Withdrawal of Approval of New Animal Drug Applications; Dichlorophene and Toluene Capsules, 52768 [2010-21295]

Download as PDF 52768 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857. VII. References 1. ‘‘Useful Written Consumer Medication Information (CMI)’’ published in July 2006, available on the Internet at https://www.fda.gov/ downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ ucm080602.pdf. 2. Kimberlin CL, Winterstein AG. ‘‘Expert and Consumer Evaluation of Consumer Medication Information— 2008.’’ Final Report to FDA. November 2008 available on the Internet at https:// www.fda.gov/downloads/AboutFDA/ CentersOffices/CDER/ReportsBudgets/ UCM163783.pdf. 3. FDA’s Risk Communication Advisory Committee meeting, held on February 26 and 27, 2009 (73 FR 74505, December 8, 2008), available on the Internet at https://www.fda.gov/ downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/ RiskCommunication AdvisoryCommittee/UCM152593.pdf. 4. ‘‘Providing Effective Information to Consumers about Prescription Drug Risks and Benefits—The Issues Paper’’ from the 2009 public workshop available on the Internet at https:// www.fda.gov/downloads/Drugs/ NewsEvents/UCM182799.pdf. 5. ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes,’’ available on the Internet at2 https:// edocket.access.gpo.gov/2010/pdf/201010359.pdf approval of two new animal drug applications (NADAs) for use of dichlorophene and toluene deworming capsules for cats and dogs. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the regulations to remove portions reflecting approval of these NADAs. DATES: Withdrawal of approval is effective September 7, 2010. 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; email: john.bartkowiak@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 has requested that FDA withdraw approval of NADA 101– 497 for TINY TIGER (dichlorophene/ toluene) Worming Capsules, NADA 101–498 for LK (dichlorophene/toluene) Worming Capsules because they are 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 NADAs 101–497 and 101–498, and all supplements and amendments thereto, is hereby withdrawn, effective September 7, 2010. 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 these NADAs. Dated: August 23, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. Dated: August 23, 2010. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2010–21326 Filed 8–26–10; 8:45 am] [FR Doc. 2010–21295 Filed 8–26–10; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HOMELAND SECURITY Food and Drug Administration [Docket No. DHS–2010–0071] [Docket No. FDA–2010–N–0002] Withdrawal of Approval of New Animal Drug Applications; Dichlorophene and Toluene Capsules WReier-Aviles on DSKGBLS3C1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: National Protection and Programs Directorate; Agency Information Collection Activities: Office of Infrastructure Protection; Chemical Security Awareness Training Program National Protection and Programs Directorate, DHS. ACTION: 60-Day notice and request for comments. AGENCY: Notice. The Food and Drug Administration (FDA) is withdrawing SUMMARY: 2 FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register. VerDate Mar<15>2010 15:33 Aug 26, 2010 Jkt 220001 Extension of a Currently Approved Information Collection: 1670–0009. SUMMARY: The Department of Homeland Security, National Protection and PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Programs Directorate, Office of Infrastructure Protection, SectorSpecific Agency Executive Management Office (NPPD/SSA EMO), submits the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chapter 35). Comments are encouraged and will be accepted until October 26, 2010. This process is conducted in accordance with 5 CFR 1320.1. DATES: Written comments and questions about this Information Collection Request should be forwarded to the Department of Homeland Security, NPPD/SSA EMO, Chemical Sector-Specific Agency, 245 Murray Lane, SW., Mail Stop 0608, Washington, DC 20528–0608. E-mailed requests should go to Amy Graydon at chemicalsector@dhs.gov. Written comments should reach the contact person listed no later than October 26, 2010. Comments must be identified by DHS–2010–0071 and may be submitted by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. • E-mail: chemicalsector@dhs.gov. Include the docket number in the subject line of the message. Instructions: All submissions received must include the words ‘‘Department of Homeland Security’’ and the docket number for this action. Comments received will be posted without alteration at https://www.regulations.gov, including any personal information provided. ADDRESSES: The Chemical Sector-Specific Agency, within the DHS NPPD/SSA EMO, provides an on-line voluntary training program to improve security in the chemical industry sector. Information is automatically collected in a computer database as a result of individuals engaging in the training. Explicit reporting or recordkeeping is not required. The training is designed for the general chemical facility employee. U.S. chemical industry direct employment is about 850,000 (2009 per the American Chemistry Council); approximately 400,000 employees are estimated as potential participants. Estimated duration in the first year to complete the registration, training, and survey is 60 minutes, and less if individuals take refresher training in succeeding years. Minimal participation data is collected as trainees complete the online exercises. Upon completion, SUPPLEMENTARY INFORMATION: E:\FR\FM\27AUN1.SGM 27AUN1

Agencies

[Federal Register Volume 75, Number 166 (Friday, August 27, 2010)]
[Notices]
[Page 52768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0002]


Withdrawal of Approval of New Animal Drug Applications; 
Dichlorophene and Toluene Capsules

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of two new animal drug applications (NADAs) for use of 
dichlorophene and toluene deworming capsules for cats and dogs. In a 
final rule published elsewhere in this issue of the Federal Register, 
FDA is amending the regulations to remove portions reflecting approval 
of these NADAs.

DATES:  Withdrawal of approval is effective September 7, 2010.

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; email: 
john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pegasus Laboratories, Inc., 8809 Ely Rd., 
Pensacola, FL 32514 has requested that FDA withdraw approval of NADA 
101-497 for TINY TIGER (dichlorophene/toluene) Worming Capsules, NADA 
101-498 for LK (dichlorophene/toluene) Worming Capsules because they 
are 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 NADAs 
101-497 and 101-498, and all supplements and amendments thereto, is 
hereby withdrawn, effective September 7, 2010.
    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 these NADAs.

    Dated: August 23, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-21295 Filed 8-26-10; 8:45 am]
BILLING CODE 4160-01-S

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