71 FR 44886 E6-12862. New Animal Drugs For Use in Animal Feeds; Oxytetracycline  

  • 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.

    Table of Contents

    DATES: Back to Top

    This rule is effective August 8, 2006.

    FOR FURTHER INFORMATION CONTACT: Back to Top

    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: Back to Top

    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 Back to Top

    Animal drugs, Animal feeds.

    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 Back to Top

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

    Authority: Back to Top

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

    § 558.450 [Amended]

    2. In § 558.450, in the table in paragraph (d)(2)(i) in the “Limitations” column, remove “in feed containing oxytetracycline hydrochloride or mono-alkyl (C 8-C 18) 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 (C 8-C 18) trimethyl ammonium oxytetracycline”; and in the table in paragraph (d)(2)(iii) in the “Limitations” column, remove “in feed containing monoalkyl (C 8-C 18) 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

Document Information

Effective Date:
8/8/2006
Published:
08/08/2006
EntryType:
Rule
Action:
Final rule.
Document Number:
E6-12862
Document Citation:
71 FR 44886
Dates:
This rule is effective August 8, 2006.
Pages:
44886-44887 (2 pages)
CFR: (1)
21 CFR 558.450