[Federal Register Volume 62, Number 90 (Friday, May 9, 1997)]
[Rules and Regulations]
[Page 25477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12257]
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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; Medicated Feed
Applications; Semduramicin
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 Pfizer, Inc. The supplemental NADA provides
for revised assay limits for Type C medicated semduramicin chicken feed
to 80 to 110 percent of labeled claim.
EFFECTIVE DATE: May 9, 1997.
FOR FURTHER INFORMATION CONTACT: William G. Marnane, Center for
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0678.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed supplemental NADA 140-940, which provides for revising the
assay limits for Type C medicated chicken feed containing
AviaxTM (semduramicin sodium) from 85 to 110 percent of
labeled claim to 80 to 110 percent. The supplemental NADA is approved
as of April 8, 1997, and the regulations are amended in 21 CFR 558.4(d)
to reflect the approval.
Revision of the assay limits for a Type C medicated feed is based
on the evaluation of the assay procedure used to analyze the feed and
analysis of the assays of those feeds. The initial assay limits were
established based on the results of the method trial. Evaluation of the
feeds used in the market support trials, comparable to commercial
manufacturing operations, support a wider assay range. This action did
not require reevaluation of the safety and effectiveness data
supporting the original approval. Therefore, a freedom of information
summary is not 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).
Sec. 558.4 [Amended]
2. Section 558.4 Medicated feed applications is amended in
paragraph (d), in the table entitled ``Category I,'' in the entry for
``Semduramicin,'' in the last column by removing the assay limits ``85-
110'' and adding in its place ``80-110.''
Dated: April 30, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-12257 Filed 5-8-97; 8:45 am]
BILLING CODE 4160-01-F
