Notices. Notice of public workshop
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/register/2005/06/21/05-12185·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0227] Update on Leukocyte Reduction of Blood and Blood Components; 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 “Update on Leukocyte Reduction of Blood and Blood Components.” The public workshop sponsors are FDA; the National Institutes of Health
(NIH)National Heart, Lung, and Blood Institute (NHLBI); and the Office of Public Health and Science
(OPHS)in the Department of Health and Human Services. The purpose of the public workshop is to address current issues related to leukocyte-reduced blood and blood components. *Date and Time* : The public workshop will be held on July 20, 2005, from 8 a.m. to 5:30 p.m. *Location* : The public workshop will be held at the National Institutes of Health, Lister Hill Center Auditorium, Bldg. 38A, 8600 Rockville Pike, Bethesda, MD 20894. *Contact* : Rhonda Dawson, Center for Biologics Evaluation and Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-3514, FAX: 301-827-2843, e-mail: *dawsonr@cber.fda.gov* . *Registration* : Send registration information (including name, title, firm name, address, telephone, and fax number) to Rhonda Dawson (see *Contact* ) by July 1, 2005. Because seating is limited, we recommend early registration. Registration at the site on the day of the public workshop will be provided on a space available basis beginning at 7:15 a.m. There is no registration fee for the public workshop. If you need special accommodations due to a disability, please contact Rhonda Dawson at least 7 days in advance. SUPPLEMENTARY INFORMATION: FDA, NHLBI, and OPHS are sponsoring a public workshop entitled “Update on Leukocyte Reduction of Blood and Blood Components.” The workshop will include the following topics: • Leukoreduction in targeted and non-targeted recipients; • Current data on the potential advantages and hazards ofproviding leukocyte-reduced blood and blood components; • A review of observed clinical adverse events and manufacturing failures associated with leukoreduction procedures; • FDA's current considerations for regulatory standards for leukocyte-reduced components and approaches to quality control testing; and • New scientific developments in filtration, including developing technologies for prion removal from blood components. *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. 12A-16, 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 14, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05-12185 Filed 6-20-05; 8:45 am]