Agency Information Collection Activities; Proposed Collection; Public Comment Request; Semiannual Performance Measures for the ACL Traumatic Brain Injury State Partnership Program (ICR New), 52305-52306 [2017-24525]
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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
Demonstration and Prior
Authorization Demonstration
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.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Information Collection
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: Hospital
Conditions of Participation and
Supporting Regulations; Use: The
information collection requirements
described in this information collection
request are needed to implement the
Medicare and Medicaid conditions of
participation (CoP) for 4,890 accredited
and non-accredited hospitals and an
additional 101 critical access hospitals
(CAHs) that have distinct part
psychiatric or rehabilitation units
(DPUs). CAHs that have DPUs must
comply with all of the hospital CoPs on
these units. Thus, this package reflects
the burden for a total of 4,991 hospitals
(that is, 4,890 accredited/non-accredited
hospitals and 101 CAHs which include
81 CAHs that have psychiatric DPUs
and 20 CAHs that have rehabilitation
DPUs). The information collection
requirements for the remaining 1,183
CAHs have been approved in a separate
package under CMS–10239 (OMB
control number: 0938–1043).
The CoPs and accompanying
regulatory requirements are used by our
surveyors as a basis for determining
whether a hospital qualifies for a
provider agreement under Medicare and
Medicaid. CMS and the health care
industry believe that the availability to
the facility of the type of records and
general content of records is standard
medical practice and is necessary to
ensure the well-being and safety of
patients and professional treatment
accountability. Form Number: CMS–R–
48 (OMB control number: 0938–0328);
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Frequency: Yearly; Affected Public:
Private sector (Business or other forprofit); Number of Respondents: 4,991;
Total Annual Responses: 1,342,424;
Total Annual Hours: 18,840,617. (For
policy questions regarding this
collection contact Scott Cooper at 410–
786–9465.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Fee-for-Service
Recovery Audit Prepayment Review
Demonstration and Prior Authorization
Demonstration; Use: OMB approved the
collections required for two
demonstrations of prepayment review
and prior authorization. The first
demonstration allows Medicare
Recovery Auditors to review claims on
a pre-payment basis in certain States.
The second demonstration established a
prior authorization program for Power
Mobility Device claims in certain States.
The first demonstration has ended, so
we are only extending the collection of
information for the second
demonstration, prior authorization of
power mobility devices.
For the Prior Authorization of Power
Mobility Devices (PMDs)
Demonstration, we are piloting prior
authorization for PMDs. Prior
authorization will allow the applicable
documentation that supports a claim to
be submitted before the item is
delivered. For prior authorization,
relevant documentation for review is
submitted before the item is delivered or
the service is rendered. CMS will
conduct this demonstration in
California, Florida, Illinois, Michigan,
New York, North Carolina, Texas,
Pennsylvania, Ohio, Louisiana,
Missouri, Maryland, New Jersey,
Indiana, Kentucky, Georgia, Tennessee,
Washington, and Arizona based on
beneficiary address as reported to the
Social Security Administration and
recorded in the Common Working File
(CWF). For the demonstration, a prior
authorization request can be completed
by the (ordering) physician or treating
practitioner and submitted to the
appropriate Durable Medical Equipment
Medicare Administrative Contractor
(DME MAC) for an initial decision. The
supplier may also submit the request on
behalf of the physician or treating
practitioner. The physician, treating
practitioner or supplier who submits the
request on behalf of the physician or
treating practitioner, is referred to as the
‘‘submitter.’’ Under this demonstration,
the submitter will submit to the DME
MAC a request for prior authorization
and all relevant documentation to
support Medicare coverage of the PMD
item.
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52305
Form Number: CMS–10421 (OMB
control number: 0938–1169); Frequency:
Occasionally; Affected Public: State,
Local or Tribal Governments; Number of
Respondents: 50,500; Total Annual
Responses: 50,500; Total Annual Hours:
25,125. (For policy questions regarding
this collection contact Daniel Schwartz
at 410–786–4197.)
Dated: November 7, 2017.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–24524 Filed 11–9–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request; Semiannual
Performance Measures for the ACL
Traumatic Brain Injury State
Partnership Program (ICR New)
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
certain information by the agency.
Under the Paperwork Reduction Act of
1995 (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 notice solicits comments on
proposed semiannual performance
measures for the ACL Traumatic Brain
Injury State Partnership program as
reauthorized under the Traumatic Brain
Injury Reauthorization Act of 2014.
DATES: Submit written or electronic
comments on the collection of
information by January 12, 2018.
ADDRESSES: Submit electronic
comments on the collection of
information to: TBI@acl.gov. Submit
written comments to: U.S. Department
of Health and Human Services,
Administration for Community Living,
Washington, DC 20201, Attention:
Thom Campbell.
FOR FURTHER INFORMATION CONTACT:
Thom Campbell by telephone: (202)
795–7263 or by email: TBI@acl.gov.
SUMMARY:
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52306
Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
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
before submitting the collection to OMB
for approval.
To comply with the above
requirement, ACL is publishing a notice
of a new collection of information as set
forth in this document. With respect to
the following collection of information,
ACL invites comments on: (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 and/or help ACL illustrate the
program’s return on investment; (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;
(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
SUPPLEMENTARY INFORMATION:
on respondents, including through the
use of automated collection techniques
when appropriate and other forms of
information technology.
Purpose
The purpose of the Traumatic Brain
Injury (TBI) State Partnership program
is to increase access to rehabilitation
and other services for individuals with
traumatic brain injury. Under the
Traumatic Brain Injury Reauthorization
Act of 2014 (Pub. L. 113–196), the
Traumatic Brain Injury State
Partnership program transitioned from
the Health Resources and Services
Administration (HRSA) to the
Administration for Community Living
(ACL). Under this law, the Secretary,
acting through ACL, was authorized to
‘‘make grants to States and American
Indian consortia for the purpose of
carrying out projects to improve access
to rehabilitation and other services
regarding traumatic brain injury.’’ ACL
seeks to collect performance measure
data from state grantees consistent with
the TBI State Partnership program’s
purpose and ACL’s mission to
‘‘Maximize the independence, wellbeing, and health of older adults, people
with disabilities across the lifespan, and
their families and caregivers.’’
ACL seeks data on a semi-annual
basis on the types of practices,
protocols, and activities performed by
each grantee, as well as the cost of each
activity and the number and types of
people they served. ACL also seeks
Number of
respondents
Type of respondent
Form name
States ............................
State Performance Report ...................................
information about the number and types
of individuals who receive TBI-related
home and community based services.
Finally, ACL seeks information
regarding the involvement of people
with TBI in advisory and program
support roles.
The data collected will allow ACL to
determine the extent to which the grant
program is meeting its goals of
expanding and improving services,
generating sustainable funding streams,
and enriching service systems to better
serve individuals with TBI and their
families. The data will also help ACL
develop and expand baseline
information around the nature and
scope of the incidence of TBI.
Additionally, this data collection will
help ACL illustrate the return on
investment of the TBI funds in terms of
system change (i.e., changes in policies
and practices and the development of
networks). By matching the project
dollars spent against measurable
improvements in state systems for
delivering services and supports to
people living with TBI, ACL will have
a strong indicator of the effect of the TBI
program on the quality of services
which ultimately impact the lives of
people across the country living with
TBI. The proposed data collection forms
may be found on the ACL Web site for
review at: https://www.acl.gov/aboutacl/public-input.
Estimated Program Burden: The
annual reporting burden estimates are
shown below.
Number of
responses per
respondent
* 45
2
Average
burden per
response
(in hours)
16
Total
burden hours
1,440
* This is the highest number of awards anticipated, but it is possible that there will be less. If less than 45 grants are awarded, the total burden
hours will be adjusted proportionally.
Dated: November 7, 2017.
Mary Lazare,
Principal Deputy Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–24525 Filed 11–9–17; 8:45 am]
asabaliauskas on DSKBBXCHB2PROD with NOTICES
BILLING CODE 4154–01–P
Food and Drug Administration
[Docket No. FDA–2017–D–5138]
S5(R3) Detection of Toxicity to
Reproduction for Human
Pharmaceuticals; International Council
for Harmonisation; 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
SUMMARY:
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18:38 Nov 09, 2017
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guidance entitled ‘‘S5(R3) Detection of
Toxicity to Reproduction for Human
Pharmaceuticals.’’ The draft guidance
was prepared under the auspices of the
International Council for Harmonisation
(ICH), formerly the International
Conference on Harmonisation. The draft
guidance replaces the existing guidance
entitled ‘‘S5(R2) Detection of Toxicity to
Reproduction for Human
Pharmaceuticals.’’ The draft guidance is
intended to align with other ICH
guidances, elaborate on concepts to
consider when designing studies, and
identify potential circumstances in
which a risk assessment can be made
based on preliminary studies. It also
clarifies the qualification and potential
use of alternative assays.
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]]>Agencies
[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Notices]
[Pages 52305-52306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24525]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Proposed Collection;
Public Comment Request; Semiannual Performance Measures for the ACL
Traumatic Brain Injury State Partnership Program (ICR New)
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) is announcing an
opportunity for the public to comment on the proposed collection of
certain information by the agency. Under the Paperwork Reduction Act of
1995 (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 notice solicits comments on proposed semiannual performance
measures for the ACL Traumatic Brain Injury State Partnership program
as reauthorized under the Traumatic Brain Injury Reauthorization Act of
2014.
DATES: Submit written or electronic comments on the collection of
information by January 12, 2018.
ADDRESSES: Submit electronic comments on the collection of information
to: TBI@acl.gov. Submit written comments to: U.S. Department of Health
and Human Services, Administration for Community Living, Washington, DC
20201, Attention: Thom Campbell.
FOR FURTHER INFORMATION CONTACT: Thom Campbell by telephone: (202) 795-
7263 or by email: TBI@acl.gov.
[[Page 52306]]
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 before
submitting the collection to OMB for approval.
To comply with the above requirement, ACL is publishing a notice of
a new collection of information as set forth in this document. With
respect to the following collection of information, ACL invites
comments on: (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 and/or help ACL
illustrate the program's return on investment; (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; (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.
Purpose
The purpose of the Traumatic Brain Injury (TBI) State Partnership
program is to increase access to rehabilitation and other services for
individuals with traumatic brain injury. Under the Traumatic Brain
Injury Reauthorization Act of 2014 (Pub. L. 113-196), the Traumatic
Brain Injury State Partnership program transitioned from the Health
Resources and Services Administration (HRSA) to the Administration for
Community Living (ACL). Under this law, the Secretary, acting through
ACL, was authorized to ``make grants to States and American Indian
consortia for the purpose of carrying out projects to improve access to
rehabilitation and other services regarding traumatic brain injury.''
ACL seeks to collect performance measure data from state grantees
consistent with the TBI State Partnership program's purpose and ACL's
mission to ``Maximize the independence, well-being, and health of older
adults, people with disabilities across the lifespan, and their
families and caregivers.''
ACL seeks data on a semi-annual basis on the types of practices,
protocols, and activities performed by each grantee, as well as the
cost of each activity and the number and types of people they served.
ACL also seeks information about the number and types of individuals
who receive TBI-related home and community based services. Finally, ACL
seeks information regarding the involvement of people with TBI in
advisory and program support roles.
The data collected will allow ACL to determine the extent to which
the grant program is meeting its goals of expanding and improving
services, generating sustainable funding streams, and enriching service
systems to better serve individuals with TBI and their families. The
data will also help ACL develop and expand baseline information around
the nature and scope of the incidence of TBI. Additionally, this data
collection will help ACL illustrate the return on investment of the TBI
funds in terms of system change (i.e., changes in policies and
practices and the development of networks). By matching the project
dollars spent against measurable improvements in state systems for
delivering services and supports to people living with TBI, ACL will
have a strong indicator of the effect of the TBI program on the quality
of services which ultimately impact the lives of people across the
country living with TBI. The proposed data collection forms may be
found on the ACL Web site for review at: https://www.acl.gov/about-acl/public-input.
Estimated Program Burden: The annual reporting burden estimates are
shown below.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
States........................ State * 45 2 16 1,440
Performance
Report.
----------------------------------------------------------------------------------------------------------------
* This is the highest number of awards anticipated, but it is possible that there will be less. If less than 45
grants are awarded, the total burden hours will be adjusted proportionally.
Dated: November 7, 2017.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2017-24525 Filed 11-9-17; 8:45 am]
BILLING CODE 4154-01-P
