[Federal Register: August 8, 2006 (Volume 71, Number 152)]
[Rules and Regulations]
[Page 44886-44887]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au06-3]
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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:
joan.gotthardt@fda.hhs.gov.
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]
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