Animal drugs, feeds, and related products: Halofuginone and roxarsone,

[Federal Register: July 25, 2000 (Volume 65, Number 143)]

[Rules and Regulations]

[Page 45711-45712]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr25jy00-6]

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.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filedby 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, filedNADA 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. 00-18744Filed7-24-00; 8:45 am]

   BILLING CODE 4160-01-F