E8-31187. Blood Products Advisory Committee; Notice of Meeting; Amendment

AGENCY:

Food and Drug Administration, HHS

ACTION:

Notice.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of the Blood Products Advisory Committee. This meeting was announced in the Federal Register of December 9, 2008 (73 FR 74725). The amendment is being made to reflect a change in the Agenda portion of the document.

FOR FURTHER INFORMATION CONTACT:

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. 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.

SUPPLEMENTARY INFORMATION:

In the Federal Register of December 9, 2008, FDA announced that a meeting of the Blood Products Advisory Committee would be held on January 9, 2009. On page 74725, in the first column, in the 13th line of the Agenda portion of the document, after the phrase “Acid Constructs” the following has been added:

“Included in the update will be an overview of the Center of Veterinary Medicine's review of the new animal drug application pertaining to the genetically engineered animals producing milk that contains recombinant Antithrombin III and of the environmental assessment for that application.”

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.

Dated: December 24, 2008.

Randall W. Lutter,

Deputy Commissioner for Policy.