Write to the FDA to support approval facial fillers for HIV lipoatrophy

[Guest guest]

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

General and Plastic Surgery Devices Panel

Date and Time

The meeting will be held on the following dates:Mar 25, 2004 8:00 AM - 5:00 PM

Location

Hilton Washington, DC North/Gaithersburg620 Parkway, Salons A, B, C, and DGaithersburg , MD

Hotel Accommodations

A block of sleeping rooms has been reserved at the Hilton Washington, DC North - Gaithersburg, 620 Parkway, Gaithersburg, MD (phone: ) for arrival on March 24, 2004 and departure on March 25, 2004. Rooms not reserved by March 11, 2004 will be released back to the hotel. Please reference FDA’s General and Plastic Surgery Devices Panel when making your reservation.

Disability Accommodations

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 Shirley Meeks, Conference Management Staff, at , ext. 105, at least 7 days in advance of the meeting. at least 7 days in advance of the meeting.

Contact Information

Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, , ext. 141. Information can be found on the FDA Advisory Committee Information Line, 1- ( in the Washington, DC area), code 3014512519. Please call the Information Line or access this Internet page for up-to-date information on this meeting.

Agenda

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients. Background information for this PMA, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. The material for this meeting will be posted on March 24, 2004.

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 March 11, 2004. On March 25, 2004, oral presentations from the public will be scheduled for approximately one hour at the beginning of committee deliberations and for approximately one hour near the end of the deliberations. Time allotted for oral public presentations may be limited. Those desiring to make formal oral presentations should notify the contact person before March 11, 2004 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.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

VergelDirector, Program for Wellness Restoration (PoWeR)An all volunteer non profit organizationwww.powerusa.org

AIDS is not over. There are 40 million people infected with HIV and 20 million people have died so far while 14,000 people are infected every day. Only 5% of those needing treatment get it. Most PWAs in the world are dying helplessly while rich nations watch. We will be remembered by future generations as the people who allowed greed and profits to be more important than human suffering and lives.