[Federal Register Volume 73, Number 207 (Friday, October 24, 2008)]
[Notices]
[Pages 63490-63491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee, 
Drug Safety and Risk Management Advisory Committee, and the Pediatric 
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 Committees: Pulmonary-Allergy Drugs Advisory Committee, 
Drug Safety and Risk Management Advisory Committee, and the Pediatric 
Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 10 and 11, 
2008, from 8:30 a.m. to 5 p.m.
    Location: Hilton Washington DC/Rockville, Plaza Ballrooms, 1750 
Rockville Pike, Rockville, MD. The hotel phone number is 301-468-1100.
    Contact Person: Kristine T. Khuc, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5630 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), codes 301-451-2545, 301-451-2535, or 873-
231-0001. Please call the Information Line for up-to-date information 
on this meeting. A notice in the Federal Register about last minute 
modifications that impact a previously announced advisory committee 
meeting cannot always be published quickly enough to provide timely 
notice. Therefore, you should always check the agency's Web site and 
call the appropriate advisory committee hot line/phone line to learn 
about possible modifications before coming to the meeting.
    Agenda: The committees will discuss the benefit risk assessment of 
long acting beta-2 adrenergic agonists for the treatment of asthma in 
adults and children.
    FDA intends to make background material available to the public no 
later than 2 business days 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 2008 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 
November 25, 2008. Oral presentations from the public will be scheduled 
between approximately 9 a.m. to 10 a.m. on December 11, 2008. 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 November 10, 2008. 
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 November 17, 2008.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.

[[Page 63491]]

    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 Kristine T. Khuc at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee 
meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 16, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-25386 Filed 10-23-08; 8:45 am]
BILLING CODE 4160-01-S