Agency Information Collection Request; 30-Day Public Comment Request, 33319-33320 [2021-13211]
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Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices
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]
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2015), available at https://www.congress.gov/114/
plaws/publ10/PLAW-114publ10.pdf.
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33319
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0260]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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
SUMMARY:
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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
Number of
respondents
Common rule provision
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
Number of
respondents
Common rule provision
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
.109(d) [Pre-2018 and 2018 Requirements]—Written notification of IRB approval or disapproval of research ..........
.46.116(a) and (b) (Pre-2018 Requirements)/.46.116 (b),
(c) and (d) [2018 Requirements]—Elements of informed
consent and broad consent ..............................................
.46.116(h)—[2018 Requirements]—Posting clinical trial
consent form .....................................................................
.117(a) [Pre-2018 and 2018 Requirements]—Documentation of informed consent ...................................................
.117(c)(2) [Pre-2018 and 2018 Requirements]—Written
statement about the research when informed consent
documentation is waived ..................................................
Total ..............................................................................
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2021–13211 Filed 6–23–21; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
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
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Jkt 253001
Number of disclosures per
respondent
Average
burden per
disclosure
Total hours
6,000
25
150,000
0.5
75,000
6,000
25
150,000
0.5
75,000
100
3
300
0.5
150
6,000
25
150,000
0.5
75,000
6,000
10
60,000
1
60,000
........................
........................
510,300
........................
285,150
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
PO 00000
Total annual
disclosures
Frm 00115
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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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]]>Agencies
[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33319-33320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13211]
-----------------------------------------------------------------------
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: [email protected] 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
[[Page 33320]]
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 non-exempt 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
----------------------------------------------------------------------------------------------------------------
Number of Average
Common rule provision Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
.103(b)(5), .113 [Pre-2018 5,200 1 5,200 1 5,200
Requirements]/.108(a)(4), .113
[2018 Requirements]--Incident
Reporting, Suspension or
Termination of IRB approval
Reporting......................
-------------------------------------------------------------------------------
Total....................... .............. .............. 5,200 .............. 5,200
----------------------------------------------------------------------------------------------------------------
Table 2--Estimated Annual IRB Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
Common rule provision Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
.115 [Pre-2018 and 2018 6,000 16 96,000 12 1,152,000
Requirement]--Preparation and
documentation of IRB activities
-------------------------------------------------------------------------------
Total....................... 6,000 .............. 96,000 .............. 1,152,000
----------------------------------------------------------------------------------------------------------------
Table 3--Estimated Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of disclosures Total annual burden per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
.109(d) [Pre-2018 and 2018 6,000 25 150,000 0.5 75,000
Requirements]--Written
notification of IRB approval or
disapproval of research........
.46.116(a) and (b) (Pre-2018 6,000 25 150,000 0.5 75,000
Requirements)/.46.116 (b), (c)
and (d) [2018 Requirements]--
Elements of informed consent
and broad consent..............
.46.116(h)--[2018 Requirements]-- 100 3 300 0.5 150
Posting clinical trial consent
form...........................
.117(a) [Pre-2018 and 2018 6,000 25 150,000 0.5 75,000
Requirements]--Documentation of
informed consent...............
.117(c)(2) [Pre-2018 and 2018 6,000 10 60,000 1 60,000
Requirements]--Written
statement about the research
when informed consent
documentation is waived........
-------------------------------------------------------------------------------
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
