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From: TSS (216-119-134-134.ipset14.wt.net)
Subject: TSE ADVISORY COMMITTEE; ACTION: Notice.
Date: September 22, 2004 at 7:08 am PST

-------- Original Message --------
Subject: Transmissible Spongiform Encephalopathies Advisory Committee;
Date: Wed, 22 Sep 2004 09:01:40 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE


##################### Bovine Spongiform Encephalopathy #####################

[Federal Register: September 22, 2004 (Volume 69, Number 183)]
[Notices]
[Page 56771]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se04-63]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Transmissible Spongiform Encephalopathies 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: Transmissible Spongiform Encephalopathies
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 14, 2004, from 8
a.m. to 5:30 p.m.
Location: Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD
20910.
Contact Person: William Freas or Sheila D. Langford, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD, 301-827-0314, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512392. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On October 14, 2004, the committee will hear updates on the
following issues: USDA-licensed tests for the diagnosis of bovine
spongiform encephalopathy (BSE) and other transmissible spongiform
encephalopathies (TSE), review of the worldwide BSE situation, new FDA/
Center for Food Safety and Applied Nutrition BSE-food safety rules, and
labeling claims for TSE clearance studies for plasma derivative
products. The committee will then discuss and make recommendations
regarding presumptive transfusion transmissions of variant Creutzfeldt
Jakob Disease (vCJD) and current FDA-recommended safeguards.
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 5,
2004. Oral presentations from the public will be scheduled between
approximately 9:20 a.m. and 9:50 a.m., and 2:45 p.m. and 3:15 p.m. on
October 14, 2004. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person before October 7, 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 William Freas or
Sheila D. Langford 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 15, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-21282 Filed 9-21-04; 8:45 am]

BILLING CODE 4160-01-S

http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-21282.htm

===================================================
===================================================

[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]]

=======================================================================
-----------------------------------------------------------------------

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.

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

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

http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-21283.htm

TSS

################# BSE-L-subscribe-request@uni-karlsruhe.de #################





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