Federal Register / Vol. 83, No. 125 / Thursday, June 28, 2018 / Notices 30449 

Intellectual Property 

United States Provisional Patent 

Application No. 61/040,005, filed March 

27, 2008 and entitled ‘‘Human 

Monoclonal Antibodies Specific for 

Mesothelin’’ [HHS Reference No. 

E–079–2008/0–US–01]; 

PCT Patent Application PCT/US2009/ 

038228, filed March 25, 2009 and 

entitled ‘‘Human Monoclonal Antibody 

Against Mesothelin’’ [HHS Reference 

No. E–079–2008/0–PCT–02]; and US 

Patent No. 8,357,783, filed September 

22, 2010, Issued January 22, 2013 and 

entitled ‘‘Human Anti-Mesothelin 

Monoclonal Antibodies’’ [HHS 

Reference No. E–079–2008/0–US–06]. 

The patent rights in these inventions 

have been assigned and/or exclusively 

licensed to the government of the 

United States of America. 

The prospective exclusive license 

territory may be worldwide and the 

field of use may be limited to: ‘‘The 

development of a mesothelin chimeric 

antigen receptor (CAR)-based 

immunotherapy using autologous or 

allogeneic T cells either transduced 

with a retroviral vector (including 

lentiviral vectors) or modified using a 

gene-editing technology, wherein the 

vector expresses a CAR comprising: 

(1) Single antigen specificity for 

binding to mesothelin, and 

(2) at least (a) the complementary 

determining region (CDR) sequences of 

the anti-mesothelin antibody known as 

m912, and (b) a T cell signaling domain; 

for the prophylaxis and treatment of 

mesothelin-expressing human cancers.’’ 

This technology discloses a 

monoclonal antibody and methods of 

using the antibody for the treatment of 

mesothelin-expressing cancers, 

including mesothelioma, lung cancer, 

stomach/gastric cancer, ovarian cancer, 

and pancreatic cancer. The specific 

antibody covered by this technology is 

designated as m912, which is a fully 

human monoclonal antibody against 

mesothelin. 

Mesothelin is a cell surface antigen 

that is preferentially expressed on 

certain types of cancer. The m912 

antibody selectively binds to the 

mesothelin on the surface of cancer cells 

and induces cell death of those cancer 

cells while leaving healthy cells 

unharmed. This selectivity may lead to 

fewer side effects due to decreased nonspecific killing of cells. 

This notice is made in accordance 

with 35 U.S.C. 209 and 37 CFR part 404. 

The prospective exclusive license will 

be royalty bearing, and the prospective 

exclusive license may be granted unless 

within fifteen (15) days from the date of 

this published notice, the National 

Cancer Institute 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. 

In response to this Notice, the public 

may file comments or objections. 

Comments and objections, other than 

those in the form of a license 

application, will not be treated 

confidentially, and may be made 

publicly available. 

License applications submitted in 

response to this Notice will be 

presumed to contain business 

confidential information and any release 

of information in these license 

applications will be made only as 

required and upon a request under the 

Freedom of Information Act, 5 U.S.C. 

552. 

Dated: June 21, 2018 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2018–13893 Filed 6–27–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Secretary; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Interagency Pain 

Research Coordinating Committee, July 

09, 2018, 02:00 p.m. to July 09, 2018, 

04:00 p.m., National Institutes of Health, 

Building 31, 31 Center Drive, 

Conference Room 6, Bethesda, MD, 

20892 which was published in the 

Federal Register on May 18, 2018, 83 

FR 23283. 

The meeting notice is amended to 

change the time of the meeting from 2– 

4 p.m. to 4–6 p.m. Date has not changed. 

The meeting is open to the public. 

Dated: June 22, 2018. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–13895 Filed 6–27–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Notice of Meetings 

AGENCY: Substance Abuse and Mental 

Health Services Administration; Centers 

for Disease Control and Prevention; 

Department of Health and Human 

Services. 

ACTION: Notice of meetings. 

SUMMARY: Notice is hereby given of the 

meetings on July 22–23, 2018, of the 

Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Tribal Technical Advisory Committee 

(TTAC); on July 23 and July 25, 2018, 

of the Centers for Disease Control and 

Prevention (CDC)/Agency for Toxic 

Substances and Disease Registry 

(ATSDR) Tribal Advisory Committee 

(TAC); and on July 24, 2018, of the Joint 

Tribal Advisory Committee (JTAC). 

DATES: 

SAMHSA TTAC 

July 22, 2018, 1:00 p.m. to 5:00 p.m. 

EDT (OPEN) 

July 23, 2018, 9:00 a.m. to 5:00 p.m. 

EDT (OPEN) 

• CDC/ATSDR TAC 

July 23, 2018, 8:00 a.m. to 6:00 p.m. 

EDT (OPEN) 

July 25, 2018, 8:00 a.m. to 12:00 p.m. 

EDT (OPEN) 

• JTAC 

July 24, 2018, 1:00 p.m. to 5:00 p.m. 

EDT, (OPEN) 

ADDRESSES: 

• SAMHSA TTAC 

Marriott Wardman Park Hotel, 2660 

Woodley Road NW, Washington, 

DC 20008 

• CDC/ATSDR TAC 

HHS Headquarters, Hubert H. 

Humphrey Building, 200 

Independence Avenue SW, 

Washington, DC 20201 

• JTAC 

HHS Headquarters, Hubert H. 

Humphrey Building, 200 

Independence Avenue SW, 

Washington, DC 20201. 

FOR FURTHER INFORMATION CONTACT: 

TTAC and JTAC, Mirtha Beadle, MPA, 

Director, Office of Tribal Affairs and 

Policy, Substance Abuse and Mental 

Health Services Administration, 5600 

Fishers Lane, Rockville, Maryland 

20857, Telephone: (240) 276–0641, 

Email: otap@samhsa.hhs.gov. 

CDC/ATSDR/TAC, Carmen Clelland, 

PharmD, MPA, MPH, Associate 

Director for Tribal Support, Office for 

State, Tribal, Local and Territorial 

Support, Centers for Disease Control 

and Prevention, 4770 Buford 

Highway, Mailstop E–70, Atlanta, GA 

30341–3717, Telephone: (404) 498– 

2205, Email: cclelland@cdc.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Presidential Executive Order 13175 

signed on November 6, 2000 and the 

Presidential Memorandum of September 

23, 2004, SAMHSA established the 


amozie on DSK3GDR082PROD with NOTICES1
30450 Federal Register / Vol. 83, No. 125 / Thursday, June 28, 2018 / Notices 

TTAC to provide a complementary 

venue wherein tribal leaders and 

SAMHSA officials exchange 

information about public health issues 

in Indian Country; identify urgent 

mental health and substance abuse 

needs in tribal communities; and 

discuss collaborative approaches for 

addressing issues and needs. The 

SAMHSA TTAC serves as a national 

advisory body to SAMHSA. 

The TTAC meeting will include 

updates and discussion related to tribal 

priorities for SAMHSA; collaborative 

opportunities between SAMHSA and 

CDC/ATSDR; behavioral health policy, 

budget, and legislative activities; tribal 

input in response to recent consultation 

and listening sessions; and essential 

coordination with other SAMHSA and 

HHS efforts to improve tribal behavioral 

health and wellness. 

The purpose of the CDC/ATSDR TAC 

meeting is to advance CDC and ATSDR 

support for and partnership with 

American Indian and Alaska Native (AI/ 

AN) tribes, and to improve the health of 

tribes by pursuing goals that include 

assisting in eliminating the health 

disparities faced by tribes; ensuring that 

access to critical health and human 

services is maximized to advance or 

enhance the social, physical, and 

economic status of AI/AN people; and 

promoting health equity for all AI/AN 

people. 

The CDC/ATSDR TAC agenda will 

include discussions on tribal priorities 

for CDC and ATSDR, public health 

capacity in Indian Country, AI/AN 

health concerns, CDC and ATSDR 

budget and funding opportunities, and 

programmatic highlights from the 

agencies. Agenda items are subject to 

change as priorities dictate. All tribal 

leaders are encouraged to submit 

written testimony for the CDC/ATSDR 

TAC by 5:00 p.m. EDT Friday, July 15, 

2018, to Captain Carmen Clelland, 

Associate Director of Tribal Support, 

OSTLTS, via mail to 4770 Buford 

Highway NE, MS E–70, Atlanta, GA, 

30341–3717, or email TribalSupport@

cdc.gov. Tribal leaders can find 

guidance to assist in developing tribal 

testimony for CDC and ATSDR at 

www.cdc.gov/tribal/consultation. 

The TTAC and JTAC meetings are 

open to the public. Interested persons 

may submit data, information, or views 

on issues pending before the TTAC or 

JTAC in writing. The designated 

SAMHSA contact official must receive 

TTAC and JTAC submissions no later 

than July 15, 2018. Individuals 

interested in making public comments 

during the TTAC meeting must notify 

the designated SAMHSA contact official 

by July 15, 2018. Time is available for 

public comments at the end of the 

TTAC meeting on July 23 (two minutes 

will be allotted for each public 

comment). Oral comments will not be 

scheduled for the JTAC meeting. 

The TTAC and JTAC meetings are 

accessible via web conferencing. To 

attend on site, obtain web conferencing 

information, submit written comments, 

provide brief oral comments (TTAC 

only), or request special 

accommodations for persons with 

disabilities, please register online at: 

http://nac.samhsa.gov/Registration/ 

meetingsRegistration.aspx, or submit 

information for Mirtha Beadle, Director, 

Office of Tribal Affairs and Policy, 

SAMHSA, at otap@samhsa.hhs.gov. 

SAMHSA and CDC are publishing 

their committee meeting notices 

together as CDC/ATSDR TAC members 

will join the SAMHSA TTAC for a 

collaborative discussion on July 22. 

Further, based on recommendations 

from tribal leaders, a JTAC meeting has 

been scheduled to discuss issues of 

common concern across the SAMHSA 

TTAC, CDC/ATSDR TAC, Indian Health 

Service (IHS) National Tribal Advisory 

Committee on Behavioral Health, and 

other U.S. Department of Health and 

Human Services (HHS) operating 

division tribal advisory committees. The 

intent of the JTAC meeting is to improve 

coordination across shared TAC topics 

to strengthen tribal health. The topics 

for JTAC discussion include improving 

data on American Indian and Alaska 

Native Health and the tribal health 

workforce (i.e., primary care, behavioral 

health, public health, research, etc.). 

Carlos Castillo, 

Committee Management Officer, SAMHSA. 

[FR Doc. 2018–13878 Filed 6–27–18; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID FEMA–2018–0002; Internal 

Agency Docket No. FEMA–B–1832] 

Proposed Flood Hazard 

Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: Comments are requested on 

proposed flood hazard determinations, 

which may include additions or 

modifications of any Base Flood 

Elevation (BFE), base flood depth, 

Special Flood Hazard Area (SFHA) 

boundary or zone designation, or 

regulatory floodway on the Flood 

Insurance Rate Maps (FIRMs), and 

where applicable, in the supporting 

Flood Insurance Study (FIS) reports for 

the communities listed in the table 

below. The purpose of this notice is to 

seek general information and comment 

regarding the preliminary FIRM, and 

where applicable, the FIS report that the 

Federal Emergency Management Agency 

(FEMA) has provided to the affected 

communities. The FIRM and FIS report 

are the basis of the floodplain 

management measures that the 

community is required either to adopt 

or to show evidence of having in effect 

in order to qualify or remain qualified 

for participation in the National Flood 

Insurance Program (NFIP). In addition, 

the FIRM and FIS report, once effective, 

will be used by insurance agents and 

others to calculate appropriate flood 

insurance premium rates for new 

buildings and the contents of those 

buildings. 

DATES: Comments are to be submitted 

on or before September 26, 2018. 

ADDRESSES: The Preliminary FIRM, and 

where applicable, the FIS report for 

each community are available for 

inspection at both the online location 

https://www.fema.gov/preliminary

floodhazarddata and the respective 

Community Map Repository address 

listed in the tables below. Additionally, 

the current effective FIRM and FIS 

report for each community are 

accessible online through the FEMA 

Map Service Center at https://

msc.fema.gov for comparison. 

You may submit comments, identified 

by Docket No. FEMA–B–1832, to Rick 

Sacbibit, Chief, Engineering Services 

Branch, Federal Insurance and 

Mitigation Administration, FEMA, 400 

C Street SW, Washington, DC 20472, 

(202) 646–7659, or (email) 

patrick.sacbibit@fema.dhs.gov. 

FOR FURTHER INFORMATION CONTACT: Rick 

Sacbibit, Chief, Engineering Services 

Branch, Federal Insurance and 

Mitigation Administration, FEMA, 400 

C Street SW, Washington, DC 20472, 

(202) 646–7659, or (email) 

patrick.sacbibit@fema.dhs.gov; or visit 

the FEMA Map Information eXchange 

(FMIX) online at https://

www.floodmaps.fema.gov/fhm/fmx_

main.html. 

SUPPLEMENTARY INFORMATION: FEMA 

proposes to make flood hazard 

determinations for each community 

listed below, in accordance with section 

110 of the Flood Disaster Protection Act 

of 1973, 42 U.S.C. 4104, and 44 CFR 

67.4(a). 


amozie on DSK3GDR082PROD with NOTICES1