Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices 11547 

This live-attenuated RSV vaccine is 

designed to be administered intranasally 

by drops or spray to infants and young 

children. Based on experience with 

other live-attenuated RSV vaccine 

candidates, the present candidates are 

anticipated to be well tolerated in 

humans and are available for clinical 

evaluation. The National Institute of 

Allergy and Infectious Diseases has 

extensive experience and capability in 

evaluating live-attenuated RSV vaccine 

candidates in pediatric clinical studies, 

and opportunity for collaboration exists. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications: 

• Viral diagnostics 

• Vaccine research 

Competitive Advantages: 

• Ease of manufacture 

• B cell and T cell activation 

• Low-cost vaccines 

• Intranasal administration/needle-free 

delivery 

Development Stage: 

• In vivo data assessment (animal) 

Inventors: Cyril Le Nouen (NIAID), 

Ursula Buchholz (NIAID), Peter Collins 

(NIAID). 

Intellectual Property: HHS Reference 

No. E–104–2020–0—U.S. Provisional 

Application No. 63/023,949, filed May 

13, 2020. 

Licensing Contact: Peter Soukas, J.D., 

301–594–8730; peter.soukas@nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate or 

commercialize for development of a 

vaccine for respiratory or other 

infections. For collaboration 

opportunities, please contact Peter 

Soukas, J.D., 301–594–8730; 

peter.soukas@nih.gov. 

Dated: February 18, 2021. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2021–03872 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; Generic Clearance 

To Support the Safe to Sleep®

Campaign at the Eunice Kennedy 

Shriver National Institute for Child 

Health and Human Development 

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: Lorena Kaplan, 

M.P.H., CHES, Office of 

Communications, Eunice Kennedy 

Shriver National Institute of Child 

Health and Human Development, 

National Institutes of Health, 31 Center 

Drive, Room 2A32, Bethesda, Maryland 

20892, or call non-toll free number (301) 

496–6670 or Email your request, 

including your address to 

lorena.kaplan@nih.gov. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on December 11, 2020, page 

80123–80124 (85 FR 80123–80124) 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 Eunice Kennedy Shriver National 

Institute for Child Health and Human 

Development, National Institutes of 

Health, 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: Generic 

Clearance to Support the Safe to Sleep®

Campaign at the Eunice Kennedy 

Shriver National Institute for Child 

Health and Human Development 

(NICHD), 0925–0701, exp., date 02/28/ 

2021, REVISION, Eunice Kennedy 

Shriver National Institute of Child 

Health and Human Development 

(NICHD), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: This is a request for a 

revision to a generic clearance used for 

submissions specific to the Eunice 

Kennedy Shriver National Institute of 

Child Health and Human Development 

(NICHD) Safe to Sleep® (STS) public 

education campaign. Submissions for 

the STS campaign will be used to assess 

the understanding and reach of STS 

campaign materials and messages, and 

to monitor and improve campaign 

activities such as training workshops 

and overall implementation. The 

purpose of this information collection is 

to monitor and modify campaign 

activities, to plan future campaign 

activities, to develop messages and 

materials, and to develop distribution 

and outreach strategies that are effective 

at communicating their message to bring 

about the intended response, awareness, 

and/or behavioral change for the target 

audiences. This generic clearance will 

enable the NICHD to: (1) More 

efficiently assess the implementation of 

campaign activities; (2) better 

understand the target audiences’ 

knowledge, attitudes, and beliefs toward 

STS messages and materials; (3) better 

understand how the campaign activities 

have influenced the target audiences’ 

behaviors and practices; and (4) monitor 

and improve activities such as trainings, 

materials, and messages. Having a way 

to gather feedback on the STS campaign 

activities is critical to assessing the 

reach and effect of campaign efforts. 

Data collected for the campaign can 

inform where future STS campaign 

resources can produce the most 

meaningful results. Data collected for 

the STS campaign generic clearance will 

be used by a number of audiences, 

including STS campaign staff, NICHD 

leadership, STS campaign collaborators, 

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