[Federal Register Volume 66, Number 227 (Monday, November 26, 2001)]
[Rules and Regulations]
[Pages 58934-58935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29351]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 Bimeda, Inc., that provides 
for a revised withdrawal time for use of oxytetracycline hydrochloride 
soluble powder in the drinking water of turkeys and swine. The 
regulations are also being amended to reflect approval of an additional 
pail size, which was approved under ANADA 200-144 on June 26, 1995; 
however, inadvertently this change has not yet been made in title 21 
CFR. This document corrects that omission and improves the accuracy of 
the regulations.

DATES: This rule is effective November 26, 2001.

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.

SUPPLEMENTARY INFORMATION: Bimeda, Inc., 288 County Rd. 28, LeSueur, MN 
56058-9322, filed a supplement to ANADA 200-144 that provides for use 
of TETROXY (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 ANADA is approved as of September 17, 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 
3.09-pound pail size, which was approved under ANADA 200-144 on June 
26, 1995.
    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

[[Page 58935]]

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.


Sec. 520.1660d  [Amended]

    2. Section 520.1660d Oxytetracycline hydrochloride soluble powder 
is amended in paragraph (a)(9) by adding ``3.09 and '' after 
``pails:''; in paragraphs (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and 
(d)(1)(ii)(C)(3) by removing ``and 053389'' and by adding in its place 
``, 053389, and 061133''; and in paragraph (d)(1)(iii)(C) by removing 
``No. 046573'' and by adding in its place ``Nos. 046573 and 061133.''

    Dated: November 8, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-29351 Filed 11-23-01; 8:45 am]
BILLING CODE 4160-01-S