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Home » 2003 Issues » 68 FR (06/10/2003) » 03-14547. Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor

  03-14547. 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 two approved new Start Printed Page 34534animal drug applications (NADAs) from Anthony Products Co. to Cross Vetpharm Group Ltd.

    DATES:

    This rule is effective June 10, 2003.

    Start Further Info

    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:

    Anthony Products Co., 5600 Peck Rd., Arcadia, CA 91006, has informed FDA that it has transferred ownership of, and all rights and interest in, the following two approved NADAs to Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:

    NADA NumberTrade Name
    065-505MICROCILLIN Injectable Suspension
    065-506COMBICILLIN Injectable Suspension

    Accordingly, the agency is amending the regulations in 21 CFR 522.1696a and 522.1696b 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

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

    End Amendment Part Start Authority

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

    End Authority
    [Amended]
    Start Amendment Part

    2. Section 522.1696a Penicillin G benzathine and penicillin G procaine sterile suspension is amended in paragraph (b)(1) by removing “000864, 010515, and 049185” and by adding in its place “010515, 049185, and 061623”; and in paragraph (b)(3) by removing “000864, 010515, and 059130” and by adding in its place “010515, 059130, and 061623”.

    End Amendment Part
    [Amended]
    Start Amendment Part

    3. Section 522.1696b Penicillin G procaine aqueous suspension is amended in paragraph (b)(2) by removing “000864 and 055529” and by adding in its place “055529 and 061623”; in paragraph (d)(2)(i)(A) by removing “000864, 010515, 053501, and 059130” and by adding in its place “010515, 053501, 059130, and 061623”; and in paragraph (d)(2)(iii)(A) by removing “000864, 010515, 053501, and 059130” and by adding in its place “010515, 053501, and 059130”.

    End Amendment Part Start Signature

    Dated: May 19, 2003.

    Steven D. Vaughn,

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

    End Signature End Supplemental Information

    [FR Doc. 03-14547 Filed 6-9-03; 8:45 am]

    BILLING CODE 4160-01-S

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Document Information

Effective Date:
6/10/2003
Published:
06/10/2003
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
03-14547
Dates:
This rule is effective June 10, 2003.
Pages:
34533-34534 (2 pages)
PDF File:
03-14547.pdf
CFR: (2)
21 CFR 522.1696a
21 CFR 522.1696b