[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Rules and Regulations]
[Pages 61624-61626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30337]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 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 61 approved new 
animal drug applications (NADA's) from Mallinckrodt Veterinary, Inc., 
to Schering-Plough Animal Health Corp.

EFFECTIVE DATE: November 19, 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: Mallinckrodt Veterinary, Inc., Mundelein, IL 
60060, has informed FDA that it has transferred the ownership of, and 
all rights and interests in the approved NADA's to Schering-Plough 
Animal Health Corp. The agency is amending 21 CFR 510, 520, 522, 524, 
and 558 to reflect the change of sponsor.

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, and 524

     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, 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.

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 ``Mallinckrodt Veterinary Inc.''; and 
in the table in paragraph (c)(2) by removing the entry for ``011716''.

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. 520.82a  [Amended]

     4. Section 520.82a Aminopropazine fumarate tablets is amended in 
paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.82b  [Amended]

     5. Section 520.82b Aminopropazine fumarate, neomycin sulfate 
tablets is amended in paragraph (b) by removing ``011716'' and adding 
in its place ``000061''.


Sec. 520.222  [Amended]

     6. Section 520.222 Bunamidine hydrochloride is amended in 
paragraph (c) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.580  [Amended]

     7. Section 520.580 Dichlorophene and toluene capsules is amended 
in paragraph (b)(2) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.622c  [Amended]

     8. Section 520.622c Diethylcarbamazine citrate chewable tablets is 
amended in paragraph (b)(5) by removing ``011716'' and adding in its 
place ``000061''.


Sec. 520.784  [Amended]

     9. Section 520.784 Doxylamine succinate tablets is amended in 
paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.863  [Amended]

     10. Section 520.863 Ethylisobutrazine hydrochloride tablets is 
amended in paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.1120a  [Amended]

     11. Section 520.1120a Haloxon drench is amended in paragraph (c) 
by removing ``011716'' and adding in its place ``000061''.

[[Page 61625]]

Sec. 520.1120b  [Amended]

     12. Section 520.1120b Haloxon boluses is amended in paragraph (c) 
by removing ``011716'' and adding in its place ``000061''.


Sec. 520.1242a  [Amended]

     13. Section 520.1242a Levamisole hydrochloride drench and drinking 
water is amended in paragraph (c)(2) by removing ``011716'' and adding 
in its place ``000061''.


Sec. 520.1242b  [Amended]

     14. Section 520.1242b Levamisole hydrochloride tablet or oblet 
(bolus) is amended in paragraph (c) by removing ``011716'' and adding 
in its place ``000061''.


Sec. 520.1242g  [Amended]

     15. Section 520.1242g Levamisole resinate and famphur paste is 
amended in paragraph (c) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.1320  [Amended]

     16. Section 520.1320 Mebendazole oral is amended in paragraph (c) 
by removing ``011716'' and adding in its place ``000061''.


Sec. 520.1326a  [Amended]

     17. Section 520.1326a Mebendazole and trichlorfon powder is 
amended in paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.1326b  [Amended]

     18. Section 520.1326b Mebendazole and trichlorfon paste is amended 
in paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.1720a  [Amended]

     19. Section 520.1720a Phenylbutazone tablets and boluses is 
amended in paragraph (b)(1) by removing ``011716'' and adding in its 
place ``000061''.


Sec. 520.1720b  [Amended]

    20. Section 520.1720b Phenylbutazone granules is amended in 
paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.1720c  [Amended]

    21. Section 520.1720c Phenylbutazone paste is amended in paragraph 
(b) by removing ``010797 and 011716'' and adding in its place ``000061 
and 010797''.


Sec. 520.1805  [Amended]

     22. Section 520.1805 Piperazine phosphate with thenium closylate 
tablets is amended in paragraph (b) by removing ``011716'' and adding 
in its place ``000061''.


Sec. 520.2220b  [Amended]

     23. Section 520.2220b Sulfadimethoxine tablets and boluses is 
amended in paragraph (b)(3) by removing ``011716'' and adding in its 
place ``000061''.


Sec. 520.2220c  [Amended]

     24. Section 520.2220c Sulfadimethoxine oral suspension is amended 
in paragraph (c) by removing ``000069 and 011716'' and adding in its 
place ``000061 and 000069''.


Sec. 520.2362  [Amended]

     25. Section 520.2362 Thenium closylate tablets is amended in 
paragraph (c) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.2610  [Amended]

     26. Section 520.2610 Trimethoprim and sulfadiazine tablets is 
amended in paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.2611  [Amended]

     27. Section 520.2611 Trimethoprim and sulfadiazine oral paste is 
amended in paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 520.2612  [Amended]

     28. Section 520.2612 Trimethoprim and sulfadiazine oral suspension 
is amended in paragraph (b) by removing ``011716'' and adding in its 
place ``000061''.

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

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

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


Sec. 522.82  [Amended]

     30. Section 522.82 Aminopropazine fumarate sterile solution 
injection is amended in paragraph (b) by removing ``011716'' and adding 
in its place ``000061''.


Sec. 522.150  [Amended]

     31. Section 522.150 Azaperone injection is amended in paragraph 
(b) by removing ``011716'' and adding in its place ``000061''.


Sec. 522.784  [Amended]

     32. Section 522.784 Doxylamine succinate injection is amended in 
paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 522.863  [Amended]

     33. Section 522.863 Ethylisobutrazine hydrochloride injection is 
amended in paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 522.1155  [Amended]

     34. Section 522.1155 Imidocarb dipropionate sterile powder is 
amended in paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 522.1244  [Amended]

     35. Section 522.1244 Levamisole phosphate injection is amended in 
paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 522.1503  [Amended]

     36. Section 522.1503 Neostigmine methylsulfate injection is 
amended in paragraph (b) by removing ``011716'' and adding in its place 
``000061''.


Sec. 522.1704  [Amended]

     37. Section 522.1704 Sodium pentobarbital injection is amended in 
paragraph (a)(2) by removing ``011716'' and adding in its place 
``000061''.


Sec. 522.1720  [Amended]

     38. Section 522.1720 Phenylbutazone injection is amended in 
paragraph (b)(1) by removing ``011716'' and adding in its place 
``000061''.


Sec. 522.2005  [Amended]

     39. Section 522.2005 Propofol injection is amended in paragraph 
(b) by removing ``011716'' and adding in its place ``000061''.


Sec. 522.2610  [Amended]

     40. Section 522.2610 Trimethoprim and sulfadiazine sterile 
suspension is amended in paragraph (a)(2) by removing ``000856 and 
011716'' and adding in its place ``000061 and 000856''.


Sec. 522.2680  [Amended]

     41. Section 522.2680 Zeranol is amended in paragraph (b) by 
removing ``011716'' and adding in its place ``000061''.

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

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

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


Sec. 524.154  [Amended]

     43. Section 524.154 Bacitracin or bacitracin zinc-neomycin 
sulfate-polymyxin B sulfate ophthalmic ointment is amended in paragraph 
(a)(2) by removing ``011716'' and adding in its place ``000061''.

[[Page 61626]]

Sec. 524.155  [Amended]

     44. Section 524.155 Bacitracin zinc-polymyxin B sulfate-neomycin 
sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment is 
amended in paragraph (a)(1) by removing ``011716'' and adding in its 
place ``000061''.


Sec. 524.900  [Amended]

    45. Section 524.900 Famphur is amended in paragraph (c) by removing 
``011716'' and adding in its place ``000061''.


Sec. 524.1240  [Amended]

    46. Section 524.1240 Levamisole is amended in paragraph (b) by 
removing ``010042 and 011716'' and adding in its place ``000061 and 
010042''.


Sec. 524.1443  [Amended]

     47. Section 524.1443 Miconazole nitrate cream; miconazole nitrate 
lotion; miconazole nitrate spray is amended in paragraph (b) by 
removing ``011716'' and adding in its place ``000061''.


Sec. 524.1742  [Amended]

     48. Section 524.1742 N-(Mercaptomethyl) phthalimide S-(O,O-
dimethyl phosphorodithioate) emulsifiable liquid is amended in 
paragraph (b) by removing ``011536 and 011716'' and adding in its place 
``000061 and 011536''.

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

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

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

Sec. 558.175  [Amended]

     50. Section 558.175 Clopidol is amended in paragraph 
(c)(1)(iii)(b) and (c)(1)(iv)(b) by removing ``011716'' and adding in 
its place ``000061''.


Sec. 558.195  [Amended]

     51. Section 558.195 Decoquinate is amended in the table in 
paragraph (d), under the ``Limitations'' column by removing ``011716'' 
wherever it appears and adding in its place ``000061''.


Sec. 558.254  [Amended]

     52. Section 558.254 Famphur is amended in paragraph (a) by 
removing ``011716'' and adding in its place ``000061''.


Sec. 558.311  [Amended]

     53. Section 558.311 Lasalocid is amended in the table in paragraph 
(e)(1)(ii), under the ``Limitations'' column, 5th paragraph, by 
removing ``011716'' and adding in its place ``000061''.


Sec. 558.515  [Amended]

     54. Section 558.515 Robenidine hydrochloride is amended in 
paragraph (d)(1)(vi)(b) by removing ``011716'' and adding in its place 
``000061''.

    Dated: November 3, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-30337 Filed 11-18-97; 8:45 am]
BILLING CODE 4160-01-F