[Federal Register Volume 69, Number 154 (Wednesday, August 11, 2004)]
[Rules and Regulations]
[Page 48776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18361]


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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, 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 
supplemental ANADA provides for a new packet size and strength of 
oxytetracycline hydrochloride soluble powder used to make medicated 
drinking water.

DATES:  This rule is effective August 11, 2004.

FOR FURTHER INFORMATION CONTACT:  Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-8549, 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 166 (oxytetracycline hydrochloride) Soluble Powder for 
making medicated drinking water for the treatment of various bacterial 
diseases of livestock. The supplemental ANADA provides for a new packet 
size and strength of oxytetracycline hydrochloride soluble powder used 
to make medicated drinking water. The supplemental application is 
approved as of July 13, 2004, and the regulations are amended in 21 CFR 
520.1660d 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 21 CFR 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 Division of Dockets Management 
(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 Subject in 21 CFR Part 520

    Animal drugs.

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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

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.1660d   [Amended]

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2. Section 520.1660d is amended in paragraph (a)(6) by adding ``Each 
2.73 grams of powder contains 1 gram of OTC HCl (packet: 9.87 oz).'' 
after the last sentence.

    Dated: July 30, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-18361 Filed 8-10-04; 8:45 am]
BILLING CODE 4160-01-S