[Federal Register: December 24, 2002 (Volume 67, Number 247)]
[Rules and Regulations]
[Page 78356]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24de02-9]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Lincomycin Hydrochloride
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 reducing the preslaughter withdrawal
time to zero days for use of lincomycin soluble powder in medicated
drinking water for swine.
DATES: This rule is effective December 24, 2002.
FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail:
jmessenh@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, filed a supplement to ANADA 200-189 for
Lincomycin (lincomycin HCl) Soluble requesting a reduction in the
preslaughter withdrawal time to zero days for use of lincomycin soluble
powder in medicated drinking water for swine. The supplemental ANADA is
approved as of September 19, 2002, and the regulations are amended in
Sec. 520.1263c (21 CFR 520.1263c) 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 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 Sec. 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 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. 520.1263c [Amended]
2. Section 520.1263c Lincomycin hydrochloride soluble powder is
amended in paragraph (d)(1)(iii) by removing ``Nos. 046573 and 051259''
and by adding in its place ``No. 051259''.
Dated: December 5, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 02-32343 Filed 12-23-02; 8:45 am]
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