Prospective Grant of Exclusive License: Small Molecule Therapeutics Against Hepatitis C Virus Infection, 16389-16390 [2015-06974]
Download as PDF
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
corporations: 15.15 hours; investment
Edge and agreement corporations: 9.60
hours.
Number of respondents: Banking Edge
and agreement corporations (quarterly):
7; banking Edge and agreement
corporations (annual): 1; investment
Edge and agreement corporations
(quarterly): 20; investment Edge and
agreement corporations (annual): 19.
General description of report: This
information is mandatory (12 U.S.C.
602, 625). In addition, with respect to
the contact information collected in the
Patriot Act Contact Information section,
the Board’s regulation’s (12 CFR part
211.5(m)) instruct Edge and agreement
corporations to comply with the
information sharing regulations that the
Department of the Treasury issued
pursuant to Section 314(a) of the USA
Patriot Act of 2001, Public Law 107–56,
115 Stat. 307 (31 U.S.C. 5318(h)); and
implemented at 31 CFR part
1010.520(b).
For Edge corporations engaged in
banking, current Schedules RC–M (with
the exception of item 3) and RC–V are
held confidential pursuant to Section
(b)(4) of FOIA (5 U.S.C. 552(b)(4)). For
investment Edge corporations, only
information collected on Schedule RC–
M (with the exception of item 3) are
given confidential treatment pursuant to
Section (b)(4) of FOIA (5 U.S.C.
552(b)(4)).
In addition, the information provided
in the Patriot Act Contact Information
section may be withheld as confidential
under FOIA to prevent unauthorized
individuals from falsely posing as an
institution’s point-of-contact in order to
gain access to the highly sensitive and
confidential communications sent by
email between the Financial Crimes
Enforcement Network or federal law
enforcement officials and the Patriot Act
point-of-contact. The identity and
contact information of private
individuals, which is collected and
maintained for law enforcement
purposes under the Patriot Act, may be
exempt from disclosure pursuant to
exemption 7(C) of FOIA (5 U.S.C.
552(b)(7)(C)). Lastly, the language
indicating that the Emergency Contact
information will not be released to the
public will be removed.
Abstract: The FR 2886b collects
quarterly financial data from banking
Edge and agreement corporations and
investment (nonbanking) Edge and
agreement corporations. Except for
examination reports, it provides the
only financial data available for these
corporations. The Federal Reserve is
solely responsible for authorizing,
supervising, and assigning ratings to
Edge and agreement corporations. The
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
Federal Reserve uses the data collected
on the FR 2886b to identify present and
potential problems and monitor and
develop a better understanding of
activities within the industry.
Current Actions: The Federal Reserve
proposes to add questions regarding
confidential treatment in the form of
check boxes to all of the reports listed
above so institutions may indicate
whether they are requesting confidential
treatment for any portion of the data
provided, and whether they are
submitting a formal justification with
the data or separately. The proposed
revision would enhance existing
processes related to the handling of data
confidentiality requests. The questions
regarding confidential treatment in the
form of check boxes would be effective
June 30, 2015.
Board of Governors of the Federal Reserve
System, March 24, 2015.
Robert deV. Frierson,
Secretary of the Board.
[FR Doc. 2015–07067 Filed 3–26–15; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Small Molecule Therapeutics
Against Hepatitis C Virus Infection
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of a
start-up exclusive commercial patent
license agreement to practice the
inventions embodied in U.S. provisional
patent application no. 61/909,414 (NIH
Ref. No. E–011–2014/0–US–01) filed
November 27, 2013; International PCT
application no. PCT/US2014/066680
(NIH Ref. No. E–011–2014/0–PCT–02)
filed November 20, 2014; Taiwanese
patent application no. 103141004 (NIH
Ref. No. E–011–2014/0–TW–03) filed
November 26, 2014; and U.S.
provisional patent application no. 62/
011,462 (NIH Ref. No. E–161–2014/0–
US–01) filed June 12, 2014; all entitled,
‘‘Heterocyclic Compounds and Methods
of Use Thereof;’’ and all continuing
applications and foreign counterparts to
Virotas Biopharmaceuticals, LLC, a
company having a place of business in
California. The patent rights in these
inventions have (a) been assigned to the
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
16389
United States of America, as represented
by the Secretary, Department of Health
and Human Services who has delegated
authority for the licensing of inventions
to the National Institutes of Health or (b)
been exclusively licensed to the
National Institutes of Health.
The prospective exclusive license
territory may be ‘‘worldwide’’, and the
field of use may be limited to the
following: ‘‘Prevention and treatment of
Hepatitis C Virus infection.’’
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before April
13, 2015 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Kevin W. Chang, Ph.D.,
Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–5018; Facsimile: (301) 402–
0220; Email: changke@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
subject technologies are small molecule
compounds for the treatment of HCV
infection identified using a novel cellbased high throughput assay. Some of
these compounds are derivatives of
chlorcyclizine that show potent
antiviral properties against HCV.
Chlorcyclizine is already on the market
for the treatment of allergic reactions,
have been used extensively in humans,
and have excellent safety profiles with
known pharmaceutical properties. The
other compounds are also heterocyclic
compounds that show anti-HCV
activity. The subject technologies can
potentially be used in combination with
each other and/or with other HCV
therapeutics.
The prospective start-up exclusive
commercial patent license will be
royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404. The
prospective start-up exclusive
commercial patent license may be
granted unless within fifteen (15) 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 part 404.
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.
Comments and objections submitted to
this notice will not be made available
E:\FR\FM\27MRN1.SGM
27MRN1
16390
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
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.
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Dated: March 23, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
Proposed Project
Health Insurance Plans Research
Study—New—Office of Health System
Collaboration, Office of the Associate
Director for Policy, Office of the
Director, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 2015–06974 Filed 3–26–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–15CF]
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
Background and Brief Description
The CDC Office of the Associate
Director for Policy intends to request
that the Office of Management and
Budget (OMB) approve a new collection
of information under the Paperwork
Reduction Act for three years. This data
collection will occur once, and
respondents will be surveyed once.
The Health Insurance Plans Research
Study will uniquely examine the
prevalence, characteristics, and
differences of prevention and wellness
programs offered by health insurance
plans in this critical era of healthcare
reform. There are no known studies that
have addressed the prevalence of
prevention and wellness programs
across health plans or explored the
granular details of these programs as
this study is intended to do. Not
conducting this study would be one less
step toward increasing healthy years of
life.
Furthermore, the Health Insurance
Plans Research Study will address the
priorities and goals of the CDC Office of
the Associate Director for Policy, Office
of Health System Collaboration: (a)
Identify and catalyze policy
opportunities such as the Affordable
Care Act to enhance healthcare
transformation, (b) advance CDC’s
public health-healthcare strategy to
improve population health, (c)
strengthen strategic partnerships with
healthcare systems and payers, federal
and non-federal, and (d) fully leverage
performance measures as a tool to
improve the health of individuals across
health systems and payers.
The results of this study are of great
interest not only to the CDC Office of
the Associate Director for Policy but to
other CDC Centers, Institutes, and
Offices; and other federal agencies and
partners such as the Health Resources
and Services Administration (HRSA),
the members of the CDC Advisory
Committee to the Director, and the CDC
Public Health-Health Care Collaboration
Workgroup (federal, state, and local
public health; public and private
organizations; healthcare providers;
professional membership associations;
and academia representation).
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
CDC will select a sample of
approximately 150 commercial health
insurance plans in the United States
that differ by size and geography, in the
50 states and the District of Columbia,
to complete a web-based survey, the
Prevention and Wellness Assessment
Survey. The project team will provide
information and instructions about the
survey to health plan points of contact
in advance. The team will also make
information and instructions available
on the Web site, eliminating any
interactions between the respondent
and the project team, unless a
respondent(s) has questions or concerns
during completion of the survey.
The Prevention and Wellness
Assessment Survey will take
approximately 30 minutes to complete
per respondent for a total estimated
burden of 75 hours. Key health plan
contacts (e.g., medical directors, nurse
directors, or other healthcare
professional) will incur burden
associated with coordinating the time
and identifying a person to take the
survey. The burden associated with this
activity is estimated at 30 minutes per
key health plan contact for a maximum
of one key contact per health plan (1 key
contact × 150 health plans = 150 key
contacts), resulting in a total burden of
75 hours. In addition, administrative
support staff at select health plans may
assist with coordinating
communications between key health
plan points of contact and America’s
Health Insurance (AHIP). The estimated
administrative support burden is 30
minutes per health plan, resulting in a
total burden of 75 hours.
Following the analysis of survey data,
the project team will conduct one-hour
telephone interviews with no more than
nine health plans (1 hour × 9 health
plans) to gain a better understanding of
lessons learned and best practices
associated with the design and
implementation of prevention and
wellness programs by commercial
health insurance plans. The project
team will use this information to build
upon the knowledge gained through the
survey. For example, there may be
differences in how health plans
structure prevention and wellness
programs for different employer
accounts based on employer requests.
The estimated burden is one hour per
health plan, resulting in a total burden
of nine hours.
Best practices in outreach will be
utilized to maximize survey response
rates. Key health plan contacts at nonresponding health plans will receive
follow up by telephone, and one-to-one
assistance will be provided if needed.
E:\FR\FM\27MRN1.SGM
27MRN1
Agencies
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16389-16390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06974]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Small Molecule
Therapeutics Against Hepatitis C Virus Infection
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of a start-up exclusive
commercial patent license agreement to practice the inventions embodied
in U.S. provisional patent application no. 61/909,414 (NIH Ref. No. E-
011-2014/0-US-01) filed November 27, 2013; International PCT
application no. PCT/US2014/066680 (NIH Ref. No. E-011-2014/0-PCT-02)
filed November 20, 2014; Taiwanese patent application no. 103141004
(NIH Ref. No. E-011-2014/0-TW-03) filed November 26, 2014; and U.S.
provisional patent application no. 62/011,462 (NIH Ref. No. E-161-2014/
0-US-01) filed June 12, 2014; all entitled, ``Heterocyclic Compounds
and Methods of Use Thereof;'' and all continuing applications and
foreign counterparts to Virotas Biopharmaceuticals, LLC, a company
having a place of business in California. The patent rights in these
inventions have (a) been assigned to the United States of America, as
represented by the Secretary, Department of Health and Human Services
who has delegated authority for the licensing of inventions to the
National Institutes of Health or (b) been exclusively licensed to the
National Institutes of Health.
The prospective exclusive license territory may be ``worldwide'',
and the field of use may be limited to the following: ``Prevention and
treatment of Hepatitis C Virus infection.''
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
April 13, 2015 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Kevin W. Chang, Ph.D., Senior Licensing
and Patenting Manager, Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
MD 20852-3804; Telephone: (301) 435-5018; Facsimile: (301) 402-0220;
Email: changke@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The subject technologies are small molecule
compounds for the treatment of HCV infection identified using a novel
cell-based high throughput assay. Some of these compounds are
derivatives of chlorcyclizine that show potent antiviral properties
against HCV. Chlorcyclizine is already on the market for the treatment
of allergic reactions, have been used extensively in humans, and have
excellent safety profiles with known pharmaceutical properties. The
other compounds are also heterocyclic compounds that show anti-HCV
activity. The subject technologies can potentially be used in
combination with each other and/or with other HCV therapeutics.
The prospective start-up exclusive commercial patent license will
be royalty bearing and will comply with the terms and conditions of 35
U.S.C. 209 and 37 CFR part 404. The prospective start-up exclusive
commercial patent license may be granted unless within fifteen (15)
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 part 404.
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. Comments and objections submitted to
this notice will not be made available
[[Page 16390]]
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: March 23, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-06974 Filed 3-26-15; 8:45 am]
BILLING CODE 4140-01-P