[Federal Register Volume 65, Number 143 (Tuesday, July 25, 2000)]
[Rules and Regulations]
[Pages 45711-45712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18744]


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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; Halofuginone 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 a new animal drug application 
(NADA) filed by Alpharma, Inc. The NADA provides for use of approved, 
single-ingredient halofuginone hydrobromide and roxarsone Type A 
medicated articles to make two-way combination Type C medicated feeds 
used for prevention of coccidiosis, increased rate of weight gain, 
improved feed efficiency, and improved pigmentation in broiler and 
replacement chickens.

DATES: This rule is effective July 25, 2000.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-157 that provides for use of 
STENOROL (2.72 grams per pound (g/lb) of halofuginone 
hydrobromide) and 3-NITRO (45.4, 90, 227, or 360 g/lb of 
roxarsone) Type A medicated articles to make combination Type C 
medicated feeds for broiler chickens, replacement broiler breeder 
chickens, and replacement caged laying chickens prior to sexual 
maturity. The combination Type C medicated feeds contain 2.72 grams per 
ton (g/ton) halofuginone hydrobromide and 22.7 to 45.4 g/ton roxarsone 
and are used for the prevention of coccidiosis caused by Eimeria 
tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. 
maxima, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation. The NADA is approved as of July 
3, 2000, and the regulations are amended in 21 CFR 558.265 and 
Sec. 558.530 (21 CFR 558.530) to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    Also, Sec. 558.530 is editorially amended in paragraphs (a) and 
(d)(5) to simplify the regulation.
    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)(2) 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

[[Page 45712]]

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 558.265 is amended by adding paragraphs (c)(1)(viii) and 
(c)(3)(ii) to read as follows:


Sec. 558.265  Halofuginone hydrobromide.

* * * * *
    (c) * * *
    (1) * * *
    (viii) Amount per ton. Halofuginone hydrobromide, 2.72 grams plus 
roxarsone, 22.7 to 45.4 grams.
    (A) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, 
and E. maxima; for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (B) Limitations. Feed continuously as sole ration to replacement 
cage laying chickens until 20 weeks of age. Feed continuously as sole 
ration to replacement broiler breeder chickens until 16 weeks of age. 
Use as the sole source of organic arsenic; drug overdose or lack of 
water intake may result in leg weakness or paralysis. Do not feed to 
laying chickens or waterfowl. Withdraw 5 days before slaughter.
* * * * *
    (3) * * *
    (ii) Amount per ton. Halofuginone hydrobromide, 2.72 grams plus 
roxarsone, 22.7 to 45.4 grams.
    (A) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, 
and E. maxima; for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (B) Limitations. Feed continuously as sole ration to replacement 
cage laying chickens until 20 weeks of age. Feed continuously as sole 
ration to replacement broiler breeder chickens until 16 weeks of age. 
Use as the sole source of organic arsenic; drug overdose or lack of 
water intake may result in leg weakness or paralysis. Do not feed to 
laying chickens or waterfowl. Withdraw 5 days before slaughter.

    3. Section 558.530 is amended by revising paragraphs (a) and (d)(5) 
and by removing paragraph (d)(6) to read as follows:


Sec. 558.530  Roxarsone.

    (a) Approvals. Type A medicated articles: 10, 20, 50, and 80 
percent to 046573 in Sec. 510.600(c) of this chapter for use as in 
paragraphs (d)(1) through (d)(4) of this section.
* * * * *
    (d) * * *
    (5) Permitted combinations. It may be used in accordance with this 
section in combination with:
    (i) Aklomide as in Sec. 558.35.
    (ii) Amprolium as in Sec. 558.55.
    (iii) Amprolium and ethopabate as in Sec. 558.58.
    (iv) Bacitracin methylene disalicylate as in Sec. 558.76.
    (v) Bacitracin zinc as in Sec. 558.78.
    (vi) Bambermycins and bambermycins plus certain anticoccidials as 
in Sec. 558.95.
    (vii) Chlortetracycline as in Sec. 558.128.
    (viii) Clopidol as in Sec. 558.175.
    (ix) Decoquinate alone or in combination as in Sec. 558.195.
    (x) [Reserved]
    (xi) Halofuginone alone or in combination as in Sec. 558.265.
    (xii) Lasalocid alone or in combination as in Sec. 558.311.
    (xiii) Monensin alone or in combination as in Sec. 558.355.
    (xiv) Narasin alone or in combination as in Sec. 558.363.
    (xv) Nequinate as in Sec. 558.365.
    (xvi) Nicarbazin alone or in combination as in Sec. 558.366.
    (xvii) Nitromide and sulfanitran as in Sec. 558.376.
    (xviii) Penicillin and zoalene as in Sec. 558.680.
    (xix) Robenidine hydrochloride as in Sec. 558.515.
    (xx) Salinomycin alone or in combination as in Sec. 558.550.
    (xxi) Semduramicin alone or in combination as in Sec. 558.555.
    (xxii) Sulfadimethoxine, ormetoprim as in Sec. 558.575.
    (xxiii) Zoalene alone or in combination as in Sec. 558.680.

    Dated: July 17, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-18744 Filed 7-24-00; 8:45 am]
BILLING CODE 4160-01-F