[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
