[Federal Register: November 28, 2006 (Volume 71, Number 228)]
[Notices]
[Page 68822-68823]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28no06-59]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0347]
Draft Guidance for Industry, Clinical Laboratories, and Food and
Drug Administration Staff on In Vitro Diagnostic Multivariate Index
Assays; Availability; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period on the ``Draft Guidance for Industry, Clinical
Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index
Assays.'' The agency announced the availability of this draft guidance
in the Federal Register of September 7, 2006 (71 FR 52800). The initial
comment period closes on December 6, 2006. To provide interested
persons additional time to review and submit comments on the draft
guidance, the agency has decided to extend the comment period.
DATES: Submit written or electronic comments on this draft guidance by
March 5, 2007. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Draft Guidance for Industry, Clinical Laboratories,
and FDA Staff on In Vitro Diagnostic Multivariate Index Assays'' 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 240-276-3151. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit written comments concerning this draft guidance to the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: Courtney Harper, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0490, ext. 162.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is extending the comment period on the ``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.
The agency issued this draft guidance on September 7, 2006. The
initial comment period on the draft guidance closes on December 6,
2006, but at the request of in vitro diagnostic device stakeholders,
the agency has decided to extend the comment period for an additional
90 days, until March 5, 2007.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. 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.
Submit two paper copies of any mailed comments, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Draft Guidance for Industry,
Clinical Laboratories, and FDA Staff on In Vitro Diagnostic
Multivariate Index Assays,'' you may either send an e-mail request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 240-276-3151 to receive a hard copy. Please use
the document number 1610 to identify the guidance you are requesting.
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.
[[Page 68823]]
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://.
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
.
Dated: November 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20032 Filed 11-27-06; 8:45 am]
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