[Federal Register Volume 71, Number 152 (Tuesday, August 8, 2006)]
[Rules and Regulations]
[Pages 44886-44887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12862]


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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 Feeds; 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 
provides for the approval of the dihydrate salt of oxytetracycline in 
their Type A medicated article used in aquaculture feed, a change of 
oxytetracycline concentration in the Type A medicated article, and the 
addition of an indication for control of gaffkemia in lobsters.

DATES: This rule is effective August 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 38-439 for 
TERRAMYCIN for Fish (oxytetracycline) Type A medicated article used for 
control of certain bacterial diseases in several aquaculture species 
and for skeletal marking of Pacific salmon. The supplement provides for 
the approval of the dihydrate salt of oxytetracycline, a change of 
oxytetracycline concentration in the Type A medicated article, and the 
addition of an indication for control of gaffkemia in lobsters. The 
supplemental NADA is approved as of June 30, 2006, and the regulations 
are amended in 21 CFR 558.450 to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a) 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

[[Page 44887]]

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)(2)(i) in the 
``Limitations'' column, remove ``in feed containing oxytetracycline 
hydrochloride or mono-alkyl (C8-C18) trimethyl 
ammonium oxytetracycline''; in the table in paragraph (d)(2)(ii) in the 
``Limitations'' column for both entries ``1'' and ``2'', remove ``as 
mono-alkyl (C8-C18) trimethyl ammonium 
oxytetracycline''; and in the table in paragraph (d)(2)(iii) in the 
``Limitations'' column, remove ``in feed containing monoalkyl 
(C8-C18) trimethyl ammonium oxytetracycline''.

    Dated: July 25, 2006.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. E6-12862 Filed 8-7-06; 8:45 am]
BILLING CODE 4160-01-S