, 22789 [2012-9195]
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22789
Federal Register / Vol. 77, No. 74 / Tuesday, April 17, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0262]
Withdrawal of Approval of Part of a
New Animal Drug Application;
Tiamulin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of those parts of a new animal
drug application (NADA) for a tiamulin
Type A medicated article that pertain to
the production indications for use of
increased rate of weight gain and
improved feed efficiency in swine. This
action is being taken at the sponsor’s
request because this product is no
longer marketed for these uses.
DATES: Withdrawal of approval is
effective April 17, 2012.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Novartis
Animal Health US, Inc. (Novartis), 3200
Northline Ave., suite 300, Greensboro,
NC 27408, has requested that FDA
withdraw approval of those parts of
NADA 139–472 for DENAGARD
(tiamulin) Type A medicated article
pertaining to the production indications
for use of increased rate of weight gain
and improved feed efficiency in swine.
Novartis requested voluntary
withdrawal of approval of these
indications for use because this product
is no longer marketed for these uses.
Revised product labeling reflecting the
SUMMARY:
withdrawal of these indications has
been approved in a supplement to
NADA 139–472.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Director of the
Center for Veterinary Medicine, and in
accordance with § 514.116 Notice of
withdrawal of approval of application
(21 CFR 514.116), notice is given that
approval of those parts of NADA 139–
472 pertaining to the production
indications for use of increased rate of
weight gain and improved feed
efficiency in swine are hereby
withdrawn, effective April 17, 2012.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the
withdrawal of approval of those parts of
NADA 139–472.
Dated: March 21, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012–9195 Filed 4–16–12; 8:45 am]
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U.S.C. Chapter 35). To request a copy of
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Number of
respondents
Instrument
Responses
per
respondent
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1984.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: The Health
Professions Student Loan (HPSL) and
Nursing Student Loan (NSL) Programs:
Forms (OMB No. 0915–0044)—
[Revision]
The HPSL Program provides longterm, low interest loans to students
attending schools of medicine,
osteopathic medicine, dentistry,
veterinary medicine, optometry,
podiatric medicine, and pharmacy. The
NSL Program provides long-term, lowinterest loans to students who attend
eligible schools of nursing in programs
leading to a diploma in nursing, an
associate degree, a baccalaureate degree,
or graduate degree in nursing.
Participating HPSL and NSL schools
are responsible for determining the
eligibility of applicants, making loans,
and collecting monies owed by
borrowers on their outstanding loans.
The Deferment Form (Deferment-HRSA
Form 519) provides the schools with
documentation of a borrower’s
eligibility for deferment. The Annual
Operating Report (AOR–HRSA Form
501) relates to HPSL and NSL program
operations and financial activities, and
provides the Federal Government with
information from participating active
schools, as well as schools that no
longer grant loans, but are required to
report and maintain program records,
student records, and repayment records
until all student loans are repaid in full
and all monies due to the Federal
Government are returned.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
3,234
834
1
1
3,234
834
0.533333
12.000000
1,725
10,008
Total ..............................................................................
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Deferment—HRSA Form 519 ..............................................
AOR–HRSA—Form 501 ......................................................
4,068
........................
4,068
........................
11,733
VerDate Mar<15>2010
14:27 Apr 16, 2012
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]]>Agencies
[Federal Register Volume 77, Number 74 (Tuesday, April 17, 2012)]
[Notices]
[Page 22789]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9195]
[[Page 22789]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0262]
Withdrawal of Approval of Part of a New Animal Drug Application;
Tiamulin
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of those parts of a new animal drug application (NADA) for a tiamulin
Type A medicated article that pertain to the production indications for
use of increased rate of weight gain and improved feed efficiency in
swine. This action is being taken at the sponsor's request because this
product is no longer marketed for these uses.
DATES: Withdrawal of approval is effective April 17, 2012.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341,
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc. (Novartis),
3200 Northline Ave., suite 300, Greensboro, NC 27408, has requested
that FDA withdraw approval of those parts of NADA 139-472 for DENAGARD
(tiamulin) Type A medicated article pertaining to the production
indications for use of increased rate of weight gain and improved feed
efficiency in swine. Novartis requested voluntary withdrawal of
approval of these indications for use because this product is no longer
marketed for these uses. Revised product labeling reflecting the
withdrawal of these indications has been approved in a supplement to
NADA 139-472.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Director of the Center for Veterinary
Medicine, and in accordance with Sec. 514.116 Notice of withdrawal of
approval of application (21 CFR 514.116), notice is given that approval
of those parts of NADA 139-472 pertaining to the production indications
for use of increased rate of weight gain and improved feed efficiency
in swine are hereby withdrawn, effective April 17, 2012.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the withdrawal of approval of
those parts of NADA 139-472.
Dated: March 21, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-9195 Filed 4-16-12; 8:45 am]
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