[Federal Register Volume 72, Number 116 (Monday, June 18, 2007)]
[Notices]
[Page 33509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11615]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0217]


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: 301-827-2843, 
e-mail: [email protected].
    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.
[FR Doc. E7-11615 Filed 6-15-07; 8:45 am]
BILLING CODE 4160-01-S