[Federal Register Volume 69, Number 90 (Monday, May 10, 2004)]
[Rules and Regulations]
[Pages 25827-25828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; Insulin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Intervet, Inc. The NADA provides for the veterinary 
prescription use of an injectable suspension of zinc insulin of porcine 
origin for the reduction of hyperglycemia and hyperglycemia-associated 
clinical signs in dogs with diabetes mellitus.

DATES: This rule is effective May 10, 2004.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 405 State St., 
Millsboro, DE 19966, filed NADA 141-236 for the veterinary prescription 
use of VETSULIN (porcine zinc insulin) Suspension for the reduction of 
hyperglycemia and hyperglycemia-associated clinical signs in dogs with 
diabetes mellitus. The NADA is approved as of April 1, 2004, and the 
regulations are amended in part 522 (21 CFR part 522) by adding Sec.  
522.1160 to reflect the approval. The basis of approval is discussed in 
the freedom of information summary.
    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.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning April 1, 2004.
    The agency has determined under 21 CFR 25.33(d)(1) 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.

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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

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

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

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2. Section 522.1160 is added to read as follows:


Sec.  522.1160  Insulin.

    (a) Specifications. Each milliliter of porcine zinc insulin 
suspension

[[Page 25828]]

contains 40 international units (IU) of insulin.
    (b) Sponsor. See No. 057926 in Sec.  510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. (i) Administer by 
subcutaneous injection. An initial once-daily dose, administered by 
subcutaneous injection concurrently with or right after a meal, is 
calculated as follows:

------------------------------------------------------------------------
            Body Weight                          Initial Dose
------------------------------------------------------------------------
<10 kg\1\ (<22 lb\2\)                1 IU/kg + 1 IU
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10 to 11 kg (22 to 24 lb)            1 IU/kg + 2 IU
------------------------------------------------------------------------
12 to 20 kg (25 to 44 lb)            1 IU/kg + 3 IU
------------------------------------------------------------------------
>20 kg (>44 lb)                      1 IU/kg + 4 IU
------------------------------------------------------------------------
\1\ kg means kilograms.
\2\ lb means pounds.

    (ii) Adjust the once-daily dose described in paragraph (c)(1)(i) of 
this section at appropriate intervals based on clinical signs, 
urinalysis results, and glucose curve/spot check values until adequate 
glycemic control has been attained. Twice-daily therapy should be 
initiated if the duration of insulin action is determined to be 
inadequate. If twice-daily treatment is initiated, the two doses should 
be 25 percent less than the once daily dose required to attain an 
acceptable nadir.
    (2) Indications for use. For the reduction of hyperglycemia and 
hyperglycemia-associated clinical signs in dogs with diabetes mellitus.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: April 23, 2004.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 04-10498 Filed 5-7-04; 8:45 am]
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