Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pre-Submission Program for Medical Devices, 72593-72594 [2016-25359]
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Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices
long-term care ombudsman programs
are housed within an umbrella agency,
this also increases the likelihood that
state programs have multiple
organizational conflicts that must be
identified, remedied or removed, and
reported via NORS.
In response to NASOP’s concerns
about burden estimates, we made a
change in our estimated burden hours
from one-half hour per state to one hour
per state.
NASOP requested additions to the
instructions and report form such as the
ability to certify that there was no
change in conflicts/remedies from the
previous reporting year; and to allow for
the ability to report a conflict and
remedy that applies to many entities as
a reporting entry. These suggestions
were helpful and were incorporated into
the instructions and form. They did not
affect the estimated burden.
NASOP also recommended that AoA/
ACL add a reporting option in a check
box to indicate a state has identified a
conflict, but the conflict has not been
remedied. We do not intend to take this
recommendation because it would be
contrary to the rule and law which
require states to identify, remove or
remedy conflicts and to report on such
remedies. ACL is providing on-going
technical assistance to states on the
implementation of the Ombudsman
program rule, including technical
assistance on conflicts of interest and
steps to remedy any identified conflicts.
A reporting form and instructions
may be viewed in the ombudsman
section of the AoA Web site: https://
www.aoa.acl.gov/AoA_Programs/Elder_
Rights/Ombudsman/index.aspx. AoA
estimates the burden of this collection
and entering the additional report
information as follows: Approximately
10 to 60 minutes per respondent,
depending on the number of conflicts to
report, with 52 state Ombudsman
programs responding annually. This
brings the total burden hours to
approximately 7,753 hours, (149 hours
on average per program) with 52 Offices
of Long-Term Care Ombudsman
programs responding annually.
Summary
Local Ombudsman
programs
Office of state
Ombudsman
Total burden
hours
Hours ...................................................................................
132.1
17
149.1
Dated: October 12, 2016.
Edwin L. Walker,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2016–25418 Filed 10–19–16; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0530]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Pre-Submission
Program for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
21, 2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
VerDate Sep<11>2014
16:40 Oct 19, 2016
Jkt 241001
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0756. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Pre-Submission Program for Medical
Devices—OMB Control Number 0910–
0756—Extension
The guidance entitled ‘‘Requests for
Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ describes
the Pre-Submission program for medical
devices reviewed in the Center for
Devices and Radiological Health (CDRH)
and the Center for Biologics Evaluation
and Research (CBER). The guidance
provides recommendations regarding
the information that should be
submitted in a Pre-Submission package
and procedures that should be followed
for meetings between CDRH and CBER
staff and industry representatives or
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72593
52 Programs
7,753 hours.
application sponsors. In addition to PreSubmissions, the guidance addresses
other feedback mechanisms including
Informational Meetings, Study Risk
Determinations, Formal Early
Collaboration Meetings, and Submission
Issue Meetings and the procedures to
request feedback using these
mechanisms.
A Pre-Submission is defined as a
formal written request from an applicant
for feedback from FDA to be provided
in the form of a formal written response
or, if the manufacturer chooses, a
meeting or teleconference in which the
feedback is documented in meeting
minutes. A Pre-Submission is
appropriate when FDA’s feedback on
specific questions is necessary to guide
product development and/or
application preparation. The proposed
collections of information are necessary
to allow the Agency to receive PreSubmission packages in order to
implement this voluntary submission
program.
For clarity, we are requesting that the
title of the information collection
request, OMB control number 0910–
0756, be changed to ‘‘Pre-Submission
Program for Medical Devices.’’
In the Federal Register of July 28,
2016 (81 FR 49678), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\20OCN1.SGM
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72594
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]
BILLING CODE 4164–01–P
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
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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
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]]>Agencies
[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72593-72594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25359]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0530]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Pre-Submission
Program for Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 21, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0756.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Pre-Submission Program for Medical Devices--OMB Control Number 0910-
0756--Extension
The guidance entitled ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and Drug
Administration Staff'' describes the Pre-Submission program for medical
devices reviewed in the Center for Devices and Radiological Health
(CDRH) and the Center for Biologics Evaluation and Research (CBER). The
guidance provides recommendations regarding the information that should
be submitted in a Pre-Submission package and procedures that should be
followed for meetings between CDRH and CBER staff and industry
representatives or application sponsors. In addition to Pre-
Submissions, the guidance addresses other feedback mechanisms including
Informational Meetings, Study Risk Determinations, Formal Early
Collaboration Meetings, and Submission Issue Meetings and the
procedures to request feedback using these mechanisms.
A Pre-Submission is defined as a formal written request from an
applicant for feedback from FDA to be provided in the form of a formal
written response or, if the manufacturer chooses, a meeting or
teleconference in which the feedback is documented in meeting minutes.
A Pre-Submission is appropriate when FDA's feedback on specific
questions is necessary to guide product development and/or application
preparation. The proposed collections of information are necessary to
allow the Agency to receive Pre-Submission packages in order to
implement this voluntary submission program.
For clarity, we are requesting that the title of the information
collection request, OMB control number 0910-0756, be changed to ``Pre-
Submission Program for Medical Devices.''
In the Federal Register of July 28, 2016 (81 FR 49678), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 72594]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
FDA center Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
CDRH............................ 2,465 1 2,465 137 337,705
CBER............................ 79 1 79 137 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 Pre-Submissions, estimate that an average of 137 hours is
required to prepare a Pre-Submission.
Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25359 Filed 10-19-16; 8:45 am]
BILLING CODE 4164-01-P
