Agency Information Collection Activities; Public Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions, 72592-72593 [2016-25418]
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72592
Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices
collection tool may be found on the ACL
Web site: https://www.aoa.acl.gov/
Program_Results/Program_survey.aspx.
The total burden estimate for the
remaining data collection is: 482.67
hours.
Dated: October 12, 2016.
Edwin L. Walker,
Acting Assistant Secretary for Aging.
[FR Doc. 2016–25416 Filed 10–19–16; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Evaluation
of the Elderly Nutritional Services
Program
AGENCY:
Administration for Community
Living, HHS.
ACTION: Notice.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
The Administration for
Community Living (formerly the
Administration on Aging (AoA)) is
announcing that the continuation of
collection of information listed below
has been submitted to the Office of
Management and Budget (OMB) for
review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments on the
collection of information by November
21, 2016.
ADDRESSES: Submit written comments
on the collection of information by fax
202.395.6974 to the OMB Desk Officer
for ACL, Office of Information and
Regulatory Affairs, OMB.
FOR FURTHER INFORMATION CONTACT:
Susan Jenkins, 202.795.7369.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, the
Administration for Community Living
(Formerly the Administration for Aging)
has submitted the following proposed
collection of information to OMB for
review and clearance. The data
collection associated with the
Evaluation of the Elderly Nutrition
Services Program (ENSP) is necessary to
meet three broad objectives of ACL: (1)
To provide information to support
program planning, including an analysis
of program processes, (2) to develop
information about program efficiency
and cost issues, and (3) to assess
program effectiveness, as measured by
the program’s effects on a variety of
important outcomes, including nutrient
adequacy, socialization opportunities,
health outcomes, and, ultimately,
VerDate Sep<11>2014
16:40 Oct 19, 2016
Jkt 241001
helping elderly people avoid
institutionalization. The renewal is to
complete the data collection related to
objective 3.
In response to the 60-day Federal
Register notice related to this proposed
data collection and published on July
19, 2016, no relevant comments were
was received. The proposed data
collection tool may be found on the ACL
Web site: https://www.aoa.acl.gov/
Program_Results/Program_survey.aspx.
The total burden estimate for the
remaining data collection is: 192 hours.
Dated: October 14, 2016.
Edwin L. Walker,
Acting Assistant Secretary for Aging.
[FR Doc. 2016–25414 Filed 10–19–16; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living/
Administration on Aging
Agency Information Collection
Activities; Public Comment Request;
State Annual Long-Term Care
Ombudsman Report and Instructions
AGENCY:
Administration for Community
Living/Administration on Aging, HHS.
ACTION: Notice.
SUMMARY:
The Administration on Aging
(AoA) is announcing that the proposed
collection of information listed below
has been submitted to the Office of
Management and Budget (OMB) for
review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments on the
collection of information by November
21, 2016.
ADDRESSES: Submit written comments
on the collection of information by fax
202.395.5806 or by email to OIRA_
submission@omb.eop.gov, Attn: OMB
Desk Officer for ACL.
FOR FURTHER INFORMATION CONTACT:
Louise Ryan, telephone: (206) 615–2514;
email: louise.ryan@acl.hhs.gov
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, AoA
has submitted the following proposed
collection of information to OMB for
review and clearance.
States provide the following data and
narrative information in the report:
1. Numbers and descriptions of cases
filed and complaints made on behalf of
long-term care facility residents to the
statewide ombudsman program;
2. Major issues identified that impact
the quality of care and life of long-term
care facility residents;
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
3. Statewide program operations; and
4. Ombudsman activities in addition
to complaint investigation.
5. A new requirement to include
organizational conflict of interest
reporting as required by the
reauthorized Older Americans Act and
the LTC Ombudsman program rule CFR
1324.21.
The report form and instructions have
been in continuous use, with minor
modifications, since they were first
approved by OMB for the FY 1995
reporting period. This current request is
for a Revision of a Currently Approved
Collection (ICR Rev), which will
provide approval for FFY 2016–2018
with modifications to include
organizational conflict of interest
reporting as required by the
reauthorized Older Americans Act,
Section 712(f) and the LTC Ombudsman
program rule CFR 1324.21.
The data collected on complaints filed
with ombudsman programs and
narrative on long-term care issues
provide information to Centers for
Medicare and Medicaid Services and
others on patterns of concerns and
major long-term care issues affecting
residents of long-term care facilities.
Both the complaint and program data
collected assist the states and local
ombudsman programs in planning
strategies and activities, providing
training and technical assistance and
developing performance measures.
Comments in Response to the 60 Day
Federal Register Notice
A notice was published in the Federal
Register/Vol. 81, No. 126/Thursday,
June 30, 2016 Notices, Pages 42712–
42713, announcing that AoA was
requesting modification of the current
form and instructions to incorporate
conflict of interest reporting
requirements, directing readers to the
AoA Web site where these documents
are posted and providing an opportunity
for public comment. One comment was
received from the National Association
of Ombudsman Programs (NASOP).
NASOP members disagreed with the
burden estimate developed by AoA,
stating:
Because an overwhelming majority of
state long-term care ombudsman
programs designate local ombudsman
entities, those circumstances lead to a
greater likelihood of organizational
conflicts of interest. The burden is
compounded by the number of local
ombudsman entities within a state and
will have multiple sources of reporting
organizational conflicts at local or
regional levels up to the states before
states can report via NORS. Further,
because approximately half of state
E:\FR\FM\20OCN1.SGM
20OCN1
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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Frm 00032
Fmt 4703
Sfmt 4703
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
20OCN1
]]>Agencies
- DEPARTMENT OF HEALTH AND HUMAN SERVICES
- Administration for Community Living/Administration on Aging
[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72592-72593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25418]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living/Administration on Aging
Agency Information Collection Activities; Public Comment Request;
State Annual Long-Term Care Ombudsman Report and Instructions
AGENCY: Administration for Community Living/Administration on Aging,
HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration on Aging (AoA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments on the collection of information by
November 21, 2016.
ADDRESSES: Submit written comments on the collection of information by
fax 202.395.5806 or by email to OIRA_submission@omb.eop.gov, Attn: OMB
Desk Officer for ACL.
FOR FURTHER INFORMATION CONTACT: Louise Ryan, telephone: (206) 615-
2514; email: louise.ryan@acl.hhs.gov
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, AoA has
submitted the following proposed collection of information to OMB for
review and clearance.
States provide the following data and narrative information in the
report:
1. Numbers and descriptions of cases filed and complaints made on
behalf of long-term care facility residents to the statewide ombudsman
program;
2. Major issues identified that impact the quality of care and life
of long-term care facility residents;
3. Statewide program operations; and
4. Ombudsman activities in addition to complaint investigation.
5. A new requirement to include organizational conflict of interest
reporting as required by the reauthorized Older Americans Act and the
LTC Ombudsman program rule CFR 1324.21.
The report form and instructions have been in continuous use, with
minor modifications, since they were first approved by OMB for the FY
1995 reporting period. This current request is for a Revision of a
Currently Approved Collection (ICR Rev), which will provide approval
for FFY 2016-2018 with modifications to include organizational conflict
of interest reporting as required by the reauthorized Older Americans
Act, Section 712(f) and the LTC Ombudsman program rule CFR 1324.21.
The data collected on complaints filed with ombudsman programs and
narrative on long-term care issues provide information to Centers for
Medicare and Medicaid Services and others on patterns of concerns and
major long-term care issues affecting residents of long-term care
facilities. Both the complaint and program data collected assist the
states and local ombudsman programs in planning strategies and
activities, providing training and technical assistance and developing
performance measures.
Comments in Response to the 60 Day Federal Register Notice
A notice was published in the Federal Register/Vol. 81, No. 126/
Thursday, June 30, 2016 Notices, Pages 42712-42713, announcing that AoA
was requesting modification of the current form and instructions to
incorporate conflict of interest reporting requirements, directing
readers to the AoA Web site where these documents are posted and
providing an opportunity for public comment. One comment was received
from the National Association of Ombudsman Programs (NASOP).
NASOP members disagreed with the burden estimate developed by AoA,
stating:
Because an overwhelming majority of state long-term care ombudsman
programs designate local ombudsman entities, those circumstances lead
to a greater likelihood of organizational conflicts of interest. The
burden is compounded by the number of local ombudsman entities within a
state and will have multiple sources of reporting organizational
conflicts at local or regional levels up to the states before states
can report via NORS. Further, because approximately half of state
[[Page 72593]]
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Local Ombudsman Office of state
Summary programs Ombudsman Total burden hours 52 Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hours.......................................... 132.1 17 149.1 7,753 hours.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
