30 Day FRN - Add 3 Sites

32129

Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Total
number of
respondents
Administrative Data List .......................................................

Estimated Total Annual Burden
Hours: 849.
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, 330
C Street SW, Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
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.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–14792 Filed 7–10–18; 8:45 am]
BILLING CODE 4184–25–P

Annual
number of
respondents

30

Number of
responses per
respondent

10

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review: Updates
to Approved Information Collection
Office of Planning, Research,
and Evaluation; ACF; HHS.
ACTION: Public comment request.
AGENCY:

Title: Evaluation of Employment
Coaching for TANF and Other LowIncome Populations (0970–0506).
SUMMARY: The Administration for
Children and Families (ACF) is
proposing an increase in the number of
sites for data collection activities to be
conducted as part of the Evaluation of
Employment Coaching for TANF and
Other Low-Income Populations. The
Office of Management and Budget
(OMB) Office of Information and
Regulatory Affairs approved this
information collection in March 2018
(0970–0506). As approved, we planned
to include three employment programs.
We have since identified three
additional employment programs to
include in the study. This Notice
provides the opportunity for public
comment on the addition of three sites.
This study will provide an
opportunity to learn more about the
potential of coaching to help clients
achieve self-sufficiency and other
desired employment-related outcomes.
The programs included in the study
are Temporary Assistance for Needy
Families (TANF) agencies and other
public or private employment programs
that serve low-income individuals.

2

Average
burden hour
per response
5.00

Annual
burden hours
100

Selected sites include a robust coaching
component and have the capacity to
conduct a rigorous impact evaluation,
among other criteria. This study will
provide information on whether
coaching helps people obtain and retain
jobs, advance in their careers, move
toward self-sufficiency, and improve
their overall well-being. To meet these
objectives, this study includes an
impact and implementation study.
The impact study involves
participants being randomly assigned to
either a ‘‘program group,’’ who will be
paired with a coach, or to a ‘‘control
group,’’ who will not be paired with a
coach. The effectiveness of the coaching
will be determined by differences
between members of the program and
control groups in outcomes such as
obtaining and retaining employment,
earnings, measures of self-sufficiency,
and measures of self-regulation.
The implementation study will
document coaching practices, describe
lessons learned from implementing
coaching, and enhance interpretation of
the impact study findings.
The proposed information collection
activities have not changed since OMB/
OIRA approval. The only change to this
information collection is to add three
additional sites.
Respondents: Program staff and
individuals enrolled in the Evaluation
of Employment Coaching for TANF and
Other Low-Income Populations.
Program staff may include coaches, case
managers, workshop instructors, job
developers, supervisors, and managers.
All participants will be able to opt out
of participating in the data collection
activities.

ANNUAL BURDEN ESTIMATES

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Instrument

Original
request:
Total number
of respondents

Updated
request:
Total number
of respondents

Updated
request:
Annual
number
of respondents

Number of
responses per
respondent

6,000
60
2,400
66
48
24
30
27

6,000
60
4,800
132
96
48
60
54

2,000
20
1,600
44
32
16
20
18

1
100
1
1
1
1
5,200
10

Baseline data collection—study participants .....................................................
Baseline data collection—staff .................
First follow-up survey ...............................
Semi-structured staff interviews ...............
Staff survey ..............................................
In-depth participant interviews .................
Staff reports of program service receipt ..
Video recordings of coaching sessions ...

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Average
burden hours
per response

.33
.33
1
1.5
.75
2.5
.03
.1

Updated
request:
Annual
burden hours

660
660
1,600
66
24
40
3,120
18

32130

Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices

Estimated Total Annual Burden
Hours: 6,188.
DATES: Comments due within 30 days of
publication. 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:

ADDRESSES:

Office of Management and Budget,
Paperwork Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn: Desk
Officer for the Administration for Children
and Families.

Copies of the proposed collection may
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
should be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
(Authority: Section 413 of the Social Security
Act, as amended by the FY 2017
Consolidated Appropriations Act, 2017 (Pub.
L. 115–31)
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–14793 Filed 7–10–18; 8:45 am]
BILLING CODE 4184–09–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2434]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Formal Meetings With
Sponsors and Applicants for
Prescription Drug User Fee Act
Products
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
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 notice in the
Federal Register concerning each

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SUMMARY:

VerDate Sep<11>2014

16:26 Jul 10, 2018

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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 the information
collection contained in the guidance for
industry on formal meetings with
sponsors and applicants for Prescription
Drug User Fee Act (PDUFA) products.
DATES: Submit either electronic or
written comments on the collection of
information by September 10, 2018.
ADDRESSES: 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 September 10,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 10, 2018.
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.
Electronic Submissions
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.

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• 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.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–2434 for ‘‘Guidance for
Industry on Formal Meetings with
Sponsors and Applicants for PDUFA
Products.’’ 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.

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