[Federal Register: July 8, 2009 (Volume 74, Number 129)]
[Notices]
[Page 32620]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jy09-85]
[[Page 32620]]
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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). The meeting will
be open 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 July 20, 2009, from 8
a.m. to 6 p.m. and on July 21, 2009, from 9 a.m. to 12 noon.
Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD 20877, 301-977-8900.
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 July 20, 2009, in the morning, the committee will review
proposed strategies to demonstrate the effectiveness of new coral snake
antivenoms. In the afternoon, the committee will discuss alternative
clinical and surrogate endpoints for evaluating efficacy of Alpha-1
Proteinase Inhibitor (Human) augmentation therapy in Alpha-1
antitrypsin deficiency. Alpha-1 antitrypsin deficiency is a genetic
condition associated with decreased circulating levels of alpha-1
antitrypsin that significantly increases the risk of serious lung
disease (i.e. emphysemia) in adults. On July 21, 2009, the committee
will hear updates on the following topics: The April 30 to May 1, 2009,
meeting of the Department of Health and Human Services Advisory
Committee on Blood Safety and Availability (http://www.hhs.gov/ophs/
bloodsafety/index.html); the June 12, 2009, meeting of the FDA
Transmissible Spongiform Encephalopathies Advisory Committee (http://
www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/
TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/
ucm129559.htm); and an overview of the epidemiology and virology of the
2009 A/H1N1 influenza virus and its impact on the U.S. blood system.
The committee will also hear informational presentations on recent
public and private hemovigilance efforts, including the pilot
hemovigilance module in the National Healthcare Safety Network.
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. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm, scroll down to the appropriate advisory committee link.
Procedure: 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 July
15, 2009. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. and 11 a.m. and between approximately 3:45
p.m. and 5 p.m. on July 20, 2009, and between approximately 11:30 a.m.
and 12 noon on July 21, 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 July 13, 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 July 8,
2009.
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.
FDA regrets that it was unable to publish this notice 15 days prior
to the July 20, 2009, Blood Advisory Committee meeting. Because the
agency believes there is some urgency to bring these issues to public
discussion and qualified members of the Blood Advisory Committee were
available at this time, the Commissioner of Food and Drugs concluded
that it was in the public interest to hold this meeting even if there
was not sufficient time for the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 29, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-16101 Filed 7-7-09; 8:45 am]
BILLING CODE 4160-01-S