Document ID: FDA-2011-N-0002-0127
Agency: fda
Document Type: Notice
Title: Data Needs to Advance Risk Assessment for Infectious Diseases Relevant to Blood and Blood Products
Posted Date: 2011-10-12T04:00Z

[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63308-63309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26295]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Data and Data Needs To Advance Risk Assessment for Emerging 
Infectious Diseases Relevant to Blood and Blood Products; 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: ``Data and Data Needs to Advance Risk Assessment for 
Emerging Infectious Diseases Relevant to Blood and Blood Products.'' 
The purpose of the public workshop is to discuss data and data sources 
currently used by FDA, possible new sources of data, and development of 
new studies and information through collaboration with stakeholders. 
The public workshop will include presentations and panel discussions 
with experts from stakeholders, academia, regulated industry, and 
government.
    Date and Time: The public workshop will be held on November 29, 
2011, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Gaithersburg 
Hilton, 620 Perry Pkwy., Gaithersburg, MD 20877, 301-977-8900.
    Contact Person: Lou Gallagher, Center for Biologics Evaluation and 
Research (HFM-210), Food and Drug Administration, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852-1448,

[[Page 63309]]

301-827-5988, e-mail: lou.gallagher@fda.hhs.gov.
    Registration: Mail, fax, or e-mail your registration information 
(including name, title, firm name, address, telephone and fax numbers) 
to Lou Gallagher (see Contact Person) by November 10, 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 8 a.m.
    If you need special accommodations due to a disability, please 
contact Lou Gallagher (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: Quantitative risk assessments (QRAs) are an 
important tool for evaluating the risks associated with new emerging 
infectious diseases (EIDs) that are relevant to blood and blood 
products and the benefits of mitigation options. QRAs make it possible 
for decisionmakers to develop policy for blood and blood product safety 
and availability using sound science and the best data and information 
available.
    Rapid data collection, information sharing, and analyses estimating 
the magnitude and probability of risk can be expedited by proactively 
building and maintaining critical relationships both within the Center 
for Biologics Evaluation and Research (CBER) and with external 
stakeholders. In this public workshop, CBER is seeking access to 
accurate, reliable data on factors such as disease prevalence, 
incubation periods, behavioral risks associated with disease 
transmission, potential donor exposure risks, and susceptibility to 
EIDs, product handling, usage, and other factors.
    Lack of data and information is a major challenge FDA faces when 
there is a new EID. The public workshop will: (1) Provide a forum for 
discussion of data used in conducting quantitative risk assessments for 
EIDs, (2) address approaches to facilitate the timely access to data 
required to evaluate public health measures designed to reduce the 
potential risk associated with EIDs that are relevant to blood and 
blood products, and (3) provide a forum for discussion of the 
development of new data sources and enhanced access to already existing 
data sources.
    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: October 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-26295 Filed 10-11-11; 8:45 am]
BILLING CODE 4160-01-P