Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid, 70566 [2013-28255]

Download as PDF 70566 Federal Register / Vol. 78, No. 228 / Tuesday, November 26, 2013 / Notices Dated: November 20, 2013. Bernadette Dunahm, Director, Center for Veterinary Medicine. Web site for the FACA database is https://fido.gov/facadatabase/. Naomi Goldstein, Director, Office of Planning, Research, and Evaluation, ACF. Rebecca Slifkin, Director, Office of Planning, Analysis and Evaluation, HRSA. [FR Doc. 2013–28255 Filed 11–25–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2013–28324 Filed 11–25–13; 8:45 am] National Institutes of Health BILLING CODE 4184–22–P Office of the Director, National Institutes of Health; Notice of Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0002] Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at the sponsor’s request because the product is no longer manufactured or marketed. SUMMARY: Withdrawal of approval is effective December 6, 2013. DATES: 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. FOR FURTHER INFORMATION CONTACT: Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008– 019 for PRO–GEN (arsanilic acid) Type A medicated article because the product, used to manufacture Type B and Type C medicated feeds, is no longer manufactured or marketed. 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(21 CFR 514.116), notice is given that approval of NADA 008–019, and all supplements and amendments thereto, is hereby withdrawn.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 this application. emcdonald on DSK67QTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 18:04 Nov 25, 2013 Jkt 232001 Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a stakeholder meeting hosted by the NIH Scientific Management Review Board (SMRB). The SMRB’s Working Group on Approaches to Assess the Value of Biomedical Research Supported by NIH will present their findings and conclusions regarding optimal approaches to assessing the value of biomedical research supported by the NIH. The NIH Reform Act of 2006 (Pub. L. 109–482) provides organizational authorities to HHS and NIH officials to: (1) Establish or abolish national research institutes; (2) reorganize the offices within the Office of the Director, NIH including adding, removing, or transferring the functions of such offices or establishing or terminating such offices; and (3) reorganize, divisions, centers, or other administrative units within an NIH national research institute or national center including adding, removing, or transferring the functions of such units, or establishing or terminating such units. The purpose of the SMRB is to advise appropriate HHS and NIH officials on the use of these organizational authorities and identify the reasons underlying the recommendations. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: Scientific Management Review Board (SMRB). Date: December 18, 2013. Time: 10:00 a.m. to 12:00 p.m. (EST). Agenda: The teleconference will focus on the findings and recommendations of the Working Group on Approaches to Assess the Value of Biomedical Research Supported by NIH. The full Board will review and vote on the draft report from the Working Group. SMRB members will also be presented with a new charge regarding science, technology, PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 engineering, and mathematics (STEM) education. Time will be allotted on the agenda for public comment. To sign up for public comment, please submit your name and affiliation to the contact person listed below by December 17, 2013. Sign-up will be restricted to one sign-up per person. In the event that time does not allow for all those interested to present oral comments, any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. The toll-free number to participate in the teleconference is 800–369–1872, and the passcode will be 7887272. Place: National Institutes of Health, Office of the Director, NIH, Office of Science Policy, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Juanita Marner, Office of Science Policy, Office of the Director, NIH, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, smrb@mail.nih.gov, (301) 435–1770. The draft meeting agenda and other information about the SMRB will be available at https://smrb.od.nih.gov. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxis, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS). Dated: November 20, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–28266 Filed 11–25–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. E:\FR\FM\26NON1.SGM 26NON1

Agencies

[Federal Register Volume 78, Number 228 (Tuesday, November 26, 2013)]
[Notices]
[Page 70566]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28255]


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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; Arsanilic 
Acid

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) for an arsanilic acid Type A 
medicated article at the sponsor's request because the product is no 
longer manufactured or marketed.

DATES: Withdrawal of approval is effective December 6, 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: Fleming Laboratories, Inc., P.O. Box 34384, 
Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 
008-019 for PRO-GEN (arsanilic acid) Type A medicated article because 
the product, used to manufacture Type B and Type C medicated feeds, is 
no longer manufactured or marketed.
    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 NADA 
008-019, 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 this application.

    Dated: November 20, 2013.
Bernadette Dunahm,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-28255 Filed 11-25-13; 8:45 am]
BILLING CODE 4160-01-P
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