[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:
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NADA No. Product Name
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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