Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Notices 2431 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Annual Report 

on Home and Community Based 

Services Waivers and Supporting 

Regulations; Use: We use this report to 

compare actual data to the approved 

waiver estimates. In conjunction with 

the waiver compliance review reports, 

the information provided will be 

compared to that in the Medicaid 

Statistical Information System (MSIS) 

(CMS–R–284; OMB control number 

0938–0345) report and FFP claimed on 

a state’s Quarterly Expenditure Report 

(CMS–64; OMB control number 0938– 

1265), to determine whether to continue 

the state’s home and community-based 

services waiver. States’ estimates of cost 

and utilization for renewal purposes are 

based upon the data compiled in the 

CMS–372(S) reports. Form Number: 

CMS–372(S) (OMB Control Number: 

0938–0272); Frequency: Yearly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

48; Total Annual Responses: 315; Total 

Annual Hours: 13,545. (For policy 

questions regarding this collection 

contact Ralph Lollar at 410–786–0777). 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Outpatient/

Ambulatory Surgery Patient Experience 

of Care Survey (O/ASPECS); Use: The 

information collected in the national 

implementation of Outpatient/

Ambulatory Surgery Patient Experience 

of Care Survey (A/ASPECS) will be used 

to: (1) Provide a source of information 

from which selected measures can be 

publicly reported to beneficiaries to 

help them make informed decisions for 

outpatient surgery facility selection; (2) 

aid facilities with their internal quality 

improvement efforts and external 

benchmarking with other facilities; and 

(3) provide us with information for 

monitoring and public reporting 

purposes. Form Number: CMS–10500 

(OMB Control Number: 0938–1240); 

Frequency: Once; Affected Public: 

Individuals and households; Number of 

Respondents: 2,813,610; Total Annual 

Responses: 2,813,610; Total Annual 

Hours: 365,769. (For policy questions 

regarding this collection contact 

Memuna Ifedirah at 410–786–6849). 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Site 

Investigation for Independent 

Diagnostic Testing Facilities (IDTFs); 

Use: We enroll Independent Diagnostic 

Testing Facilities (IDTFs) into the 

Medicare program via a uniform 

application, the CMS 855B. 

Implementation of enhanced procedures 

for verifying the enrollment information 

has improved the enrollment process as 

well as identified and prevented 

fraudulent IDTFs from entering the 

Medicare program. As part of this 

process, verification of compliance with 

IDTF performance standards is 

necessary. The primary function of the 

site investigation form for IDTFs is to 

provide a standardized, uniform tool to 

gather information from an IDTF that 

tells us whether it meets certain 

standards to be a IDTF (as found in 42 

CFR 410.33(g)) and where it practices or 

renders its services. The site 

investigation form has been used in the 

past to aid in verifying compliance with 

the required performance standards 

found in 42 CFR 410.33(g). No revisions 

have been made to this form since the 

last submission for OMB approval. Form 

Number: CMS–10221 (OMB Control 

Number: 0938–1029); Frequency: 

Occasionally; Affected Public: Private 

Sector (Business or other for-profits and 

Not-for-profit institutions); Number of 

Respondents: 900; Total Annual 

Responses: 900; Total Annual Hours: 

1,800. (For policy questions regarding 

this collection contact Kim McPhillips 

at 410–786–5374). 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Site 

Investigation for Suppliers of Durable 

Medical Equipment, Prosthetics, 

Orthotics and Supplies (DMEPOS); Use: 

We enroll suppliers of durable medical 

equipment, prosthetics, orthotics, and 

supplies (DMEPOS) into the Medicare 

program via a uniform application, the 

CMS 855S. Implementation of enhanced 

procedures for verifying the enrollment 

information has improved the 

enrollment process as well as identified 

and prevented fraudulent DMEPOS 

suppliers from entering the Medicare 

program. As part of this process, 

verification of compliance with supplier 

standards is necessary. The primary 

function of the site investigation form is 

to provide a standardized, uniform tool 

to gather information from a DMEPOS 

supplier that tells us whether it meets 

certain qualifications to be a DMEPOS 

supplier (as found in 42 CFR 424.57(c)) 

and where it practices or renders its 

services. The site investigation form has 

been used in the past to aid in verifying 

compliance with the required supplier 

standards found in 42 CFR 424.57(c). No 

revisions have been made to this form 

since the last submission for OMB 

approval. Form Number: CMS–R–263 

(OMB Control Number: 0938–0749); 

Frequency: Occasionally; Affected 

Public: Private Sector (Business or other 

for-profits and Not-for-profit 

institutions); Number of Respondents: 

30,000; Total Annual Responses: 

30,000; Total Annual Hours: 15,000. 

(For policy questions regarding this 

collection contact Kim McPhillips at 

410–786–5374). 

Dated: January 13, 2015. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–00627 Filed 1–15–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[OMB No.: 0970–0167] 

Submission for OMB Review; 

Comment Request: Child Care 

Quarterly Case Record Report—ACF– 

801 

Description: Section 658K of the 

Child Care and Development Block 

Grant Act (42 U.S.C. 9858) requires that 

States and Territories submit monthly 

case-level data on the children and 

families receiving direct services under 

the Child Care and Development Fund 

(CCDF). The implementing regulations 

for the statutorily required reporting are 

at 45 CFR 98.70. Case-level reports, 

submitted quarterly or monthly (at 

grantee option), include monthly 

sample or full population case-level 

data. The data elements to be included 

in these reports are represented in the 

ACF–801. ACF uses disaggregate data to 

determine program and participant 

characteristics as well as costs and 

levels of child care services provided. 

This provides ACF with the information 

necessary to make reports to Congress, 

address national child care needs, offer 

technical assistance to grantees, meet 

performance measures, and conduct 

research. On November 19, 2014, the 

President signed the Child Care and 

Development Block Grant Act of 2014 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
2432 Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Notices 

1See the Drugged Driving Web page on the Office 

of National Drug Control Policy Web site at 

http://www.whitehouse.gov/ondcp/drugged-driving. 

(Pub. L. 113–86) which reauthorized the 

CCDF program and made some changes 

to ACF–801 reporting requirements. 

Owing to the need to consult with CCDF 

administrators and other interested 

parties on these changes, and a limited 

amount of time before the current ACF– 

801 form expires, ACF is not proposing 

changes to the ACF–801 at this time. We 

request to extend the ACF–801 without 

changes in order to ensure the form does 

not expire. In the near future, ACF plans 

to initiate a new clearance process 

under the Paperwork Reduction Act to 

implement the data reporting changes in 

the newly-reauthorized law. 

Respondents: States, the District of 

Columbia, and Territories including 

Puerto Rico, Guam, the Virgin Islands, 

American Samoa, and the Northern 

Marianna Islands. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ACF–801 .......................................................................................................... 56 4 25 5,600 

Estimated Total Annual Burden 

Hours: 5,600. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–00560 Filed 1–15–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–2300] 

Evaluating Drug Effects on the Ability 

To Operate a Motor Vehicle; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Evaluating Drug 

Effects on the Ability to Operate a Motor 

Vehicle.’’ The purpose of this guidance 

is to assist sponsors in the evaluation of 

the effects of psychoactive drugs on the 

ability to operate a motor vehicle. 

Driving is a complex activity involving 

a wide range of cognitive, perceptual, 

and motor activities. Reducing the 

incidence of motor vehicle accidents 

(MVAs) that occur because of drugimpaired driving is a public health 

priority. This draft guidance 

recommends using a systematic effort to 

identify drugs that increase the risk of 

MVAs as a critical component of 

assessing drug risk and designing 

strategies to reduce this risk. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by March 17, 

2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Sherman, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4339, 

Silver Spring, MD 20993–0002, 240– 

402–0493. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Evaluating Drug Effects on the Ability 

to Operate a Motor Vehicle.’’ The 

purpose of this guidance is to assist 

sponsors in the evaluation of the effects 

of psychoactive drugs on the ability to 

operate a motor vehicle. 

Driving is a complex activity 

involving a wide range of cognitive, 

perceptual, and motor activities that can 

be adversely affected by therapeutic 

drugs. Reducing the incidence of MVAs 

that occur because of drug-impaired 

driving is a public health priority.1

Drugs that impair driving ability may 

also impair the ability to judge the 

extent of one’s own impairment. This 

increases the need for objective 

evaluation of the presence and degree of 

driving impairment, with risk mitigation 

strategies based on that information. 

This guidance recommends a systematic 

effort to identify drugs for which 

evaluation of effects on driving abilities 

may be needed, and the types of studies 

that such an evaluation entails. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on evaluating drug effects on the ability 

to operate a motor vehicle. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 


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