[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Rules and Regulations]
[Page 29481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14650]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Semduramicin With 
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 Pfizer, Inc. The NADA provides for using approved 
single ingredient Type A medicated articles to make combination drug 
Type C medicated broiler chicken feeds containing semduramicin with 
bacitracin methylene disalicylate and roxarsone. The Type C medicated 
feed is used for prevention of coccidiosis and for improved feed 
efficiency.

EFFECTIVE DATE: June 11, 1996.
FOR FURTHER INFORMATION CONTACT: James F. McCormack, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1607.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed NADA 141-058, which provides for combining approved Type A 
medicated articles containing Aviax<Register> (semduramicin sodium) 
with BMD<Register> (bacitracin methylene disalicylate) and 3-
Nitro<Register> (roxarsone) to make combination drug Type C medicated 
broiler chicken feeds containing 22.7 grams (g) of semduramicin, 10 to 
50 g of bacitracin methylene disalicylate, and 45.4 g of roxarsone per 
ton. The Type C medicated feed is used for the prevention of 
coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. 
mivati/E. miti, E. necatrix, and E. tenella, including some field 
strains of E. tenella that are more susceptible to semduramicin 
combined with roxarsone than semduramicin alone, and for improved feed 
efficiency in broiler chickens. The NADA is approved as of June 11, 
1996, and the regulations are amended by adding new 21 CFR 
558.555(b)(2) to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    Roxarsone is a Category II drug which, as provided in 21 CFR 558.4, 
requires an approved medicated feed application (Form FDA 1900) for 
making a Type C medicated feed. Therefore, making a Type C medicated 
feed containing semduramicin, bacitracin methylene disalicylate, and 
roxarsone requires an approved Form FDA 1900.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years marketing exclusivity beginning June 11, 1996, because the 
application contains reports of new clinical or field investigations 
(other than bioequivalence or residue studies) essential to the 
approval of the application and conducted or sponsored by the 
applicant.
    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 558.555 is amended by adding new paragraph (b)(2) to 
read as follows:


Sec. 558.555  Semduramicin.

 *  *  *  *  *
    (b) * * *
    (2) Amount. Semduramicin 22.7 grams with bacitracin methylene 
disalicylate 10 to 50 grams and roxarsone 45.4 grams per ton.
    (i) Indications for use. For the prevention of coccidiosis caused 
by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. 
necatrix, and E. tenella, including some field strains of E. tenella 
that are more susceptible to semduramicin combined with roxarsone than 
semduramicin alone, and for improved feed efficiency.
    (ii) Limitations. Feed continuously as sole ration. Use feed within 
2 weeks of production. Withdraw 5 days before slaughter. Do not feed to 
laying hens. 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.

    Dated: May 28, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-14650 Filed 6-10-96; 8:45 am]
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