[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Rules and Regulations]
[Pages 45880-45881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18826]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Neomycin Sulfate

AGENCY: Food and Drug Administration, HHS.

[[Page 45881]]


ACTION: Final rule.

-----------------------------------------------------------------------

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 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.

DATES: This rule is effective July 26, 2000.

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.

SUPPLEMENTARY 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.

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. 558.364  [Amended]

    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''.

    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