30 Day FRN

Federal Register / Vol. 83, No. 243 / Wednesday, December 19, 2018 / Notices

OMB control
No.

21 CFR part; guidance; or FDA form

Topic

820 ..............................................................................................

Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.

Dated: December 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–27433 Filed 12–18–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0955–new]

Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

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: National
Survey of Health Information Exchange
Organizations (HIO)
Abstract: Electronic health
information exchange (HIE) is one of
three goals specified by Congress in the
2009 Health Information Technology for
Economic and Clinical Health (HITECH)
Act to ensure that the $30 billion federal
investment in electronic health records
(EHRs) results in higher-quality, lowercost care. The ability of providers to
share data electronically is a core goal
of HITECH and a central feature of a
high-performing healthcare delivery
system. Greater EHR adoption without
data flowing between systems
substantially limits quality and
efficiency gains as well as reduces the
value of the health IT investment.

SUPPLEMENTARY INFORMATION:

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 January 18, 2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0955-New-30D and project title for
reference.
SUMMARY:

65171

0910–0073

There is growing consensus that
achieving broad-based HIE is one of the
most difficult components of HITECH.
This is because successful HIE at scale
involves coordination between many
stakeholders, including but not limited
to federal and state policymakers,
healthcare delivery organizations, EHR
and HIE vendors, and specific
organizations supporting HIE, such as
health information organizations (HIOs)
and health information service
providers (HISPs). Further, the issues
requiring coordination are diverse,
spanning technical standards, consent
regulations, business models and
incentives, workflow integration, trust
and governance, and information
privacy and security.
Three HIE issues have proven
particularly challenging:
Implementation of and use of standards,
information blocking, and
sustainability. The ultimate goal of our
project is to administer a survey
instrument to HIOs in order to generate
the most current national statistics and
associated actionable insights on
electronic health information exchange
to inform policy efforts.
Need and Proposed Use of the
Information: Collecting timely, national
data from HIOs in the three domains of
standards, information blocking, and
sustainability is valuable to inform both
HIE-specific policy efforts as well as
broader health system reform efforts.

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents

amozie on DSK3GDR082PROD with NOTICES1

Form name

Number of
responses
per
respondent

Average
burden per
response
(in hours)

Total burden
hours

HIO Survey ......................................................................................................

200

1

20/60

67

Total ..........................................................................................................

........................

........................

........................

67

Terry Clark,
Assistant Paperwork Reduction Act Reports
Clearance Officer, Office of the Secretary.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2018–27469 Filed 12–18–18; 8:45 am]

[Document Identifier: OS–0990–new]

BILLING CODE 4150–45–P

Agency Information Collection
Request. 30-Day Public Comment
Request
AGENCY:
ACTION:

VerDate Sep<11>2014

17:59 Dec 18, 2018

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PO 00000

Office of the Secretary, HHS.

Notice.

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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 January 18, 2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
SUMMARY:

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