[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
