[Federal Register Volume 63, Number 10 (Thursday, January 15, 1998)]
[Rules and Regulations]
[Pages 2306-2307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Chlortetracycline, 
Sulfathiazole, Penicillin

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 Hoffmann-La Roche, Inc. The ANADA provides 
for use of Type A medicated article containing chlortetracycline, 
sulfathiazole, and penicillin to make a Type C medicated swine feed.

EFFECTIVE DATE: January 15, 1998

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: Hoffmann-La Roche, Inc., 340 Kingsland St., 
Nutley, NJ 07110-1199, filed ANADA 200-167 that provides using 
Aureozol, a Type A medicated article containing 
chlortetracycline calcium complex equivalent to 40 grams per pound (g/
lb) chlortetracycline hydrochloride, sulfathiazole 8.8 percent (40 g/
lb), and penicillin (from penicillin procaine) 20 g/lb, to make a Type 
C medicated swine feed. The Type C swine feed contains 100 g of 
chlortetracycline, 100 g of sulfathiazole, and 50 g of penicillin per 
ton of feed. It is a complete feed for swine raised in confinement (dry 
lot) or on limited pasture. It is used in swine pre-starter and starter 
feeds for reduction of incidence of cervical abscesses, treatment of 
bacterial enteritis (salmonellosis or necrotic enteritis caused by 
Salmonella choleraesuis and vibrionic dysentery), maintenance of weight 
gain in the presence of atropic rhinitis, increased rate of weight 
gains and improved feed efficiency from 10 pounds of body weight to 6 
weeks post-weaning. It is used for swine grower and finisher feed for 
reduction of incidence of cervical abscesses, treatment of bacterial

[[Page 2307]]

enteritis (salmonellosis or necrotic enteritis caused by S. 
choleraesuis and vibrionic dysentery), maintenance of weight gains in 
the presence of atropic rhinitis, increased rate of weight gain from 6 
to 16 weeks post-weaning. Hoffmann-LaRoche's ANADA 200-167 is approved 
as a generic copy of Boehringer Ingelheim Animal Health, Inc.'s NADA 
39-077 CSP 500 Fermazole Brand (chlortetracycline (as hydrochloride), 
sulfathiazole, penicillin (from penicillin procaine)). The ANADA is 
approved as of January 15, 1998, and the regulations are amended in 21 
CFR 558.155(a)(2) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    This approval is for use of a Type A medicated article to make Type 
C medicated feeds. The Type A medicated article is a Category II drug 
which, as provided in 21 CFR 558.4, requires an approved form FDA 1900 
for making a Type C medicated feed. The Animal Drug Availability Act of 
1996 (Pub. L. 104-250) replaces the procedures for approval of certain 
medicated feeds with a general licensing system. A medicated feed 
previously requiring an approved medicated feed application now 
requires manufacturing in a licensed medicated feed mill. Therefore, 
use of this Type A medicated article to make Type C medicated feeds as 
provided in ANADA 200-167 is required to be manufactured at a licensed 
feed mill.
    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.
    FDA 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 558

    Animal drugs, Animal feeds.
    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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec. 558.155  [Amended]

    2. Section 558.155 Chlortetracycline, sulfathiazole, penicillin is 
amended in paragraph (a)(2) by removing ``000010'' and adding in its 
place ``054273''.

    Dated: January 2, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-703 Filed 1-14-98; 8:45 am]
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