Document ID: FDA-2013-N-0002-0008
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor
Posted Date: 2013-04-09T04:00Z

[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Rules and Regulations]
[Pages 21058-21060]
From the Federal Register Online via the Government Printing 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: 
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:

                   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.
------------------------------------------------------------------------

    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) * * *

------------------------------------------------------------------------
          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