[Federal Register Volume 70, Number 26 (Wednesday, February 9, 2005)]
[Notices]
[Page 6890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2452]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 March 17, 2005, from 8 
a.m. to 5:30 p.m., and on March 18, 2005, from 8:30 a.m. to 2:30 p.m.
    Location: Holiday Inn Gaithersburg, 2 Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: William Freas or Pearline K. Muckelvene, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, 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.
    Agenda: On March 17, 2005, the committee will hear updates on the 
following topics: Summary of the Department of Health and Human 
Services Advisory Committee on Blood Safety and Availability meeting, 
summary of the Transmissible Spongiform Encephalopathies Advisory 
Committee meeting, update on West Nile Virus guidance, and summaries of 
the Critical Path Initiative workshop. In the morning, the committee 
will also discuss and provide recommendations on the safety of albumin. 
In the afternoon, the committee will hear additional updates on the 
following topics: International agreements, and a presentation on 
sharing information with the public. Additionally, the committee will 
hear presentations, and discuss and provide recommendations on rapid 
freezing of plasma for transfusion. On the morning of March 18, 2005, 
the committee will hear presentations, and discuss and provide 
recommendations on the study design for the abbreviated uniform donor 
history questionnaire. The committee also will hear presentations 
related to the review of the site visit report for the Laboratory of 
Molecular Virology, Division of Emerging and Transfusion Transmitted 
Diseases, Office of Blood Research and Review.
    Procedure: On March 17, 2005, from 8 a.m. to 5:30 p.m., and on 
March 18, 2005, from 8:30 a.m. to 12:30 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 by February 25, 2005. 
Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon, and 3:30 p.m. and 4:45 p.m. on March 
17, 2005, and between approximately 9:30 a.m. and 10 a.m. on March 18, 
2005. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before March 9, 2005, 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.
    Closed Committee Deliberations: On March 18, 2005, between 1:30 
p.m. and 2:30 p.m., the meeting will be closed to permit discussion 
where disclosure would constitute a clearly unwarranted invasion of 
personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss the 
site visit report for the Laboratory of Molecular Virology, Division of 
Emerging and Transfusion Transmitted Diseases, Office of Blood Research 
and Review, Center for Biologics Evaluation and Research.
    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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-2452 Filed 2-8-05; 8:45 am]
BILLING CODE 4160-01-S