[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]]

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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