99-14517. Oral Dosage Form New Animal Drugs; Decoquinate; Technical Amendment

[Federal Register Volume 64, Number 109 (Tuesday, June 8, 1999)]
[Rules and Regulations]
[Pages 30386-30387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14517]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Decoquinate; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending a final 
rule that provided for adding a dry powder containing decoquinate to 
whole milk to be fed to calves for prevention of coccidiosis. The 
document incorrectly referred to those calves as replacement calves in 
the heading of Sec. 520.534(d) (21 CFR 520.534(d)) for conditions of 
use. This document amends the regulation to state that decoquinate is 
for use in calves.

EFFECTIVE DATE: March 2, 1999.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 2, 1999 (64 
FR 10103), FDA added Sec. 520.534 to reflect approval of Alpharma 
Inc.'s new animal drug application (NADA 141-060) for use of 0.8 
percent decoquinate powder in whole milk for ruminating and 
nonruminating calves including veal calves. In the heading for 
Sec. 520.534(d), the document incorrectly stated that decoquinate 
medicated milk was for use in replacement calves. This document amends 
the heading for Sec. 520.534(d) to state that decoquinate is for use in 
calves by removing the word ``replacement''.

List of Subjects in 21 CFR Part 520

    Animal drugs.
    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec. 520.534  [Amended]

    2. Section 520.534 Decoquinate is amended in the heading for 
paragraph

[[Page 30387]]

(d) by removing the phrase ``Replacement calves'' and adding the word 
``Calves''.

    Dated: May 25, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-14517 Filed 6-7-99; 8:45 am]
BILLING CODE 4160-01-F