[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7548-7549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Annual Computational Science Symposium; Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration, 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 project groups will address specific challenges in 
accessing and reviewing data to support product development. These 
project groups will focus on solutions and practical ways to implement 
them.

DATES: The meeting will be held on March 13, 2016, from 3 p.m. to 7 
p.m., and March 14 to 15, 2016, from 9 a.m. to 5:30 p.m.

ADDRESSES: The meeting will be held at the Silver Spring Civic Building 
at Veterans Plaza, One Veterans Pl., Silver Spring, MD 20910, 1-240-
777-5300.

FOR FURTHER INFORMATION CONTACT: Chris Decker, PhUSE FDA Liaison 
Director, Pharmaceutical Users Software Exchange (PhUSE), Kent 
Innovation Centre, Broadstairs, Kent CT10 2QQ, United Kingdom; 1-609-
514-5105 (US), [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Since 2008, the Office of Computational Science (formerly the 
Computational Science Center) of FDA's Center for Drug Evaluation and 
Research (CDER) has supported CDER's scientific community by offering 
innovative solutions that improve the scientific drug review process by 
integrating data, tools, services, and training. Since the first 
Computational Science Symposium four years ago, FDA has played an 
important part in the development and ongoing support of the conference 
and the associated PhUSE Computational Science Working Groups. The 
PhUSE Collaboration was formed to bring together experts from industry, 
FDA and other regulatory agencies, academia, and

[[Page 7549]]

technology providers in specific areas to collaborate on computational 
science, describe best practices in challenging areas, and propose 
methods for addressing knowledge gaps. A description of the project 
groups and planned activities can be found at http://www.phuse.eu/css.aspx.

II. Registration and Accommodations

A. Registration

    All registrants (with the exception of a limited number of speakers 
and/or organizers who will have a complimentary registration) will pay 
a fee for this meeting to help defray the costs of facilities, 
materials, and food. Seats are limited, and registration will be on a 
first-come, first-served basis.
    To register, please complete the registration form online at 
(https://www.phuse.eu/PhUSE-CSS-2016-Registration.aspx. (FDA has 
verified the Web site address, but is not responsible for subsequent 
changes to the Web site after this document publishes in the Federal 
Register). The costs of registration for the different categories of 
attendees are as follows:

------------------------------------------------------------------------
                    Attendee category                        Fee  ($)
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Government/nonprofit/academia...........................             300
Industry Organizing Committee & PhUSE Board of Directors             350
 (password required)....................................
Poster presenter (includes the printing of the poster by             375
 PhUSE, password required)..............................
Industry................................................             750
Single-day..............................................             650
Registering after the conference begins.................            1250
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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: [email protected].

B. Accommodations

    Attendees are responsible for their own hotel accommodations. 
Attendees making reservations at the DoubleTree by Hilton Silver Spring 
Hotel are eligible for a reduced rate of $189 not including applicable 
taxes. Those making reservations online should use the following link 
to receive the reduced rate: http://doubletree.hilton.com/en/dt/groups/personalized/D/DCASSDT-PHU-20160312/index.jhtml?WT.mc_id=POG.
    If you need special accommodations because of disability, please 
contact Chris Decker (see FOR FURTHER INFORMATION CONTACT) at least 14 
days in advance.

III. Transcripts

    We expect that transcripts will be available approximately 30 days 
after the meeting. A transcript can be obtained either in hard copy or 
on CD-ROM, after submission of a Freedom of Information request. Send 
written requests to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. Send faxed requests to 301-827-9267.

    Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02877 Filed 2-11-16; 8:45 am]
 BILLING CODE 4164-01-P