[Federal Register Volume 62, Number 218 (Wednesday, November 12, 1997)]
[Rules and Regulations]
[Page 60656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29650]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Chlortetracycline Powder

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

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 chlortetracycline hydrochloride soluble powder 
in the drinking water of swine for control and treatment of certain 
diseases caused by pathogens susceptible to chlortetracycline and 
chickens and turkeys for control of certain diseases caused by 
pathogens susceptible to chlortetracycline.

EFFECTIVE DATE: November 12, 1997.

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: Phoenix Scientific, Inc., 3915 South 48th 
Street Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 
200-236 that provides for oral use of chlortetracycline hydrochloride 
soluble powder in animal drinking water as follows: (1) Swine: Control 
and treatment of bacterial enteritis (scours) caused by Escherichia 
coli and Salmonella spp., and bacterial pneumonia associated with 
Pasteurella spp., Actinobacillus pleuropneumoniae (Haemophilus spp.) 
and Klebsiella spp.; (2) Chickens: Control of infectious synovitis 
caused by Mycoplasma synoviae, and chronic respiratory disease (CRD) 
and air-sac infections caused by M. gallisepticum and E. coli; and (3) 
Turkeys: Control of infectious synovitis caused by M. synoviae and 
complicating bacterial organisms associated with bluecomb 
(transmissible enteritis, coronaviral enteritis).
    Approval of Phoenix Scientific Inc.'s ANADA 200-236 
chlortetracycline hydrochloride soluble powder is as a generic copy of 
ADM Animal Health & Nutrition Div.'s NADA 65-256 Chlortet<SUP>TM</SUP>-
Soluble-O chlortetracycline hydrochloride soluble powder. ANADA 200-236 
is approved as of September 24, 1997, and the regulations are amended 
in 21 CFR 520.445b(b) 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 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, 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 25.33(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.

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: 21 U.S.C. 360b.

Sec. 520.445b  [Amended]

    2. Section 520.445b Chlortetracycline powder (chlortetracycline 
hydrochloride or chlortetracycline bisulfite) is amended in paragraph 
(b) by removing ``No. 017519'' and adding in its place ``Nos. 017519 
and 059130.''

    Dated: October 22, 1997.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 97-29650 Filed 11-10-97; 8:45 am]
BILLING CODE 4160-01-F