SUPPLEMENTARY INFORMATION:

I. Approval Actions

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during September and October 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., ( printed page 11507) 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. Change of Sponsorship

Sogeval S. A., 200 Avenue de Mayenne, 53000 Laval, France has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France:

Following these changes of sponsorship, Sogeval S. A. is no longer the sponsor of an approved NADA. Accordingly, the firm's name, address, and drug labeler code are being removed from § 510.600(c) (21 CFR 510.600(c)).

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 applications to Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509:

Following these changes of sponsorship, Kinetic Technologies, LLC is now the sponsor of an approved NADA. Accordingly, the firm's name, address, and drug labeler code are being added to § 510.600(c).

III. Withdrawals of Approval

In addition, Putney, Inc., One Monument Square, Suite 400, Portland, ME 04101 has requested that FDA withdraw approval of ANADA 200-524 for Mupirocin Ointment 2% because the product is no longer manufactured or marketed.

Elsewhere in this issue of the Federal Register , FDA gave notice that approval of ANADA 200-524, and all supplements and amendments thereto, is withdrawn, effective March 6, 2017. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this voluntary withdrawal of approval.

IV. Technical Amendments

Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort Collins, CO 80524 has informed FDA that it has changed its address to 1230 W. Ash St., Suite D, Windsor, CO 80550. In addition, FDA has noticed that a sponsor name in § 510.600 does not reflect the particular punctuation used in this sponsor's applications and other correspondence. At this time, we are amending the list of sponsors of approved applications in § 510.600(c) to reflect this change of sponsor address and sponsor's punctuation.

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.

( printed page 11508)

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 510, 520, 522, 524, and 558 are amended as follows:

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. Revise § 510.600 as follows:

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

i. In the entry for “Elanco US, Inc.”, remove “Elanco US, Inc.” and in its place add “Elanco US Inc.”;

ii. Alphabetically add an entry for “Kinetic Technologies, LLC”;

iii. Remove the entry for “Sogeval S. A.”; and

iv. Revise the entry for “Wildlife Laboratories, Inc.”

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

i. Numerically add an entry for “051031”;

ii. Revise the entry for “053923”

iii. In the entry for “058198”, remove “Elanco US, Inc.” and in its place add “Elanco US Inc.”; and

iv. Remove the entry for “059120”.

The additions and revisions read as follows:

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

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

4. In § 520.88g, in paragraph (b), remove “No. 054771” and in its place add “Nos. 026637 and 054771”.

5. In § 520.540c, in paragraph (b), remove “054771” and in its place add “051031”.

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

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

7. In § 522.540, in paragraph (d)(2)(i), remove “054771” and in its place add “051031”.

8. In § 522.1055, in paragraph (b), remove “059120” and in its place add “013744”.

9. In § 522.1182, in paragraph (b)(3), remove “059120” and in its place add “013744”.

10. In § 522.1380, in paragraph (b), remove “054771” and in its place add “051031”.

11. In § 522.2615, in paragraph (b), remove “054771” and in its place add “051031”.

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

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

13. In § 524.1005, in paragraph (b)(1), remove “054771” and in its place add “051031”.

14. Effective March 6, 2017, in § 524.1465, in paragraph (b), remove “026637”.

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

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

( printed page 11509)

16. In § 558.68, revise paragraph (e)(1)(ii) to read as follows: