[Federal Register Volume 71, Number 123 (Tuesday, June 27, 2006)]
[Rules and Regulations]
[Page 36483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10053]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Oxytetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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 Pfizer, Inc. The supplemental NADA revises 
labeling of oxytetracycline soluble powder with the current genus for 
the causative bacteria for American foul brood of honeybees.

DATES: This rule is effective June 27, 2006.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed a supplement to NADA 8-622 that provides for use of 
TERRAMYCIN-343 (oxytetracycline HCl) Soluble Powder for treatment of 
various bacterial diseases of livestock. The supplemental NADA revises 
labeling with the current genus for the causative bacteria for American 
foul brood of honeybees. The supplemental NADA is approved as of May 9, 
2006, and the regulations in 21 CFR 520.1660d are amended to reflect 
the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    FDA has determined under Sec.  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 the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

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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.


Sec.  520.1660d  [Amended]

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2. In paragraph (d)(2)(ii) of Sec.  520.1660d, remove ``Bacillus'' and 
add in its place ``Paenibacillus''.

    Dated: June 7, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10053 Filed 6-26-06; 8:45 am]
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