New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib; Sulfadimethoxine; Change of Sponsor; Change of Sponsor's Address

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2013. 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 a change of sponsorship of an NADA and a change to a sponsor's address.

DATES:

This rule is effective February 27, 2014.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during December 2013, 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 Center for Veterinary Medicine FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.

In addition, West Agro, Inc., 11100 North Congress Ave., Kansas City, MO 64153 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 055-028 for QUARTERMASTER (penicillin G procaine and dihydrostreptomycin sulfate) Dry Cow Treatment to HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, Paramus, NJ 07652. Following this change of sponsorship, West Agro, Inc., is no longer a sponsor of an approved NADA, and HQ Specialty Pharma Corp. is now the sponsor of an approved NADA. Also, Putney, Inc., 400 Congress St., Suite 200, Portland, ME 04101 has informed FDA of a change of address to One Monument Sq., Suite 400, Portland, ME 04101. Accordingly, the Agency is amending the regulations to reflect this change of sponsorship and change of sponsor's address.

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, 526, and 529

• 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, 526, 529, and 558 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR 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 “HQ Specialty Pharma Corp.”, revise the entry for “Putney, Inc.”, and remove the entry for “West Agro, Inc.”; and in the table in paragraph (c)(2), revise the entry for “026637”, remove the entry for “033392”, and numerically add an entry for “042791” to read as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 520 continues to read as follows:

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

4. In § 520.1195, revise paragraphs (b)(1) and (b)(2) to read as follows:

5. In § 520.2075, in paragraph (c)(2), remove “at least 6 months of age” and in its place add “at least 4 months of age”.

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

6. The authority citation for 21 CFR part 522 continues to read as follows:

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

7. In § 522.2220, revise paragraphs (a)(1), (a)(2), and (a)(3)(iii) to read as follows:

PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

8. The authority citation for 21 CFR part 526 continues to read as follows:

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

9. In paragraph (b) of § 526.1696c, remove “033392” and in its place add “042791”.

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

10. The authority citation for 21 CFR part 529 continues to read as follows:

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

11. In § 529.1940, in paragraphs (b) and (e)(1)(iii), remove “000009” and in its place add “054771”; in paragraph (c), remove “§ 556.540(a)” and in its place add “§ 556.540”; and add paragraph (e)(1)(ii)(D) to read as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

12. The authority citation for 21 CFR part 558 continues to read as follows:

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

13. In paragraph (d)(5) of § 558.95, redesignate paragraphs (d)(5)(iii) through (d)(5)(x) as paragraphs (d)(5)(iv) through (d)(5)(xi); and add new paragraph (d)(5)(iii) to read as follows:

14. In § 558.175:

a. Redesignate paragraph (d)(9) as paragraph (d)(11).

b. Redesignate paragraphs (d)(5) through (d)(8) as paragraphs (d)(6) through (d)(9).

c. Add new paragraphs (d)(5) and (d)(10).

The additions read as follows: