Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33319 

6Public Law 114–10, 129 Stat. 87 (April 16, 

2015), available at https://www.congress.gov/114/ 

plaws/publ10/PLAW-114publ10.pdf. 

CHIP Reauthorization Act of 2015 

(MACRA).6

Building on recent work of both 

NCVHS and the Office of the National 

Coordinator for Health Information 

Technology (ONC), the Subcommittee is 

gathering input to inform phase 1 of its 

two-year project Standardization of 

Information for Burden Reduction and 

Post-Pandemic America. This work 

involves assessing the current landscape 

of standards development and 

regulatory adoption processes and 

identifying opportunities for improving 

coordination of standards development, 

adoption, implementation, and 

conformity across disparate healthrelated data systems. NCVHS may use 

the information to inform 

recommendations to HHS. These 

recommendations may include an 

updated framework for standards 

adoption and implementation that takes 

into consideration public health, 

wellness, social services, clinical and 

claims information and newer 

technologies that promote 

interoperability across the health care 

system. 

In conjunction with the August 25th 

listening session, the Subcommittee is 

including in this notice a Request for 

Public Comment to obtain written input 

from any interested stakeholders 

including: Trading partners and 

consumers; payers; providers; patients; 

standards organizations; advocacy 

groups; data exchanges; health 

information technology developers; and 

other data producers and data 

consumers including long term and 

post-acute care providers; public health 

agencies; population health registries; 

and operators of public and private 

sector claims and encounter data 

reporting systems. The Committee has 

developed specific questions to ensure 

comments address key issues under 

consideration by the Committee. Those 

questions are outlined here and 

available at: https://ncvhs.hhs.gov/ 

Request-for-Public-Comment-StandardsSubcommittee-August-ListeningSession. 

(1) How can data sharing be improved 

between patients, providers, payers, 

public health system, and other actors 

in health care? What are the barriers to 

these improvements? 

(2) Are there any new standards or 

use cases available or under 

development that should be considered 

by NCVHS for recommendation to HHS 

for adoption to support interoperability, 

burden reduction and administrative 

simplification? Some examples might 

include new information sharing in 

health care, such as data or semantics 

for social determinants of health, public 

health case reporting, or All Payer 

Claims Databases. Please do not limit 

responses to these examples. 

(3) How have other industries 

effectively implemented, tested, and 

certified standards for data and their 

exchange that could be considered for 

health care? 

(4) What short term, mid-term and 

long-term opportunities or solutions do 

you believe should be priorities for 

HHS? 

Please submit comments to 

NCVHSmail@cdc.gov by close of 

business Friday, July 30, 2021. 

The Subcommittee will consider 

information from the invited panelists 

as well as all timely submitted written 

comments from the public in its 

development of a landscape assessment 

and potential recommendations. 

There will be a public comment 

period. The meeting times and topics 

are subject to change. Please refer to the 

NCVHS website posted agenda for any 

updates. 

Contact Person for More Information: 

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, telephone (301) 458–4715, email 

NCVHSmail@cdc.gov. Summaries of 

meetings and a roster of Committee 

members are available on the home page 

of the NCVHS website https://

ncvhs.hhs.gov/. Further information, 

including an agenda and instructions to 

access the broadcast of the meeting, will 

be posted as soon as the information is 

available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment 

Opportunity on (770) 488–3210 as soon 

as possible. 

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. 2021–13334 Filed 6–23–21; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0260] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, 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 July 26, 2021. 

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: 

Sherrette.Funn@hhs.gov or (202) 795– 

7714. When submitting comments or 

requesting information, please include 

the document identifier 0990–0260 and 

project title for reference. 

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: Protection of 

Human Subjects: Assurance of 

Compliance with Federal Policy/IRB 

Review/IRB Recordkeeping/Informed 

Consent/Consent Documentation. 

Type of Collection: Extension with 

change. 

OMB No. 0990–0260 Office of the 

Assistant Secretary for Health, Office for 

Human Research Protections. 

Abstract: The Office of the Assistant 

Secretary for Health, Office for Human 

Research Protections is requesting a 

three-year extension of the Protection of 

Human Subjects: Assurance of 

Compliance with Federal Policy/IRB 


khammond on DSKJM1Z7X2PROD with NOTICES
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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