New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Name and Address

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 April, May, and June 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 October 7, 2019.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (CVM) (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 April, May, and June 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. Change of Sponsor's Names and Addresses

Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 85258 has informed FDA that it has changed its name and address to Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. Accordingly, we are amending § 510.600(c) to reflect these changes.

III. Technical Amendments

A section describing tolerances of hetacillin residues (21 CFR 556.316) has been added to subpart B of part 556. This section cross-references the sole hetacillin product approved for use in food-producing animals, an intramammary infusion for use in lactating dairy cows (21 CFR 526.1130). This new section codifies FDA's finding at the time of product approval that, because hetacillin is rapidly hydrolyzed to ampicillin, existing ampicillin tolerances provide appropriate tolerances for hetacillin in edible tissues of cattle (38 FR 31172, November 12, 1973). This amendment is being made to make the regulations more comprehensive.

FDA is also revising the regulations to reflect the approved conditions of use of sulfaquinoxaline soluble powder as a veterinary prescription product for oral administration to cattle as a drench. Finally, we are also revising the regulations for use of monensin in medicated goat feed to reflect the approved incorporation level. These actions are being taken to improve the accuracy of the regulations.

IV. 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, 526, and 529

• 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, 21 CFR parts 510, 520, 522, 526, 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, in the table in paragraph (c)(1), remove the entry for “Medicis Dermatologics, Inc.” and add an entry in alphabetic order for “Bausch Health US, LLC”; and in the table in paragraph (c)(2), revise the entry for “099207”.

The addition and revision read as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

4. In § 520.812, in paragraph (a)(1)(i), remove “2.7” and in its place add “22.7”.

5. In § 520.2325b, revise paragraph (d)(3) to read as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

7. In § 522.313b, revise paragraphs (a)(2) and (e)(1)(iii) to read as follows:

8. In § 522.812, revise paragraphs (b)(1) and (2) to read as follows:

PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

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

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

10. In § 526.1130, revise the section heading, redesignate paragraph (c) as paragraph (d), and add new paragraph (c).

The revision and addition read as follows:

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

12. In § 529.1030, revise paragraph (b) and add paragraphs (d)(1)(iv) and (d)(2)(iv) to read as follows:

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

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

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

14. Add § 556.316 to read as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

16. In § 558.4, in paragraph (d), in the “Category II” table, revise the row entry for “Tilmicosin” to read as follows:

17. In § 558.330, revise paragraph (d) to read as follows:

18. In § 558.355, in paragraph (f)(6)(i), in the “Monensin in grams/ton” column, remove “5 to 40” and in its place add “20”; and redesignate paragraphs (f)(7)(iv) through (xi) as paragraphs (f)(7)(v) through (xii) and add new paragraph (f)(7)(iv).

The addition reads as follows:

19. In § 558.625, redesignate paragraphs (e)(2)(vii) through (xv) as paragraphs (e)(2)(ix) through (xvii), and add new paragraphs (e)(2)(vii) and (viii).

The additions read as follows: