[Federal Register Volume 72, Number 5 (Tuesday, January 9, 2007)]
[Notices]
[Pages 967-968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-93]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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draft guidance entitled ``Draft Guidance for Industry, Clinical 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 This draft guidance is intended to provide clarification on 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 FDA is seeking comments on this draft guidance.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://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    The comment period on this draft guidance closes on March 5, 2007.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 Submit electronic comments on the draft guidance 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://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: 
[email protected].

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://www.fda.gov/cdrh/oivd/meetings/020807agenda.html.

III. Registration

    Those interested in attending may register online at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfSUD/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://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]
BILLING CODE 4160-01-S