[Federal Register Volume 63, Number 27 (Tuesday, February 10, 1998)]
[Rules and Regulations]
[Page 6644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3293]


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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; Salinomycin

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 Hoffmann-La Roche, Inc. The NADA provides 
for use of an alternate formulation of salinomycin Type A medicated 
articles to make Type C medicated feeds.

EFFECTIVE DATE: February 10, 1998.
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: Hoffmann-La Roche, Inc., Nutley, NJ 07110-
1199, is sponsor of NADA 128-686 that provides for use of Bio-
Cox (salinomycin) Type A medicated articles to make Type C 
medicated feeds for broiler, roaster, and replacement chickens, and 
quail. The firm filed a supplement to the NADA that provides for use of 
a 60-grams-per-pound (g/lb) salinomycin Type A medicated article in 
addition to the currently approved 30-g/lb product. The supplemental 
NADA is approved as of January 9, 1998, and the regulations are amended 
in 21 CFR 558.550(a)(1) to reflect the approval.
    Approval of this supplemental NADA does not require additional 
safety or effectiveness data or information. A freedom of information 
summary as provided under 21 CFR part 20 and 514.11(e)(2)(ii) is not 
required.
    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 
the 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. 558.550  [Amended]

    2. Section 558.550 Salinomycin is amended in paragraph (a)(1) by 
removing ``30'' and adding in its place ``30 and 60''.

    Dated: January 28, 1998.
 Andrew J. Beaulieau,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-3293 Filed 2-9-98; 8:45 am]
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