[Federal Register Volume 72, Number 117 (Tuesday, June 19, 2007)]
[Notices]
[Pages 33765-33766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11817]


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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://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://www.fda.gov/
cdrh. Search capabilities for guidance documents are available at 
http://www.fda.gov/cdrh/guidance.html (for CDRH guidances) and 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://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