Prospective Grant of Exclusive License: System and Methods for Detecting and Characterizing Macromolecular Interactions in Solution, 50932-50933 [E6-14190]
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50932
Federal Register / Vol. 71, No. 166 / Monday, August 28, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
mstockstill on PROD1PC61 with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings 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; Diabetic
Neuropathy.
Date: August 29, 2006.
Time: 5:30 p.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: William C. Benzing, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5206,
MSC 7846, Bethesda, MD 20892, (301) 435–
1254, benzingw@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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Confocal
Microscopy Shared Instrumentation Panel.
Date: September 18–19, 2006.
Time: 8:30 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Beacon Hotel and Corporate
Quarters, 1615 Rhode Island Avenue, NW.,
Washington, DC 20036.
Contact Person: Laura M. Roman, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2138,
MSC 7720, Bethesda, MD 20892, 301–435–
0715, romanl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Bacterial
Pathogenesis.
Date: September 20, 2006.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Fouad A. El-Zaatari, PhD,
Scientific Review Administrator, Center for
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206,
MSC 7808, Bethesda, MD 20814–9692, (301)
435–1149, elzaataf@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Project Review: Cryo-Electon Microscopy.
Date: September 25, 2006.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Sally Ann Amero, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4190,
MSC 7849, Bethesda, MD 20892, 301–435–
1159, ameros@csr.nih.gov.
(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, 93.837–83.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: August 21, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–7175 Filed 8–25–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: System and Methods for
Detecting and Characterizing
Macromolecular Interactions in
Solution
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
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 to practice the inventions
embodied in PCT (application number
pending) filed July 28, 2006 from U.S.
provisional application 60/703,814 (E–
167–2005/0–US–01), entitled ‘‘System
and Methods for Detecting and
Characterizing Macromolecular
Interactions in Solution’’ (Inventors:
Drs. Allen Minton and Arun Attri) to
Wyatt Technology Corporation
(hereafter Wyatt), having a place of
business in Goleta, California. The
patent rights in these inventions have
been assigned to the United States of
America.
PO 00000
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Fmt 4703
Sfmt 4703
Only written comments and/or
application for a license, which are
received by the NIH Office of
Technology Transfer on or before
October 27, 2006 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Chekesha Clingman, Ph.D., Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804; email: clingmac@mail.nih.gov; telephone:
(301) 435–5018; facsimile: (301) 402–
0220.
SUPPLEMENTARY INFORMATION: The
present invention relates to systems and
methods for sensitive detection and
characterization of macromolecular
interactions in homogenous or
heterogeneous solutions of
macromolecules, such as proteins, DNA,
RNA, biopolymers, organic and
inorganic polymers, macromolecular
pharmaceutical compounds and others.
The methods employed by this system
do not require the need for labeling or
chemical modification of any test
substance, and it is more rapid than any
conventional methods. The system
includes a dispenser to dispense a
solution containing the macromolecule,
and one or more detectors to measure a
light scattering and concentration
associated with the macromolecule in
solution. For instance, the first detector
can be a light scattering detector (such
as a static light-scattering detector). The
second detector (such as a UV–Vis
detector) can be added in to measure
light absorbance and hence
concentration. The detectors can be
arranged in parallel, to receive identical
flow of solution from the dispenser, so
that at any given time point, both
detectors collect data on flow of
identical concentrations.
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,
within 60 days from the date of this
published Notice, 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.
The field of use may be limited to the
development of a system and method
for detecting and characterizing
macromolecular interactions in
solution.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
DATES:
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28AUN1
50933
Federal Register / Vol. 71, No. 166 / Monday, August 28, 2006 / Notices
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: August 21, 2006.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E6–14190 Filed 8–25–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Proposed Project: Opioid Drugs in
Maintenance and Detoxification
Treatment of Opioid Dependence—42
CFR part 8 (OMB No. 0930–0206)—
Revision
This regulation establishes a
certification program managed by
SAMHSA’s Center for Substance Abuse
Treatment (CSAT). The regulation
requires that Opioid Treatment
Programs (OTPs) be certified.
‘‘Certification’’ is the process by which
SAMHSA determines that an OTP is
qualified to provide opioid treatment
under the Federal opioid treatment
standards established by the Secretary
of Health and Human Services. To
become certified, an OTP must be
accredited by a SAMHSA-approved
accreditation body. The regulation also
provides standards for such services as
individualized treatment planning,
increased medical supervision, and
assessment of patient outcomes. This
submission seeks continued approval of
the information collection requirements
in the regulation and of the forms used
in implementing the regulation.
SAMHSA currently has approval for
the Application for Certification to Use
Opioid Drugs in a Treatment Program
Under 42 CFR 8.11 (Form SMA–162);
the Application for Approval as
Accreditation Body Under 42 CFR 8.3(b)
(Form SMA–163); and the Exception
Request and Record of Justification
Under 42 CFR 8.12 (Form SMA–168),
which may be used on a voluntary basis
by physicians when there is a patient
care situation in which the physician
must make a treatment decision that
differs from the treatment regimen
required by the regulation. Form SMA–
162 is used as the initial application to
request certification of an OTP, to
request renewal of certification and to
change existing information regarding
the program’s location, sponsor and
medical director. This form collects
information such as address, program
name, contact information, sponsor
name and address and medical director
name and address. Attachments are
required to complete this form regarding
the OTPs accrediting status,
organizational structure, and operating
procedures. Form SMA–163 is used as
an application to become a SAMHSA
approved accrediting body. This form
collects accrediting body name, address
and contact information. Attachments
are required to complete this form
regarding the accrediting body’s
operating procedures and standards and
their staff’s education and experience.
Form SMA–168 is a simplified,
standardized form to facilitate the
documentation, request, and approval
process for exceptions. This form
collects patient admission date, dosage
amount, patient status, attendance
schedule per week, dates of exception
and justification.
The tables that follow summarize the
annual reporting burden associated with
the regulation, including burden
associated with the forms.
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES
Number of
respondents
42 CFR citation
Purpose
8.3(b)(1–11) ....................................
8.3(c) ...............................................
8.3(e) ...............................................
8.3(f)(2) ...........................................
Initial approval (SMA–163) .............
Renewal of approval (SMA–163) ...
Relinquishment notification ............
Non-renewal notification to accredited OTPs.
Notification to SAMHSA for seriously noncompliant OTPs.
Notification to OTP for serious noncompliance.
General documents and information to SAMHSA upon request.
Accreditation survey to SAMHSA
upon request.
List of surveys, surveyors to
SAMHSA upon request.
Report of less than full accreditation to SAMHSA.
Summaries of Inspections ..............
Notifications of Complaints .............
Revocation notification to Accredited OTPs.
Submission of 90-day corrective
plan to SAMHSA.
Notification to accredited OTPs of
Probationary Status.
8.4(b)(1)(ii) ......................................
8.4(b)(1)(iii) .....................................
8.4(d)(1) ..........................................
8.4(d)(2) ..........................................
8.4(d)(3) ..........................................
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8.4(d)(4) ..........................................
8.4(d)(5) ..........................................
8.4(e) ...............................................
8.6(a)(2) and (b)(3) .........................
8.6(b) ...............................................
8.6(b)(1) ..........................................
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respondent
Hours/response
Total hours
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2
1
1
6.0
1.0
0.5
0.1
6
2
0.5
9
2
2
1.0
4
2
10
1.0
20
6
5
0.5
15
6
75
0.02
9
6
6
0.2
7.2
6
5
0.5
15
6
6
1
50
6
185
0.5
0.5
0.3
150
18
55.5
1
1
1
Sfmt 4703
1
1
1
90
185
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0.3
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]]>Agencies
[Federal Register Volume 71, Number 166 (Monday, August 28, 2006)]
[Notices]
[Pages 50932-50933]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14190]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: System and Methods for
Detecting and Characterizing Macromolecular Interactions in Solution
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 to practice the inventions embodied in PCT
(application number pending) filed July 28, 2006 from U.S. provisional
application 60/703,814 (E-167-2005/0-US-01), entitled ``System and
Methods for Detecting and Characterizing Macromolecular Interactions in
Solution'' (Inventors: Drs. Allen Minton and Arun Attri) to Wyatt
Technology Corporation (hereafter Wyatt), having a place of business in
Goleta, California. The patent rights in these inventions have been
assigned to the United States of America.
DATES: Only written comments and/or application for a license, which
are received by the NIH Office of Technology Transfer on or before
October 27, 2006 will be considered.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Chekesha Clingman, Ph.D., Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852-3804; e-mail: clingmac@mail.nih.gov;
telephone: (301) 435-5018; facsimile: (301) 402-0220.
SUPPLEMENTARY INFORMATION: The present invention relates to systems and
methods for sensitive detection and characterization of macromolecular
interactions in homogenous or heterogeneous solutions of
macromolecules, such as proteins, DNA, RNA, biopolymers, organic and
inorganic polymers, macromolecular pharmaceutical compounds and others.
The methods employed by this system do not require the need for
labeling or chemical modification of any test substance, and it is more
rapid than any conventional methods. The system includes a dispenser to
dispense a solution containing the macromolecule, and one or more
detectors to measure a light scattering and concentration associated
with the macromolecule in solution. For instance, the first detector
can be a light scattering detector (such as a static light-scattering
detector). The second detector (such as a UV-Vis detector) can be added
in to measure light absorbance and hence concentration. The detectors
can be arranged in parallel, to receive identical flow of solution from
the dispenser, so that at any given time point, both detectors collect
data on flow of identical concentrations.
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, within 60 days
from the date of this published Notice, 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.
The field of use may be limited to the development of a system and
method for detecting and characterizing macromolecular interactions in
solution.
Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. Comments
[[Page 50933]]
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: August 21, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E6-14190 Filed 8-25-06; 8:45 am]
BILLING CODE 4140-01-P
