Guidance for Industry and Food and Drug Administration Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers; Availability, 33765-33766 [E7-11817]
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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
Frm 00031
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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
33766
Federal Register / Vol. 72, No. 117 / Tuesday, June 19, 2007 / Notices
Internet site at https://www.fda.gov/
ohrms/dockets.
ACTION:
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
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5117–N–48]
Notice of Submission of Proposed
Information Collection to OMB;
Restriction on Assistance to
Noncitizens
SUMMARY: The proposed information
collection requirement described below
has been submitted to the Office of
Management and Budget (OMB) for
review, as required by the Paperwork
Reduction Act. The Department is
soliciting public comments on the
subject proposal.
Section 214 of the Housing and
Community Development Act of 1980,
as amended, prohibits HUD from
making financial assistance available for
noncitizens, unless they meet one of the
categories of eligible immigration status
specified in Section 214. Prior to being
admitted, all eligible noncitizens
younger than age 62 must sign a
declaration of their status and a
verification consent form and provide
their original Immigration and
Naturalization Service (INS)
documentation.
DATES:
Comments Due Date: July 19,
2007.
Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
approval Number (2501–0014) and
should be sent to: HUD Desk Officer,
Office of Management and Budget, New
Executive Office Building, Washington,
DC 20503; fax: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Lillian Deitzer, Departmental Reports
Management Officer, QDAM,
Department of Housing and Urban
Development, 451 Seventh Street, SW.,
Washington, DC 20410; e-mail
Lillian_L._Deitzer@HUD.gov or
telephone (202) 708–2374. This is not a
toll-free number. Copies of available
documents submitted to OMB may be
obtained from Ms. Deitzer or from
HUD’s Web site at https://
www5.hud.gov:63001/po/i/icbts/
collectionsearch.cfm.
ADDRESSES:
This
notice informs the public that the
Department of Housing and Urban
Development has submitted to OMB a
request for approval of the information
SUPPLEMENTARY INFORMATION:
Office of the Chief Information
Officer, HUD.
AGENCY:
Notice.
collection described below. This notice
is soliciting comments from members of
the public and affecting agencies
concerning the proposed collection of
information to: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; (3) Enhance the quality,
utility, and clarity of the information to
be collected; and (4) Minimize the
burden of the collection of information
on those who are to respond; including
through the use of appropriate
automated collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
This notice also lists the following
information:
Title of Proposal: Restriction on
Assistance to Noncitizens.
OMB Approval Number: 2501–0014
Form Numbers: HUD–9886, HUD–
9887.
Description of the Need for the
Information and Its Proposed Use:
Section 214 of the Housing and
Community Development Act of 1980,
as amended, prohibits HUD from
making financial assistance available for
noncitizens, unless they meet one of the
categories of eligible immigration status
specified in Section 214. Prior to being
admitted, all eligible noncitizens
younger than age 62 must sign a
declaration of their status and a
verification consent form and provide
their original Immigration and
Naturalization Service (INS)
documentation.
Frequency of Submission: On
occasion, Annually.
Number of
respondents
rwilkins on PROD1PC63 with NOTICES
Reporting Burden ..............................................................................
VerDate Aug<31>2005
19:06 Jun 18, 2007
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PO 00000
Frm 00032
Annual
responses
2,886,392
3.74
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E:\FR\FM\19JNN1.SGM
×
Hours per
response
.0333
19JNN1
=
Burden hours
360,214
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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 (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 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
[[Page 33766]]
Internet site at https://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
