80 FR 15797 - Ninth Annual Drug Information Association/Food and Drug Administration Statistics Forum-2015; Public Conference

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 57 (March 25, 2015)

The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ``Ninth Annual DIA/FDA Statistics Forum--2015''. The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic 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 trial data and measuring the progress being made in designing and implementing innovative solutions.

[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)]
[Notices]
[Pages 15797-15798]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Ninth Annual Drug Information Association/Food and Drug 
Administration Statistics Forum--2015; 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 ``Ninth Annual DIA/FDA Statistics Forum--2015''. 
The purpose of the conference is to discuss relevant statistical issues 
associated with the development and review of therapeutic 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 trial data 
and measuring the progress being made in designing and implementing 
innovative solutions.

DATES: The public conference will be held from April 20, 2015, to April 
22, 2015, from 8:30 a.m. to 5 p.m. each day.

ADDRESSES: The public conference will be held at the Marriott Bethesda 
North Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, 
MD 20852, 301-822-9200.

FOR FURTHER INFORMATION CONTACT: Ellen Diegel, Drug Information 
Association, 800 Enterprise Rd., Horsham, PA 19044, 215-442-6100, 
[email protected]; or Stephen Wilson, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3630, Silver 
Spring, MD 20993-0002, 301-796-0579, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This annual FDA/DIA statistics forum will be a unique, open, 
international forum for statisticians and clinicians from industry, 
academia, contract research organizations, and 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-US/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=3630578&EventType=Meeting.

II. Registration and Accommodations

A. Registration

    To register, please submit the registration form online at http://www.diahome.org/en-US/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=3630578&EventType=Meeting. (FDA has 
verified this Web site address but is not responsible for changes to 
the Web site after this document publishes in the Federal Register.) 
Seats are limited, and conference space will be filled in the order in 
which registrations are received. On-site 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 
attendees are as follows:

------------------------------------------------------------------------
                        Category                               Cost
------------------------------------------------------------------------
Industry Representatives................................          $1,440
Charitable Nonprofit/Academic (Full time)...............             720
Government (Full time)..................................             430
Tutorial Fees...........................................             405
------------------------------------------------------------------------

    All registrants will be required to pay the applicable fee, with 
the exception of a limited number of speakers/organizers who will have 
a complimentary registration. (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].) Registration fees cover the costs of 
facilities, materials, and food functions.

B. Accommodations

    Attendees are responsible for their own accommodations. 
Reservations may be made online via the conference hotel reservation 
page at https://www.tphousing.com/ph2/

[[Page 15798]]

startres.aspx?EICode=3132&Attcode=72.
    The Marriott Bethesda North Hotel and Conference Center has a 
limited number of rooms available at the discounted rate of $199 per 
night until April 3, 2015, or until the block is filled. To receive 
this rate, attendees are asked to make reservations using the link to 
the hotel reservation page or by calling 855-355-0302 or 212-532-1660. 
If calling, please select the first option for ``Hotel Reservations'' 
and inform the phone agent that you are making a reservation for 
``Event #15008''.
    If you need special accommodations because of disability, please 
contact [email protected] at least 7 days before the meeting.

    Dated: March 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06702 Filed 3-24-15; 8:45 am]
 BILLING CODE 4164-01-P