[Federal Register Volume 76, Number 138 (Tuesday, July 19, 2011)]
[Notices]
[Pages 42715-42716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18093]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Quarantine Release Errors in Blood Establishments; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Quarantine Release Errors in Blood
Establishments.'' The purpose of this public workshop is to provide a
forum for discussion of quarantine release errors (QREs) and provide
FDA and industry with information necessary to reduce the rates of
QREs. The workshop will focus on the extent and characteristics of QREs
in blood establishments and the specifications of blood establishment
computer software
[[Page 42716]]
(BECS) as they relate to inventory control. The public workshop has
been planned in partnership with the Department of Health and Human
Services (HHS) Office of the Assistant Secretary for Health, America's
Blood Centers, and AABB. This public workshop will include
presentations and panel discussions by experts knowledgeable in this
field from government Agencies and industry.
Date and Time: The public workshop will be held on September 13,
2011, from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at the Universities at
Shady Grove Conference Center, 9630 Gudelsky Dr., Rockville, MD 20850-
5820, 301-738-6000.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, 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 Rhonda Dawson (see Contact Person) by September 1, 2011. 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.
SUPPLEMENTARY INFORMATION: QREs refer to the inadvertent release of
blood or blood components either before completion of testing and
determination that all other criteria affecting the safety, purity, or
potency of the product have been met, or despite findings that would
render the blood or blood components unsuitable for release. Although
QREs that result in the distribution of blood or blood components are
required to be reported to FDA as biologic product deviation reports
(BPDRs), the amount of information provided in BPDRs varies and often
represents a summary of information rather than a detailed description
and analysis of the problem. Thus, the root causes of QREs are not
known with certainty. Further, the rates of QREs are also not known
with certainty, and actions necessary to correct and prevent them are
unclear.
There has been a recent focus on QREs related to the release of
units with incomplete or absent testing for transfusion-transmitted
infectious diseases. On June 10 and 11, 2010, the HHS Advisory
Committee on Blood Safety and Availability (the Committee) met to
discuss the current FDA blood donor deferral policy on men who have sex
with other men. While the Committee recommended that the current
deferral policy not be changed at the present time, it found the
current policy to be suboptimal in permitting some potentially high
risk donations while preventing some low risk donations. The Committee
made a number of recommendations and indicated that HHS should take
action to investigate and reduce the risk of QREs in blood collection
establishments.
This public workshop will serve as a forum for discussion of QREs
and provide FDA and industry with information necessary to reduce the
rates of QREs. The public workshop presentations and panel discussions
will: (1) Review recent BPDR data to better determine the root causes
for QREs and identify activities that could address those causes; (2)
evaluate the use of 510(k) cleared BECS or implementation of BECS
performance standards in reducing the rate of QREs; and (3) explore
other potential strategies to address QREs. The public workshop will
conclude with a summary of the issues discussed.
Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop is available, it will be accessible
on the Internet at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Transcripts of the public workshop may also be requested in writing
from the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Rockville, MD 20857.
Dated: July 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-18093 Filed 7-18-11; 8:45 am]
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