[Federal Register Volume 66, Number 63 (Monday, April 2, 2001)]
[Rules and Regulations]
[Pages 17509-17510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8059]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529


New Animal Drugs; Change of Sponsor

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.

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.

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

[[Page 17510]]

agency is amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) 
and   Sec.  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, Sec. 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 Sec. 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.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 529

    Animal drugs.

    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:

PART 510--NEW ANIMAL DRUGS

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

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


Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c)    *    *    *
    (1)    *    *    *

------------------------------------------------------------------------
         Firm name and address                  Drug labeler code
------------------------------------------------------------------------
 
*                  *                  *                  *
                  *                  *                  *
Minrad, Inc., 836 Main St., 2d floor,    060307
 Buffalo, NY 14202
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

    (2)    *    *    *

------------------------------------------------------------------------
           Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
*                  *                  *                  *
                  *                  *                  *
060307                                   Minrad, Inc., 836 Main St., 2d
                                          floor, Buffalo, NY 14202
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec. 529.1186   [Amended]

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

    Dated: March 2, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-8059 Filed 3-30-01; 8:45 am]
BILLING CODE 4160-01-S