[Federal Register Volume 68, Number 21 (Friday, January 31, 2003)]
[Rules and Regulations]
[Page 4916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Levamisole 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 an abbreviated new animal drug 
application (ANADA) filed by Phoenix Scientific, Inc. The ANADA 
provides for use of levamisole hydrochloride soluble powder in the 
drinking water of swine for the treatment of various internal 
parasites.

DATES:  This rule is effective January 31, 2003.

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: Phoenix Scientific, Inc., 3915 South 48th 
Street Terrace, St. Joseph, MO 64503, filed ANADA 200-313 for 
Levamisole Hydrochloride Soluble Pig Wormer used to make medicated 
drinking water for the treatment of various internal parasites. Phoenix 
Scientific, Inc.'s Levamisole Hydrochloride Soluble Pig Wormer is 
approved as a generic copy of Schering-Plough Animal Health's TRAMISOL 
(levamisole hydrochloride) Soluble Pig Wormer, approved under NADA 112-
049. The ANADA is approved as of October 25, 2002, and the regulations 
are amended in 21 CFR 520.1242a 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.
    2. Section 520.1242a is amended by adding paragraph (b)(4) to read 
as follows:


Sec.  520.1242a  Levamisole hydrochloride drench and drinking water.

* * * * *
    (b) * * *
    (4) See No. 059130 for use of 18.15-gram packages as in paragraph 
(d)(3) of this section.
* * * * *

    Dated: January 6, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-2212 Filed 1-30-03; 8:45 am]
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