Withdrawal of Approval of New Animal Drug Applications; Argent Laboratories; Formalin; Tricaine Methanesulfonate

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of two new animal drug applications (NADAs) held by Argent Laboratories. Withdrawal of approval of these NADAs was at the sponsor's request because the products are no longer manufactured or marketed.

DATES:

This final rule is effective January 27, 2014.

FOR FURTHER INFORMATION CONTACT:

David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6843 david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Argent Laboratories, 8702 152d Ave. NE., Redmond, WA 98052 has requested that FDA withdraw approval of the following two NADAs because the products are no longer manufactured or marketed: NADA 042-427 for FINQUEL (tricaine methanesulfonate) and NADA 140-831 for PARACIDE-F (formalin).

Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 042-427 and 140-831, and all supplements and amendments thereto, is withdrawn. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval.

Following these withdrawals of approval, Argent Laboratories will no longer be the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for this firm.

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 Part 529

• Animal drugs

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 529 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), remove the entry for “Argent Laboratories”; and in the table in paragraph (c)(2), remove the entry for “051212”.

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

4. In § 529.1030:

a. Revise paragraph (b);

b. Remove paragraphs (d)(1)(i) and (d)(1)(ii), and redesignate paragraphs (d)(1)(iii), (d)(1)(iv), and (d)(1)(v) as paragraphs (d)(1)(i), (d)(1)(ii), and (d)(1)(iii);

c. Remove paragraphs (d)(2)(i) and (d)(2)(ii), and redesignate paragraphs (d)(2)(iii), (d)(2)(iv), and (d)(2)(v) as paragraphs (d)(2)(i), (d)(2)(ii), and (d)(2)(iii); and

d. Revise the introductory text in newly designated paragraph (d)(2)(ii), and revise paragraph (d)(2)(iii).

The revisions read as follows:

5. Revise § 529.2503 to read as follows: