30 Day Federal Register Notice

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Federal Register / Vol. 77, No. 15 / Tuesday, January 24, 2012 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of T Cell
Receptors and Chimeric Antigen
Receptors Into Therapeutics for
Adoptive Transfer in Humans To Treat
Cancer
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
CFR404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license, subject to existing nonexclusive licenses and current nonexclusive license applications under
consideration, to practice the inventions
embodied in U.S. Provisional Patent
Application No. 61/405,668 and PCT
Patent Application No. PCT/US2011/
057272 and foreign equivalents thereof
entitled ‘‘Anti-MAGE–A3 T cell
receptors and related materials and
methods of use’’ (HHS Ref. No. E–236–
2010/0); U.S. Provisional Patent
Application No. 61/384,931 and PCT
Patent Application No. PCT/US2011/
051537 and foreign equivalents thereof
entitled ‘‘Anti-SSX–2 T cell receptors
and related materials and methods of
use’’ (HHS Ref. No. E–269–2010/0); U.S.
Provisional Patent Application No. 61/
473,409 entitled ‘‘Anti-epidermal
growth factor receptor variant III
chimeric antigen receptors and use of
same for the treatment of cancer’’ (HHS
Ref. No. E–148–2011/0); and U.S.
Provisional Patent Application No. 61/
535,086 entitled ‘‘T cell receptors
recognizing HLA–A1- or HLA–Cw7restricted MAGE–A’’ (E–266–2011/0) to
Kite Pharma, Inc., which is located in
Los Angeles, California. The patent
rights in these inventions have been
assigned to the United States of
America.
Other than license applications
submitted as objections to this Notice of
Intent to Grant an Exclusive License, no
further license applications will be
considered for the exclusive field of use
set forth below if Kite Pharma, Inc. is
granted an exclusive license pursuant to
this Notice of Intent to Grant an
Exclusive License. The prospective
exclusive license territory may be
worldwide and the field of use may be
limited to the treatment of cancers,
which may include brain cancer, breast
cancer, colorectal cancer, esophageal

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SUMMARY:

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cancer, gastric cancer, head and neck
cancer, liver cancer, lung cancer,
melanoma, multiple myeloma, ovarian
cancer, prostate cancer, sarcoma, and
urothelial cancer, as claimed in the
Licensed Patent Rights.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
February 23, 2012 will be considered, in
addition to the current non-exclusive
applications under consideration, for
the prospective license territory and
field of use to be granted under the
contemplated exclusive patent license.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Samuel E. Bish, Ph.D.,
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5282; Facsimile: (301) 402–0220; Email:
[email protected].
SUPPLEMENTARY INFORMATION: The
technologies describe T cells engineered
to express MAGE–A3, MAGE–A12, or
SSX–2 T cell receptors (TCRs) or
EGFRvIII chimeric antigen (CARs) and
methods of using these engineered T
cells to treat and/or prevent cancer.
These technologies include the TCR and
CAR amino acid sequences, the nucleic
acid sequences that encode these
compositions, vectors to express the
TCRs and CARs, host cells and
populations of host cells, such as T
cells, that express the compositions,
antibodies to the TCRs and CARs,
pharmaceutical compositions, and
associated methods of detecting,
preventing, and treating diseases, such
as cancer, with these TCRs and CARs.
TCRs and CARs are proteins that
recognize antigens, such as cancer
antigens, and activate the cells
expressing these compositions to
destroy the antigen-expressing cell.
TCRs consist of two domains, one
variable domain that recognizes the
antigen and one constant region that
helps the TCR anchor to the membrane
and transmit recognition signals by
interacting with other proteins. CARs
are hybrid proteins consisting of a
portion of an antibody that recognizes
an antigen fused to protein domains that
signal to activate the CAR-expressing
cell. Therapies utilizing these
technologies involve isolating a cancer
patient’s own T cells to be engineered
with the TCR and/or CAR that recognize
the tumor antigen(s) expressed on that
specific patient’s cancer cell.

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Afterwards, the engineered T cells from
the patient are adoptively transferred
back into the patient to mediate tumor
regression. Personalized adoptive cell
transfer therapies developed from these
technologies could yield innovative
therapeutics for any cancers that express
the antigens recognized by these TCRs
and CARs.
The prospective exclusive license,
subject to current non-exclusive license
applications under consideration and
any further license applications
received as objections to this Notice of
Intent to Grant an Exclusive License,
will be royalty bearing and will comply
with the terms and conditions of 35
U.S.C. 209 and 37 CFR Part 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.
Any additional 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: January 18, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–1383 Filed 1–23–12; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2011–0029; OMB No.
1660–0095]

Agency Information Collection
Activities: Submission for OMB
Review; Comment Request, National
Flood Insurance Claims Appeals
Process
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:

The Federal Emergency
Management Agency (FEMA) has
submitted the following information
collection to the Office of Management

SUMMARY:

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Federal Register / Vol. 77, No. 15 / Tuesday, January 24, 2012 / Notices
and Budget (OMB) for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
describes the nature of the information
collection, the categories of
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
includes the actual data collection
instruments FEMA will use.
Comments must be submitted on
or before February 23, 2012.

DATES:

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 the Desk Officer
for the Department of Homeland
Security, Federal Emergency
Management Agency, and sent via
electronic mail to
[email protected] or faxed
to (202) 395–5806.

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

Requests for additional information or
copies of the information collection
should be made to Director, Records
Management Division, 1800 South Bell
Street, Arlington, VA 20598–3005,
facsimile number (202) 646–3347, or
email address [email protected].

srobinson on DSK4SPTVN1PROD with NOTICES

SUPPLEMENTARY INFORMATION:

Title: National Flood Insurance
Claims Appeals Process.
Type of Collection: Revision of a
currently approved information
collection.
OMB Number: 1660–0095.
Abstract: The process requires
policyholders to submit a written appeal
to FEMA (Mitigation Directorate/Risk
Insurance Division), in the form of a
signed letter explaining the nature of
their claim appeal, names and titles of
persons contacted, dates of contact,
contact information, and details of the
contact relevant to their claim appeal.
FEMA will review the documentation
submitted by the policyholder, conduct
any necessary additional investigation,
and advise, both the policyholder and
the appropriate flood insurance carrier,
of its decision regarding the appeal.
Affected Public: Individuals and
Households.
Number of Respondents: 1,055.
Estimated Time per Respondent:
State, 5 hours; Local, 5 hours; and Tribal
5 hours.
Estimated Total Annual Burden
Hours: 2,110 hours.

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Frequency of Response: One Time.
John G. Jenkins, Jr.,
Records Management Division, Office of
Management, Federal Emergency
Management Agency, Department of
Homeland Security.
[FR Doc. 2012–1312 Filed 1–23–12; 8:45 am]
BILLING CODE 9111–11–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2011–0031; OMB No.
1660–0038]

Agency Information Collection
Activities: Submission for OMB
Review; Comment Request, Write Your
Own (WYO) Company Participation
Criteria; New Applicant
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:

The Federal Emergency
Management Agency (FEMA) will
submit the information collection
abstracted below to the Office of
Management and Budget for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
will describe the nature of the
information collection, the categories of
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
the actual data collection instruments
FEMA will use.
DATES: Comments must be submitted on
or before February 23, 2012.
ADDRESSES: 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 the Desk Officer
for the Department of Homeland
Security, Federal Emergency
Management Agency, and sent via
electronic mail to
[email protected] or faxed
to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be made to Director, Records
Management Division, 1800 South Bell
Street, Arlington, VA 20598–3005,
facsimile number (202) 646–3347, or
email address [email protected].
SUPPLEMENTARY INFORMATION:
SUMMARY:

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3483

Collection of Information
Title: Write Your Own (WYO)
Company Participation Criteria; New
Applicant.
Type of Information Collection:
Extension, without change, of a
currently approved information
collection.
OMB Number: 1660–0038.
Form Titles and Numbers: None.
Abstract: New insurance companies
that seek to participate in the WYO
program, as well as former WYO
companies seeking to return, must meet
standards for WYO Financial Control
Plan (approved under OMB Control
#1660–0020). Private Insurance
Companies and/or public entity risksharing organizations wishing to enter
or reenter the WYO program must
demonstrate the ability to meet the
financial requirements. The information
allows FEMA to determine the
applicant’s capability of meeting
program goals including marketing of
flood insurance, training agents and
staff in the program rules, and its
capabilities for claims handling and
disaster response.
Affected Public: Business of other forprofit.
Estimated Number of Respondents: 5.
Frequency of Response: Once.
Estimated Average Hour Burden per
Respondent: Application Process, 7
hours.
Estimated Total Annual Burden
Hours: 35 hours.
Estimated Cost: The estimated annual
cost to respondents for the hour burden
is $2,223.55. There are no annual costs
to respondents operations and
maintenance costs for technical
services. There is no annual start-up or
capital costs. The cost to the Federal
Government is $1,204.
John G. Jenkins, Jr.,
Acting Director, Records Management
Division, Mission Support Bureau, Federal
Emergency Management Agency, Department
of Homeland Security.
[FR Doc. 2012–1313 Filed 1–23–12; 8:45 am]
BILLING CODE 9110–11–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2007–0008]

National Advisory Council
Federal Emergency
Management Agency, DHS.
ACTION: Committee Management; Notice
of Federal Advisory Committee Meeting.
AGENCY:

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