[Federal Register Volume 63, Number 228 (Friday, November 27, 1998)]
[Rules and Regulations]
[Pages 65553-65554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31575]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Chlortetracycline, 
Salinomycin, and Roxarsone

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, salinomycin, and roxarsone 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 Escherichia coli infections.

EFFECTIVE DATE: November 27, 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 200-259 and 200-260 
that provide for combining approved ChlorMaxTM (50, 65, or 
70 grams per pound (g/lb) chlortetracycline), Sacox or Bio-
Cox (30 or 60 g/lb salinomycin sodium), and 3-Nitro 
(10, 20, or 50 percent roxarsone) Type A medicated articles to make 
Type C medicated broiler feeds containing chlortetracycline 500 grams 
per ton (g/t), salinomycin 40 to 60 g/t, and roxarsone 45.4 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, including some field strains of E. tenella that are more 
susceptible to roxarsone combined with salinomycin than salinomycin 
alone, and as an aid in the reduction of mortality due to E.

[[Page 65554]]

coli infections susceptible to such treatment.
    Alpharma Inc.'s ANADA 200-259 is approved as a generic copy of 
Hoechst-Roussel's ANADA 200-091. Alpharma Inc.'s ANADA 200-260 is 
approved as a generic copy of Roche Vitamins, Inc.'s NADA 140-867. 
Alpharma Inc.'s ANADA's 200-259 and 200-260 are approved as of 
September 21, 1998, and 21 CFR 558.550(a)(3) is added and paragraph 
(d)(1)(xv) 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 this application 
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 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.

    2. Section 558.550 is amended by revising paragraph (a) and the 
last sentence in paragraph (d)(1)(xv)(c) to read as follows:


Sec. 558.550  Salinomycin.

    (a) Approvals. Type A medicated articles containing 30 or 60 grams 
of salinomycin activity per pound (as salinomycin sodium biomass) as 
follows:
    (1) To 063238 in Sec. 510.600(c) of this chapter for use as in 
paragraph (d) of this section.
    (2) To 012799 for use as in paragraphs (d)(1)(i), (d)(1)(iii) 
through (d)(1)(xvi), and (d)(3)(i) through (d)(3)(iii) of this section.
    (3) To 046573 for use as in paragraph (d)(1)(xv) of this section.
 * * * * *
    (d) * * *
    (1) * * *
    (xv) * * *
    (c) * * * Chlortetracycline as provided by Nos. 046573 and 063238 
and roxarsone as provided by No. 046573 in Sec. 510.600(c) of this 
chapter.
 * * * * *

    Dated: November 12, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-31575 Filed 11-25-98; 8:45 am]
BILLING CODE 4160-01-F