[Federal Register: December 3, 2002 (Volume 67, Number 232)]
[Rules and Regulations]
[Page 71819]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de02-10]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520
Oral Dosage Form New Animal Drugs; Lincomycin Hydrochloride
Soluble Powder
AGENCY: Food and Drug Administration, HHS.
ACTION: Technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations for preslaughter withdrawal time for lincomycin
soluble powder products used to make medicated drinking water for swine
to correct inadvertant editorial errors. This action is being taken to
ensure accuracy and clarity in the agency's regulations.
DATES: This rule is effective December 3, 2002.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail:
ghaibel@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: FDA has found that Sec. 520.1263c (21 CFR
520.1263c) does not reflect the approved preslaughter withdrawal time
for three lincomycin soluble powder products used to make medicated
drinking water for swine. The 6-day withdrawal time was inadvertently
removed for a generic product approved under ANADA 200-189 at the time
it was being removed for the pioneer product approved under NADA 111-
636 (64 FR 13341, March 18, 1999). The conditions of use for two other
products approved February 4, 1999, under ANADA 200-241 (64 FR 13508,
March 19, 1999) and September 22, 1999, under ANADA 200-233 (64 FR
66382, November 26, 1999) were subsequently codified without a
withdrawal period. At this time, the regulations are being amended in
Sec. 520.1263c to correct these errors.
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 adding at the end the sentence
``For Nos. 046573 and 051259: Do not slaughter swine for 6 days
following last treatment.''
Dated: November 8, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 02-30639 Filed 12-2-02; 8:45 am]
BILLING CODE 4160-01-S