[Federal Register Volume 76, Number 138 (Tuesday, July 19, 2011)]
[Notices]
[Pages 42715-42716]
From the Federal Register Online via the Government Publishing 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: [email protected].
    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]
BILLING CODE 4160-01-P