Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone, 70062 [2013-27916]
Download as PDF
<![CDATA[
70062
Federal Register / Vol. 78, No. 226 / Friday, November 22, 2013 / Notices
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Rockville, MD 20855, 240–276–9079,
john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis
Inc., 333 Portage St., Kalamazoo, MI
49007, has requested that FDA
withdraw approval of the following
three NADAs because the products,
used to manufacture Type B and Type
C medicated feeds, are no longer
manufactured or marketed: NADA 007–
891 for 3–NITRO (roxarsone) Type A
medicated article, NADA 092–953 for
Roxarsone Type A Medicated Articles,
and NADA 010–285 for CARB–O–SEP
(carbarsone) Type A medicated article.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to 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 NADAs 007–891, 092–953, and 010–
285, and all supplements and
amendments thereto, is hereby
withdrawn.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–27916 Filed 11–21–13; 8:45 am]
Dated: November 18, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
BILLING CODE 4160–01–P
[FR Doc. 2013–28062 Filed 11–21–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Food and Drug Administration
[Docket No. FDA–2013–N–0002]
Withdrawal of Approval of New Animal
Drug Applications; Carbarsone;
Roxarsone
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of three new animal drug
applications (NADAs) for roxarsone or
carbarsone Type A medicated articles at
the sponsor’s request because the
products are no longer manufactured or
marketed.
DATES: Withdrawal of approval is
effective December 2, 2013.
FOR FURTHER INFORMATION CONTACT: John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:47 Nov 21, 2013
Jkt 232001
Proposed Collection; 60-Day Comment
Request: Clearance for Surveys of
Customers and Partners of the Office
of Extramural Research of the National
Institutes of Health
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
Office of Extramural Research (OER),
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.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To submit comments in writing,
request more information on the
proposed project, or to obtain a copy of
the data collection plans and
instruments, contact Dr. Sherry Mills,
Director, Office of Extramural Programs,
OER, NIH, 6705 Rockledge Drive, Suite
350, Bethesda, MD 20892, or call nontoll-free number (301) 435–2729, or
Email your request, including your
address to: OEPMailbox@mail.nih.gov.
Comments regarding this information
collection are best assured of having
their full effect if received within 60days of the date of this publication.
Proposed Collection: Generic
Clearance for Surveys of Customers and
Partners of the Office of Extramural
Research of the National Institutes of
Health—Extension—0925–0627—Office
of the Director (OD), Office of
Extramural Research (OER), Office of
Extramural Programs (OEP), National
Institutes of Health (NIH).
Need and Use of Information
Collection: OER develops, coordinates
the implementation of, and evaluates
NIH-wide policies and procedures for
the award of extramural funds. To move
forward with our initiatives to ensure
success in accomplishing the NIH
mission, input from partners and
customers is essential. Quality
management principles have been
integrated into OER’s culture and these
surveys will provide customer
satisfaction input on various elements of
OER’s business processes. The
approximately 14 (10 quantitative and 4
qualitative) customer satisfaction
surveys that will be conducted under
this generic clearance will gather and
measure customer and partner
satisfaction with OER processes and
operations. The data collected from
these surveys will provide the feedback
to track and gauge satisfaction with
NIH’s statutorily mandated operations
and processes. OER/OD/NIH will
present data and outcomes from these
surveys to inform the NIH staff, officers,
leadership, advisory committees, and
other decision-making bodies as
appropriate. Based on feedback from
these stakeholders, OER/OD/NIH will
E:\FR\FM\22NON1.SGM
22NON1
]]>Agencies
[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Notices]
[Page 70062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27916]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0002]
Withdrawal of Approval of New Animal Drug Applications;
Carbarsone; Roxarsone
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of three new animal drug applications (NADAs) for roxarsone or
carbarsone Type A medicated articles at the sponsor's request because
the products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective December 2, 2013.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007, has requested that FDA withdraw approval of the following three
NADAs because the products, used to manufacture Type B and Type C
medicated feeds, are no longer manufactured or marketed: NADA 007-891
for 3-NITRO (roxarsone) Type A medicated article, NADA 092-953 for
Roxarsone Type A Medicated Articles, and NADA 010-285 for CARB-O-SEP
(carbarsone) Type A medicated article.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to 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 NADAs
007-891, 092-953, and 010-285, and all supplements and amendments
thereto, is hereby withdrawn.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.
Dated: November 18, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-27916 Filed 11-21-13; 8:45 am]
BILLING CODE 4160-01-P
