[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Rules and Regulations]
[Page 67725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33919]


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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 a fixed combination Type A medicated article containing 
chlortetracycline, sulfathiazole, and penicillin to make a Type C 
medicated swine feed.

EFFECTIVE DATE: December 30, 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: Hoffmann-La Roche, Inc., 340 Kingsland St., 
Nutley, NJ 07110-1199, filed ANADA 200-140 that provides for using a 
fixed combination Type A medicated article containing chlortetracycline 
calcium complex equivalent to 20 grams per pound (g/lb) 
chlortetracycline hydrochloride, 4.4 percent sulfathiazole (20 g/lb), 
and penicillin procaine equivalent to 10 g/lb penicillin to make a Type 
C medicated swine feed. The Type C swine medicated feed contains 100 g/
ton (t) chlortetracycline, 100 g/t sulfathiazole, and 50 g/t 
penicillin, for making prestarter, starter, grower, and finisher Type C 
medicated feeds.
     Hoffmann-La Roche's ANADA 200-140 is approved as a generic copy of 
Boehringer Ingelheim's NADA 39-077. The ANADA is approved as of 
December 30, 1997, and the regulations are amended in 21 CFR 
558.155(a)(1) 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 human food safety data and 
information submitted to support this approval 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 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)(1) by removing ``000010'' and adding in its 
place ``000004 and 000010''.

    Dated: December 19, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-33919 Filed 12-30-97; 8:45 am]
BILLING CODE 4160-01-F