SUPPLEMENTARY INFORMATION:

I. Approval Actions

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during November and December 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 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.

Following the conditional approval of NADA 141-175, VetDC, Inc. will now be included in the list of sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)).

II. Change of Sponsorship

ECO LLC, 344 Nassau St., Princeton, NJ 08540 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-600 for WORMX (pyrantel pamoate) Flavored Tablets to Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. The regulations will be amended to reflect this change of sponsorship.

III. Withdrawals of Approval

During November and December 2016, the following sponsors 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, FDA gave notice that approval of NADA 135-773 and ANADA 200-524, and all supplements and amendments thereto, is withdrawn, effective March 13, 2017. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this voluntary withdrawal of approval. Following this withdrawal of approval, neither Baxter Healthcare Corp. nor Hospira, Inc. is the sponsor of an approved application.

IV. Technical Amendments

iVaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155 has informed FDA that it has changed its name to Ivaoes Animal Health. Accordingly, we are amending § 510.600 (c) to reflect this change of sponsor name. We are also making several technical amendments 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.

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, 516, 520, 522, 529, 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. Amend § 510.600 as follows:

a. Effective March 13, 2017, in the table in paragraph (c)(1), remove the entries for “Baxter Healthcare Corp.” and “Hospira, Inc.”;

b. Effective March 1, 2017, in the table in paragraph (c)(1), revise the entry for “iVaoes Animal Health” and alphabetically add an entry for “VetDC, Inc.”;

c. Effective March 13, 2017, in the table in paragraph (c)(2), remove the entries for “000409” and “010019”; and

d. Effective March 1, 2017, in the table in paragraph (c)(2), revise the entry for “086064” and numerically add an entry for “086072”. ( printed page 12169)

The revisions and additions read as follows:

3. The authority citation for part 516 continues to read as follows:

Authority: 360ccc, 360ccc-2, 371.

4. Add § 516.2065 to read as follows:

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

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

6. In § 520.370, in paragraph (c)(2), remove “(group G, -hemolytic)” and in its place add “(group G, beta-hemolytic)”.

7. In § 520.955, revise paragraph (b) to read as follows:

8. Add § 520.1189 to read as follows:

9. In § 520.2041, in paragraph (b), remove “017135, 051311, and 066916” and in its place add “066916, 017135, and 051311”.

10. In § 520.2086, revise paragraph (c)(2) to read as follows:

11. In § 520.2325b, in paragraph (b), remove “050749” and in its place add “016592”.

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

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

13. Effective March 13, 2017, in § 522.313c, in paragraph (b), remove ( printed page 12170) “000409, 054771, and 068330” and in its place add “054771 and 068330”.

14. In § 522.2075, revise paragraph (c) to read as follows:

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

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

16. Effective March 13, 2017, in § 529.1186, in paragraph (b), remove “010019,”.

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 § 558.325, revise paragraph (e)(1)(ii) to read as follows: