Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice, 30426-30427 [E6-8088]
Download as PDF
<![CDATA[
30426
Federal Register / Vol. 71, No. 102 / Friday, May 26, 2006 / Notices
distribution of the device is in the
interests of the public health. Section
812.36(f) identifies the reports required
to allow FDA to monitor the size and
scope of the treatment IDE, to assess the
sponsor’s due diligence in obtaining
marketing clearance of the device and to
ensure the integrity of the controlled
clinical trials.
Section 812.140 lists the
recordkeeping requirements for
investigators and sponsors. FDA
requires this information for tracking
and oversight purposes. Investigators
are required to maintain records,
including correspondence and reports
concerning the study; records of receipt,
use or disposition of devices; records of
each subject’s case history and exposure
to the device; informed consent
documentation; study protocol and
documentation of any deviation from
the protocol. Sponsors are required to
maintain records including
correspondence and reports concerning
the study; records of shipment and
disposition; signed investigator
agreements; adverse device effects
information; and, for a nonsignificant
risk device study, an explanation of the
nonsignificant risk determination,
records on device name and intended
use, study objectives, investigator
information, investigational review
board (IRB) information, and statement
on the extent that good manufacturing
practices will be followed.
The most likely respondents to this
information collection will primarily be
medical device manufacturers,
investigators, hospitals, health
maintenance organizations, and
businesses.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Annual Frequency per
Response
No. of Respondents
812.10
1
Total Annual Responses
1
Hours per Response
Total Hours
1
1
1
812.20, 812.25,
and 812.27
600
0.5
275
80
22,000
812.35 and
812.150 (reports for significant risk
studies)
600
7.8
4700
6
28,200
812.150 (reports
for non-significant risk studies)
600
0.017
10
6
60
812.36(c)
1
1
1
120
120
812.36(f)
1
2
2
20
40
Total
1There
50,421
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of Recordkeepers
812.140 Original
812.140 Supplemental
812.140 Non-significant
Total
1There
Annual Frequency per
Recordkeeping
600
0.5
600
600
Total Annual Records
Total Hours
275
10
2,750
7
4,700
1
4,700
1
600
6
3,600
11,050
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–8125 Filed 5–25–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
jlentini on PROD1PC65 with NOTICES
Hours per Recordkeeper
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee; Amendment of
Notice
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Aug<31>2005
16:12 May 25, 2006
Jkt 208001
PO 00000
Notice
Frm 00062
Fmt 4703
Sfmt 4703
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Orthopaedic
and Rehabilitation Devices Panel of the
Medical Devices Advisory Committee.
This meeting was announced in the
Federal Register of April 19, 2006 (71
FR 20111). The amendment is being
made to reflect a change in the
Procedure portion of the document,
specifically due to a change in the
scheduling of the oral presentations
E:\FR\FM\26MYN1.SGM
26MYN1
Federal Register / Vol. 71, No. 102 / Friday, May 26, 2006 / Notices
from the public. There are no other
changes.
FOR FURTHER INFORMATION CONTACT:
Janet L. Scudiero, Center for Devices
and Radiological Health (HFZ–410),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–594–1184, ext. 176, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512521. Please call the Information
Line for up-to-date information on this
meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 19, 2006, FDA
announced that a meeting of the
Orthopaedic and Rehabilitation Devices
Panel of the Medical Devices Advisory
Committee would be held on June 2,
2006, from 8:30 a.m. to 3:30 p.m. On
page 20111, in the second and third
columns, the Procedure portion is
amended to read as follows:
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before May 19, 2006. Oral
presentations from the public will be
scheduled for approximately 30 minutes
at the beginning of the committee
deliberations and for approximately 30
minutes near the end of the
deliberations. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before May 19,
2006.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: May 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–8088 Filed 5–25–06; 8:45 am]
BILLING CODE 4160–01–S
jlentini on PROD1PC65 with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
VerDate Aug<31>2005
16:12 May 25, 2006
Jkt 208001
ACTION:
Notice.
SUMMARY: 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.
Tetrahalogenated Compounds Useful as
Inhibitors
Description of Technology: Cancer is
the second leading cause of death in
United States and it is estimated that
there will be approximately 600,000
deaths caused by cancer in 2006. A
major drawback of the existing
chemotherapies is the cytotoxic sideeffects that are associated with them.
Thus, there is a need to develop new
therapeutic approaches with reduced
side-effects.
Anti-angiogenic therapy is a recent
approach in cancer therapeutics
targeting the formation of blood vessels
that are necessary for tumor growth.
Recently, the anti-angiogenic molecule
bevacizumab (Avastin) has gained
approval from the FDA for the first-line
treatment of metastatic colon cancer in
combination with standard
chemotherapy. Another promising antiangiogenic molecule is thalidomide.
Thalidomide has been approved as an
anti-cancer agent and for other use in
Europe and Australia. However, its use
as a drug has been limited by its effect
as a teratogen, necessitating the
development of new thalidomide
analogs with improved efficacy and
reduced toxicity.
This technology describes synthesis of
several tetrahalogenated thalidomide
derivatives that are potentially more
anti-angiogenic than thalidomide. More
specifically, two series of analogs based
on two major common pharmacophores
have been synthesized. One series
preserves the thalidomide common
structure, while the other series
contains a different common structure
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
30427
(tetrafluorobenzamides). Several analogs
from both series have shown significant
anti-angiogenic properties, in vitro. This
technology has therapeutic potential for
a broad spectrum of cancer related
diseases alone, or in combination with
existing therapies.
Applications: Novel tetrahalogenated
thalidomide analogs containing the
thalidomide pharmacophore with
improved anti-angiogenic activity;
Novel tetrahalogenated thalidomide
analogs containing a different common
structure (tetrafluorobenzamides) with
considerable anti-angiogenic activity;
Use of the compounds for the treatment
of several cancers; Use of the
compounds for the treatment other
diseases including autoimmune
diseases.
Market: 600,000 deaths from cancer
related diseases estimated in 2006. The
technology platform involving novel
anti-angiogenic small molecule cancer
therapy technology has a potential
market of more than 2 billion U.S.
dollars. The technology platform has
additional market in treating several
other clinical problems such as
autoimmune diseases.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: William D. Figg (NCI), Erin
Lepper (SAIC), et al.
Publications:
SS Ng et al., ‘‘Antitumor effects of
thalidomide analogs in human prostate
cancer xenografts implanted in
immunodeficient mice,’’ Clin Cancer
Res. 2004 Jun 15; 10 (12 Pt 1):4192–7.
WL Dahut et al., ‘‘Randomized phase
II trial of docetaxel plus thalidomide in
androgen-independent prostate cancer,’’
J Clin Oncol. 2004 Jul 1; 22 (13): 2532–
9.
S Kumar et al., ‘‘Antimyeloma activity
of two novel N-substituted and
tetraflourinated thalidomide analogs,’’
Leukemia 2005 Jul; 19 (7):1253–61.
Patent Status: U.S. Provisional
Application filed 13 Apr 2006 (HHS
Reference No. E–080–2006/0–US–01).
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: David A.
Lambertson, PhD.; 301–435–4632;
lambertsond@od.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Center for
Cancer Research, Medical Oncology
Branch, Molecular Pharmacology
Section is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize tetrafluorinated
compounds as anti-cancer therapeutics.
E:\FR\FM\26MYN1.SGM
26MYN1
]]>Agencies
[Federal Register Volume 71, Number 102 (Friday, May 26, 2006)]
[Notices]
[Pages 30426-30427]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8088]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Orthopaedic and Rehabilitation Devices
Panel of the Medical Devices Advisory Committee. This meeting was
announced in the Federal Register of April 19, 2006 (71 FR 20111). The
amendment is being made to reflect a change in the Procedure portion of
the document, specifically due to a change in the scheduling of the
oral presentations
[[Page 30427]]
from the public. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Janet L. Scudiero, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512521. Please call the Information
Line for up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 19, 2006,
FDA announced that a meeting of the Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices Advisory Committee would be held
on June 2, 2006, from 8:30 a.m. to 3:30 p.m. On page 20111, in the
second and third columns, the Procedure portion is amended to read as
follows:
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
19, 2006. Oral presentations from the public will be scheduled for
approximately 30 minutes at the beginning of the committee
deliberations and for approximately 30 minutes near the end of the
deliberations. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before May 19, 2006.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: May 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-8088 Filed 5-25-06; 8:45 am]
BILLING CODE 4160-01-S
