Document ID: FDA-2009-N-0664-0059
Agency: fda
Document Type: Notice
Title: Blood Products Advisory Committee; Notice of Meeting
Posted Date: 2009-07-08T04:00Z

[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]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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