Animal drugs, feeds, and related products: Bacitracin methylene disalicylate and robenidine hydrochloride,

[Federal Register: May 7, 2002 (Volume 67, Number 88)]

[Rules and Regulations]

[Page 30545-30546]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr07my02-3]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

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) filedby 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: svaughn@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filedNADA 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.

   [[Page 30546]]

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:

   Sec. 558.515 Robenidine hydrochloride.

   * * * * *

   (d) * * *

   Robenidine hydrochloride in Combination in

   Indications for use

   Limitations

   Sponsor grams/ton

   grams/ton

   *

   *

   *

   *

   *

   * * Bacitracin (as * * *

   * * *

   * * * bacitracin methylene disalicylate) 27 to 50 Bacitracin (as For broiler and fryer Feed continuously as sole 046573 bacitracin

   chickens: As an aid in ration. Do not feed to methylene

   the prevention of

   laying hens. Withdraw 5 disalicylate) 50 necrotic enteritis caused days before slaughter. or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Bacitracin (as For broiler and fryer To control a necrotic 046573 bacitracin

   chickens: As an aid in enteritis outbreak, start methylene

   the control of necrotic medication at first disalicylate) 100 enteritis caused or

   clinical signs of to 200

   complicated by

   disease; administer Clostridium spp. or other continuously for 5 to 7 organisms susceptible to days or as long as bacitracin.

   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. *

   *

   *

   *

   *

   * *

   Dated: April 18, 2002. Stephen F. Sundlof, Director, Center for Veterinary Medicine.

   [FR Doc. 02-11207Filed5-6-02; 8:45 am]

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