Draft Guidance for Industry and Food and Drug Administration Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers; Availability, 6779-6781 [E6-1787]
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Federal Register / Vol. 71, No. 27 / Thursday, February 9, 2006 / Notices
controls) and retain those that contain
any therapeutic biologic (e.g., bone
morphogenic protein) in class III. This
draft guidance is not final, nor is it in
effect at this time.
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comments on this draft guidance by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draft guidance document entitled ‘‘Class
II Special Controls Guidance Document:
Intervertebral Body Fusion Device’’ 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 selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–443–8818. See the
SUPPLEMENTARY INFORMATION section of
this document for information on
electronic access to the draft guidance.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this draft guidance to the Division of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 https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Jodi
N. Anderson, Center for Devices and
Radiological Health (HFZ–410), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–594–2036, ext. 186.
SUPPLEMENTARY INFORMATION:
cprice-sewell on PROD1PC66 with NOTICES
I. Background
On December 11, 2003, the
Orthopedic and Restorative Devices
Panel (the panel) recommended that
intervertebral body fusion devices that
contain bone grafting material be
reclassified from class III into class II.
The panel also provided
recommendations on the types of
information the agency should include
in a class II special controls guidance
document for these devices. This
document announces the draft guidance
that is based on these recommendations.
Elsewhere in this issue of the Federal
Register, FDA is publishing a proposed
rule to reclassify these devices.
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This draft guidance is being issued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 intervertebral body fusion devices. It
VerDate Aug<31>2005
13:56 Feb 08, 2006
Jkt 208001
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 ‘‘Class II Special Controls
Guidance Document: Intervertebral
Body Fusion Device’’ by fax, call the
Center for Devices and Radiological
Health (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
(1540) 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
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501–3520). The
collections of information addressed in
the draft guidance document have been
approved by OMB in accordance with
the PRA under the regulations
governing premarket notification
submissions (21 CFR part 807, subpart
E, OMB control number 0910–0120).
The labeling provisions addressed in the
draft guidance have been approved by
OMB under OMB control number 0910–
0485.
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
6779
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: February 1, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–1735 Filed 2–8–06; 8:45 am]
BILLING CODE 4160–01–S
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.
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
E:\FR\FM\09FEN1.SGM
09FEN1
6780
Federal Register / Vol. 71, No. 27 / Thursday, February 9, 2006 / Notices
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 selfaddressed 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 https://
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:
cprice-sewell on PROD1PC66 with NOTICES
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
VerDate Aug<31>2005
13:56 Feb 08, 2006
Jkt 208001
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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 touchtone 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
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
CBER’s guidance documents are
available at https://www.fda.gov/cber/
guidelines.htm. Guidance documents
are also available on the Division of
Dockets Management Internet site at
https://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.
E:\FR\FM\09FEN1.SGM
09FEN1
Federal Register / Vol. 71, No. 27 / Thursday, February 9, 2006 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines; Notice of Meeting
cprice-sewell on PROD1PC66 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Commission on
Childhood Vaccines (ACCV).
Date and Time: March 9, 2006, 9 a.m.–3:30
p.m., EST.
Place: Audio Conference Call and
Parklawn Building, Conference Rooms G & H,
5600 Fishers Lane, Rockville, MD 20857.
The ACCV will meet on Thursday, March
9, from 9 a.m. to 3:30 p.m. The public can
join the meeting in person at the address
listed above or by audio conference call by
dialing 1–800–369–6048 on March 9 and
providing the following information:
Leader’s Name: Dr. Geoffrey Evans.
Password: ACCV.
Agenda: The agenda items for the March
meeting will include, but are not limited to:
An overview of compensation programs in
other countries; results of the National
Vaccine Injury Compensation Program’s
(VICP) Program Assessment Rating Tool; a
discussion of the Division of Vaccine Injury
Compensation’s (DVIC) communication
strategies; a report from the ACCV
Workgroup looking at proposed guidelines
for future changes to the Vaccine Injury
Table; and updates from DVIC, Department of
Justice, National Vaccine Program Office,
Immunization Safety Office (Centers for
Disease Control and Prevention), National
Institute of Allergy and Infectious Diseases
VerDate Aug<31>2005
16:34 Feb 08, 2006
Jkt 208001
(National Institutes of Health), and Center for
Biologics and Evaluation Research (Food and
Drug Administration). Agenda items are
subject to change as priorities dictate.
Public Comments: Persons interested in
providing an oral presentation should submit
a written request, along with a copy of their
presentation to: Ms. Cheryl Lee, Principal
Staff Liaison, DVIC, Healthcare Systems
Bureau (HSB), Health Resources and Services
Administration (HRSA), Room 11C–26, 5600
Fishers Lane, Rockville, Maryland 20857 or
e-mail clee@hrsa.gov. Requests should
contain the name, address, telephone
number, and any business or professional
affiliation of the person desiring to make an
oral presentation. Groups having similar
interests are requested to combine their
comments and present them through a single
representative. The allocation of time may be
adjusted to accommodate the level of
expressed interest. DVIC will notify each
presenter by mail or telephone of their
assigned presentation time. Persons who do
not file an advance request for a presentation,
but desire to make an oral statement, may
announce it at the time of the comment
period. These persons will be allocated time
as it permits.
For Further Information Contact: Anyone
requiring information regarding the ACCV
should contact Ms. Cheryl Lee, Principal
Staff Liaison, DVIC, HSB, HRSA, Room 11C–
26, 5600 Fishers Lane, Rockville, MD 20857;
telephone (301) 443–2124 or e-mail
clee@hrsa.gov.
Dated: February 2, 2006.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–1733 Filed 2–8–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Privacy Act System of Records Notice
09–17–0001, ‘‘Medical, Health and
Billing Records’’: Correction
AGENCY:
Indian Health Service (IHS),
HHS.
ACTION:
Notice: correction.
SUMMARY: The Indian Health Service
published a document in the Federal
Register on December 30, 2005. The
document contained an error.
FOR FURTHER INFORMATION CONTACT:
Contact Ms. Patricia Gowan, IHS Lead
Health Information Management (HIM)
Consultant (Acting), Office of Health
Programs, Phoenix Area Office IHS,
Two Renaissance Square, Suite 606, 40
North Central Avenue, Phoenix, AZ
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
6781
85004 or via the Internet at
Patricia.Gowan@ihs.gov.
Correction
In the Federal Register of December
30, 2005, in FR Doc 05–24644, on page
77407, in the second column, correct
number 5 to read: ‘‘Records may be
disclosed to the Bureau of Indian Affairs
(BIA) or its contractors under an
agreement between IHS and the BIA
relating to disabled AI/AN children for
the purposes of carrying out its
functions under the Individuals with
Disabilities Education Act (IDEAS), 20
U.S.C. 1400, et seq.’’
Re-number 5 to number 6 and so forth
for a total of twenty-four routine uses
instead of twenty-three.
Dated: February 2, 2006.
Robert G. McSwain,
Deputy Director, Indian Health Service.
[FR Doc. 06–1188 Filed 2–8–06; 8:45 am]
BILLING CODE 4165–16–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Program Exclusions: January 2006
AGENCY:
Office of Inspector General,
HHS.
ACTION:
Notice of program exclusions.
During the month of January 2006, the
HHS Office of Inspector General
imposed exclusions in the cases set
forth below. When an exclusion is
imposed, no program payment is made
to anyone for any items or services
(other than an emergency item or
service not provided in a hospital
emergency room) furnished, ordered or
prescribed by an excluded party under
the Medicare, Medicaid, and all Federal
Health Care programs. In addition, no
program payment is made to any
business or facility, e.g., a hospital, that
submits bills for payment for items or
services provided by an excluded party.
Program beneficiaries remain free to
decide for themselves whether they will
continue to use the services of an
excluded party even though no program
payments will be made for items and
services provided by that excluded
party. The exclusions have national
effect and also apply to all Executive
Branch procurement and nonprocurement programs and activities.
E:\FR\FM\09FEN1.SGM
09FEN1
]]>Agencies
[Federal Register Volume 71, Number 27 (Thursday, February 9, 2006)]
[Notices]
[Pages 6779-6781]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1787]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://www.fda.gov/cdrh. A search capability for all CDRH
guidance documents is available at https://www.fda.gov/cdrh/
guidance.html. CBER's guidance documents are available at https://
www.fda.gov/cber/guidelines.htm. Guidance documents are also available
on the Division of Dockets Management Internet site at https://
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
