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On December 2, 2014, the FDA Blood Products Advisory 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 Advisory Committee on Blood and Tissue Safety and Availability where the MSM blood donor deferral policy was discussed.
Location:
The meeting will be conducted at the FDA White Oak Campus, located at 10903 New Hampshire Avenue., Building 31 Conference Center, The Great Room, room 1503. Silver Spring, MD 20993-0002
Public Participation:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
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Written submissions may be made to 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@xxxxxxxxxxx or email: Joanne.Lipkind@xxxxxxxxxxx on or before November 25, 2014. -
Time for oral presentations on December 2, 2014 from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m.
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For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following link on December 2, 2014: https://collaboration.fda.gov/bpac1214/ The link for the webcast will be available at 8 a.m. December 2, 2014.
Request for Public Comment:
- 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 FDA-2014-N-1617. 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.
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. There is no cost or per-registration required to attend. FDA 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.
Meeting Materials
Background materials for this meeting will be available at the Blood, Vaccines and Other Biologics Advisory Committee page prior to the meeting.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
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