[Federal Register Volume 61, Number 80 (Wednesday, April 24, 1996)]
[Rules and Regulations]
[Pages 18081-18082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10019]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs; 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 the change of sponsor for 33 approved new 
animal drug applications (NADA's) from American Cyanamid Co. to 
Hoffmann-La Roche, Inc. In addition, the agency is amending its 
regulations to correct some errors. This action is being taken to 
clarify and improve the accuracy of the animal drug regulations.

EFFECTIVE DATE: April 24, 1996.

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: American Cyanamid Co., Berdan Ave., Wayne, 
NJ 07470, has informed FDA that it has transferred ownership of, and 
all rights and interests in, the following approved NADA's to Hoffmann-
La Roche, Inc., Nutley, NJ 07110-1199.

                                                                        
------------------------------------------------------------------------
                 NADA no.                            Ingredients        
------------------------------------------------------------------------
33-950....................................  Sulfamerazine.              
 35-688...................................  Chlortetracycline Calcium   
                                             Complex, Penicillin G      
                                             Procaine, Sulfamethazine   
35-805....................................  Chlortetracycline           
                                             Hydrochloride,             
                                             Sulfamethazine.            
36-361....................................  Chlortetracycline Calcium   
                                             Complex, Amprolium ,       
                                             Ethopabate, Sodium Sulfate.
41-647....................................  Sulfamethazine,             
                                             Chlortetracycline Calcium  
                                             Complex.-                  
41-648....................................  Sulfamethazine,             
                                             Chlortetracycline Calcium  
                                             Complex.                   
 41-649...................................  Sulfamethazine,             
                                             Chlortetracycline Calcium  
                                             Complex.                   
41-650....................................  Sulfamethazine,             
                                             Chlortetracycline Calcium  
                                             Complex.                   
41-651....................................  Sulfamethazine,             
                                             Chlortetracycline Calcium  
                                             Complex.                   
41-652....................................  Sulfamethazine,             
                                             Chlortetracycline Calcium  
                                             Complex.                   
41-653....................................  Sulfamethazine,             
                                             Chlortetracycline Calcium  
                                             Complex.                   
41-654....................................  Sulfamethazine,             
                                             Chlortetracycline Calcium  
                                             Complex.                   
46-920....................................  Bacitracin zinc.            
48-486....................................  Robenidine Hydrochloride.   
48-761....................................  Chlortetracycline Calcium   
                                             Complex.                   
48-762....................................  Chlortetracycline Calcium   
                                             Complex.                   
48-763....................................  Chlortetracycline Calcium   
                                             Complex.                   
55-040....................................  Chlortetracycline           
                                             Hydrochloride.             
92-507....................................  Chlortetracycline Calcium   
                                             Complex, Robenidine        
                                             Hydrochloride.             
93-372....................................  Chlortetracycline           
                                             Hydrochloride.             
95-546....................................  Robenidine Hydrochloride,   
                                             Roxarsone.                 
96-933....................................  Bacitracin zinc, Robenidine 
                                             Hydrochloride.             
97-085....................................  Robenidine Hydrochloride,   
                                             Bacitracin MD.             
105-758...................................  Bacitracin zinc, Amprolium, 
                                             Ethopabate, Roxarsone.     
114-794...................................  Bacitracin zinc, Amprolium, 
                                             Ethopabate.                
121-553...................................  Monensin Sodium,            
                                             Chlortetracycline          
                                             Hydrochloride.             
123-154...................................  Monensin Sodium, Bacitracin 
                                             ZN, Roxarsone.             
136-484...................................  Bacitracin zinc, Carbasone. 
139-075...................................  Maduramicin ammonium.       
139-190...................................  Bacitracin zinc,            
                                             Salinomycin, Sodium        
                                             Roxarsone.                 
139-235...................................  Bacitracin zinc,            
                                             Salinomycin, Sodium        
                                             Roxarsone.                 
140-859...................................  Chlortetracycline Calcium   
                                             Complex, Salinomycin       
                                             Sodium.                    
140-867...................................  Chlortetracycline Calcium   
                                             Complex, Roxarsone,        
                                             Salinomycin Sodium.        
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in part 558 (21 
CFR part 558) to reflect the change of sponsor. FDA is also correcting 
some errors that have been incorporated into the agency's codified 
regulations. The errors in the regulations are as follows:
    In Sec. 558.95(b)(1)(xiii)(b) the reference to the limitations 
cited in (e)(1)(vii)(b) is incorrect; the correct cite is ``paragraph 
(b)(1)(vii)(b) of this section''. In Sec. 558.355(b)(9) the cited 
reference ``paragraphs (f)(1)(xv), (xvi), and (xvii)'' incorrectly 
listed the sponsor, ``(xvii)'' should refer to sponsor 012799. The 
agency is correcting this error by removing ``(xvii)'' from 
Sec. 558.355(b)(9) and adding sponsor 012799 to Sec. 558.355(b)(10).

List of Subjects in 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 part 558 is 
amended as follows:

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

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


[[Page 18082]]


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


Sec. 558.58  [Amended]

    2. Section 558.58 Amprolium and ethopabate is amended in the table 
in paragraph (d)(1), in the entry for (iii), under the ``Limitations'' 
and the ``Sponsor'' columns by removing ``010042'' wherever it appears 
and adding in its place ``000004''.


Sec. 558.78  [Amended]

    3. Section 558.78 Bacitracin zinc is amended in paragraph (a)(2), 
and in the table in paragraph (d)(1) in the entries for (i), (ii), (v), 
and (vi) under the ``Sponsor'' column, and in paragraph (d)(2)(ii) by 
removing ``010042'' and adding in its place ``000004''.


Sec. 558.95  [Amended]

    4. Section 558.95 Bambermycins is amended in paragraph 
(b)(1)(xiii)(b) by removing ``(e)(1)(vii)(b)'' and adding in its place 
``(b)(1)(vii)(b)''.


Sec. 558.120  [Amended]

    5. Section 558.120 Carbarsone (not U.S.P.) is amended in paragraph 
(c)(1)(iii)(b) by removing ``010042'' and adding in its place 
``000004''.


Sec. 558.128  [Amended]

    6. Section 558.128 Chlortetracycline is amended in paragraph (a) by 
removing ``010042'' and adding in its place ``000004''.


Sec. 558.145  [Amended]

    7. Section 558.145 Chlortetracycline, procaine penicillin, and 
sulfamethazine is amended in paragraphs (a)(1) and (a)(2) by removing 
``010042'' and adding in its place ``000004''.


Sec. 558.340  [Amended]

    8. Section 558.340 Maduramicin ammonium is amended in paragraph (a) 
by removing ``010042'' and adding in its place ``000004''.


Sec. 558.355  [Amended]

    9. Section 558.355 is amended in paragraphs (b)(8), (b)(9), 
(f)(1)(iv)(b), (f)(1)(v)(b), (f)(1)(xiv)(b), (f)(1)(xv)(b), and 
(f)(1)(xvi)(b) by removing ``010042'' and adding in its place 
``000004'', in paragraph (b)(9) by removing ``, (xvi), and (xvii)'' and 
adding in its place ``and (xvi)'', and by adding paragraph (b)(10) to 
read as follows:

Sec. 558.355  Monensin.

* * * * *
    (b) * * *
    (10) To 012799: 45 and 60 grams per pound, as monensin sodium, 
paragraph (f)(1)(xvii) of this section.
* * * * *


Sec. 558.515  [Amended]

    10. Section 558.515 Robenidine hydrochloride is amended in 
paragraphs (a), (d)(1)(iii)(b), (d)(1)(iv)(b), and (d)(1)(v)(b) by 
removing ``010042'' and adding in its place ``000004'' and in paragraph 
(d)(1)(vi)(b) by removing ``No. 011716'' and adding in its place ``Nos. 
000004 and 011716''.


Sec. 558.550  [Amended]

    11. Section 558.550 Salinomycin is amended in paragraphs 
(b)(1)(vii)(c), (b)(1)(ix)(c), (b)(1)(xv)(c), and (b)(1)(xvi)(c) by 
removing ``010042'' and adding in its place ``000004''.


Sec. 558.582  [Amended]

    12. Section 558.582 Sulfamerazine is amended in paragraph (a) by 
removing ``010042'' and adding in its place ``000004''.

    Dated: April 4, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-10019 Filed 4-23-96; 8:45 am]
BILLING CODE 4160-01-F