This PDF is the current document as it appeared on Public Inspection on 09/13/2016 at 08:45 am.
Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine and to reflect the reformulation of the Type A medicated article as a 2-way, fixed-ratio, combination drug product without penicillin.
This rule is effective September 14, 2016.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0817, email: email@example.com.End Further Info End Preamble Start Supplemental Information
Pharmgate LLC (Pharmgate), 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 has requested that FDA withdraw approval of those parts of NADA 138-934 for PENNCHLOR SP 500 (chlortetracycline, procaine penicillin, and sulfamethazine) Type A medicated article that pertain to use of the procaine penicillin component for the production indications of growth promotion and increased feed efficiency in swine. Pharmgate requested voluntary withdrawal of approval of these indications for use because PENNCHLOR SP 500 Type A medicated article is no longer manufactured.
With the withdrawal of approval of the production indications for procaine penicillin, the product approved under NADA 138-934 was reformulated as PENNCHLOR S 40/40 (chlortetracycline and sulfamethazine) Type A Medicated Article, a 2-way, fixed-ratio, combination drug Type A medicated article that does not contain penicillin procaine and is not labeled for production indications.Start Printed Page 63054
The Agency has determined under 21 CFR 25.33(a) that this action is categorically excluded from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
Elsewhere in this issue of the Federal Register, FDA gave notice that the approval of those parts of NADA 138-934 pertaining to the procaine penicillin component indications for growth promotion and increased feed efficiency in swine is withdrawn, effective September 14, 2016. As provided for in the regulatory text of this document, the animal drug regulations are amended to reflect this partial withdrawal of approval and subsequent product reformulation.
NADA 138-934 was 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.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.Start List of Subjects
List of Subjects in 21 CFR Part 558
- Animal drugs
- Animal feeds
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director of the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
1. The authority citation for part 558 continues to read as follows:End Amendment Part
2. In § 558.140, in paragraph (b)(2), remove “No. 054771” and in its place add “Nos. 054771 and 069254”.End Amendment Part
3. In § 558.145, remove and reserve paragraph (a)(2).End Amendment Part Start Signature
Dated: September 6, 2016.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-21985 Filed 9-13-16; 8:45 am]
BILLING CODE 4164-01-P