New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. 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 changes of sponsorship of applications that occurred in January and February.

DATES:

This rule is effective April 18, 2016.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Approval Actions

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January and February 2016, 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 .

Also, FDA is amending the regulations to reflect the approval of several minor supplemental applications that revised classes of food-producing animals in indications and in food safety warnings for decoquinate and robenidine in medicated feeds. A food safety precautionary statement has also been revised for use of monensin in medicated chicken feed.

II. Changes of Sponsorship

Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee, Mission, KS 66201 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:

Also, Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666.

In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:

As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship.

III. Technical Amendments

FDA has noticed that it failed to amend all necessary regulations to reflect the change of sponsorship of an oxytetracycline soluble powder (80 FR 13226, March 13, 2015). At this time, we are amending 21 CFR 529.1660 to include the drug labeler code for the new sponsor. This action is being taken to improve the accuracy of the regulations.

FDA has also noticed that in § 558.355 (21 CFR 558.355) use of bacitracin methylenedisalicylate at 100 to 200 grams/ton in combination with monensin in broiler and replacement chicken feeds was codified in error for NADA 141-140 (66 FR 13236, March 5, 2001). At this time, § 558.355 is amended by removing paragraphs (f)(1)(xxx) and (f)(4)(v). In addition, paragraph (f)(4)(iv), a remnant of a previous technical amendment (79 FR 10963, February 27, 2014), is also being removed. We have also noticed that certain paragraphs describing approved conditions of use were removed in error from § 558.355 during codification of a supplemental application to NADA 138-456 that increased the dose range for monensin used in combination with bacitracin methylenedisalicylate in broiler chicken feed (57 FR 6554, February 26, 1992). At this time, § 558.355 is amended by adding paragraphs (f)(1)(xxiv)(a) and (b). These actions are being taken to improve the accuracy of the regulations.

FDA has noticed that in error we removed the approved conditions of use for gleptoferron, an injectable iron used to prevent anemia in young piglets. At this time, 21 CFR 522.1055 is being added. This action is being taken to improve the accuracy of the 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 Parts 520, 522, 524, and 529

• Animal drugs

21 CFR Part 556

• Animal drugs
• Food

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 520, 522, 524, 529, 556, and 558 are amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for part 520 continues to read as follows:

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

2. In § 520.100, remove and reserve paragraph (b)(3).

3. In § 520.441, revise paragraph (b)(1), remove paragraph (b)(2); redesignate paragraphs (b)(3) and (4) as paragraphs (b)(2) and (3); and revise newly redesignated paragraph (b)(2).

The revisions read as follows:

4. In § 520.905a, in paragraph (a), remove “paragraph (e)(5)” and in its place add “paragraphs (e)(5) and (6)”; and add paragraph (e)(6) to read as follows:

5. In § 520.1044b, in paragraph (b), remove “000859” and in its place add “016592”.

6. Add § 520.1248 to read as follows:

7. In § 520.1263c, revise paragraph (b) to read as follows:

8. In § 520.1484, in paragraph (b)(2), remove “054771” and in its place add “016592, 054771,”; and in paragraph (b)(3), remove “000859” and in its place add “016592”.

9. In § 520.1660d, in paragraph (b)(2), remove “054771” and in its place add “016592”; and in paragraph (b)(3), remove “054628” and in its place add “066104”.

10. In § 520.1696b, in paragraph (b), in numerical order add “016592”.

11. In § 520.1705, in paragraph (a), remove “pergolide mesylate” and in its place add “pergolide (as pergolide mesylate)”.

12. In § 520.2041, in paragraph (b), remove “Nos. 017135 and 051311” and in its place add “Nos. 017135, 051311, and 066916”.

13. Add § 520.2086 to read as follows:

14. In § 520.2123c, in paragraph (b), remove “000859” and in its place add “016592”.

15. In § 520.2218, in paragraph (b), remove “054771” and in its place add “016592”.

16. In § 520.2220a, in paragraph (b)(1), remove “000859” and in its place add “016592”.

17. In § 520.2260b, in paragraph (f)(1), remove “000859” and in its place add “016592”.

18. In § 520.2325a, in paragraph (a)(1), remove “000859” and in its place add “016592”; and in paragraph (a)(3), remove “No. 054771” and in its place add “Nos. 016592 and 054771”.

19. In § 520.2345d, in paragraph (b)(2), remove “054628” and in its place add “066104”; in paragraph (b)(3), remove “No. 054771” and in its place add “Nos. 016592 and 054771”; and revise the first sentence in paragraph (d)(1)(iii) and paragraph (d)(2)(iii) to read as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

20. The authority citation for part 522 continues to read as follows:

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

21. Revise § 522.535 to read as follows:

22. In § 522.540, in paragraphs (a)(2)(i) and (d)(2)(i), remove “000859” and in its place add “016592”.

23. In § 522.1044, in paragraph (b)(4), remove “000859” and in its place add “016592”.

24. Add § 522.1055 to read as follows:

25. In § 522.1182, in paragraph (b)(6), remove “000859” and in its place add “016592”; and remove paragraph (b)(8).

26. In § 522.1315, in paragraphs (c)(1)(i) and (c)(2)(i), remove “subcutaneous injection” and in its place add “subcutaneous or intravenous injection”.

27. In § 522.1660a, in paragraph (b), remove “000859” and in its place add “016592”.

28. In § 522.1662a, in paragraphs (h)(2) and (i)(2), remove “000859” and in its place add “016592”.

29. In § 522.1696a, in paragraph (b)(2), remove “000859” and in its place add “016592”.

30. In § 522.1696b, in paragraph (b)(1), remove “000859” and in its place add “016592”.

31. In § 522.2120, in paragraph (b), remove “000859” and in its place add “016592”.

32. In § 522.2220, in paragraph (b)(3), remove “000859” and in its place add “016592”.

33. In § 522.2615, in paragraph (b), remove “000859” and in its place add “016592”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

34. The authority citation for part 524 continues to read as follows:

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

35. In paragraph (b)(2) of § 522.1193, remove “000859” and in its place add “016592”.

36. In § 522.1484k, revise the section heading to read: Neomycin and prednisolone suspension.

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

37. The authority citation for part 529 continues to read as follows:

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

38. In § 529.1660, in paragraph (b)(2), remove “048164, 054771, and 061623” and in its place add “054771, 061623, and 069254”.

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

39. The authority citation for part 556 continues to read as follows:

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

40. In § 556.275, in paragraph (b)(2)(i), remove “6 ppm” and in its place add “3.2 ppm”; redesignate paragraphs (b)(3) and (4) as paragraphs (b)(4) and (5); and add new paragraph (b)(3) and paragraph (c) to read as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

41. The authority citation for part 558 continues to read as follows:

Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

42. Amend § 558.195 as follows:

a. In the table in paragraph (e)(1)(i), in the “Limitations” column, remove “Do not feed to laying chickens.” and in its place add “Do not feed to laying hens producing eggs for human consumption.”;

b. In the table in paragraph (e)(2)(i), in the “Limitations” column, remove “Do not feed to cows producing milk for food.” and in its place add “Do not feed to cows producing milk for human consumption.”;

c. In the table in paragraphs (e)(3)(i)1. and (e)(3)(ii)1., in the “Limitations” column, remove “Do not feed to sheep producing milk for food.” and in its place add “Do not feed to sheep producing milk for human consumption.”; and

d. In the table in paragraphs (e)(3)(i)2. and (e)(3)(ii)2., in the “Limitations” column, remove “Do not feed to goats producing milk for food.” and in its place add “Do not feed to goats producing milk for human consumption.”

43. In § 558.340, redesignate paragraphs (c)(1)(i) and (ii) as paragraphs (c)(2) and (3); and revise newly redesignated paragraph (c)(2) to read as follows:

44. In § 558.355, revise paragraph (f)(1)(xxiv); and revise paragraph (f)(1)(xxv) introductory text and remove and reserve paragraphs (f)(1)(xxx), (f)(4)(iv), and (f)(4)(v).

The revisions read as follows:

45. In § 558.515, in the table in paragraph (d), in the entry for “30 (0.0033 pct)”, in the first entry under the “Indications for use” column, remove “For broiler and fryer chickens:” and in its place add “Broiler chickens:”; and in the first entry under the “Limitations” column, remove “Do not feed to layers.” and in its place add “Do not feed to chickens producing eggs for food.”

46. Amend § 558.550 as follows:

a. In paragraph (b)(1), remove “054771” and in its place add “016592”;

b. Remove paragraph (b)(2) and redesignate paragraph (b)(3) as paragraph (b)(2);

c. In paragraph (d)(1)(xvi)( c), remove “Chlortetracycline as provided by Nos. 054771 and 069254; salinomycin as provided by Nos. 054771 and 016592 in § 510.600(c) of this chapter.” and in its place add “Chlortetracycline as provided by Nos. 054771 and 069254; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter.”;

d. In paragraph (d)(1)(xx)(C) and (xxi)(C), remove “Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in § 510.600(c) in this chapter.” and in its place add “Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter.”;

e. In paragraph (d)(1)(xxii)(B), remove “Salinomycin as provided by Nos. 016592 and 054771; tylosin phosphate as provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter.” and in its place add “Salinomycin as provided by No. 016592; tylosin phosphate as provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter.”;

f. In paragraph (d)(1)(xxiii)( b), remove “Salinomycin as provided by Nos. 054771 and 016592; bambermycins by No. 016592 in § 510.600(c) of this chapter.” and in its place add “Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.”;

g. In paragraphs (d)(3)(ii)(B), (iii)(B), and (v)(B), remove “Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in § 510.600(c) of this chapter.” and in its place add “Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.”; and

h. In paragraph (d)(4)(i)( b), remove “Salinomycin as provided by Nos. 054771 and 016592; oxytetracycline as provided by No. 066104 in § 510.600(c) of this chapter.” and in its place add “Salinomycin as provided by No. 016592; oxytetracycline as provided by No. 066104 in § 510.600(c) of this chapter.”

47. In § 558.586, in paragraph (b), remove “000859” and in its place add “016592”.