[Federal Register Volume 69, Number 122 (Friday, June 25, 2004)]
[Rules and Regulations]
[Pages 35512-35513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14438]


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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; N-
Butylscopolammonium Bromide

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 Boehringer Ingelheim Vetmedica, Inc. The NADA provides 
for the veterinary prescription use of a solution of N-
butylscopolammonium bromide by intravenous injection for the control of 
abdominal pain (colic) associated with spasmodic colic, flatulent 
colic, and simple impactions in horses.

DATES:  This rule is effective June 25, 2004.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-228 for 
the veterinary prescription use of BUSCOPAN (N-butylscopolammonium 
bromide) Injectable Solution by intravenous injection for the control 
of abdominal pain (colic) associated with spasmodic colic, flatulent 
colic, and simple impactions in horses. The NADA is approved as of May 
3, 2004, and 21 CFR part 522 is amended by adding Sec.  522.275 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 May 3, 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 522.275 is added to read as follows:


Sec.  522.275  N-Butylscopolammonium bromide.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) N-butylscopolammonium bromide.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 0.3 mg per kilogram of 
body weight (0.14 mg per pound) slowly intravenously.
    (2) Indications for use. For the control of abdominal pain (colic) 
associated with spasmodic colic, flatulent colic, and simple 
impactions.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


[[Page 35513]]


    Dated: June 14, 2004.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 04-14438 Filed 6-24-04; 8:45 am]
BILLING CODE 4160-01-S