[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Rules and Regulations]
[Pages 20733-20734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9579]


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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; Bambermycins; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is updating the animal 
drug regulations to correctly reflect the previously approved use level 
for bambermycins Type C medicated cattle feed. This document amends the 
regulations to state the correct use level is 2 to 40 grams (g) of 
bambermycins per ton of feed. This action is being taken to improve the 
accuracy of the agency's regulations.

DATES:  This rule is effective April 18, 2000.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0217.

SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, Perryville Corporate 
Park III, P.O. Box 4010, Clinton, NJ 08809-4010, is sponsor of NADA 
141-034 that provides for use of GAINPRO (bambermycins) Type 
A medicated articles to make Type B and Type C medicated cattle feeds. 
In its approval letter of October 17, 1994, the Center for Veterinary 
Medicine approved the use of Type C medicated feeds containing 2 to 40 
g of bambermycins per ton of feed, used to provide 10 to 20 milligrams 
bambermycins per head per day for increased rate of weight gain in 
pasture cattle. At this time, 21 CFR 558.95(d)(4)(ii) is amended by 
removing ``4 to 20'' and adding in its place ``2 to 40'' to reflect the 
correct Type C medicated feed levels.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because

[[Page 20734]]

it is a rule of ``particular applicability.'' Therefore, it is not 
subject to the 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. 558.95  [Amended]

    2. Section 558.95 Bambermycins is amended in paragraph (d)(4)(ii) 
by removing ``4 to 20'' and adding in its place ``2 to 40''.

    Dated: March 17, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-9579 Filed 4-17-00; 8:45 am]
BILLING CODE 4160-01-F