[Federal Register Volume 62, Number 103 (Thursday, May 29, 1997)]
[Rules and Regulations]
[Pages 29014-29015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14106]


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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, Roxarsone, 
Bacitracin Methylene Disalicylate

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 supplemental new animal drug 
application (NADA) filed by Hoffmann-La Roche, Inc. The supplemental 
NADA provides for using approved single ingredient Type A medicated 
articles to make Type C medicated broiler feeds containing salinomycin 
with roxarsone and bacitracin methylene disalicylate.

EFFECTIVE DATE: May 29, 1997

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2604.

SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., Nutley, NJ 07110-
1199, filed supplemental NADA 135-321 which provides for use of single 
ingredient Type A medicated articles containing Bio-Cox 
(salinomycin as salinomycin sodium) 30 grams-per-pound (g/lb), 
BMD (bacitracin methylene disalicylate) 30, 50, 60, or 75 g/
lb bacitracin activity, 3-Nitro (roxarsone) 45.4, 90, or 227 
g/lb roxarsone activity, to make Type C broiler chicken feeds 
containing 40 to 60 g per ton (g/t) salinomycin sodium, 34.1 or 45.4 g/
t roxarsone, and 4 to 50 g/t bacitracin methylene disalicylate, for 
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 for increased rate of 
weight gain. Use of 34.1 or 45.4 g/t roxarsone is indicated to meet the 
E. tenella challenge, which varies with environmental and management 
conditions. The supplement is approved as of May 29, 1997. The basis of 
approval is discussed in the freedom of information summary.
    Also, 21 CFR 558.550 is amended to redesignate existing paragraph 
(b) as paragraph (d) and to add new paragraphs (b) and (c) to provide 
for more uniform regulations and for future expansion. The regulations 
are amended in newly redesignated paragraph (d) by adding new paragraph 
(d)(1)(xvii) to reflect the approval.
    This approval is for use of three single ingredient Type A 
medicated articles to make combination drug Type C medicated feeds. One 
ingredient, roxarsone, is a Category II drug as defined in 21 CFR 
558.3(b)(1)(ii). Under section 512(m) of the act (21 U.S.C. 360b(m)), 
as amended by the Animal Drug Availability Act of 1996 (Pub. L. 104-
250), use of salinomycin, roxarsone, and bacitracin methylene 
disalicylate Type A medicated articles to make Type C medicated feeds 
as provided in NADA 135-321 is limited to manufacture in a licensed 
feed mill.
    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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act, this approval for food-producing animals qualifies for 3 
years of marketing exclusivity beginning May 29, 1997, because the 
supplemental application contains substantial evidence of the 
effectiveness of the drug involved, any studies of animal safety or, in 
the case of food-producing animals, human food safety studies (other 
than bioequivalence or residue studies) required for approval of the 
application and conducted or sponsored by the applicant. The 3 years of 
marketing exclusivity applies only to the new combination providing for 
a 34.1 g/t level of roxarsone.
    The agency has determined under 21 CFR 25.24(d)(1)(ii) 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 
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: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

    2. Section 558.550 is amended by redesignating paragraph (b) as 
paragraph (d), by adding and reserving new paragraphs (b) and (c), and 
by adding new paragraph (d)(1)(xvii) to newly redesignated paragraph 
(d) to read as follows:

Sec. 558.550  Salinomycin.

* * * * *
    (b) [Reserved]
    (c) [Reserved]
    (d) * * *

[[Page 29015]]

    (1) * * *
    (xvii) (A) Amount per ton. Salinomycin 40 to 60 grams with 
roxarsone 34.1 or 45.4 grams and bacitracin methylene disalicylate 4 to 
50 grams.
    (B) Indications for use. 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 to salinomycin 
alone; for increased rate of weight gain. Use of 34.1 or 45.4 grams per 
ton roxarsone is indicated to meet the E. tenella challenge which 
varies with environmental and management conditions.
    (C) Limitations. Feed continuously as sole ration. Use as sole 
source of organic arsenic. Not approved for use with pellet binders. Do 
not feed to laying chickens. May be fatal if accidentally fed to adult 
turkeys or horses. Poultry should have access to drinking water at all 
times. Overdosage or lack of water may result in leg weakness or 
paralysis. Withdraw 5 days before slaughter. Salinomycin as provided by 
No. 000004 in Sec. 510.600(c) of this chapter. Roxarsone and bacitracin 
as provided by No. 046573 in Sec. 510.600(c) of this chapter.
* * * * *

    Dated: May 16, 1997.
 Robert C. Livingston,
 Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-14106 Filed 5-28-97; 8:45 am]
BILLING CODE 4160-01-F