[Federal Register Volume 71, Number 174 (Friday, September 8, 2006)]
[Rules and Regulations]
[Pages 53006-53007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14898]


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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 Feed; 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 Phibro Animal Health. The supplemental NADA 
revises labeling of oxytetracycline Type A medicated article with the 
current genus for the causative bacteria for American foulbrood of 
honeybees.

DATES: This rule is effective September 8, 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: Phibro Animal Health, 65 Challenger Rd., 3d 
floor, Ridgefield Park, NJ 07660, filed a supplement to NADA 95-143 
that provides for use of TERRAMYCIN 100MR (oxytetracycline dihydrate) 
Type A medicated article for treatment of various bacterial diseases of 
livestock. The supplemental NADA revises labeling with the current 
genus for the causative bacteria for American foulbrood of honeybees. 
The supplemental NADA is approved as of August 11, 2006, and the 
regulations in 21 CFR 558.450 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 558

    Animal drugs, Animal feeds.

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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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.450  [Amended]

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2. In Sec.  558.450, in the table in paragraph (d)(1)(xiv) in the 
``Indications for use'' column, remove ``Bacillus'' and add in its 
place ``Paenibacillus''.


[[Page 53007]]


    Dated: August 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-14898 Filed 9-7-06; 8:45 am]
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