[Federal Register Volume 62, Number 212 (Monday, November 3, 1997)]
[Notices]
[Page 59358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29049]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Current Topics in Immunohematologic Testing; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Current Topics in Immunohematologic Testing.'' The
topics to be discussed include specificity and sensitivity of Anti-D
Blood Grouping Reagents; the development of performance standards for
antiglobulin control cells and blood bank saline; user interpretation
of labeling information; and the validation and use of blood grouping
instrumentation.
Date and Time: The workshop will be held on December 10, 1997, 8
a.m. to 5 p.m.
Location: The workshop will be held at Natcher Auditorium, National
Institutes of Health, 9000 Rockville Pike, Bldg. 45, Bethesda, MD.
Contact Person: Joseph Wilczek, Center for Biologics Evaluation and
Research (HFM-350), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-3514, FAX 301-827-2843.
SUPPLEMENTARY INFORMATION: The goals of the workshop are specific to
each topic and include the following: (1) Distinguish between those
issues that are medically important and those issues that are primarily
of scientific interest with respect to Anti-D specificity and
sensitivity; (2) present examples of significant problems attributable
to the variability seen within two types of product, antiglobulin
control cells and blood bank saline, due to the lack of standards; (3)
identify areas of immunohematologic product labeling which need to be
modified to provide the user with a better understanding of its uses
and limitations; and (4) discuss user validation of complete systems as
well as partial or site-assembled systems regarding blood grouping
instrumentation. The information obtained from these presentations and
discussions will assist FDA in taking the necessary steps for assuring
the safety and effectiveness of these medical devices.
Registration and Requests for Oral Presentations: Send or fax
registration information (including name, title, firm name, address,
telephone, and fax number), written material, and requests to make oral
presentations by November 28, 1997, to Cody Bridges, 14504 Greenview
Dr., suite 500, Laurel, MD 20708, 301-490-5500, FAX 301-490-7260, e-
mail [email protected] Registration at the site will be done on a
space available basis on the day of the workshop beginning at 7:30 a.m.
There is no registration fee for the workshop.
If you need special accommodations due to a disability, please
contact Cody Bridges at least 7 days in advance.
Transcripts: Transcripts of the 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 workshop at a cost of 10 cents
per page.
Dated: October 24, 1997.
William K. Hubbard.
Associate Commissioner for Policy Coordination.
[FR Doc. 97-29049 Filed 10-31-97; 8:45 am]
BILLING CODE 4160-01-F
