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On May 15, 2012, the FDA Blood Products Advisory Committee will meet from 8:30 a.m. to approximately 5:00 p.m. to discuss the evaluation of the safety and effectiveness of the OraQuick In-Home HIV Test.
The meeting will take place at the Hilton Washington DC/North, 620 Perry Pkwy., Gaithersburg, MD, Tel: 1-301-977-8900 .
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Written submissions may be made on or before May 8, 2012 by submitting them to:
Bryan Emery or Rosanna Harvey
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-1277
FAX: 301-827-0294
or via e-mail: Bryan.Emery@fda.hhs.gov or email: Rosanna.Harvey@fda.hhs.gov
Oral presentations at the meeting from the public will be scheduled between approximately 1:30 p.m. and 3:15 p.m. Those individuals interested in making formal oral presentations should notify Bryan Emery or Rosanna Harvey on or before April 30, 2012, 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.
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. Those making a request to speak will be notified regarding their request by May 1, 2012.
For those unable to attend in person, the meeting will also be Webcast.
FDA intends to make background material available to the public on its Web site no later than 2 business days before the meeting. If FDA is unable to post the background material prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and be posted on FDA’s Web site after the meeting.
On May 16, 2012, in the afternoon, the committee will hear update presentations on HHS activities related to the evaluation of the blood donor deferral policy for men who have had sex with other men.
The notice and complete description of the May 15 and May 16 meetings is available on the FDA web site.
Please check the agency’s Web site and call the FDA Advisory Committee Information Line 1-800-741-8138 (301-443-0572 in the Washington, DC, area) code 3014512391 for up-to-date information on this meeting.
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 Bryan Emery or Rosanna Harvey 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 for procedures on public conduct during advisory committee meetings.
There is no cost or registration requirement to attend FDA advisory committee meetings.
Please note that FDA cannot be responsible for providing access to electrical outlets at the meeting.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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