
[Federal Register Volume 77, Number 19 (Monday, January 30, 2012)]
[Notices]
[Pages 4568-4569]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1887]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Annual Computational Science Symposium; Public Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with 
the Pharmaceutical Users Software Exchange (PhUSE), is announcing a 
public conference entitled ``The FDA/PhUSE Annual Computational Science 
Symposium.'' The purpose of the conference is to help the broader 
community align and share experiences to advance computational science. 
At the conference, which will bring together FDA, industry, and 
academia, FDA will update participants on current initiatives, and 
collaborative working groups will address specific challenges in 
accessing and reviewing data to support product development. These 
working groups will focus on solutions and practical ways to implement 
them.

DATES: Date and Time: The public conference will be held on March 19 
and 20, 2012, from 9 a.m. to 4:30 p.m.
    Location: The public conference will be held at the Silver Spring 
Civic Building at Veterans Plaza, One Veterans Pl., Silver Spring, MD 
20910, 1-(240)-777-5300.
    Contact: Chris Decker, U.S. Regional Director, Pharmaceutical Users 
Software Exchange (PhUSE), 64 High St., BROADSTAIRS CT10 1JT, United 
Kingdom, (202) 386-6722, e-mail: office@phuse.eu.

SUPPLEMENTARY INFORMATION: 

I. Working Groups and Their Areas of Focus

    Six working groups will address particular challenges related to 
the access and review of data to support product development:
     Working Group 1: Data Validation and Quality Assessment,
     Working Group 2: Reducing Risk Within the Inspection Site 
Selection Process,
     Working Group 3: Challenges of Integrating and Converting 
Data Across Studies,
     Working Group 4: Standards Implementation Issues With the 
Clinical Data Interchange Standards Consortium Data Models,
     Working Group 5: Development of Standard Scripts for 
Analysis and Programming, and
     Working Group 6: ``Non-Clinical Road-Map'' and Impacts on 
Implementation.
    A description of the planned activities of the working groups can 
be found at http://www.phuse.eu/Working-Groups.aspx. (FDA has verified 
the Web site addresses throughout this document, but FDA is not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)

II. Registration and Accommodations

A. Registration

    To register, please submit the registration form online at https://www.phuse.eu/PhUSE-Conference-2012-Registration.aspx. Registration fees 
cover the cost of facilities, materials, and food functions. Seats are 
limited, and conference space will be filled in the order in which 
registrations are received. Onsite registration will be available to 
the extent that space is available on the day of the conference. The 
costs of registration for different categories of attendee are as 
follows:

                          Cost of Registration
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                            Category                               Cost
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Industry representatives registering by January 15, 2012.......     $750
Industry representatives registering after January 15, 2012....      950
Those with Government affiliation..............................      300
Representatives of nonprofit organizations.....................      600
Those attending for a single day...............................      650
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    Government and nonprofit attendees and exhibitors will need an 
invitation code to register at the discounted rate. An invitation code 
can be obtained by sending an email to: office@phuse.eu. All 
registrants will pay a fee with the exception of a limited number of 
speakers/organizers who will have a complimentary registration.

B. Accommodations

    Attendees are responsible for their own accommodations. Attendees 
making reservations at the Courtyard by Marriott Silver Spring Downtown 
Hotel are eligible for a reduced conference rate of $199, not including 
applicable taxes. Those making reservations online should use the group 
code ``SPRSPRB'' to receive the special rate. If you need special 
accommodations because of disability, please contact Chris Decker (see 
Contact) at least 7 days before the meeting.

III. Posters and Exhibits Information

    Posters will be presented and may include demonstrations to provide 
an interactive experience. Although PhUSE welcomes demonstrations to 
support and explore the posters that are presented, neither PhUSE nor 
FDA endorse any commercial software or vendor. The creator of what is 
judged the best poster will be recognized and offered the opportunity 
to present the poster at the closing session.
    Poster topics include:
     Data submission standards development, implementation, and 
best practices;
     User experience and evaluation of current processes and 
tools and their effects on organizational performance;
     Needs and specifications for proposed new tools and 
processes;
     Business processes driving the development of information 
systems; and
     The effect of processes and tools on problem solving 
quality, efficiency, and cost.

[[Page 4569]]

    Those interested in more information should refer to the PhUSE Web 
site at http://www.phuse.eu/ssc4p.aspxweb.
    The conference will make available an exhibition hall. The 
exhibitor price for this conference is $3,500.

    Dated: January 24, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1887 Filed 1-27-12; 8:45 am]
BILLING CODE 4160-01-P


