[Federal Register: May 23, 2006 (Volume 71, Number 99)]
[Notices]
[Page 29651-29652]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my06-51]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0191]
Draft Guidance for Industry and Food and Drug Administration
Staff; Guidance for the Use of Bayesian Statistics in Medical Device
Clinical Trials; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Guidance for the Use of
Bayesian Statistics in Medical Device Clinical Trials.'' This draft
guidance provides FDA's recommendations on the use of Bayesian
statistical methods in the design and analysis of medical device
clinical trials. This draft guidance is neither final nor is it in
effect at this time.
DATES: Submit written or electronic comments on this draft guidance by
August 21, 2006.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for the Use of Bayesian
Statistics in Medical Device Clinical Trials'' to the Division of Small
Manufacturers, International, and Consumer Assistance (HFZ-220), Center
for Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit written comments concerning this 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: Greg Campbell, Center for Devices and
Radiological Health (HFZ-542), Food
[[Page 29652]]
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,
240-276-3127.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance outlines FDA's current thinking on the use of
Bayesian statistical methods in medical device clinical trials.
Bayesian statistical methods are currently used in a variety of medical
device applications to FDA. This draft guidance includes a general
description of Bayesian methods, discussions on design and analysis of
Bayesian medical device clinical trials, the benefits and difficulties
with the Bayesian approach, and comparisons with standard (frequentist)
statistical methods. Finally, the draft guidance presents some ideas on
using Bayesian methods in postmarket studies.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on use of
Bayesian statistics in medical device clinical trials. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.
III. Electronic Access
To receive ``Guidance for the Use of Bayesian Statistics in Medical
Device Clinical Trials'' by fax, call the CDRH Facts-On-Demand system
at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to
enter the system. At the second voice prompt, press 1 to order a
document. Enter the document number (1601) followed by the pound sign
(). Follow the remaining voice prompts to complete your
request.
Persons interested in obtaining a copy of the draft guidance may
also do so by using the Internet. CDRH maintains an entry on the
Internet for easy access to information including text, graphics, and
files that may be downloaded to a personal computer with Internet
access. Updated on a regular basis, the CDRH home page includes device
safety alerts, Federal Register reprints, information on premarket
submissions (including lists of approved applications and
manufacturers' addresses), small manufacturer's assistance, information
on video conferencing and electronic submissions, Mammography Matters,
and other device-oriented information. The CDRH Web site may be
accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/.
guidance.html. Guidance documents are also available on the Division of
Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807 have been approved under
0910-0120; the collections of information in 21 CFR part 812 have been
approved under 0910-0078; the collections of information in 21 CFR part
814 have been approved under 0910-0231; and the collections of
information in 21 CFR part 822 have been approved under 0910-0449.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Comments received may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7855 Filed 5-22-06; 8:45 am]
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