Attachment A_PJAC 60 Day Federal Register Notice

Federal Register / Vol. 84, No. 92 / Monday, May 13, 2019 / Notices
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.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
[email protected].
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10105 National Implementation
of the In-Center Hemodialysis CAHPS
Survey
CMS–10407 Summary of Benefits and
Coverage and Uniform Glossary
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.

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Information Collection
1. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: National
Implementation of the In-Center
Hemodialysis CAHPS Survey; Use: The
Centers for Medicare & Medicaid
Services (CMS) is requesting clearance
from the Office of Management and
Budget (OMB) to continue the In-center
Hemodialysis CAHPS (ICH CAHPS)

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Survey to measure patients’ experience
of care with in-center hemodialysis
(ICH) facilities. Data collected in the
national implementation of the ICH
CAHPS Survey are used for the
following purposes: To provide a source
of information from which selected
measures can be publicly reported to
beneficiaries as a decision aid for
dialysis facility selection; to aid
facilities with their internal quality
improvement efforts and external
benchmarking with other facilities; to
provide CMS with information for
monitoring and public reporting
purposes; and to support the ESRD
value-based purchasing program. Form
Number: CMS–10105 (OMB control
number: 0938–0926); Frequency: Yearly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
108,800; Total Annual Responses:
108,800; Total Annual Hours: 58,753.
(For policy questions regarding this
collection contact Julia Zucco at 410–
786–6677.)
2. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Summary of
Benefits and Coverage and Uniform
Glossary; Use: This information
collection will ensure that consumers
shopping for or enrolled in private,
individually purchased, or non-federal
governmental group health plan
coverage receive the consumer
protections of the Affordable Care Act.
Employers, employees, and individuals
will use this information to compare
coverage options prior to selecting
coverage and to understand the terms of,
and extent of medical benefits offered
by, their coverage (or exceptions to such
coverage or benefits) once they have
coverage. CMS recently received OMB
approval for a non-substantive change to
the SBC calculator. Specifically, CMS
requested that issuers begin using an
updated 2020 SBC calculator starting on
or after January 1, 2020. However, at
this time, CMS is alerting issuers to
immediately discontinue use of the
2020 calculator. Until further notice
from CMS, issuers should revert back to
using the 2017 SBC Calculator and all
associated materials (including the 2017
SBC Calculator Excel file, the Guides
and Narratives for the coverage
examples, and the calculator
instructions) to calculate coverage
example costs for the SBC. Form
Number: CMS–10407 (OMB control
number: 0938–1146); Frequency: Yearly;
Affected Public: Private Sector—
Business or other for-profits and not-forprofit institutions; Number of
Respondents: 128,511; Total Annual

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Responses: 24,433,233; Total Annual
Hours: 41,551. (For policy questions
regarding this collection contact Jessica
Weinberg at 301–492–4404.)
Dated: May 8, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–09781 Filed 5–10–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Procedural Justice-Informed
Alternatives to Contempt
Demonstration Project Data Collection
(OMB #0970–0505)
Office of Child Support
Enforcement; Administration for
Children and Families; HHS.
ACTION: Request for public comment.
AGENCY:

The Office of Child Support
Enforcement (OCSE), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing to collect
data as part of the rigorous evaluation of
the Procedural Justice-Informed
Alternatives to Contempt (PJAC)
demonstration.

SUMMARY:

Comments due by July 12, 2019.
In compliance with the requirements of
Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The Office of Child
Support Enforcement (OCSE) within the
Administration for Children and
Families (ACF) is proposing a data
collection activity as part of the
Procedural Justice-Informed
Alternatives to Contempt (PJAC)
DATES:

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20892

Federal Register / Vol. 84, No. 92 / Monday, May 13, 2019 / Notices

Demonstration. In September 2016,
OCSE issued grants to five state child
support agencies to provide alternative
approaches to the contempt process
with the goal of increasing noncustodial
parents’ compliance with child support
orders by building trust and confidence
in the child support agency and its
processes. OCSE also awarded a grant to
support a rigorous evaluation of PJAC.
The PJAC Demonstration is a five-year
project that allows grantees and OCSE to
learn whether incorporating principles
of procedural justice into child support
business practices increases reliable
child support payments, reduces
arrears, minimizes the need for
continued enforcement actions and
sanctions, and reduces the use of
contempt proceedings.
The PJAC demonstration will yield
information about the efficacy of
applying procedural justice principles
via a set of alternative services to the
current use of a civil contempt process
to address nonpayment of child support.
It will generate knowledge regarding
how the PJAC intervention operates, the
effects the alternative services have, and
whether the benefits of this approach
exceed the costs. The information
gathered will help inform future policy
decisions related to the contempt
process within the field of child support
enforcement.
PJAC demonstration will include
three interconnected evaluation
components:
1. Implementation Study. The
implementation study will provide a
detailed description of the PJAC
intervention—how it is implemented,
whether it was implemented as
intended, participant characteristics, the
contexts in which it is operated, how
treatment differed from the status quo,
and the implications of PJAC practices.
The study will identify the intervention

features and conditions necessary for
effective replication or improvement of
the intervention. Key elements of the
implementation study include: A
Management Information System (MIS)
for random assignment and data
collection on participant engagement in
PJAC activities; semi-structured
interviews with staff from child support
agencies and selected partner
organizations; separate semi-structured
interviews with study participants and
the custodial parents connected to their
child support case to learn about their
experiences with and perceptions of the
child support program; and a staff
questionnaire to gather quantitative
information on the implementation of
PJAC services and staff experiences.
2. Impact Study. The impact study
will provide rigorous estimates of the
effectiveness of the PJAC intervention
using an experimental research design.
Noncustodial parents whose cases are
being referred to the contempt process
will be randomly assigned to either a
program group that is offered PJAC
services or to a control group that is
offered business-as-usual services.
Random assignment will require child
support program staff to complete a
brief data entry protocol. The impact
study will rely on administrative data
from state and county child support
programs, court records, criminal justice
records, and data from the National
Directory of New Hires. Administrative
records data will be used to estimate
impacts on child support payments,
enforcement actions, contempt
proceedings, and jail stays.
3. Benefit-Cost Study. The benefit-cost
study will estimate the costs and
benefits associated with the
implementation and impact of the PJAC
interventions. The study will examine
the costs and benefits from the

perspective of the government,
noncustodial parents, custodial parents,
and society. Pertinent benefits and costs
will be added together to determine the
net value of the program for each
perspective. Key outcomes to be
assessed include the cost of PJAC
interventions, costs for contempt
actions, child support payments from
noncustodial parents (program and
control), court costs, and jail time,
among others. The benefit-cost study
will rely on the results of the impact
study, analysis of participation data
from the MIS, and results of a staff time
study to quantify various PJAC-related
costs and benefits.
This notice is specific to the following
data collection activities: The
noncustodial parent participant
interviews (these interview topic guides
were approved under a previous
submission and require content
modification which also significantly
lowers the collective public burden
hours); the staff survey; the staff time
study; and the custodial parent
interviews. Data collection activities
that were previously approved by OMB,
following public comment, are the staff
data entry on participant baseline
information, study MIS to track receipt
of services, staff and community partner
interview topic guide, the participant
interview topic guide, and the
participant survey tracking letter. A
participant survey has been eliminated
from the data collections plans, so the
OMB-approved participant survey
tracking letter will no longer be used.
Respondents: Respondents include
study participants, child support
program staff at the six PJAC
demonstration sites, custodial parents
associated with study participants, and
the federal Office of Child Support
Enforcement.

ANNUAL BURDEN ESTIMATES
Instrument

Total number
of respondents

Total number
of responses
per respondent

60
20
30
60

1
1
1
1

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Noncustodial parent participant interview ........................................................
Staff Survey .....................................................................................................
Staff time study ................................................................................................
Custodial parent interview ...............................................................................

Estimated Total Annual Burden
Hours: 175
Comments: 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;

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(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

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Average
burden hours
per response
1
.5
1.5
1

Total burden
hours
60
10
45
60

or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.

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Federal Register / Vol. 84, No. 92 / Monday, May 13, 2019 / Notices
Authority: 42 U.S.C. 1315.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–09756 Filed 5–10–19; 8:45 am]
BILLING CODE 4184–41–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1875]

Financial Transparency and Efficiency
of the Prescription Drug User Fee Act,
Biosimilar User Fee Act, and Generic
Drug User Fee Amendments; Public
Meeting; Request for Comments
AGENCY:

Food and Drug Administration,

HHS.

Electronic Submissions

Notice of public meeting;
request for comments.

ACTION:

The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
meeting entitled ‘‘Financial
Transparency and Efficiency of the
Prescription Drug User Fee Act,
Biosimilar User Fee Act, and Generic
Drug User Fee Amendments.’’ The
purpose of the public meeting is to meet
performance commitments included in
the Prescription Drug User Fee Act
(PDUFA) VI, Biosimilar User Fee Act
(BsUFA) II, and Generic Drug User Fee
Amendments (GDUFA) II. The public
meeting will include presentations from
FDA on the 5-year plans for the PDUFA
VI, BsUFA II, and GDUFA II; the
Agency’s progress in implementing
resource capacity planning and
modernized time reporting; and the
results of the fiscal year (FY) 2018
evaluation of PDUFA, BsUFA, and
GDUFA resource management. The
Agency will also address the impact of
the modernized fee structure changes on
the PDUFA and BsUFA programs and
report on the contribution of the BsUFA
spending trigger to the BsUFA program.
DATES: The public meeting will be held
on June 7, 2019, from 9 a.m. to 12 p.m.
Submit either electronic or written
comments on this public meeting by
July 8, 2019. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be

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SUMMARY:

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performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before July 8, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
July 8, 2019. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’

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Instructions: All submissions received
must include the Docket No. FDA–
2019–N–1875 for ‘‘Financial
Transparency and Efficiency of the
Prescription Drug User Fee Act,
Biosimilar User Fee Act, and Generic
Drug User Fee Amendments; Public
Meeting; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Graham Thompson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New

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