00-9579. New Animal Drugs for Use in Animal Feeds; Bambermycins; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

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 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.

§ 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.