[Federal Register Volume 62, Number 229 (Friday, November 28, 1997)]
[Rules and Regulations]
[Pages 63269-63271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 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 a change of sponsor for 47 new animal drug 
applications (NADA's) from Rhone Merieux, Inc., and 54 NADA's from 
Merck Research Laboratories, Division of Merck & Co., Inc., to Merial 
Ltd.

EFFECTIVE DATE: November 28, 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: Rhone Merieux, Inc., 7101 College Blvd., 
Overland Park, KS 66210, and 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 approved 
NADA's to Merial Ltd., 2100 Ronson Rd., Iselin, NJ 08830-3077.
    Accordingly, the agency is amending the regulations in 21 CFR parts 
510, 520, 522, 524, and 558 to reflect the change of sponsor. The 
agency is also amending Sec. 510.600(c)(1) and (c)(2) to remove the 
sponsor name for Rhone Merieux, Inc., and Merck Research Laboratories, 
Division of Merck & Co., Inc., because the firm no longer is the holder 
of any approved NADA's. The drug labeler code assigned to Rhone 
Merieux, Inc., is being retained as the drug labeler code for Merial 
Ltd.

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 558

    Animal drugs.

[[Page 63270]]

    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, 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: 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 entries for ``Rhone Merieux, Inc.'' and ``Merck Research 
Laboratories, Division of Merck & Co., Inc.'' and by alphabetically 
adding a new entry for ``Merial Ltd.,'' and in the table in paragraph 
(c)(2) by removing the entry for ``000006'' and by revising the entry 
for ``050604'' 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      
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Merial Ltd., 2100 Ronson Rd., Iselin, NJ   050604                       
 08830-3077.                                                            
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

    (2) * * *

                                                                        
------------------------------------------------------------------------
            Drug labeler code                  Firm name and address    
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
050604...................................  Merial Ltd., 2100 Ronson Rd.,
                                            Iselin, NJ 08830-3077       
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

    Authority: 21 U.S.C. 360b.

Sec. 520.100a  [Amended]

    4. Section 520.100a Amprolium drinking water is amended in 
paragraph (b) by removing ``000006'' and adding in its place 
``050604''.


Sec. 520.100b  [Amended]

    5. Section 520.100b Amprolium drench is amended in paragraph (b) by 
removing ``000006'' and adding in its place ``050604''.


Sec. 520.100c  [Amended]

    6. Section 520.100c Amprolium crumbles is amended in paragraph (b) 
by removing ``000006'' and adding in its place ``050604''.


Sec. 520.300a  [Amended]

    7. Section 520.300a Cambendazole suspension is amended in paragraph 
(b) by removing ``000006'' and adding in its place ``050604''.


Sec. 520.300b  [Amended]

    8. Section 520.300b Cambendazole pellets is amended in paragraph 
(b) by removing ``000006'' and adding in its place ``050604''.


Sec. 520.300c  [Amended]

    9. Section 520.300c Cambendazole paste is amended in paragraph (b) 
by removing ``000006'' and adding in its place ``050604''.


Sec. 520.420  [Amended]

    10. Section 520.420 Chlorothiazide tablets and boluses is amended 
in paragraph (a)(2) by removing ``000006'' and adding in its place 
``050604''.


Sec. 520.462  [Amended]

    11. Section 520.462 Clorsulon drench is amended in paragraph (b) by 
removing ``000006'' and adding in its place ``050604''.


Sec. 520.804  [Amended]

    12. Section 520.804 Enalapril tablets is amended in paragraph (b) 
by removing ``000006'' and adding in its place ``050604''.


Sec. 520.1192  [Amended]

    13. Section 520.1192 Ivermectin paste is amended in paragraph (b) 
by removing ``000006'' and adding in its place ``050604''.


Sec. 520.1193  [Amended]

    14. Section 520.1193 Ivermectin tablets and chewables is amended in 
paragraph (b) by removing ``000006'' and adding in its place 
``050604''.


Sec. 520.1194  [Amended]

    15. Section 520.1194 Ivermectin drench is amended in paragraph (b) 
by removing ``000006'' and adding in its place ``050604''.


Sec. 520.1195  [Amended]

    16. Section 520.1195 Ivermectin liquid is amended in paragraph (b) 
by removing ``000006'' and adding in its place ``050604''.


Sec. 520.1196  [Amended]

    17. Section 520.1196 Ivermectin and pyrantel pamoate chewable 
tablet is amended in paragraph (b) by removing ``000006'' and adding in 
its place ``050604''.


Sec. 520.1197  [Amended]

    18. Section 520.1197 Ivermectin sustained-release bolus is amended 
in paragraph (b) by removing ``000006'' and adding in its place 
``050604''.


Sec. 520.2170  [Amended]

    19. Section 520.2170 Sulfabromomethazine sodium boluses is

[[Page 63271]]

amended in paragraph (c) by removing ``000006'' and adding in its place 
``050604''.


Sec. 520.2380a  [Amended]

    20. Section 520.2380a Thiabendazole top dressing and mineral 
protein feed block is amended in paragraph (c)(2) by removing 
``000006'' and adding in its place ``050604''.


Sec. 520.2380b  [Amended]

    21. Section 520.2380b Thiabendazole drench or oral paste is amended 
in paragraph (c) by removing ``000006'' and adding in its place 
``050604''.


Sec. 520.2380c  [Amended]

    22. Section 520.2380c Thiabendazole bolus is amended in paragraph 
(c) by removing ``000006'' and adding in its place ``050604''.


Sec. 520.2380d  [Amended]

    23. Section 520.2380d Thiabendazole, piperazine citrate suspension 
is amended in paragraph (b) by removing ``000006'' and adding in its 
place ``050604''.


Sec. 520.2380f  [Amended]

    24. Section 520.2380f Thiabendazole, piperazine phosphate powder is 
amended in paragraph (b) by removing ``000006'' and adding in its place 
``050604''.

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: 21 U.S.C. 360b.


Sec. 522.1150  [Amended]

    26. Section 522.1150 Hydrochlorothiazide injection is amended in 
paragraph (b) by removing ``000006'' and adding in its place 
``050604''.


Sec. 522.1192  [Amended]

    27. Section 522.1192 Ivermectin injection is amended in paragraph 
(b) by removing ``000006'' and adding in its place ``050604''.


Sec.  522.1193  [Amended]

    28. Section 522.1193 Ivermectin and clorsulon injection is amended 
in paragraph (b) by removing ``000006'' and adding in its place 
``050604''.


Sec. 522.1452  [Amended]

    29. Section 522.1452 Nalorphine hydrochloride injection is amended 
in paragraph (b) by removing ``000006'' and adding in its place 
``050604''.


Sec. 522.1885  [Amended]

    30. Section 522.1885 Prednisolone tertiary butylacetate suspension 
is amended in paragraph (b) by removing ``000006'' and adding in its 
place ``050604''.

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

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

    Authority: 21 U.S.C. 360b.


Sec. 524.1193  [Amended]

    32. Section 524.1193 Ivermectin pour-on is amended in paragraph (b) 
by removing ``000006'' and adding in its place ``050604''.


Sec. 524.1484g  [Amended]

    33. Section 524.1484g Neomycin sulfate-thiabendazole-dexamethasone 
solution is amended in paragraph (b) by removing ``000006'' and adding 
in its place ``050604''.


Sec. 524.1883  [Amended]

    34. Section 524.1883 Prednisolone sodium phosphate-neomycin sulfate 
ophthalmic ointment is amended in paragraph (b) by removing ``000006'' 
and adding in its place ``050604''.

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

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

    Authority: 21 U.S.C. 360b, 371.


Sec. 558.55  [Amended]

     36. Section 558.55 Amprolium is amended in paragraph (a) by 
removing ``000006'' and adding in its place ``050604''.


Sec. 558.58  [Amended]

     37. Section 558.58 Amprolium and ethopabate is amended in the 
table in paragraph (d)(1), in the ``Limitations'' column by removing 
``000006'' each time it appears and adding in its place ``050604''.


Sec. 558.95  [Amended]

    38. Section 558.95 Bambermycins is amended in paragraphs 
(d)(1)(ii)(b), (d)(1)(iii)(b), (d)(1)(iv)(b), (d)(1)(v)(b), and 
(d)(1)(xiii)(b)(2)(iii)(b) by removing ``000006'' and adding in its 
place ``050604''.


Sec. 558.235  [Amended]

    39. Section 558.235 Efrotomycin is amended in paragraph (a) by 
removing ``000006'' and adding in its place ``050604''.


Sec. 558.300  [Amended]

     40. Section 558.300 Ivermectin is amended in paragraphs (a)(1) and 
(a)(2) by removing ``000006'' and adding in its place ``050604''.


Sec. 558.615  [Amended]

    41. Section 558.615 Thiabendazole is amended in paragraph (a) by 
removing ``000006'' and adding in its place ``050604''.

    Dated: November 10, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-31148 Filed 11-26-97; 8:45 am]
BILLING CODE 4160-01-F