[Federal Register: June 19, 2007 (Volume 72, Number 117)]
[Notices]
[Page 33765-33766]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jn07-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0012]
Guidance for Industry and Food and Drug Administration Staff;
Pharmacogenetic Tests and Genetic Tests for Heritable Markers;
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 document entitled ``Pharmacogenetic Tests
and Genetic Tests for Heritable Markers.'' This document is intended to
provide guidance on preparing and reviewing premarket approval
applications (PMAs) and 510(k) submissions for pharmacogenetic and
other genetic tests, whether testing is for single markers or for
multiple markers simultaneously (multiplex tests).
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 ``Pharmacogenetic Tests and Genetic Tests for
Heritable Markers'' 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. You may also obtain the guidance by mail by calling the
Center for Biologics Evaluation and Research at 1-800-835-4709 or 301-
827-1800, or by faxing your request to 301-443-8818. 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: Robert Becker, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-0493, ext. 212.
For use of the guidance in relation to applications to CBER
contact: Stephen M. Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, 301-827-6210.
For use of the guidance in relation to applications to CDER
contact: Felix Frueh, Office of Clinical Pharmacology and
Biopharmaceutics (HFD-850), 10903 New Hampshire Ave., Silver Spring, MD
20993, 301-796-1530.
SUPPLEMENTARY INFORMATION:
I. Background
The draft of this guidance document was published in the Federal
Register of February 9, 2006 (71 FR 6779). The guidance provides
recommendations on preparing and reviewing PMAs and 510(k) submissions
for pharmacogenetic and other human genetic tests, whether testing is
for single markers or for multiple markers simultaneously (multiplex
tests). FDA received several sets of comments on the guidance and
considered all comments. The guidance was revised where needed to
provide additional clarification.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on pharmacogenetic tests and genetic tests
for heritable markers. 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 ``Pharmacogenetic Tests and Genetic
Tests for Heritable Markers'' 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 1594 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.
Search capabilities for guidance documents are available at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html (for CDRH guidances) and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/cber/guidelines.htm (for CBER guidances). Guidance
documents are also available on the Division of Dockets Management
[[Page 33766]]
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 number 0910-0120; the collections of
information in 21 CFR part 814, have been approved under OMB control
number 0910-0231; and the collections of information in 21 CFR parts
801 and 809 have been approved under OMB control number 0910-0485.
V. 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: May 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11817 Filed 6-18-07; 8:45 am]
BILLING CODE 4160-01-S