Submission for OMB Review; Comment Request: Child Care Quarterly Case Record Report-ACF-801, 2431-2432 [2015-00560]
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Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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
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17:36 Jan 15, 2015
Jkt 235001
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
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Frm 00051
Fmt 4703
Sfmt 4703
2431
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
E:\FR\FM\16JAN1.SGM
16JAN1
2432
Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Notices
(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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[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.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
SUMMARY:
VerDate Sep<11>2014
17:36 Jan 15, 2015
Jkt 235001
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.
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 https://
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,
ADDRESSES:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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.
1 See the Drugged Driving Web page on the Office
of National Drug Control Policy Web site at
https://www.whitehouse.gov/ondcp/drugged-driving.
E:\FR\FM\16JAN1.SGM
16JAN1
Agencies
[Federal Register Volume 80, Number 11 (Friday, January 16, 2015)]
[Notices]
[Pages 2431-2432]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00560]
-----------------------------------------------------------------------
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
[[Page 2432]]
(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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response 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