02-11207. New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Robenidine Hydrochloride

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 new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved single-ingredient bacitracin methylene disalicylate (BMD) and robenidine hydrochloride Type A medicated articles to make two-way combination Type C medicated broiler and fryer chicken feeds used for prevention of coccidiosis, and as an aid in the prevention or control of necrotic enteritis.

DATES:

This rule is effective May 7, 2002.

FOR FURTHER INFORMATION CONTACT:

Steven D. Vaughn, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7584, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141-154 that provides for use of BMD (10, 25, 30, 40, 50, 60, or 75 grams per pound (g/lb) BMD) and ROBENZ (30 g/lb robenidine hydrochloride) Type A medicated articles to make two-way combination Type C medicated feeds containing 30 g/ton robenidine hydrochloride and 50 or 100 to 200 g/ton BMD for use in broiler and fryer chickens.

The combination Type C medicated feeds containing 50 g/ton BMD are used for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. The combination Type C medicated feeds containing 100 to 200 g/ton BMD are used for prevention of coccidiosis caused E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. NADA 141-154 is approved as of February 11, 2002, and the regulations are amended in 21 CFR 558.515 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(2) 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 the 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. Section 558.515 is amended in the table in paragraph (d) by adding new entries after the entry for “Bacitracin (as bacitracin methylene disalicylate) 27 to 50” under the “Combination in grams/ton” column to read as follows:

§ 558.515

Robenidine hydrochloride.

* * * * *

(d) * * *

Robenidine ­hydrochloride in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor
*        *         *         *         *         *         *
	Bacitracin (as bacitracin ­methylene disalicylate) 27 to 50	*  *  *	*  *  *	*  *  *
	Bacitracin (as bacitracin ­methylene disalicylate) 50	For broiler and fryer chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.	Feed continuously as sole ration. Do not feed to laying hens. Withdraw 5 days before slaughter.	046573
	Bacitracin (as bacitracin ­methylene disalicylate) 100 to 200	For broiler and fryer chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.	To control a necrotic enteritis outbreak, start medication at first clinical signs of disease; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin methylene disalicylate to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter.	046573
*         *         *         *         *         *         *

Dated: April 18, 2002.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.