[Federal Register: September 22, 2004 (Volume 69, Number 183)]
[Notices]               
[Page 56770]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se04-61]                         


[[Page 56770]]

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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). 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 October 21, 2004, from 8 
a.m. to 5:30 p.m. and on October 22, 2004, from 8:30 a.m. to 12:45 p.m.
    Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Linda A. Smallwood, Center for Biologics Evaluation 
and Research (HFM-302), Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852, 301-827-3514, 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 October 21, 2004, the committee will hear updates on the 
following topics: Summary of the Transmissible Spongiform 
Encephalopathies Advisory Committee (TSEAC) meeting discussion of new 
variant Creutzfeldt-Jacob disease (vCJD) transmission by transfusion in 
the United Kingdom and supplemental testing for human immunodeficiency 
virus (HIV) and hepatitis C virus (HCV). In the morning, the committee 
will also discuss and provide recommendations on the agency's current 
thinking on re-entry of donors previously deferred for anti-HBc 
reactivity. In the afternoon, the committee will discuss and provide 
recommendations on the potential risk of transmission of Simian Foamy 
Virus (SFV) by blood transfusions. On October 22, 2004, the committee 
will hear updates on these topics: a summary of the Plasma Workshop 
held on August 31 through September 1, 2004, draft uniform donor health 
questionnaire acceptance guidance: review of public comments, and FDA 
current thinking on monitoring weight in source plasma donors. The 
committee will also hear presentations, discuss and provide 
recommendations on the agency's current thinking on donor deferral for 
potential or documented infection with West Nile Virus (WNV).
    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 by October 8, 
2004. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11 a.m., 4 p.m. and 4:30 p.m. on October 
21, 2004, and between approximately 11 a.m. and 11:45 a.m. on October 
22, 2004. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before October 8, 2004, 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.
    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 Linda A. Smallwood, 
or Pearline K. Muckelvene at 301-827-1281 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: September 13, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-21283 Filed 9-21-04; 8:45 am]

BILLING CODE 4160-01-S