[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Notices]
[Page 24605-24606]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-94]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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
implications
[[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
outlets.
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]
BILLING CODE 4160-01-S