82_FR_11545 82 FR 11509 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application

82 FR 11509 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 36 (February 24, 2017)

Page Range11509-11509
FR Document2017-03678

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.

Federal Register, Volume 82 Issue 36 (Friday, February 24, 2017) 
[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Page 11509]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

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withdrawn, effective March 6, 2017.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

Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations 11509 ■ 16. In § 558.68, revise paragraph § 558.68 Avilamycin. (e) * * * (e)(1)(ii) to read as follows: * * * * * (1) * * * Avilamycin in Combination in Indications for use Limitations Sponsor grams/ton grams/ton * * * * * * * (ii) 13.6 to 40.9 ........ Monensin 90 to 110; Broiler chickens: For the prevention of Feed as the sole ration for 21 consecu- 058198 as provided by mortality caused by necrotic enteritis tive days. To assure responsible anti- No. 058198 in associated with Clostridium perfringens microbial drug use in broiler chickens, § 510.600(c) of in broiler chickens; and as an aid in the treatment administration must begin on this chapter. prevention of coccidiosis caused by or before 10 days of age. See Eimeria necatrix, E. tenella, E. § 558.355(d) of this chapter for addi- acervulina, E. brunetti, E. mivati, and tional required labeling. E. maxima. * * * * * Therefore, under authority delegated approval of NADAs and ANADAs for Dated: February 21, 2017. to the Commissioner of Food and Drugs antimicrobial drugs of importance to Leslie Kux, and redelegated to the Center for human medicine that are administered Veterinary Medicine, and in accordance to food-producing animals in medicated Associate Commissioner for Policy. with § 514.116 Notice of withdrawal of feed are being made because the [FR Doc. 2017–03677 Filed 2–23–17; 8:45 am] approval of application (21 CFR products are no longer manufactured or BILLING CODE 4164–01–P 514.116), notice is given that approval marketed. These actions are consistent of ANADA 200–524, and all with the FDA Center for Veterinary supplements and amendments thereto, Medicine’s initiative for the Judicious DEPARTMENT OF HEALTH AND is hereby withdrawn, effective March 6, Use of Antimicrobials. HUMAN SERVICES 2017. DATES: Withdrawal of approval is Food and Drug Administration Elsewhere in this issue of the Federal effective February 24, 2017. Register, FDA is amending the animal drug regulations to reflect the voluntary FOR FURTHER INFORMATION CONTACT: 21 CFR Part 524 Sujaya Dessai, Center for Veterinary withdrawal of approval of this [Docket No. FDA–2016–N–0002] application. Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., New Animal Drugs; Withdrawal of Dated: February 21, 2017. Rockville, MD 20855, 240–402–5761, Approval of a New Animal Drug Leslie Kux, sujaya.dessai@fda.hhs.gov. Application Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: FDA is [FR Doc. 2017–03678 Filed 2–23–17; 8:45 am] AGENCY: Food and Drug Administration, withdrawing approval of 18 NADAs and BILLING CODE 4164–01–P HHS. 2 ANADAs. These applications were ACTION: Notification of withdrawal. identified as being affected by guidance for industry (GFI) #213, ‘‘New Animal SUMMARY: The Food and Drug DEPARTMENT OF HEALTH AND Drugs and New Animal Drug Administration (FDA) is withdrawing HUMAN SERVICES Combination Products Administered in approval of an abbreviated new animal or on Medicated Feed or Drinking Water Food and Drug Administration drug application (ANADA) at the of Food-Producing Animals: sponsor’s request because the product is Recommendations for Drug Sponsors for 21 CFR Part 558 no longer manufactured or marketed. Voluntarily Aligning Product Use DATES: Withdrawal of approval is [Docket No. FDA–2016–N–0002] Conditions With GFI #209,’’ December effective March 6, 2017. 2013 (http://www.fda.gov/downloads/ FOR FURTHER INFORMATION CONTACT: New Animal Drugs; Withdrawal of AnimalVeterinary/ Sujaya Dessai, Center for Veterinary Approval of New Animal Drug GuidanceComplianceEnforcement/ Medicine (HFV–212), Food and Drug Applications GuidanceforIndustry/UCM299624.pdf). Administration, 7519 Standish Pl., AGENCY: Food and Drug Administration, Their withdrawal of approval is Rockville, MD 20855, 240–402–5761, HHS. consistent with the FDA Center for sujaya.dessai@fda.hhs.gov. ACTION: Notification of withdrawal. Veterinary Medicine’s initiative for the SUPPLEMENTARY INFORMATION: Putney, Judicious Use of Antimicrobials. Inc., One Monument Square, Suite 400, SUMMARY: The Food and Drug Approval of the following Portland, ME 04101 has requested that Administration (FDA) is withdrawing applications for new animal drugs FDA withdraw approval of ANADA approval of 18 new animal drug administered in medicated feed is being 200–524 for Mupirocin Ointment 2% applications (NADAs) and 2 abbreviated voluntarily withdrawn at the sponsors’ because the product is no longer new animal drug applications requests because these products are no pmangrum on DSK3GDR082PROD with RULES manufactured or marketed. (ANADAs). These withdrawals of longer manufactured or marketed: File No. Product name Sponsor 044–820 ...................................... LINCOMIX (lincomycin)/AMPROL PLUS (amprolium Zoetis Inc. and ethopabate). 333 Portage St. Kalamazoo, MI 49007 (Zoetis Inc.). VerDate Sep<11>2014 14:13 Feb 23, 2017 Jkt 241001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 E:\FR\FM\24FER1.SGM 24FER1


Document Created: 2017-02-24 01:17:12
Document Modified: 2017-02-24 01:17:12
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionNotification of withdrawal.
DatesWithdrawal of approval is effective March 6, 2017.
ContactSujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, [email protected]
FR Citation82 FR 11509 
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