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 July, August, and September 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 January 24, 2020, except for amendatory instruction number 3 to 21 CFR 510.600, number 8 to 21 CFR 520.1807, number 21 to 21 CFR 529.1115, and number 24 to 21 CFR 556.513, which are effective February 3, 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 July, August, and September 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/​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: https://www.fda.gov/​AnimalVeterinary/​Products/​ApprovedAnimalDrugProducts/​default.htm.

II. Changes of Sponsor

The sponsors of the following approved applications have informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor:

Following these changes of sponsorship, American Pharmaceuticals and Cosmetics, Inc.; Aratana Therapeutics, Inc.; and Dragon Fire Holding Co., Inc. are no longer the sponsor of an approved application. Accordingly, the regulations in parts 510, 520, 522, and 524 are being amended to reflect these changes.

III. Change of Sponsor's Address

Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661 has informed FDA that it has changed its address to 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092. Accordingly, we are amending § 510.600(c) to reflect this change.

IV. Withdrawals of Approval

Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234, has requested that FDA withdraw approval of NADA 010-005 for use of WAZINE (dipiperazine sulfate and piperazine hydrochloride) Soluble Powders because the product is no longer manufactured or marketed. Following this withdrawal of approval, Fleming Laboratories, Inc., is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c). In addition, Fleming Laboratories, Inc.'s product was the only piperazine product approved for use in food-producing animals. Accordingly, tolerances for piperazine will be removed from part 556.

Also, Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092, has requested that FDA withdraw approval of ANADA 200-200 for use of Halothane USP (halothane) because the product is no longer manufactured or marketed.

Lastly, Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103, has requested that FDA withdraw approval of ANADA 200-472 for use of Fomepizole Injection because the product is no longer manufactured or marketed.

Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 010-005 and ANADAs 200-200 and 200-472, and all supplements and amendments thereto, is withdrawn effective February 3, 2020. As provided in the regulatory text of this document, the animal drug regulations in parts 510, 520, 556, and 529 are amended to reflect these actions.

V. Technical Amendments

FDA is revising the regulations at 21 CFR 520.2520d to reflect the approved conditions of use of trichlorfon, phenothiazine, and piperazine soluble powder for oral administration to horses as an anthelmintic. This information was deleted in error during redesignation (79 FR 28833, May 20, 2014). FDA is also revising the regulations at 21 CFR 520.2612 to reflect the currently approved dosage for trimethoprim and sulfadiazine suspension for oral administration to horses as an antimicrobial. Lastly, FDA is revising the assay limits for nicarbazin medicated feeds at 21 CFR 558.4(d) in the “Category II” table. These actions are being taken to improve the accuracy of the regulations.

VI. Legal Authority

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (the 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 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

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, 21 CFR parts 510, 520, 522, 524, 529, 556, and 558 are amended as follows:

PART 510—NEW ANIMAL DRUGS

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

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

2. In § 510.600:

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

i. Remove the entries for “American Pharmaceuticals and Cosmetics. Inc.”, “Aratana Therapeutics, Inc.”, and “Dragon Fire Holding Co., Inc.”;

ii. Revise the entry for “Halocarbon Products Corp.”; and

iii. Add an entry in alphabetical order for “Union Agener, Inc.”;

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

i. Revise the entry for “012164”;

ii. Remove the entries for “065531”, “076033”, and “086026”; and

iii. Add an entry in numerical order for “086106”.

The revisions and additions read as follows:

3. Effective February 3, 2020, § 510.600 is further amended, in the table in paragraph (c)(1), remove the entry for “Fleming Laboratories, Inc.”; and in the table in paragraph (c)(2), remove the entry for “015565”.

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

5. In § 520.292, in paragraph (b), remove “086026” and in its place add “058198”.

6. In § 520.304, in paragraph (b)(1), remove “062250, and 076033” and in its place add “and 062250”.

7. In § 520.1286, in paragraph (c)(2), remove “for the treatment of flea infestations” and in its place add “for the treatment and prevention of flea infestations”.

8. Effective February 3, 2020, § 520.1807 is removed.

9. In § 520.2520d, revise the section heading and add paragraph (c) to read as follows:

10. In § 520.2612, revise paragraph (c)(2)(i) to read as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

12. In § 522.90b, in paragraph (b), remove “010515” and in its place add “042791”.

13. In § 522.224, in paragraph (b), remove “086026” and in its place add “058198”.

14. In § 522.460, add paragraph (b)(3), revise paragraphs (c)(1)(ii) and (iii), add paragraph (c)(1)(iv), and revise paragraph (c)(2) to read as follows:

15. Revise § 522.1451 to read as follows:

16. In § 522.2112, in paragraph (b), remove “058198” and in its place add “086106”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

18. In § 524.1044c, in paragraph (b), remove “043264” and in its place add “026637”.

19. In § 524.1044f, in paragraph (b), remove “058829, and 065531” and in its place add “and 058829”.

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

21. Effective February 3, 2020, in § 529.1115, in paragraph (b), remove “Nos. 012164 and 054771” and in its place add “No. 054771”.

22. In § 529.1150, revise paragraph (c) to read as follows:

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

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

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

24. Effective February 3, 2020, § 556.513 is removed.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

26. In § 558.4, in paragraph (d), revise the entry for “Nicarbazin (powder)” to read as follows:

27. In § 558.68, revise paragraphs (e)(1)(ii), (iii), and (v) to read as follows:

28. In § 558.355, revise paragraphs (b) and (f)(6)(i) to read as follows:

29. Amend § 558.625:

a. By removing “monensin as provided by No. 058198” and adding in its place “monensin as provided by Nos. 016592 or 058198” in the “Limitations” column, in:

1. Paragraph (e)(2)(iv),

2. Paragraph (e)(2)(v),

3. Paragraph (e)(2)(x),

4. Paragraph (e)(2)(xi),

5. Paragraph (e)(2)(xii), and

6. Paragraph (e)(2)(xiii); and

b. By adding “016592” in numerical order in the “Sponsors” column in:

1. Paragraph (e)(2)(x),

2. Paragraph (e)(2)(xi),

3. Paragraph (e)(2)(xii), and

4. Paragraph (e)(2)(xiii).