[Federal Register: June 29, 2006 (Volume 71, Number 125)]
[Notices]
[Page 37084]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn06-61]
[[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 The draft guidance entitled ``Guidance for the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electronic comments on the draft guidance by August 21, 2006.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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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on the draft guidance to the Division of Dockets Management (HFA-305),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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Cynthia.garris@fda.hhs.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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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