Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components

Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components

September 15, 2009
8:00 a.m. – 5:30 p.m.

September 16, 2009
8:00 a.m. – 4:00 p.m.

Workshop Goals and Objectives
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.

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 general sessions as well as break-out sessions with a particular focus on Whole Blood and blood components or Source Plasma. A question and answer session with workshop participants will also be included in 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

Location
The Universities at Shady Grove Conference Center
9630 Gudelsky Drive,
Bldg II, Multipurpose Room
Rockville, MD 20850
http://www.shadygrove.umd.edu/about/directions/

Registration
There is no registration fee for the workshop. Early registration is recommended before August 17, 2009, as seating is limited. Registration on the day of the workshop will be provided on a space available basis beginning at 7:30 a.m. To register, complete the attached registration form in this announcement and mail, fax or e-mail it to Rhonda Dawson, Food and Drug Administration, HFM-302, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail: rhonda.dawson@fda.hhs.gov Registrants will receive an e-mail confirmation.

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

Overnight Accommodations
Participants requiring overnight accommodations can contact one of the following hotels. These hotels offer reduced rates and shuttle bus service to the Universities at Shady Grove Conference Center and the Shady Grove Metro Station.

Crowne Plaza
3 Research Court
Rockville, MD 20850
(301) 840-0200
http://www.cprockville.com Woodfin Suites Hotel
1380 Piccard Drive
Rockville, MD 20850
(301) 590-9880
Comfort Inn Shady Grove
16216 Frederick Road
Gaithersburg, MD 20877
(301) 330-0023
http://www.comfortinnshadygrove.com Residence Inn by Marriott
9721 Washington Blvd.
Gaithersburg, MD 20878
(301) 590-3003
http://www.residenceinngaithersburg.com
Holiday Inn Gaithersburg
2 Montgomery Village Avenue
Gaithersburg, MD 20879
(301) 948-8900

For Program Information Contact
Rhonda Dawson
Program Coordinator
Food and Drug Administration
Office of Blood Research & Review
Center for Biologics Evaluation and Research
1401 Rockville Pike, HFM-302
Rockville, MD 20852
Phone: 301-827-6129
Fax: 301-827-2843
e-mail: rhonda.dawson@fda.hhs.gov

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Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components