Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period, 44267 [2010-18406]
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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Notices
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, including the validity of
the methodology and assumptions used;
(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 the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Ms.
Kimberly Allen, NIGMS, NIH, Natcher
Building, Room 2AN–18H, 45 Center
Drive, MSC 6200, Bethesda, MD 20892–
6200, or call non-toll-free number 301–
594–2755 or e-mail your request,
including your address to
allenki@nigms.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: July 19, 2010.
Sally Lee,
Executive Officer, NIGMS, National Institute
of General Medical Sciences, National
Institutes of Health.
[FR Doc. 2010–18509 Filed 7–27–10; 8:45 am]
BILLING CODE 4140–01–P
Food and Drug Administration
sroberts on DSKD5P82C1PROD with NOTICES
[Docket No. FDA–2009–N–0495]
Draft Guidance for Industry and Food
and Drug Administration Staff; Medical
Devices; Neurological and Physical
Medicine Device Guidance Document;
Reopening of Comment Period
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
period.
The Food and Drug
Administration (FDA) is reopening until
SUMMARY:
VerDate Mar<15>2010
19:05 Jul 27, 2010
Jkt 220001
Submit either electronic or
written comments by September 7,
2010.
DATES:
Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
ADDRESSES:
III. How to Submit Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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: July 22, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–18406 Filed 7–27–10; 8:45 am]
BILLING CODE 4160–01–S
FOR FURTHER INFORMATION CONTACT:
Robert J. DeLuca, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. G214, Silver Spring,
MD 20993–0002, e-mail:
Robert.DeLuca@fda.hhs.gov, 301–796–
6630.
In the Federal Register of April 5,
2010 (75 FR 17093), FDA published a
notice announcing the availability of
draft special controls guidance
documents for 11 neurological and
physical medicine devices. Interested
persons were originally given until July
6, 2010, to comment on the draft
guidance documents. The agency
expressed specific interest in comments
on the types of claims appropriate for
devices included within the 11
classifications and, for devices that
remain subject to premarket review, the
data sponsors should submit to support
those claims.
Following publication of the April 5,
2010, notice, FDA received requests to
allow interested persons additional time
to comment. The requests asserted that
the 90-day time period was insufficient
to respond fully to FDA’s specific
requests for comments and to allow
potential respondents to thoroughly
evaluate and address pertinent issues.
The agency has considered the requests
and is reopening the comment period
until September 7, 2010. The agency
believes the additional comment period
allows adequate time for interested
persons to submit comments without
significantly delaying rulemaking on
these important issues.
Frm 00054
Fmt 4703
Sfmt 4703
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
I. Background
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
SUPPLEMENTARY INFORMATION:
II. Request for Comments
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
September 7, 2010, the comment period
for the notice that appeared in the
Federal Register of April 5, 2010 (75 FR
17143). In the notice, FDA requested
comments on draft guidance documents
for 11 neurological and physical
medicine devices. FDA is reopening the
comment period to allow further
comment and to receive any new
information.
44267
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: (301)
496–7057; fax: (301) 402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Software System With Applications in
Clinical Prognosis, Personalized
Medicine and Clinical Research
Description of Invention: Available for
licensing is software that can provide
prognostic information for different
diseases and in particular for cancer.
The software can determine whether a
particular genotype has a significant
association with survival time for an
E:\FR\FM\28JYN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Notices]
[Page 44267]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18406]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0495]
Draft Guidance for Industry and Food and Drug Administration
Staff; Medical Devices; Neurological and Physical Medicine Device
Guidance Document; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reopening until
September 7, 2010, the comment period for the notice that appeared in
the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA
requested comments on draft guidance documents for 11 neurological and
physical medicine devices. FDA is reopening the comment period to allow
further comment and to receive any new information.
DATES: Submit either electronic or written comments by September 7,
2010.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Robert J. DeLuca, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. G214, Silver Spring, MD 20993-0002, e-
mail: Robert.DeLuca@fda.hhs.gov, 301-796-6630.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 5, 2010 (75 FR 17093), FDA
published a notice announcing the availability of draft special
controls guidance documents for 11 neurological and physical medicine
devices. Interested persons were originally given until July 6, 2010,
to comment on the draft guidance documents. The agency expressed
specific interest in comments on the types of claims appropriate for
devices included within the 11 classifications and, for devices that
remain subject to premarket review, the data sponsors should submit to
support those claims.
II. Request for Comments
Following publication of the April 5, 2010, notice, FDA received
requests to allow interested persons additional time to comment. The
requests asserted that the 90-day time period was insufficient to
respond fully to FDA's specific requests for comments and to allow
potential respondents to thoroughly evaluate and address pertinent
issues. The agency has considered the requests and is reopening the
comment period until September 7, 2010. The agency believes the
additional comment period allows adequate time for interested persons
to submit comments without significantly delaying rulemaking on these
important issues.
III. How to Submit Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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: July 22, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-18406 Filed 7-27-10; 8:45 am]
BILLING CODE 4160-01-S
