New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of 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 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 March and April 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 and the voluntary withdrawals of approval of applications that occurred in January and February.

DATES:

This rule is effective June 8, 2016 except for the amendments to 21 CFR 520.1696b, 520.2325a, 520.2261a, 558.248, and 558.625, which are effective June 20, 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 March and April 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.

II. Changes of Sponsorship

Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 (Bayer) has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:

Bayer has also transferred sponsorship of NADA 141-070 for RAPINOVET (propofol) Injectable Emulsion to iVaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship.

III. Withdrawals of Approval

In addition, during March and April 2016, the following two sponsors have requested that FDA withdraw approval of the NADAs and ANADAs 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 007-076, 008-244, 041-955, 049-729, 100-128, and ANADA 200-307, and all supplements and amendments thereto, is withdrawn, effective June 20, 2016. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval.

IV. Technical Amendments

FDA has noticed that the section heading for 21 CFR 520.1430 does not accurately reflect the new animal drug for which approved conditions of use are codified. At this time, we are amending the section heading to read “Mibolerone” rather than “Megestrol acetate tablets.” 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 Part 510

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

21 CFR Parts 520 and 522

• 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, parts 510, 520, 522, 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), alphabetically add entries for “Aratana Therapeutics, Inc.” and “iVaoes Animal Health” and revise entry for “Huvepharma AD;” and

b. In the table in paragraph (c)(2), revise the entry for “016592” and numerically add entries for “086026” and “086064.”

The additions and revisions 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. Add § 520.1084 to read as follows:

5. Revise the heading of § 520.1430 to read as follows:

6. Effective June 20, 2016, in § 520.1696b, in paragraph (b), remove “059320,”.

7. Effective June 20, 2016, in § 520.2261a, in paragraph (b), remove “Nos. 016592 and 061623” and in its place add “No. 016592”.

8. Effective June 20, 2016, in § 520.2325a, remove paragraph (a)(2) and redesignate paragraphs (a)(3) and (4) as paragraphs (a)(2) and (3).

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

10. In § 522.690, in paragraph (b)(3), remove “000859” and in its place add “061623”.

11. In § 522.1077, in paragraph (b)(3), remove “000859 and 050604” and in its place add “050604 and 061623”.

12. In § 522.1680, in paragraph (b), remove “000859”.

13. Add § 522.1684 to read as follows:

14. In § 522.2005, in paragraph (b)(1), remove “000859” and in its place add “086064”.

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

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

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

16. In § 556.748, revise paragraph (c) to read as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

18. In § 558.4, in paragraph (d), in the “Category I” table, add an entry in alphabetical order for “Tylvalosin” to read as follows:

19. Effective June 20, 2016, in § 558.248, revise paragraphs (a) and (b) and remove and reserve paragraph (d)(1)(iii).

The revisions read as follows:

20. Effective June 20, 2016, in § 558.625, remove paragraph (b)(3) and redesignate paragraphs (b)(4) and (5) as paragraphs (b)(3) and (4).

21. Add § 558.633 to read as follows: