Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35665 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Development and 

Commercialization of Cancer 

Immunotherapy 

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 Midissia 

Therapeutics (‘‘Midissia’’) located in 

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 August 13, 2018 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

Exclusive Patent License should be 

directed to: Ricquita Pollard, 

Technology Transfer Manager, NCI 

Technology Transfer Center, 9609 

Medical Center Drive, RM 1E530 MSC 

9702, Bethesda, MD 20892–9702 (for 

business mail), Rockville, MD 20850– 

9702; Telephone: (240) 276–5530; 

Facsimile: (240) 276–5504; Email: 

pollardrd@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

1. United States Provisional Patent 

Application No. 62/248,964 filed Oct. 30, 

2015 for ‘‘Compositions and Methods for 

the Treatment of HER2-Expressing Solid 

Tumor ‘‘[HHS Ref. No. E–187–2015/ 

0US–01]; 

2. International Patent Application No. PCT/ 

US2016/059680 filed October 31, 2016 

for ‘‘Compositions and Methods for 

Treatment of HER2-Expressing Solid 

Tumor’’ [HHS Reference No. E–187– 

2015/0–PCT–02]; 

3. Canadian National Stage Patent 

Application (No. not yet assigned), filed 

April 30, 2018 [HHS Ref. No. E–187– 

2015/0–CA–03]; 

4. Japanese National Stage Patent Application 

No. 2018–521518, filed April 30, 2018 

[HHS Ref. No. E–187–2015/0–JP–04]; 

5. Australian National Stage Patent 

Application No. 2016343845, filed April 

30, 2018 [HHS Ref. No. E–187–2015/0– 

AU–05]; 

6. European National Stage Patent 

Application. (No. not yet assigned), filed 

April 30, 2018 [HHS Ref. No. E–187– 

2015/0–EP–06]; 

7. U.S. National Stage Patent Application No. 

15/771,932, filed April 30, 2018 [HHS 

Ref. No. E–187–2015/0–US–07]; 

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 

‘‘development and commercialization of 

Ad-HER2 vaccines as a therapeutic 

against HER2-positive cancers as 

covered within the scope of the 

Licensed Patent Rights, excluding uses 

in combination with vectors/adjuvants, 

checkpoint inhibitors or other immune 

modulators.’’ 

This technology describes a 

recombinant adenoviral vector that 

expresses the extracellular (EC) and 

transmembrane (TM) domains of the 

human HER2 protein and is designed to 

induce a polyclonal anti-tumor 

response. HER2 is a member of the 

epidermal growth factor family and is 

overexpressed in subsets of breast, 

ovarian, gastric, colorectal, pancreatic 

and endometrial cancers. This vaccine 

encodes for the entire EC and TM 

domains of human HER2neu and is 

specifically contained within a 

recombinant adenoviral vector that has 

the knob of Adenovirus 5 and 

substituted fiber of Adenovirus 35. The 

substitution of the knob of Adenovirus 

35 whose receptor is CD46 allows for 

efficient and maximal transduction of 

human dendritic and hematopoietic 

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: July 19, 2018. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2018–16058 Filed 7–26–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Intramural Continuing 

Umbrella of Research Experiences 

(iCURE) Application (National Cancer 

Institute) 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995 to provide 

opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI) will 

publish periodic summaries of propose 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 60 days of the date of this 

publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project, 

contact: Alison Lin, 9609 Medical 

Center Drive, Rockville, MD 20850 or 

call non-toll-free number (240) 276– 

6177 or Email your request, including 

your address to: linaj@mail.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

SUPPLEMENTARY INFORMATION: Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

to address one or more of the following 

points: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 


amozie on DSK3GDR082PROD with NOTICES1
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