[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Rules and Regulations]
[Pages 51081-51082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19905]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Oxytetracycline

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 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.

DATES: This rule is effective August 7, 2002.

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 protected].

SUPPLEMENTARY 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.

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:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec. 558.450   [Amended]

    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

[[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''.

    Dated: July 17, 2002.
Alan Rudman,
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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