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Home » 2003 Issues » 68 FR (07/31/2003) » 03-19445. Intramammary Dosage Forms; Change of Sponsor

  03-19445. Intramammary Dosage Forms; Change of Sponsor  

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    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 three approved new animal drug applications (NADAs) from Pfizer, Inc., to Schering-Plough Animal Health Corp.

    DATES:

    This rule is effective July 31, 2003.

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    FOR FURTHER INFORMATION CONTACT:

    David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: dnewkirk@cvm.fda.gov.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    Pfizer, Inc., 235 East 42d St., New York, NY 10017, has informed FDA that it has transferred ownership of, and all rights and interest in, the following three approved NADAs to Schering-Plough Animal Health Corp., 1095 Morris Ave., Union, NJ 07083:

    NADA No.Trade Name
    55-069ORBENIN DC (cloxacillin benzathine)
    55-070DARICLOX (cloxacillin sodium)
    55-100AMOXI-MAST (amoxicillin trihydrate)

    Accordingly, the agency is amending the regulations in 21 CFR 526.88, 526.464b, and 526.464c 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.

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    List of Subjects in 21 CFR Part 526

    • 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 526 is amended as follows:

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    PART 526—INTRAMAMMARY DOSAGE FORMS

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    1. The authority citation for 21 CFR part 526 continues to read as follows:

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

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    [Amended]
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    2. Section 526.88 Amoxicillin trihydrate for intramammary infusion is amended in paragraph (b) by removing “000069” and by adding in its place “000061”.

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    [Amended]
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    3. Section 526.464b Cloxacillin benzathine for intramammary infusion, sterile is amended in paragraph (d) by removing “000069” and by adding in its place “000061”.

    End Amendment Part
    [Amended]
    Start Amendment Part

    4. Section 526.464c Cloxacillin sodium for intramammary infusion, sterile is amended in paragraph (b) by removing “000069” and by adding in its place “000061”.

    End Amendment Part Start Signature

    Dated: July 18, 2003.

    Steven D. Vaughn,

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

    End Signature End Supplemental Information

    [FR Doc. 03-19445 Filed 7-30-03; 8:45 am]

    BILLING CODE 4160-01-S

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Document Information

Effective Date:
7/31/2003
Published:
07/31/2003
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
03-19445
Dates:
This rule is effective July 31, 2003.
Pages:
44878-44878 (1 pages)
PDF File:
03-19445.pdf
CFR: (3)
21 CFR 526.88
21 CFR 526.464b
21 CFR 526.464c