[Federal Register Volume 62, Number 218 (Wednesday, November 12, 1997)]
[Rules and Regulations]
[Page 60657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29649]


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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; Medicated Feed 
Applications; Lasalocid; 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 the animal 
drug regulations to reflect the correct assay limits for lasalocid in 
Type A medicated articles. Although a supplement to the new animal drug 
application (NADA) was approved, the regulations had not been 
previously amended to reflect that approval. At this time the 
regulations are amended to reflect the current assay limits in the 
approved NADA.

EFFECTIVE DATE: November 12, 1997.

FOR FURTHER INFORMATION CONTACT: Mary G. Leadbetter, Center for 
Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1662.

SUPPLEMENTARY INFORMATION: FDA is amending the regulation concerning 
use of animal drugs in medicated feeds in Sec. 558.4(d) (21 CFR 
558.4(d)) to reflect that the assay limit for lasalocid Type A 
medicated articles is 95 to 115 percent of the labeled amount. Although 
the original approval for NADA 96-298 Hoffmann-LaRoche, Inc., provided 
for a 10 percent overage (an assay limit of 100 to 120 percent), a 
supplemental approval dated August 25, 1992, revised that overage to 5 
percent (95 to 115 percent). The regulation in Sec. 558.4(d) is amended 
in the table entitled ``Category I,'' in the entry for ``Lasalocid,'' 
accordingly.

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. 558.4  [Amended]

    2. Section 558.4 Medicated feed applications is amended in 
paragraph (d), in the table entitled ``Category I,'' in the entry for 
``Lasalocid,'' in the second column by removing ``100-120'' and adding 
in its place ``95-115''.

    Dated: October 21, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-29649 Filed 11-10-97; 8:45 am]
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