Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 54467-54469 [2013-21398]
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Federal Register / Vol. 78, No. 171 / Wednesday, September 4, 2013 / Notices
a private citizen and one from an
executive branch ethics official.
The private citizen suggested several
changes to the form including requiring
filers to indicate whether or not a
reported asset in Part I was over $15,000
and changing OGE’s underlying
regulation to require filers to report the
value of any assets. OGE does not
believe that making either change is
necessary or desirable because reporting
specific asset values will not provide
the ethics official with sufficient
information for making the conflicts
analysis. This commenter also suggested
that OGE create a customized version of
the OGE Form 450 for special
Government employee (SGE) filers. OGE
does not see the need for an additional
form for use throughout the executive
branch because agencies already have
available an alternative procedure
process at 5 CFR 2634.905(a) to collect
the information necessary to perform
the conflicts analysis tailored for its SGE
filers.
The comment from an executive
branch ethics official suggested
modifying the instructions for Part III of
the OGE Form 450 by adding more
examples. OGE has decided not to make
this change to the form because this
type of information is best conveyed to
filers in reference materials that can
easily be updated. OGE will consider
creating reference materials containing
additional descriptions of reportable
positions to those provided in the broad
language of 5 CFR 2634.907(e)(1).
Request for Comments: Agency and
public comment is again invited
specifically on the need for and
practical utility of this information
collection, the accuracy of OGE’s
burden estimate, the enhancement of
quality, utility and clarity of the
information collected, and the
minimization of burden (including the
use of information technology).
Comments received in response to this
notice will be summarized for, and may
be included with, the OGE request for
extension of OMB paperwork approval.
The comments will also become a
matter of public record.
Approved: August 27, 2013.
Walter M. Shaub, Jr.,
Director, Office of Government Ethics.
[FR Doc. 2013–21392 Filed 9–3–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–20296–30D]
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
revision of the approved information
collection assigned OMB control
number 0945–0003 scheduled to expire
on 12/31/2015. 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 October 4, 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 OMB
control number 0945–0003 and
document identifier HHS–OS–20296–
30D for reference.
Information Collection Request Title:
Standards for Privacy of Individually
Identifiable Health Information,
Security Standards for the Protection of
Electronic Protected Health Information,
and Supporting Regulations Contained
in 45 CFR Parts 160 and 164
OMB No.: 0945–0003.
Abstract: The Office for Civil Rights
(OCR) is notifying the public of
revisions to a previously approved OCR
data collection. The revisions reflect
certain regulatory modifications to the
SUMMARY:
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54467
HIPAA Privacy and Security Rules,
pursuant to the Health Information for
Economic and Clinical Health (HITECH)
Act and the Genetic Information
Nondiscrimination Act (GINA), that
were finalized in the Omnibus HIPAA
Final Rule published on January 25,
2013 (78 FR 5566). These modifications
strengthen privacy and security
protections for individually identifiable
health information used or disclosed by
business associates and enhance the
rights of individuals with respect to
their identifiable health information.
Need and Proposed Use of the
Information: The information collection
addresses HIPAA requirements related
to the use, disclosure, and safeguarding
of individually identifiable health
information by covered entities affected
by the HIPAA Rules. The information is
routinely used by covered entities and
business associates for treatment,
payment, and health care operations. In
addition, the information is used for
specified public policy purposes,
including research, public health, and
as required by other laws. The Privacy
Rule also ensures that the individuals
are able to exercise certain rights with
respect to their information, including
the rights to access and seek
amendments to their health records and
to receive a Notice of Privacy Practices
(NPP) from their direct treatment
providers and health plans.
Likely Respondents: Respondents
include HIPAA covered entities and
their business associates, as well as
members of the public.
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 tables below.
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Federal Register / Vol. 78, No. 171 / Wednesday, September 4, 2013 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Section
Number of respondents
Type of respondent
Average number of responses per
respondent
Average burden hours per
response
Total burden
hours
New Burdens Associated With the Final Rule
164.316 .............................................
164.504 .............................................
164.520 .............................................
164.520 .............................................
164.520 .............................................
Total ...........................................
Documentation of Security Rule
Policies and Procedures and Administrative Safeguards (business
associates).
Business Associates Needing to Establish or Modify Business Associate Agreements with Subcontractors.
Revision of Notice of Privacy Practices for Protected Health Information (drafting revised language)
(health plans).
Dissemination of Notice of Privacy
Practices for Protected Health Information (health plans).
Revision of Notice of Privacy Practices (providers).
...........................................................
300,000
1
70/60
350,000
375,000
1
20/60
125,000
1,500
1
.111
167
20,000,000
1
.00333335
66,667
697,000
1
.11111
77,444
........................
........................
........................
619,278
Ongoing Annual Burdens of Compliance with the Rules
160.204 .............................................
164.504 .............................................
164.508 .............................................
164.512 .............................................
164.520 .............................................
164.520 .............................................
164.520 .............................................
164.522 .............................................
164.524 .............................................
164.526 .............................................
164.526 .............................................
164.528 .............................................
tkelley on DSK3SPTVN1PROD with NOTICES
Total ...........................................
Process for Requesting Exception
Determinations (states or persons).
Uses and Disclosures—Organizational Requirements.
Uses and Disclosures for Which Individual authorization is required.
Uses and Disclosures for Research
Purposes.
Notice of Privacy Practices for Protected Health Information (health
plans—periodic distribution of
NPPs by paper mail).
Notice of Privacy Practices for Protected Health Information (health
plans—periodic distribution of
NPPs by electronic mail).
Notice of Privacy Practices for Protected Health Information (health
care
providers—dissemination
and acknowledgement).
Rights to Request Privacy Protection for Protected Health Information.
Access of Individuals to Protected
Health Information (disclosures).
Amendment of Protected Health Information (requests).
Amendment of Protected Health Information (denials).
Accounting for Disclosures of Protected Health Information.
...........................................................
1
1
16
16
700,000
1
5/60
58,333
700,000
1
1
700,000
113,524
1
5/60
9,460
100,000,000
1
0.25
416,667
100,000,000
1
0.167
278,333
613,000,000
1
3/60
30,650,000
150,000
1
3/60
7,500
150,000
1
3/60
7,500
150,000
1
3/60
7,500
50,000
1
3/60
2,500
70,000
1
3/60
5,833
........................
........................
........................
32,143,642
TOTAL HOURS
32,762,920
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Federal Register / Vol. 78, No. 171 / Wednesday, September 4, 2013 / Notices
Keith A. Tucker,
Information Collection Clearance Officer.
[FR Doc. 2013–21398 Filed 9–3–13; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Written Comments on
Draft National Action Plan for Adverse
Drug Event Prevention
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
AGENCY:
ACTION:
Notice.
The Office of Disease
Prevention and Health Promotion is
soliciting public comment on the draft
National Action Plan for Adverse Drug
Event Prevention.
SUMMARY:
Comments on the draft National
Action Plan for Adverse Drug Event
Prevention must be received no later
than 5 p.m. on October 4, 2013. This
document provides an overview of
current federal efforts to support
surveillance, prevention, research, and
the use of policy levers to reduce
adverse drug events across the United
States. The draft Action Plan reflects the
work of many offices across the
Department of Health and Human
Services, Department of Defense,
Department of Justice, and Department
of Veterans Affairs. The draft Action
Plan also reflects input from national
experts.
DATES:
The draft National Action
Plan for the Prevention of Adverse Drug
Events is available at: https://
www.hhs.gov/ash/initiatives/ade/adeaction-plan.pdf. Comments are
preferred electronically and may be
addressed to ADE@hhs.gov. Please use
the title ‘‘Draft National ADE Action
Plan’’ when sending comments
electronically. Written responses should
be addressed to the Department of
Health and Human Services, Office of
Disease Prevention and Health
Promotion, 1101 Wootton Parkway,
Suite LL100, Rockville MD 20852,
Attention: Draft National ADE Action
Plan.
tkelley on DSK3SPTVN1PROD with NOTICES
ADDRESSES:
Yael
Harris, Director, Division of Health Care
Quality, Office of Disease Prevention
and Health Promotion, 240–453–8206,
yael.harris@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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I. Background
Adverse drug events (ADEs) have
been defined by the Institute of
Medicine as ‘‘an injury resulting from
medical intervention related to a drug.’’
This broad term encompasses harms
that occur during medical care that are
directly caused by the drug and can
include, but are not limited to,
medication errors, adverse drug
reactions, allergic reactions, and
overdoses. ADEs can occur in any
health care setting, including both
inpatient and outpatient settings and
even more likely to occur during patient
transitions from one health care setting
to another. ADEs are the single largest
contributor to hospital-related
complications within hospitals and
account for over 3.5 million physician
office visits, approximately 1 million
emergency department (ED) visits, and
an estimated 125,000 hospital
admissions every year.
For these reasons, the reduction of
ADEs is a top priority for the
Department of Health and Human
Services (HHS). Multiple Operating and
Staff Divisions within HHS have been
working to reduce the incidence and
prevalence of adverse drug events for
years. To further these efforts, in 2012,
a Cross-Federal Steering Committee for
Adverse Drug Event Prevention was
established. The Steering Committee
was charged with developing a
comprehensive strategy to significantly
reduce adverse drug events within the
three drug classes which account for a
significant proportion of all ADEs:
anticoagulants, diabetes agents, and
opioids. The draft Action Plan focuses
on four main opportunities for federal
engagement: surveillance, prevention,
incentives and oversight, and research.
The draft Action Plan identifies
current federal activity across both
inpatient and outpatient settings, as
well as transitions of care, that are
related to these four opportunities, with
a focus on the three drug classes
associated with high levels of harm. It
also highlights opportunities to advance
these efforts through cross-federal
partnerships and coordinated resources.
The release of the plan is only the
beginning of a coordinated process that
will result in stakeholders who are more
engaged, aware, and knowledgeable of
issues regarding the safe use of
prescribed medications to prevent
ADEs. Although the initial phase of the
Action Plan reflects primarily the efforts
and resources of federal agencies, the
draft Action Plan was developed with
the expectation and understanding that
outlining ADE prevention goals and,
more importantly, actually achieving
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54469
ADE reductions and improving patient
safety can be considered neither
complete nor feasible without further
engagement of professional
organizations representing medical,
nursing, pharmacy, and other allied
health professionals, academia, patient
and consumer representatives, and other
private sector stakeholders. For this
reason, every opportunity to ensure that
feedback of and engagement with these
entities will be sought through the
public release of the draft Action Plan.
Through coordinated federal
partnerships, as well as public and
private sector collaborations and aligned
approaches, we can improve the quality
and safety of health care, reduce health
care costs, and improve the health and
quality of life of millions of people in
the United States.
II. Information Request
The Office of Disease Prevention and
Health Promotion, on behalf of the HHS
Steering Committee for Adverse Drug
Event Prevention, requests input on the
revised draft National Action Plan for
Adverse Drug Event Prevention.
III. Potential Responders
HHS invites input from a broad range
of individuals and organizations that
have interests in reducing adverse drug
events. Some examples of these
organizations include, but are not
limited to the following:
• Caregivers or health system
providers (e.g., physicians, physician
assistants, nurses, pharmacists)
• Collaboratives and consortia
• Foundations
• Health care, professional, and
educational organizations/societies
• Insurers and business groups
• Medicaid- and Medicare-related
organizations
• Patients and their advocates
• Pharmaceutical Industry
• Prescription drug monitoring
programs
• Public health organizations
• State and local public health
agencies.
When responding, please self-identify
with any of the above or other categories
(include all that apply) and your name.
Anonymous submissions will not be
considered. Written materials submitted
for consideration should not exceed 10
pages, not including appendices and
supplemental documents. Responders
may submit other forms of electronic
materials to demonstrate or exhibit
concepts of their written responses,
however, we request that comments are
identified by section, subsection, and
page number so they may be addressed
accordingly. All comments received
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]]>Agencies
[Federal Register Volume 78, Number 171 (Wednesday, September 4, 2013)]
[Notices]
[Pages 54467-54469]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21398]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-20296-30D]
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 revision of the approved
information collection assigned OMB control number 0945-0003 scheduled
to expire on 12/31/2015. 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 October 4,
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 OMB control number 0945-0003 and
document identifier HHS-OS-20296-30D for reference.
Information Collection Request Title: Standards for Privacy of
Individually Identifiable Health Information, Security Standards for
the Protection of Electronic Protected Health Information, and
Supporting Regulations Contained in 45 CFR Parts 160 and 164
OMB No.: 0945-0003.
Abstract: The Office for Civil Rights (OCR) is notifying the public
of revisions to a previously approved OCR data collection. The
revisions reflect certain regulatory modifications to the HIPAA Privacy
and Security Rules, pursuant to the Health Information for Economic and
Clinical Health (HITECH) Act and the Genetic Information
Nondiscrimination Act (GINA), that were finalized in the Omnibus HIPAA
Final Rule published on January 25, 2013 (78 FR 5566). These
modifications strengthen privacy and security protections for
individually identifiable health information used or disclosed by
business associates and enhance the rights of individuals with respect
to their identifiable health information.
Need and Proposed Use of the Information: The information
collection addresses HIPAA requirements related to the use, disclosure,
and safeguarding of individually identifiable health information by
covered entities affected by the HIPAA Rules. The information is
routinely used by covered entities and business associates for
treatment, payment, and health care operations. In addition, the
information is used for specified public policy purposes, including
research, public health, and as required by other laws. The Privacy
Rule also ensures that the individuals are able to exercise certain
rights with respect to their information, including the rights to
access and seek amendments to their health records and to receive a
Notice of Privacy Practices (NPP) from their direct treatment providers
and health plans.
Likely Respondents: Respondents include HIPAA covered entities and
their business associates, as well as members of the public.
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 tables below.
[[Page 54468]]
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average number Average burden
Section Type of Number of of responses hours per Total burden
respondent respondents per respondent response hours
----------------------------------------------------------------------------------------------------------------
New Burdens Associated With the Final Rule
----------------------------------------------------------------------------------------------------------------
164.316....................... Documentation of 300,000 1 70/60 350,000
Security Rule
Policies and
Procedures and
Administrative
Safeguards
(business
associates).
164.504....................... Business 375,000 1 20/60 125,000
Associates
Needing to
Establish or
Modify Business
Associate
Agreements with
Subcontractors.
164.520....................... Revision of 1,500 1 .111 167
Notice of
Privacy
Practices for
Protected
Health
Information
(drafting
revised
language)
(health plans).
164.520....................... Dissemination of 20,000,000 1 .00333335 66,667
Notice of
Privacy
Practices for
Protected
Health
Information
(health plans).
164.520....................... Revision of 697,000 1 .11111 77,444
Notice of
Privacy
Practices
(providers).
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 619,278
----------------------------------------------------------------------------------------------------------------
Ongoing Annual Burdens of Compliance with the Rules
----------------------------------------------------------------------------------------------------------------
160.204....................... Process for 1 1 16 16
Requesting
Exception
Determinations
(states or
persons).
164.504....................... Uses and 700,000 1 5/60 58,333
Disclosures--Or
ganizational
Requirements.
164.508....................... Uses and 700,000 1 1 700,000
Disclosures for
Which
Individual
authorization
is required.
164.512....................... Uses and 113,524 1 5/60 9,460
Disclosures for
Research
Purposes.
164.520....................... Notice of 100,000,000 1 0.25 416,667
Privacy
Practices for
Protected
Health
Information
(health plans--
periodic
distribution of
NPPs by paper
mail).
164.520....................... Notice of 100,000,000 1 0.167 278,333
Privacy
Practices for
Protected
Health
Information
(health plans--
periodic
distribution of
NPPs by
electronic
mail).
164.520....................... Notice of 613,000,000 1 3/60 30,650,000
Privacy
Practices for
Protected
Health
Information
(health care
providers--diss
emination and
acknowledgement
).
164.522....................... Rights to 150,000 1 3/60 7,500
Request Privacy
Protection for
Protected
Health
Information.
164.524....................... Access of 150,000 1 3/60 7,500
Individuals to
Protected
Health
Information
(disclosures).
164.526....................... Amendment of 150,000 1 3/60 7,500
Protected
Health
Information
(requests).
164.526....................... Amendment of 50,000 1 3/60 2,500
Protected
Health
Information
(denials).
164.528....................... Accounting for 70,000 1 3/60 5,833
Disclosures of
Protected
Health
Information.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 32,143,642
----------------------------------------------------------------------------------------------------------------
TOTAL HOURS
----------------------------------------------------------------------------------------------------------------
32,762,920
----------------------------------------------------------------------------------------------------------------
[[Page 54469]]
Keith A. Tucker,
Information Collection Clearance Officer.
[FR Doc. 2013-21398 Filed 9-3-13; 8:45 am]
BILLING CODE 4153-01-P
