[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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