National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 42503-42504 [2012-17492]
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Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK67QTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Ophthalmic
Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 28, 2012, from 8 a.m.
to 6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, C and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900.
Contact Person: Natasha Facey, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
1544, Silver Spring, MD 20993–0002,
Natasha.Facey@fda.hhs.gov, 301–796–
5290, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), to find out further information
regarding FDA advisory committee
information. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On September 28, 2012, the
committee will discuss, make
recommendations and vote on
information regarding the humanitarian
device exemption (HDE) application for
the Argus II Retinal Prosthesis System
sponsored by Second Sight Medical
Products, Inc. The proposed Indication
for Use for the Argus II (as stated in the
HDE) is as follows:
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The Argus II System is indicated for
use in patients with severe to profound
retinitis pigmentosa who meet the
following criteria:
• Adults, age 25 years or older.
• Bare light or no light perception in
both eyes with Snellen acuity worse
than 20/2100 or 2.1 logMAR. If the
patient has no residual light perception,
the retina must be able to respond to
electrical stimulation as evidenced by
an electrically evoked response.
• Previous history of useful form
vision.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
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 September 17, 2012.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on September 28, 2012.
Those individuals interested in making
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 September 7, 2012. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
September 10, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
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42503
require special accommodations due to
a disability, please contact AnnMarie
Williams at
Annmarie.Williams@fda.hhs.gov or
301–796–5966, at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 16, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–17668 Filed 7–18–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Science Education
Awards (R25).
Date: July 31, 2012.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Richard W. Morris, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 6700–B
Rockledge Drive, MSC–7616, Room 3251,
Bethesda, MD 20892–7616, 301–451–2663,
rmorris@niaid.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
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Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Notices
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: July 13, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: July 13, 2012.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–17512 Filed 7–18–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
[FR Doc. 2012–17492 Filed 7–18–12; 8:45 am]
Prospective Grant of Exclusive
License: Development of a Diagnostic
Tool for Diagnosing Benign Versus
Malignant Thyroid Lesions
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
emcdonald on DSK67QTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: CMIP and MEDI Continuous
Submission Review Panel.
Date: July 27, 2012.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Guo Feng Xu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5122,
MSC 7854, Bethesda, MD 20892, 301–237–
9870, xuguofen@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
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This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in PCT Patent Application
No. PCT/US2005/12289, U.S. Patent No.
7,901,881, U.S. Patent Application No.
13/024,845 and foreign equivalents
thereof entitled ‘‘Diagnostic Tool for
Diagnosing Benign Versus Malignant
Thyroid Lesions’’ (HHS Ref. No. E–124–
2004/0,1,2) and PCT Patent Application
No. PCT/US2008/010139 and U.S.
Patent Application No. 12/675,209
entitled ‘‘Diagnostic Tool for Diagnosing
Benign Versus Malignant Thyroid
Lesions’’ (HHS Ref. No. E–326–2007/0)
to Veracyte, Inc., which is located in
San Francisco, California. The patent
rights in these inventions have been
assigned to the United States of
America.
Other than license applications
submitted as objections to this Notice of
Intent to Grant an Exclusive License, no
further license applications will be
considered for the exclusive field of use
set forth below if Veracyte, Inc. is
granted an exclusive license pursuant to
this Notice of Intent to Grant an
Exclusive License. The prospective
exclusive license territory may be
worldwide and the field of use may be
limited to the use of Licensed Patent
Rights for the diagnosis and prognosis of
thyroid cancer.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
August 20, 2012 will be considered, in
addition to the current non-exclusive
applications under consideration, for
the prospective license territory and
SUMMARY:
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field of use to be granted under the
contemplated exclusive patent license.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Whitney A. Hastings,
Ph.D., Licensing and Patenting Manager,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 451–
7337; Facsimile: (301) 402–0220; Email:
hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
technology is based on the discovery of
differentially expressed thyroid (DET)
genes and their encoded proteins whose
expression levels can be correlated to
benign or malignant states in a thyroid
cell. Specifically, this data arose from a
microarray analysis of genes expressed
in the eight subtypes of thyroid tumors
that are typically difficult to diagnose by
cytology of fine needle aspiration (FNA)
biopsies. Analysis of the (DET) genes
led to the development of 6 gene and 10
gene models that distinguish benign vs.
malignant papillary thyroid tumors.
Subsequently, a 72 gene model has been
developed for diagnosing less common
forms of thyroid cancer such as
follicular carcinoma. These results
provide a molecular classification
system for thyroid tumors and this in
turn provides a more accurate
diagnostic tool for the clinician
managing patients with suspicious
thyroid lesions. In addition to
diagnostics, this invention can be used
in the staging of thyroid malignancies
by measuring changes in DET gene and
protein expression relative to reference
cells. Finally, this invention can also be
used in the discovery of therapeutic
agents through the detection in changes
of DET gene and protein levels prior to
and after treatment.
The prospective exclusive license and
any further license applications
received as objections to this Notice of
Intent to Grant an Exclusive License,
will be royalty bearing and will comply
with the terms and conditions of 35
U.S.C. 209 and 37 CFR 404.7. The
prospective exclusive license may be
granted unless within thirty (30) days
from the date of this published notice,
the NIH receives written evidence and
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR 404.7.
Any additional applications for a
license in the field of use filed in
response to this notice will be treated as
objections to the grant of the
contemplated exclusive license.
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Agencies
[Federal Register Volume 77, Number 139 (Thursday, July 19, 2012)]
[Notices]
[Pages 42503-42504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17492]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; NIAID Science Education Awards
(R25).
Date: July 31, 2012.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6700B Rockledge Drive,
Bethesda, MD 20817, (Telephone Conference Call).
Contact Person: Richard W. Morris, Ph.D., Scientific Review
Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, 6700-B
Rockledge Drive, MSC-7616, Room 3251, Bethesda, MD 20892-7616, 301-
451-2663, rmorris@niaid.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing
[[Page 42504]]
limitations imposed by the review and funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: July 13, 2012.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-17492 Filed 7-18-12; 8:45 am]
BILLING CODE 4140-01-P