[Federal Register Volume 67, Number 249 (Friday, December 27, 2002)]
[Rules and Regulations]
[Page 78971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


New Animal Drugs; Neomycin Sulfate Soluble Powder

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 abbreviated new 
animal drug application (ANADA) filed by Alpharma, Inc. The 
supplemental ANADA provides for use of neomycin sulfate soluble powder 
in the drinking water of growing turkeys for the control of mortality 
associated with Escherichia coli organisms susceptible to neomycin.

DATES: This rule is effective December 27, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed a supplement to ANADA 200-130 that 
provides for use of NEO-SOL 50 (neomycin sulfate) soluble powder for 
making medicated drinking water for administration to cattle (excluding 
veal calves), swine, sheep, and goats for the treatment and control of 
colibacillosis (bacterial enteritis) caused by E. coli susceptible to 
neomycin. The supplemental ANADA provides for use of neomycin in the 
drinking water of growing turkeys for the control of mortality 
associated with E. coli organisms susceptible to neomycin. The 
supplemental application is approved as of October 25, 2002, and the 
regulations are amended in 21 CFR 520.1484 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 21 CFR 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.
    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 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.  520.1484  [Amended]

    2. Section 520.1484 Neomycin sulfate soluble powder is amended in 
paragraph (b)(1) by removing ``046573'' and in paragraph (b)(2) by 
adding in numerical sequence ``046573''.

    Dated: December 17, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 02-32748 Filed 12-26-02; 8:45 am]
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