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Home » 2001 Issues » 66 FR (11/06/2001) » 01-27812. Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor

  01-27812. Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor  

  • 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 a change of sponsor for an approved new animal drug application (NADA) from Elanco Animal Health, A Division of Eli Lilly & Co., to Ivy Laboratories, Div. of Ivy Animal Health, Inc.

    DATES:

    This rule is effective November 6, 2001.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, has informed FDA that it has transferred to Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, ownership of, and all rights and interests in NADA 118-123 for COMPUDOSE 200 (estradiol) and COMPUDOSE 400 implants for cattle. Accordingly, the agency is amending the regulations in 21 CFR 522.840 to reflect the transfer of ownership.

    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 522

    • 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 522 is amended as follows:

    End Amendment Part Start Part

    PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    End Part

    1. The authority citation for 21 CFR part 522 continues to read as follows:

    Start Authority

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

    End Authority
    [Amended]
    Start Amendment Part

    2. Section 522.840 Estradiol is amended in paragraph (b) by removing “000986” and by adding in its place “No. 021641”.

    End Amendment Part Start Signature

    Dated: October 26, 2001.

    Claire M. Lathers,

    Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

    End Signature End Supplemental Information

    [FR Doc. 01-27812 Filed 11-5-01; 8:45 am]

    BILLING CODE 4160-01-S

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Document Information

Effective Date:
11/6/2001
Published:
11/06/2001
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
01-27812
Dates:
This rule is effective November 6, 2001.
Pages:
56035-56035 (1 pages)
PDF File:
01-27812.pdf
CFR: (1)
21 CFR 522.840