Document ID: FDA-2009-N-0665-0068
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Insulin - Final Rule
Posted Date: 2009-12-14T05:00Z

[Federal Register: December 14, 2009 (Volume 74, Number 238)]
[Rules and Regulations]               
[Page 66047-66048]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14de09-10]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]

 
Implantation or Injectable Dosage Form New Animal Drugs; Insulin

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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[[Page 66048]]

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: 
melanie.berson@fda.hhs.gov.

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.

0
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. In Sec.  522.1160, revise paragraphs (a), (b), and (c)(2)(i) to read 
as follows:

Sec.  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 Sec.  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.
[FR Doc. E9-29583 Filed 12-11-09; 8:45 am]

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