New Animal Drugs; Approval of New Animal Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendments.

SUMMARY:

The Food and Drug Administration (FDA) 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 2015. 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 nonsubstantive change. This technical amendment is being made to improve the accuracy of the regulations.

DATES:

This rule is effective September 4, 2015.

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:

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during May and June 2015, 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.

Also, the animal drug regulations are being amended to reflect approved labeling for hand feeding bambermycins medicated cattle feed. This technical amendment is being made 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 Parts 520 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 520, 524, and 558 are amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

2. In § 520.1315, revise paragraph (c)(1) to read as follows:

3. In § 520.1367, in paragraph (b)(2), remove “No. 013744” and in its place add “Nos. 013744 and 055529”.

4. In § 520.1855, revise paragraph (c)(1) to read as follows:

5. In § 520.2598, in paragraph (a), remove “10, 30, or 60 milligrams” and in its place add “5, 10, 30, 60, or 120 milligrams”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

6. The authority citation for 21 CFR part 524 continues to read as follows:

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

7. In § 524.1450, and revise paragraphs (a), (b), and (d), and remove paragraph (e).

The revisions read as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

9. In § 558.95, in the table in paragraph (d)(4)(ii), in the “Bambermycins in grams/ton” column, remove “2 to 40” and in its place add “2 to 80”; and in the “Limitations” column, remove the first sentence and in its place add “Feed continuously on a hand-fed basis at a rate of 10 to 40 milligrams per head per day in 1 to 10 pounds of supplemental Type C medicated feed.”.

10. In § 558.665, revise paragraphs (d)(2) and (e) to read as follows: