30448 Federal Register / Vol. 83, No. 125 / Thursday, June 28, 2018 / Notices 

State Enforcement Notifications 

OMB Control Number 0910–0275— 

Extension 

This information collection supports 

Agency regulations. Specifically, section 

310(b) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

337(b)) authorizes a State to enforce 

certain sections of the FD&C Act in its 

own name and within its own 

jurisdiction. However, before doing so, 

a State must provide notice to FDA 

according to § 100.2 (21 CFR 100.2). The 

information required in a letter of 

notification under § 100.2(d) enables us 

to identify the food against which a 

State intends to take action and to 

advise that State whether Federal 

enforcement action against the food has 

been taken or is in process. With certain 

narrow exceptions, Federal enforcement 

action precludes State action under the 

FD&C Act. 

In the Federal Register of February 7, 

2018 (83 FR 5438), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. FDA received one 

comment in support of the information 

collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part Number of 

respondents 

Number of 

responses per 

respondents 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

21 CFR Section 100.2(d) ..................................................... 1 1 1 10 10 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The estimated burden for this 

information collection has not changed 

since the last OMB approval. The 

estimated reporting burden for 

§ 100.2(d) is minimal because 

enforcement notifications are seldom 

used by States. During the last 3 years, 

we have not received any new 

enforcement notifications; therefore, we 

estimate that one or fewer notifications 

will be submitted annually. Although 

we have not received any new 

enforcement notifications in the last 3 

years, we believe these information 

collection provisions should be 

extended to provide for the potential 

future need of a State government to 

submit enforcement notifications 

informing us when it intends to take 

enforcement action under the FD&C Act 

against a particular food located in the 

State. 

Dated: June 21, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13868 Filed 6–27–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Developmental Therapeutics. 

Date: July 9, 2018. 

Time: 12:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Sharon K. Gubanich, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6195D, 

MSC 7804, Bethesda, MD 20892, (301) 408– 

9512, gubanics@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: June 22, 2018. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–13894 Filed 6–27–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Development of an 

Anti-Mesothelin Chimeric Antigen 

Receptor (CAR) for the Treatment of 

Human Cancer 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute, 

an institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Patent License to 

practice the inventions embodied in the 

U.S. Patents and Patent Applications 

listed in the Supplementary Information 

section of this notice to Atara 

Biotherapeutics Inc. (‘‘Atara’’) located in 

South San Francisco, CA. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Cancer 

Institute’s Technology Transfer Center 

on or before July 13, 2018 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

an Exclusive Patent License should be 

directed to: Rose M. Freel, Ph.D., 

Licensing and Patenting Manager, NCI 

Technology Transfer Center, 8490 

Progress Drive, Suite 400, Frederick, MD 

21701; Telephone: (301)–624–8775; 

Facsimile: (240)–276–5504; Email: 

rose.freel@nih.gov. 

SUPPLEMENTARY INFORMATION: 


amozie on DSK3GDR082PROD with NOTICES1
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