[Federal Register Volume 65, Number 131 (Friday, July 7, 2000)]
[Rules and Regulations]
[Pages 41876-41877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17196]


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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, Bacitracin 
Methylene Disalicylate, 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 using approved, 
single-ingredient salinomycin, bacitracin methylene disalicylate (BMD), 
and roxarsone Type A medicated articles to make three-way combination 
Type C medicated feeds used for prevention of coccidiosis, as an aid in 
the prevention and control of necrotic enteritis, and for increased 
rate of weight gain, improved feed efficiency, and improved 
pigmentation in broiler, roaster, and replacement (breeder and layer) 
chickens.

DATES: This rule is effective July 7, 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 141-121 that provides for use of 
approved BIO-COX (30 or 60 grams per pound (g/lb) of 
salinomycin activity), BMD (10, 25, 30, 40, 50, 60, or 75 g/
lb BMD), and 3-NITRO (45.4, 90, 227, or 360 g/lb roxarsone) 
Type A medicated articles to make combination Type C medicated feeds 
for use in broiler, roaster, and replacement chickens. The combination 
Type C medicated feeds contain 40 to 60 grams per ton (g/ton) 
salinomycin, 50 or 100 to 200 g/ton BMD, 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. maxima, E. brunetti, 
and E. mivati, as an aid in the prevention (at 50 g/ton BMD) or control 
(at 100 to 200 g/ton BMD) of necrotic enteritis caused or complicated 
by Clostridium spp. or other organisms susceptible to bacitracin, and 
for increased rate of weight gain, improved feed efficiency, and 
improved pigmentation. The NADA is approved as of December 23, 1999, 
and the regulation in Sec. 558.550 (21 CFR 558.550) is amended to 
reflect the approval. The basis for approval is discussed in the 
freedom of information summary.
    Also, due to an error in structuring the regulations, the approval 
entry in Sec. 558.550(a)(3) is removed. Also, Sec. 558.500(d)(1)(xv) 
and (d)(1)(xvi) are amended under limitations to reflect the change due 
to the error.
    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.

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 removing the phrase ``through 
(d)(3)(iii)'' from paragraph (a)(2), by removing paragraph (a)(3), by 
revising the last sentence of paragraphs (d)(1)(xv)(c) and 
(d)(1)(xvi)(c), by adding paragraphs (d)(1)(xviii) and (xix), by 
redesignating paragraphs (d)(3)(i), (d)(3)(ii), and (d)(3)(iii) as 
paragraphs (d)(3)(i)(A), (d)(3)(i)(B), and (d)(3)(i)(C), respectively, 
and by adding new paragraphs (d)(3)(ii) and (d)(3)(iii) to read as 
follows:


Sec. 558.550  Salinomycin.

* * * * *
    (d) * * *
    (1) * * *
    (xv) * * *
    (c) Limitations. * * * Chlortetracycline as provided by Nos. 046573 
and 063238; roxarsone as provided by No. 046573; and salinomycin as 
provided by Nos. 012799 and 063238 in Sec. 510.600(c) of this chapter.
    (xvi) * * *
    (c) Limitations. * * * Chlortetracycline as provided by Nos. 046573 
and 063238; salinomycin as provided by Nos. 012799 and 063238 in 
Sec. 510.600(c) of this chapter.
* * * * *

[[Page 41877]]

    (xviii)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin 
methylene disalicylate, 50 grams; and roxarsone, 22.7 to 45.4 grams.
    (B) Indications for use. For the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, as an aid in the prevention of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (C) Limitations. Feed continuously as sole ration. Do not feed to 
laying chickens. Use as sole source of organic arsenic. Poultry should 
have access to drinking water at all times. Drug overdosage or lack of 
water intake may result in leg weakness or paralysis. May be fatal if 
fed to adult turkeys or to horses. Withdraw 5 days before slaughter. 
Salinomycin as provided by Nos. 063238; bacitracin methylene 
disalicylate and roxarsone as provided by No. 046573 in Sec. 510.600(c) 
of this chapter.
    (xix)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin 
methylene disalicylate, 100 to 200 grams; and roxarsone, 22.7 to 45.4 
grams.
    (B) Indications for use. For the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (C) Limitations. Feed continuously as sole ration. To control 
necrotic enteritis, start medication at first clinical signs of 
disease; vary dosage based on the severity of infection; administer 
continuously for 5 to 7 days or as long as clinical signs persist, then 
reduce bacitracin to prevention level (50 g/ton). Do not feed to laying 
chickens. Use as sole source of organic arsenic. Poultry should have 
access to drinking water at all times. Drug overdosage or lack of water 
intake may result in leg weakness or paralysis. May be fatal if fed to 
adult turkeys or to horses. Withdraw 5 days before slaughter. 
Salinomycin as provided by No. 063238; bacitracin methylene 
disalicylate and roxarsone as provided by No. 046573 in Sec. 510.600(c) 
of this chapter.
* * * * *
    (3) * * *
    (ii)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin 
methylene disalicylate, 50 grams; and roxarsone, 22.7 to 45.4 grams.
    (B) Indications for use. For the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, as an aid in the prevention of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (C) Limitations. Feed continuously as sole ration. Discontinue use 
prior to sexual maturity. Do not feed to laying chickens. Use as sole 
source of organic arsenic. Poultry should have access to drinking water 
at all times. Drug overdosage or lack of water intake may result in leg 
weakness or paralysis. May be fatal if fed to adult turkeys or to 
horses. Withdraw 5 days before slaughter. Salinomycin as provided by 
No. 063238; bacitracin methylene disalicylate and roxarsone as provided 
by No. 046573 in Sec. 510.600(c).
    (iii)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin 
methylene disalicylate, 100 to 200 grams; and roxarsone, 22.7 to 45.4 
grams.
    (B) Indications for use. For the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (C) Limitations. Feed continuously as sole ration. To control 
necrotic enteritis, start medication at first clinical signs of 
disease; vary dosage based on the severity of infection; administer 
continuously for 5 to 7 days or as long as clinical signs persist, then 
reduce bacitracin to prevention level (50 g/ton). Discontinue use prior 
to sexual maturity. Do not feed to laying chickens. Use as sole source 
of organic arsenic. Poultry should have access to drinking water at all 
times. Drug overdosage or lack of water intake may result in leg 
weakness or paralysis. May be fatal if fed to adult turkeys or to 
horses. Withdraw 5 days before slaughter. Salinomycin as provided by 
No. 063238; bacitracin methylene disalicylate and roxarsone as provided 
by No. 046573 in Sec. 510.600(c).
* * * * *

    Dated: June 26, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-17196 Filed 7-6-00; 8:45 am]
BILLING CODE 4160-01-F