Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Older American Act Title III and Title VII (Chapters 3 and 4) Annual State Program Reporting (Annual Performance Data Collection); This is a Revision to the Existing State Program Report (OMB Approval 0985-0008), 13989-13990 [2018-06662]
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daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
year 2019, the SNP–MOC program area
has been more accurately renamed
Special Needs Program Care
Coordination Quality Improvement
Performance Evaluation (SNP–CCQIPE).
In addition, the Medication Therapy
Management (MTM) pilot protocol has
been suspended until further notice. For
that reason, it is no longer posted to the
CMS website.
Beginning in audit year 2019, the data
collected via program-specific record
layouts, and collected via impact
analyses on an as-needed basis, will be
consolidated into each program area
data request document. The pre-audit
issue summary was updated for
technical terminology changes. Three of
the questionnaires and the power point
template that previously have been
distributed as part of our CPE audits
will remain. However, the CPE selfassessment questionnaire and the CDAG
and ODAG questionnaires have been
removed. We have added new
questionnaires for FA and SNP–
CCQIPE. A revised template for
collecting root cause analyses from
organizations on an as-needed basis
during the program audit has been
included in this package.
We have also included a new
independent validation audit work plan
template that will be collected from
sponsors that are required to undergo an
independent validation audit. The
validation audit is part of our robust
audit process where CMS requires
sponsoring organizations that have been
audited and found to have deficiencies
to undergo a validation audit to ensure
correction. The validation audit utilizes
the same audit protocols, but only tests
the elements where deficiencies were
found, as opposed to re-administering
the entire audit. This validation audit
work plan template will be populated
by the sponsoring organization’s
independent auditing firm to describe
how it plans to test for correction of the
deficiencies identified during the
program audit.
To assist in improving the audit
process, we have also included an audit
feedback questionnaire that is
representative of the survey link we
send to sponsoring organizations at the
end of each program audit. Completion
of this questionnaire is optional for
sponsoring organizations to provide
feedback on the audit process.
The proposed changes to each data
collection instrument, along with the
new FA and SNP–CCQIPE
questionnaires, root cause template,
validation audit work plan template and
audit feedback questionnaire are
included in the posted PRA package.
VerDate Sep<11>2014
19:06 Mar 30, 2018
Jkt 244001
Finally, separate from the audit
process and in order to address
sponsoring organizations’ concerns
regarding undue harm in Star Ratings
during audit years. The number of
sponsoring organizations that are
required to submit universes annually
for their coverage/organization
determinations and appeals increased.
In 2016, CMS expanded this annual
collection to all MA and Part D
sponsoring organizations. The universes
are submitted in the same format as
required for audits under the Part D
CDAG protocol and the Part C ODAG
protocol. The universes are then
analyzed for timeliness on an annual
basis, across all sponsoring
organizations, to allow a more
comprehensive review of the accuracy
of Part C and D appeals data to calculate
Star Ratings. Form Number: CMS–10191
(OMB control number: 0938–1000);
Frequency: Yearly; Affected Public:
Private Sector (business or other forprofit and not-for-profit institutions);
Number of Respondents: 166; Total
Annual Responses: 211; Total Annual
Hours: 51,548. (For policy questions
regarding this collection contact Brenda
Hudson at 443–743–9299.)
Dated: March 28, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–06645 Filed 3–30–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Submission for OMB
Review; Public Comment Request;
Older American Act Title III and Title VII
(Chapters 3 and 4) Annual State
Program Reporting (Annual
Performance Data Collection); This is a
Revision to the Existing State Program
Report (OMB Approval 0985–0008)
Administration for Community
Living (ACL), HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living is announcing that
the proposed collection of information
listed above has been submitted to the
Office of Management and Budget
(OMB) for review and clearance as
required under section 506(c)(2)(A) of
the Paperwork Reduction Act of 1995.
This 30-Day notice collects comments
on the information collection
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
13989
requirements related to annual
performance data from State grantees
under the Older Americans Act related
to Title III and Title VII (Chapters 3 and
4) of that act. Title III includes, for
example, home delivered and
congregate meal services, transportation
and caregiver service; and Title VII
includes Elder Abuse Prevention and
Legal Assistance Development (ICR
Rev).
Submit written comments on the
collection of information by May 2,
2018.
DATES:
Submit written comments
on the collection of information by:
(a) Email to: OIRA_submission@
omb.eop.gov, Attn: OMB Desk Officer
for ACL;
(b) Fax to 202.395.5806, Attn: OMB
Desk Officer for ACL; or
(c) By mail to the Office of
Information and Regulatory Affairs,
OMB, New Executive Office Bldg., 725
17th St. NW, Rm. 10235, Washington,
DC 20503, Attn: OMB Desk Officer for
ACL.
FOR FURTHER INFORMATION CONTACT:
ACL’s Office of Performance and
Evaluation at SPRredesign.comments@
acl.hhs.gov.
ADDRESSES:
In
compliance with 44 U.S.C. 3507, ACL
has submitted the following proposed
collection of information to OMB for
review and clearance. This collection is
a revision of the 2016 approved version
of the State Program Report and
incorporates significant reduction in
data collected. This data collection is
essential to provide performance
measures as required by Congress and
the GPRA Modernization Act of 2010
(GPRAMA). Significant revisions to the
SPR were last implemented in 2005.
This proposed collection is a revision of
the currently approved version
(effective 2016–2019). The factors that
influenced the proposed revision of the
SPR, include: (1) The need to modernize
the data structure to allow for more
efficient reporting and the ability to use
current technology for reporting and
analysis; (2) the interest in aligning data
elements within and across data
collections; (3) the need to consider
alternative data elements that reflect the
current Aging Network and long-term
care services and supports; and (4) the
need to reduce reporting burden while
enhancing data quality. The proposed
SPR revision reduces the number of data
elements reported by 70% and the
amount of time for completion by 30%
as compared to the current 2016–2019
SPR. This is a reduction of 874 hours
from the previous version.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\02APN1.SGM
02APN1
13990
Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
Reductions in data elements are found
throughout the data collection but are
concentrated in the consumer
demographic components. Due to the
aggregate level nature of the SPR,
information on combinations of
demographic characteristics (e.g.,
number of women served who are 65
years or older and have 2 activity of
daily living limitations) require
exponentially larger numbers of data
elements compared to single
demographic characteristics (e.g.
number of women served). To reduce
the reporting burden associated with the
number of data elements ACL is
proposing to limit data element
combinations. For example, the revised
SPR asks for demographic characteristic
such as age, race, and gender for three
or more ADL and IADLs rather than for
zero, one, two and three or more ADLs
and IADLs. The remaining proposed
demographic data elements include
indicators of priority populations (i.e.,
social and economic vulnerability and
frailty) found in the OAA and will allow
ACL to continue to measure efforts to
target services.
Limited expansions in data elements
are found in the Title III–E National
Family Caregiver Support Program
service component. The proposal
separates out three service areas that
were reported as a whole (i.e.,
counseling, training and support group
services). Separation allows for support
group services to be categorized as a
non-registered service for which
consumer demographic details are no
longer reported. Additional information
regarding the types of respite services
provided under the OAA is sought. The
proposal separates assistance services
into two types: (1) Case management,
and (2) information and assistance. Case
management assistance services are
categorized as registered, meaning
caregiver demographic data are reported
while information and assistance
services do not include reporting of
demographic data. Supplemental
services are reported in the same
manner as ‘‘other service’’ under Title
III–B, Home and Community-based
Services (HCBS) program. Across the
OAA services, greater detail regarding
expenditure data is proposed. Under
Title III–B, HCBS program, the proposed
data collection expands data regarding
Title VII legal assistance services. The
ACL seeks data on the OAA identified
priority legal issues for closed cases.
Comments in Response to the 60-Day
Federal Register Notice
A 60-day Federal Register Notice was
published in the Federal Register on
June 1, 2017, Vol. 82, No. 104, pp.
25293–25294.
ACL received comments from
fourteen (14) organizations and one (1)
individual about the State Performance
Report (SPR) redesign. ACL reviewed all
of the comments, but some of the
comments were deemed not relevant
because they were: (a) About the data
submission process itself (b) did not
request a change (c) only commented on
the format (d) indicated topics for
technical assistance and training for the
final data collection or (e) provided
commentary without referencing the
SPR. Regarding concerns about the:
• Timeline-ACL proposes moving the
effective date back by 12 months,
• Cost, burden, and changes to data
elements-ACL recognizes that there is
Number of
respondents
Respondent/data collection activity
always a cost to changing data systems,
but believes that the anticipated
improvement in the data justifies the
proposed changes,
• New items related to Legal ServicesACL worked closely with program staff
and stakeholders to develop a
reasonable data collection to measure
the contribution of this important
program about which performance data
were not previously collected,
• Need for additional elements
including sub-state and individual level
data-ACL is not adding more elements
or more granular data collection at this
time but will consider those suggestions
for future data collections,
• Need for improved definitions and
language-ACL made several changes to
specific elements and is using these
comments to inform the training and
technical assistance it provides, and
• Caregiver program-ACL made
revisions to several items and is using
these comments to inform the training
and technical assistance it provides.
A detailed analysis of the comments
and responses can be found at (https://
www.reginfo.gov/public/do/PRAMain.
The proposed data collection template
may be found on the ACL website at
https://www.acl.gov/about-acl/publicinput.
Estimated Program Burden: ACL
estimates the burden of this collection
of information as follows: 56 State
Agencies on Aging respond annually
and it will take an average of 33.5 hours
for a total of 1,876 hours. This is a
reduction of 874 hours from the
previous version. The burden estimate
of 33.5 hours was derived from feedback
from grantees.
Responses
per
respondent
Hours per
response
Annual burden
hours
Older American Act Title III and Title VII (Chapters 3 and 4) Annual State
Program Reporting .......................................................................................
56
1
33.5
1,876
Total ..........................................................................................................
56
1
33.5
1,876
Dated: March 26, 2018.
Mary Lazare,
Principal Deputy Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–06662 Filed 3–30–18; 8:45 am]
[Docket No. FDA–2018–N–1010]
BILLING CODE 4154–01–P
daltland on DSKBBV9HB2PROD with NOTICES
Food and Drug Administration
Food and Drug Administration
Prescription Drug User Fee Act VI
Benefit-Risk Implementation Plan;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Sep<11>2014
19:06 Mar 30, 2018
Jkt 244001
PO 00000
Notice; request for comments.
Frm 00048
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft 5year plan describing the Agency’s
approach to further the implementation
of structured benefit-risk assessment,
including the incorporation of the
patient’s voice in drug development and
decision-making, in the human drug
review program and the opportunity for
public comment on the draft plan. This
new draft plan is an update to the 5-year
plan published in February 2013 on
FDA’s website. This new draft plan is
SUMMARY:
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 13989-13990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06662]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Submission for OMB
Review; Public Comment Request; Older American Act Title III and Title
VII (Chapters 3 and 4) Annual State Program Reporting (Annual
Performance Data Collection); This is a Revision to the Existing State
Program Report (OMB Approval 0985-0008)
AGENCY: Administration for Community Living (ACL), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living is announcing that the
proposed collection of information listed above has been submitted to
the Office of Management and Budget (OMB) for review and clearance as
required under section 506(c)(2)(A) of the Paperwork Reduction Act of
1995. This 30-Day notice collects comments on the information
collection requirements related to annual performance data from State
grantees under the Older Americans Act related to Title III and Title
VII (Chapters 3 and 4) of that act. Title III includes, for example,
home delivered and congregate meal services, transportation and
caregiver service; and Title VII includes Elder Abuse Prevention and
Legal Assistance Development (ICR Rev).
DATES: Submit written comments on the collection of information by May
2, 2018.
ADDRESSES: Submit written comments on the collection of information by:
(a) Email to: [email protected], Attn: OMB Desk Officer
for ACL;
(b) Fax to 202.395.5806, Attn: OMB Desk Officer for ACL; or
(c) By mail to the Office of Information and Regulatory Affairs,
OMB, New Executive Office Bldg., 725 17th St. NW, Rm. 10235,
Washington, DC 20503, Attn: OMB Desk Officer for ACL.
FOR FURTHER INFORMATION CONTACT: ACL's Office of Performance and
Evaluation at [email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL has
submitted the following proposed collection of information to OMB for
review and clearance. This collection is a revision of the 2016
approved version of the State Program Report and incorporates
significant reduction in data collected. This data collection is
essential to provide performance measures as required by Congress and
the GPRA Modernization Act of 2010 (GPRAMA). Significant revisions to
the SPR were last implemented in 2005. This proposed collection is a
revision of the currently approved version (effective 2016-2019). The
factors that influenced the proposed revision of the SPR, include: (1)
The need to modernize the data structure to allow for more efficient
reporting and the ability to use current technology for reporting and
analysis; (2) the interest in aligning data elements within and across
data collections; (3) the need to consider alternative data elements
that reflect the current Aging Network and long-term care services and
supports; and (4) the need to reduce reporting burden while enhancing
data quality. The proposed SPR revision reduces the number of data
elements reported by 70% and the amount of time for completion by 30%
as compared to the current 2016-2019 SPR. This is a reduction of 874
hours from the previous version.
[[Page 13990]]
Reductions in data elements are found throughout the data
collection but are concentrated in the consumer demographic components.
Due to the aggregate level nature of the SPR, information on
combinations of demographic characteristics (e.g., number of women
served who are 65 years or older and have 2 activity of daily living
limitations) require exponentially larger numbers of data elements
compared to single demographic characteristics (e.g. number of women
served). To reduce the reporting burden associated with the number of
data elements ACL is proposing to limit data element combinations. For
example, the revised SPR asks for demographic characteristic such as
age, race, and gender for three or more ADL and IADLs rather than for
zero, one, two and three or more ADLs and IADLs. The remaining proposed
demographic data elements include indicators of priority populations
(i.e., social and economic vulnerability and frailty) found in the OAA
and will allow ACL to continue to measure efforts to target services.
Limited expansions in data elements are found in the Title III-E
National Family Caregiver Support Program service component. The
proposal separates out three service areas that were reported as a
whole (i.e., counseling, training and support group services).
Separation allows for support group services to be categorized as a
non-registered service for which consumer demographic details are no
longer reported. Additional information regarding the types of respite
services provided under the OAA is sought. The proposal separates
assistance services into two types: (1) Case management, and (2)
information and assistance. Case management assistance services are
categorized as registered, meaning caregiver demographic data are
reported while information and assistance services do not include
reporting of demographic data. Supplemental services are reported in
the same manner as ``other service'' under Title III-B, Home and
Community-based Services (HCBS) program. Across the OAA services,
greater detail regarding expenditure data is proposed. Under Title III-
B, HCBS program, the proposed data collection expands data regarding
Title VII legal assistance services. The ACL seeks data on the OAA
identified priority legal issues for closed cases.
Comments in Response to the 60-Day Federal Register Notice
A 60-day Federal Register Notice was published in the Federal
Register on June 1, 2017, Vol. 82, No. 104, pp. 25293-25294.
ACL received comments from fourteen (14) organizations and one (1)
individual about the State Performance Report (SPR) redesign. ACL
reviewed all of the comments, but some of the comments were deemed not
relevant because they were: (a) About the data submission process
itself (b) did not request a change (c) only commented on the format
(d) indicated topics for technical assistance and training for the
final data collection or (e) provided commentary without referencing
the SPR. Regarding concerns about the:
Timeline-ACL proposes moving the effective date back by 12
months,
Cost, burden, and changes to data elements-ACL recognizes
that there is always a cost to changing data systems, but believes that
the anticipated improvement in the data justifies the proposed changes,
New items related to Legal Services-ACL worked closely
with program staff and stakeholders to develop a reasonable data
collection to measure the contribution of this important program about
which performance data were not previously collected,
Need for additional elements including sub-state and
individual level data-ACL is not adding more elements or more granular
data collection at this time but will consider those suggestions for
future data collections,
Need for improved definitions and language-ACL made
several changes to specific elements and is using these comments to
inform the training and technical assistance it provides, and
Caregiver program-ACL made revisions to several items and
is using these comments to inform the training and technical assistance
it provides.
A detailed analysis of the comments and responses can be found at
(https://www.reginfo.gov/public/do/PRAMain.
The proposed data collection template may be found on the ACL
website at https://www.acl.gov/about-acl/public-input.
Estimated Program Burden: ACL estimates the burden of this
collection of information as follows: 56 State Agencies on Aging
respond annually and it will take an average of 33.5 hours for a total
of 1,876 hours. This is a reduction of 874 hours from the previous
version. The burden estimate of 33.5 hours was derived from feedback
from grantees.
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Annual burden
Respondent/data collection activity respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Older American Act Title III and Title VII 56 1 33.5 1,876
(Chapters 3 and 4) Annual State Program
Reporting......................................
---------------------------------------------------------------
Total....................................... 56 1 33.5 1,876
----------------------------------------------------------------------------------------------------------------
Dated: March 26, 2018.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2018-06662 Filed 3-30-18; 8:45 am]
BILLING CODE 4154-01-P
