E6-12568. Oral Dosage Form New Animal Drugs; Kanamycin, Bismuth Subcarbonate, Activated Attapulgite

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to remove inactive ingredients from the specifications for an oral suspension and for tablets containing kanamycin, bismuth subcarbonate, and activated attapulgite; and to consolidate and reformat these sections. These actions are being taken to improve the accuracy and readability of the animal drug regulations.

DATES:

This rule is effective August 3, 2006.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA is amending the animal drug regulations in part 520 (21 CFR part 520) in §§ 520.1204 and 520.1205 to remove aminopentamide hydrogen sulfate and pectin from the specifications for an oral suspension and for tablets containing kanamycin, bismuth subcarbonate, and activated attapulgite. These ingredients have been declared inactive or have been removed from the formulations. In addition, these sections are being reformatted and consolidated. These actions are being taken to improve the accuracy and readability of the animal drug regulations.

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 520

• Animal drugs

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. In § 520.1204, revise the section heading and paragraphs (a) and (c) to read as follows:

§ 520.1204

Kanamycin, bismuth subcarbonate, activated attapulgite.

(a) Specifications—(1) Each 5 milliliters (mL) of suspension contains 100 milligrams (mg) kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite (aluminum magnesium silicate).

(2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite.

* * * * *

(c) Conditions of use in dogs—(1) Amount. 5 mL of suspension or 1 tablet per 20 pounds body weight every 8 hours. Maximum dose: 5 mL of suspension or 3 tablets every 8 hours. Dogs under 10 pounds: 2.5 mL of suspension or 1/2 tablet every 8 hours. A recommended initial loading dose should be twice the amount of a single dose.

(2) Indications for use. For the treatment of bacterial enteritis caused by organisms susceptible to kanamycin and the symptomatic relief of the associated diarrhea.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.1205

[Removed]

3. Remove § 520.1205.

Dated: July 21, 2006.

Daniel G. McChesney,

Director, Office of Surveillance and Compliance, Center for Veterinary Medicine.