[Federal Register Volume 71, Number 149 (Thursday, August 3, 2006)]
[Rules and Regulations]
[Pages 43967-43968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12568]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Kanamycin, Bismuth
Subcarbonate, Activated Attapulgite
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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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
[[Page 43968]]
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:
[email protected].
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
in part 520 (21 CFR part 520) in Sec. Sec. 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.
0
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
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. In Sec. 520.1204, revise the section heading and paragraphs (a) and
(c) to read as follows:
Sec. 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.
Sec. 520.1205 [Removed]
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3. Remove Sec. 520.1205.
Dated: July 21, 2006.
Daniel G. McChesney,
Director, Office of Surveillance and Compliance, Center for Veterinary
Medicine.
[FR Doc. E6-12568 Filed 8-2-06; 8:45 am]
BILLING CODE 4160-02-S