35666 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Proposed Collection Title: Intramural 

Continuing Umbrella of Research 

Experiences (iCURE) Application, 0925– 

XXXX, Exp., Date XX/XXXX, EXISTING 

COLLECTION IN USE WITHOUT OMB 

APPROVAL, National Cancer Institute 

(NCI), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: The new Intramural 

Continuing Umbrella of Research 

Experiences (iCURE) program supports 

mentored research experiences for 

qualified post-baccalaureate (including 

post masters) individuals, graduate 

students, and postdoctoral fellows in 

the multidisciplinary National Cancer 

Institute (NCI) intramural research 

environment. This information 

collection request are applications and a 

reference letter to help evaluate the 

merits of the candidates and their 

potential match for the iCURE program. 

iCURE is an extension of the highly 

successful NCI Center to Reduce Cancer 

Health Disparities’ (CRCHD) Continuing 

Umbrella of Research Experiences 

(CURE) program which helps support 

the career progress of its scholars 

toward research independence, as well 

as fosters and sustains diversity in the 

biomedical research pipeline. Like the 

CURE program, iCURE strongly 

encourages the participation of 

individuals from underrepresented 

populations and is aligned with NCI’s 

interest in diversity. The benefit of 

collecting this information is to enable 

the selection of the best matching 

candidates for the iCURE program. The 

iCURE program aims to, 1. Enhance the 

diversity of the NCI Intramural Research 

Program (IRP), and 2. Promote the career 

progress of the iCURE scholars in cancer 

research. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated burden hours are 305. 

ESTIMATED ANNUALIZED BURDEN HOURS

Form name Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

time per 

response 

(in hours) 

Total annual 

burden hour 

Postbac Supplemental Application ... Post-Baccalaureate (Including PostMaster’s) Individuals.50 1 30/60 25 

Graduate Student Application ........... Graduate Students ........................... 30 1 2 60 

Postdoctoral Fellowship Application Postdoctoral Candidates .................. 50 1 2 100 

Reference Letter ............................... PIs, professors, supervisors ............. 240 1 30/60 120 

Total ........................................... ........................................................... 370 370 ........................ 305 

Patricia M. Busche, 

Project Clearance Liaison, National Cancer 

Institute, National Institutes of Health. 

[FR Doc. 2018–16053 Filed 7–26–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke, Muscular 

Dystrophy Coordinating Committee 

Call for Committee Membership 

Nominations 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The Office of the Secretary of 

the Department of Health and Human 

Services (HHS) is seeking nominations 

for an individual to serve as a 

nonfederal public member on the 

Muscular Dystrophy Coordinating 

Committee. 

DATES: Nominations are due by 5 p.m. 

EDT on August 31, 2018. 

ADDRESSES: Nominations must be sent 

to Glen Nuckolls, Ph.D., by email to 

nuckollg@ninds.nih.gov. 

FOR FURTHER INFORMATION CONTACT: Glen 

Nuckolls, Ph.D., by email to nuckollg@

ninds.nih.gov. or (301) 496–5745. 

SUPPLEMENTARY INFORMATION: The 

Muscular Dystrophy Coordinating 

Committee (MDCC) is a federal advisory 

committee established in accordance 

with the Muscular Dystrophy 

Community Assistance, Research, and 

Education Amendments of 2001 (MD– 

CARE Act; Pub. L. 107–84). The MD– 

CARE Act was reauthorized in 2008 by 

Public Law 110–361, and again in 2014 

by Public Law 113–166. The MD–CARE 

Act specifies that the committee 

membership be composed of 2⁄3

governmental agency representatives 

and 1⁄3 public members. We are seeking 

nominations for two non-federal, public 

members at this time, due to turnover of 

committee membership. Nominations 

will be accepted between July 31 and 

August 31, 2018. 

Who is Eligible: Nominations are 

encouraged for new or reappointment of 

non-federal public members who can 

provide the public and/or patient 

perspectives to discussions of issues 

considered by the Committee. Selfnominations and nominations of other 

individuals are both permitted. Only 

one nomination per individual is 

required. Multiple nominations for the 

same individual will not increase 

likelihood of selection. Non-federal, 

public members may be selected from 

the pool of submitted nominations or 

other sources as needed to meet 

statutory requirements and to form a 

balanced committee that represents the 

diversity within the muscular dystrophy 

communities. Nominations are 

especially encouraged from leaders or 

representatives of muscular dystrophy 

research, advocacy, or service 

organizations, individuals with 

muscular dystrophy or their parents or 

guardians. In accordance with White 

House Office of Management and 

Budget guidelines (FR Doc. 2014– 

19140), federally-registered lobbyists are 

not eligible. 

Committee Composition: The 

Department strives to ensure that the 

membership of HHS Federal advisory 

committees is fairly balanced in terms of 

points of view represented and the 

committee’s function. Every effort is 

made to ensure that the views of all 

genders, all ethnic and racial groups, 

and people with disabilities are 


amozie on DSK3GDR082PROD with NOTICES1
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 


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