Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Phibro Animal Health, Inc., which provide for a zero-day preslaughter withdrawal time for use of oxytetracycline in swine feed.
This rule is effective August 7, 2002.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7580, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
Phibro Animal Health, 710 Rte. 46 East, suite 401, Fairfield, NJ 07004, filed supplements to NADA 8-804 for TM-50, TM-50D, TM-100, and TM-100D (oxytetracycline) Type A medicated articles and NADA 95-143 for OXTC (oxytetracycline) Type A medicated articles used for making medicated feeds for the treatment of various bacterial diseases of livestock. The supplemental NADAs provide for a zero-day withdrawal time prior to slaughter when Type C medicated feeds containing oxytetracycline are fed continuously to swine at a dosage of 10 milligrams per pound (mg/lb) of body weight for up to 14 days. The supplemental NADAs are approved as of April 29, 2002, and the regulations are amended in 21 CFR 558.450 to reflect the approval. The basis of approval is discussed in the freedom of information summaries.
In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), summaries of safety and effectiveness data and information submitted to support approval of these applications 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 these actions are of a type that do 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 558
- Animal drugs
- Animal feeds
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 558 is amended as follows:End Amendment Part Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 558 continues to read as follows:End Amendment Part
2. Section 558.450 Oxytetracycline is amended in the table in paragraph (d)(1)(ix), in entries 4 and 5, under the “Limitations” column, by removing Start Printed Page 51082“withdraw 5 d before slaughter” and by adding in its place “for No. 053389, withdraw 5 d before slaughter; for No. 066104, zero-day withdrawal”.End Amendment Part Start Signature
Dated: July 17, 2002.
Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 02-19905 Filed 8-6-02; 8:45 am]
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