Document ID: FDA-2009-N-0664-0091
Agency: fda
Document Type: Notice
Title: Meetings: Blood Products Advisory Committee
Posted Date: 2009-09-29T04:00Z

[Federal Register: September 29, 2009 (Volume 74, Number 187)]
[Notices]               
[Page 49880-49881]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se09-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.

    Name of Committee: Blood Products Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 16, 2009, 
from 8 a.m. to 5:30 p.m. and on November 17, 2009, from 8 a.m. to 5 
p.m.
    Location: Bethesda Marriott Hotel, 5151 Pooks Hill Rd., 
Bethesda, MD 20814.
    Contact Person: William Freas or Pearline K. Muckelvene, Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike (HFM-71), Rockville, MD 20852, 
301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), code 3014519516. 
Please call the Information Line for up-to-date information on this 
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.
    Agenda: On November 16, 2009, in the morning the Committee will 
hear updates on the following topics: the HHS Advisory Committee on 
Blood Safety and Availability, Dengue virus outbreak, and 2009 A/
H1N1 Pandemic and the impact on blood safety and availability. The 
Committee will then discuss blood donor deferral for malaria risk 
associated with travel to Mexico. In the afternoon the Committee 
will discuss the design of a new phase III study of pathogen 
inactivation of human platelets using the Cerus, INTERCEPT Blood 
System. On November 17, 2009, in the morning the Committee will 
discuss blood pressure and pulse as blood donor eligibility 
criteria, and in the afternoon the committee will discuss the public 
health need and performance characteristics of over-the-counter 
home-use HIV test kits.
    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

[[Page 49881]]

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. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: On November 16, 2009, from 8 a.m. to 5:30 p.m. and on 
November 17, 2009, from 8 a.m. to 3:15 p.m., the meeting is open to 
the public. 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 9, 2009. Oral presentations from the public will be 
scheduled between approximately 11 a.m. and 11:30 a.m. and between 4 
p.m. and 4:30 p.m. on November 16, 2009, and between approximately 
10:30 a.m. and 11 a.m., and 2:15 and 2:45 p.m. on November 17, 2009. 
Those desiring to make 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 
October 30, 2009. 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 2, 2009.
    Closed Committee Deliberations : On November 17, 2009, from 
approximately 3 p.m. until 5 p.m., the meeting will be closed to 
permit discussion and review of trade secret and/or confidential 
commercial information (5 U.S.C. 552b(c)(4)). The committee will 
hear presentations and discuss sponsor, trade secret and 
confidential information.
    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 William Freas or 
Pearline K. Muckelvene 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 at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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).

    Dated: September 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23434 Filed 9-28-09; 8:45 am]

BILLING CODE 4160-01-S