[Federal Register: May 9, 2007 (Volume 72, Number 89)]
[Notices]
[Page 26398-26399]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my07-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0137]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Gene Expression Profiling
Test System for Breast Cancer Prognosis; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document: Gene Expression Profiling Test System for Breast
Cancer Prognosis.'' This guidance document describes a means by which
gene expression profiling test systems for breast cancer prognosis may
comply with the requirement of special controls for class II devices.
It includes recommendations for validation of performance
characteristics and recommendations for product labeling. Elsewhere in
this issue of the Federal Register, FDA is publishing a final rule to
classify gene expression profiling test systems for breast cancer
prognosis into class II (special controls). This guidance document is
immediately in effect as the special control for gene expression
profiling test systems for breast cancer prognosis, but it remains
subject to comment in accordance with the agency's good guidance
practices (GGPs).
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document: Gene
Expression Profiling Test System for Breast Cancer Prognosis'' 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 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: Reena Philip, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-1286.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying gene expression profiling test systems for
breast cancer prognosis into class II (special controls) under section
513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360c(f)(2)). This guidance document will serve as the special
control for gene expression profiling test systems for breast cancer
prognosis devices. Section 513(f)(2) of the act provides that any
person who submits a premarket notification under section 510(k) of the
act (21 U.S.C. 360(k)) for a device that has not previously been
classified may, within 30 days after receiving an order classifying the
device in class III under section 513(f)(1), request FDA to classify
the device under the criteria set forth in section 513(a)(1). FDA
shall, within 60 days of receiving such a request, classify the device
by written order. This classification shall be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing such classification. Because of the timeframes
established by section 513(f)(2) of the act, FDA has determined, under
Sec. 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to
allow for public participation before issuing this guidance as a final
guidance document. Thus, FDA is issuing this guidance document as a
level 1 guidance document that is immediately in effect. FDA will
consider any comments that are received in response to this notice to
determine whether to amend the guidance document.
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGPs regulation
(Sec. 10.115). The guidance represents the agency's current thinking
on gene expression profiling test systems for breast cancer prognosis.
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.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Class II Special Controls Guidance
Document: Gene Expression Profiling Test System for Breast Cancer
Prognosis,'' 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 1627 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. 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
.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB Control No. 0910-0120; the collections of
information in 21 CFR part 814 have been approved under OMB Control No.
0910-0231; the collections of information in 21 CFR part 809 have been
approved under OMB Control No. 0910-0485; and the collections of
information in 21 CFR part 820 have been approved under OMB Control No.
0910-0073.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic
[[Page 26399]]
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: May 1, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-8872 Filed 5-8-07; 8:45 am]
BILLING CODE 4160-01-S