Agency Information Collection Activities; Public Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions, 72057-72058 [2016-25118]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
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
Administration for Community
Living/Administration on Aging, HHS.
ACTION: Notice.
AGENCY:
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
18, 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 at 45
CFR 1324.21.
SUMMARY:
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 at 45 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
72057
the states before states can report via
NORS. Further, because approximately
half of state 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.
sradovich on DSK3GMQ082PROD with NOTICES
Summary
Local
Ombudsman
programs
Office of
state
Ombudsman
Total burden
hours
52 Programs
(hours)
Hours ...............................................................................................................
132.1
17
149.1
7,753
VerDate Sep<11>2014
17:39 Oct 18, 2016
Jkt 241001
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
E:\FR\FM\19OCN1.SGM
19OCN1
72058
Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
Dated: October 12, 2016.
Edwin L. Walker,
Acting Administrator and Assistant Secretary
for Aging.
detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
[FR Doc. 2016–25118 Filed 10–18–16; 8:45 am]
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–2406 for ‘‘Emerging Issues and
Cross-Cutting Scientific Advances.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2406]
Emerging Issues and Cross-Cutting
Scientific Advances; Establishment of
a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is establishing a
public docket to receive input on
emerging issues and cross-cutting
scientific advances that may impact
FDA preparedness and inter-Agency
activities. Interested parties are invited
to submit comments regarding emerging
technologies and cross-cutting scientific
advances of importance to FDA. The
focus is on areas that may impact FDA
in 5 or more years.
DATES: Submit either electronic or
written comments by October 21, 2019.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public submit the comment as a written/
paper submission and in the manner
VerDate Sep<11>2014
17:39 Oct 18, 2016
Jkt 241001
Written/Paper Submissions
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Donna Mendrick, National Center for
Toxicological Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–8892, Donna.Mendrick@
fda.hhs.gov; or Michael Morgan, Office
of Regulatory Science and Innovation,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, 240–402–3832,
Michael.Morgan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
responsible for protecting the public
health by assuring the safety, efficacy,
and security of human and veterinary
drugs, biological products, medical
devices, our Nation’s food supply,
cosmetics, and products that emit
radiation. FDA is tasked with advancing
the public health by helping to speed
innovations that protect the public
health. FDA also has responsibility for
regulating the manufacturing,
marketing, and distribution of tobacco
products, to protect the public health,
and to reduce tobacco use by minors.
Finally, FDA plays a significant role in
the Nation’s counterterrorism capability.
FDA fulfills this responsibility by
ensuring the security of the food supply,
and by fostering development of
medical products used to respond to
deliberate and naturally emerging
public health threats.
FDA’s ability to achieve its mission
relies on awareness of, and proactive
preparedness for, emerging issues and
scientific advances, which will impact
the development of regulated products
well in advance of formal FDA
regulatory submissions (e.g., 5–10
years). To realize this goal requires longrange horizon scanning by a cadre of
scientific leaders from FDA, other
government Agencies, interested
stakeholders, and the public. Emerging
sciences, such as synthetic biology, are
expected to impact FDA regulated
products in the relatively near term. The
goal of this initiative is to identify issues
and advances that will impact the
Agency in the longer term and thus may
be in their infancy.
FDA formed the Emerging Sciences
Working Group to provide an FDA-wide
science-based forum to identify and
E:\FR\FM\19OCN1.SGM
19OCN1
]]>Agencies
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72057-72058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25118]
[[Page 72057]]
-----------------------------------------------------------------------
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 18, 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 at 45 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 at 45 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 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 Total burden 52 Programs
Summary programs Ombudsman hours (hours)
----------------------------------------------------------------------------------------------------------------
Hours....................................... 132.1 17 149.1 7,753
----------------------------------------------------------------------------------------------------------------
[[Page 72058]]
Dated: October 12, 2016.
Edwin L. Walker,
Acting Administrator and Assistant Secretary for Aging.
[FR Doc. 2016-25118 Filed 10-18-16; 8:45 am]
BILLING CODE 4154-01-P
