[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]
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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
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 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
