Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone, 70062 [2013-27916]

Download as PDF 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is given that approval of NADAs 007–891, 092–953, and 010– 285, and all supplements and amendments thereto, is hereby withdrawn.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

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[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]


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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.

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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