[Federal Register Volume 63, Number 228 (Friday, November 27, 1998)]
[Rules and Regulations]
[Page 65554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31572]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Chlortetracycline

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 a supplemental new animal drug 
application (NADA) filed by Roche Vitamins, Inc. The supplemental NADA 
provides for a zero-day withdrawal period for use of 500 grams per ton 
(g/t) chlortetracycline (CTC) Type C medicated chicken feeds.

EFFECTIVE DATE: November 27, 1998.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0212.

SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd., 
Parsippany, NJ 07054-1298, filed supplemental NADA 48-761 that provides 
for use of Aureomycin (CTC) Type A medicated articles to make 
500 g/t CTC Type C chicken feeds. The 500 g/t CTC Type C chicken feeds 
are used for 5 days for reduction of mortality due to CTC susceptible 
Escherichia coli infections. The supplement provides for reducing the 
24-hour withdrawal period to a zero-day slaughter withdrawal period. 
The supplemental NADA is approved as of October 26, 1998, and the 
regulations in 21 CFR 558.128(d)(1)(viii) are amended 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 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this supplemental 
application may be seen in the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(3) 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. 558.128   [Amended]

    2. Section 558.128 Chlortetracycline is amended in the table in 
paragraph (d)(1) in the entry for ``(viii) 500 g/ton'' under the column 
``Limitations'' by removing the phrase ``; withdraw 24 h prior to 
slaughter''.

    Dated: November 16, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-31572 Filed 11-25-98; 8:45 am]
BILLING CODE 4160-01-F