[Federal Register Volume 59, Number 193 (Thursday, October 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24749]


[[Page Unknown]]

[Federal Register: October 6, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 510

 

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 the change of sponsor for 13 new animal 
drug applications (NADA's) from Central Soya Co., Inc., to Premiere 
Agri Technologies, Inc.

EFFECTIVE DATE: October 6, 1994.

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: Central Soya Co., Inc., P. O. Box 1400, Fort 
Wayne, IN 46801-1400, has informed FDA that it has transferred 
ownership of, and all rights and interests in, approved NADA 91-582 
(Tylosin) to Premiere Agri Technologies, Inc., P.O. Box 2508, Fort 
Wayne, IN 46801-2508.
    Included in the sale were all of the assets of the following 
wholly-owned subsidiaries or divisions of Central Soya Co., Inc.; these 
subsidiaries will continue to operate under their current sponsor name 
and drug labeler code: 

------------------------------------------------------------------------
   NADA Number                Drug                      Sponsor         
------------------------------------------------------------------------
48-480............  Chlortetracycline........  Feed Specialties Co.,    
                                                Inc., 1877 NE. 58th     
                                                Ave., Des Moines, IA    
                                                50313                   
65-256............  Chlortetracycline          Feed Specialties Co.,    
                     hydrochloride.             Inc.                    
107-957...........  Tylosin and                Feed Specialties Co.,    
                     sulfamethazine.            Inc.                    
108-484...........  Tylosin and                Feed Specialties Co.,    
                     sulfamethazine.            Inc.                    
110-045...........  Tylosin..................  Good-Life, Division of   
                                                Central Soya Co., Inc., 
                                                Good-Life Dr., P.O. Box 
                                                687, Effingham, IL 62401
110-439...........  Hygromycin B.............  Feed Specialties Co.,    
                                                Inc.                    
118-877...........  Pyrantel tartrate........  Feed Specialties Co.,    
                                                Inc.                    
128-411...........  Tylosin and                Good-Life, Division of   
                     sulfamethazine.            Central Soya Co., Inc.  
131-956...........  Tylosin and                MAC-PAGE, Inc., 1600 S.  
                     sulfamethazine.            Wilson Ave., Dunn, NC   
                                                28334                   
132-448...........  Bambermycins.............  Feed Specialties Co.,    
                                                Inc.                    
133-490...........  Pyrantel tartrate........  MAC-PAGE, Inc.           
140-842...........  Hygromycin B.............  MAC-PAGE, Inc.           
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2). The sponsor labeler code of Central Soya Co., 
Inc. is being retained as the labeler code for the new company.

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 ``Central Soya Co., Inc.,'' and by 
alphabetically adding a new entry for ``Premiere Agri Technologies, 
Inc.,'' and in the table in paragraph (c)(2) in the entry for 
``012286'' 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
------------------------------------------------------------------------
                                                                        
                                  *****                                 
Premiere Agri Technologies, Inc., P.O. Box 2508, Fort                   
 Wayne, IN 46801-2508................................             012286
                                                                        
                                  *****                                 
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug                                                                
  labeler                       Firm name and address                   
   code                                                                 
------------------------------------------------------------------------
                                                                        
                                  *****                                 
012286.....  Premiere Agri Technologies, Inc., P.O. Box 2508, Fort      
              Wayne, IN 46801-2508.                                     
                                                                        
                                  *****                                 
------------------------------------------------------------------------


    Dated: September 28, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-24749 Filed 10-5-94; 8:45 am]
BILLING CODE 4160-01-F