[Federal Register Volume 71, Number 228 (Tuesday, November 28, 2006)]
[Notices]
[Pages 68822-68823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20032]


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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Draft Guidance for Industry, Clinical Laboratories, and Food and 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comment period on the ``Draft Guidance for Industry, Clinical 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 The agency announced the availability of this draft guidance 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persons additional time to review and submit comments on the draft 
guidance, the agency has decided to extend the comment period.

DATES: Submit written or electronic comments on this draft guidance by 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document entitled ``Draft Guidance for Industry, Clinical Laboratories, 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    Submit written comments concerning this draft guidance to the 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://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://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 
[email protected] 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://www.fda.gov/cdrh. A search 
capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available 
on the Division of Dockets Management Internet site at 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]
BILLING CODE 4160-01-S