[Federal Register Volume 64, Number 51 (Wednesday, March 17, 1999)] [Rules and Regulations] [Page 13068] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-6458] [[Page 13068]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Bacitracin Methylene Disalicylate Soluble
Agency
Food and Drug Administration, HHS.
Action
Final rule.
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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 Alpharma Inc. The supplemental NADA provides for using soluble bacitracin methylene disalicylate (BMD) powder to make a medicated drinking water for replacement chickens as an aid in the prevention and control of necrotic enteritis.
EFFECTIVE DATE: March 17, 1999.
For Further Information Contact
William T. Flynn, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7570.
Supplementary Information
Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024, filed supplemental NADA 65-470 that provides for use of BMD Soluble (BMD soluble powder) to make a medicated drinking water for replacement chickens. Medicated drinking water containing the equivalent of 100 milligrams (mg) of bacitracin per gallon is used as an aid in the prevention of necrotic enteritis caused by Clostridium perfringens susceptible to BMD. Medicated drinking water containing the equivalent of 200 to 400 mg of bacitracin per gallon is used as an aid in the control of necrotic enteritis caused by C. perfringens susceptible to BMD. The supplemental NADA is approved as of February 2, 1999, and the regulations in Sec. 520.154a (21 CFR 520.154a) are amended to reflect the approval. The basis for approval is discussed in the freedom of information summary. In addition, the specifications paragraph is revised to reflect that the 200 grams per pound concentration has been previously approved for use in all species as in Sec. 520.154a(d). 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)(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.
List of Subjects in 21 CFR Part 520
Animal drugs. 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 520 is amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.154a [Amended]
2. Section 520.154a Soluble bacitracin methylene disalicylate is amended in paragraph (a) by removing the phrase ``paragraphs (d)(3) and (d)(4)'' and by adding in its place the phrase ``paragraph (d)'', and in paragraph (d)(2) by removing the heading ``Broiler chickens'' and by adding in its place ``Broiler and replacement chickens''.
Dated: February 26, 1999. Margaret Ann Miller, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 99-6458 Filed 3-16-99; 8:45 am] BILLING CODE 4160-01-F