
[Federal Register Volume 74, Number 132 (Monday, July 13, 2009)]
[Notices]
[Page 33451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16657]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0284]


Food and Drug Administration Regulation and Licensure of Whole 
Blood and Blood Components, Including Source Plasma; Public Workshop; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``FDA Regulation and Licensure of Whole Blood and 
Blood Components, Including Source Plasma.'' The purpose of the 
workshop is to educate industry on the licensure requirements and 
license application procedures for Whole Blood and blood components, 
including Source Plasma, and request comments on this topic.
    Dates and Time: The public workshop will be held on September 15, 
2009, from 8 a.m. to 5:30 p.m. and September 16, 2009, from 8 a.m. to 4 
p.m.
    Location: The public workshop will be held at The Universities at 
Shady Grove Conference Center, 9630 Gudelsky Dr., Bldg. 1, Rockville, 
MD 20850.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
suite 400N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843, 
e-mail: rhonda.dawson@fda.hhs.gov.
    Registration: Mail, fax, or e-mail your registration information 
(including name, title, firm name, address, telephone, and fax numbers) 
to the contact person (see Contact Person) by August 17, 2009. 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 (see Contact Person) at least 7 days in advance 
of the workshop.
    Comments: All individuals wishing to submit questions to be 
addressed at the public workshop should submit written or electronic 
comments by August 17, 2009, 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.regulations.gov. Submit a single copy of electronic comments or two 
paper copies of any mailed comments, except that individuals may submit 
one paper copy. 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.

SUPPLEMENTARY INFORMATION: FDA held a licensing workshop for blood 
establishments in 1995 to advise the blood and plasma industry on how 
to apply for a U.S. license to distribute Whole Blood and blood 
components, including Source Plasma, in interstate commerce. This 
workshop will build upon the 1995 workshop and provide regulatory 
updates since the last workshop. The workshop will include 
presentations by FDA on the following topics: (1) Requirements for 
licensure and applicable regulations and guidance documents for Whole 
Blood and blood components, including Source Plasma; (2) managed review 
process; (3) review criteria for various submissions; (4) blood 
establishment registration and product listing requirements; (5) 
inspections of blood establishments pending licensure and approval; and 
(6) requests for exceptions or use of alternative procedures to the 
regulations. The workshop will include a question and answer session 
with workshop participants.
    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: July 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16657 Filed 7-10-09; 8:45 am]
BILLING CODE 4160-01-S


