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

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 May and June 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, changes of sponsors' names and addresses, and the voluntary withdrawals of approval of applications.

DATES:

This rule is effective August 29, 2016, except for the amendments to 21 CFR 558.274, 58.355, 58.363, 58.550, 558.625, and 558.630, which are effective September 8, 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 May and June 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 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma EOOD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:

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 May and June 2016, Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 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 NADAs 012-548, 013-162, 013-388, 015-166, 127-507, 141-640, 141-170, and 141-198, and all supplements and amendments thereto, is withdrawn, effective September 8, 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 a drug labeler code in 21 CFR 520.2325a does not accurately reflect the sponsorship of a new animal drug application. At this time, we are amending this section. This action is being taken to improve the accuracy of the regulations.

Also, ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105 has informed FDA that it is changing its name and address to Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138.

Alexion Pharmaceuticals, Inc., 33 Hayden Ave., Lexington, MA 02421 has informed FDA that it has changed its address to 100 College St., New Haven, CT 06510. At this time, this firm is being added to the list of sponsors of approved application in 21 CFR 510.600(c) which we had not done previously.

FDA has noticed that the maximum concentration of sulfadimethoxine with ormetoprim in 2-way, fixed-ratio combination drug Type B medicated feeds in 21 CFR 558.4 was amended in error. At this time, we are revising this section to provide for appropriate concentrations in Type B medicated feeds for salmonids and catfish. 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, 522, and 524

• Animal drugs

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, 21 CFR parts 510, 520, 522, 524, 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), alphabetically add an entry for “Alexion Pharmaceuticals, Inc.”, remove the entry for “ConAgra Pet Products Co.”, and alphabetically add an entry for “Sergeant's Pet Care Products, Inc.”; and in the table in paragraph (c)(2), revise the entry for “021091” and numerically add an entry for “069334”.

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. In § 520.100, remove paragraphs (b)(3) and (4).

5. Redesignate §§ 520.300, 520.300a, 520.300b, and 520.300c as §§ 520.284, 520.284a, 520.284b, and 520.284c.

6. Add § 520.292 to read as follows:

7. In § 520.2075, revise paragraphs (a) and (c) to read as follows:

8. In § 520.2325a, in paragraph (a)(3), remove “053501” and in its place add “054771”.

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. Revise § 522.1055 to read as follows:

11. In § 522.1182, in paragraph (b) introductory text, remove “baby pigs” and in its place add “young piglets”; in paragraph (b)(7) introductory text, remove “000859” and in its place add “016592”; and in paragraphs (b)(7)(i) and (ii), remove “baby pig”.

12. In § 522.1192, in paragraph (b)(2), remove “000859” and in its place add “016592,”.

13. In § 522.1260, in paragraph (b)(2), remove “000859” and in its place add “016592”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

15. In § 524.1044h, revise paragraphs (a) and (b) to read as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

17. In § 558.4, in paragraph (d), in the “Category I” table, in the “Type B maximum (200 ×)” column, in the row entry for “Avilamycin”, remove “3.65 g/lb (0.8%)” and in its place add “7.3 g/lb (1.6%)”; and in the “Category II” table, remove the row entry for “Sulfadimethoxine” and two following row entries for “Ormetoprim”, and in their place add row entries for “Sulfadimethoxine” and “Ormetoprim”.

The additions read as follows:

18. In § 558.68, revise paragraphs (a) and (e) to read as follows:

19. Effective September 8, 2016, in § 558.274, remove and reserve paragraphs (c)(1)(ii) and (c)(2)(ii).

20. Effective September 8, 2016, in § 558.355, remove and reserve paragraph (f)(1)(xxviii) and revise paragraphs (f)(8)(i) and (ii).

The revisions read as follows:

21. Effective September 8, 2016, in § 558.363, remove and reserve paragraph (d)(1)(vi).

22. Effective September 8, 2016, in § 558.550, remove and reserve paragraph (d)(1)(xxii).

23. In § 558.618, in paragraphs (e)(2)(ii) and (iii):

a. In the “Limitations” column, add “Tilmicosin as provided by Nos. 000986 or 016952; monensin as provided by No. 000986 in § 510.600(c) of this chapter.” to the end of the existing entries; and

b. In the “Sponsor” column, numerically add “016952”.

24. Effective September 8, 2016, in § 558.625, revise paragraphs (b)(1), (f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and remove paragraphs (f)(2)(viii) and (ix).

The revisions read as follows:

25. Effective September 8, 2016, in § 558.630, revise paragraph (b)(1) to read as follows: