Request for Comments on the Proposed Measures and 2020 Targets for the National Action Plan for Adverse Drug Event Prevention: Inpatient and Outpatient Measures for Reduction of Adverse Drug Events From Anticoagulants, Diabetes Agents, and Opioid Analgesics, 72594-72595 [2016-25424]
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Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA center
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
CDRH ...................................................................................
CBER ...................................................................................
2,465
79
1
1
2,465
79
137
137
337,705
10,823
Total ..............................................................................
........................
........................
........................
........................
348,528
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents are medical device
manufacturers subject to FDA’s laws
and regulations. FDA’s annual estimate
of 2,544 submissions is based on
experienced trends over the past several
years. FDA’s administrative and
technical staffs, who are familiar with
the requirements for current PreSubmissions, estimate that an average of
137 hours is required to prepare a PreSubmission.
Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25359 Filed 10–19–16; 8:45 am]
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DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Comments on the
Proposed Measures and 2020 Targets
for the National Action Plan for
Adverse Drug Event Prevention:
Inpatient and Outpatient Measures for
Reduction of Adverse Drug Events
From Anticoagulants, Diabetes Agents,
and Opioid Analgesics
AGENCY:
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
The Office of Disease
Prevention and Health Promotion
(ODPHP), on behalf of the U.S.
Department of Health and Human
Services (HHS) Federal Interagency
Steering Committee for Adverse Drug
Events, proposes new measures and
targets for adverse drug events (ADEs)
from anticoagulants, diabetes agents,
and opioid analgesics for the National
Action Plan for Adverse Drug Event
Prevention (ADE Action Plan). Based on
input from the Federal Interagency
Workgroups for Adverse Drug Events,
six national measures and targets for the
reduction of ADEs are being proposed.
Each drug class highlighted in the ADE
Action Plan (anticoagulants, diabetes
agents, and opioid analgesics) includes
VerDate Sep<11>2014
16:40 Oct 19, 2016
Jkt 241001
a proposed inpatient and outpatient
measure to track national progress in
reduction of ADEs from these drug
classes. The proposed targets will reflect
improvement efforts over a four to six
year period since the release of the ADE
Action Plan in August 2014. As such,
HHS is proposing a baseline year of
2014 for five of the measures and 2016
for one measure. All targets are to be
achieved by 2020. HHS invites
interested public and private
professionals, organizations, and
consumer representatives to submit
written comments on the proposed 2020
ADE targets, found at https://health.gov/
hcq/ade-measures.asp.
Comments on the proposed ADE
2020 measures and targets must be
received no later than 5 p.m. on
November 21, 2016.
ADDRESSES:
Interested persons or
organizations are invited to submit
written comments by any of the
following methods:
• Email: OHQ@hhs.gov (please
indicate in the subject line: Proposed
ADE Measures and Targets)
• Mail/Courier: Office of Disease
Prevention and Health Promotion, Attn:
Division of Health Care Quality,
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
LL100, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Anna Gribble, Health Policy Fellow,
Office of Disease Prevention and Health
Promotion, via email at anna.gribble@
hhs.gov.
SUPPLEMENTARY INFORMATION:
In
September 2012, in response to
heightened awareness of the
contribution of ADEs to the burden of
health care-related harm and costs, the
Office of the Assistant Secretary for
Health (OASH) marshaled the wideranging and diverse resources of federal
partners to form an extensive
interagency partnership, the Federal
Interagency Steering Committee and
Workgroups for Adverse Drug Events,
whose goals would be to develop the
ADE Action Plan, as well as identify
measures to track national progress in
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
reducing ADEs and targets to meet
based on those measures.
ODPHP, in conjunction with the
Federal Interagency Steering Committee
and three Federal Interagency
Workgroups, developed and released
the final ADE Action Plan in 2014. The
ADE Action Plan seeks to engage all
stakeholders in a coordinated, aligned,
and multi-sector effort to reduce ADEs
that are clinically significant, account
for the greatest number of measurable
harms as identified by existing
surveillance systems, and are largely
preventable; these were identified as
ADEs resulting from inpatient and
outpatient use of anticoagulants,
diabetes agents, and opioid analgesics
(with specific focus on ADEs from
therapeutic use of opioids). The ADE
Action Plan identifies the federal
government’s highest priority strategies
and opportunities for advancement,
which will have the greatest impact on
reducing ADEs. Implementation of these
strategies is expected to result in safer
and higher quality health care services,
reduced health care costs, informed and
engaged consumers and ultimately,
improved health outcomes. The
reduction of ADEs subsequent to
implementation of these strategies will
be tracked by the proposed measures
and will aim to meet the targeted
reduction rate by 2020.
The six proposed measures use data
from the Agency for Healthcare
Research and Quality (AHRQ), the
Centers for Disease Control and
Prevention (CDC), and the Food and
Drug Administration (FDA). The
inpatient and outpatient measures for
anticoagulants and diabetes agents and
the outpatient measure for opioids will
set baseline rates using data from 2014
and establish targets to be achieved by
2020. The inpatient opioids measure
will have a 2016 baseline and a 2020
target year. The inpatient opioids
measure will use data from AHRQ’s
Quality Safety Review System (QSRS)
which will begin collecting data in
2016. The inpatient measures for
anticoagulants and diabetes agents will
use AHRQ’s Medicare Patient
Monitoring System (MPSMS) for 2015
E:\FR\FM\20OCN1.SGM
20OCN1
Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices
and QSRS for 2016–2020 and data will
be adjusted accordingly. MPSMS did
not include an opioids specific measure
and QSRS now allows AHRQ to now
track inpatient opioids adverse drug
events.
Descriptions of the surveillance
systems, measures, and targets can be
found here: https://health.gov/hcq/ademeasures.asp.
Interested persons or organizations
are invited to submit written comments
in response to the proposed measures
and targets. Written comments should
not exceed more than two pages per
ADE measure. The comments should
reference the specific measure or target
to which feedback refers. To be
considered, the person or representative
from an organization must self-identify
and submit the written comments by
close of business on November 21, 2016.
Dated: September 30, 2016.
Don Wright,
Deputy Assistant Secretary for Health,
Director, Office of Disease Prevention and
Health Promotion Office of the Assistant
Secretary for Health.
[FR Doc. 2016–25424 Filed 10–19–16; 8:45 am]
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Pursuant to section 10(d) of the
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hereby given of the following meetings.
The meetings will be closed to the
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as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
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Date: October 25, 2016.
Time: 3:30 p.m. to 6:30 p.m.
Agenda: To review and evaluate grant
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Scientific Review Officer, Center for
Scientific Review, National Institutes of
VerDate Sep<11>2014
16:40 Oct 19, 2016
Jkt 241001
Health, 6701 Rockledge Drive, Room 1108,
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Agenda: To review and evaluate grant
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D.,
IRG CHIEF, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
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Institutes of Health, HHS)
Dated: October 14, 2016.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–25336 Filed 10–19–16; 8:45 am]
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National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
PO 00000
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72595
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
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Research, National Institutes of Health, HHS)
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Program Analyst, Office of Federal Advisory
Committee Policy.
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[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72594-72595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25424]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Comments on the Proposed Measures and 2020 Targets
for the National Action Plan for Adverse Drug Event Prevention:
Inpatient and Outpatient Measures for Reduction of Adverse Drug Events
From Anticoagulants, Diabetes Agents, and Opioid Analgesics
AGENCY: Office of Disease Prevention and Health Promotion, Office of
the Assistant Secretary for Health, Office of the Secretary, Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Office of Disease Prevention and Health Promotion (ODPHP),
on behalf of the U.S. Department of Health and Human Services (HHS)
Federal Interagency Steering Committee for Adverse Drug Events,
proposes new measures and targets for adverse drug events (ADEs) from
anticoagulants, diabetes agents, and opioid analgesics for the National
Action Plan for Adverse Drug Event Prevention (ADE Action Plan). Based
on input from the Federal Interagency Workgroups for Adverse Drug
Events, six national measures and targets for the reduction of ADEs are
being proposed. Each drug class highlighted in the ADE Action Plan
(anticoagulants, diabetes agents, and opioid analgesics) includes a
proposed inpatient and outpatient measure to track national progress in
reduction of ADEs from these drug classes. The proposed targets will
reflect improvement efforts over a four to six year period since the
release of the ADE Action Plan in August 2014. As such, HHS is
proposing a baseline year of 2014 for five of the measures and 2016 for
one measure. All targets are to be achieved by 2020. HHS invites
interested public and private professionals, organizations, and
consumer representatives to submit written comments on the proposed
2020 ADE targets, found at https://health.gov/hcq/ade-measures.asp.
DATES: Comments on the proposed ADE 2020 measures and targets must be
received no later than 5 p.m. on November 21, 2016.
ADDRESSES: Interested persons or organizations are invited to submit
written comments by any of the following methods:
Email: OHQ@hhs.gov (please indicate in the subject line:
Proposed ADE Measures and Targets)
Mail/Courier: Office of Disease Prevention and Health
Promotion, Attn: Division of Health Care Quality, Department of Health
and Human Services, 1101 Wootton Parkway, Suite LL100, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT: Anna Gribble, Health Policy Fellow,
Office of Disease Prevention and Health Promotion, via email at
anna.gribble@hhs.gov.
SUPPLEMENTARY INFORMATION: In September 2012, in response to heightened
awareness of the contribution of ADEs to the burden of health care-
related harm and costs, the Office of the Assistant Secretary for
Health (OASH) marshaled the wide-ranging and diverse resources of
federal partners to form an extensive interagency partnership, the
Federal Interagency Steering Committee and Workgroups for Adverse Drug
Events, whose goals would be to develop the ADE Action Plan, as well as
identify measures to track national progress in reducing ADEs and
targets to meet based on those measures.
ODPHP, in conjunction with the Federal Interagency Steering
Committee and three Federal Interagency Workgroups, developed and
released the final ADE Action Plan in 2014. The ADE Action Plan seeks
to engage all stakeholders in a coordinated, aligned, and multi-sector
effort to reduce ADEs that are clinically significant, account for the
greatest number of measurable harms as identified by existing
surveillance systems, and are largely preventable; these were
identified as ADEs resulting from inpatient and outpatient use of
anticoagulants, diabetes agents, and opioid analgesics (with specific
focus on ADEs from therapeutic use of opioids). The ADE Action Plan
identifies the federal government's highest priority strategies and
opportunities for advancement, which will have the greatest impact on
reducing ADEs. Implementation of these strategies is expected to result
in safer and higher quality health care services, reduced health care
costs, informed and engaged consumers and ultimately, improved health
outcomes. The reduction of ADEs subsequent to implementation of these
strategies will be tracked by the proposed measures and will aim to
meet the targeted reduction rate by 2020.
The six proposed measures use data from the Agency for Healthcare
Research and Quality (AHRQ), the Centers for Disease Control and
Prevention (CDC), and the Food and Drug Administration (FDA). The
inpatient and outpatient measures for anticoagulants and diabetes
agents and the outpatient measure for opioids will set baseline rates
using data from 2014 and establish targets to be achieved by 2020. The
inpatient opioids measure will have a 2016 baseline and a 2020 target
year. The inpatient opioids measure will use data from AHRQ's Quality
Safety Review System (QSRS) which will begin collecting data in 2016.
The inpatient measures for anticoagulants and diabetes agents will use
AHRQ's Medicare Patient Monitoring System (MPSMS) for 2015
[[Page 72595]]
and QSRS for 2016-2020 and data will be adjusted accordingly. MPSMS did
not include an opioids specific measure and QSRS now allows AHRQ to now
track inpatient opioids adverse drug events.
Descriptions of the surveillance systems, measures, and targets can
be found here: https://health.gov/hcq/ade-measures.asp.
Interested persons or organizations are invited to submit written
comments in response to the proposed measures and targets. Written
comments should not exceed more than two pages per ADE measure. The
comments should reference the specific measure or target to which
feedback refers. To be considered, the person or representative from an
organization must self-identify and submit the written comments by
close of business on November 21, 2016.
Dated: September 30, 2016.
Don Wright,
Deputy Assistant Secretary for Health, Director, Office of Disease
Prevention and Health Promotion Office of the Assistant Secretary for
Health.
[FR Doc. 2016-25424 Filed 10-19-16; 8:45 am]
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