Prospective Grant of Exclusive License: Prevention, Prophylaxis, Cure, Amelioration, and/or Treatment of Infection and/or the Effects Thereof of Chikungunya Infections in Humans, 58415-58416 [2010-23975]
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Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices
harms of on-label and off-label use of
Autologous Cellular Immunotherapy
Treatment of Metastatic Prostate Cancer.
Background information about this
topic, including panel materials, is
available at https://www.cms.hhs.gov/
center/coverage.asp. We encourage the
participation of appropriate
organizations with expertise in the use
of Autologous Cellular Immunotherapy
Treatment of Metastatic Prostate Cancer.
II. Meeting Format
This meeting is open to the public.
The Committee will hear oral
presentations from the public for
approximately 45 minutes. The
Committee may limit the number and
duration of oral presentations to the
time available. Your comments should
focus on issues specific to the list of
topics that we have proposed to the
Committee. The list of research topics to
be discussed at the meeting will be
available on the following Web site
prior to the meeting: https://
www.cms.hhs.gov/mcd/
index_list.asp?list_type=mcac. We
require that you declare at the meeting
whether you have any financial
involvement with manufacturers (or
their competitors) of any items or
services being discussed.
The Committee will deliberate openly
on the topics under consideration.
Interested persons may observe the
deliberations, but the Committee will
not hear further comments during this
time except at the request of the
chairperson. The Committee will also
allow a 15-minute unscheduled open
public session for any attendee to
address issues specific to the topics
under consideration. At the conclusion
of the day, the members will vote and
the Committee will make its
recommendation(s) to CMS.
srobinson on DSKHWCL6B1PROD with NOTICES
III. Registration Instructions
CMS’ Coverage and Analysis Group is
coordinating meeting registration. While
there is no registration fee, individuals
must register to attend. You may register
online at https://www.cms.gov/mcd/
index_list.asp?list_type=mcac, via email at
MEDCAC_Registration@cms.hhs.gov, or
by phone by contacting the person listed
in the FOR FURTHER INFORMATION
CONTACT section of this notice by the
deadline listed in the DATES section of
this notice. Please provide your full
name (as it appears on your state-issued
driver’s license), address, organization,
telephone, fax number(s), and e-mail
address. You will receive a registration
confirmation with instructions for your
arrival at the CMS complex or you will
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be notified the seating capacity has been
reached.
You must register for the Webinar
portion of the meeting at https://
webinar.cms.hhs.gov/_a7/
txmetaprostatemedcac1117/event/
registration.html by the deadline listed
in the DATES section of this notice.
IV. Security, Building, and Parking
Guidelines
This meeting will be held in a Federal
government building; therefore, Federal
security measures are applicable. We
recommend that confirmed registrants
arrive reasonably early, but no earlier
than 45 minutes prior to the start of the
meeting, to allow additional time to
clear security. Security measures
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• Presentation of government-issued
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Service personnel.
• Inspection of vehicle’s interior and
exterior (this includes engine and trunk
inspection) at the entrance to the
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vehicle inspection.
• Inspection, via metal detector or
other applicable means of all persons
brought entering the building. We note
that all items brought into CMS,
whether personal or for the purpose of
presentation or to support a
presentation, are subject to inspection.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set-up, safety, or
timely arrival of any personal
belongings or items used for
presentation or to support a
presentation.
Note: Individuals who are not registered in
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meeting. The public may not enter the
building earlier than 45 minutes prior to the
convening of the meeting.
All visitors must be escorted in areas other
than the lower and first floor levels in the
Central Building.
Authority: 5 U.S.C. App. 2, section 10(a).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: September 8, 2010.
Barry M. Straube
Chief Medical Officer and Director, Office
of Clinical Standards and Quality, Centers
for Medicare & Medicaid Services.
[FR Doc. 2010–23582 Filed 9–23–10; 8:45 am]
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58415
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Prevention, Prophylaxis,
Cure, Amelioration, and/or Treatment
of Infection and/or the Effects Thereof
of Chikungunya Infections in Humans
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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 invention
embodied in Patent Applications USSN
61/118,206, filed on November 26, 2008,
and 61/201,118, filed on December 5,
2008; and PCT/US2009/006294, filed
November 24, 2009; entitled ‘‘Virus Like
Particle Compositions and Methods of
Use’’, to Merck Sharp & Dohme Corp.
having a place of business in 770
Sumneytown Pike, West Point, PA
19486. The patent rights in this
invention have been assigned to the
United States of America.
DATES: Only written comments and/or
application for a license that are
received by the NIH Office of
Technology Transfer on or before
October 25, 2010 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: Cristina Thalhammer-Reyero, PhD ,
M.B.A., Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; E-mail:
ThalhamC@mail.nih.gov; Telephone:
301–435–4507; Facsimile: 301–402–
0220.
SUPPLEMENTARY INFORMATION: The
prospective worldwide 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 30 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 invention relates to compositions
and methods of use as vaccines of viruslike particles (VLPs) expressing one or
more alphavirus capsid or envelope
proteins, and in particular Chikungunya
SUMMARY:
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Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices
virus (CHIKV) envelope proteins. The
invention also describes DNA, viral or
other gene-based vector and VLP
vaccines, methods of making and
methods of their use in inducing
immunity to alphavirus infection.
Alphaviruses are RNA-containing
viruses that cause a wide variety of
mosquito-transmitted diseases,
including equine encephalitis. CHIKV,
an alphavirus in the family Togaviridae,
was first isolated in Tanzania in 1952
and is transmitted to humans by
mosquitoes. The disease caused by
CHIKV resembles infection by dengue
virus, characterized by rash, high fever,
and severe, sometimes persistent
arthritis.
The field of use may be limited to
‘‘Prevention, prophylaxis, cure,
amelioration, and/or treatment of
infection and/or the effects thereof of
Chikungunya infections in humans’’.
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: September 20, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–23975 Filed 9–23–10; 8:45 am]
communication and outreach, customer
service and system and analytical
support.
Chapter RU—Bureau of Clinician
Recruitment and Service
Section RU–10, Organization
Delete in its entirety and replace with
the following:
The Office of the Associate
Administrator (RU) is headed by the
Associate Administrator, Bureau of
Clinician Recruitment and Service
(BCRS), who reports directly to the
Administrator, Health Resources and
Services Administration. BCRS includes
the following components:
(1) Office of the Associate Administrator
(RU);
(2) Office of Legal and Compliance
(RU1);
(3) Division of National Health Service
Corps (RU5);
(4) Division of Nursing and Public
Health (RU6);
(5) Division of External Affairs (RU7);
(6) Office of Policy and Program
Development (RU8);
(7) Division of Program Operations
(RU9);
(8) Division of Regional Operations
(RU10); and
(9) Office of Business Operations
(RU11).
Section RU–20, Functions
(1) Delete the functional statement for
the Bureau of Clinician Recruitment and
Service (RU) and replace in its entirety.
BILLING CODE 4140–01–P
Office of the Associate Administrator
(RU)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Provides overall leadership, direction,
coordination, and planning in support
of Bureau of Clinician Recruitment and
Service (BCRS) programs that are
designed to improve the health of the
Nation’s underserved communities and
vulnerable populations by coordinating
the recruitment and retention of caring
health professionals in the healthcare
system and supporting communities’
efforts to build more integrated and
sustainable systems of care. Specifically:
(1) Establishes program goals, objectives
and priorities, and provides oversight as
to their execution; (2) plans, directs,
coordinates and evaluates Bureau-wide
management activities; (3) maintains
effective relationships within HRSA and
with other Department of Health and
Human Services (HHS) organizations,
other Federal agencies, State and local
governments, and other public and
private organizations concerned with
improving the health status of the
Nation’s underserved communities and
vulnerable populations by recruiting
Health Resources and Services
Administration
srobinson on DSKHWCL6B1PROD with NOTICES
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 75 FR 57282–57283
dated September 20, 2010).
This notice reflects organizational
changes in the Health Resources and
Services Administration. Specifically,
this notice updates the functional
statement for the Bureau of Clinician
Recruitment and Service (RU) to reduce
fragmentation and overlap and establish
an increased emphasis on policy and
program development, external
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and retaining health care clinicians into
service in areas of greatest need; (4)
plans, directs and coordinates Bureauwide administrative management
activities, i.e., budget, personnel,
procurements, delegations of authority,
and has responsibilities related to the
awarding of BCRS funds; and (5)
oversees the development of BCRS
program policies.
Office of Legal and Compliance (RU1)
Serves as the focal point for service
obligation issue resolution and quality
assurance for the Bureau’s programs.
Specifically: (1) Analyzes, administers
and manages procedures for the BCRS
portfolio of scholarship and loan
repayment participants who have
breached their service obligation,
requested a waiver or suspension, and/
or are in default and have requested to
serve under a Forbearance, Judgment or
Settlement Agreement; (2) reviews
default recommendations, determines
the action of default, and initiates and
monitors procedures for default debt
collection; (3) provides programmatic
information to Agency officials, the
Office of the General Counsel, the Office
of Inspector General, Program Support
Center, and the Department of Justice
for default debt collection, trials,
bankruptcy hearings, and other
activities; (4) reviews requests and
makes determinations regarding
scholarship and loan repayment
participants’ eligibility for a suspension
or waiver of their service or default debt
obligation; (5) implements policies and
procedures in conjunction with default
reduction activities, including return to
service arrangements and other actions
to maximize compliance with
scholarship and loan repayment service
obligations; and (6) serves as the BCRS
quality assurance function.
Division of National Health Service
Corps (RU5)
Serves as the point of contact for
responding to inquiries, disseminating
program information, providing
technical assistance, and processing
applications and awards pertaining to
National Health Service Corps (NHSC)
scholarship and loan repayment
programs and site approvals.
Specifically: (1) Reviews, ranks and
selects participants for the scholarship
and loan repayment programs; (2)
verifies and processes loan and lender
related payments in prescribed manner
and maintains current information on
scholarship and loan repayment
applications and awards through
automated BCRS information systems;
(3) provides oversight, processing and
coordination of reviews of NHSC site
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[Federal Register Volume 75, Number 185 (Friday, September 24, 2010)]
[Notices]
[Pages 58415-58416]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23975]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Prevention, Prophylaxis,
Cure, Amelioration, and/or Treatment of Infection and/or the Effects
Thereof of Chikungunya Infections in Humans
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 invention embodied in Patent
Applications USSN 61/118,206, filed on November 26, 2008, and 61/
201,118, filed on December 5, 2008; and PCT/US2009/006294, filed
November 24, 2009; entitled ``Virus Like Particle Compositions and
Methods of Use'', to Merck Sharp & Dohme Corp. having a place of
business in 770 Sumneytown Pike, West Point, PA 19486. The patent
rights in this invention have been assigned to the United States of
America.
DATES: Only written comments and/or application for a license that are
received by the NIH Office of Technology Transfer on or before October
25, 2010 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: Cristina Thalhammer-Reyero, PhD , M.B.A., Office
of Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; E-mail:
ThalhamC@mail.nih.gov; Telephone: 301-435-4507; Facsimile: 301-402-
0220.
SUPPLEMENTARY INFORMATION: The prospective worldwide 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 30 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 invention relates to compositions and methods of use as
vaccines of virus-like particles (VLPs) expressing one or more
alphavirus capsid or envelope proteins, and in particular Chikungunya
[[Page 58416]]
virus (CHIKV) envelope proteins. The invention also describes DNA,
viral or other gene-based vector and VLP vaccines, methods of making
and methods of their use in inducing immunity to alphavirus infection.
Alphaviruses are RNA-containing viruses that cause a wide variety of
mosquito-transmitted diseases, including equine encephalitis. CHIKV, an
alphavirus in the family Togaviridae, was first isolated in Tanzania in
1952 and is transmitted to humans by mosquitoes. The disease caused by
CHIKV resembles infection by dengue virus, characterized by rash, high
fever, and severe, sometimes persistent arthritis.
The field of use may be limited to ``Prevention, prophylaxis, cure,
amelioration, and/or treatment of infection and/or the effects thereof
of Chikungunya infections in humans''.
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: September 20, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-23975 Filed 9-23-10; 8:45 am]
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