Prospective Grant of Exclusive License: FDA Approvable Human Diagnostic for Osteoarthritis, 3314-3315 [E6-590]
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Federal Register / Vol. 71, No. 13 / Friday, January 20, 2006 / Notices
TABLE 1.—RESPONDENT AND BURDEN ESTIMATES
Estimated number
of respondents
Type of respondents
Estimated number
of responses per
respondent
Telephone Clients (36% sampled):
Demographic questions only ............................................
40,700
Quitline Clients (36% sampled for demographic questions and 100% for smoking questions):
Demographic and smoking questions ..............................
2,400
Smoking questions only ...................................................
4,300
Average burden
hours per
response
Estimated total
annual burden
hours requested
1
.0178
724
1
1
.2678
.25
643
1,075
Subtotal Quitline Clients ............................................
LiveHelp Clients (50% sampled):
Demographic questions ....................................................
6,700
..............................
..............................
..............................
2,000
1
.0178
36
Total ...........................................................................
49,400
..............................
..............................
2,478
The annualized cost to respondents is
estimated at approximately: $44,827.
There are no Capital Costs, Operating
Costs, or Maintenance Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) 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) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to 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.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Linda Squiers,
PhD., Project Officer for Research,
Cancer Information Service Branch,
National Cancer Institute, NIH, 6116
Executive Blvd, MSC 8322, Rockville,
MD, 20892–8322, or call non-toll-free
number (301) 594–9075 or E-mail your
request, including your address, to:
squiersl@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
wwhite on PROD1PC65 with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Aug<31>2005
16:16 Jan 19, 2006
Jkt 208001
Dated: January 8, 2006.
Rachelle Ragland-Greene,
National Institutes of Health, NCI Project
Clearance Liaison.
[FR Doc. E6–593 Filed 1–19–06; 8:45 am]
BILLING CODE 4167–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: FDA Approvable Human
Diagnostic for Osteoarthritis
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: 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 (NIH), Department
of Health and Human Services, is
contemplating the grant of an exclusive
license worldwide to practice the
invention embodied in U.S. Patent
Application Number 60/602,334 filed
August 18, 2005, entitled ‘‘Biomarkers
for Osteoarthritis,’’ to PeptiFarma, Inc.,
having a place of business in San Diego,
CA 92191. The contemplated exclusive
license may be limited to an FDA
approvable human diagnostic for
osteoarthritis. The United States of
America is an assignee of the patent
rights in this invention.
DATES: Only written comments and/or
application for a license which is
received by the NIH Office of
Technology Transfer on or before March
21, 2006 will be considered.
ADDRESSES: Request for a copy of the
patent, inquires, comments, and other
materials relating to the contemplated
license should be directed to: Marlene
Astor, Technology Licensing Specialist,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
PO 00000
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Fmt 4703
Sfmt 4703
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: 301–435–4426;
Facsimile: 301–402–0220; e-mail:
ms482m@nih.gov.
SUPPLEMENTARY INFORMATION:
Osteoarthritis is a chronic, often
progressive and substantially disabling
condition that becomes more common
with advanced age. Osteoarthritis
commonly involves the knees, hands,
hips, neck and back resulting in pain
and limitations of movement.
Unfortunately clinically available
tests are neither capable of detecting
osteoarthritis early in its development,
nor sensitive enough to adequately
assess disease progression. A better
means of diagnosing early osteoarthritis
and its progression that can be used to
assess the response to therapeutic
treatments is needed. The currently
available laboratory techniques are
highly sensitive but either lack
specificity or require large volumes of
sample. Rolling Circle Amplification
(RCA) is a new technology that precisely
localizes unique signals arising from
single reporter molecules. RCA has been
incorporated into antibody-based
microarray system protein chips that
enable testing with high sensitivity and
specificity for hundreds of proteins
simultaneously, using small sample
volumes.
This invention describes a method of
using RCA technology for detecting the
expression of serum proteins that are
perturbed in osteoarthritis patients. The
results of this testing can be used to
identify proteins associated with
osteoarthritis presence, prediction of
osteoarthritis development and
prognosis, predict response to
osteoarthritis treatment and potentially
also identify future anti-osteoarthritic
drugs.
The prospective 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,
E:\FR\FM\20JAN1.SGM
20JAN1
Federal Register / Vol. 71, No. 13 / Friday, January 20, 2006 / Notices
within 60 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.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: January 10, 2006.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer
National Institutes of Health.
[FR Doc. E6–590 Filed 1–19–06; 8:45 am]
BILLING CODE 4167–01–P
DEPARTMENT OF HOMELAND
SECURITY
Bureau of Customs and Border
Protection
[USCBP–2006–0017]
Automated Commercial Environment
(ACE): National Customs Automation
Program Test of Periodic Monthly
Payment Statement Process
Customs and Border Protection;
Department of Homeland Security.
ACTION: General notice.
wwhite on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: This document announces a
modification in the Bureau of Customs
and Border Protection’s (CBP) National
Customs Automation Program (NCAP)
test concerning periodic monthly
deposit of estimated duties and fees.
CBP will no longer require Automated
Clearing House (ACH) credit
participants to initiate payment earlier
than the 15th working day of the month
as was required by a Federal Register
notice published on August 8, 2005.
CBP, however, must receive the
settlement for the credit by the 15th
working day in order to have the
periodic monthly statement marked
paid and treated as a timely payment.
DATES: The changes announced in this
Notice are effective immediately.
FOR FURTHER INFORMATION CONTACT: For
questions regarding periodic monthly
statement payments: Mr. Michael
Maricich via e-mail at
Michael.Maricich@dhs.gov, or by
telephone at (703) 921–7520.
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
16:16 Jan 19, 2006
Jkt 208001
Background
On February 4, 2004, the Bureau of
Customs and Border Protection (CBP)
published a General Notice in the
Federal Register (69 FR 5362)
announcing the National Customs
Automation Program (NCAP) test for
Periodic Monthly Payment Statement
Process. The test, which is part of CBP’s
Automated Commercial Environment
(ACE), benefits participants by giving
them access to operational data through
the ACE Secured Data Portal (‘‘ACE
Portal’’), which provides them the
capability to interact electronically with
CBP, and by allowing them to deposit
estimated duties and fees on a monthly
basis based on a Periodic Monthly
Statement issued by CBP.
When the test started, only importers
were eligible to apply for the test.
Eligibility was later expanded to allow
brokers to apply if they were
specifically designated by an ACE
importer.
On September 8, 2004, CBP published
a General Notice in the Federal Register
(69 FR 54302) which invited customs
brokers, regardless of whether they were
designated by participating importers to
make Periodic Monthly Statement
payments on their behalf, to apply to
participate in the test. That notice set
forth eligibility requirements for both
importers and brokers.
On February 1, 2005, CBP published
a General Notice in the Federal Register
(70 FR 5199) announcing that applicants
seeking to establish importer or broker
accounts so as to access the ACE Portal,
or to participate in any ACE test
(including the test for Periodic Monthly
Payment Statement Process), are no
longer required to provide a statement
certifying participation in the Customs
Trade Partnership Against Terrorism
(C–TPAT).
As provided in the February 4, 2004
General Notice announcing the test,
participants in the Periodic Monthly
Statement test are required to schedule
entries for monthly payment. A Periodic
Monthly Statement will list Periodic
Daily Statements that have been
designated for monthly payment. The
Periodic Monthly Statement can be
created on a port basis by the importer
or broker, as was the case with existing
daily statements in the Automated
Commercial System (ACS) (ACE is the
successor to ACS). The Periodic
Monthly Statement can be created on a
national basis by an Automated Broker
Interface (ABI) filer. If an importer
chooses to file the Periodic Monthly
Statement on a national basis he must
use his filer code and schedule and pay
the monthly statements. The Periodic
PO 00000
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3315
Monthly Statement will be routed under
existing CBP procedures. Brokers will
only view/receive information that they
have filed on an importer’s behalf. ACE
will not route a Periodic Monthly
Statement to a broker through ABI if
that statement lists information filed by
another broker.
On August 8, 2005, CBP published a
General Notice in the Federal Register
(70 FR 45736) changing the time period
allowed for the periodic monthly
deposit of estimated duties and fees
from the 15th calendar day to the 15th
working day of the month following the
month in which the goods are either
entered or released. That change was
made in order to comply with the
provisions of section 2004 of the
Miscellaneous Trade and Technical
Corrections Act of 2004, Public Law
108–429, which extended the time of
deposit of those estimated duties and
fees from the 15th calendar day to the
15th working day of the month
following the month in which the goods
are either entered or released. The
document also advised that entries
containing Census errors will be eligible
to be placed on a Periodic Daily
Statement and designated for monthly
payment. Finally, the document
announced that a participant would be
subject to a claim for liquidated
damages if the participant removed an
entry from a Periodic Daily Statement
after expiration of a 10-working-day
period after release.
On September 22, 2005, CBP
published a General Notice in the
Federal Register (70 FR 55623)
eliminating the requirement that
participants in the Periodic Monthly
Statement test provide a bond rider
covering the periodic payment of
estimated duties and fees. The Notice
indicated that nonpayment or untimely
payment of estimated duties and fees,
however, may result in action by CBP to
impose sanctions on the delinquent
importer of record or to allow the surety
to terminate its basic importation bond.
If the bond principal is a participant in
the Periodic Monthly Statement test,
sureties will now be allowed, under
certain conditions, to terminate bonds
with 3 business days notice to the bond
principal and CBP.
Modification of the Monthly Payment
Statement Process
This Notice modifies the payment
procedure set forth in the August 8,
2005 Notice (70 FR 45736) by
specifically eliminating the requirement
that ‘‘ACH credit participants must
initiate payment no later than the 14th
working day of the month.’’ CBP did not
intend to dictate the time in which
E:\FR\FM\20JAN1.SGM
20JAN1
]]>Agencies
[Federal Register Volume 71, Number 13 (Friday, January 20, 2006)]
[Notices]
[Pages 3314-3315]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-590]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: FDA Approvable Human
Diagnostic for Osteoarthritis
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 (NIH),
Department of Health and Human Services, is contemplating the grant of
an exclusive license worldwide to practice the invention embodied in
U.S. Patent Application Number 60/602,334 filed August 18, 2005,
entitled ``Biomarkers for Osteoarthritis,'' to PeptiFarma, Inc., having
a place of business in San Diego, CA 92191. The contemplated exclusive
license may be limited to an FDA approvable human diagnostic for
osteoarthritis. The United States of America is an assignee of the
patent rights in this invention.
DATES: Only written comments and/or application for a license which is
received by the NIH Office of Technology Transfer on or before March
21, 2006 will be considered.
ADDRESSES: Request for a copy of the patent, inquires, comments, and
other materials relating to the contemplated license should be directed
to: Marlene Astor, Technology Licensing Specialist, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-
4426; Facsimile: 301-402-0220; e-mail: ms482m@nih.gov.
SUPPLEMENTARY INFORMATION: Osteoarthritis is a chronic, often
progressive and substantially disabling condition that becomes more
common with advanced age. Osteoarthritis commonly involves the knees,
hands, hips, neck and back resulting in pain and limitations of
movement.
Unfortunately clinically available tests are neither capable of
detecting osteoarthritis early in its development, nor sensitive enough
to adequately assess disease progression. A better means of diagnosing
early osteoarthritis and its progression that can be used to assess the
response to therapeutic treatments is needed. The currently available
laboratory techniques are highly sensitive but either lack specificity
or require large volumes of sample. Rolling Circle Amplification (RCA)
is a new technology that precisely localizes unique signals arising
from single reporter molecules. RCA has been incorporated into
antibody-based microarray system protein chips that enable testing with
high sensitivity and specificity for hundreds of proteins
simultaneously, using small sample volumes.
This invention describes a method of using RCA technology for
detecting the expression of serum proteins that are perturbed in
osteoarthritis patients. The results of this testing can be used to
identify proteins associated with osteoarthritis presence, prediction
of osteoarthritis development and prognosis, predict response to
osteoarthritis treatment and potentially also identify future anti-
osteoarthritic drugs.
The prospective 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,
[[Page 3315]]
within 60 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.
Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. Comments and objections submitted in response to
this notice will not be made available for public inspection, and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: January 10, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer National Institutes of Health.
[FR Doc. E6-590 Filed 1-19-06; 8:45 am]
BILLING CODE 4167-01-P
