10082 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 

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 March 5, 2021 will 

be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

an Exclusive Patent License should be 

directed to: David A Lambertson, Ph.D., 

Senior Technology Transfer Manager, at 

Telephone (240)-276–5530 or Email: 

david.lambertson@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

The following represents the 

intellectual property to be licensed 

under the prospective agreement: 

(A) U.S. Provisional Patent 

Application 62/006,313 entitled 

‘‘Chimeric Antigen Receptors Targeting 

CD–19’’ [HHS Ref. E–042–2014–0–US– 

01], PCT Patent Application PCT/ 

US2015/033473 entitled ‘‘Chimeric 

Antigen Receptors Targeting CD–19’’ 

[HHS Ref. E–042–2014–0–PCT–02], 

Australian Patent 2015270912 entitled 

‘‘Chimeric Antigen Receptors Targeting 

CD–19’’ [HHS Ref. E–042–2014–0–AU– 

03], Canadian Patent Application 

2951045 entitled ‘‘Chimeric Antigen 

Receptors Targeting CD–19’’ [HHS Ref. 

E–042–2014–0–CA–04], Chinese Patent 

Application 201580033802.5 entitled 

‘‘Chimeric Antigen Receptors Targeting 

CD–19’’ [HHS Ref. E–042–2014–0–CN– 

05], European Patent 3149044 entitled 

‘‘Chimeric Antigen Receptors Targeting 

CD–19’’ [HHS Ref. E–042–2014–0–EP– 

06] (validated in Germany [HHS Ref. E– 

042–2014–0–DE–19], Spain [HHS Ref. 

E–042–2014–0–ES–20], France [HHS 

Ref. E–042–2014–0–FR–21], the United 

Kingdom [HHS Ref. E–042–2014–0–GB– 

22], Italy [HHS Ref. E–042–2014–0–IT– 

23], and Ireland [HHS Ref. E–042–2014– 

0–IE–24], and lodged in Hong Kong [E– 

042–2014–0–HK–16]), Israeli Patent 

Application 249305 entitled ‘‘Chimeric 

Antigen Receptors Targeting CD–19’’ 

[HHS Ref. E–042–2014–0–IL–07], Indian 

Patent Application 291647041047 

entitled ‘‘Chimeric Antigen Receptors 

Targeting CD–19’’ [HHS Ref. E–042– 

2014–0–IN–08], Japanese Patent 

Application 2016–571017 entitled 

‘‘Chimeric Antigen Receptors Targeting 

CD–19’’ [HHS Ref. E–042–2014–0–JP– 

09], South Korean Patent Application 

2016–7036828 entitled ‘‘Chimeric 

Antigen Receptors Targeting CD–19’’ 

[HHS Ref. E–042–2014–0–KR–10], 

Mexican Patent Application MX/a/ 

2016/015834 entitled ‘‘Chimeric 

Antigen Receptors Targeting CD–19’’ 

[HHS Ref. E–042–2014–0–MX–11], New 

Zealand Patent Application 727167 

entitled ‘‘Chimeric Antigen Receptors 

Targeting CD–19’’ [HHS Ref. E–042– 

2014–0–NZ–12], Saudi Arabian Patent 

Application 516380406 entitled 

‘‘Chimeric Antigen Receptors Targeting 

CD–19’’ [HHS Ref. E–042–2014–0–SA– 

13], Singaporean Patent Application 

11201609960Q entitled ‘‘Chimeric 

Antigen Receptors Targeting CD–19’’ 

[HHS Ref. E–042–2014–0–SG–14], 

United States Patent 10,287,350 entitled 

‘‘Chimeric Antigen Receptors Targeting 

CD–19’’ [HHS Ref. E–042–2014–0–US– 

15], United States Patent Application 

16/360,281 entitled ‘‘Chimeric Antigen 

Receptors Targeting CD–19’’ [HHS Ref. 

E–042–2014–0–US–17], New Zealand 

Patent Application 764530 entitled 

‘‘Chimeric Antigen Receptors Targeting 

CD–19’’ [HHS Ref. E–042–2014–0–NZ– 

18], European Patent Application 

20197459.9 entitled ‘‘Chimeric Antigen 

Receptors Targeting CD–19’’ [HHS Ref. 

E–042–2014–0–EP–25], Australian 

Patent Application 2020267211 entitled 

‘‘Chimeric Antigen Receptors Targeting 

CD–19’’ [HHS Ref. E–042–2014–0–AU– 

26], and Japanese Patent Application 

XXX entitled ‘‘Chimeric Antigen 

Receptors Targeting CD–19’’ [HHS Ref. 

E–042–2014–0–JP–27], and all 

continuing U.S. and foreign patents/ 

patent applications for the technology 

family. 

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 development, production and 

commercialization of an anti-CD19 targeting 

chimeric antigen receptor (CAR)-based 

immunotherapy using autologous (meaning 

one individual is both the donor and the 

recipient) T lymphocytes transfected using a 

lentivirus, wherein the vector expresses a 

CAR having at least: 

(1) The complementary determining region 

(CDR) sequences of the anti-CD19 antibody 

known as Hu19; 

(2) a CD8a hinge and transmembrane 

domain; 

(3) and a CD28z T cell signaling domain; 

for the treatment of autoimmune diseases.’’ 

This technology discloses the 

development of chimeric antigen 

receptors that recognize the CD19 cell 

surface protein. CD19 is expressed on 

the cell surface of several autoimmune 

disease cells, including lupus nephritis. 

For many autoimmune diseases there 

are no FDA-approved therapies, 

underscoring that there is an unmet 

need. The development of an 

autoimmune disease therapeutic 

targeting CD19 will benefit public 

health by providing a treatment for 

patients who may not have any options. 

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 completed 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: February, 4, 2021. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2021–03222 Filed 2–17–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Legal Services for 

Unaccompanied Alien Children (New 

Collection) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, Department of Health and 

Human Services. 

ACTION: Request for Public Comment. 

SUMMARY: The Office of Refugee 

Resettlement (ORR), Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), is inviting public 

comment on the proposed collection. 

The request consists of several forms 

that allow the Unaccompanied Alien 

Children (UAC) Program to provide 

legal services to UAC. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of Section 3506(c)(2)(A) of 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 10083 

the Paperwork Reduction Act of 1995, 

ACF is soliciting public comment on the 

specific aspects of the information 

collection described in this notice. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

forwarded by emailing infocollection@

acf.hhs.gov. Alternatively, copies can 

also be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation (OPRE), 330 C Street 

SW, Washington, DC 20201, Attn: ACF 

Reports Clearance Officer. All requests, 

emailed or written, should be identified 

by the title of the information collection. 

SUPPLEMENTARY INFORMATION: 

Description 

The components of this information 

request include: 

1. Legal Service Provider List for UAC 

in ORR Care (Form LRG–5/5s): This 

instrument is provided to UAC by their 

case manager. The instrument contains 

a list of legal services providers 

available to UAC. UAC initial and sign 

the instrument upon admission and 

release of ORR custody to acknowledge 

receipt of documents contained in 

ORR’s Legal Resource Guide. This form 

was previously approved under OMB 

Number 0970–0498 and is being 

reinstated without changes under this 

new OMB number. 

2. Request for a Flores Bond Hearing 

(Form LRG–7/7s): This instrument is 

provided to UAC placed by their case 

manager. The instrument is always 

provided to UAC placed in a restrictive 

setting (secure, staff secure, and 

residential treatment center facilities) 

and to UAC placed in other types of 

facilities upon request. UAC may use 

this instrument to request or withdraw 

a request for a Flores bond hearing. 

3. Motion to Request a Bond 

Hearing—Secure or Staff Secure 

Custody (Form LRG–8A): This 

instrument is completed by case 

managers upon receipt of a Request for 

a Flores Bond Hearing for a UAC in 

secure or staff secure custody and 

provided to ORR. ORR files the motion 

with the local immigration court. 

4. Motion to Request a Bond 

Hearing—Non-Secure Custody (Form 

LRG–8B): This instrument is completed 

by case managers upon receipt of a 

Request for a Flores Bond Hearing for a 

UAC placed in a non-secure program 

(e.g., shelter, foster care) and provided 

to ORR. ORR files the motion with the 

local immigration court. 

5. Request for Specific Consent to 

Juvenile Court Jurisdiction (Form L–1): 

This instrument is used by legal service 

providers and attorneys of record to 

request specific consent from ORR in 

cases where they are seeking Special 

Immigrant Juvenile legal relief for their 

UAC client and are also seeking to 

invoke the jurisdiction of a state court 

to determine or alter the UAC’s custody 

status or placement. This form is 

currently approved under OMB Number 

0970–0385, but has been revised and is 

being moved under this new OMB 

number consisting of related forms. 

6. Specific Consent Request Case 

Summary (Form L–2): This instrument 

is completed by ORR Federal Field 

Specialists (FFS) when ORR receives a 

request for specific consent. FFS 

provide case information that will allow 

the ORR Director to make an informed 

decision on whether to grant specific 

consent. 

7. Notice of Attorney Representation 

(Form L–3): This instrument is 

completed by attorneys of record for 

UAC to notify ORR of the purpose of 

legal representation and the 

representation timeframe. ORR uses this 

instrument to ensure that case updates 

are provided to attorneys of record. This 

instrument may also be used by 

attorneys of record when requesting a 

copy of their client’s case file. 

8. UAC Legal Information (Form L–4): 

This instrument is used by case 

managers to document, as applicable, 

referrals to the Office of Trafficking in 

Persons; meetings between the UAC and 

their legal service provider or attorney 

of record; the provision of ORR’s Legal 

Resource Guide to the UAC; information 

about the UAC’s legal service provider 

or attorney of record; immigration and 

administrative hearings; and provision 

of the Notice of Placement in a 

Restrictive Setting to the UAC. The 

instrument also includes an area to 

upload legal documents. 

9. Legal Service Provider Record 

(Form L–6): This instrument is used by 

case managers to create a record 

containing certain information and 

documents that ORR makes accessible 

to ORR-funded legal service providers 

without requiring a formal records 

request. 

10. Motion for Change of Venue (Form 

L–7): This instrument is used by case 

managers to file a motion for change of 

venue when a UAC is transferred or 

discharged to a new immigration court 

jurisdiction. 

11. Post Legal Status Plan (Form L–8): 

This instrument is used by case 

managers to create and obtain Federal 

Field Specialist Supervisor approval for 

a plan for UAC expected to obtain legal 

status, at which time the UAC must be 

released from ORR custody. 

Respondents: ORR grantee and 

contractor staff; UAC; parents/legal 

guardians of UAC; attorneys of record; 

and legal service providers. 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual total 

number of 

respondents 

Annual total 

number of 

responses per 

respondent 

Average 

burden 

minutes per 

response 

Annual total 

burden hours 

Legal Service Provider List for UAC in ORR Care (Form LRG–5/5s) ............ 216 556.0 15 30,024 

Request for a Flores Bond Hearing (Form LRG–7/7s) ................................... 216 0.2 10 7 

Motion to Request a Bond Hearing—Secure or Staff Secure Custody (Form 

LRG–8A) ...................................................................................................... 8 3.0 10 4 

Motion to Request a Bond Hearing—Non-Secure Custody (Form LRG–8B) 208 0.1 10 3 

Request for Specific Consent to Juvenile Court Jurisdiction (Form L–1) ....... 40 1.0 15 10 

Specific Consent Request Case Summary (Form L–2) .................................. 216 0.2 20 14 

Notice of Attorney Representation (Form L–3) ............................................... 13,000 1.0 15 3,250 

UAC Legal Information (Form L–4) ................................................................. 216 241.0 60 52,056 

Legal Service Provider Record (Form L–6) ..................................................... 216 241.0 5 4,338 

Change of Venue (Form L–7) ......................................................................... 216 208.0 10 7,488 

Post Legal Status Plan (Form L–8) ................................................................. 216 24.0 15 1,296 

Estimated Annual Burden Hours Total: .................................................... ........................ ........................ ........................ 98,490 


jbell on DSKJLSW7X2PROD with NOTICES
10084 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 6 U.S.C. 279; 8 U.S.C. 1232; 

Flores v. Reno Settlement Agreement, No. 

CV85–4544–RJK (C.D. Cal. 1996) 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–03261 Filed 2–17–21; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10326] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

April 19, 2021. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs 

Division of Regulations Development. 

Attention: Document Identifier/OMB 

Control Number CMS–10326, Room C4– 

26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10326—Electronic Submission of 

Medicare Graduate Medical Education 

(GME) Affiliation Agreements 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Reinstatement without change 

of a currently approved collection; Title 

of Information Collection: Electronic 

Submission of Medicare Graduate 

Medical Education (GME) Affiliation 

Agreements; Use: Existing regulations at 

§ 413.75(b) permit hospitals that share 

residents to elect to form a Medicare 

GME affiliated group if they are in the 

same or contiguous urban or rural areas, 

if they are under common ownership, or 

if they are jointly listed as program 

sponsors or major participating 

institutions in the same program by the 

accrediting agency. The purpose of a 

Medicare GME affiliated group is to 

provide flexibility to hospitals in 

structuring rotations under an aggregate 

full time equivalent (FTE) resident cap 

when they share residents. The existing 

regulations at § 413.79(f)(1) specify that 

each hospital in a Medicare GME 

affiliated group must submit a Medicare 

GME affiliation agreement (as defined 

under § 413.75(b)) to the Medicare 

Administrative Contractor (MAC) 

servicing the hospital and send a copy 

to the Centers for Medicare and 

Medicaid Services’ (CMS) Central 

Office, no later than July 1 of the 

residency program year during which 

the Medicare GME affiliation agreement 

will be in effect. 

CMS will use the information 

contained in electronic affiliation 

agreements as documentation of the 

existence of Medicare GME affiliations, 

and to verify that the affiliations being 

formed by teaching hospitals for the 

purposes of sharing their Medicare GME 

FTE cap slots are valid according to 

CMS regulations. CMS will also use 

these affiliation agreements as reference 

materials when potential issues 

involving specific affiliations arise. 

While we have used hard copies of 

affiliation agreements for those same 

purposes in the past, we implemented 

this electronic submission process in 

order to expedite and ease the process 

of retrieving, analyzing and evaluating 

affiliation agreements. Form Number: 

CMS–10326 (OMB control number: 

0938–1111); Frequency: Annually; 

Affected Public: Private Sector, Business 

or other for profits, Not for profit 

institutions; Number of Respondents: 

125; Total Annual Responses: 125; Total 


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