E9-29583. Implantation or Injectable Dosage Form New Animal Drugs; Insulin

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 of an original new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for veterinary prescription use of an injectable suspension of protamine zinc recombinant human insulin for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.

DATES:

This rule is effective December 14, 2009.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-297 that provides for the veterinary prescription use of PROZINC (protamine zinc recombinant human insulin), an injectable suspension for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus. The NADA is approved as of October 28, 2009, and the regulations are amended in 21 CFR 522.1160 to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application 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.

The agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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 in 21 CFR Part 522

• Animal drugs

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 part 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

2. In § 522.1160, revise paragraphs (a), (b), and (c)(2)(i) to read as follows:

§ 522.1160

Insulin.

(a) Specifications—(1) Each milliliter (mL) of porcine insulin zinc suspension contains 40 international units (IU) of insulin.

(2) Each mL of protamine zinc recombinant human insulin suspension contains 40 IU of insulin.

(b) Sponsors. See sponsors in § 510.600 of this chapter for use as in paragraph (c) of this section.

(1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1), (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of this section.

(2) No. 000010 for use of product described in paragraph (a)(2) of this section as in paragraphs (c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii) of this section.

(c) * * *

(2) Cats—(i) Amount—(A) Porcine insulin zinc. Administer an initial dose of 1 to 2 IU by subcutaneous injection. Injections should be given twice daily at approximately 12-hour intervals. For cats fed twice daily, the injections should be concurrent with or right after a meal. For cats fed ad libitum, no change in feeding is needed. Adjust the dose at appropriate intervals based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained.

(B) Protamine zinc recombinant human insulin. Administer an initial dose of 0.1 to 0.3 IU/pound of body weight (0.2 to 0.7 IU/kilogram) every 12 hours. The dose should be given concurrently with or right after a meal. Re-evaluate the cat at appropriate intervals and adjust the dose based on both clinical signs and glucose nadirs until adequate glycemic control has been attained.

Dated: December 8, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.