Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35667 

represented on HHS Federal advisory 

committees and, therefore, the 

Department encourages nominations of 

qualified candidates from these groups. 

The Department also encourages 

geographic diversity in the composition 

of the Committee. Appointment to this 

Committee shall be made without 

discrimination on the basis of age, race, 

ethnicity, gender, sexual orientation, 

disability, and cultural, religious, or 

socioeconomic status. Requests for 

reasonable accommodation to enable 

participation on the Committee should 

be indicated in the nomination 

submission. 

Member Terms: Non-Federal public 

members of the Committee serve for a 

term of 3 years, and may serve for an 

unlimited number of terms if 

reappointed. Members may serve after 

the expiration of their terms, until their 

successors have taken office. 

Meetings and Travel: As specified by 

Public Law 113–166, the MDCC ‘‘shall 

meet no fewer than two times per 

calendar year.’’ Travel expenses are 

provided for non-federal public 

Committee members to facilitate 

attendance at in-person meetings. 

Members are expected to make every 

effort to attend all full committee 

meetings, twice per year, either in 

person or via remote access. 

Participation in relevant subcommittee, 

working and planning group meetings, 

and workshops, is also encouraged. 

Submission Instructions and 

Deadline: Nominations are due by 5 

p.m. EDT on August 31, 2018, and 

should be sent to Glen Nuckolls, Ph.D., 

by email to nuckollg@ninds.nih.gov. 

Nominations must include contact 

information for the nominee, a current 

curriculum vitae or resume of the 

nominee and a paragraph describing the 

qualifications of the person to represent 

some portion(s) of the muscular 

dystrophy research, advocacy and/or 

patient care communities. 

More information about the MDCC is 

available at https://mdcc.nih.gov/. 

Dated: July 24, 2018. 

Walter J. Koroshetz, 

Director, National Institute of Neurological 

Disorders and Stroke, National Institutes of 

Health. 

[FR Doc. 2018–16112 Filed 7–26–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: Radiotherapy for Metastatic 

Castration-Resistant Prostate Cancer 

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 

commercialization patent license to 

Sinotau Pharmaceutical Group, 

headquartered in Beijing, China, to 

practice the inventions embodied in the 

patent application(s) 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 Sinotau Pharmaceutical 

Group: U.S. Provisional Patent 

Application 62/633,648, ‘‘Chemical 

Conjugates Of Evans Blue Derivatives 

And Their Use As Radiotherapy And 

Imaging Agents For Targeting Prostate 

Cancer,’’ filed February 22, 2018 (HHS 

Ref. No. E–054–2018–0). The patent 

rights in this invention have been 

assigned to the Government of the 

United States of America. The 

perspective license would be granted 

worldwide and in a field of use not 

broader than radiotherapeutics for 

metastatic castration-resistant prostate 

cancer. 

The invention covered by the patents 

and patent applications pertaining to 

HHS Ref. No. E–054–2018–0 pertain to 

a therapeutic agent that includes a 

chemically conjugated residue derived 

from (((R-)-1-carboxy-2- 

mercaptoethyl)carbamoyl)-L-glutamic 

acid that is further bound to an Evans 

blue analog (EB). The EB analog 

reversibly binds to circulating serum 

albumin to provide a 

radiopharmaceutical that retains affinity 

and specificity to prostate specific 

membrane antigen (PSMA; in this case 

PSMA-617). PSMA is a surface molecule 

shown to be specifically expressed by 

prostate tumor cells. PSMA expression 

levels correlate with disease stage and 

with hormone refractory cancers. 

Although most PSMA expression 

appears to be restricted to the prostate 

cancer, low levels of expression can also 

be detected in the brain, kidneys, 

salivary glands, and small intestine. The 

antigen is also shown to be expressed by 

neovascular tumor vessels of multiple 

other cancers. Inclusion of the Evans 

blue analog promotes high 

internalization and retention rates of the 

conjugated target ligand, and therefore, 

higher accumulation in PSMA positive 

tumors. Labeling EB-PSMA-617 

derivatives with the therapeutic beta 

emitters, e.g., 90Y, 86Y, and 177Lu gives 

rise to improved tumor response and 

survival rates. 

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 19, 2018. 

Michael A. Shmilovich, 

Senior Licensing and Patenting Manager, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development. 

[FR Doc. 2018–16066 Filed 7–26–18; 8:45 am] 

BILLING CODE 4140–01–P 


amozie on DSK3GDR082PROD with NOTICES1