[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Pages 13072-13073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04331]



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.


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.


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: 


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 
     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:

                            Category                               Cost
Industry Representatives.......................................   $1,400
Charitable Nonprofit/Academic (Full time)......................      700
Government (Full time).........................................      420
Tutorial Fees..................................................      405

    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]