78 FR 68 pgs. 21058-21060 - New Animal Drugs; Change of Sponsor
Type: RULEVolume: 78Number: 68Pages: 21058 - 21060
Docket number: [Docket No. FDA-2013-N-0002]
FR document: [FR Doc. 2013-07542 Filed 4-8-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 526, 529, and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Change of Sponsor
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 43 approved new animal drug applications (NADAs) and 3 approved abbreviated new animal drug applications (ANADAs) from Boehringer Ingelheim Vetmedica, Inc. to Strategic Veterinary Pharmaceuticals, Inc.
DATES:
This rule is effective April 9, 2013.
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8300, email: steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002 has informed FDA that it has transferred ownership of, and all rights and interest in, the following 43 approved NADAs and 3 approved ANADAs to Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503:
| Application No. | Trade name |
|---|---|
| 11-531 | DIZAN (dithiazanine iodide) Tablets. |
| 11-674 | DIZAN (dithiazanine iodide) Powder. |
| 12-469 | DIZAN Suspension With Piperazine. |
| 31-512 | ATGARD (dichlovos) Swine Wormer Type A Medicated Article. |
| 33-803 | TASK (dichlovos) Dog Anthelmintic. |
| 35-918 | EQUIGARD (dichlovos). |
| 38-200 | MEDAMYCIN (oxytetracycline hydrochloride) Soluble Antibiotic. |
| 39-483 | BIO-TAL (thiamylal sodium) Injectable Solution. |
| 40-848 | ATGARD C (dichlovos) Swine Wormer Type A Medicated Article. |
| 43-606 | ATGARD V (dichlovos) Swine Wormer Type A Medicated Article. |
| 45-143 | OXYJECT (oxytetracycline hydrochloride) Injectable Solution. |
| 47-278 | OXY-TET 50 (oxytetracycline hydrochloride) Injectable Solution. |
| 47-712 | BIZOLIN-100 (phenylbutazone) Tablets. |
| 48-010 | ANAPLEX (dichlorophene and toluene) Capsules. |
| 48-237 | EQUIGEL (dichlovos) Oral Gel. |
| 48-271 | TASK (dichlovos) Tablets. |
| 49-032 | ATGARD C (dichlovos) 9.6% Type A Medicated Article. |
| 55-097 | DRY-MAST (penicillin G procaine/dihydrostreptomycin sulfate) Intramammary Infusion. |
| 65-178 | FERMYCIN (chlortetracycline hydrochloride or chlortetracycline bisulfate) Soluble Powder. |
| 65-461 | ANACETIN (chloramphenicol) Tablets. |
| 65-481 | Chlortetracycline Pneumonia/Calf Scour Boluses. |
| 65-486 | Chlortetracycline Bisulfate Soluble Powder. |
| 65-491 | MEDICHOL (chloramphenicol) Tablets. |
| 65-496 | Tetracycline Soluble Powder. |
| 92-837 | NEMACIDE (diethylcarbamazine citrate) Oral Syrup. |
| 93-516 | BIZOLIN (phenylbutazone) Injection 20%. |
| 97-452 | OXYJECT 100 (oxytetracycline hydrochloride) Injectable Solution. |
| 98-569 | MEDACIDE-SDM (sulfadimethoxine) Injection 10%. |
| 99-618 | BIZOLIN (phenylbutazone) 1-G Tablets. |
| 108-963 | MEDAMYCIN (oxytetracycline hydrochloride) Injectable Solution. |
| 109-305 | Oxytocin Injection. |
| 117-689 | NEUROSYN (primidone) Tablets. |
| 125-797 | Nitrofurazone Dressing. |
| 126-236 | Nitrofurazone Soluble Powder. |
| 126-676 | D & T (dichlorophene and toluene) Worm Capsules. |
| 127-627 | NEMACIDE-C (diethylcarbamazine citrate) Tablets. |
| 128-069 | NEMACIDE (diethylcarbamazine citrate) Chewable Tablets. |
| 132-028 | ANESTATAL (thiamylal sodium) Powder for Injection. |
| 135-771 | Methylprednisolene Tablets. |
| 136-212 | Methylprednisolone Acetate Injectable Suspension. |
| 137-310 | Gentamicin Sulfate Injectable Solution. |
| 138-869 | Triamcinolone Acetonide Injectable Suspension. |
| 140-442 | Xylazine HCl Injection. |
| 200-023 | Gentamicin Sulfate Intrauterine Solution. |
| 200-029 | Ketamine Hydrochloride Injection. |
| 200-165 | SDM (sulfadimethoxine) 12.5% Oral Solution. |
Accordingly, the Agency is amending the regulations in 21 CFR parts 510, 520, 522, 524, 526, 529, and 558 to reflect the transfer of ownership.
This rule does not meet the definition of "rule" in 5 U.S.C. 804(3)(A) because it is a rule of "particular applicability." Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, 526, 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, 526, 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:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. In the table in paragraph (c)(1) of § 510.600, alphabetically add an entry for "Strategic Veterinary Pharmaceuticals, Inc."; and in the table in paragraph (c)(2), numerically add an entry for "054628" to read as follows:
§ 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
(c) * * *
(1) * * *
| Firm name and address | Drug labeler code |
|---|---|
| ***** | |
| Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 | 054628 |
| ***** |
(2) * * *
| Drug labeler code | Firm name and address |
|---|---|
| ***** | |
| 054628 | Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 |
| ***** |
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.
§ 520.390a [Amended]
4. In paragraph (b)(1)(i) of § 520.390a, remove "000010" and in its place add "054628".
§ 520.441 [Amended]
5. In paragraph (b)(3) of § 520.441, remove "000010" and in its place add "054628".
§ 520.443 [Amended]
6. In paragraph (b) of § 520.443, remove "000010" and in its place add "054628".
§ 520.580 [Amended]
7. In paragraph (b)(2), remove "000010 and 000061" and in its place add "Nos. 000061 and 054628".
§ 520.600 [Amended]
8. In paragraph (c) of § 520.600, remove "000010" and in its place add "054628".
§ 520.622a [Amended]
9. In paragraph (a)(6) of § 520.622a, remove "000010" and in its place add "054628".
§ 520.622b [Amended]
10. In paragraph (c)(2) of § 520.622b, remove "000010" and in its place add "054628".
§ 520.622c [Amended]
11. In paragraph (b)(6) of § 520.622c, remove "000010" and in its place add "054628".
§ 520.763a [Amended]
12. In § 520.763a, remove and reserve paragraph (a); in paragraph (c), remove "000010" and in its place add "054628"; and remove paragraph (e).
§ 520.763b [Amended]
13. In § 520.763b, remove and reserve paragraph (a); and in paragraph (c), remove "000010" and in its place add "054628".
§ 520.763c [Amended]
14. In paragraph (b) of § 520.763c, remove "000010" and in its place add "054628"; and remove and reserve paragraph (c).
§ 520.1408 [Amended]
15. In paragraph (b) of § 520.1408, remove "000010" and in its place add "054628"; and remove and reserve paragraph (c).
§ 520.1660d [Amended]
16. In § 520.1660d:
a. In paragraph (b)(3), remove "000010" and in its place add "054628".
b. In paragraph (d)(1)(ii)(A)( 3 ), remove "000010" and in its place add "054628".
c. In paragraph (d)(1)(ii)(B)( 3 ), remove "000010" and in its place add "054628".
d. In paragraph (d)(1)(ii)(C)( 3 ), remove "000010" and in its place add "054628".
§ 520.1720a [Amended]
17. In paragraph (b)(2) of § 520.1720a, remove "000010 and 000859" and in its place add "000859 and 054628".
§ 520.1900 [Amended]
18. In paragraph (b) of § 520.1900, remove "000010" and in its place add "054628"; and in paragraphs (c)(1), (c)(2), and (c)(3), remove the footnote.
§ 520.2220a [Amended]
19. In paragraph (a)(1) of § 520.2220a, remove "000010, 000069, 000859, 054925, and 057561" and in its place add "000069, 000859, 054628, 054925, and 057561".
§ 520.2345d [Amended]
20. In paragraph (b)(2) of § 520.2345d, remove "000010" and in its place add "054628".
PART 522-IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
21. The authority citation for 21 CFR part 522 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 522.1044 [Amended]
22. In paragraph (b)(3) of § 522.1044, remove "000010" and in its place add "054628".
§ 522.1222a [Amended]
23. In paragraph (b) of § 522.1222a, remove "000010, 000859, 061690, 026637, and 063286" and in its place add "000859, 026637, 054628, 061690, and 063286".
§ 522.1410 [Amended]
24. In paragraph (b) of § 522.1410, remove "000010" and in its place add "054628".
§ 522.1662a [Amended]
25. In paragraphs (a)(2), (b)(2), (g)(2), and (h)(2) of § 522.1662a, remove "000010" and in its place add "054628".
26. In § 522.1680, revise the section heading to read as set forth below; and in paragraph (b), remove "000010, 000856, 000859, and 061623" and in its place add "000856, 000859, 054628, and 061623".
§ 522.1680 Oxytocin.
27. In § 522.1720, revise the section heading to read as set forth below; and in paragraph (b)(2), remove "000010" and in its place add "054628".
§ 522.1720 Phenylbutazone.
28. In § 522.2220, revise the section heading as set forth below; and in paragraph (c)(2), remove "000010" and in its place add "054628".
§ 522.2220 Sulfadimethoxine.
29. In § 522.2424, revise the section heading as set forth below; and in paragraph (b), remove "000010 and 000856" and in its place add "000856 and 054628"; and remove paragraph (c)(4).
§ 522.2424 Sodium thiamylal.
§ 522.2483 [Amended]
30. In paragraph (b) of § 522.2483, remove "000010" and in its place add "054628".
§ 522.2662 [Amended]
31. In paragraph (b)(1) of § 522.2662, remove "000010" and in its place add "054628".
PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
32. The authority citation for 21 CFR part 524 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 524.1580b [Amended]
33. In paragraph (b)(1) of § 524.1580b, remove "000010, 000069, 050749, 054925, 058005, and 061623" and in its place add "000069, 050749, 054628, 054925, 058005, and 061623".
§ 524.1580c [Amended]
34. In paragraph (b) of § 524.1580c, remove "000010 and 000069" and in its place add "000069 and 054628".
PART 526-INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
35. The authority citation for 21 CFR part 526 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 526.1696b [Amended]
36. In paragraph (b) of § 526.1696b, remove "000010" and in its place add "054628".
PART 529-CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
37. The authority citation for 21 CFR part 529 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 529.1044a [Amended]
38. In paragraph (b) of § 529.1044a, remove "000010, 000061, 000856, 000859 057561, 058005, and 061623" and in its place add "000061, 000856, 000859, 054628, 057561, 058005, and 061623".
PART 558-NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
39. The authority citation for 21 CFR part 558 continues to read as follows:
Authority:
21 U.S.C. 360b, 371.
§ 558.205 [Amended]
40. In paragraph (a) of § 558.205, remove "000010" and in its place add "054628".
Dated: March 26, 2013.
Steven D. Vaughn,
Director,Office of New Animal Drug Evaluation,Center for Veterinary Medicine.
[FR Doc. 2013-07542 Filed 4-8-13; 8:45 am]
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