01-8059. 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 abbreviated new animal drug application (ANADA) from Inhalon Pharmaceuticals, Inc., to Minrad, Inc.

    DATES:

    This rule is effective April 2, 2001.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Norman J. Turner, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0214.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    Inhalon Pharmaceuticals, Inc., P.O. Box 21170, Lehigh Valley, PA 18002, has informed FDA that it has transferred to Minrad, Inc., 836 Main St., 2d floor, Buffalo, NY 14202, ownership of, and all rights and interests in, ANADA 200-141 for Isoflurane, USP. Accordingly, the Start Printed Page 17510agency is amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) and § 529.1186 (21 CFR 529.1186) to reflect the transfer of ownership.

    In addition, Minrad, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, § 510.600(c) is being amended to add entries for the firm. Since Inhalon Pharmaceuticals, Inc., no longer is the sponsor of any approved new animal drug application, their drug labeler code (060307) is being reassigned to Minrad, Inc., as requested. This drug labeler code was removed from § 529.1186(b) in error (60 FR 40455, August 9, 1995), and it is being added at this time.

    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

    21 CFR Part 510

    • Administrative practice and procedure
    • Animal drugs
    • Labeling
    • Reporting and recordkeeping requirements

    21 CFR Part 529

    • 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 parts 510 and 529 are amended as follows:

    End Amendment Part Start Part

    PART 510—NEW ANIMAL DRUGS

    End Part Start Amendment Part

    1. The authority citation for 21 CFR part 510 continues to read as follows:

    End Amendment Part Start Authority

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

    End Authority Start Amendment Part

    2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for “Inhalon Pharmaceuticals, Inc.,” and by alphabetically adding an entry for “Minrad, Inc.,” and in the table in paragraph (c)(2) by revising the entry for “060307” to read as follows:

    End Amendment Part
    Names, addresses, and drug labeler codes of sponsors of approved applications.
    * * * * *

    (c)  *  *  *

    (1)  *  *  *

    Firm name and addressDrug labeler code
    *         *         *         *         *         *         *
    Minrad, Inc., 836 Main St., 2d floor, Buffalo, NY 14202060307
    *         *         *         *         *         *         *

    (2)  *  *  *

    Drug labeler codeFirm name and address
    *         *         *         *         *         *         *
    060307Minrad, Inc., 836 Main St., 2d floor, Buffalo, NY 14202
    *         *         *         *         *         *         *
    Start Part

    PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    End Part Start Amendment Part

    3. The authority citation for 21 CFR part 529 continues to read as follows:

    End Amendment Part Start Authority

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

    End Authority
    [Amended]
    Start Amendment Part

    4. Section 529.1186 Isoflurane is amended in paragraph (b) by removing “and 059258” and adding in its place “059258, and 060307”.

    End Amendment Part Start Signature

    Dated: March 2, 2001.

    Claire M. Lathers,

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

    End Signature End Supplemental Information

    [FR Doc. 01-8059 Filed 3-30-01; 8:45 am]

    BILLING CODE 4160-01-S

Document Information

Effective Date:
4/2/2001
Published:
04/02/2001
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
01-8059
Dates:
This rule is effective April 2, 2001.
Pages:
17509-17510 (2 pages)
PDF File:
01-8059.pdf
CFR: (2)
21 CFR 510.600
21 CFR 529.1186