E7-11615. Licensure of Apheresis Blood Products; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing a public workshop entitled: Licensure of Apheresis Blood Products. The purpose of the public workshop is to educate industry on the licensure requirements and license application procedures for Platelets, Pheresis; Red Blood Cells; and Plasma collected by automated blood cell separator devices.

Date and Time: The public workshop will be held on August 15, 2007, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Lister Hill Center Auditorium, Bldg. 38A, National Institutes of Health, 8800 Rockville Pike, Bethesda, MD 20894.

Contact Person: Rhonda Dawson, Center for Biologics Evaluation and Research(HFM-302), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6129, FAX: [phone], e-mail: [e-mail].

Registration: Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by July 31, 2007. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m.

If you need special accommodations due to a disability, please contact Rhonda Dawson at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

The public workshop will feature presentations by experts from government and industry. The workshop will include presentations by FDA on: (1) Requirements for licensure, and applicable regulations and guidances, for Platelets, Pheresis; Red Blood Cells; and Plasma (intended for transfusion) collected by apheresis instruments; (2) the FDA managed review process; and (3) failure investigations of apheresis products. Device manufacturers will present an overview of their devices and review validation procedures and quality control processes. Representatives from blood establishments will present case studies of licensing applications. FDA will lead a question and answer session with workshop participants.

Comments: All individuals wishing to submit questions to be addressed at the public workshop should submit written or electronic comments by July 31, 2007, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Transcripts: Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm.6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at http://www.fda.gov/​cber/​minutes/​workshop-min.htm.

Dated: June 11, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.