E9-28468. Oral Dosage Form New Animal Drugs; Chlortetracycline Powder  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Alpharma Inc. The ANADA provides for use of generic chlortetracycline soluble powder to make medicated drinking water for cattle, swine, chickens, and turkeys for the treatment of several bacterial diseases.

    DATES:

    This rule is effective November 30, 2009.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: john.harshman@fda.hhs.gov.Start Printed Page 62491

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    Alpharma Inc., 440 Route 22, Bridgewater, NJ 08807, filed ANADA 200-441 that provides for the use of A-MYCIN (chlortetracycline) Soluble Powder to make medicated drinking water for cattle, swine, chickens, and turkeys for the treatment of several bacterial diseases. Alpharma Inc.'s A-MYCIN Soluble Powder is approved as a generic copy of Fort Dodge Animal Health, A Division of Wyeth Holdings Corp.'s AUREOMYCIN (chlortetracycline) Soluble Powder, approved under NADA 65-440. The ANADA is approved as of October 9, 2009, and the regulations are amended in 21 CFR 520.445b to reflect the approval.

    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.

    FDA has determined under 21 CFR 25.33 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.

    Start List of Subjects

    List of Subjects in 21 CFR Part 520

    • Animal drugs
    End List of Subjects Start Amendment Part

    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:

    End Amendment Part Start Part

    PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

    End Part Start Amendment Part

    1. The authority citation for 21 CFR part 520 continues to read as follows:

    End Amendment Part Start Authority

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

    End Authority Start Amendment Part

    2. In § 520.445b, revise paragraph (b)(2) to read as follows:

    End Amendment Part
    Chlortetracycline powder.

    (b) * * *

    (2) Nos. 046573 and 053501 for use as in paragraph (d) of this section.

    Start Signature

    Dated: November 23, 2009.

    Bernadette Dunham,

    Director, Center for Veterinary Medicine.

    End Signature End Supplemental Information

    [FR Doc. E9-28468 Filed 11-27-09; 8:45 am]

    BILLING CODE 4160-01-S

Document Information

Comments Received:
0 Comments
Effective Date:
11/30/2009
Published:
11/30/2009
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
E9-28468
Dates:
This rule is effective November 30, 2009.
Pages:
62490-62491 (2 pages)
Docket Numbers:
Docket No. FDA-2009-N-0665
Topics:
Animal drugs
PDF File:
e9-28468.pdf
CFR: (1)
21 CFR 520.445b