Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices 52305 

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. 

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); 

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. 

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) 

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. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
52306 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices 

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, 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 

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. 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 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. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2017–24525 Filed 11–9–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

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. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

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. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES