[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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