E7-11611. New Animal Drugs for Use in Animal Feeds; Lincomycin

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Div. of Pfizer, Inc. The supplemental NADA provides for the use of lincomycin in feed of swine weighing greater than 250 pounds and for the addition of a reproductive cautionary statement to labeling.

DATES:

This rule is effective June 18, 2007.

FOR FURTHER INFORMATION CONTACT:

Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Pharmacia & Upjohn Co., a Div. of Pfizer, Inc., 235 E. 42d St., New York, NY 10017, filed a supplement to NADA 97-505 that provides for use of LINCOMIX 20 (lincomycin hydrochloride) and LINCOMIX 50 Feed Medications in single-ingredient Type B and Type C medicated feeds for swine weighing greater than 250 pounds and for the addition of a reproductive caution statement to labeling. The supplemental application is approved as of May 23, 2007, and the regulations are amended in 21 CFR 558.325 to reflect the approval.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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 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 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

2. In § 558.325, add paragraph (c) and in the table in paragraphs (d)(2)(i) through (d)(2)(iv), in the “Limitations” column, remove “Not to be fed to swine that weigh more than 250 lb.” wherever it occurs to read as follows:

§ 558.325

Lincomycin.

(c) Special considerations—(1) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following directions: “CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.”

(2) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following directions: “CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.”

(3) Labeling of Type A medicated articles and single-ingredient Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following directions:

(i) No. 000009: “CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined. Not for use in swine intended for breeding when lincomycin is fed at 20 grams per ton of complete feed.”

(ii) Nos. 043733 and 051311: “CAUTION: Not to be fed to swine that weigh more than 250 lb.”

Dated: June 8, 2007.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.