30-Day FRN

Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of T Cell
Receptors for Adoptive Transfer in
Humans To Treat Cancer
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404, that
the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive patent license to Kite
Pharma, Inc., which is located in Los
Angeles, California to practice the
inventions embodied in the following
patent applications and applications
claiming priority to these applications:

SUMMARY:

asabaliauskas on DSK5VPTVN1PROD with NOTICES

1. U.S. Provisional Patent Application No.
61/701,056 filed September 14, 2012 entitled
‘‘T Cell Receptors Recognizing MCH Class IIRestricted Mage-A3’’ (HHS Ref No. E–230–
2012/0–US–01) and
2. PCT Application No. PCT/US13/059608
filed September 13, 2013 entitled ‘‘T Cell
Receptors Recognizing MCH Class IIRestricted Mage-A3’’ (HHS Ref No. E–230–
2012/0–PCT–02).
3. US Provisional Patent Application no.
61/535,086 filed September 15 2011, entitled
‘‘T cell receptors recognizing HLA-A1 or
HLA-Cw7 restricted MAGE’’ (HHS Ref No. E–
266–2011/0–US–01).
4. PCT Application No. PCT/US2012/
054623 filed September 11 2012, entitled ‘‘T
cell receptors recognizing HLA-A1 or HLACw7 restricted MAGE’’ (HHS Ref No. E–266–
2011).

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 limited to the
development, manufacture and
commercialization of melanoma antigen
family (MAGE) A3 and A6-specific T
cell receptor (TCR)-based autologous
peripheral blood T cell therapy products
as set forth in the Licensed Patent Rights
for the treatment of MAGE A3 and A6
expressing cancers.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
November 17, 2014 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: Whitney A. Hastings,
Ph.D., Licensing and Patenting Manager,

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Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 451–
7337; Facsimile: (301) 402–0220; Email:
[email protected].
SUPPLEMENTARY INFORMATION: There are
twelve melanoma antigen family
antigens (MAGE–A) designated A1–
A12. Their normal function is not well
defined, but in cancer cells they block
the functions of tumor suppressor
proteins to mediate tumor growth and
spreading. The MAGE–A proteins are
some of the most widely expressed
cancer testis antigens expressed on
human tumors. Other than non-MHC
expressing germ cells of the testis,
normal cells do not express these
antigens, which make them ideal targets
for cancer immunotherapies anticipated
to generate less toxic side effects than
conventional cancer treatments. These
TCRs deliver a robust immune response
against MAGE–A3 or A6 expressing
cancerous cells and could prove to be a
powerful approach for selectively
attacking tumors without generating
toxicity against healthy cells.
The instant technology describes T
cell receptors (TCRs) against the MAGE–
A3 and A6 tumor antigens in the
context of major histocompatibility
complex (MHC) class II molecule HLADP-beta1*04, and against MAGE–A3
antigen in context of the HLA-A*0101.
They comprise the first HLA class II
restricted MAGE–A3/A6-specific TCRs
developed for use in adoptive
immunotherapy. Since approximately
80% of patients express the HLA-DPbeta1*04 class II HLA allele, this TCR
greatly expands the population pool
treatable with MAGE–A3/A6 TCRs to
include the majority of patients with an
amenable target expression profile.
Cancer immunotherapy with these new
HLA class II TCRs could yield a robust
and effective CD8+ and CD4+ T cell
immune response and selectively target
MAGE–A3/A6 expressing tumors
without generating toxicity against
healthy cells. Finally, they complement
TCRs that are restricted to MHC class I
molecules such as HLA-A*01,
expanding the population of patients
beyond HLA-DP-beta1*04 MHC class II
positive.
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 Part 404.
Complete applications for a license in
the field of use filed in response to this

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notice will be treated as objections to
the grant of the contemplated exclusive
evaluation option 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: October 8, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–24502 Filed 10–15–14; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2014–0018; OMB No.
1660–0039]

Agency Information Collection
Activities: Submission for OMB
Review; Comment Request; National
Fire Academy Long-Term Evaluation
Form for Supervisors and National Fire
Academy Long-Term Evaluation for
Students/Trainees
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 November 17, 2014.
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 oira.submission@
omb.eop.gov or faxed to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
SUMMARY:

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62170

Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices

copies of the information collection
should be made to Director, Records
Management Division, 500 C Street SW.,
Room 7NE, Washington, DC 20472–
3100, facsimile number (202) 212–4701,
or email address [email protected].

DEPARTMENT OF HOMELAND
SECURITY

SUPPLEMENTARY INFORMATION:

Agency Information Collection
Activities: Submission for OMB
Review; Comment Request; Chemical
Stockpile Emergency Preparedness
Program (CSEPP) Evaluation and
Customer Satisfaction Survey

Collection of Information

asabaliauskas on DSK5VPTVN1PROD with NOTICES

Title: National Fire Academy LongTerm Evaluation Form for Supervisors
and National Fire Academy Long-Term
Evaluation for Students/Trainees.
Type of information collection:
Revision of a currently approved
information collection.
Form Titles and Numbers: FEMA
Form 078–0–2A, National Fire Academy
Long-Term Evaluation Student/Trainee;
FEMA Form 078–0–2, National Fire
Academy Long-Term Evaluation
Supervisors.
Abstract: The National Fire Academy
Long-Term Evaluation Forms will be
used to evaluate all National Fire
Academy (NFA) on-campus resident
training courses. Course graduates and
their supervisors will be asked to
evaluate the impact of the training on
both individual job performance and the
performance of the fire and emergency
response department where the student
works. The data provided by students
and supervisors is used to update
existing NFA course materials and to
develop new courses that reflect the
emerging issues/needs of the Nation’s
fire service.
Affected Public: State, local or Tribal
government.
Estimated Number of Respondents:
3,000.
Estimated Total Annual Burden
Hours: 405.
Estimated Cost: There are no record
keeping, capital, startup or maintenance
costs associated with this information
collection.
Dated: October 8, 2014.
Charlene D. Myrthil,
Director, Records Management Division,
Mission Support Bureau, Federal Emergency
Management Agency, Department of
Homeland Security.
[FR Doc. 2014–24486 Filed 10–15–14; 8:45 am]
BILLING CODE 9111–45–P

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Federal Emergency Management
Agency
[Docket ID FEMA–2014–0024; OMB No.
1660–0057]

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 November 17, 2014.
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 oira.submission@
omb.eop.gov 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, 500 C Street SW.,
Room 7NE, Washington, DC 20472–
3100, facsimile number (202) 212–4701,
or email address [email protected].
SUPPLEMENTARY INFORMATION:
SUMMARY:

Collection of Information

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Dated: October 8, 2014.
Charlene D. Myrthil,
Director, Records Management Division,
Mission Support Bureau, Federal Emergency
Management Agency, Department of
Homeland Security.
[FR Doc. 2014–24483 Filed 10–15–14; 8:45 am]
BILLING CODE 9111–46–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[CIS No. 2543–14; DHS Docket No. USCIS–
2014–0007]
RIN 1615–ZB28

Title: Chemical Stockpile Emergency
Preparedness Program (CSEPP)
Evaluation and Customer Satisfaction
Survey.
Type of Information Collection:
Revision of a currently approved
information collection.
FEMA Forms: FEMA Form 008–0–3,
Pueblo EPZ Residential Survey; FEMA

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Form 008–0–3INT, Pueblo EPZ
Residential Survey; FEMA Form 008–0–
4, Pueblo City Residential Survey;
FEMA Form 008–0–5, Pueblo EPZ
Business Survey; and FEMA Form 008–
0–7, Blue Grass EPZ Residential Survey.
Abstract: To support the development
of public outreach and education efforts
that will improve emergency
preparedness, DHS/FEMA’s Chemical
Stockpile Emergency Preparedness
Program (CSEPP) will collect data from
the citizens living in the Immediate
Response Zones and Protective Action
Zones surrounding stockpile sites.
Program managers use survey data
findings to evaluate public awareness of
protective actions at CSEPP sites, and
identify outreach weaknesses and
strengths to develop effective outreach
and education campaigns. Results from
this information collection are shared
with State, local, Tribal, and other
FEMA officials for subsequent action
plans addressing program-wide and
stockpile site-specific issues. Results are
also shared with other Federal agencies
that lend expertise in specific areas of
the program.
Affected Public: Individuals or
households, business or other for-profit.
Estimated Number of Respondents:
2,078.
Estimated Number of Responses:
2,078.
Estimated Total Annual Burden
Hours: 490 hours.
Estimated Cost: There are no record
keeping, capital, startup or maintenance
costs associated with this information
collection.

Extension of the Designation of
Honduras for Temporary Protected
Status
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: Notice.
AGENCY:

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