[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Rules and Regulations]
[Pages 66432-66433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32141]


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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 and 
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 two abbreviated new animal drug 
applications (ANADA's) filed by Alpharma Inc. The ANADA's provide for 
using approved chlortetracycline and salinomycin Type A medicated 
articles to make Type C medicated broiler chicken feeds used for 
prevention of coccidiosis and as an aid in the reduction of mortality 
due to E. coli infections.

EFFECTIVE DATE: December 2, 1998.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20852, 301-827-0209.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, is sponsor of ANADA's 200-261 and 200-262 
that provide for combining approved ChlorMaxTM (50, 65, or 
70 grams per pound (g/lb) chlortetracycline) and Sacox or 
Bio-Cox (30 or 60 g/lb salinomycin sodium) Type A medicated 
articles to make Type C medicated broiler feeds containing 
chlortetracycline 500 grams per ton (g/t) and salinomycin 40 to 60 g/t. 
The Type C medicated feed is used for the prevention of coccidiosis 
caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. 
brunetti, and E. mivati, and as an aid in the reduction of mortality 
due to E. coli infections susceptible to such treatment.
    Alpharma Inc.'s ANADA 200-261 is approved as a generic copy of 
Roche Vitamins, Inc.'s NADA 140-859. Alpharma Inc.'s ANADA 200-262 is 
approved as a generic copy of Hoechst Roussel's ANADA 200-095. Alpharma 
Inc.'s ANADA's 200-261 and 200-262 are approved as of September 21, 
1998, and 21 CFR 558.550(a)(3) is amended to reflect the approvals. The 
basis for approval is discussed in the freedom of information 
summaries.
    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 these 
applications 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)(1) that these 
actions are of a type that do 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.
    2. Section 558.550 is amended by revising paragraph (a)(3) to read 
as follows:


Sec. 558.550   Salinomycin.

    (a) * * *

[[Page 66433]]

    (3) To 046573 for use as in paragraphs (d)(1)(xv) and (d)(1)(xvi) 
of this section.
* * * * *

    Dated: November 12, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-32141 Filed 12-1-98; 8:45 am]
BILLING CODE 4160-01-F