33320 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 

Review/IRB Recordkeeping/Informed 

Consent/Consent Documentation, OMB 

No. 0990–0260. 

Information reported to the Federal 

departments and agencies under the 

Common Rule with respect to a 

satisfactory assurance is used to ensure 

that an institution engaged in nonexempt research involving human 

subjects conducted or supported by a 

Common Rule department or agency has 

(1) established adequate administrative 

policies and procedures for protecting 

the rights and welfare of human subjects 

in research, and (2) accepts that 

responsibility. Other reporting 

requirements are used to: Assess 

whether the institution is following the 

established procedures; ensure that 

Federal funds are not expended for 

unapproved human subjects research; 

and, determine if the approved status of 

an awarded grant, contract, or 

cooperative agreement should be 

reviewed, with the ultimate goal of 

maintaining or increasing human 

subject protections. 

Likely Respondents: Institutions, 

institutional review boards and 

investigators. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Common rule provision Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 

[2018 Requirements]—Incident Reporting, Suspension 

or Termination of IRB approval Reporting ....................... 5,200 1 5,200 1 5,200 

Total .............................................................................. ........................ ........................ 5,200 ........................ 5,200 

TABLE 2—ESTIMATED ANNUAL IRB RECORDKEEPING BURDEN

Common rule provision Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

.115 [Pre-2018 and 2018 Requirement]—Preparation and 

documentation of IRB activities ........................................ 6,000 16 96,000 12 1,152,000 

Total .............................................................................. 6,000 ........................ 96,000 ........................ 1,152,000 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN

Number of 

respondents 

Number of disclosures per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

.109(d) [Pre-2018 and 2018 Requirements]—Written notification of IRB approval or disapproval of research .......... 6,000 25 150,000 0.5 75,000 

.46.116(a) and (b) (Pre-2018 Requirements)/.46.116 (b), 

(c) and (d) [2018 Requirements]—Elements of informed 

consent and broad consent .............................................. 6,000 25 150,000 0.5 75,000 

.46.116(h)—[2018 Requirements]—Posting clinical trial 

consent form ..................................................................... 100 3 300 0.5 150 

.117(a) [Pre-2018 and 2018 Requirements]—Documentation of informed consent ................................................... 6,000 25 150,000 0.5 75,000 

.117(c)(2) [Pre-2018 and 2018 Requirements]—Written 

statement about the research when informed consent 

documentation is waived .................................................. 6,000 10 60,000 1 60,000 

Total .............................................................................. ........................ ........................ 510,300 ........................ 285,150 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2021–13211 Filed 6–23–21; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Notice of Meeting and 

Request for Public Comment 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following advisory 

committee meeting. 

Name: National Committee on Vital 

and Health Statistics (NCVHS), Hearing 

of the Subcommittee on Privacy, 

Confidentiality and Security 

DATES: Wednesday July 14, 2021: 9:30 

a.m.–5:30 p.m. EST. 

ADDRESSES: Virtual open meeting. 

FOR FURTHER INFORMATION CONTACT: 

Substantive program information may 

be obtained from Rebecca Hines, MHS, 

Executive Secretary, NCVHS, National 

Center for Health Statistics, Centers for 

Disease Control and Prevention, 3311 

Toledo Road, Hyattsville, Maryland 

20782, or via electronic mail to vgh4@

cdc.gov; or by telephone (301) 458– 

4715. Summaries of meetings and a 

roster of Committee members are 

available on the home page of the 

NCVHS website, https://ncvhs.hhs.gov/, 

where further information including an 

agenda and instructions to access the 

broadcast of the meeting will also be 

posted. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment 


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Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33321 

Opportunity on (770) 488–3210 as soon 

as possible. 

SUPPLEMENTARY INFORMATION: On July 

14, 2021, the National Committee on 

Vital and Health Statistics (NCVHS), 

Subcommittee on Privacy, 

Confidentiality, and Security, will seek 

input from experts to examine solutions 

for improving the security posture of the 

healthcare industry. At the hearing, the 

Subcommittee will hear from invited 

experts on the range of security 

challenges affecting the health care 

industry and business partners. The 

Subcommittee will also hear about the 

range of policy options that may be 

available to the Department of Health 

and Human Services (HHS) and data 

stewards to improve the security 

posture of those organizations holding 

individually identifiable information 

(III), including federal, state, local, and 

tribal organizations. 

The Committee will use this input to 

identify and describe the changing 

security landscape and risks to the 

privacy and security of III held by the 

health care industry and highlight 

promising policies, practices, and 

technologies. The Committee will lay 

out integrative models for how best to 

secure individually identifiable 

information while enabling beneficial 

uses, services, and technologies. The 

Committee will formulate 

recommendations for the Secretary on 

actions that HHS might take and prepare 

a report for the Secretary. 

The Committee requests comments 

from the public in advance of the 

hearing to inform its deliberations and 

will consider them together with the 

input of subject matter experts at the 

hearing. Please submit comments to 

NCVHSmail@cdc.gov by close of 

business Tuesday, July 13, 2021. There 

also will be a public comment period at 

the meeting. The meeting times and 

topics are subject to change. Please refer 

to the NCVHS website for information 

and agenda updates. 

Sharon Arnold, 

Associate Deputy Assistant Secretary for 

Planning and Evaluation, Science and Data 

Policy, Office of the Assistant Secretary for 

Planning and Evaluation. 

[FR Doc. 2021–13329 Filed 6–23–21; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Delivery of a 

Corrective Glucose-6-PhosphataseAlpha Gene to Treat Glycogen Storage 

Disease Type 1a (GSD-Ia) in Humans 

AGENCY: National Institutes of Health, 

DHHS. 

ACTION: Notice. 

SUMMARY: The National Institute of 

Child Health and Human Development, 

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. and foreign Patents and Patent 

Applications listed in the 

Supplementary Information section of 

this notice to Panacea Opportunity, Ltd. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Institute of 

Child Health and Human Development 

c/o National Cancer Institute’s 

Technology Transfer Center on or before 

July 9, 2021 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: Alan Hubbs, Ph.D., Senior 

Technology Transfer Manager at 

Telephone: (240)–276–5530 or Email: 

hubbsa@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

following represents the intellectual 

property to be licensed under the 

prospective agreement: 

Intellectual Property 

1. Priority Application, U.S.P.T.O. No. 

62/096,400, filed December 23, 2014 

[HHS Reference No. E–039–2015/0–US– 

01]; 

2. PCT Patent Application No. PCT/ 

US2015/067338, filed December 22, 

2015 [HHS Reference No. E–039–2015– 

0–PCT–02]; 

3. Pending Canadian Patent 

Application No. 2972038, filed on 

December 22, 2015, [HHS Reference No. 

E–039–2015–0–CA–03]; 

4. Issued China Patent No. 

ZL201580076462.4, filed on December 

22, 2015, Issued December 11, 2020 

[HHS Reference No. E–039–2015–0– 

CN–04]; 

5. Issued European Patent No. 

2182936, filed December 22, 2015, 

Issued July 22, 2020 [HHS Reference No. 

E–039–2015–0–EP–05]; 

6. Issued Israeli Patent No. 253103, 

filed on December 22, 2015, Issued 

April 1, 2020 [HHS Reference No. E– 

039–2015–0–IL–06]; 

7. Issued Japan Patent No. 6824169, 

filed June 22, 2017, Issued January 14, 

2021 [HHS Reference No. E–039–2015– 

0–JP–07]; 

8. Issued United States Patent No. 

10,415,044, filed September 17, 2019, 

Issued September 17, 2019 [HHS 

Reference No. E–039–2015–0–US–08] 

9. Pending United States Patent 

Application No. 16/526,327, filed July 

30, 2019, [HHS Reference No. E–039– 

2015–0–US–08] 

With respect to persons who have an 

obligation to assign their right, title and 

interest to the Government of the United 

States of America, the patent rights in 

these inventions have been assigned to 

the Government of the United States of 

America. The prospective exclusive 

license territory may be world-wide, 

and the field of use may be limited to 

the use of Licensed Patent Rights for the 

following: ‘‘Delivery of a corrective 

glucose-6-phosphatase-alpha gene to 

treat glycogen storage disease type 1a 

(GSD-Ia) in humans.’’ 

This technology discloses a gene 

therapy to treat glycogen storage disease 

type 1a (GSD-Ia) in humans using 

adeno-associated virus mediated 

delivery of a corrective glucose-6- 

phosphatase-alpha (G6Pase-a) gene 

nucleic acid sequence that codes for a 

protein having an amino acid sequence 

that differs from the wildtype human 

amino acid sequence at amino acid 

position 293. 

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 

Institute of Child Health and Human 

Development 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. 


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