[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12499-12500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05219]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2016-N-0001]


Tenth Annual Drug Information Association/Food and Drug 
Administration Statistics Forum--2016; 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 co-sponsorship with 
the Drug Information Association (DIA), is announcing a public 
conference entitled ``Tenth Annual DIA/Food and Drug Administration 
Statistics Forum--2016.'' This public conference is intended to be an 
open forum for the timely discussion of topics of mutual theoretical 
and practical interest to statisticians and clinical trialists who 
develop and review new drugs and biologics. A primary focus for this 
public conference will be to establish an ongoing dialogue between 
industry and regulatory Agencies--emphasizing the regulatory and 
statistical challenges associated with innovative approaches to the 
design and analysis of clinical trials and measuring the progress being 
made in designing and implementing innovative solutions.

DATES: The main meeting will be held over 3 days: April 25, 2016, from 
1 p.m. to 5:30 p.m.; April 26, 2016, from 8:30 a.m. to 5 p.m.; and 
April 27, 2016, from 8:30 a.m. to 3:30 p.m. On April 25, there will 
also be pre-meeting tutorials from 8:30 a.m. to 12 p.m. and a 
scientific working group session from 5:40 p.m. to 7 p.m.

ADDRESSES: The meeting 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: Meredith Kaganovskiy, DIA, 800 
Enterprise Rd., Horsham, PA 19044, 215-442-6117, 
[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

    FDA and DIA will sponsor an open public discussion between 
industry, academia, contract research organizations, regulatory 
scientists, and other parties on topics related to the innovative 
statistical methodologies and quantitative approaches used by sponsors 
to provide evidence for the approval of new therapies.
    The forum will provide a unique opportunity for all of the relevant 
stakeholders to collaboratively describe the issues and discuss 
appropriate solutions. It is important that all of the stakeholders 
examine their roles in making the necessary changes and improvements in 
the framework used to develop evidence for the regulatory decisions and 
work to foster a mutual understanding of relevant scientific issues and 
challenges.
    The conference will benefit FDA by enhancing communication with the 
broader statistical community.
    The goals of the program are as follows:

 Explore and implement innovative statistical solutions to 
important issues associated with the quantitative evidence needed for 
the regulatory review of therapeutic drugs and biologics
 Describe the application of statistical methodologies and 
thinking regarding 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 regulatory reviewers

    A description of the planned activities of the working groups can 
be found at http://www.diaglobal.org/en/conference-listing/meetings/2016/04/dia-fda-statistics-2016-forum.

II. Registration and Accommodations

A. Registration

    There is a registration fee to attend this meeting. The 
registration fee is to help defray the costs of the event; including 
meeting facilities, program materials, refreshments, staff time and 
administrative overhead, and costs involved in getting speakers to the 
events; and will not result in any profits. Seats are limited, and 
registration will be on a first-come, first-served basis. On-site 
registration will be available to the extent that space is available on 
the day of the conference. Please note: Registration will open at 7:30 
a.m. each day.
    To register, please complete registration online at http://www.diaglobal.org/en/conference-listing/meetings/2016/04/dia-fda-statistics-2016-forum/register. (FDA has verified the Web 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:

------------------------------------------------------------------------
                           Category                               Cost
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Industry Representatives......................................    $1,350
Charitable Nonprofit/Academic (Full time).....................       675
Government (Full time)........................................       405
Tutorial Fees.................................................       405
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    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.

B. Accommodations

    Attendees are responsible for their own hotel accommodations. 
Attendees making reservations at the Bethesda North Marriot Hotel and 
Conference Center, 5701 Marinelli Rd., North Bethesda, MD 20852 are 
eligible for a reduced rate of $199, not including applicable taxes.
    The Marriott Bethesda North Hotel and Conference Center has a 
limited

[[Page 12500]]

number of rooms available at the discounted rate of $199 per night 
until April 1, 2016, or until the block is filled. To receive the 
reduced rate, hotel reservations must be made with onPeak, https://compass.onpeak.com/e/72FOR16, and not directly with the hotel. If you 
need special accommodations due to a disability, please contact 
[email protected] at least 7 days in advance.

    Dated: March 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05219 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P