[Federal Register Volume 73, Number 153 (Thursday, August 7, 2008)]
[Notices]
[Pages 46021-46022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Advisory Committee for Reproductive Health Drugs; 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: Advisory Committee for Reproductive Health 
Drugs.
    General Function of the Committee: To provide advice and 
recommendations to theagency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 8, 2008, from 
8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Rockville, Plaza Ballrooms I and II, 
1750 Rockville Pike, Rockville, MD. The hotel phone number is 301-468-
1100.
    Contact Person: Kalyani Bhatt, 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 301-451-2537. 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 committee will discuss new drug application (NDA) 22-
242, proposed trade name FABLYN (lasofoxifene tartrate) Tablets, 0.5 
milligrams (mg), Pfizer Inc., for the proposed indication of the 
treatment of osteoporosis in postmenopausal women at increased risk of 
fracture.
    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

[[Page 46022]]

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 
August 27, 2008. 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 August 19, 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 August 
20, 2008.
    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 Kalyani Bhatt (301) 
827-7001 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: July 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-18131 Filed 8-6-08; 8:45 am]
BILLING CODE 4160-01-S