[Federal Register Volume 71, Number 212 (Thursday, November 2, 2006)]
[Rules and Regulations]
[Page 64451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18444]


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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; 
Glycopyrrolate

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 an abbreviated new animal drug 
application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides 
for veterinary prescription use of glycopyrrolate solution as an 
injectable preanesthetic agent in dogs and cats.

DATES: This rule is effective November 2, 2006.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV 104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed ANADA 200-365 that provides 
for veterinary prescription use of Glycopyrrolate Injectable as a 
preanesthetic agent in dogs and cats. IVX Animal Health, Inc.'s 
Glycopyrrolate Injectable is approved as a generic copy of Fort Dodge 
Animal Health's, Division of Wyeth's ROBINUL-V (glycopyrrolate), 
approved under NADA 101-777. The ANADA is approved as of October 2, 
2006, and the regulations are amended in 21 CFR 522.1066 to reflect the 
approval and a current format. 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.
    FDA has determined under 21 CFR 25.33(a)(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. Revise Sec.  522.1066 to read as follows:


Sec.  522.1066  Glycopyrrolate.

    (a) Specifications. Each milliliter of solution contains 0.2 
milligram glycopyrrolate.
    (b) Sponsors. See Nos. 000856 and 059130 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. 5 micrograms 
per pound of body weight (0.25 milliliter per 10 pounds of body weight) 
by intravenous, intramuscular, or subcutaneous injection in dogs or by 
intramuscular injection in cats.
    (2) Indications for use. As a preanesthetic agent.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: October 23, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-18444 Filed 11-1-06; 8:45 am]
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