Document ID: FDA-2015-N-0002-0030
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application; Penicillin G Procaine
Posted Date: 2015-10-13T04:00Z

[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Rules and Regulations]
[Page 61298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25919]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2015-N-0002]

New Animal Drugs for Use in Animal Feed; Withdrawal of Approval 
of a New Animal Drug Application; Penicillin G Procaine

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 a new animal drug application (NADA) providing for the use of 
penicillin G procaine in medicated feed of poultry and swine. This 
action is being taken at the sponsor's request because this product is 
no longer manufactured or marketed.

DATES: Withdrawal of approval is effective October 23, 2015.

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: Zoetis Inc., 333 Portage St., Kalamazoo, MI 
49007 has requested that FDA withdraw approval of NADA 046-666 that 
provides for use of Type A medicated articles containing penicillin G 
procaine to manufacture medicated feeds administered to poultry and 
swine. This action is being taken at the sponsor's request because this 
product is no longer manufactured or marketed. Note this NADA was 
identified as being affected by guidance for industry #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.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with 21 CFR 514.116 Notice of withdrawal of approval of 
application, notice is given that approval of NADA 046-666, and all 
supplements and amendments thereto, is hereby withdrawn, effective 
October 23, 2015.
    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: October 6, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-25919 Filed 10-9-15; 8:45 am]
 BILLING CODE 4164-01-P