Science Board to the Food and Drug Administration; Amendment of Notice; Correction, 33765 [E7-11727]
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Federal Register / Vol. 72, No. 117 / Tuesday, June 19, 2007 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0195]
Science Board to the Food and Drug
Administration; Amendment of Notice;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
June 7, 2007 (72 FR 31587). The
document announced an amendment to
the notice of meeting of the Science
Board to the Food and Drug
Administration. The meeting was
originally announced in the Federal
Register of May 21, 2007 (72 FR 28499).
The document was published with an
incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy and
Planning (HF–27), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7010.
SUPPLEMENTARY INFORMATION: In FR Doc.
07–2829, appearing on page 31587 in
the Federal Register of Thursday, June
7, 2007, the following correction is
made:
1. On page 31587, in the first column,
in the heading of the document,
‘‘[Docket No. 2007N–0208]’’ is corrected
to read ‘‘[Docket No. 2007N–0195]’’.
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).
Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
DATES:
Dated: June 11, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E7–11727 Filed 6–18–07; 8:45 am]
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 selfaddressed 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 https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
BILLING CODE 4160–01–S
FOR FURTHER INFORMATION CONTACT:
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
rwilkins on PROD1PC63 with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance document
VerDate Aug<31>2005
18:32 Jun 18, 2007
Jkt 211001
ADDRESSES:
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:
PO 00000
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33765
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
https://www.fda.gov/cdrh. Search
capabilities for guidance documents are
available at https://www.fda.gov/cdrh/
guidance.html (for CDRH guidances)
and https://www.fda.gov/cber/
guidelines.htm (for CBER guidances).
Guidance documents are also available
on the Division of Dockets Management
E:\FR\FM\19JNN1.SGM
19JNN1
]]>Agencies
[Federal Register Volume 72, Number 117 (Tuesday, June 19, 2007)]
[Notices]
[Page 33765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11727]
[[Page 33765]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0195]
Science Board to the Food and Drug Administration; Amendment of
Notice; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a notice that
appeared in the Federal Register of June 7, 2007 (72 FR 31587). The
document announced an amendment to the notice of meeting of the Science
Board to the Food and Drug Administration. The meeting was originally
announced in the Federal Register of May 21, 2007 (72 FR 28499). The
document was published with an incorrect docket number. This document
corrects that error.
FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and
Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7010.
SUPPLEMENTARY INFORMATION: In FR Doc. 07-2829, appearing on page 31587
in the Federal Register of Thursday, June 7, 2007, the following
correction is made:
1. On page 31587, in the first column, in the heading of the
document, ``[Docket No. 2007N-0208]'' is corrected to read ``[Docket
No. 2007N-0195]''.
Dated: June 11, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-11727 Filed 6-18-07; 8:45 am]
BILLING CODE 4160-01-S
