[Federal Register: January 9, 2007 (Volume 72, Number 5)]
[Notices]
[Page 967-968]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja07-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0347]
In Vitro Diagnostic Multivariate Index Assays; 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 a public
meeting on In Vitro Diagnostic Multivariate Index Assays. The meeting
is intended to provide a public forum during which FDA will hear
presentations and comments from interested stakeholders regarding the
draft guidance entitled ``Draft Guidance for Industry, Clinical
Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index
Assays.'' This draft guidance is intended to provide clarification on
FDA's approach to regulation of in vitro diagnostic multivariate index
assays. FDA is seeking comments on this draft guidance.
DATES: The public meeting will be held on February 8, 2007, from 8 a.m.
to 5 p.m. Online registration is available until 5 p.m. on February 5,
2007; however, if space permits onsite registration will be permitted
on February 8, 2007 (see the Registration section of this notice for
details).
ADDRESSES: The public meeting will be held at the Grand Ballroom of
the Hilton Washington DC/Gaithersburg Hotel located at 620 Perry Pkwy.,
Gaithersburg, MD 20877. Additional information about and directions to
the facility are available by calling the hotel at 1-301-977-8900 or on
the Internet at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.hilton.com (under Find a Hotel, type in
Gaithersburg, MD under city and State). (FDA has verified the Web site
address, but FDA is not responsible for any subsequent changes to the
Web site after this document publishes in the Federal Register.)
The comment period on this draft guidance closes on March 5, 2007.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments on the draft guidance
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: Sousan Altaie, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0450, ext. 106, e-mail:
Sousan.Altaie@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA announced the availability of a draft guidance entitled ``Draft
Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro
Diagnostic Multivariate Index Assays,'' on September 7, 2006 (71 FR
52800). This draft guidance addresses the definition and regulatory
status of a class of in vitro diagnostic devices referred to as In
Vitro Diagnostic Multivariate Index Assays (IVDMIAs). The draft
guidance also addresses premarket and postmarket requirements with
respect to IVDMIAs. An IVDMIA employs clinical data, which may be
derived in part from one or more in vitro assays, and an algorithm to
integrate the variables, and reports a result that cannot be
interpreted by the well-trained health care practitioner using prior
knowledge of medicine without information from the test developer
regarding its clinical performance and effectiveness.
FDA is seeking comments on this draft guidance and has extended the
comment period to March 5, 2007 (71 FR 68822). FDA is announcing in
this notice a public meeting on this draft guidance.
II. Agenda
FDA will start the meeting with a brief presentation on the draft
guidance entitled ``Draft Guidance for Industry, Clinical Laboratories,
and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.'' The
purpose of this meeting is to obtain public input on this guidance.
Hence, presentations by the public will make-up the remainder of the
agenda. Interested persons who would like to make a presentation during
the meeting will be given 10 minutes to do so if they submit their
request (electronic or written) and a copy of the material to be
presented by February 1, 2007, to the contact person, Sousan Altaie, at
the address or the email above and to the docket for this draft
guidance. Depending upon the number of presenters submitting requests
to present, the allotted time may be expanded or shortened to provide
appropriate representation by all interested parties. Presentations and
comments are to be identified with the docket number found in brackets
in the heading of this document.
This public meeting agenda will be available on the Internet on
February 7, 2007, at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/[fxsp0]cdrh/[fxsp0]oivd/
meetings/[fxsp0]020807agenda.html.
III. Registration
Those interested in attending may register online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/
[fxsp0]scripts/[fxsp0]cdrh/[fxsp0]cfdocs/cfSUD/
[fxsp0]oivd--meeting.cfm. There is no registration fee to attend the
meeting. Please submit registration early in order to reserve a space,
as space is limited. You may register online until February 5, 2007;
however, onsite registration will be permitted if space remains. If you
require special accommodations due to a disability, please contact the
Hilton Washington DC/Gaithersburg Hotel directly at 1-301-977-8900, at
least 7 days in advance.
Persons without Internet access may call Sousan Altaie at 240-276-
0450 ext. 106, by February 5, 2007, to register for onsite meeting
attendance.
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
[[Page 968]]
receives on the docket (Docket Number 2006D-0347). Suggestions,
recommendations, and materials may be seen at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
V. Transcripts
Following the meeting, transcripts will be available for review at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/oivd/presentations.html#r, and the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: January 3, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-93 Filed 1-8-07; 8:45 am]
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