[Federal Register Volume 62, Number 103 (Thursday, May 29, 1997)]
[Rules and Regulations]
[Pages 29010-29011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


Animal Drugs, Feeds, and Related Products; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for five new animal 
drug applications (NADA's) from Merck Research Laboratories, Division 
of Merck & Co., Inc., Rahway, NJ 07065 to Koffolk, Inc.

EFFECTIVE DATE: May 29, 1997.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Merck Research Laboratories, Division of 
Merck & Co., Inc., Rahway, NJ 07065, has informed FDA that it has 
transferred ownership of, and all rights and interests in, the 
following NADA's to Koffolk, Inc., One Parker Plaza, Fort Lee, NJ 
07024:

                                                                        
------------------------------------------------------------------------
              NADA No.                            Ingredient            
------------------------------------------------------------------------
9-476..............................  NICARB 25%                         
98-378.............................  Nicarbazin-Bacitracin Methylene    
                                      Disalicylate                      
107-997............................  Nicarbazin-Roxarsone-Lincomycin    
                                      Medicated Feed                    
108-115............................  Nicarbazin-Roxarsone               
108-116............................  Nicarbazin-Lincomycin              
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) by alphabetically adding a new listing for 
Koffolk, Inc. The agency is also amending Sec. 558.366 to reflect the 
transfer of ownership.

List of Subjects

21 CFR Part 510

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

21 CFR Part 558

    Animal drugs, animal feeds.
    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 
558 are 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 
alphabetically adding a new entry for ``Koffolk, Inc.,'' and in the 
table in paragraph (c)(2) by numerically adding a new entry for 
``063271'' to read as follows:


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

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

[[Page 29011]]



                                                                        
------------------------------------------------------------------------
       Firm name and address                  Drug labeler code         
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Koffolk, Inc., One Parker Plaza,     063271                             
 Fort Lee, NJ 07024.                                                    
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

    (2) * * *

                                                                        
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address       
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
063271.............................  Koffolk, Inc., One Parker Plaza,   
                                      Fort Lee, NJ 07024                
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

 PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

Sec. 558.366  [Amended]

    4. Section 558.366 Nicarbazin is amended in paragraph (a) by 
removing ``000006, 000986, and 060728'' and adding in its place 
``000986, 060728, and 063271'' and in the table in paragraph (c), under 
the ``Sponsor'' column in the entry for ``113.5 (0.0125 pct)'' by 
removing the number ``000006'' and numerically adding ``063271'', and 
in the same column in the items ``Bacitracin methylene disalicylate 
30,'' ``Lincomycin 2 (0.00044 pct),'' ``Roxarsone 22.7 (0.0025),'' and 
``Roxarsone 22.7 (0.0025) plus lincomycin 2 (0.0004)'' by removing the 
number ``000006'' and numerically adding ``063271''.

    Dated: May 16, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-14101 Filed 5-28-97; 8:45 am]
BILLING CODE 4160-01-F