[Federal Register Volume 62, Number 125 (Monday, June 30, 1997)]
[Rules and Regulations]
[Pages 35075-35077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16967]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, 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 the change of sponsor for 52 approved new 
animal drug applications (NADA's) from Fermenta Animal Health Co. to 
Boehringer Ingelheim Animal Health, Inc.

EFFECTIVE DATE: June 30, 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: Fermenta Animal Health Co., 10150 North 
Executive Hills Blvd., Kansas City, MO 64153, has informed FDA that it 
has transferred the ownership of, and all rights and interests in, the 
following approved NADA's to Boehringer Ingelheim Animal Health, Inc., 
2621 North Belt Hwy., St. Joseph, MO 65406:

                                                                        
------------------------------------------------------------------------
           NADA No.                           Product Name              
------------------------------------------------------------------------
011-531                        DIZAN Tablets                            
011-674                        DIZAN Soluble Powder                     
012-469                        DIZAN Suspension                         
031-512                        ATGARD V (dichlorvos)/Swine    
                                Wormer (V-3)                            
033-803                        TASK (dichlorvos) Dog          
                                Anthelmintic                            
035-918                        EQUIGARD (dichlorvos) Equine   
                                Anthelmintic/Horse Wormer               
038-200                        OXY WSTM (oxytetracycline HCl soluble    
                                powder)                                 
039-077                        CSPTM Premixes                           
040-848                        ATGARD V (dichlorvos)/Swine    
                                Wormer                                  
043-606                        ATGARD V (dichlorvos)/Swine    
                                Wormer (V-22)                           
045-143                        OXYJECT (5% oxytetracycline    
                                HCl)                                    
048-237                        EQUIGEL (dichlorvos) Equine    
                                Anthelmintic                            
048-271                        TASK (dichlorvos) Tabs         
                                Anthelmintic for Cats & Puppies         
049-032                        ATGARD C (dichlorvos)          
                                Production Efficiency Improver          
065-178                        FERMYCINTM (Chlortetracycline) Soluble   
065-486                        CTC Bisulfate Soluble                    
065-491                        MEDICHOL (Chloramphenicol)     
                                Tablets                                 
065-496                        Tetracycline HCl Soluble Powder          
092-837                        Nemacide (DECC) Oral Syrup     
097-452                        OXYJECT 100 (10%               
                                oxytetracycline HCl)                    
098-569                        Medacide (SDM) 10% Injection             
106-772                        Iron Hydrogenated Dextran Injection, 100 
                                mg                                      
108-963                        MEDAMYCIN (OTC-HCl) Injection, 
                                50 mg & 100 mg                          
109-305                        Oxytocin Injection                       
117-531                        Acepromazine Maleate Injection, (dogs) 10
                                mg                                      
117-532                        Acepromazine Maleate Tablets, 10 & 25 mg 
117-689                        NEUROSYNTM (primidone) Tablets           
125-797                        Nitrofurazone Dressing                   
126-236                        Nitrofurazone Soluble Powder             
126-676                        D & T Worm Capsules                      
127-034                        DISAL (furosemide) 5% Injection
                                (horses only)                           
127-627                        NEMIACIDE (DECC) Tablets       
128-069                        NEMIACIDE (DECC) Chewable      
                                Tablets                                 
129-034                        DISAL (furosemide) Tablets,    
                                12.5 & 50 mg                            
131-538                        DISAL (furosemide) 5% Injection
                                (dogs/horses)                           
132-028                        ANESTATALTM (Sodium Thiamylal for        
                                Injection)                              
134-644                        DENAGARD (tiamulin) Soluble    
                                Antibiotic                              
134-708                        Iron Dextran Injection, 200 mg/mL        
135-771                        Methylprednisolone Tablets               
136-212                        Methylprednisolone Acetate Sterile       
                                Suspension                              
137-310                        Gentamicin Injection, 50 mg/mL           
137-694                        Triamicinolone Acetonide Tablets         
138-869                        Triamicinolone Acetonide Sterile         
                                Suspension                              
138-955                        Tylosin Injection, 50 & 200 mg/mL        
139-472                        DENAGARD (tiamulin) Premixes   
140-270                        Sulfamethazine SR Boluses                
140-442                        Xylazine HCl Injection (100 mg base/mL)  
140-916                        DENAGARD (tiamulin) Liquid     
                                Concentrate                             
141-011                        DENAGARD 10 + CTC Premixes     
200-023                        Gentamicin Sulfate Solution, 100 mg/mL   
200-029                        Ketamine Hydrochloride Injection, 100 mg/
                                mL Ketamine Base                        
200-165                        SMD Sulfadimethoxine 12.5% Oral Solution 
------------------------------------------------------------------------

    The agency is amending 21 CFR parts 510, 520, 522, 524, 529, and 
558 to reflect the change of sponsor. The agency is amending 
Sec. 510.600(c)(1) and (c)(2) to remove the sponsor name for Fermenta 
Animal Health Co. because the firm no longer is the holder of any 
approved NADA's.

List of Subjects

 21 CFR Part 510

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

21 CFR Parts 520, 522, 524, 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 510, 
520, 522, 524, 529, 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).


Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entry for ``Fermenta Animal Health Co.'' and in 
the table in paragraph (c)(2) by removing the entry for ``054273''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. 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. 520.23  [Amended]

    4. Section 520.23 Acepromazine maleate tablets is amended in 
paragraph (a)(2) by removing ``054273'' and adding in its place 
``000010''.

[[Page 35076]]

Sec. 520.390a  [Amended]

    5. Section 520.390a Chloramphenicol tablets is amended in paragraph 
(a)(2) by removing ``054273'' and adding in its place ``000010''.


Sec. 520.445b  [Amended]

    6. Section 520.445b Chlortetracycline powder (chlortetracycline 
hydrochloride or chlortetracycline bisulfate) is amended in paragraph 
(b) by removing ``054273'' and adding in its place ``000010''.


Sec. 520.580  [Amended]

    7. Section 520.580 Dichlorophene and toluene capsules is amended in 
paragraph (b)(2) by removing ``011716, 038782, and 054273'' and adding 
in its place ``000010, 011716, and 038782''.


Sec. 520.600  [Amended]

    8. Section 520.600 Dichlorvos is amended in paragraph (c) by 
removing ``054273'' and adding in its place ``000010''.


Sec.  520.622a  [Amended]

    9. Section 520.622a Diethylcarbamazine citrate tablets is amended 
in paragraph (a)(6) by removing ``054273'' and adding in its place 
``000010''.


Sec.  520.622b  [Amended]

    10. Section 520.622b Diethylcarbamazine citrate syrup is amended in 
paragraph (c)(2) by removing ``054273'' and adding in its place 
``000010''.


Sec. 520.622c  [Amended]

    11. Section 520.622c Diethylcarbamazine citrate chewable tablets is 
amended in paragraph (a)(6) by removing ``054273'' and adding in its 
place ``000010''.


Sec. 520.763a  [Amended]

    12. Section 520.763a Dithiazanine iodide tablets is amended in 
paragraph (c) by removing ``054273'' and adding in its place 
``000010''.


Sec. 520.763b  [Amended]

    13. Section 520.763b Dithiazanine iodide powder is amended in 
paragraph (c) by removing ``054273'' and adding in its place 
``000010''.


Sec. 520.763c  [Amended]

    14. Section 520.763c Dithiazanine iodide and piperazine citrate 
suspension is amended in paragraph (b) by removing ``054273'' and 
adding in its place ``000010''.


Sec. 520.1010a  [Amended]

    15. Section 520.1010a Furosemide tablets or boluses is amended in 
paragraph (b) by removing ``054273'' and adding in its place 
``000010''.


Sec. 520.1408  [Amended]

    16. Section 520.1408 Methylprednisolone tablets is amended in 
paragraph (b) by removing ``054273'' and adding in its place 
``000010''.


Sec. 520.1660d  [Amended]

    17. Section 520.1660d Oxytetracycline hydrochloride soluble powder 
is amended in paragraphs (b)(3), (e)(1)(ii)(A)(3), (e)(1)(ii)(B)(3), 
and (e)(1)(ii)(C)(3) by removing ``054273'' and adding in its place 
``000010''.


Sec. 520.1900  [Amended]

    18. Section 520.1900 Primidone tablets is amended in paragraph (b) 
by removing ``054273'' and adding in its place ``000010''.


Sec. 520.2220a  [Amended]

    19. Section 520.2220a Sulfadimethoxine oral solution and soluble 
powder is amended in paragraph (b) by removing ``000069, 054273, and 
057561'' and adding in its place ``000010, 000069, and 057561''.


Sec. 520.2260b  [Amended]

    20. Section 520.2260b Sulfamethazine sustained-release boluses is 
amended in paragraphs (f)(1) and (h)(1) by removing ``054273'' and 
adding in its place ``000010''.


Sec. 520.2345d  [Amended]

    21. Section 520.2345d Tetracycline hydrochloride soluble powder is 
amended in paragraphs (a)(1), (d)(1)(iii), and (d)(2)(iii) by removing 
``054273'' and adding in its place ``000010''.


Sec. 520.2455  [Amended]

    22. Section 520.2455 Tiamulin soluble powder is amended in 
paragraph (b) by removing ``054273'' and adding in its place 
``000010''.


Sec. 520.2456  [Amended]

    23. Section 520.2456 Tiamulin liquid concentrate is amended in 
paragraph (b) by removing ``054273'' and adding in its place 
``000010''.


Sec. 520.2481  [Amended]

    24. Section 520.2481 Triamcinolone acetonide tablets is amended in 
paragraph (b) by removing ``053501 and 054273'' and adding in its place 
``000010 and 053501''.


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

    25. 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. 522.23  [Amended]

    26. Section 522.23 Acepromazine maleate injection is amended in 
paragraph (c) by removing ``054273'' and adding in its place 
``000010''.


Sec. 522.1010  [Amended]

    27. Section 522.1010 Furosemide injection is amended in paragraph 
(b) by removing ``054273'' and adding in its place ``000010''.


Sec. 522.1044  [Amended]

    28. Section 522.1044 Gentamicin sulfate injection is amended in 
paragraph (b)(3) by removing ``054273'' and adding in its place 
``000010''.


Sec. 522.1182  [Amended]

    29. Section 522.1182 Iron dextran complex injection is amended in 
paragraph (b)(2)(i) by removing ``054273'' and adding in its place 
``000010''.


Sec. 522.1183  [Amended]

    30. Section 522.1183 Iron hydrogenated dextran injection is amended 
in paragraph (e)(1) by removing ``017287, 050604, and 054273'' and 
adding in its place ``000010, 017287, and 050604''.


Sec. 522.1222a  [Amended]

    31. Section 522.1222a Ketamine hydrochloride injection is amended 
in paragraph (c) by removing ``000856, 045984, 054273, and 059130'' and 
adding in its place ``000010, 000856, 045984, and 059130''.


Sec. 522.1410  [Amended]

    32. Section 522.1410 Sterile methylprednisolone acetate suspension 
is amended in paragraph (b) by removing ``054273'' and adding in its 
place ``000010''.


Sec. 522.1662a  [Amended]

    33. Section 522.1662a Oxytetracycline hydrochloride injection is 
amended in paragraphs (a)(2), (g)(2), and (h)(2) by removing ``054273'' 
and adding in its place ``000010''.


Sec. 522.1680  [Amended]

    34. Section 522.1680 Oxytocin injection is amended in paragraph (b) 
by removing ``054273,''and numerically adding ``000010,''.


Sec. 522.2220  [Amended]

    35. Section 522.2220 Sulfadimethoxine injection is amended in 
paragraph (c)(2) by removing ``054273'' and adding in its place 
``000010''.


Sec. 522.2424  [Amended]

    36. Section 522.2424 Sodium thiamylal for injection is amended in

[[Page 35077]]

paragraph (b) by removing ``, 000856, and 054273'' and adding in its 
place ``and 000856''.


Sec. 522.2483  [Amended]

    37. Section 522.2483 Sterile triamcinolone acetonide suspension is 
amended in paragraph (b) by removing ``054273'' and adding in its place 
``000010''.


Sec. 522.2640a  [Amended]

    38. Section 522.2640a Tylosin injection is amended in paragraph 
(b)(2) by removing ``054273'' and adding in its place ``000010''.


Sec. 522.2662  [Amended]

    39. Section 522.2662 Xylazine hydrochloride injection is amended in 
paragraph (b) by removing ``054273'' and adding in its place 
``000010''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    40. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec. 524.1580b  [Amended]

    41. Section 524.1580b Nitrofurazone ointment is amended in 
paragraph (b) by removing ``000857, 000864, 000069, 050749, 023851, 
051259, and 054273'' and adding in its place ``000010, 000857, 000864, 
000069, 050749, 023851, and 051259''.


Sec. 524.1580c  [Amended]

    42. Section 524.1580c Nitrofurazone soluble powder is amended in 
paragraph (b) by removing ``000069, 050749, and 054273'' and adding in 
its place ``000010, 000069, and 050749''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec. 529.1044a  [Amended]

    44. Section 529.1044a Gentamicin sulfate intrauterine solution is 
amended in paragraph (b) by removing ``054273'' and adding in its place 
``000010''.

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

    45. 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. 558.155  [Amended]

    46. Section 558.155 Chlortetracycline, sulfathiazole, penicillin is 
amended in paragraphs (a)(1) and (a)(2) by removing ``054273'' and 
adding in its place ``000010''.


Sec. 558.205  [Amended]

    47. Section 558.205 Dichlorvos is amended in paragraph (a) by 
removing ``054273'' and adding in its place ``000010''.


Sec. 558.600  [Amended]

    48. Section 558.600 Tiamulin is amended in paragraph (a) by 
removing ``054273'' and adding in its place ``000010''.

    Dated: June 9, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-16967 Filed 6-27-97; 8:45 am]
BILLING CODE 4160-01-F