[Federal Register Volume 67, Number 25 (Wednesday, February 6, 2002)]
[Rules and Regulations]
[Page 5469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2589]


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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; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 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.

DATES: This rule is effective February 6, 2002.

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: 
[email protected].

SUPPLEMENTARY 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.

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.

    2. Section 520.1660d is amended in paragraph (a)(6) by adding ``; 
pail: 5 lb'' after ``oz.''; in paragraphs (d)(1)(ii)(A)(3), 
(d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3) in the sixth sentence by 
removing ``, 057561,'' and in the eighth sentence by numerically adding 
``057561,''; and in paragraph (d)(1)(iii)(C) by revising the last 
sentence 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, 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]
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