May 15-16, 2012
May 15 from 8:30 a.m. to approximately 5:00 p.m.
Hilton Washington DC/North,
On May 15, 2012, the committee will discuss as a device panel the evaluation of the safety and effectiveness of the OraQuick In-Home HIV Test. On May 16, 2012, the committee will discuss the evaluation of possible new plasma products frozen following in-process storage at room temperature for up to 24 hours, namely plasma for transfusion prepared from Whole Blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing. In the afternoon, the committee will hear update presentations on the following topics: HHS activities related to the evaluation of the donor deferral policy for men who have had sex with other men; a summary of the November 8-9, 2011, public workshop on hemoglobin standards and maintaining an adequate blood supply; and a summary of the November 29, 2011, public workshop on data and data needs to advance risk assessment for emerging infectious diseases for blood and blood products.
Background material is available on the website.
Public Participation Information
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 May 8, 2012
- Oral presentations on May 15, 2012 from the public will be scheduled between approximately 1:30 p.m. and 3:15 p.m. Oral presentations on May 16, 2012 from the public will be scheduled between 11:30 a.m. and 12:45 p.m. Those individuals interested in making 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 30, 2012. 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 May 1, 2012.
- For those unable to attend in person, the meeting will also be Webcast.
- Bryan Emery or Rosanna Harvey
1401 Rockville Pike, HFM-71, Rockville, MD 20852
e-mail: Bryan.Emery@fda.hhs.gov or email: Rosanna.Harvey@fda.hhs.gov
- FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington, DC, area)
code 3014512391. Please call the Information Line for up-to-date information on this meeting.
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.
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.
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 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.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).