[Federal Register Volume 71, Number 125 (Thursday, June 29, 2006)]
[Notices]
[Page 37084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5804]



[[Page 37084]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0191]


The Use of Bayesian Statistics in Medical Device Clinical Trials; 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public meeting: The Use of Bayesian Statistics in Medical 
Device Clinical Trials. The draft guidance entitled ``Guidance for the 
Use of Bayesian Statistics in Medical Device Clinical Trials'' provides 
FDA's recommendations on the use of Bayesian statistical methods in the 
design and analysis of medical device clinical trials.

DATES: The public meeting will be held on July 27, 2006, from 8:30 a.m. 
to 5 p.m. Registration for this meeting is required (see the 
Registration section of this document for details). Submit written or 
electronic comments on the draft guidance by August 21, 2006.

ADDRESSES: The public meeting will be held at The Universities at Shady 
Grove, 9630 Gudelsky Dr., Rockville, MD. Additional information about 
and directions to the facility are available on the Internet at http://www.fda.gov/cdrh/meetings/072706-bayesian.html. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Cindy Garris, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-3150, ext. 121, FAX: 240-276-
3151, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Bayesian statistics is a theory and approach to data analysis that 
provides a coherent method for learning from evidence as evidence 
accumulates. In situations where good information on clinical use of a 
device already exists, the Bayesian approach may enable FDA to reach 
the same decision on a device with a smaller-sized or shorter-duration 
pivotal trial. In other instances, a Bayesian approach can provide 
flexible methods for handling interim analyses and other modifications 
to trials. The draft guidance entitled ``Guidance for the Use of 
Bayesian Statistics in Medical Device Clinical Trials'' describes FDA's 
current thinking on statistical aspects of the design and analysis of 
medical device clinical trials that use Bayesian statistical methods. 
FDA announced the availability of the draft guidance on May 23, 2006 
(71 FR 29651). The draft guidance is available at http://www.fda.gov/cdrh/osb/guidance/1601.html.

II. Agenda

    FDA will provide presentations on the draft guidance entitled 
``Guidance for the Use of Bayesian Statistics in Medical Device 
Clinical Trials'' in the morning. In the afternoon, panels will discuss 
the draft guidance. There will be opportunities for public 
participation throughout the day.

III. Registration

    Online registration for the meeting is required. Acceptance will be 
on a first-registered, first-served basis. There are no assurances of 
onsite registration. Please register online at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfsud/bayesian_meeting.cfm.
    FDA is pleased to provide the opportunity for interested persons to 
listen from a remote location to the live proceedings of the meeting. 
In order to ensure that a sufficient number of call-in lines are 
available, please register to listen to the meeting at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfsud/bayesian_meeting.cfm 
by July 21, 2006.
    Persons without Internet access may call 240-276-3150, ext. 121, by 
July 21, 2006, to register for onsite meeting attendance or to register 
to listen to the meeting by phone. If you need special accommodations 
due to a disability, please contact Cindy Garris (see FOR FURTHER 
INFORMATION CONTACT) at least 7 days in advance of the meeting.

IV. Request for Input and Materials

    FDA is interested in receiving input from stakeholders on the draft 
guidance. Send suggestions or recommendations to the Division of 
Dockets Management (see ADDRESSES). FDA will place an additional copy 
of any material it receives on the docket (Docket No. 2006D-0191). 
Suggestions, recommendations, and materials may be seen at the Division 
of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Transcripts

    Following the meeting, transcripts will be available for review at 
the Division of Dockets Management (see ADDRESSES).

    Dated: June 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-5804 Filed 6-26-06; 12:30 pm]
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