[Federal Register Volume 72, Number 179 (Monday, September 17, 2007)]
[Notices]
[Pages 52885-52886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18221]


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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Draft Guidance for Industry, Clinical Laboratories, and Food and 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; Reopening of the Comment Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; reopening of comment period.

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SUMMARY:  The Food and Drug Administration (FDA) is reopening until 
October 17, 2007, the comment period for ``Draft Guidance for Industry, 
Clinical Laboratories, and FDA Staff on In Vitro Diagnostic 
Multivariate Index Assays'' published in the Federal Register of July 
26, 2007 (72 FR 41081). That guidance was a revised version of the 
original draft, which was published on September 7, 2006, with a 90-day 
comment period that was extended to 180 days. In addition, FDA held a 
public meeting on the draft guidance in February 2006. FDA is reopening 
the comment period on the revised draft to allow sufficient time for 
stakeholder comment.

DATES:  Submit written or electronic comments by October 17, 2007.

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document entitled ``Draft Guidance for industry, Clinical Laboratories, 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    Submit written comments concerning this draft guidance to the 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 or http://www.regulations.gov. 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, 240-276-0694.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 26, 2007 (72 FR 41081), FDA 
published a notice of availability of a revised draft guidance, ``Draft 
Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro 
Diagnostic Multivariate Index Assays'' with a 30-day comment period. 
The In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) guidance 
document has been the subject of attention, comment, and public 
discussion for almost a year. The original draft was published on 
September 7, 2006, with a 90-day comment period. In response to 
requests for further opportunity to comment, FDA extended the comment 
period to 180 days and held a public meeting on the guidance document. 
The second draft, which was published July 26, 2007, incorporated many 
of the suggested comments on the first draft. Among other things, the 
second draft simplified the definition of IVDMIAs, and provided a 
variety of specific examples to assist sponsors in understanding the 
definition. In light of the opportunities for comment on the first 
draft, we had originally set a 30-day period for comments on the second 
draft. The initial comment period closed on August 27, 2007. However, 
at the request of in vitro diagnostic device stakeholders, the agency 
has decided to reopen the comment period for an additional 30 days 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 IVDMIAs.

II. Request for Comments

    Following publication of the July 26, 2007, ``Draft Guidance for 
Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic 
Multivariate Index Assays,'' FDA received requests to allow interested 
persons additional time to comment. The requesters asserted that the 
time period of 30 days was insufficient to respond fully to FDA's 
specific requests for comments and to allow potential respondents to 
thoroughly evaluate and address pertinent issues.

III. 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 IVDMIAs. 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.

IV. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To received ``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

[[Page 52886]]

on video conferencing and electronic submissions, Mammography Matters, 
and other device-oriented information. 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.

V. How to Submit 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: September 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18221 Filed 9-14-07; 8:45 am]
BILLING CODE 4160-01-S