Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 50895 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0475] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before November 12, 

2021. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0475–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, or call (202) 

795–7714 the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: ASPA COVID– 

19 Public Education Campaign 

Evaluation Surveys. 

Type of Collection: Extension. 

OMB No. 0990–0475. 

Abstract: The Office of the Assistant 

Secretary for Public Affairs (ASPA), U.S. 

Department of Health and Human 

Services (HHS) is requesting an 

extension on a currently approved 

collection including two components: 1. 

COVID–19 Attitudes and Beliefs Survey 

(CABS), and 2. Monthly Outcome 

Survey (MOS). Throughout execution of 

the campaign, this information will 

primarily be used by ASPA to determine 

whether the campaign is having the 

intended impact on target audiences’ 

(e.g., parents, young adults, 65+) 

knowledge, attitudes, and beliefs as they 

relate to COVID–19, COVID–19 

vaccination, and adherence to 

preventative behaviors. It will also keep 

key stakeholders informed of the 

Campaign’s progress. Ultimately, the 

data will inform a thorough evaluation 

of the efficacy of the campaign and its 

impact on vaccine uptake. 

COVID–19 Attitudes and Beliefs Survey 

(CABS) 

The CABS is a longitudinal survey 

that will be fielded tri-annually to 4,000 

U.S. adults for the duration of the 

Campaign via NORC at the University of 

Chicago’s AmeriSpeak Panel. The 

survey will be fielded online, and each 

fielding period will last between 3 and 

6 weeks. Those that respond to wave 1 

of the survey will be recontacted in each 

wave, facilitating a comparison of 

COVID–19 behavior change over time 

for a representative sample and 

evaluation of U.S. adults. Panel 

members selected to participate in the 

study will receive one pre-invitation 

postcard in the mail, one email 

invitation, and three email reminders to 

complete the survey in each wave. 

Monthly Outcome Survey (MOS) 

The MOS is a shorter, cross-sectional 

survey that will be fielded monthly to 

5,000 U.S. adults for the duration of the 

Campaign via the Ipsos KnowledgePanel 

5K Omnibus Survey. The survey will be 

fielded online, and each fielding period 

will last between 7 and 10 days. 

ANNUALIZED BURDEN HOUR TABLE

CABS MOS 

Hours to complete survey ........................................................................................................................................ 0.58 0.17 

Participants (per wave) ............................................................................................................................................ 4,000 5,000 

Number of waves (per year) .................................................................................................................................... 3 12 

Total respondents per year .............................................................................................................................. 12,000 60,000 

Total burden hours per year ............................................................................................................................. 6,960 10,200 

Sum of Both Studies 

Total respondents per year: 72,000. 

Total burden hours per year: 17,160. 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2021–19681 Filed 9–10–21; 8:45 am] 

BILLING CODE 4150–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Development and 

Commercialization of Allogeneic T Cell 

and Gene Therapy Vector Chimeric 

Antigen Receptor (CAR) Therapies 

Targeting CD22 Alone or in 

Combination With CARs Targeting 

CD19 for the Treatment of B-Cell 

Malignancies 

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 Sana 

Biotechnology Inc. Life Sciences Inc., 

(‘‘Sana’’), located in Seattle, 

Washington. 

DATES: Only written comments and/or 

complete applications for a license 

which are received by the National 

Cancer Institute’s Technology Transfer 

Center on or before September 28, 2021 

will be considered. 


lotter on DSK11XQN23PROD with NOTICES1
50896 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

Exclusive Patent License should be 

directed to: Jim Knabb, Senior 

Technology Transfer Manager, at 

Telephone: (240)–276–7856; or at Email: 

jim.knabb@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

E–080–2012–0: Human Monoclonal 

Antibodies Specific for CD22 

1. US Provisional Patent Application 

61/042,329, filed April 4, 2008 (E–080– 

2008–0–US–01); 

2. International Patent Application 

PCT/US2009/039,080, Filed April 1, 

2009 (E–080–2008/0–PCT–02); 

3. US Patent Application: 12/934,214, 

filed September 23, 2010 (E–080–2008– 

0–US–03); 

4. US Patent Application 13/959,061, 

filed August 5, 2015 (E–080–2008–0– 

US–04); 

5. US Patent Application 15/012,023, 

filed February 1, 2016 (E–080–2008–0– 

US–05); 

6. US Patent Application 15/424,238, 

filed February 3, 2017 (E–080–2008–0– 

US–06). 

E–291–2012–0: M971 Chimeric Antigen 

Receptors 

1. US Provisional Patent Application 

61/717,960, filed October 24, 2012 (E– 

291–2012–0–US–01); 

2. International Patent Application 

PCT/US2013/060332, filed September 

18, 2013 (E–291–2012–0–PCT–02); 

3. Australia Patent Application No: 

2019235926, filed September 2, 2020 

(E–291–2012–0–AU–03); 

4. Brazil Patent Application 

BR112015009003–6, filed April 22, 2015 

(E–291–2012–0–BR–04); 

5. Canada Application No: 2889055, 

filed September 18, 2013 (E–291–2012– 

0–CA–05); 

6. China Application No: 

201380061387.5, filed May 25, 2015 (E– 

291–2012–0–CN–06); 

7. European Patent Application No: 

13773468.7, filed September 18, 2013 

(E–291–2012–0–EP–07); 

8. India Patent Application No: 2344/ 

CHENP/2015, filed September 18, 2013 

(E–291–2012–0–IN–08); 

9. Japan Application No: 539602/ 

2015, filed April 24, 2015 (E–291–2012– 

0–JP–09); 

10. Russia Patent Application: 

2015117237, filed May 7, 2015 (E–291– 

2012–0–RU–10); 

11. US Patent Application: 14/ 

437,889, filed April 23, 2015 (E–291– 

2012–0–US–11); 

12. Hong Kong Patent Application: 

16101891.0, filed February 19, 2016 (E– 

291–2012–0–HK–12); 

13. Russia Patent Application: 

2018116582, filed May 4, 2018 (E–291– 

2012–0–RU–13); 

14. Japan Patent Application: 2018– 

088908, filed May 2, 2018, (E–291– 

2012–0–JP–14); 

15. Australia Patent Application: 

2018204257, filed June 14, 2018 (E– 

291–2012–0–AU–16); 

16. US Patent Application: 16/ 

107,271, filed August 21, 2018 (E–291– 

2012–0–US–17); 

17. Germany Patent Application: 

13773468.7, filed April 22, 2015 (E– 

291–2012–0–DE–18); 

18. Spain Patent Application: 

13773468.7, filed April 22, 2015 (E– 

291–2012–0–ES–19); 

19. France Patent Application: 

13773468.7, filed April 22, 2015 (E– 

291–2012–0–FR–20); 

20. Great Britain Patent Application: 

13773468.7, filed April 22, 2015 (E– 

291–2012–0–GB–21); 

21. Italy Patent Application: 

13773468.7, filed April 22, 2015 (E– 

291–2012–0–IT–22); 

22. China Patent Application: 

201910500128.7, filed June 11, 2019 (E– 

291–2012–0–CN–23); 

23. US Patent Application: 16/ 

869,792, filed May 8, 2020 (E–291– 

2012–0–US–24). 

E–106–2015–0: Chimeric Antigen 

Receptors Targeting Both CD19 and 

CD22 

1. US Provisional Patent Application 

No.: 62/135,442, filed March 19, 2015 

(E–106–2015–0–US–01); 

2. International Patent Application 

PCTUS2016/023055, Filed March 18, 

2016 (E–106–2015–0–PCT–02); 

3. US Patent Application: 15/559,485. 

Filed September 19, 2017 (E–106–2015– 

0–US–03). 

E–017–2017–0: CD19/CD22 Bicistronic 

CAR Targeting Human B-Cell 

Malignancies 

1. US Provisional Patent Application 

No.: 62/135,442, filed May 15, 2017 (E– 

017–2017–0–US–01); 

2. International Patent Application 

PCT/US2018/032,809, filed May 15, 

2018 (E–017–2017–0–PCT–02); 

3. Australia Patent Application No.: 

2018269194, filed October 28, 2019 (E– 

017–2017–0–AU–03; 

4. Canada Patent Application No: 

3062433, filed May 15, 2018 (E–017– 

2017–0–CA–04); 

5. China Patent Application No.: 

201880032676.5, filed Date: May 15, 

2018 (E–017–2017–0–CN–05); 

6. European Patent Application No.: 

18733012.1, filed May 15, 2018 (E–017– 

2017–0–EP–06); 

7. Japan Patent Application No.: 

2019–563082, filed November 13, 2019 

(E–017–2017–0–JP–07); 

8. Korea Patent Application No.: 

2019–7017289, filed December 13, 2019, 

(E–017–2017–0–KR–08); 

9. Singapore Patent Application No.: 

11201910499V, filed November 11, 2019 

(E–017–2017–0–SG–09); 

10. United States Patent Application 

No.: 16/613,187, filed November 13, 

2019 (E–017–2017–0–US–10). 

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 

fields of use may be limited to the 

following: 

‘‘Field 1: ‘‘Ex vivo allogeneic CAR–T’’ 

The development, manufacture and 

commercialization of chimeric antigen 

receptor T cells (CAR–T cells) for the 

treatment of B cell malignancies, wherein the 

CAR–T cells are engineered to express a CAR 

that comprises the m971 binder and is monospecific for CD22, or is specific to both CD22 

and CD19 (but are not engineered to bind to 

any other B cell antigen), and the engineered 

CAR–T cells are generated ex vivo using 

allogeneic T cells that are engineered to overexpress CD47. 

Field 2: ‘‘In vivo gene therapy vector’’ 

The development, manufacture and 

commercialization of gene therapy vectors 

encoding a chimeric antigen receptor 

construct (CAR construct), wherein the CAR 

construct comprises either (i) a CD22 binder 

m971 or (ii) the CD22 binder m971 and a 

CD19 binder, but, in each case (i) and (ii), 

comprises no other binder against a B cell 

antigen. For the avoidance of doubt, the field 

of use excludes development, manufacture 

and commercialization of genetically 

modified autologous T cells made by 

obtaining a patient’s T cells via a standard 

leukapheresis procedure, genetically 

modifying the T cells ex vivo, expanding the 

T cells in cell culture, and formulating the T 

cells for later administration to the patient.’’ 

This technology discloses CAR 

therapies that target CD22 alone or in 

combination with CD19 by utilizing the 

anti-CD22 binder known as m971. CD22 

and CD19 are expressed on the surface 

of B cells in B cell malignancies and 

CAR–T utilizing binders targeting CD 19 

and CD22 have shown early promise in 

clinical trials for B cell malignancies. 

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 


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Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 50897 

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 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: September 7, 2021. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2021–19618 Filed 9–10–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Division of Extramural 

Research and Training (DERT) 

Extramural Grantee Data Collection 

National Institute of Environmental 

Health Science (NIEHS) 

AGENCY: National Institutes of Health, 

Health and Human Services (HHS). 

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 Institute of Environmental 

Health Sciences (NIEHS), will publish 

periodic summaries of proposed 

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: Dr. Kristianna Pettibone, 

Evaluator, Program Analysis Branch, 

NIEHS, NIH, 530 Davis Dr., Room 3055, 

Morrisville, NC 20560, or call non-tollfree number (984) 287–3303 or Email 

your request, including your address to: 

pettibonekg@niehs.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 

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: Division of 

Extramural Research and Training 

(DERT) Extramural Grantee Data 

Collection, 0925–0757, Expiration Date 

11/30/2021—REVISION, National 

Institute of Environmental Health 

Sciences (NIEHS), National Institutes of 

Health (NIH). 

Need and Use of Information 

Collection: In order to make informed 

management decisions about its 

research programs and to demonstrate 

the outputs, outcomes and impacts of its 

research programs NIEHS will collect, 

analyze and report on data from 

extramural grantees who are currently 

receiving funding or who have received 

funding in the past on topics such as: (1) 

Key scientific outcomes achieved 

through the research and the impact on 

the field of environmental health 

science; (2) Contribution of research 

findings to program goals and 

objectives; (3) Satisfaction with the 

program support received; (4) 

Challenges and benefits of the funding 

mechanism used to support the science; 

and (5) Emerging research areas and 

gaps in the research. 

Information gained from this primary 

data collection will be used in 

conjunction with data from grantee 

progress reports and presentations at 

grantee meetings to inform internal 

programs and new funding initiatives. 

Outcome information to be collected 

includes measures of agency-funded 

research resulting in dissemination of 

findings, investigator career 

development, grant-funded knowledge 

and products, commercial products and 

drugs, laws, regulations and standards, 

guidelines and recommendations, 

information on patents and new drug 

applications and community outreach 

and public awareness relevant to 

extramural research funding and 

emerging areas of research. 

OMB approval is requested for 3 

years. There are no costs to respondents, 

other than their time. The total 

estimated annualized burden hours are 

700. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Number of 

respondents 

Number of 

responses 

per 

respondent 

Average time 

per response 

(in hours) 

Total annual 

burden hour 

NICHD Grantee ............................................................................................... 200 1 30/60 100 

NIDCD Grantee ............................................................................................... 200 1 30/60 100 

NIMH Grantee .................................................................................................. 200 1 30/60 100 

NINDS Grantee ................................................................................................ 200 1 30/60 100 

NCI Grantee ..................................................................................................... 400 1 30/60 200

NIEHS Grantee ................................................................................................ 200 1 30/60 100 

Total .......................................................................................................... 1,400 1,400 ........................ 700 


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