[Federal Register Volume 67, Number 32 (Friday, February 15, 2002)]
[Rules and Regulations]
[Page 7072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3738]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529


Certain Other Dosage Form New Animal Drugs; Albuterol

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 a new animal drug application 
(NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides 
for use of an intranasal aerosol of albuterol sulfate for relief of 
bronchospasm and bronchoconstriction in horses.

DATES: This rule is effective February 15 2002.

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.

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-180 that 
provides for use of TORPEX (albuterol sulfate) Aerosol for the 
immediate relief of bronchospasm and bronchoconstriction associated 
with reversible airway obstruction in horses. The NADA is approved as 
of November 16, 2001, and the regulations are amended in 21 CFR part 
529 by adding Sec. 529.40 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 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 Dockets Management Branch (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 (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval 
qualifies for 5 years of marketing exclusivity beginning November 16, 
2001, because no active ingredient (including any ester or salt of the 
drug) has been previously approved in any other application filed under 
section 512(b)(1) of the act.
    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 529

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
    2. Section 529.40 is added to read as follows:


Sec. 529.40  Albuterol.

    (a) Specifications. A net weight of 6.7 grams of formulated 
albuterol sulfate is supplied in a pressurized aluminum canister within 
an actuator system equipped with a detachable nasal delivery bulb.
    (b) Approvals. See No. 000010 in Sec. 510.600(c) of this chapter 
for uses as in paragraph (d) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Amount. Each valve actuation (puff) of 
the device delivers 120 micrograms (mcg) of albuterol sulfate. One dose 
is three (3) puffs, totaling 360 mcg.
    (2) Indications for use. For the immediate relief of bronchospasm 
and bronchoconstriction associated with reversible airway obstruction 
in horses.
    (3) Limitations. Not for use in horses intended for food.

    Dated: February 4, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-3738 Filed 2-14-02; 8:45 am]
BILLING CODE 4160-01-S