Agency Information Collection Activities: Proposed Collection; Public Comment Request; New Data Collection (ICR New) of the No Wrong Door (NWD) System Management Tool, 55186-55187 [2018-24053]
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55186
Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices
[FR Doc. 2018–23924 Filed 11–1–18; 8:45 am]
BILLING CODE 4120–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities: Proposed Collection; Public
Comment Request; New Data
Collection (ICR New) of the No Wrong
Door (NWD) System Management Tool
Administration for Community
Living, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
information listed above. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish a notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice.
This New Data Collection (ICR New)
solicits comments on the information
collection requirements relating to the
Aging and Disability Resource Center/
No Wrong Door System (ADRC/NWD).
The statutory authority for ADRC/NWD
is contained in Title IV of the Older
Americans Act (OAA), as amended by
the Older Americans Act Amendments
of 2006, Public Law 109–365.
DATES: Comments on the collection of
information must be submitted
electronically by 11:59 p.m. (EST) or
postmarked by January 2, 2019.
ADDRESSES: Submit electronic
comments on the collection of
information to: Ami Patel, ami.patel@
acl.hhs.gov. Submit written comments
on the collection of information to
Administration for Community Living,
330 C Street SW, Washington, DC
20201, Attention: Ami Patel.
FOR FURTHER INFORMATION CONTACT: Ami
Patel at (202) 795–7376 or ami.patel@
acl.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
SUMMARY:
VerDate Sep<11>2014
17:57 Nov 01, 2018
Jkt 247001
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, ACL is publishing a notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, ACL invites
comments on our burden estimates or
any other aspect of this collection of
information, including:
(1) Whether the proposed collection
of information is necessary for the
proper performance of ACL’s functions,
including whether the information will
have practical utility;
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates;
(3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) ways to minimize the burden of
the collection of information on
respondents, including through the use
of automated collection techniques
when appropriate, and other forms of
information technology.
ACL, the Centers for Medicare and
Medicaid Services (CMS), and the
Veterans Health Administration (VHA)
have partnered to support states’ efforts
in developing coordinated systems of
access, or No Wrong Door (NWD)
Systems, to make it easier for people to
learn about and access long-term
services and supports (LTSS). When
seeking services and supports,
individuals and caregivers often face
multiple, fragmented processes that are
complex and confusing. States’ access
systems have been built over time as
programs and funding streams have
been added, creating duplicative
eligibility and intake processes that are
difficult for individuals and their
caregivers to use. To address these
issues, the NWD System model supports
state efforts to streamline access to LTSS
options for all populations and provides
the infrastructure to promote the
collaboration of local service
organizations, making service delivery
more efficient and person-centered.
Examples of coordinated efforts include
processes where individuals are
assessed once via a common or
standardized data collection method
that captures a core set of individual
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
level data relevant for determining the
range of necessary LTSS.
The federal vision for the NWD
System gives states flexibility in
determining how best to organize,
structure and operate the various
functions of their NWD System. States
continue to integrate, in some cases
restructure, and over time strengthen
their existing programs in order to
realize the joint ACL/CMS/VHA vision
for a fully coordinated and integrated
system of access. These efforts are
supported by a variety of initiatives,
including the VHA’s Veteran Directed
Care (VDC) program, an evidence-based
self-directed program where personcentered counselors from aging and
disability network agencies within a
state’s NWD System provide facilitated
assessment and care planning, arrange
fiscal management services and provide
ongoing counseling and support to
Veterans, their families and caregivers.
The NWD System Management Tool
(NWD MT) provides a platform for data
collection necessary to evaluate the four
primary functions of a NWD System:
State Governance and Administration,
Public Outreach and Coordination with
Key Referral Sources, Person Centered
Counseling, and Streamlined Access to
Public LTSS Programs. In addition, this
tool will include data collection for the
VDC program to collect qualitative and
quantitative data elements necessary to
evaluate the impact of the VDC program.
The VDC tool will track key
performance measures and identify best
practices and technical assistance
needs.
The NWD MT and the VDC tool will
enable ACL and its partners to collect
and analyze data elements necessary to
assess the progress of the NWD System
model, track performance measures, and
identify gaps and best practices. These
tools have been designed in close
collaboration with states and are
intended to simplify grant reporting
requirements to reduce burden on local
and state entities and will provide a
consistent, streamlined and coordinated
statewide approach to help states govern
their NWD System and manage their
programs efficiently.
The proposed data collection tools
may be found on the ACL website for
review at: https://www.acl.gov/aboutacl/public-input.
Estimated Program Burden:
ACL estimates the burden of this
collection of information as follows:
Fifty-six lead NWD System state and
territorial agencies will respond to the
NWD MT bi-annually and it will take
approximately half an hour to collect
the data and an additional half hour to
input the data into a web-based system.
E:\FR\FM\02NON1.SGM
02NON1
55187
Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices
Additionally, an estimated 996 local
agencies will take approximately three
hours to collect the data and one hour
to submit the data to their lead NWD
System state agency. If all state and
local agencies respond bi-annually, the
national burden estimate for the NWD
MT would be a total of 8,080 hours
annually. This burden estimate is
calculated based upon a sample of three
states that tested a demonstration of the
NWD MT as a part of the grantee
requirements under the NWD System
NWD local-level entities, for an annual
burden of 2,400 hours. This burden
estimate is calculated based upon
information provided by a current VDC
program provider testing a
demonstration of the VDC tool. The
NWD MT and the VDC tool have been
developed to increase ease and
uniformity of reporting and improve the
ability of ACL to manage and analyze
data.
Implementation grant, a competitive
funding opportunity funded in 2016
through 2018. Each state entity
submitting data will receive local-level
data from designated NWD System
entities. The estimated response burden
includes time to review the instructions,
gather existing information, and
complete and review the data entries in
a web-based system.
An estimated 400 VDC program
entities will respond to the VDC Tool on
a monthly basis, all of which are also
Responses
per
respondent
Number of
respondents
Respondent/data collection activity
Hours per
response
Annual burden
hours
NWD Management Tool data collection and entry—State Level ....................
NWD Management Tool data collection and entry—Local Level ...................
Veteran Directed Care Tool .............................................................................
56
996
400
2
2
12
1.0
4.0
0.5
112
7,968
2,400
Total: .........................................................................................................
1,452
........................
........................
10,480
Dated: October 23, 2018.
Mary Lazare,
Principal Deputy Administrator.
Electronic Submissions
[FR Doc. 2018–24053 Filed 11–1–18; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3903]
Chronic Hepatitis B Virus Infection:
Developing Drugs for Treatment; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Chronic
Hepatitis B Virus Infection: Developing
Drugs for Treatment.’’ The purpose of
this guidance is to assist sponsors in the
clinical development of drugs and
biologics for the treatment of chronic
hepatitis B virus (HBV) infection from
the initial investigational new drug
application (IND) through the new drug
application (NDA)/biologics license
application (BLA) and postmarketing
phases.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by January 2, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
VerDate Sep<11>2014
17:57 Nov 01, 2018
Jkt 247001
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 detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–3903 for ‘‘Chronic Hepatitis B
Virus Infection: Developing Drugs for
Treatment.’’ 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
Dockets Management Staff 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 Dockets Management
Staff. 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
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Notices]
[Pages 55186-55187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24053]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities: Proposed Collection;
Public Comment Request; New Data Collection (ICR New) of the No Wrong
Door (NWD) System Management Tool
AGENCY: Administration for Community Living, Department of Health and
Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) is announcing an
opportunity for the public to comment on the proposed collection of
information listed above. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish a notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice.
This New Data Collection (ICR New) solicits comments on the
information collection requirements relating to the Aging and
Disability Resource Center/No Wrong Door System (ADRC/NWD). The
statutory authority for ADRC/NWD is contained in Title IV of the Older
Americans Act (OAA), as amended by the Older Americans Act Amendments
of 2006, Public Law 109-365.
DATES: Comments on the collection of information must be submitted
electronically by 11:59 p.m. (EST) or postmarked by January 2, 2019.
ADDRESSES: Submit electronic comments on the collection of information
to: Ami Patel, [email protected]. Submit written comments on the
collection of information to Administration for Community Living, 330 C
Street SW, Washington, DC 20201, Attention: Ami Patel.
FOR FURTHER INFORMATION CONTACT: Ami Patel at (202) 795-7376 or
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, ACL is publishing a notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, ACL
invites comments on our burden estimates or any other aspect of this
collection of information, including:
(1) Whether the proposed collection of information is necessary for
the proper performance of ACL's functions, including whether the
information will have practical utility;
(2) the accuracy of ACL's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used to determine burden estimates;
(3) ways to enhance the quality, utility, and clarity of the
information to be collected; and
(4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques when appropriate, and other forms of information technology.
ACL, the Centers for Medicare and Medicaid Services (CMS), and the
Veterans Health Administration (VHA) have partnered to support states'
efforts in developing coordinated systems of access, or No Wrong Door
(NWD) Systems, to make it easier for people to learn about and access
long-term services and supports (LTSS). When seeking services and
supports, individuals and caregivers often face multiple, fragmented
processes that are complex and confusing. States' access systems have
been built over time as programs and funding streams have been added,
creating duplicative eligibility and intake processes that are
difficult for individuals and their caregivers to use. To address these
issues, the NWD System model supports state efforts to streamline
access to LTSS options for all populations and provides the
infrastructure to promote the collaboration of local service
organizations, making service delivery more efficient and person-
centered. Examples of coordinated efforts include processes where
individuals are assessed once via a common or standardized data
collection method that captures a core set of individual level data
relevant for determining the range of necessary LTSS.
The federal vision for the NWD System gives states flexibility in
determining how best to organize, structure and operate the various
functions of their NWD System. States continue to integrate, in some
cases restructure, and over time strengthen their existing programs in
order to realize the joint ACL/CMS/VHA vision for a fully coordinated
and integrated system of access. These efforts are supported by a
variety of initiatives, including the VHA's Veteran Directed Care (VDC)
program, an evidence-based self-directed program where person-centered
counselors from aging and disability network agencies within a state's
NWD System provide facilitated assessment and care planning, arrange
fiscal management services and provide ongoing counseling and support
to Veterans, their families and caregivers.
The NWD System Management Tool (NWD MT) provides a platform for
data collection necessary to evaluate the four primary functions of a
NWD System: State Governance and Administration, Public Outreach and
Coordination with Key Referral Sources, Person Centered Counseling, and
Streamlined Access to Public LTSS Programs. In addition, this tool will
include data collection for the VDC program to collect qualitative and
quantitative data elements necessary to evaluate the impact of the VDC
program. The VDC tool will track key performance measures and identify
best practices and technical assistance needs.
The NWD MT and the VDC tool will enable ACL and its partners to
collect and analyze data elements necessary to assess the progress of
the NWD System model, track performance measures, and identify gaps and
best practices. These tools have been designed in close collaboration
with states and are intended to simplify grant reporting requirements
to reduce burden on local and state entities and will provide a
consistent, streamlined and coordinated statewide approach to help
states govern their NWD System and manage their programs efficiently.
The proposed data collection tools may be found on the ACL website
for review at: https://www.acl.gov/about-acl/public-input.
Estimated Program Burden:
ACL estimates the burden of this collection of information as
follows:
Fifty-six lead NWD System state and territorial agencies will
respond to the NWD MT bi-annually and it will take approximately half
an hour to collect the data and an additional half hour to input the
data into a web-based system.
[[Page 55187]]
Additionally, an estimated 996 local agencies will take approximately
three hours to collect the data and one hour to submit the data to
their lead NWD System state agency. If all state and local agencies
respond bi-annually, the national burden estimate for the NWD MT would
be a total of 8,080 hours annually. This burden estimate is calculated
based upon a sample of three states that tested a demonstration of the
NWD MT as a part of the grantee requirements under the NWD System
Implementation grant, a competitive funding opportunity funded in 2016
through 2018. Each state entity submitting data will receive local-
level data from designated NWD System entities. The estimated response
burden includes time to review the instructions, gather existing
information, and complete and review the data entries in a web-based
system.
An estimated 400 VDC program entities will respond to the VDC Tool
on a monthly basis, all of which are also NWD local-level entities, for
an annual burden of 2,400 hours. This burden estimate is calculated
based upon information provided by a current VDC program provider
testing a demonstration of the VDC tool. The NWD MT and the VDC tool
have been developed to increase ease and uniformity of reporting and
improve the ability of ACL to manage and analyze data.
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Annual burden
Respondent/data collection activity respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
NWD Management Tool data collection and entry-- 56 2 1.0 112
State Level....................................
NWD Management Tool data collection and entry-- 996 2 4.0 7,968
Local Level....................................
Veteran Directed Care Tool...................... 400 12 0.5 2,400
---------------------------------------------------------------
Total:...................................... 1,452 .............. .............. 10,480
----------------------------------------------------------------------------------------------------------------
Dated: October 23, 2018.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2018-24053 Filed 11-1-18; 8:45 am]
BILLING CODE 4154-01-P
