[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13072-13073]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04331]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Seventh Annual Drug Information Association/Food and Drug
Administration Statistics Forum--2013; 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 Drug Information Association (DIA), is announcing a public
conference entitled ``Seventh Annual DIA/FDA Statistics Forum--2013.''
The purpose of the conference is to discuss relevant statistical issues
associated with the development and review of therapeutic drugs and
biologics. This meeting is intended to be an open forum for the timely
discussion of topics of mutual theoretical and practical interest to
statisticians and clinical investigators who are involved in the
development of new drugs and biologics. A primary focus for this
meeting will be to establish an ongoing dialogue regarding FDA's
``Critical Path'' initiative--emphasizing the regulatory and
statistical challenges associated with innovative approaches to the
design and analysis of clinical trials data and measuring the progress
being made in designing and implementing innovative solutions.
DATES: The public conference will be held on April 28, 2013, to May 1,
2013, from 8:30 a.m. to 5 p.m.
ADDRESSES: The public conference will be held at the Marriott Bethesda
North Hotel and Conference Center, 5701 Marinelli Rd., Bethesda, MD
20852, 1-301-822-9200.
FOR FURTHER INFORMATION CONTACT:
Constance Burnett, Drug Information Association, 800 Enterprise Rd.,
Horsham, PA 19044, 1-215-293-5800, email:
Constance.Burnett@diahome.org; or
Stephen Wilson, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301-796-0579, email:
Stephen.Wilson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
This annual FDA/DIA statistics forum will establish a unique, open,
international forum for statisticians and clinicians from industry,
academia, contract research organizations, and
[[Page 13073]]
Government Agencies. Meeting participants will learn, discuss, and
collaborate on the current and emerging statistical methodologies and
quantitative approaches used by sponsors to provide evidence for the
approval of new therapies.
The goals of the program are to:
Explore and implement innovative statistical solutions to
issues associated with the regulatory review of therapeutic drugs and
biologics.
Describe the application of statistical methodologies and
thinking to the development of new therapeutic biologics and drugs.
Assess the impact of regulations and guidance on
statistical practice.
Discuss ideas for improving the communication between
industry statisticians and FDA reviewers.
A description of the planned activities of the working groups can
be found at http://www.diahome.org/en/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=30457&EventType=Meeting.
II. Registration and Accommodations
A. Registration
To register, please submit the registration form online at http://www.diahome.org/en/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=30457&EventType=Meeting (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.) 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:
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Category Cost
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Industry Representatives....................................... $1,400
Charitable Nonprofit/Academic (Full time)...................... 700
Government (Full time)......................................... 420
Tutorial Fees.................................................. 405
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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: Constance.Burnett@diahome.org.
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 Marriott Bethesda North Hotel and Conference
Center, Bethesda, MD, are eligible for a reduced conference rate of
$209, not including applicable taxes. Those making reservations online
should use the group code ``13008'' to receive the special rate. If you
need special accommodations because of disability, please contact
Constance.Burnett@diahome.org at least 7 days before the meeting.
Dated: February 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04331 Filed 2-25-13; 8:45 am]
BILLING CODE 4160-01-P