82 FR 52305 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; Semiannual Performance Measures for the ACL Traumatic Brain Injury State Partnership Program (ICR New)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living Federal Register Volume 82, Issue 217 (November 13, 2017)
Administration for Community Living
Federal Register Volume 82, Issue 217 (November 13, 2017)
| Page Range | 52305-52306 | |
| FR Document | 2017-24525 |
[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)] [Notices] [Pages 52305-52306] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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: [email protected]. [[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
![Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices 52305
Demonstration and Prior Frequency: Yearly; Affected Public: Form Number: CMS–10421 (OMB
Authorization Demonstration Private sector (Business or other for- control number: 0938–1169); Frequency:
Under the PRA (44 U.S.C. 3501– profit); Number of Respondents: 4,991; Occasionally; Affected Public: State,
3520), federal agencies must obtain Total Annual Responses: 1,342,424; Local or Tribal Governments; Number of
approval from the Office of Management Total Annual Hours: 18,840,617. (For Respondents: 50,500; Total Annual
and Budget (OMB) for each collection of policy questions regarding this Responses: 50,500; Total Annual Hours:
information they conduct or sponsor. collection contact Scott Cooper at 410– 25,125. (For policy questions regarding
The term ‘‘collection of information’’ is 786–9465.) this collection contact Daniel Schwartz
defined in 44 U.S.C. 3502(3) and 5 CFR 2. Type of Information Collection at 410–786–4197.)
1320.3(c) and includes agency requests Request: Extension of a currently
Dated: November 7, 2017.
or requirements that members of the approved collection; Title of
Martique Jones,
public submit reports, keep records, or Information Collection: Fee-for-Service
Recovery Audit Prepayment Review Director, Regulations Development Group,
provide information to a third party. Office of Strategic Operations and Regulatory
Section 3506(c)(2)(A) of the PRA Demonstration and Prior Authorization
Affairs.
Demonstration; Use: OMB approved the
requires federal agencies to publish a [FR Doc. 2017–24524 Filed 11–9–17; 8:45 am]
collections required for two
60-day notice in the Federal Register BILLING CODE 4120–01–P
demonstrations of prepayment review
concerning each proposed collection of
and prior authorization. The first
information, including each proposed
demonstration allows Medicare
extension or reinstatement of an existing DEPARTMENT OF HEALTH AND
Recovery Auditors to review claims on
collection of information, before HUMAN SERVICES
a pre-payment basis in certain States.
submitting the collection to OMB for
The second demonstration established a Administration for Community Living
approval. To comply with this
prior authorization program for Power
requirement, CMS is publishing this
Mobility Device claims in certain States. Agency Information Collection
notice. The first demonstration has ended, so Activities; Proposed Collection; Public
Information Collection we are only extending the collection of Comment Request; Semiannual
information for the second Performance Measures for the ACL
1. Type of Information Collection
demonstration, prior authorization of Traumatic Brain Injury State
Request: Reinstatement without change
power mobility devices. Partnership Program (ICR New)
of a previously approved collection; For the Prior Authorization of Power
Title of Information Collection: Hospital Mobility Devices (PMDs) AGENCY: Administration for Community
Conditions of Participation and Demonstration, we are piloting prior Living, HHS.
Supporting Regulations; Use: The authorization for PMDs. Prior ACTION: Notice.
information collection requirements authorization will allow the applicable
described in this information collection documentation that supports a claim to SUMMARY: The Administration for
request are needed to implement the be submitted before the item is Community Living (ACL) is announcing
Medicare and Medicaid conditions of delivered. For prior authorization, an opportunity for the public to
participation (CoP) for 4,890 accredited relevant documentation for review is comment on the proposed collection of
and non-accredited hospitals and an submitted before the item is delivered or certain information by the agency.
additional 101 critical access hospitals the service is rendered. CMS will Under the Paperwork Reduction Act of
(CAHs) that have distinct part conduct this demonstration in 1995 (PRA), federal agencies are
psychiatric or rehabilitation units California, Florida, Illinois, Michigan, required to publish a notice in the
(DPUs). CAHs that have DPUs must New York, North Carolina, Texas, Federal Register concerning each
comply with all of the hospital CoPs on Pennsylvania, Ohio, Louisiana, proposed collection of information,
these units. Thus, this package reflects Missouri, Maryland, New Jersey, including each proposed extension of an
the burden for a total of 4,991 hospitals Indiana, Kentucky, Georgia, Tennessee, existing collection of information, and
(that is, 4,890 accredited/non-accredited Washington, and Arizona based on to allow 60 days for public comment in
hospitals and 101 CAHs which include beneficiary address as reported to the response to the notice.
81 CAHs that have psychiatric DPUs Social Security Administration and This notice solicits comments on
and 20 CAHs that have rehabilitation recorded in the Common Working File proposed semiannual performance
DPUs). The information collection (CWF). For the demonstration, a prior measures for the ACL Traumatic Brain
requirements for the remaining 1,183 authorization request can be completed Injury State Partnership program as
CAHs have been approved in a separate by the (ordering) physician or treating reauthorized under the Traumatic Brain
package under CMS–10239 (OMB practitioner and submitted to the Injury Reauthorization Act of 2014.
control number: 0938–1043). appropriate Durable Medical Equipment DATES: Submit written or electronic
The CoPs and accompanying Medicare Administrative Contractor
regulatory requirements are used by our comments on the collection of
(DME MAC) for an initial decision. The
surveyors as a basis for determining information by January 12, 2018.
supplier may also submit the request on
whether a hospital qualifies for a behalf of the physician or treating ADDRESSES: Submit electronic
provider agreement under Medicare and practitioner. The physician, treating comments on the collection of
information to: TBI@acl.gov. Submit
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Medicaid. CMS and the health care practitioner or supplier who submits the
industry believe that the availability to request on behalf of the physician or written comments to: U.S. Department
the facility of the type of records and treating practitioner, is referred to as the of Health and Human Services,
general content of records is standard ‘‘submitter.’’ Under this demonstration, Administration for Community Living,
medical practice and is necessary to the submitter will submit to the DME Washington, DC 20201, Attention:
ensure the well-being and safety of MAC a request for prior authorization Thom Campbell.
patients and professional treatment and all relevant documentation to FOR FURTHER INFORMATION CONTACT:
accountability. Form Number: CMS–R– support Medicare coverage of the PMD Thom Campbell by telephone: (202)
48 (OMB control number: 0938–0328); item. 795–7263 or by email: TBI@acl.gov.
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![52306 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
SUPPLEMENTARY INFORMATION: Under the on respondents, including through the information about the number and types
PRA (44 U.S.C. 3501–3520), federal use of automated collection techniques of individuals who receive TBI-related
agencies must obtain approval from the when appropriate and other forms of home and community based services.
Office of Management and Budget information technology. Finally, ACL seeks information
(OMB) for each collection of regarding the involvement of people
Purpose
information they conduct or sponsor. with TBI in advisory and program
‘‘Collection of information’’ is defined The purpose of the Traumatic Brain support roles.
in 44 U.S.C. 3502(3) and 5 CFR Injury (TBI) State Partnership program The data collected will allow ACL to
1320.3(c) and includes agency requests is to increase access to rehabilitation determine the extent to which the grant
or requirements that members of the and other services for individuals with program is meeting its goals of
public submit reports, keep records, or traumatic brain injury. Under the expanding and improving services,
provide information to a third party. Traumatic Brain Injury Reauthorization generating sustainable funding streams,
Section 3506(c)(2)(A) of the PRA (44 Act of 2014 (Pub. L. 113–196), the and enriching service systems to better
U.S.C. 3506(c)(2)(A)) requires federal Traumatic Brain Injury State serve individuals with TBI and their
agencies to provide a 60-day notice in Partnership program transitioned from families. The data will also help ACL
the Federal Register concerning each the Health Resources and Services develop and expand baseline
proposed collection of information Administration (HRSA) to the information around the nature and
before submitting the collection to OMB Administration for Community Living scope of the incidence of TBI.
for approval. (ACL). Under this law, the Secretary, Additionally, this data collection will
To comply with the above acting through ACL, was authorized to help ACL illustrate the return on
requirement, ACL is publishing a notice ‘‘make grants to States and American investment of the TBI funds in terms of
of a new collection of information as set Indian consortia for the purpose of system change (i.e., changes in policies
forth in this document. With respect to carrying out projects to improve access and practices and the development of
the following collection of information, to rehabilitation and other services networks). By matching the project
ACL invites comments on: (1) Whether regarding traumatic brain injury.’’ ACL dollars spent against measurable
the proposed collection of information seeks to collect performance measure improvements in state systems for
is necessary for the proper performance data from state grantees consistent with delivering services and supports to
of ACL’s functions, including whether the TBI State Partnership program’s people living with TBI, ACL will have
the information will have practical purpose and ACL’s mission to a strong indicator of the effect of the TBI
utility and/or help ACL illustrate the ‘‘Maximize the independence, well- program on the quality of services
program’s return on investment; (2) the being, and health of older adults, people which ultimately impact the lives of
accuracy of ACL’s estimate of the with disabilities across the lifespan, and people across the country living with
burden of the proposed collection of their families and caregivers.’’ TBI. The proposed data collection forms
information, including the validity of ACL seeks data on a semi-annual may be found on the ACL Web site for
the methodology and assumptions used; basis on the types of practices, review at: https://www.acl.gov/about-
(3) ways to enhance the quality, utility, protocols, and activities performed by acl/public-input.
and clarity of the information to be each grantee, as well as the cost of each Estimated Program Burden: The
collected; and (4) ways to minimize the activity and the number and types of annual reporting burden estimates are
burden of the collection of information people they served. ACL also seeks shown below.
Average
Number of
Number of burden per Total
Type of respondent Form name responses per
respondents response burden hours
respondent (in hours)
States ............................ State Performance Report ................................... * 45 2 16 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. DEPARTMENT OF HEALTH AND guidance entitled ‘‘S5(R3) Detection of
Mary Lazare, HUMAN SERVICES Toxicity to Reproduction for Human
Principal Deputy Administrator. Pharmaceuticals.’’ The draft guidance
Food and Drug Administration was prepared under the auspices of the
[FR Doc. 2017–24525 Filed 11–9–17; 8:45 am]
International Council for Harmonisation
BILLING CODE 4154–01–P [Docket No. FDA–2017–D–5138] (ICH), formerly the International
Conference on Harmonisation. The draft
S5(R3) Detection of Toxicity to guidance replaces the existing guidance
Reproduction for Human entitled ‘‘S5(R2) Detection of Toxicity to
Pharmaceuticals; International Council
Reproduction for Human
for Harmonisation; Draft Guidance for
Pharmaceuticals.’’ The draft guidance is
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Industry; Availability
intended to align with other ICH
AGENCY: Food and Drug Administration, guidances, elaborate on concepts to
HHS. consider when designing studies, and
ACTION: Notice of availability. identify potential circumstances in
which a risk assessment can be made
SUMMARY: The Food and Drug based on preliminary studies. It also
Administration (FDA or Agency) is clarifies the qualification and potential
announcing the availability of a draft use of alternative assays.
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Document Created: 2017-11-10 01:18:03
Document Modified: 2017-11-10 01:18:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit written or electronic comments on the collection of information by January 12, 2018. | |
| Contact | Thom Campbell by telephone: (202) 795- 7263 or by email: [email protected] | |
| FR Citation | 82 FR 52305 |
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