[Federal Register Volume 69, Number 55 (Monday, March 22, 2004)]
[Rules and Regulations]
[Page 13221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6247]


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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; Semduramicin, 
Virginiamycin, 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 Phibro Animal Health. The NADA provides for the use of 
approved, single-ingredient Type A medicated articles containing 
semduramicin, virginiamycin, and roxarsone to formulate three-way 
combination drug Type C medicated feeds for broiler chickens.

DATES: This rule is effective March 22, 2004.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phibro Animal Health, 710 Rte. 46 East, 
suite 401, Fairfield, NJ 07004, filed NADA 141-226 that provides for 
the use of AVIAX (semduramicin sodium), STAFAC (virginiamycin), and 3-
NITRO (roxarsone) Type A medicated articles to formulate three-way 
combination drug Type C medicated feeds for broiler chickens. The Type 
C medicated feeds contain 22.7 grams per ton (g/ton) semduramicin, 20 
g/ton virginiamycin, and 22.7 to 45.4 g/ton roxarsone, and are used for 
the prevention of coccidiosis caused by Eimeria acervulina, E. 
brunetti, E. maxima, E. mivati/E. mitis, E. necatrix, and E. tenella; 
for prevention of necrotic enteritis caused by Clostridium perfringens 
susceptible to virginiamycin; and for increased rate of weight gain, 
improved feed efficiency, and improved pigmentation in broiler 
chickens. The application is approved as of February 23, 2004, and the 
regulations are amended in 21 CFR 558.555 and 558.635 to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Division of Dockets Management 
(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.

0
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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.
0
2. Section 558.555 is amended by adding paragraph (d)(8) to read as 
follows:


Sec.  558.555  Semduramicin.

* * * * *
    (d) * * *
    (8) Amount. Semduramicin 22.7 grams with virginiamycin 20 grams and 
roxarsone 22.7 to 45.4 grams/ton.
    (i) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, 
and E. mivati/mitis; for prevention of necrotic enteritis caused by 
Clostridium perfringens susceptible to virginiamycin; and for increased 
rate of weight gain, improved feed efficiency, and improved 
pigmentation.
    (ii) Limitations. Feed continuously as sole ration throughout 
growing period. Withdraw 5 days before slaughter. For broiler chickens 
only. Do not feed to laying hens. Use as sole source of organic 
arsenic. Poultry should have access to drinking water at all times. 
Drug overdose or lack of water may result in leg weakness. Roxarsone 
provided by No. 046573; semduramicin and virginiamycin provided by No. 
066104 in Sec.  510.600(c) of this chapter.
0
3. Section 558.635 is amended by revising paragraph (d)(4)(vii) to read 
as follows:


Sec.  558.635  Virginiamycin.

* * * * *
    (d) * * *
    (4) * * *
    (vii) Semduramicin alone or with roxarsone as in Sec.  558.555.

    Dated: March 11, 2004.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 04-6247 Filed 3-19-04; 8:45 am]
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