
[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31026-31027]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12593]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Use of Computer Simulation of the United States Blood Supply in 
Support of Planning for Emergency Preparedness and Medical 
Countermeasures; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled: ``Use of Computer Simulation of the United States 
Blood Supply in Support of Planning for Emergency Preparedness and 
Medical Countermeasures.'' The purpose of this public workshop is to 
provide stakeholders a forum for discussion of data needs and to obtain 
feedback on possible modeling scenarios to explore emergency supply 
situations should a pandemic or epidemic disease or other events that 
could adversely impact the blood supply in the United States occur.
    The public workshop will include presentations and panel 
discussions with experts from academia, regulated industry, government, 
and other stakeholders.
    Date and Time: The public workshop will be held on July 24, 2012, 
from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Hyatt Regency 
Bethesda, One Bethesda Metro Center, 7400 Wisconsin Ave., Bethesda, MD 
20814, 301-657-1234.
    Contact Person: Mark Walderhaug, Center for Biologics Evaluation 
and Research (HFM-210), Food and Drug Administration, 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6028, email: 
Mark.Walderhaug@fda.hhs.gov.
    Registration: Mail or email your registration information 
(including name, title, firm name, address, telephone, and fax numbers) 
to Mark Walderhaug (see Contact Person) by July 17, 2012. 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 Mark Walderhaug (see Contact Person) at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION: The public workshop presentations and panel 
discussions will: (1) Discuss

[[Page 31027]]

simulation modeling of the U.S. blood supply, including the possible 
application of an FDA computer simulation model of the U.S. blood 
supply in support of emergency preparedness and planning for potential 
disruptions in blood donations; (2) discuss with the blood community 
the utility of simulation methods as a complementary approach to 
support planning for daily inventory needs and forecasting for future 
blood donations and demand; (3) discuss the capabilities and 
limitations of the U.S. computer simulation model, assumptions used in 
the model and data gaps for model validation; (4) describe and 
prioritize future model enhancements to extend the model predictions 
from red blood cell units to other blood components, such as plasma and 
platelets; and (5) discuss the level of detail required for a model to 
characterize the U.S. blood supply and to develop possible scenarios in 
which shortages may be addressed through countermeasures such as the 
use of local and interregional transfers of blood and blood components.
    Transcripts: Transcripts of the public workshop may be requested in 
writing from the Division of Freedom of Information (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, 
MD 20857, approximately 15 working days after the public workshop at a 
cost of 10 cents per page. A transcript of the public workshop will be 
available on the Internet at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.

    Dated: May 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12593 Filed 5-23-12; 8:45 am]
BILLING CODE 4160-01-P


