[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Rules and Regulations]
[Page 66985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33376]


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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 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 and 
roxarsone used for prevention of coccidiosis.

EFFECTIVE DATE:  December 23, 1997.

FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed NADA 141-066, which provides for combining approved Type A 
medicated articles containing AviaxTM (semduramicin sodium) 
(22.7 grams per pound (g/lb.)) and 3-Nitro (roxarsone) (45.4, 90, and 
227 g/lb.) to make combination drug Type C medicated broiler chicken 
feeds containing 22.7 grams per ton of semduramicin and 45.4 grams per 
ton of roxarsone. The Type C medicated feed is used 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. The NADA is approved 
as of December 23, 1997, and the regulations are amended by adding 21 
CFR 558.555(b)(4) to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    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)(ii) of the Federal Food, Drug, and 
Cosmetic Act the act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for 
food-producing animals qualifies for 3 years marketing exclusivity 
beginning December 23, 1997, because the 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 and conducted or sponsored by the 
applicant.
    This approval is for use of approved 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). 
As provided in 21 CFR 558.4(b), an approved FDA form 1900 is required 
for making a Type B or Type C medicated feed as in this application. 
Under section 512(m) of the act, as amended by the Animal Drug 
Availability Act of 1996 (Pub L. 104-250), medicated feed applications 
have been replaced by a requirement for feed mill licenses. Therefore, 
use of semduramicin and roxarsone Type A medicated articles to make 
Type C medicated feeds as provided in NADA 141-066 requires a feed mill 
license rather than an approved FDA Form 1900.
    The agency has determined under 21 CFR 25.33(a)(1) 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: 21 U.S.C. 360b, 371.

    2. Section 558.555 is amended by adding paragraph (b)(4) to read as 
follows:

Sec. 558.555  Semduramicin.

* * * * *
    (b) * * *
    (4) Amount. Semduramicin 22.7 grams with 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.
    (ii) Limitations. Feed continuously as sole ration. Withdraw 5 days 
before slaughter. For broiler chickens only. Do not feed to laying 
hens. Use as sole source of organic arsenic. Roxarsone as provided by 
046573, semduramicin as provided by 000069 in Sec. 510.600(c) of this 
chapter.

    Dated: December 15, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-33376 Filed 12-22-97; 8:45 am]
BILLING CODE 4160-01-F