[Federal Register Volume 60, Number 126 (Friday, June 30, 1995)]
[Rules and Regulations]
[Page 34135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16093]



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


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 510


New Animal Drugs; Change of Sponsor Name and Address

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 name and address from 
DDI Pharmaceuticals, Inc., to OXIS International, Inc.

EFFECTIVE DATE: June 30, 1995.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1646.

SUPPLEMENTARY INFORMATION: DDI Pharmaceuticals, Inc., 518 Logue Ave., 
Mountain View, CA 94043, has informed FDA of a change of sponsor name 
and address to OXIS International, Inc., 6040 N. Cutter Circle, suite 
317, Portland, OR 97217-3935. Accordingly, the agency is amending the 
regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of 
sponsor name and address.

List of Subjects in 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.
    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 510 is 
amended as follows:

PART 510--NEW ANIMAL DRUGS

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

    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (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 ``DDI Pharmaceuticals, Inc.,'' and by 
alphabetically adding a new entry for ``OXIS International, Inc.,'' and 
in the table in paragraph (c)(2) in the entry ``024991'' by revising 
the sponsor name and address 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         
------------------------------------------------------------------------
                      *      *      *      *      *                     
 OXIS International, Inc., 6040 N.   024991                             
 Cutter Circle, suite 317,                                              
 Portland, OR 97217-3935.                                               
                      *      *      *      *      *                     
------------------------------------------------------------------------

    (2) * * *

                                                                        
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address       
------------------------------------------------------------------------
                      *      *      *      *      *                     
024991.............................   OXIS International, Inc., 6040 N. 
                                      Cutter Circle, suite 317,         
                                      Portland, OR 97217-3935           
                      *      *      *      *      *                     
------------------------------------------------------------------------


    Dated: June 23, 1995.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 95-16093 Filed 6-29-95; 8:45 am]
BILLING CODE 4160-01-F