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]

Download as PDF 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); VerDate Sep<11>2014 18:38 Nov 09, 2017 Jkt 244001 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. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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: E:\FR\FM\13NON1.SGM 13NON1 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: VerDate Sep<11>2014 18:38 Nov 09, 2017 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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. E:\FR\FM\13NON1.SGM 13NON1

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]


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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