[Federal Register Volume 72, Number 55 (Thursday, March 22, 2007)]
[Notices]
[Pages 13501-13502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5194]


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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 May 1, 2007, from 8 a.m. 
to 5:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD.

[[Page 13502]]

    Contact Person: Teresa 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, FAX: 301-827-6776, e-mail: [email protected], 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: The committee will discuss the efficacy supplement to new 
drug application (NDA) 21-077 for the approved product Advair Diskus 
500/50 (fluticasone propionate/salmeterol inhalation powder) by 
GlaxoSmithKline, for the proposed indication of increased survival and 
reduced exacerbations in patients with chronic obstructive pulmonary 
disease (COPD).
    FDA intends to make background material available to the public no 
later than 1 business day before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2007 and scroll down to the appropriate advisory committee 
link.
    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 on or before 
April 11, 2007. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those desiring to make formal 
oral presentations should notify the contact person 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 
on or before April 3, 2007. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by April 4, 
2007.
    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 Teresa Watkins 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: March 14, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-5194 Filed 3-21-07; 8:45 am]
BILLING CODE 4160-01-S