Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 32389-32390 [2013-12828]
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Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Notices
FHCs to document any routine
management or operation of a portfolio
company and to make this
documentation available to the Federal
Reserve on request.10 Examiners use this
information to assess whether the FHC
is conducting its merchant banking
activities in a safe and sound manner
and whether the FHC is in compliance
with applicable regulatory requirements
for engaging in merchant banking
activities.
There are no formal reporting forms
for these collections of information,
which are event generated, though in
each case the type of information
required to be filed is described in the
Board’s regulations. These collections of
information are required pursuant to
amendments made by the GLB Act to
the BHC Act or the Federal Reserve Act,
or Board regulations issued to carry out
the GLB Act.
Current Actions: The Federal Reserve
proposes to revise FR 4012 to include
SLHCs, consistent with interim final
Regulation LL (CFR 238.66(b)).11
Board of Governors of the Federal Reserve
System, May 23, 2013.
Robert deV. Frierson,
Secretary of the Board.
[FR Doc. 2013–12715 Filed 5–29–13; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–19129–30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for a
new collection. Comments submitted
during the first public review of this ICR
will be provided to OMB. OMB will
accept further comments from the
public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before July 1, 2013.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
Information Collection Request Title
and document identifier HHS–OS–
19129–30D for reference.
Information Collection Request Title:
HIPAA Audit Review Survey.
Abstract: This information collection
consists of an online survey of 115
covered entities (health plans, health
care clearinghouses, and health care
providers) that were audited in 2012
through the Office for Civil Rights
HIPAA Audit Program. The survey will
gather information on the effect of the
audits on the audited entities and the
entities’ opinions about the audit
process.
Need and Proposed Use of the
Information: The Office for Civil Rights
is currently conducting a review of the
HIPAA Audit program to determine its
efficacy in assessing the HIPAA
compliance efforts of covered entities.
SUMMARY:
As part of that review, the online survey
will be used to:
• Measure the effect of the HIPAA
Audit program on covered entities;
• Gauge their attitudes towards the
audit overall and in regards to major
audit program features, such as the
document request, communications
received, the on-site visit, the auditreport findings and recommendations;
• Obtain estimates of costs incurred
by covered entities, in time and money,
spent responding to audit-related
requests;
• Seek feedback on the effect of the
HIPAA Audit program on the day-to-day
business operations; and
• Assess whether improvements in
HIPAA compliance were achieved as a
result of the Audit program.
The information, opinions, and
comments collected using the online
survey will be used to produce
recommendations for improving the
HIPAA Audit program.
Likely Respondents: The 115 audit
points-of-contact for each covered entity
audited as part of the 2012 HIPAA
Compliance Audit Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total burden
hours
Form name
Covered Entity Privacy and Security
Officer(s).
OCR HIPAA Audit Evaluation Survey.
115
1
27
52
Total ...........................................
TKELLEY on DSK3SPTVN1PROD with NOTICES
Type of respondent
...........................................................
........................
........................
........................
52
10 12
CFR 225.171(e)(4).
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32390
Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Notices
Darius Taylor,
Deputy, Information Collection Clearance
Officer.
[FR Doc. 2013–12828 Filed 5–29–13; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Food and Drug Administration Safety
and Innovation Act (FDASIA): Request
for Comments on the Development of
a Risk-Based Regulatory Framework
and Strategy for Health Information
Technology
Office of the National
Coordinator for Health Information
Technology, Department of Health and
Human Services.
ACTION: Notice of public meeting and
request for comments.
AGENCY:
The Food and Drug
Administration (FDA), Office of the
National Coordinator for Health
Information Technology (ONC), and
Federal Communication Commission
(FCC) seek broad input from
stakeholders and experts on the
elements we should consider as we
develop a report that contains a
proposed strategy and recommendations
on an appropriate, risk-based regulatory
framework for health IT, including
mobile medical applications, that
promotes innovation, protects patient
safety, and avoids regulatory
duplication. To that end, we are
requesting comments on the topics
identified in Section III.
DATES: This Docket on regulations.gov
will remain open for public comments
until 11:59pm Eastern Time, August 31,
2013.
FOR FURTHER INFORMATION CONTACT:
Steven Posnack, Director, Federal Policy
Division, Office of Policy and Planning,
Office of the National Coordinator for
Health IT, 202–690–7151.
SUPPLEMENTARY INFORMATION:
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
I. The Food and Drug Administration
Safety and Innovation Act Workgroup
Under ONC’s HIT Policy Committee
Section 618(a) of the Food and Drug
Administration Safety and Innovation
Act (FDASIA) of 2012 (Pub. L. 112–144)
directs the Secretary of the Department
of Health and Human Services (HHS),
acting through the Commissioner of the
Food and Drug Administration (FDA),
and in consultation with the HHS Office
of the National Coordinator for Health
Information Technology (ONC) and the
Chairman of the Federal
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Communications Commission (FCC), to
publish a report that will offer a
proposed strategy and recommendations
for an appropriate risk-based Health IT
regulatory framework that would
include mobile medical applications
and promotes innovation, protects
patient safety, and avoids regulatory
duplication.
To assist the agencies’ efforts in
developing this report, the FDA in
collaboration with ONC and FCC
formed a new workgroup, referred to as
the FDASIA Workgroup, under ONC’s
HIT Policy Committee to help the HIT
Policy Committee provide appropriate
input and recommendations to FDA,
ONC, and FCC as suggested by section
618(b) of FDASIA. Accordingly, the
FDASIA Workgroup is charged with
providing input on issues relevant to the
report FDA, ONC, and FCC will
develop, which include:
• Types of risk that may be posed by
health IT that impact patient safety, the
likelihood that these risks will be
realized, and the impact of these
considerations on a risk-based
approach;
• Factors or approaches that could be
included in a risk-based regulatory
approach for health IT that also promote
innovation and protect patient safety;
and
• Approaches to avoid duplicative or
overlapping regulatory requirements.
The workgroup’s membership
includes agency officials and
representatives from a wide range of
stakeholders, including patients,
consumers, health care providers,
startup companies, health plans and
other third-party payers, venture capital
investors, information technology
vendors, health information technology
vendors, small businesses, purchasers,
and employers.
Through this request for comments,
FDA, ONC, and FCC would like to
provide an opportunity for broad public
input on section 618 of FDASIA. Timely
submitted written comments will
inform the new FDASIA Workgroup’s
deliberations on the input it will
provide to the HIT Policy Committee
regarding the report required by section
618 of FDASIA. We seek input on a
number of specific topics identified in
Section III, but welcome any other
pertinent information stakeholders wish
to share. For commenters that wish to
have their comments considered by the
FDASIA Workgroup, we encourage you
to submit your comments as early as
possible and preferably before June 30,
2013.
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FDASIA Workgroup In-Person Meeting
On May 30 and 31, 2013, in
Washington, DC, the FDASIA
Workgroup will hold an in-person
meeting which will also be Webcast.
Persons interested in attending the inperson meeting or viewing the Webcast
can access information about doing so at
this URL: https://www.healthit.gov/
policy-researchers-implementers/policyfdasia-1.
Interested parties may submit
electronic comments to https://
www.regulations.gov. Submit written
comments to Office of the National
Coordinator for Health Information
Technology, Attention: FDASIA Report
Hubert H. Humphrey Building, Suite
729D, 200 Independence Ave. SW.,
Washington, DC 20201.
II. Background
Health IT is being rapidly adopted by
the health care industry and there is a
growing need for the Federal
government to develop a coordinated
approach to its oversight of health IT
that promotes innovation, protects
patient safety, and avoids regulatory
duplication. FDA, FCC, and ONC each
have important roles with respect to the
development and use of health IT that
significantly impacts public health and
welfare. Congress recognized the
importance of a coordinated regulatory
approach and through FDASIA,
specifically tasked the FDA, ONC, and
FCC with creating a report that includes
a proposed strategy and
recommendations for an appropriate,
risk-based regulatory framework for
health IT. To inform the report required
by FDASIA, FDA, ONC, and FCC, in
addition to receiving input from the HIT
Policy Committee, intend to provide
multiple opportunities, as appropriate,
for input from other stakeholders at
different stages throughout the report’s
development, including, if feasible,
feedback on the draft framework prior to
finalizing the report.
III. Topics for Discussion
Public comment is sought on any or
all of the following topics below.
1. Taxonomy
a. What types of health IT should be
addressed by the report developed by
FDA, ONC, and FCC?
2. Risk and Innovation
a. What are the risks to patient safety
posed by health IT and what is the
likelihood of these risks?
b. What factors or approaches could
be included in a risk-based regulatory
approach for health IT to promote
innovation and protect patient safety?
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]]>Agencies
[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Notices]
[Pages 32389-32390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12828]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-19129-30D]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, has submitted an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB) for review and approval. The ICR is for a new collection.
Comments submitted during the first public review of this ICR will be
provided to OMB. OMB will accept further comments from the public on
this ICR during the review and approval period.
DATES: Comments on the ICR must be received on or before July 1, 2013.
ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the Information Collection Request Title
and document identifier HHS-OS-19129-30D for reference.
Information Collection Request Title: HIPAA Audit Review Survey.
Abstract: This information collection consists of an online survey
of 115 covered entities (health plans, health care clearinghouses, and
health care providers) that were audited in 2012 through the Office for
Civil Rights HIPAA Audit Program. The survey will gather information on
the effect of the audits on the audited entities and the entities'
opinions about the audit process.
Need and Proposed Use of the Information: The Office for Civil
Rights is currently conducting a review of the HIPAA Audit program to
determine its efficacy in assessing the HIPAA compliance efforts of
covered entities. As part of that review, the online survey will be
used to:
Measure the effect of the HIPAA Audit program on covered
entities;
Gauge their attitudes towards the audit overall and in
regards to major audit program features, such as the document request,
communications received, the on-site visit, the audit-report findings
and recommendations;
Obtain estimates of costs incurred by covered entities, in
time and money, spent responding to audit-related requests;
Seek feedback on the effect of the HIPAA Audit program on
the day-to-day business operations; and
Assess whether improvements in HIPAA compliance were
achieved as a result of the Audit program.
The information, opinions, and comments collected using the online
survey will be used to produce recommendations for improving the HIPAA
Audit program.
Likely Respondents: The 115 audit points-of-contact for each
covered entity audited as part of the 2012 HIPAA Compliance Audit
Program.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions, to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information, to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information, and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Covered Entity Privacy and OCR HIPAA Audit 115 1 27 52
Security Officer(s). Evaluation
Survey.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 52
----------------------------------------------------------------------------------------------------------------
[[Page 32390]]
Darius Taylor,
Deputy, Information Collection Clearance Officer.
[FR Doc. 2013-12828 Filed 5-29-13; 8:45 am]
BILLING CODE 4153-01-P
