2016-21985. New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

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.

DATES:

This rule is effective September 14, 2016.

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: [e-mail].

SUPPLEMENTARY 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.

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to the procaine penicillin component indications for growth promotion and increased feed efficiency in swine is withdrawn, effective September 14, 2016.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.

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:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for part 558 continues to read as follows:

Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

§ 558.140

[Amended]

2. In § 558.140, in paragraph (b)(2), remove “No. 054771” and in its place add “Nos. 054771 and 069254”.

§ 558.145

[Amended]

3. In § 558.145, remove and reserve paragraph (a)(2).

Dated: September 6, 2016.

William T. Flynn,

Acting Director, Center for Veterinary Medicine.