[Federal Register Volume 62, Number 24 (Wednesday, February 5, 1997)]
[Rules and Regulations]
[Pages 5318-5319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2819]


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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 Phoenix Scientific, Inc. The ANADA 
provides for oral use of tetracycline hydrochloride soluble powder in 
the drinking water of calves and swine for control and treatment of 
certain diseases caused by pathogens susceptible to tetracycline, and 
of chickens and turkeys for control of certain diseases caused by 
pathogens susceptible to tetracycline.

EFFECTIVE DATE: February 5, 1997.
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: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
136, which provides for oral use of tetracycline hydrochloride soluble 
powder in the drinking water of calves and swine for control and 
treatment of certain conditions, and of chickens and turkeys for the 
control of certain conditions, as follows: (1) For calves for control 
and treatment of bacterial enteritis (scours) caused by Escherichia 
coli, and bacterial pneumonia (shipping fever complex) associated with 
Pasteurella spp., Actinobacillus pleuropneumoniae (Hemophilus spp.), 
and Klebsiella spp. susceptible to tetracycline; (2) for swine for 
control and treatment of bacterial enteritis (scours) caused by E. 
coli, and bacterial pneumonia associated with Pasteurella spp., A. 
pleuropneumoniae (Hemophilus spp.), and Klebsiella spp. susceptible to 
tetracycline; (3) for chickens for control of chronic respiratory 
disease (CRD or air-sac disease) caused by Mycoplasma gallisepticum and 
E. coli; infectious synovitis caused by M. synoviae susceptible to 
tetracycline; (4) for turkeys for control of infectious synovitis 
caused by M. synoviae and bluecomb (transmissible enteritis or 
coronaviral enteritis) complicated by bacterial organisms susceptible 
to tetracycline.
    Approval of Phoenix's ANADA 200-136 tetracycline hydrochloride 
soluble powder is as a generic copy of Fermenta's NADA 65-496 
tetracycline hydrochloride soluble powder. ANADA 200-136 is approved as 
of December 17, 1996, and the regulations are amended in 
Sec. 520.2345d(a)(1) (21 CFR 520.2345d(a)(1)) to reflect the approval. 
The basis of approval is discussed in the freedom of information 
summary.
    In addition, due to enactment of the Generic Animal Drug and Patent 
Term Restoration Act of 1988, the paragraph concerning NAS/NRC status 
is outdated. Section 520.2345d is amended to remove paragraph (c).
    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 Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.24 (d)(1)(i) 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.

List of Subjects

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:

[[Page 5319]]

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, 054273, and 057561'' 
and adding in its place ``047864, 054273, 057561, and 059130'' and by 
removing and reserving paragraph (c).

    Dated: January 28, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-2819 Filed 2-4-97; 8:45 am]
BILLING CODE 4160-01-F