|CBER||December 2, 2014 and December 3, 2014||December 2, 2014 from 8:30 a.m. to approximately 4:30 p.m. and December 3, 2014 from 8:30 a.m. to 12:30 p.m.||10903 New Hampshire Avenue., Building 31 Conference Center, The Great Room, room 1503. Silver Spring, MD 20993-0002|
Updated 11/14/2014: Updated the agendas for the meeting.
Updated 11/05/2014: Added the agenda for the December 3, 2014 meeting.
On December 2, 2014, the Committee will meet in open session to hear scientific data related to reconsideration of the current blood donor deferral policy for men who have had sex with another man (MSM) even one time since 1977. The Committee will be presented with an update on the November 13, 2014, meeting of the U.S. Department of Health and Human Services Advisory Committee on Blood and Tissue Safety and Availability where the MSM blood donor deferral policy will be discussed. In the afternoon, the Committee will hear an informational presentation on Ebola virus, the potential implications for blood safety in the United States and FDA’s considerations on the collection of convalescent plasma for investigational use.
On December 3, 2014, the Blood Products Advisory Committee will be seated as a device classification panel. In open session, the panel will discuss the appropriate device classification of blood establishment computer software (BECS) and accessories to BECS. Blood establishment computer software is currently subject to the premarket notification (510(k)) provisions of the Federal Food, Drug, and Cosmetic Act. In the afternoon, an informational presentation will be made regarding the emergence of chikungunya virus infections in the Western Hemisphere and potential implications for blood transfusion safety. The Committee will also hear an informational presentation on the first survey of the Rapid Donor Surveillance (RapidDOS) project on Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV)
Materials for this meeting will be available at the Blood, Vaccines and Other Biologics Advisory Committee main page.
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 November 25, 2014
- Oral presentations on December 2, 2014 from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. December 3, 2014 presentations will be scheduled between approximately 10:30 a.m. and 11 a.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 November 18, 2014. 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 19, 2014.
- For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following link.
Blood Products Advisory Committee meeting December 2, 2014:
Blood Products Advisory Committee meeting December 3, 2014:
- FDA has opened a docket for the public who are interested in presenting data, information, or views, orally or in writing, on issues pending before the committee. The docket number is FDA-2014-N-1617. The docket will close November 25, 2014. Interested persons are encourages to use the docket to submit electronic or written comments regarding this meeting. Submit electronic comments to http://www.regulations.gov.
- Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday and will be posted to the docket at http://www.regulations.gov.
- Bryan Emery or Joanne Lipkind
10903 New Hampshire Ave., Bldg. 71, rm. 6132, Silver Spring, MD 20993-0002, 240-402-8054
e-mail: Bryan.Emery@fda.hhs.gov or email: Joanne.Lipkind@fda.hhs.gov
- FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington, DC, area). 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. Seating for this meeting may be limited, so the public is encouraged to watch the free webcast if you are unable to attend. The link for the webcast will be available at 8 a.m. December 2-3, 2014 at the links above. 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 Joanne Lipkind 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). Official FR Notice