[Federal Register: September 17, 2007 (Volume 72, Number 179)]
[Notices]
[Page 52885-52886]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se07-65]
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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Draft Guidance for Industry, Clinical Laboratories, and Food and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October 17, 2007, the comment period for ``Draft Guidance for Industry,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public meeting on the draft guidance in February 2006.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document entitled ``Draft Guidance for industry, Clinical Laboratories,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Submit written comments concerning this draft guidance to the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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
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
[[Page 52886]]
on video conferencing and electronic submissions, Mammography Matters,
and other device-oriented information. 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://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.
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