[Federal Register Volume 63, Number 137 (Friday, July 17, 1998)]
[Rules and Regulations]
[Page 38474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19026]


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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 growing quail for 
prevention of ulcerative enteritis.

EFFECTIVE DATE: July 17, 1998.

FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1644.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed supplemental NADA 65-470 that provides 
for use of BMD<Register> Soluble (BMD soluble powder) to make a 
medicated drinking water for growing quail containing the equivalent of 
400 milligrams of bacitracin per gallon used for prevention of 
ulcerative enteritis due to Clostridium colinum susceptible to BMD. The 
supplemental NADA is approved as of May 27, 1998, and the regulations 
in 21 CFR 520.154a are amended to reflect the approval. The basis for 
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(d)(4) 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.

    2. Section 520.154a is amended in paragraph (a) by removing the 
phrase ``paragraph (d)(3)'' and by adding in its place the phrase 
``paragraphs (d)(3) and (d)(4)'' and by adding paragraph (d)(4) to read 
as follows:

Sec. 520.154a  Soluble bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (4) Growing quail--(i) Amount. 400 milligrams per gallon in 
drinking water.
    (ii) Indications for use. For prevention of ulcerative enteritis 
due to Clostridium colinum susceptible to bacitracin methylene 
disalicylate.
    (iii) Limitations. Prepare fresh solution daily. Use as sole source 
of drinking water.

    Dated: July 9, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-19026 Filed 7-16-98; 8:45 am]
BILLING CODE 4160-01-F