[Federal Register Volume 62, Number 171 (Thursday, September 4, 1997)]
[Rules and Regulations]
[Page 46668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23372]


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

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.

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

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 Med-Pharmex, Inc. The ANADA provides for 
oral use of tetracycline hydrochloride soluble powder in the drinking 
water of swine and calves 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: September 4, 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: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767-1861, filed ANADA 200-234, which provides for oral use 
of tetracycline hydrochloride soluble powder in the drinking water of 
calves, swine, chickens, and turkeys, 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., Actinobacillus 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; and (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 Med-Pharmex's ANADA 200-234 tetracycline hydrochloride 
soluble powder is as a generic copy of Fermenta's NADA 65-496 
tetracycline hydrochloride soluble powder. ANADA 200-234 is approved as 
of July 22, 1997, and the regulations are amended in 21 CFR 
520.2345d(a)(1) 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 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 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, 000010, 057561, and 
059130'' and adding in its place ``047864, 051259, 054273, 057561, and 
059130''.

    Dated: August 22, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-23372 Filed 9-3-97; 8:45 am]
BILLING CODE 4160-01-F