[Federal Register Volume 59, Number 78 (Friday, April 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9696]


[[Page Unknown]]

[Federal Register: April 22, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

 

Oral Dosage Form New Animal Drugs; Tetracycline Hydrochloride 
Soluble Powder

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 an abbreviated new animal drug 
application (ANADA) filed by Agri Laboratories, Ltd. The ANADA provides 
for the use of generic tetracycline hydrochloride soluble powder as an 
antibacterial in drinking water for swine, calves, chickens, and 
turkeys.

EFFECTIVE DATE: April 22, 1994.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Agri Laboratories, Ltd., P.O. Box 3103, St. 
Joseph, MO 64503, is the sponsor of ANADA 200-049, which provides for 
the use of a generic tetracycline hydrochloride soluble powder as an 
antibacterial in drinking water for the control and treatment of the 
following conditions susceptible to tetracycline:
    In swine--bacterial enteritis (scours) caused by Escherichia coli 
and bacterial pneumonia associated with Pasteurella spp., 
Actinobacillus pleuropneumonia, and Klebsiella spp.;
    In calves--bacterial enteritis (scours) caused by E. coli and 
bacterial pneumonia (shipping fever complex) associated with 
Pasteurella spp., A. pleuropneumonia, and Klebsiella spp.;
    In chickens--control of chronic respiratory disease and air-sac 
infection caused by Mycoplasma gallisepticum and E. coli and infectious 
synovitis caused by M. synoviae; and
    In Turkeys--control of infectious synovitis caused by M. synoviae 
and bluecomb (transmissible enteritis or coronaviral enteritis) caused 
by complicating bacterial organisms.
    ANADA 200-049 for Agri Laboratories, Ltd.'s, Tetracycline 
Hydrochloride Soluble Powder-324 is a generic copy of Fermenta Animal 
Health's NADA 65-496 for Tetracycline Hydrochloride Soluble Powder-324. 
The ANADA is approved as of September 30, 1993, and the regulations are 
amended in 21 CFR 520.2345d to reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 520.2345d  [Amended]

    2. Section 520.2345d Tetracycline hydrochloride soluble powder is 
amended in paragraph (a)(1) by removing ``047864 and 054273,'' and 
adding in its place ``047864, 054273, and 057561,''.

    Dated: April 14, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-9696 Filed 4-21-94; 8:45 am]
BILLING CODE 4160-01-F