11548 Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices 

Federal SUID/SIDS Workgroup 

members, SUID/SIDS stakeholders, 

clinical and maternal and child health 

professionals. These audiences may use 

the information collections to: (1) 

Develop new campaign messages, 

materials, and/or training curricula; (2) 

monitor and improve campaign 

activities; (3) make decisions about 

campaign activities; (4) inform current 

campaign activities; and (5) inform and/ 

or change practices and behaviors of 

program participants. 

Examples of the types of information 

collections that could be included under 

this generic clearance include: Focus 

groups and key informant interviews 

with parents/caregivers and/or health 

professionals to get feedback on 

distribution and outreach activities, 

and/or campaign messages; and Surveys 

with parents/caregivers and/or health 

professionals to: (1) Assess the 

usefulness of the new STS campaign 

materials, including print and on-line 

multi-media materials, (2) track 

outreach experiences of program 

participants, (3) assess training 

participants’ changes in knowledge 

related to safe infant sleep behavior and 

implementation of learned outreach and 

education methods, and (4) assess 

program participants’ resource needs. 

The sub-studies for this generic 

clearance will be small in scale, 

designed to obtain results frequently 

and quickly to guide campaign 

development and implementation, 

inform campaign direction, and be used 

internally for campaign management 

purposes. NICHD’s current scope and 

capacity for STS generic sub-studies is 

non-existent and this request would fill 

this gap. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

13,305. 

ESTIMATED ANNUALIZED BURDEN HOURS

Form name Type of respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response, 

in hours 

Total annual 

burden hours 

Focus Groups ................................... General Public .................................. 215 1 1 215 

Interviews .......................................... General Public .................................. 50 1 1 50 

Pre-/Post-Tests ................................. General Public .................................. 3,000 2 15/60 1,500 

Pre-/Post-Tests ................................. Health Professionals ........................ 20,000 2 15/60 10,000 

Surveys ............................................. Health Professionals ........................ 3,000 1 30/60 1,500 

Tracking/Feedback Form .................. Health Educators .............................. 20 2 1 40 

Total ........................................... ........................................................... 26,285 49,305 ........................ 13,305 

Dated: February 12, 2021. 

Jennifer M. Guimond, 

Project Clearance Liaison, Eunice Kennedy 

Shriver National Institute of Child Health and 

Human Development, National Institutes of 

Health. 

[FR Doc. 2021–03870 Filed 2–24–21; 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: Engineered Tumor 

Infiltrating Lymphocytes for Cancer 

Therapy 

AGENCY: National Institutes of Health, 

HHS. 

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 

Patents and Patent Applications listed 

in the Supplementary Information 

section of this Notice to Iovance 

Biotherapeutics, Inc. (‘‘Iovance’’), 

headquartered in San Carlos, 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 March 12, 2021 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: Andrew Burke, Ph.D., 

Senior Technology Transfer Manager, 

NCI Technology Transfer Center, 

Telephone: (240)–276–5484; Email: 

andy.burke@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

E–068–2018: Tethered Interleukin-15 

and Interleukin-21 

1. US Provisional Patent Application 

62/628,454, filed February 9, 2018 (E– 

068–2018–0–US–01); 

2. International Patent Application 

PCT/US2019/016975, filed February 7, 

2019 (E–068–2018–0–PCT–02); 

3. Australian Patent Application 

2019218785, filed August 7, 2020 (E– 

068–2018–0–AU–03); 

4. Chinese Patent Application 

201980012443.3, filed August 7, 2020 

(E–068–2018–0–CN–04); 

5. European Patent Application 

19709154.9, filed August 18, 2020 (E– 

068–2018–0–EP–05); 

6. United States Patent Application 

16/964,796, filed July 24, 2020 (E–068– 

2018–0–US–06); and 

7. Canadian Patent Application 

3,090,512, filed August 5, 2020 (E–068– 

2018–0–CA–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 the 

following: 

‘‘The use of the Licensed Patent 

Rights to develop, manufacture, 

distribute, sell, and use unselected 

whole autologous tumor infiltrating 

lymphocyte (TIL) adoptive cell therapy 

products for the treatment of metastatic 

melanoma, lung, breast, bladder, and 

HPV-positive cancers. Specifically 

excluded from this Agreement are 

methods of generating or using selected 

subpopulations of TIL and the use of T 

cell receptors isolated from TIL.’’ 

E–068–2018 is primarily directed to 

recombinant constructs for the coexpression of Interleukins-15 and 21 

(IL–15 and 21). IL–15 and IL–21 have 

been reported to support the function of 

anti-tumor T cells; however, their 

Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices 11549 

clinical utility has been constrained, in 

part, by dose-limiting toxicity following 

systemic administration and the need 

for repeated dosing. The subject 

invention addresses these limitations 

through synthetic IL–15/21 sequences 

which incorporate flexible linker 

regions and cell membrane anchors. T 

cells engineered to express these 

constructs experience autocrine IL–15/ 

21 signaling leading to enhanced antitumor function in vivo. 

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 establishing 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 from 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: February 12, 2021. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2021–03873 Filed 2–24–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; CareerTrac 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30-days of the date of this 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Dr. Kristi 

Pettibone, Health Scientist 

Administrator, Program Analysis 

Branch, Division of Extramural Research 

and Training, NIEHS, NIH, 560 Davis 

Dr., Morrisville, NC 27560, or call nontoll-free number (984) 287–3303 or 

Email your request, including your 

address to: pettibonekg@niehs.nih.gov. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on December 12, 2020, page 

79493–79494 (64 FR 15367) and 

allowed 60 days for public comment. No 

public comments were received. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

The Fogarty International Center (FIC), 

National Cancer Institute (NCI), 

National Institute of Diabetes and 

Digestive and Kidney Diseases (NIDDK), 

and National Institute of Environmental 

Health Sciences (NIEHS), may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. 

Proposed Collection: CareerTrac0925–0568—expiration date April 30, 

2021, REVISION, Fogarty International 

Center (FIC), National Institute of 

Environmental Health Sciences 

(NIEHS), National Cancer Institute 

(NCI), National Institute of Diabetes and 

Digestive Kidney Diseases, (NIDDK), 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: The purpose of this data 

collection system is to track, evaluate 

and report short and long-term outputs, 

outcomes and impacts of trainees 

involved in health research training 

programs-specifically tracking this for at 

least ten years following training by 

having Principal Investigators enter data 

after trainees have completed the 

program. The data collection system 

provides a streamlined, web-based 

application permitting principal 

investigators to record career 

achievement progress by trainee on a 

voluntary basis. FIC, NCI, NIDDK, and 

NIEHS management will use this data to 

monitor, evaluate and adjust grants to 

ensure desired outcomes are achieved, 

comply with OMB Part requirements, 

respond to congressional inquiries, and 

as a guide to inform future strategic and 

management decisions regarding the 

grant program. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

12,705. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hour 

FIC Grantee ..................................................................................................... 90 20 40/60 1,200 

NIEHS Grantee ................................................................................................ 60 45 40/60 1,800 

NCI CRCHD Grantee ...................................................................................... 244 22 40/60 3,579 

NCI D43 Grantee ............................................................................................. 20 22 40/60 293 

Superfund Grantee .......................................................................................... 30 105 40/60 2,100