AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendments.

SUMMARY:

The Food and Drug Administration (FDA or 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 October, November, and December 2019. FDA is 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 make technical amendments to improve the accuracy of the regulations.

DATES:

This rule is effective March 30, 2020.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 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 October, November, and December 2019, 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 office of the Dockets Management Staff (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: https://www.fda.gov/​about-fda/​center-veterinary-medicine/​cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/​animal-veterinary/​products/​approved-animal-drug-products-green-book.

II. Withdrawals of Approval

Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland, has requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:

Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 055-036, 055-050, 055-056, 055-061, 055-068, 065-013, 065-493, and 065-500, and all supplements and amendments thereto, is withdrawn, effective March 30, 2020. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.

III. Changes of Sponsor

Cooperative Research Farms, Box 69, Charlotteville, NY 12036, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 119-253 for Cattle Block M (monensin) a free-choice Type C medicated cattle feed to Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616. Following this change of sponsorship, Cooperative Research Farms is no longer the sponsor of an approved application.

Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom, has informed FDA that it has transferred ownership of, and all rights and interest in, approved ANADA 200-273 for VETRO-GEN Veterinary Ophthalmic Ointment to Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101.

Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 141-472 for virginiamycin and diclazuril Type C medicated feed to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.

Accordingly, we are amending the regulations to reflect these changes.

IV. Change of Sponsors' Name and Addresses

Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101, has informed FDA that it has changed its name and address to Dechra Veterinary Products LLC, 7015 College Blvd., suite 525, Overland Park, KS 66211. In addition, Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 has informed FDA that it has changed its address to PO Box 162059, Fort Worth, TX 76161. Accordingly, we are amending § 510.600(c) (21 CFR 510.600(c)) to reflect these changes.

V. Technical Amendments

FDA is making the following amendments to improve the readability and accuracy of the animal drug regulations:

• The contact information in 21 CFR 500.1410, which provides for the incorporation by reference of the residue assay method for n-methyl-2-pyrrolidone, is being updated.
• We are removing entries for “Strategic Veterinary Pharmaceuticals, Inc.” from the lists of sponsors of approved applications in § 510.600(c) and the drug labeler code for KC Pharmacal from 21 CFR 520.260.
• The indications for use of oxytetracycline soluble powder in honey bees at 21 CFR 520.1660d are amended to reflect current labeling.
• The single section for euthanasia injectable solutions at 21 CFR 522.900 is being removed and separate sections for the active pharmaceutical ingredients are added at 21 CFR 522.1697 and 522.2092.
• The section heading in 21 CFR 524.1742 for “N-(Mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate) emulsifiable liquid” is amended to read “Phosmet emulsifiable liquid”.
• The entries in 21 CFR parts 556 and 558 for coumaphos for which approval of the last approved application was withdrawn in 2018 (83 FR 48940, September 28, 2018) are being removed.
• The entries in part 556 (21 CFR part 556) are being removed for tolerances of residues of erythromycin in swine tissues, of virginiamycin in turkey tissues, and of new animal drugs for which approval of their applications has been withdrawn.
• Cross-references to related approved uses of new animal drugs in part 556 and to related tolerances for drugs approved for use in food-producing animals in 21 CFR parts 520, 522, 524, and 558 are being corrected.
• A redundant cross-reference for related tolerances in 21 CFR 558.355 for use of monensin in medicated feeds is being removed and reserved.
• The acceptable daily intake of total residues of ivermectin and tolerances for residues of ivermectin in cattle liver and muscle in § 556.344 are being corrected.
• The acceptable daily intake of total residues of tildipirosin in § 556.733 is being corrected.
• The regulations in 21 CFR 520.2260b for sulfamethazine sustained-release boluses and in 21 CFR 522.1662a for oxytetracycline hydrochloride injection are being reformatted to present the tolerance cross-reference in a consistent location.
• Typographical errors are being corrected wherever they have been found.

VI. Legal Authority

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires Federal Register publication of “notice[s] . . . effective as a regulation,” of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities.

Although denominated a rule pursuant to the FD&C Act, this document 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. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

List of Subjects

21 CFR Part 500

• Animal drugs
• Animal feeds
• Cancer
• Incorporation by reference
• Labeling
• Packaging and containers
• Polychlorinated biphenyls (PCBs)

21 CFR Parts 520, 522, 524, and 526

• 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, 21 CFR parts 500, 510, 520, 522, 524, 526, 556, and 558 are amended as follows:

PART 500—GENERAL

1. The authority citation for part 500 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371, 379e.

2. In § 500.1410, revise paragraph (a) to read as follows:

PART 510—NEW ANIMAL DRUGS

3. The authority citation for part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

4. In § 510.600:

a. In the table in paragraph (c)(1):

i. Remove the entry for “Cooperative Research Farms”;

ii. Add entries for “Dechra Veterinary Products LLC” and “Mizner Bioscience LLC” in alphabetical order;

iii. Remove the entries for “Putney, Inc.” and “Strategic Veterinary Pharmaceuticals, Inc.”;

iv. Revise the entry for “Virbac AH, Inc.”; and

v. Add an entry for “Wildcat Feeds” in alphabetical order; and

b. In the table in paragraph (c)(2):

i. Revise the entry for “026637”;

ii. Remove the entry for “051267”;

iii. Revise the entry for “051311”;

iv. Remove the entry for “054628”; and

v. Add entries for “086039” and “086113” in numerical order.

The revisions and additions read as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

6. In § 520.88c(c), remove “§ 556.510” and in its place add “§ 556.38”.

7. Redesignate §§ 520.90b and 520.90c as §§ 520.90a and 520.90b.

8. Remove §§ 520.90d and 520.90e.

9. Redesignate § 520.90f as § 520.90c and in newly redesignated § 520.90c, revise paragraphs (b) and (d) to read as follows:

10. In § 520.260(b)(2), remove “No. 038782 for 884 or 1,768 milligram or 4.42 gram capsules;”.

11. In § 520.455(b), remove “No. 058198” and in its place add “Nos. 058198 and 086039”.

12. Redesignate §§ 520.903d and 520.903e as §§ 520.903c and 520.903d.

13. Redesignate § 520.1263c as § 520.1263b.

14. Revise § 520.1286 to read as follows:

15. In § 520.1660d, revise paragraph (d)(2)(ii) to read as follows:

16. Redesignate §§ 520.1696b, 520.1696c, and 520.1696d as §§ 520.1696a, 520.1696b, and 520.1696c.

17. In § 520.2218(c), remove “§§ 556.670 and 556.685” and in its place add “§§ 556.660, 556.670, and 556.685”.

18. In § 520.2260b, redesignate paragraphs (a) through (f) and (g) as paragraphs (b) through (g) and (a), respectively.

19. In § 520.2455, add paragraph (b)(4) 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. In § 522.650, revise paragraph (b) to read as follows:

22. Add § 522.728 to read as follows:

23. Remove § 522.900.

24. In § 522.1367(c)(1)(i), remove “§ 520.1350(c)” and in its place add “§ 520.1367(c)”.

25. In § 522.1662a:

a. Redesignate paragraphs (a) through (e) as paragraphs (b) through (f);

b. Further redesignate newly redesignated paragraphs (c)(3)(i)( a) through (c) and (c)(3)(ii)(a) through (c) as paragraphs (c)(3)(i)(A) through (C) and (c)(3)(ii)(A) through (C), respectively;

c. Further redesignate newly redesignated paragraphs (e)(3)(i)( a) through (c) as paragraphs (e)(3)(i)(A) through (C);

d. Further redesignate newly redesignated paragraphs (e)(3)(ii)( a) and (b) and paragraphs (e)(3)(ii)(A) and (B);

e. Further redesignate newly redesignated paragraphs (e)(3)(iii)( a) through (c) as paragraphs (e)(3)(iii)(A) through (C);

f. In newly redesignated paragraph (e)(3)(iii)(C), remove “paragraph (d)(3)(iii)( c) of this section” and in its place add “this paragraph (e)(3)(iii)(C)”;

g. Further redesignate newly redesignated paragraphs (f)(3)(i)( a) through (c) and (f)(3)(ii)(a) through (c) as paragraphs (f)(3)(i)(A) through (C) and (f)(3)(ii)(A) through (C), respectively;

h. Redesignate paragraphs (g)(3)(i)( a) through (c) and (g)(3)(ii)(a) through (c) as paragraphs (g)(3)(i)(A) through (C) and (g)(3)(ii)(A) through (C), respectively; and

i. Redesignate paragraph (k) as paragraph (j) and paragraph (l) as paragraph (a).

26. In § 522.1696a(b)(1) and (2) and (d)(2)(iii), remove “, 055529,”.

27. In § 522.1696b:

a. In paragraph (b)(1), remove “016592, 054771, and 055529” and in its place add “016592 and 054771”;

b. Remove paragraphs (d)(2)(i)(A) and (B); and

c. In paragraph (d)(2)(iii)(B), remove “Nos. 000859 and 055529” and in its place add “No. 016592”.

28. Add § 522.1697 to read as follows:

29. Add § 522.2092 to read as follows:

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

31. Add an undesignated center heading before § 524.981 to read as follows:

Fluocinolone Topical and Otic Dosage Forms

32. Add § 524.1001 to read as follows:

33. In § 524.1146, revise paragraphs (a) and (b) to read as follows:

34. In § 524.1742:

a. Revise the section heading;

b. Redesignate paragraphs (c) and (d) as paragraphs (d) and (c), respectively;

c. Add a heading for the table in newly redesignated paragraph (d)(1) introductory text; and

d. Further redesignate newly redesignated paragraphs (d)(1)(i)( a) and (b) as paragraphs (d)(1)(i)(A) and (B).

The revision and addition reads as follows:

35. In § 524.2098(b), remove “054771” and in its place add “Nos. 054771 and 055529”.

PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

36. The authority citation for part 526 continues to read as follows:

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

37. Remove § 526.464b.

38. Redesignate § 526.464c as § 526.464b.

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 § 556.40(c), remove “§§ 520.90e, 520.90f, 522.90a, and 522.90b” and in its place add “§§ 520.90c, 522.90a, and 522.90b”.

41. In § 556.165(c), remove “§§ 526.464a, 526.464b, and 526.464c” and in its place add “§§ 526.464a and 526.464b”.

42. Remove § 556.168.

43. In § 556.230, remove paragraph (b)(3).

44. In § 556.304(c), remove “§§ 522.1077, 522.1079, and 522.1081” and in its place add “§§ 522.1079 and 522.1081”.

45. In § 556.344:

a. In paragraph (a), remove “1 μg/kg” and in its place add “5 μg/kg”;

b. In paragraph (b)(2)(i), remove “100 ppb” and in its place add “1.6 ppm”; and

c. In paragraph (b)(2)(ii), remove “10 ppb” and in its place add “650 ppb”.

46. In § 556.360, add paragraph (b)(3) and revise paragraph (c) to read as follows:

47. In § 556.500, add paragraph (b)(6) to read as follows:

48. In § 556.510(c), remove “520.1696b” and in its place add “520.1696a”.

49. In § 556.660(c), remove “§ 558.582” and in its place add “§§ 520.2218 and 558.582”.

50. In § 556.670, in paragraph (c), remove “§§ 520.2260a, 520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 558.630” and in its place add “§§ 520.2218, 520.2260a, 520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 558.630”.

51. In § 556.685(c), remove “§§ 520.2325a, 520.2325b, and 558.586” and in its place add “§§ 520.2218, 520.2325a, 520.2325b, and 558.586”.

52. In § 556.733(a), remove “10 μg/kg” and in its place add “50 μg/kg”.

53. In § 556.746, add paragraph (b)(4) to read as follows:

54. In § 556.750, remove paragraph (b)(4).

55. In § 556.765, revise paragraph (b)(1) to read as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

57. In § 558.55, add paragraph (d)(5) to read as follows:

58. In § 558.76, revise paragraphs (e)(2)(vii), (viii), and (xi) to read as follows:

59. Remove § 558.185.

60. In § 558.195, revise paragraph (e)(2)(ii) to read as follows:

61. In § 558.342, revise paragraph (e)(1)(iv) to read as follows:

62. In § 558.355, remove and reserve paragraph (e) and revise paragraph (f)(4)(iv) to read as follows:

63. In § 558.500, revise paragraph (e)(2) to read as follows:

64. In § 558.618, revise paragraphs (e)(2)(ii) and (iii) to read as follows:

65. In § 558.625, revise paragraphs (e)(2)(vi) and (ix) to read as follows:

66. In § 558.635, revise paragraph (e)(1)(iv) to read as follows: