New Animal Drugs; Approval of New Animal Drug Applications

AGENCY:

Food and Drug Administration, Department of Health and Human Services.

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 October, November, and December 2020. 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 improve the accuracy and readability of the regulations.

DATES:

This rule is effective April 1, 2021.

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. Approvals

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during October, November, and December 2020, 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 office of 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, 240-402-7500. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.

As provided in the regulatory text, the animal drug regulations are amended to reflect these approval actions. As they are now the sponsor of an approved application, QBiotics Group Ltd. and Revivicor, Inc. will be added to the list of sponsors of approved applications in 21 CFR 510.600(c).

II. Technical Amendments

FDA is making the following amendments to improve the accuracy, consistency, and readability of the animal drug regulations:

• 21 CFR 558.128 is amended to reflect the sponsors of approved conditions of use for chlortetracycline in beef cattle.
• 21 CFR 558.342 is amended to reformat special considerations for labeling and manufacture of melengestrol medicated feeds.
• Typographical errors are being corrected wherever they have been found.

III. Legal Authority

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. This 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 the conditions of use of an approved or conditionally approved new animal drug and the name and address of the drug′s sponsor in a “notice, which upon publication shall be effective as a regulation.” A notice published pursuant to section 512(i) is not subject to the notice-and-comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 551 et seq. See section 512(i) of the FD&C Act; 21 CFR 10.40(e)(3); S. Rep. 90-1308, at 5 (1968).

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, 524, and 528

• 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, 21 CFR parts 510, 520, 522, 524, 528, 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:

a. In the table in paragraph (c)(1), add entries for “QBiotics Group Ltd.” and “Revivicor, Inc.” in alphabetical order; and

b. In the table in paragraph (c)(2), add entries for “086132” and “086134” in numerical order.

The additions 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 § 520.292, revise paragraphs (a) and (c) to read as follows:

5. In § 520.522, add paragraph (b)(3) to read as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

7. Add § 522.2450 to read as follows:

8. In § 522.2470, revise paragraphs (b)(1) and (2) to read as follows:

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

10. In § 524.2098:

a. Revise paragraphs (a) and (b);

b. Remove paragraph (c) and redesignate paragraph (d) as paragraph (c); and

c. Revise newly redesignated paragraph (c)(1).

The revisions read as follows:

PART 528—NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

11. The authority citation for part 528 continues to read as follows:

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

12 Add § 528.2001 to read as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

14. In § 558.128, revise paragraph (e)(4)(xv) to read as follows:

15. In § 558.342:

a. Revise paragraphs (d)(3) through (6); and

b. Remove paragraphs (d)(7) and (8).

The revisions read as follows: