[Federal Register Volume 71, Number 27 (Thursday, February 9, 2006)]
[Notices]
[Pages 6779-6781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0012]


Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Pharmacogenetic Tests and 
Genetic Tests for Heritable Markers.'' This draft guidance document is 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DATES: Submit written or electronic comments on this draft guidance by 
May 10, 2006.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Pharmacogenetic 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 or submit written 
requests for single copies of the

[[Page 6780]]

guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist the 
office in processing your requests. The guidance may also be obtained 
by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one 
self-addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. 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    Submit written comments concerning this draft guidance to the 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. 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 (CDRH) 
(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 the Center 
for Drug Evaluation and Research (CDER), contact: Allen Rudman, Office 
of Clinical Pharmacology and Biopharmaceutics (HFD-850), Food and Drug 
Administration, 10903 New Hampshire Ave., W021, rm. 3666, Silver 
Spring, MD 20993-0002, 301-796-1597.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document 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). Tests of gene 
expression and tests for non-heritable (somatic) mutations are not 
specifically addressed, although many of the same principles may apply. 
Likewise, this draft guidance specifically addresses only nucleic-acid 
based analysis, but some of the principles may be applied to other 
matrices (e.g., protein), when the purpose is to provide genetic 
information.
    FDA issued an earlier version of this draft guidance on February 
27, 2003, entitled ``Draft Guidance for Industry and FDA Reviewers; 
Multiplex Tests for Heritable DNA Markers, Mutations and Expression 
Patterns.'' The notice of availability for the February 27, 2003, draft 
guidance was published in the Federal Register of April 21, 2003 (68 FR 
19549) and the comment period closed on July 21, 2003. As explained in 
the February 27, 2003, draft guidance and April 21, 2003, document, we 
recognized that discussions on this topic had been introductory. 
Because of this, we explained that the February 2003 draft guidance 
would be followed by another draft guidance that would provide an 
opportunity for additional discussion. As stated in the April 2003 
document, we believe the public health will benefit from this dialogue 
with industry about appropriate ways to review this technology.
    We received several comments on the 2003 draft guidance, which 
included comments suggesting that the draft guidance was too broad in 
scope. The 2003 draft guidance document addressed both gene expression 
and genetic tests. The draft guidance announced in this Federal 
Register document, ``Pharmacogenetic Tests and Genetic Tests for 
Heritable Markers,'' instead focuses on genetic tests.
    In developing the draft guidance announced in this document, FDA 
considered the comments received on the 2003 draft guidance and also 
information we received through our participation at seminars and 
workshops with representatives from the drug and device industries, 
professional societies, laboratory professionals, healthcare providers, 
and other stakeholders. These seminars and workshops included 
discussions of the criteria that are important in the analytical and 
clinical validation of multiplex tests, including pharmacogenetic and 
genetic assays. These discussions also explored the kind of information 
the industry might submit to the agency to achieve the least burdensome 
means of demonstrating substantial equivalence or evaluating safety and 
effectiveness.

II. 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 
``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

    To receive ``Pharmacogenetic Tests and Genetic Tests for Heritable 
Markers'' by fax machine, call the CDRH Facts-On-Demand system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter 
the system. At the second voice prompt, press 1 to order a document. 
Enter the document number (1549) followed by the pound sign 
(). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. 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. A search capability for all CDRH 
guidance documents is available at http://www.fda.gov/cdrh/guidance.html. CBER's guidance documents are available at http://www.fda.gov/cber/guidelines.htm. Guidance documents are also available 
on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This draft 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; 21 CFR part 814 have been 
approved under OMB Control No. 0910-0231; 21 CFR part 801 and 21 CFR 
part 809 have been approved under OMB Control No. 0910-0485.

[[Page 6781]]

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. Comments received may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: February 1, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-1787 Filed 2-8-06; 8:45 am]
BILLING CODE 4160-01-S