Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35663 

rsvp.fitness@hhs.gov or by calling (240) 

276–9567. Registration for public 

attendance must be completed before 

close of business Wednesday, 

September 12, 2018. 

Dated: July 12, 2018. 

Holli M. Richmond, 

Executive Director, Office of the President’s 

Council on Sports, Fitness, and Nutrition, 

U.S. Department of Health and Human 

Services. 

[FR Doc. 2018–16056 Filed 7–26–18; 8:45 am] 

BILLING CODE 4150–35–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: Radiotherapeutics Against 

Somatostatin-Receptor Expressing 

Neuroendocrine Tumors 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Heart, Lung and 

Blood Institute (NHLBI), National 

Institutes of Health, Department of 

Health and Human Services, is 

contemplating the grant of an exclusive 

patent license to Molecular Targeting 

Technologies, Inc. (MTTI); a Delaware 

corporation, with its principle place of 

business in West Chester, Pennsylvania, 

to practice the inventions embodied in 

the patent application listed in the 

SUPPLEMENTARY INFORMATION section of 

this notice. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NHLBI Office of 

Technology Transfer and Development 

August 27, 2018 will be considered. 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

exclusive patent license should be 

directed to: Michael Shmilovich, Esq., 

Senior Licensing and Patent Manager, 

31 Center Drive, Room 4A29, MSC2479, 

Bethesda, MD 20892–2479, phone 

number 301–435–5019, or shmilovm@

mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

following and all continuing U.S. and 

foreign patents/patent applications 

thereof are the intellectual properties to 

be licensed under the prospective 

agreement to MTTI: HHS Ref. E–150– 

2016–1–PCT–01, International Patent 

Application PCT/US2017/054863 filed 

October 3, 2017, entitled ‘‘Chemical 

Conjugates of Evans Blue Derivatives 

and Their Use As Radiotherapy And 

Imaging Agents.’’ 

The patent rights in these inventions 

have been assigned to the Government 

of the United States of America. The 

prospective patent license will be 

granted worldwide and in a field of use 

not broader than radiotherapeutics for 

somatostatin-receptor expressing 

neuroendocrine tumors. 

The invention pertains to a 

radiotherapeutic against neuroendocrine 

tumors that express somatostatin 

receptor. Radionuclide therapies 

directed against tumors that express 

somatostatin receptors (SSTRs) have 

proven effective for the treatment of 

advanced, low- to intermediate-grade 

neuroendocrine tumors. The subject 

radiotherapeutic covered by the subject 

patent estate includes a somatostatin 

(SST) peptide derivative like octreotate 

(TATE), conjugated to an Evans Blue 

(EB) analog, and further chelated via 

DOTA to therapeutic radionuclide 

177Lu, a beta emitter. The EB analog 

reversibly binds to circulating serum 

albumin and improves the 

pharmacokinetics of SST peptide 

derivatives and reduce peptide-receptor 

radionuclide therapy toxicity. EB analog 

conjugated to octreotate (EBDOTATATE) has been shown by the 

inventors to provide reversible albumin 

binding in vivo and extended half-life in 

circulation. When EB-TATE is slowly 

released into the tumor 

microenvironment, tumor uptake and 

internalization into SSTR positive 

tumors resulted in delivery of 

radioactive particles and tumor cell 

killing. EB-TATE displayed significantly 

more favorable pharmacokinetics than 

TATE alone by achieving higher tumor 

to non-tumor penetration as evidenced 

by positron emission tomography. 

This notice is made in accordance 

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

The prospective exclusive patent license 

will be royalty bearing and may be 

granted unless within fifteen (15) days 

from the date of this published notice, 

the NHLBI 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 prospective field of use that are 

timely filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive patent 

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: July 20, 2018. 

Michael A. Shmilovich, 

Senior Licensing and Patenting Manager, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development. 

[FR Doc. 2018–16065 Filed 7–26–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; U01 SEP: 

Glycobiologists Alliance for Cancer Research. 

Date: August 30, 2018. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute, Shady 

Grove, 9609 Medical Center Drive, Room 

7W102, Rockville, MD 20850 (Telephone 

Conference Call). 

Contact Person: Shakeel Ahmad, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W102, Bethesda, MD 20892– 

9750, 240–276–6349, ahmads@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI 

Program Project IV (P01). 

Date: September 27–28, 2018. 

Time: 4:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

North Bethesda, MD 20852. 

Contact Person: Sanita Bharti, Ph.D., 

Scientific Review Officer, Research Program 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W122, 

Bethesda, MD 20892–9750, 240–276–5909, 

sanitab@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 


amozie on DSK3GDR082PROD with NOTICES1
35664 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: July 23, 2018. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–16008 Filed 7–26–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice To Announce Commission of a 

Surgeon General’s Report on Oral 

Health 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: On behalf of the United States 

Department of Health and Human 

Services, the Office of the Surgeon 

General, the National Institutes of 

Health, and the National Institute of 

Dental and Craniofacial Research, the 

U.S. Public Health Service’s Oral Health 

Coordinating Committee announces the 

commission of a Surgeon General’s 

Report presenting prominent issues 

affecting oral health. The report will 

document progress in oral health in the 

twenty years since the 2000 Surgeon 

General’s Report on Oral Health, 

identify existing knowledge gaps, and 

articulate a vision for the future. 

FOR FURTHER INFORMATION CONTACT: 

Bruce A. Dye, DDS, MPH, Dental 

Epidemiology Officer, Office of Science 

Policy and Analysis, NIDCR, NIH, 31 

Center Drive, Room 5B55, Rockville, 

MD, 20892. Phone: 301–496–7765, 

Email: bruce.dye@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Scope of Problem: The charge for the 

first Surgeon General’s report on oral 

health in 2000 was to define, describe, 

and evaluate the interaction between 

oral health and health and well-being 

(quality of life), through the lifespan in 

the context of changes in society. The 

overarching message from that report 

clearly communicated that oral health is 

essential to the general health and wellbeing of all Americans and can be 

achieved by all. In the intervening two 

decades, oral health has improved for 

many Americans, but not for all. Many 

Americans are retaining more of their 

natural teeth, complete tooth loss among 

older adults is at the lowest level ever 

measured, and many younger children 

have less untreated tooth decay. Over 

the past two decades, we have learned 

more about how changes across the 

lifespan can substantially influence oral 

health and how health promotion 

activities and interventions targeted for 

specific life stages can benefit oral 

health and quality of life. However, 

many Americans continue to experience 

unnecessary pain and complications 

from poor oral health that adversely 

affect their well-being, adding 

substantial economic and social costs. 

Poor oral health also impacts our 

nation’s ability to recruit young adults 

for military service and maintain 

military readiness. 

Oral health workforce models and 

care delivery systems have evolved in 

the past two decades. There has been a 

substantial effort to incorporate early 

detection and preventive oral health 

measures into primary care settings and 

the expansion of the State Children’s 

Health Insurance Program, Medicaid, 

and other health insurance programs 

have helped many Americans of all 

ages. Yet, as there have been some 

successes in integrating oral health into 

the broader health care system in the 

United States, many still view oral 

health care as a supplemental benefit, 

and not a priority benefit. This separate 

view of oral health negatively impacts 

our nation in a variety of ways. 

including the increasing use of 

emergency departments at substantial 

cost to treat dental pain and related 

conditions. Finally, the increasing 

problems of substance misuse and use 

disorders during the past two decades 

have impacted oral health at the patient, 

community, and provider level, which 

has raised awareness of the need to 

address dental provider prescribing 

patterns and pain management 

practices. 

The first Surgeon General’s report on 

oral health addressed determinants for 

oral health and disease. Twenty years 

later, the knowledge gained from 

science and technology has continued to 

provide a better understanding of the 

etiology and natural history of oral and 

craniofacial diseases and conditions, 

and we have gained a better 

understanding of these determinants. 

This knowledge has led to therapeutic 

interventions that have improved oral 

health over the past two decades. 

Ongoing research is improving our 

understanding of the biological 

influences on oral health, the 

relationship between oral diseases and 

general health, the role of technology 

and advanced materials in improving 

dental care, and the benefits of good oral 

health to overall well-being and the 

community. Although we benefit from 

numerous advances that influence oral 

health, we still face challenges as we try 

to reach our goal of oral health for all. 

Approach: The scope of the Surgeon 

General’s Report is intended to be broad 

and comprehensive, with the goal of 

mapping the current landscape of the 

key issues that affect oral health. It will 

present information from a variety of 

data sources such as the National Health 

and Nutrition Examination Survey, 

Medical Expenditure Panel Survey, 

Behavioral Risk Factor Surveillance 

System, and others. These sources 

highlight changes in oral health over 

time, providing opportunities to 

monitor how determinants for health 

have changed, and the effect of those 

changes over the past 20 years. The 

report is intended to: (1) Underscore the 

critical nature of poor oral health as a 

public health issue; (2) provide a 

comprehensive review of the 

importance of oral health throughout 

life; (3) describe important 

contemporary issues affecting oral 

health and the promise of science to 

transform the oral health of the nation; 

(4) outline a vision for future directions; 

and (5) educate, encourage, and call 

upon all Americans to take action. 

Potential Areas of Focus: Areas of 

focus in the report may include a 

description of the epidemiology of 

diseases and conditions that affect the 

craniofacial complex; a review of health 

promotion and disease prevention 

activities; factors that affect the etiology 

of poor oral health at the individual and 

population level; social determinants of 

health and their influence on oral health 

disparities; biological factors including 

the microbiome; social, economic, and 

health consequences of poor oral health; 

mental health, substance misuse and 

addiction impact on the oral health of 

individuals, providers, and 

communities; the state of oral health 

care access and coverage as it relates to 

prevention and treatment for dental 

diseases and related conditions; 

integration of oral health into primary 

health care settings; organization and 

financing of the provision of dental care 

within the health care system; ethical, 

legal, and policy issues; and the 

application of scientific research in the 

field, including methods, challenges, 

and current and future directions. 

Dated: July 21, 2018. 

Lawrence A. Tabak, 

Deputy Director, National Institutes of Health. 

[FR Doc. 2018–16096 Filed 7–26–18; 8:45 am] 

BILLING CODE 4140–01–P 


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