Food and Drug Administration, HHS.Start Printed Page 45881
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 Pharmacia & Upjohn Co. The supplemental NADA provides for the use of neomycin sulfate Type A medicated articles to make Type B and Type C medicated feeds for cattle, swine, sheep, and goats in a broader range of concentrations.
This rule is effective July 26, 2000.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Dianne T. McRae, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0212.End Further Info End Preamble Start Supplemental Information
Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199, has filed a supplemental application to NADA 140-976 that provides for use of Neomix® (neomycin sulfate) Type A medicated articles to make Type B and Type C medicated feeds for cattle, swine, sheep, and goats used for the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin. The supplemental NADA requested that the approved range of concentrations for neomycin Type C medicated feeds of 400 to 1,600 grams per ton (g/ton) be broadened to 250 to 2,250 g/ton. The approved daily dose of 10 milligrams per pound of body weight remains unchanged. The supplemental NADA is approved as of June 28, 2000, and the regulations are amended in 21 CFR 558.364 to reflect the approval.
Approval of this supplemental NADA does not require additional safety and effectiveness data. Therefore, a freedom of information summary is not required.
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.
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 congressional review requirements in 5 U.S.C. 801-808.Start List of Subjects
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:End Amendment Part Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 558 continues to read as follows:End Amendment Part
2. Section 558.364 Neomycin sulfate is amended in the table in paragraph (d) in entry “(1)” under “Neomycin sulfate” by removing “400 to 1,600” and by adding in its place “250 to 2,250”.End Amendment Part Start Signature
Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 00-18826 Filed 7-25-00; 8:45 am]
BILLING CODE 4160-01-F