[Federal Register Volume 66, Number 68 (Monday, April 9, 2001)]
[Notices]
[Page 18488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8641]



[[Page 18488]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Safety Issues Pertaining to the Use of Flow Cytometry to Sort 
Human Cells for Clinical Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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    The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER), is announcing the following public 
meeting: ``Safety Issues Pertaining to the Use of Flow Cytometry to 
Sort Human Cells for Clinical Applications.'' The public meeting is 
cosponsored by the International Society for Analytical Cytology 
(ISAC). The topics to be discussed are the scientific and technological 
issues related to developing voluntary safety protocols, which will be 
used to help ensure the safety of human cells that are sorted using 
flow cytometry for clinical applications.
    Date and Time: The meeting will be held on April 20, 2001, from 9 
a.m. to 5 p.m.
    Location: The public meeting will be held in Wilson Hall, Building 
1, National Institutes of Health, Bethesda, MD 20892.
    Contact: Michele Keane-Moore, Center for Biologics Evaluation and 
Research (HFM-594), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-5102, FAX 301-827-5395, 
or e-mail to: [email protected].
    Registration and Requests for Oral Presentations: Send or fax your 
registration information (including name, title, organization name, 
address, telephone, fax number, and e-mail address) and written 
material and requests to make oral presentations, to Michele Keane-
Moore (address above) by Friday, April 13, 2001. There is no 
registration fee for the public meeting. Due to limited seating, 
interested parties are encouraged to register early. Registration at 
the site will be done on a space-available basis on the day of the 
workshop, beginning at 8 a.m.
    If you need special accommodations due to a disability, contact 
Michele Keane-Moore at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The meeting on ``Safety Issues Pertaining to 
the Use of Flow Cytometry to Sort Human Cells for Clinical 
Applications'' will provide a forum for members of the public to 
discuss issues about maintaining the safety of cells prepared using 
flow cytometry.
    The meeting is cosponsored by CBER and ISAC. The meeting will be of 
primary interest to public health professionals developing clinical 
protocols that use flow cytometry to sort human cells for 
readministration to patients and to manufacturers of these instruments. 
The objectives of the public meeting are to identify the safety issues 
related to using flow cytometry to sort populations of human cells and 
to establish a working group to formulate voluntary safety protocols 
that will help investigators ensure the safety and quality of cell-
sorted products. The public meeting will specifically address: (1) The 
protection of flow cytometer operators from potential human pathogens, 
(2) the protection of the cellular product from contamination, (3) the 
cleaning and sterilization of the flow cytometer to help ensure a 
viable cellular product, and (4) other issues related to the 
development and adoption of these voluntary safety protocols.
    Transcripts: Transcripts of the public meeting 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 meeting at a cost of 10 
cents per page. The transcript will also be available on the Internet 
at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: April 3, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-8641 Filed 4-6-01; 8:45 am]
BILLING CODE 4160-01-S