FrCop 30-day notice

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Federal Register / Vol. 75, No. 62 / Thursday, April 1, 2010 / Notices
foreign counterparts [HHS Ref. No. E–
135–2007/0];
5. U.S. Patent Application No. 07/
205,189 filed June 10, 1988, as well as
all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref No. E–
136–2007];
6. U.S. Patent Application No. 60/
625,321 filed November 5, 2004, as well
as all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
138–2007]; and
7. U.S. Patent Application No. 07/
340,052 filed April 18, 1989, as well as
all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
147–2007].
The patent rights in these inventions
have been assigned to the United States
of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be use of Licensed
Patent Rights for development of
therapeutics for human cancers. The
field of use will specifically exclude
prostate cancer, melanoma and
colorectal cancer. For the avoidance of
doubt, delivery formulations shall
specifically exclude canary poxvirus
vectors, NYVAC, non-viral eukaryotic
expression vectors and recombinant
yeast vectors in all geographic
territories.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before May 3,
2010 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: Sabarni K. Chatterjee,
Ph.D. Licensing and Patenting
Associate, Cancer Branch, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 435–5587; Facsimile:
(301) 435–4013; E-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Cancer
immunotherapy is a recent approach
where tumor associated antigens
(TAAs), which are primarily expressed
in human tumor cells, and not
expressed or minimally expressed in
normal tissues, are employed to
generate a tumor-specific immune
response. Specifically, these antigens
serve as targets for the host immune
system and elicit responses that results
in tumor destruction. The initiation of
an effective T-cell immune response to

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antigens requires two signals. The first
one is antigen-specific via the peptide/
major histocompatibility complex and
the second or ‘‘costimulatory’’ signal is
required for cytokine production,
proliferation, and other aspects of T-cell
activation.
The patents and patent applications
describe a vaccine technology, TRICOM,
in conjunction with tumor associated
antigens (TAAs). The TRICOM
technology employs avirulent
poxviruses to present a combination of
costimulatory signaling molecules with
tumor-associated antigens (TAAs) to
activate T-cells and break the immune
systems tolerance towards cancer cells.
This is achieved using recombinant
poxvirus DNA vectors that encode both
T-cell costimulatory molecules and
TAAs. The combination of the three (3)
costimulatory molecules B7.1, ICAM–1
and LFA–3, hence the name TRICOM,
has been shown to have more than the
additive effect of each costimulatory
molecule when used individually to
optimally activate both CD4+ and CD8+
T cells. When a TRICOM based vaccine
expressing TAAs is administered it
greatly enhances the immune response
against the malignant cells expressing
those TAAs. By changing the TAAs
used for immunization with TRICOM
vaccines, immune responses can be
generated to diverse types of cancers.
The versatility of the vector-based
TRICOM based vaccine is that it allows,
including several TAAs, to help
maximize the effectiveness. Transgenes
reflecting alterations of TAAs can also
be inserted into TRICOM based vaccines
to further enhance immunogenicity. The
addition of the two well-known TAAs,
carcinoembryonic antigen (CEA) and
MUC–1 to the TRICOM vector results in
the PANVAC vaccine, which is used in
a prime and boost vaccine strategy. It is
well established that the overexpression
of these two (2) TAAs are associated
with the presence of a variety of
carcinomas; therefore PANVAC can
potentially be effective against a range
of tumor types.
Additionally, new TAAs are being
continually identified. One such
example is the antigen Brachyury.
Although Brachyury has been well
known for its role in developmental cell
biology, it has recently been implicated
in tumor cell invasion and metastasis.
Pre-clinical data indicates that
Brachyury is aberrantly expressed on
tumors of the lung, intestine, stomach,
kidney, bladder, uterus, ovary, and
testis, and in chronic lymphocytic
leukemia. When used in combination
with costimulatory molecules, it can
effectively activate T-cells to kill tumors
cells that originated from above

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mentioned tumors. Therefore, as one
example, Brachyury combined with
TRICOM also has potential as a cancer
immunotherapy for the treatment of
several tumors.
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 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.
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
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 26, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–7341 Filed 3–31–10; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2010–0026]

Science and Technology Directorate;
Submission for Review; Information
Collection Request for the Department
of Homeland Security Science and
Technology Directorate First
Responders Community of Practice
AGENCY: Science and Technology
Directorate, DHS.
ACTION: 30-day Notice and request for
comment.
SUMMARY: The Department of Homeland
Security (DHS) invites the general
public to comment on a new data
collection form for the Science and
Technology Directorate (S&T) First
Responders Community of Practice
(FRCoP): User Registration Page (DHS
Form 10059 (9/09)). The FRCoP webbased tool will be collecting profile
information from first responders and
select authorized non-first responder
users to facilitate networking and
formation of online communities. All
users will be required to authenticate
prior to entering the site. In addition,
the tool will provide members the

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Federal Register / Vol. 75, No. 62 / Thursday, April 1, 2010 / Notices

capability to create wikis, discussion
threads, blogs, and documents allowing
them to enter and upload content in
accordance with the site’s Rules of
Behavior. Members will also be able to
participate in threaded discussions and
comment on other members’ content.
The S&T FRCoP program is responsible
for providing a collaborative
environment for the first responder
community to share information, best
practices, and lessons learned. Section
313 of the Homeland Security Act of
2002 (Pub. L. 107–296) established this
requirement. This notice and request for
comments is required by the Paperwork
Reduction Act of 1995 (Pub. L. 104–13,
44 U.S.C. chapter 35).
DATES: Comments are encouraged and
will be accepted until May 3, 2010.
Comments: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to Desk Officer for the Department of
Homeland Security, Science and
Technology Directorate, and sent via
electronic mail to
[email protected] or faxed
to (202) 395–6974. Please include
docket number DHS–2010–0026 in the
subject line of the message.
FOR FURTHER INFORMATION CONTACT:
Jeffery Harris (202) 254–6015.
SUPPLEMENTARY INFORMATION: The User
Registration Form will be available on
the FRCoP Web site found at (https://
communities.firstresponder.gov). The
user will complete the form online and
submit it through the Web site.

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Overview of This Information
Collection
(1) Type of Information Collection:
New information collection.
(2) Title of the Form/Collection: First
Responders Community of Practice:
User Registration Form.
Agency Form Number, if any, and the
applicable component of the
Department of Homeland Security
sponsoring the collection: DHS Science
and Technology Directorate, DHS Form
10059 (09/09).
(3) Affected public who will be asked
or required to respond, as well as a brief
abstract: Individuals; the data will be
gathered from individual first
responders who wish to participate in
the FRCoP.
(4) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond:
a. Estimate of the total number of
respondents: 5000.

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b. An estimate of the time for an
average respondent to respond: 0.25
burden hours.
Dated: March 24, 2010.
Tara O’Toole,
Under Secretary for Science and Technology.
[FR Doc. 2010–7275 Filed 3–31–10; 8:45 am]
BILLING CODE 9110–9F–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form G–28, and Form G–28I,
Revision of an Existing Information
Collection; Comment Request
ACTION: 60-Day Notice of Information
Collection under Review: Form G–28,
Notice of Entry of Appearance as
Attorney or Accredited Representative,
and Form G–28I, Notice of Entry of
Appearance of Foreign Attorney. OMB
Control No. 1615–0105.

The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) has
submitted the following information
collection request for review and
clearance in accordance with the
Paperwork Reduction Act of 1995. The
information collection is published to
obtain comments from the public and
affected agencies. Comments are
encouraged and will be accepted for
sixty days until June 1, 2010.
Written comments and suggestions
regarding items contained in this notice,
and especially with regard to the
estimated public burden and associated
response time should be directed to the
Department of Homeland Security
(DHS), USCIS, Chief, Regulatory
Products Division, Clearance Office, 111
Massachusetts Avenue, NW.,
Washington, DC 20529–2210.
Comments may also be submitted to
DHS via facsimile to 202–272–8352, or
via e-mail at [email protected]. When
submitting comments by e-mail, please
make sure to add the OMB Control
Number 1615–0105 in the subject box.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information should address one or more
of the following four points:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the

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collection of information, including the
validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) 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.
Overview of this Information Collection
(1) Type of Information Collection:
Revision of an existing information
collection.
(2) Title of the Form/Collection:
Notice of Entry of Appearance as
Attorney or Accredited Representative,
and Notice of Entry of Appearance of
Foreign Attorney.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form G–28,
and Form G–28I. U.S. Citizenship and
Immigration Services (USCIS).
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
households. The data collected on
Forms G–28 and G–28I are used by DHS
to determine eligibility of the individual
to appear as a representative.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 2,479,000 responses at 20
minutes (.333) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 825,507 annual burden
hours.
If you need a copy of the information
collection instrument, please visit the
Web site at: http://www.regulations.
gov/. We may also be contacted at:
USCIS, Regulatory Products Division,
111 Massachusetts Avenue, NW.,
Washington, DC 20529–2210,
Telephone number 202–272–8377.
Dated: March 26, 2010.
Stephen Tarragon
Deputy Chief, Regulatory Products Division,
U.S. Citizenship and Immigration Services.
[FR Doc. 2010–7265 Filed 3–31–10; 8:45 am]
BILLING CODE 9111–97–P

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