[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Page 24605-24606]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Pulmonary-Allergy Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 13 and 14, 2005, 
from 8 a.m. to 5:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Teresa A. Watkins, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 
301-827-7001, e-mail: watkinst@cder.fda.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512545. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On July 13, 2005, the committee will discuss the 

[[Page 24606]]

of recently available data related to the safety of long-acting beta-
agonist bronchodilators. On July 14, 2005, the committee will discuss 
the continued need for the essential use designations of prescription 
drugs for the treatment of asthma and chronic obstructive pulmonary 
disease under 21 CFR 2.125.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by July 1, 2005. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on July 13, 2005, and between 
approximately 11 a.m. and 12 noon on July 14, 2005. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 1, 2005, and 
submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact La'Nise Giles at 
301-827-7001 at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 29, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-9229 Filed 5-9-05; 8:45 am]