[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Rules and Regulations]
[Pages 21058-21060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07542]
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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.
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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:
[email protected].
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:
Table 1.--Applications Transferred
------------------------------------------------------------------------
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.
[[Page 21059]]
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.
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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
0
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.
0
2. In the table in paragraph (c)(1) of Sec. 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:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
Strategic Veterinary Pharmaceuticals, Inc., 100 NW. 054628
Airport Rd., St. Joseph, MO 64503......................
* * * * *
------------------------------------------------------------------------
(2) * * *
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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
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.390a [Amended]
0
4. In paragraph (b)(1)(i) of Sec. 520.390a, remove ``000010'' and in
its place add ``054628''.
Sec. 520.441 [Amended]
0
5. In paragraph (b)(3) of Sec. 520.441, remove ``000010'' and in its
place add ``054628''.
Sec. 520.443 [Amended]
0
6. In paragraph (b) of Sec. 520.443, remove ``000010'' and in its
place add ``054628''.
Sec. 520.580 [Amended]
0
7. In paragraph (b)(2), remove ``000010 and 000061'' and in its place
add ``Nos. 000061 and 054628''.
Sec. 520.600 [Amended]
0
8. In paragraph (c) of Sec. 520.600, remove ``000010'' and in its
place add ``054628''.
Sec. 520.622a [Amended]
0
9. In paragraph (a)(6) of Sec. 520.622a, remove ``000010'' and in its
place add ``054628''.
Sec. 520.622b [Amended]
0
10. In paragraph (c)(2) of Sec. 520.622b, remove ``000010'' and in its
place add ``054628''.
Sec. 520.622c [Amended]
0
11. In paragraph (b)(6) of Sec. 520.622c, remove ``000010'' and in its
place add ``054628''.
Sec. 520.763a [Amended]
0
12. In Sec. 520.763a, remove and reserve paragraph (a); in paragraph
(c), remove ``000010'' and in its place add ``054628''; and remove
paragraph (e).
Sec. 520.763b [Amended]
0
13. In Sec. 520.763b, remove and reserve paragraph (a); and in
paragraph (c), remove ``000010'' and in its place add ``054628''.
Sec. 520.763c [Amended]
0
14. In paragraph (b) of Sec. 520.763c, remove ``000010'' and in its
place add ``054628''; and remove and reserve paragraph (c).
[[Page 21060]]
Sec. 520.1408 [Amended]
0
15. In paragraph (b) of Sec. 520.1408, remove ``000010'' and in its
place add ``054628''; and remove and reserve paragraph (c).
Sec. 520.1660d [Amended]
0
16. In Sec. 520.1660d:
0
a. In paragraph (b)(3), remove ``000010'' and in its place add
``054628''.
0
b. In paragraph (d)(1)(ii)(A)(3), remove ``000010'' and in its place
add ``054628''.
0
c. In paragraph (d)(1)(ii)(B)(3), remove ``000010'' and in its place
add ``054628''.
0
d. In paragraph (d)(1)(ii)(C)(3), remove ``000010'' and in its place
add ``054628''.
Sec. 520.1720a [Amended]
0
17. In paragraph (b)(2) of Sec. 520.1720a, remove ``000010 and
000859'' and in its place add ``000859 and 054628''.
Sec. 520.1900 [Amended]
0
18. In paragraph (b) of Sec. 520.1900, remove ``000010'' and in its
place add ``054628''; and in paragraphs (c)(1), (c)(2), and (c)(3),
remove the footnote.
Sec. 520.2220a [Amended]
0
19. In paragraph (a)(1) of Sec. 520.2220a, remove ``000010, 000069,
000859, 054925, and 057561'' and in its place add ``000069, 000859,
054628, 054925, and 057561''.
Sec. 520.2345d [Amended]
0
20. In paragraph (b)(2) of Sec. 520.2345d, remove ``000010'' and in
its place add ``054628''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
21. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1044 [Amended]
0
22. In paragraph (b)(3) of Sec. 522.1044, remove ``000010'' and in its
place add ``054628''.
Sec. 522.1222a [Amended]
0
23. In paragraph (b) of Sec. 522.1222a, remove ``000010, 000859,
061690, 026637, and 063286'' and in its place add ``000859, 026637,
054628, 061690, and 063286''.
Sec. 522.1410 [Amended]
0
24. In paragraph (b) of Sec. 522.1410, remove ``000010'' and in its
place add ``054628''.
Sec. 522.1662a [Amended]
0
25. In paragraphs (a)(2), (b)(2), (g)(2), and (h)(2) of Sec.
522.1662a, remove ``000010'' and in its place add ``054628''.
0
26. In Sec. 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''.
Sec. 522.1680 Oxytocin.
* * * * *
0
27. In Sec. 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''.
Sec. 522.1720 Phenylbutazone.
* * * * *
0
28. In Sec. 522.2220, revise the section heading as set forth below;
and in paragraph (c)(2), remove ``000010'' and in its place add
``054628''.
Sec. 522.2220 Sulfadimethoxine.
* * * * *
0
29. In Sec. 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).
Sec. 522.2424 Sodium thiamylal.
* * * * *
Sec. 522.2483 [Amended]
0
30. In paragraph (b) of Sec. 522.2483, remove ``000010'' and in its
place add ``054628''.
Sec. 522.2662 [Amended]
0
31. In paragraph (b)(1) of Sec. 522.2662, remove ``000010'' and in its
place add ``054628''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
32. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1580b [Amended]
0
33. In paragraph (b)(1) of Sec. 524.1580b, remove ``000010, 000069,
050749, 054925, 058005, and 061623'' and in its place add ``000069,
050749, 054628, 054925, 058005, and 061623''.
Sec. 524.1580c [Amended]
0
34. In paragraph (b) of Sec. 524.1580c, remove ``000010 and 000069''
and in its place add ``000069 and 054628''.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
35. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 526.1696b [Amended]
0
36. In paragraph (b) of Sec. 526.1696b, remove ``000010'' and in its
place add ``054628''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
37. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1044a [Amended]
0
38. In paragraph (b) of Sec. 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
0
39. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.205 [Amended]
0
40. In paragraph (a) of Sec. 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]
BILLING CODE 4160-01-P