Proposed Information Collection Activity; Comment Request, 54354-54355 [2018-23536]
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54354
Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
of Responses: 2,138; Total Annual
Hours: 170,589. (For policy questions
regarding this collection contact Kevin
Young at 410–786–6133 or Ashley
Stedding at 410–786–4250).
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Income and
Eligibility Verification System Reporting
and Supporting Regulations; Use:
Section 1137 of the Social Security Act
requires that States verify the income
and eligibility information contained on
the applicant’s application and in the
applicant’s case file through data
matches with the agencies and entities
identified in this section. The State
Medicaid/CHIP agency will report the
existence of a system to collect all
information needed to determine and
redetermine eligibility for Medicaid and
CHIP. The State Medicaid/CHIP agency
will attest to using the PARIS system in
determining beneficiary eligibility in
Medicaid or CHIP benefit programs.
Form Number: CMS–R–74 (OMB control
number: 0938–0467); Frequency:
Occasionally; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 55; Total Annual
Responses: 3,241; Total Annual Hours:
1,071. (For policy questions regarding
this collection contact Stephanie Bell at
410–786–0617.)
Dated: October 23, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–23576 Filed 10–26–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10494]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:48 Oct 26, 2018
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extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Comments on the collection(s) of
information must be received by the
OMB desk officer by November 28,
2018.
DATES:
When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 or Email:
OIRA__submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.hhs.gov/Paperwork
ReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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 (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
ADDRESSES:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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 that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a previously
approved collection; Title of
Information Collection: Exchange
Functions: Standards for Navigators and
Non-Navigator Assistance Personnel—
CAC; Use: Section 1321(a)(1) of the
Affordable Care Act directs and
authorizes the Secretary to issue
regulations setting standards for meeting
the requirements under title I of the
Affordable Care Act, with respect to,
among other things, the establishment
and operation of Exchanges. Pursuant to
this authority, regulations establishing
the certified application counselor
program have been finalized at 45 CFR
155.225. In accordance with
155.225(d)(1) and (7), certified
application counselors in all Exchanges
are required to be initially certified and
recertified on at least an annual basis
and successfully complete Exchangerequired training. Form Number: CMS–
10494 (OMB control number: 0938–
1205); Frequency: On Occasion;
Affected Public: State, Local, or Tribal
Governments, Private Sector (not-forprofit institutions); individuals or
households; Number of Respondents:
30,000; Total Annual Responses:
30,000; Total Annual Hours: 7,500. (For
policy questions regarding this
collection contact Deborah Bryant at
301–492–5213.)
Dated: October 24, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–23590 Filed 10–26–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects: Office of Child
Care CCDF Onsite Monitoring.
Title: Child Care and Development
Fund (CCDF) State Monitoring
Compliance Demonstration Packet.
OMB No.: New.
E:\FR\FM\29OCN1.SGM
29OCN1
54355
Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
Description: This is a new proposed
data collection from the Office of Child
Care (OCC) for the Onsite Monitoring
System.
Section 658I of the Child Care and
Development Block Grant Act and
Subpart J of 45 CFR, part 98 of the Child
Care and Development Fund requires
the monitoring of programs funded
under the CCDF for compliance with:
(1) The Act;
(2) CCDF Regulations; and
(3) The State/Territory CCDF
approved Plan.
The proposed data collection will be
used by the Office of Child Care (OCC)
to monitor State CCDF Lead Agencies to
determine and validate compliance with
CCDF regulations and the approved
State Plan. The data collection is
designed to provide States with the
flexibility to propose an approach that
is feasible and sufficient to demonstrate
compliance based on State
circumstances and processes. State Lead
Agencies will participate in onsite
monitoring based on a 3-year cohort;
submitting data once every three years.
OCC will begin monitoring for
compliance in FY 2019.
The data collection for the first 3years will focus on 11 topical areas: (1)
Disaster Preparedness, Response and
Recovery; (2) Consumer Education:
Dissemination of Information to Parents,
Providers, and General Public
(Monitoring Reports and Annual
Aggregate Data); (3) Twelve-Month
Eligibility; (4) Child: Staff Ratios and
Group Sizes; (5) Health and Safety
Requirements for Providers (11 Health
and Safety Topics); (6) Pre-Service/
Orientation and Ongoing Training
Requirements for Providers; (7)
Inspections for CCDF Licensed
Providers; (8) Inspections for LicenseExempt CCDF Providers; (9) Ratios for
Licensing Inspectors; (10) Child Abuse
and Neglect Reporting; and (11) Program
Integrity.
In developing the Onsite Monitoring
System, OCC convened a workgroup of
states to provide feedback and input on
the design of the Onsite Monitoring
System. As part of the workgroup
discussions, states emphasized the need
for individualized monitoring because
of the complexity of each state’s CCDF
structure and variance in
implementation strategies. As a
response, OCC developed the
Compliance Demonstration Packet that
offers states the opportunity to propose
their approach to demonstrating
compliance based on how their CCDF
program is administered. OCC also
consulted other federal programs and
monitoring experts on the Onsite
Monitoring System’s development and
incorporated their feedback regarding
the efficiency and efficacy of the
proposed process.
During the development of the Onsite
Monitoring System, OCC conducted
pilots in a number of States. Feedback
received from pilot States and the pilot
results were used to enhance the
monitoring process and data collection
method. Burden estimates below are
based on an analysis of data collected
through all of the pilot visits while
accounting for variance in state
documentation.
Respondents: State grantees and the
District of Columbia.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
amozie on DSK3GDR082PROD with NOTICES1
Compliance Demonstration Chart ....................................................................
Document Submission Chart ...........................................................................
Estimated Total Annual Burden
Hours: 1,632 hours.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
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17:48 Oct 26, 2018
Jkt 247001
17
17
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–23536 Filed 10–26–18; 8:45 am]
BILLING CODE 4184–43–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3647]
Endo Pharmaceuticals, Inc., et al.;
Withdrawal of Approval of 10 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden hours
per response
1
1
ACTION:
16
80
Total burden
hours
272
1,360
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 10 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
November 28, 2018.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
SUMMARY:
E:\FR\FM\29OCN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54354-54355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23536]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects: Office of Child Care CCDF Onsite Monitoring.
Title: Child Care and Development Fund (CCDF) State Monitoring
Compliance Demonstration Packet.
OMB No.: New.
[[Page 54355]]
Description: This is a new proposed data collection from the Office
of Child Care (OCC) for the Onsite Monitoring System.
Section 658I of the Child Care and Development Block Grant Act and
Subpart J of 45 CFR, part 98 of the Child Care and Development Fund
requires the monitoring of programs funded under the CCDF for
compliance with:
(1) The Act;
(2) CCDF Regulations; and
(3) The State/Territory CCDF approved Plan.
The proposed data collection will be used by the Office of Child
Care (OCC) to monitor State CCDF Lead Agencies to determine and
validate compliance with CCDF regulations and the approved State Plan.
The data collection is designed to provide States with the flexibility
to propose an approach that is feasible and sufficient to demonstrate
compliance based on State circumstances and processes. State Lead
Agencies will participate in onsite monitoring based on a 3-year
cohort; submitting data once every three years. OCC will begin
monitoring for compliance in FY 2019.
The data collection for the first 3-years will focus on 11 topical
areas: (1) Disaster Preparedness, Response and Recovery; (2) Consumer
Education: Dissemination of Information to Parents, Providers, and
General Public (Monitoring Reports and Annual Aggregate Data); (3)
Twelve-Month Eligibility; (4) Child: Staff Ratios and Group Sizes; (5)
Health and Safety Requirements for Providers (11 Health and Safety
Topics); (6) Pre-Service/Orientation and Ongoing Training Requirements
for Providers; (7) Inspections for CCDF Licensed Providers; (8)
Inspections for License-Exempt CCDF Providers; (9) Ratios for Licensing
Inspectors; (10) Child Abuse and Neglect Reporting; and (11) Program
Integrity.
In developing the Onsite Monitoring System, OCC convened a
workgroup of states to provide feedback and input on the design of the
Onsite Monitoring System. As part of the workgroup discussions, states
emphasized the need for individualized monitoring because of the
complexity of each state's CCDF structure and variance in
implementation strategies. As a response, OCC developed the Compliance
Demonstration Packet that offers states the opportunity to propose
their approach to demonstrating compliance based on how their CCDF
program is administered. OCC also consulted other federal programs and
monitoring experts on the Onsite Monitoring System's development and
incorporated their feedback regarding the efficiency and efficacy of
the proposed process.
During the development of the Onsite Monitoring System, OCC
conducted pilots in a number of States. Feedback received from pilot
States and the pilot results were used to enhance the monitoring
process and data collection method. Burden estimates below are based on
an analysis of data collected through all of the pilot visits while
accounting for variance in state documentation.
Respondents: State grantees and the District of Columbia.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Compliance Demonstration Chart.................. 17 1 16 272
Document Submission Chart....................... 17 1 80 1,360
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,632 hours.
In compliance with the requirements of the Paperwork Reduction Act
of 1995 (Pub. L. 104-13, 44 U.S.C. chap 35), the Administration for
Children and Families is soliciting public comment on the specific
aspects of the information collection described above. Copies of the
proposed collection of information can be obtained and comments may be
forwarded by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email
address: [email protected]. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018-23536 Filed 10-26-18; 8:45 am]
BILLING CODE 4184-43-P
