New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application, 11509 [2017-03678]

Download as PDF Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations § 558.68 16. In § 558.68, revise paragraph (e)(1)(ii) to read as follows: ■ * Avilamycin. * * * (e) * * * (1) * * * * Avilamycin in grams/ton Combination in grams/ton Indications for use * (ii) 13.6 to 40.9 ........ * Monensin 90 to 110; as provided by No. 058198 in § 510.600(c) of this chapter. * * Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. Limitations [Docket No. FDA–2016–N–0002] New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application Dated: February 21, 2017. Leslie Kux, Associate Commissioner for Policy. * * * * Dated: February 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–03677 Filed 2–23–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 AGENCY: Food and Drug Administration, ACTION: Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) at the sponsor’s request because the product is no longer manufactured or marketed. DATES: Withdrawal of approval is effective March 6, 2017. FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, sujaya.dessai@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Putney, Inc., One Monument Square, Suite 400, Portland, ME 04101 has requested that FDA withdraw approval of ANADA 200–524 for Mupirocin Ointment 2% because the product is no longer manufactured or marketed. SUMMARY: pmangrum on DSK3GDR082PROD with RULES [FR Doc. 2017–03678 Filed 2–23–17; 8:45 am] BILLING CODE 4164–01–P HHS. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA–2016–N–0002] New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of 18 new animal drug applications (NADAs) and 2 abbreviated new animal drug applications (ANADAs). These withdrawals of SUMMARY: File No. LINCOMIX (lincomycin)/AMPROL PLUS (amprolium and ethopabate). approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine’s initiative for the Judicious Use of Antimicrobials. Withdrawal of approval is effective February 24, 2017. DATES: FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, sujaya.dessai@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is withdrawing approval of 18 NADAs and 2 ANADAs. These applications were identified as being affected by guidance for industry (GFI) #213, ‘‘New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209,’’ December 2013 (http://www.fda.gov/downloads/ AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/UCM299624.pdf). Their withdrawal of approval is consistent with the FDA Center for Veterinary Medicine’s initiative for the Judicious Use of Antimicrobials. Approval of the following applications for new animal drugs administered in medicated feed is being voluntarily withdrawn at the sponsors’ requests because these products are no longer manufactured or marketed: Product name 044–820 ...................................... VerDate Sep<11>2014 14:13 Feb 23, 2017 Jkt 241001 PO 00000 Frm 00009 Fmt 4700 Sponsor Sfmt 4700 Sponsor * * * Feed as the sole ration for 21 consecu058198 tive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 10 days of age. See § 558.355(d) of this chapter for additional required labeling. 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 ANADA 200–524, and all supplements and amendments thereto, is hereby withdrawn, effective March 6, 2017. 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. * 11509 Zoetis Inc. 333 Portage St. Kalamazoo, MI 49007 (Zoetis Inc.). E:\FR\FM\24FER1.SGM 24FER1

Agencies

[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Page 11509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2016-N-0002]


New Animal Drugs; Withdrawal of Approval of a New Animal Drug 
Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of an abbreviated new animal drug application (ANADA) at the sponsor's 
request because the product is no longer manufactured or marketed.

DATES: Withdrawal of approval is effective March 6, 2017.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Putney, Inc., One Monument Square, Suite 
400, Portland, ME 04101 has requested that FDA withdraw approval of 
ANADA 200-524 for Mupirocin Ointment 2% because the product 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 ANADA 
200-524, and all supplements and amendments thereto, is hereby 
withdrawn, effective March 6, 2017.
    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: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03678 Filed 2-23-17; 8:45 am]
 BILLING CODE 4164-01-P