[Federal Register: January 31, 2003 (Volume 68, Number 21)]
[Rules and Regulations]
[Page 4916]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31ja03-12]
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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:
lluther@cvm.fda.gov.
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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