Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc, 49282 [E7-16985]

Download as PDF 49282 Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0324] Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for a bacitracin zinc Type A medicated article. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of this NADA. FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301–827– 7818; e-mail: pamela.esposito@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, has requested that FDA withdraw approval of NADA 128–550 for ANCHOR Zinc Bacitracin Type A medicated article because the product is not 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 § 514.115 Withdrawal of approval of applications (21 CFR 514.115), notice is given that approval of NADA 128– 550, and all supplements and amendments thereto, are hereby withdrawn, effective August 28, 2007. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of this NADA. Dated: August 20, 2007. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E7–16985 Filed 8–27–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Pretesting of NIAID’s HIV Vaccine Research Communications Messages SUMMARY: 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 National Institute of Allergy and Infectious Diseases (NIAID), 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. Proposed Collection: Title: Pretesting of NIAID’s HIV Vaccine Research Estimated number of respondents Type of respondents Communications Messages. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for clearance to pretest messages, materials and program activities produced for the NIAID HIV Vaccine Research Education Initiative (NHVREI). The primary objectives of the pretests are to (1) Assess audience knowledge, attitudes, behaviors and other characteristics for the planning/ development of health messages, education products, communication strategies, and public information programs; and (2) pretest these health messages, products, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions. The information obtained from audience research and pretesting results in more effective messages, materials, and programmatic strategies. By maximizing the effectiveness of these messages and strategies for reaching targeted audiences, the frequency with which publications, products, and programs need to be modified is reduced. Frequency of Response: On occasion. Affected Public: Individuals. Type of Respondents: Adults at risk for HIV/AIDS, particularly those who are Black/African-American, Hispanic/ Latino, or men who have sex with men; healthcare providers; representatives of organizations disseminating HIV-related messages or materials. The annual reporting burden is shown in the table below. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated number of responses per respondent Average burden hours per response 3,374 50 75 1 1 1 .3422 .75 .50 Total ...................................................................................................... pwalker on PROD1PC71 with NOTICES At-risk Adults ................................................................................................ Healthcare providers .................................................................................... Organization Gatekeepers ........................................................................... 3,499 ........................ .......................... Request for Comments: 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 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 VerDate Aug<31>2005 19:52 Aug 27, 2007 Jkt 211001 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 request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Katharine Kripke, Assistant FOR FURTHER INFORMATION: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Estimated total annual burden hours requested 1155 37.5 37.5 1230 Director, Vaccine Research Program, Division of AIDS, NIAID, NIH, 6700B Rockledge Dr., Bethesda, MD 20892– 7628, or call non-toll-free number 301– 402–0846, or e-mail your request, including your address to kripkek@niaid.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. E:\FR\FM\28AUN1.SGM 28AUN1

Agencies

[Federal Register Volume 72, Number 166 (Tuesday, August 28, 2007)]
[Notices]
[Page 49282]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16985]



[[Page 49282]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0324]


Withdrawal of Approval of a New Animal Drug Application; 
Bacitracin Zinc

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) for a bacitracin zinc Type A 
medicated article. In a final rule published elsewhere in this issue of 
the Federal Register, FDA is amending the animal drug regulations to 
remove portions reflecting approval of this NADA.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-7818; e-mail: 
pamela.esposito@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68144, has requested that FDA withdraw approval of NADA 128-
550 for ANCHOR Zinc Bacitracin Type A medicated article because the 
product is not 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.  514.115 Withdrawal of approval of applications 
(21 CFR 514.115), notice is given that approval of NADA 128-550, and 
all supplements and amendments thereto, are hereby withdrawn, effective 
August 28, 2007.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending the animal drug regulations to reflect the 
withdrawal of approval of this NADA.

    Dated: August 20, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-16985 Filed 8-27-07; 8:45 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.