New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a 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 July, August, and September 2017. 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 reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name and address, and to make technical amendments to improve the accuracy of the regulations.

DATES:

This rule is effective March 30, 2018, except for amendatory instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR 522.540, and 11 to 21 CFR 522.1081, which are effective April 9, 2018.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (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 July, August, and September 2017, 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 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 Sponsorship

SmartVet USA, Inc., 22201 West Innovation Dr., suite 170A, Olathe, KS 66061-1304 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215:

Following this withdrawal of approval, SmartVet USA, Inc. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)).

Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:

The animal drug regulations are being amended to reflect these changes of sponsorship.

III. Withdrawals of Approval

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:

Following this withdrawal of approval, Watson Laboratories, Inc. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c).

Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is withdrawn, effective April 9, 2018. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.

IV. Technical Amendments

Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248 has informed FDA that it has changed its name and address to Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248. ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115 has informed FDA that it has changed its name to ADM Animal Nutrition, Inc. Accordingly, we are amending § 510.600(c) to reflect these changes.

We are also making technical amendments to update the scientific name of a pathogenic bacterium, to accurately list the concentrations of ingredients in a combination new animal drug, and to correctly list the assay limits and maximum drug concentration in Type B medicated feeds for a combination new animal drug used in feed. These actions are being taken to improve the accuracy of the regulations.

V. Legal Authority

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (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, and 524

• Animal drugs

21 CFR Part 556

• Animal drugs
• Food

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, 524, 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 entries for “ADM Alliance Nutrition, Inc.”, “SmartVet USA, Inc.” and “Western Chemical, Inc.”, and add entries for “ADM Animal Nutrition, Inc.” and “Syndel USA” in alphabetical order; and in the table in paragraph (c)(2), remove the entry for “086001” and revise the entries for “012286” and “050378” to read as follows:

3. Effective April 9, 2018,” in § 510.600, in the table in paragraph (c)(1), remove the entry for “Watson Laboratories, Inc.”; and in the table in paragraph (c)(2), remove the entry for “000402”.

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

5. In § 520.48, in paragraph (b), remove “000061 and 061623” and in its place add “000061, 051072, and 061623”.

6. In § 520.1447, in paragraph (d)(1)(ii), remove “( Taenia pisiformis, Echinococcus multilocularis, and E. granulosus)” and in its place add “(Dipylidium caninum, Taenia pisiformis, Echinococcus multilocularis, and E. granulosus)”.

7. In § 520.2645, revise paragraphs (d)(1) and (2) to read as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

9. Effective April 9, 2018, remove § 522.300.

10. Effective April 9, 2018, in § 522.540, revise paragraphs (b)(2) and (c)(2) to read as follows:

11. Effective April 9, 2018, in § 522.1081, in paragraph (b)(1), remove “Nos. 000402 and 054771” and in its place add “No. 054771”.

12. In § 522.1662a, in paragraph (h)(3)(ii), remove “ Spherophorus necrophorus” and in its place add “Fusobacterium necrophorum”.

13. In § 522.1680, in paragraph (b), remove “054628,”.

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. Add § 524.970 to read as follows:

16. In § 524.1132, revise paragraph (a) to read as follows:

17. In § 524.1193, in paragraph (b)(2), remove “086001” and in its place add “058005”.

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

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

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

19. In § 556.286, in paragraph (c), remove “§§ 522.956 and 522.970” and in its place add “§§ 522.956, 522.970, and 524.970”.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

21. In § 558.4, in paragraph (d), in the “Category II” table, revise the row entries for “Neomycin” through “Pyrantel tartrate” to read as follows:

22. In § 558.128, revise paragraphs (e)(3)(vi), (e)(4)(ix), and (e)(4)(xxvi) to read as follows:

23. In § 558.325, revise paragraph (d)(2) to read as follows:

24. In § 558.575, in paragraph (e)(2)(ii) remove “and bacterial infections due to H. galmaxima,”.