[Federal Register Volume 63, Number 85 (Monday, May 4, 1998)]
[Rules and Regulations]
[Pages 24420-24421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11741]
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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; Monensin
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 two supplemental new animal
drug applications (NADA's) filed by Elanco Animal Health, Division of
Eli Lilly and Co. The supplemental NADA's provide a revised
specification for monensin bulk drug substance used to make monensin
Type A medicated articles.
EFFECTIVE DATE: May 4, 1998.
FOR FURTHER INFORMATION CONTACT: Mary G. Leadbetter, Center for
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1662.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, Division of Eli Lilly
and Co., Lilly Corporate Center, Indianapolis, IN 46285, is the sponsor
of NADA 38-878 that provides for use of monensin Type A medicated
articles to make monensin Type C medicated feeds for chickens, turkeys,
and quail, and NADA 95-735 that provides for use of monensin Type A
medicated articles to make monensin Type B and C medicated feeds for
cattle and goats. Elanco filed supplemental NADA's that provide revised
assay information used in checking the specifications of the monensin
bulk drug substance used in Type A medicated articles. The supplemental
NADA's were approved as of March 17, 1997, and the regulations are
amended in 21 CFR 558.355(a) to reflect the approval.
Approval of these supplements did not require a freedom of
information summary because the approvals concern a change in
specifications of the monensin bulk drug substance. This change does
not affect the product's safety or effectiveness.
The agency has determined under 21 CFR 25.33(a)(3) 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.
Sec. 558.355 [Amended]
2. Section 558.355 Monensin is amended in paragraph (a) after the
parenthetical phrase by removing the period at the end of the second
sentence, and by adding the phrase ``, or, using High Performance
Liquid Chromatography, the factor distribution of monensin Factor A or
B is calculated as the percentage of total biopotency of all peaks.''
[[Page 24421]]
Dated: April 21, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-11741 Filed 5-1-98; 8:45 am]
BILLING CODE 4160-01-F
