[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Rules and Regulations]
[Pages 51080-51081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19864]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride 
Soluble Powder

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 51081]]

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 Pennfield Oil Co. The 
supplemental ANADA provides for a zero-day preslaughter withdrawal time 
for use of oxytetracycline hydrochloride (HCl) soluble powder in the 
drinking water of swine.

DATES: This rule is effective August 7, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-101), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68137, filed a supplement to ANADA 200-026 that provides for 
use of PENNOX 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 
preslaughter withdrawal time after the use of the product in the 
drinking water of swine. The supplemental ANADA is approved as of April 
10, 2002, and 21 CFR 520.1660d is amended 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 had 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.

List of Subject 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.
    2. Section 520.1660d is amended by revising the last sentence in 
paragraph (d)(1)(iii)(C) to read as follows:


Sec.  520.1660d  Oxytetracycline hydrochloride soluble powder.

* * * * *
    (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, 053389, 057561, and 061133.
* * * * *

    Dated: July 17, 2002.
Alan Rudman,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-19864 Filed 8-6-02; 8:45 am]
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