New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendments.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of eight NADAs and nine ANADAs, and to make correcting amendments for a drug labeler code.

DATES:

This rule is effective March 13, 2015.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during November and December 2014, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm . Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm .

In addition, Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, has transferred ownership of, and all rights and interest in, the following approved applications to Pharmgate LLC, 161 North Franklin Turnpike, Suite 2C, Ramsey, NJ 07446:

At this time, the regulations are being amended to reflect these changes of sponsorship. Following these changes of sponsorship, Pharmgate LLC will now be the sponsor of an approved application while Pennfield Oil Co. will no longer be the sponsor of an approved application. Also, Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118, has informed FDA that it has changed its name to Hikma International Pharmaceuticals LLC. Accordingly, § 510.600 (21 CFR 510.600) is being amended to reflect these changes. In addition, FDA is amending § 510.600 and several sections of part 520 to reflect a correct drug labeler code for Akorn Animal Health, Inc. FDA is also amending the regulations in 21 CFR parts 520, 522, 556, and 558 to redesignate several sections to reflect alphabetical order and to make minor technical amendments. These corrections and technical amendments are being made to improve the accuracy of the animal drug regulations.

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, and 524

• Animal drugs

21 CFR Part 556

• Animal drugs
• Foods

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, 556, 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. Amend § 510.600 as follows:

a. In the table in paragraph (c)(1), in the entry for “Akorn Animal Health, Inc.”, in the ”Drug labeler code” column, remove “053599”, and in its place add “059399”;

b. In the table in paragraph (c)(1), in the entry for “Hikma Pharmaceuticals LLC”, in the “Firm name and address” column, remove “Hikma Pharmaceuticals LLC”, and in its place add “Hikma International Pharmaceuticals LLC”;

c. In the table in paragraph (c)(1), remove the entry for “Pennfield Oil Co.” and add an entry, in alphabetical order, for “Pharmgate LLC”;

d. In the table in paragraph (c)(2), remove the entries for “000008”, “048164”, and “053599” and add entries, in numerical order, for “059399” and “069254”; and

e. In the table in paragraph (c)(2), in the entry for “059115”, in the “Firm name and address” column, remove “Hikma Pharmaceuticals LLC”, and in its place add “Hikma International Pharmaceuticals LLC”.

The additions and revisions read as follows:

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.

4. Redesignate §§ 520.310 and 520.312 as §§ 520.301 and 520.302, respectively.

5. Redesignate § 520.309 as § 520.304 and revise newly redesignated § 520.304 by adding paragraph (b)(3) to read as follows:

6. In § 520.370, revise paragraphs (a) and (b) and in paragraph (c)(2), remove “ intermedius” and in its place add “pseudintermedius” to read as follows:

7. In § 520.441, in paragraph (b)(1), remove “048164” and in its place add “069254”.

8. Amend § 520.1660d as follows:

a. In paragraph (b)(6), remove “048164” and in its place add “069254”.

b. In paragraphs (d)(1)(ii)(A)( 3), (d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3), revise the last sentence.

The revisions read as follows:

9. In § 520.2455, revise paragraphs (b)(3) and (c) to read as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

11. In § 522.246, in paragraph (b)(3), remove “053599” and in its place add “059399”.

12. In § 522.558, revise paragraphs (a) and (b) to read as follows:

13. Amend § 522.812 as follows:

a. Revise paragraph (b)(2);

b. Remove paragraph (e)(3)(i);

c. Redesignate paragraphs (e)(3)(ii) and (e)(3)(iii) as paragraphs (e)(3)(i) and (e)(3)(ii), respectively; and

d. Revise newly redesignated paragraph (e)(3)(i).

The revisions read as follows:

14. In § 522.1222, revise paragraph (b) to read as follows:

15. In § 522.2474, in paragraph (b), remove “053599” and in its place add “059399”.

16. In § 522.2630, revise paragraphs (b)(1), (b)(2), (d)(1)(ii)(A), (d)(1)(ii)(B), and (d)(1)(iii) to read as follows:

17. In § 522.2662, in paragraph (b)(4), remove “053599” and in its place add “059399”.

18. In § 522.2670, in paragraph (b)(1), remove “053599” and in its place add “059399”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

20. Add § 524.955 to read as follows:

21. In § 524.1044i, revise paragraph (c)(2) to read as follows:

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

22. The authority citation for 21 CFR part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

23. Redesignate § 556.738 as § 556.732.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

25. In § 558.76, in paragraph (d)(1)(iv), in the “Limitations” and “Sponsor” columns, remove “048164” and in its place add “069254”.

26. In § 558.95, add paragraph (d)(4)(v) to read as follows:

27. Amend § 558.128 as follows:

a. In paragraph (b)(1), remove “Nos. 054771, 048164, and 066104” and in its place add “Nos. 054771, 066104, and 069254”;

b. In paragraphs (e)(4)(ii) and (iv), in the “Limitations” column, remove “048164” wherever it occurs and in its place add “069254”;

c. In paragraphs (e)(1)(i), (ii), and (iii), (e)(2)(i), (ii), (iii), and (iv), (e)(3)(i), (ii), (iii), and (iv), (e)(4)(i), (ii), (iv), (vii), and (viii), and (e)(5)(i) and (ii), in the “Sponsor” column, remove “048164” wherever it occurs and in its place in numerical order add “069254”; and

d. Revise paragraphs (e)(1)(iv), (e)(4)(v), and (e)(4)(ix).

The revisions read as follows:

28. In § 558.140, in paragraph (b)(1), remove “048164” and in its place add “069254”.

29. In § 558.145, in paragraph (a)(2), remove “048164” and in its place add “069254”.

30. In § 558.195, in paragraph (e)(2)(iv), in the “Limitations” and “Sponsor” columns, remove “048164” and in its place add “069254”.

31. In § 558.355, in paragraph (f)(1)(xiv)( b), remove “048164” and in its place add “069254”.

32. Amend § 558.450 as follows:

a. In paragraph (a)(2), remove “048164” and in its place add “069254”;

b. In paragraphs (d)(2)(iii), (d)(2)(iv), and (d)(4)(ii), in the “Limitations” column, remove “048164” wherever it occurs and in its place add “069254”; and

c. In paragraphs (d)(1)(i), (ii), (iii), and (iv), (d)(2)(i), (ii), (iii), and (iv), (d)(3)(i) and (ii), (d)(4)(i), (ii), (iii), (iv), and (v), and (d)(5)(i), (ii), and (iii), in the “Sponsor” column, remove “048164” and in its place add “069254”.

33. Amend § 558.455 as follows:

a. In paragraph (b), remove “Nos. 048164 and 066104” and in its place add “Nos. 066104 and 069254”; and

b. In paragraphs (e)(1)(i), (ii), (iii), and (iv), (e)(2)(i), (ii), (iii), and (iv), (e)(3)(i) and (ii), and (e)(4)(i), (ii), (iii), (iv), (v), and (vi), in the “Sponsor” column, remove “048164” and in its place in numerical order add “069254”.

34. In § 558.550, in paragraphs (b)(3) and (d)(1)(xvi)( c), remove “048164” and in its place add “069254”.

35. Redesignate § 558.600 as § 558.612 and amend newly redesignated § 558.612 as follows:

a. In paragraph (c), remove “§ 556.738” and in its place add “§ 556.732”; and

b. In paragraph (e)(1)(iii), in the “Limitations” and “Sponsor” columns, remove “048164” and in its place in numerical order add “069254”.

36. Redesignate § 558.615 as § 558.600.

37. In § 558.625, in paragraph (b)(5), remove “048164” and in its place add “069254”.

38. In § 558.630, in paragraph (b)(2), remove “No. 054771” and in its place add “Nos. 054771 and 069254”.

39. Amend § 558.665 as follows:

a. Revise paragraphs (d)(1) and (e)(1);

b. Redesignate paragraph (d)(2) as paragraph (d)(4); and

c. Add paragraphs (d)(2), (d)(3), (e)(7), and (e)(8).

The revisions and additions read as follows: