Food and Drug Administration, HHS.
Final rule; technical amendment.
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 Agri Laboratories, Ltd. The ANADA provides for a revised withdrawal time for use of oxytetracycline (OTC) hydrochloride (HCl) soluble powder in the drinking water of turkeys and swine.
This rule is effective February 6, 2002.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503, filed a supplement to ANADA 200-066 that provides for use of AGRIMYCIN 343 (oxytetracycline HCl) Soluble Powder for making medicated drinking water for the treatment of various bacterial diseases of livestock. The supplemental ANADA provides for a zero-day withdrawal time after the use of the product in the drinking water of turkeys and swine. The supplemental application is approved as of October 4, 2001, and the regulations are amended in 21 CFR 520.1660d to reflect the approval.
Section 520.1660d is also being amended to reflect approval of a 5-pound pail size, which was approved under ANADA 200-066 on June 15, 1994.
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 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.Start List of Subjects
List of Subjects in 21 CFR Part 520End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part
1. The authority citation for 21 CFR part 520 continues to read as follows:Start Amendment Part
2. Section 520.1660d is amended in paragraph (a)(6) by adding “; pail: 5 lb” after “oz.”; in paragraphs (d)(1)(ii)(A)(End Amendment Part
(d) * * *
(1) * * *
(iii) * * *
(C) * * * Administer up to 5 days; do not use for more than 5 consecutive days; withdraw zero days prior to slaughter those products sponsored by Nos. 046573, 057561, and 061133.
Dated: January 11, 2002.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 02-2589 Filed 2-5-02; 8:45 am]
BILLING CODE 4160-01-S