Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 62169 

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. 

SUMMARY: 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: 

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, 

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: 

hastingw@mail.nih.gov. 

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 

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 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: 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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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 FEMA-InformationCollections-Management@fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Collection of Information 

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 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID FEMA–2014–0024; OMB No. 

1660–0057] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request; Chemical 

Stockpile Emergency Preparedness 

Program (CSEPP) Evaluation and 

Customer Satisfaction Survey 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: 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 FEMA-InformationCollections-Management@fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Collection of Information 

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 

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. 

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 

Extension of the Designation of 

Honduras for Temporary Protected 

Status 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 

ACTION: Notice. 


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