[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Rules and Regulations]
[Pages 34727-34729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16886]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520, 522, 529, and 558


Animal Drugs, Feeds, and Related Products; 29 Various New Animal 
Drug Products and Type A Medicated Articles

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 remove those portions reflecting approval of 29 new 
animal drug applications (NADA's) held by Bayer Corp., Agriculture 
Division, Animal Health (formerly Miles, Inc., Agriculture Division, 
Animal Health Products), Hubbard Milling Co., Hoffmann-LaRoche, Inc., 
and Ohmeda, Inc. The NADA's provide for the use of 29 various new 
animal drug products and Type A medicated articles used to manufacture 
finished medicated animal feeds. In a notice published elsewhere in 
this issue of the Federal Register, FDA is withdrawing approval of the 
NADA's.

EFFECTIVE DATE: July 15, 1996.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0159.
SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this 
issue of the Federal Register, FDA is withdrawing approval of the 
following NADA's:

[[Page 34728]]



                                                                        
------------------------------------------------------------------------
                                                       Sponsor name and 
           NADA No.                   Drug name             address     
------------------------------------------------------------------------
6-462.........................  Diethylcarbamazine    Bayer Corp.,      
                                 tablets.              Agriculture      
                                                       Division, Animal 
                                                       Health, P.O. Box 
                                                       390, Shawnee     
                                                       Mission, KS      
                                                       66201.           
10-540........................  Calcium disodium      Do.               
                                 edetate injection.                     
11-380........................  Diethylcarbamazine    Do.               
                                 powder.                                
12-054........................  Protokylol            Do.               
                                 hydrochloride                          
                                 tablets and                            
                                 injection.                             
12-103........................  Triamcinolone         Do.               
                                 tablets.                               
12-392........................  Triamcinolone         Do.               
                                 injection.                             
12-598........................  Disophenol sodium     Do.               
                                 injection.                             
15-161........................  Trichlorfon powder..  Do.               
15-965........................  Coumaphos Type A      Do.               
                                 medicated article.                     
30-045........................  Triamcinolone/        Do.               
                                 neomycin sulfate                       
                                 ointment.                              
34-394........................  Niclosamide tablets.  Do.               
35-263........................  Styrylpyridinium      Do.               
                                 chloride,                              
                                 diethylcarbamazine                     
                                 (as base) oral                         
                                 liquid.                                
45-287........................  Coumaphos crumbles..  Do.               
48-645........................  Tylosin Type A        Hubbard Milling   
                                 medicated articles    Co., 424 North   
                                 (5, 10, 20, and 40    Riverfront Dr.,  
                                 grams per pound).     P.O. Box 8500,   
                                                       Mankato, MN 56002-
                                                       8500.            
49-555........................  Styrylpyridinium      Bayer Corp.       
                                 chloride,                              
                                 diethylcarbamazine                     
                                 control diet HRH/                      
                                 MSD.                                   
91-628........................  Diethylcarbamazine    Do.               
                                 citrate syrup.                         
93-372........................  Chlortetracycline     Hoffmann-LaRoche, 
                                 calcium complex       Inc., Nutley, NJ 
                                 Type A medicated      07110.           
                                 articles.                              
94-402........................  Tylosin and           Hubbard Milling   
                                 sulfamethazine Type   Co.              
                                 A medicated                            
                                 articles.                              
95-078........................  Trichlorfon oral      Bayer Corp.       
                                 liquid.                                
96-031........................  Styrylpyridinium      Do.               
                                 chloride,                              
                                 diethylcarbamazine                     
                                 citrate tablets.                       
100-201.......................  Trichlorfon paste...  Do.               
100-356.......................  Styrylpyridinium      Do.               
                                 chloride,                              
                                 diethylcarbamazine                     
                                 control diet HRH.                      
100-670.......................  Niclosamide Type A    Do.               
                                 medicated article.                     
101-078.......................  Dichlorophene and     Do.               
                                 toluene capsules.                      
120-327.......................  Diethylcarbamazine    Do.               
                                 chewable tablets.                      
120-670.......................  Styrylpyridinium,     Do.               
                                 diethylcarbamazine                     
                                 edible tablets.                        
121-291.......................  Enflurane liquid      Ohmeda, Inc.,     
                                 (anesthetic).         Pharmaceutical   
                                                       Products         
                                                       Division, P.O.   
                                                       Box 804, Liberty 
                                                       Corner, NJ 07938-
                                                       0804.            
121-813.......................  Styrylpyridinium,     Bayer Corp.       
                                 diethylcarbamazine                     
                                 film-coated tablets.                   
133-509.......................  Pyrantel tartrate     Hubbard Milling   
                                 Type A medicated      Co.              
                                 articles.                              
------------------------------------------------------------------------

    The sponsors requested withdrawal of approval of the NADA's. This 
final rule removes 21 CFR 520.500, 520.620a, 520.620b, 520.1520, 
520.2022, 520.2160a, 520.2160b, 520.2160c, 520.2160d, 520.2480, 
520.2520c, 520.2520d, 522.281, 522.740, 522.2022, 522.2480, 529.810, 
558.367, and 558.565, and amends 21 CFR 520.580, 520.622a, 520.622b, 
520.2520a, 558.185, 558.485, 558.625, and 558.630.

List of Subjects

21 CFR Parts 520, 522, and 529

    Animal drugs.

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 520, 
522, 529, and 558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec. 520.500  [Removed]

    2. Section 520.500 Coumaphos crumbles is removed.


Sec. 520.580  [Amended]

    3. Section 520.580 Dichlorophene and toluene capsules is amended in 
paragraph (b)(2) by removing ``000859,''.


Sec. 520.620a  [Removed]

    4. Section 520.620a Diethylcarbamazine is removed.


Sec. 520.620b  [Removed]

    5. Section 520.620b Diethylcarbamazine chewable tablets is removed.


Sec. 520.622a  [Amended]

    6. Section 520.622a Diethylcarbamazine citrate tablets is amended 
in paragraph (a) by removing ``000859 and''.
    7. Section 520.622b is amended by revising paragraph (b)(2) to read 
as follows:


Sec. 520.622b  Diethylcarbamazine citrate syrup.

* * * * *
    (b)(1) * * *
    (2) Sponsors. See No. 017030 for use as in paragraphs (b)(3)(ii)(a) 
and (b)(3)(ii)(c) of this section.
* * * * *


Sec. 520.1520  [Removed]

    8. Section 520.1520 Niclosamide tablets is removed.


Sec. 520.2022  [Removed]

    9. Section 520.2022 Protokylol hydrochloride tablets is removed.


Sec. 520.2160a  [Removed]

    10. Section 520.2160a Styrylpyridinium, diethylcarbamazine tablets 
is removed.

[[Page 34729]]

Sec. 520.2160b  [Removed]

    11. Section 520.2160b Styrylpyridinium chloride, diethylcarbamazine 
(as base) is removed.


Sec. 520.2160c  [Removed]

    12. Section 520.2160c Styrylpyridinium, diethylcarbamazine edible 
tablets is removed.


Sec. 520.2160d  [Removed]

    13. Section 520.2160d Styrylpyridinium, diethylcarbamazine film-
coated tablets is removed.


Sec. 520.2480  [Removed]

    14. Section 520.2480 Triamcinolone tablets is removed.


Sec. 520.2520a  [Amended]

    15. Section 520.2520a Trichlorfon oral is amended in paragraph (b) 
by removing the phrase ``Nos. 017800 and 000859'' and adding in its 
place ``No. 017800''.


Sec. 520.2520c  [Removed]

    16. Section 520.2520c Trichlorfon oral liquid is removed.


Sec. 520.2520d  [Removed]

    17. Section 520.2520d Trichlorfon paste is removed.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    18. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

Sec. 522.281  [Removed]

    19. Section 522.281 Calcium disodium edetate injection is removed.


Sec. 522.740  [Removed]

    20. Section 522.740 Disophenol sodium injection is removed.


Sec. 522.2022  [Removed]

    21. Section 522.2022 Protokylol hydrochloride injection is removed.


Sec. 522.2480  [Removed]

    22. Section 522.2480 Triamcinolone injection is removed.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec. 529.810  [Removed]

    24. Section 529.810 Enflurane is removed.

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

    25. 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. 558.185  [Amended]

    26. Section 558.185 Coumaphos is amended by removing and reserving 
paragraph (a)(1).


Sec. 558.367  [Removed]

    27. Section 558.367 Niclosamide is removed.


Sec. 558.485  [Amended]

    28. Section 558.485 Pyrantel tartrate is amended by removing and 
reserving paragraph (a)(16).


Sec. 558.565  [Removed]

    29. Section 558.565 Styrylpyridinium chloride, diethylcarbamazine 
is removed.


Sec. 558.625  [Amended]

    30. Section 558.625 Tylosin is amended by removing and reserving 
paragraph (b)(72).


Sec. 558.630  [Amended]

    31. Section 558.630 Tylosin and sulfamethazine is amended in 
paragraph (b)(10) by removing ``012190,''.

    Dated: June 3, 1996.
Michael J. Blackwell,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 96-16886 Filed 7-2-96; 8:45 am]
BILLING CODE 4160-01-F