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Notice

Transmissible Spongiform Encephalopathies Advisory Committee; Amendment of Notice

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Transmissible Spongiform Encephalopathies Advisory Committee. This meeting was announced in the Federal Register of August 3, 2006 (71 FR 44035). The amendment is being made to reflect a change in the Date and Time, Agenda, and Procedure portions of the document. Specifically, the open public hearing times in the Procedure portion of the document were changed. Because of a change in the agenda, the afternoon committee discussion topic will be cancelled. There are no changes other than those stated in this announcement.

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FOR FURTHER INFORMATION CONTACT:

William Freas or Rosanna L. Harvey, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512392.

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SUPPLEMENTARY INFORMATION:

In the Federal Register of August 3, 2006, FDA announced that a meeting of the Transmissible Spongiform Encephalopathies Advisory Committee would be held September 18, 2006 from 8 a.m. to 4:30 p.m. and September 19, 2006 from 8 a.m. to 1 p.m. On page 44035, in the third column, the Date and Time portion of the notice is amended to read as follows:

Date and Time: The meeting will be held on September 18, 2006, from 8:30 a.m. to 4 p.m. and September 19, 2006, from 8 a.m. to 1 p.m.

On page 44036, in the first column, the Agenda and Procedure portions of the notice are amended to read as follows:

Agenda: On September 18, 2006, the committee will hear updates on the following topics: United States and worldwide bovine spongiform encephalopathies (BSE); variant Creutzfeldt-Jakob disease (vCJD) epidemiology and transfusion-transmission; blood and plasma donor deferral for transfusion in France since 1980 guidance; and critical factors influencing prion decontamination using sodium hydroxide. The committee will then discuss experimental clearance of transmissible spongiform encephalopathy infectivity in plasma-derived Factor VIII products. In the afternoon, the committee will hear updates on the status of FDA's initiative on communication of the potential exposure to vCJD risk from an investigational product, plasma derived FACTOR XI that was manufactured from UK donor plasma, and a summary of World Heath Organization consultation on distribution of infectivity in tissues of animals and humans with transmissible spongiform encephalopathies. On September 19, 2006, the committee will discuss possible criteria for approval of donor screening tests for vCJD.

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 September 6, 2006. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12 noon and 3:30 p.m. and 4 p.m. on September 18, 2006, and between approximately 11:25 a.m. and 11:45 a.m. on September 19, 2006. Time allotted for each presentation may be limited. 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 September 11, 2006.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app.2) and 21 CFR part 14, relating to the advisory committees.

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Dated: September 6, 2006.

Randall W. Lutter,

Associate Commissioner for Policy and Planning.

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[FR Doc. E6-15283 Filed 9-14-06; 8:45 am]

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