30 Day FRN Published 8.10.18

Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10516 and CMS–
10561]

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
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.

SUMMARY:

Comments on the collection(s) of
information must be received by the
OMB desk officer by September 10,
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
http://www.cms.hhs.gov/
PaperworkReductionActof1995.

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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:
Reports Clearance Office at (410) 786–
1326.
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
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:
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Program
Integrity: Exchange, Premium
Stabilization Programs, and Market
Standards; Amendments to the HHS
Notice of Benefit and Payment
Parameters for 2014; Final Rule II; Use:
The original approved ICR affiliated
with this final rule was titled Program
Integrity: Exchange, Premium
Stabilization Programs, and Market
Standards; Amendments to the HHS
Notice of Benefit and Payment
Parameters for 2014; Final Rule II and
was approved on 8/26/2015. This
request serves as the formal request for
renewal of the clearance. This ICR
includes some of the ICRs from the
previously approved final rule. The
program integrity data collections and
third-party disclosure requirements will
assist HHS in determining Exchange
compliance with Federal standards. The
data collection and third-party
disclosure requirements will also assist
HHS in monitoring QHP issuers in FFEs
for compliance with Federal QHP issuer
standards. The data collected by health
insurance issuers and Exchanges will

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39759

help to inform HHS, Exchanges, and
health insurance issuers as to the
participation of individuals, employers,
and employees in the individual
Exchange, and SHOP. Form Number:
CMS–10516 (OMB Control Number:
0938–1277); Frequency: Annually;
Affected Public: Private Sector, State,
Business, and Not-for Profits; Number of
Respondents: 1,915; Number of
Responses: 1,915; Total Annual Hours:
48,732. (For questions regarding this
collection, contact Leigha Basini at (301)
492–4380.)
2. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection: Essential
Community Provider Data Collection to
Support QHP Certification for PYs
2021–2023; Use: For plan years
beginning on or after January 1, 2021,
Health and Human Services (HHS)
intends to continue collecting more
complete provider data for inclusion on
the HHS Essential Community Provider
(ECP) list to ensure a more accurate
reflection of the universe of qualified
available ECPs in a given service area
that can be counted toward an issuer’s
satisfaction of the ECP standard. HHS
intends to continue collecting these data
on qualified and available ECPs directly
from providers through the online ECP
petition. Providers will submit an ECP
petition to be added to the HHS ECP list
or update required data fields to remain
on the list. Form Number: CMS–10561
(OMB control number: 0938–1295);
Frequency: Annually; Affected Public:
Private sector (Business or other forprofits and Not-for-profit Institutions);
Number of Respondents: 14,260; Total
Annual Responses: 14,260; Total
Annual Hours: 7,468. (For policy
questions regarding this collection
contact Deborah Hunter at (202) 309–
1098).
Dated: August 7, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–17190 Filed 8–9–18; 8:45 am]
BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Multi-site Implementation
Evaluation of Tribal Home Visiting
(MUSE).

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Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices

OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF) within the
U.S. Department of Health and Human
Services has launched a national multisite evaluation of Tribal Maternal,
Infant, and Early Childhood Home
Visiting (TMIECHV) programs. MUSE is
the first multi-site, multi-model study
that will systematically explore how
home visiting programs are operating
across diverse tribal contexts and
identify factors that lead to programs’
success. The evaluation will provide
information that will help the federal
government design and support federal
home visiting initiatives in tribal
communities and similar populations.
Evaluation findings will also assist
programs with improving home visiting
services for children and families. The
aims of MUSE are to (1) identify and
describe the primary influences shaping
tribal home visiting program planning;
(2) identify and describe how home
visiting programs are being
implemented; and (3) explore supports
to home visiting implementation in
tribal communities. To address these
aims, the evaluation will gather data
about participating home visiting
programs from program staff and parent

program participants and utilize
administrative program data.
The current Notice is specific to data
collection efforts needed to address the
MUSE aims. Quantitative and
qualitative data will be collected from
program staff and parent program
participants at each program site.
Program sites will also submit local
administrative data to the evaluation
team. After obtaining informed consent
from all respondents, data collection
will include: (1) A Caregiver Enrollment
Form, (2) a survey of caregivers
receiving home visiting services at
enrollment (baseline), (3) a follow-up
survey of caregivers receiving home
visiting services at 6 and 12 months, (4)
a Rapid Reflect self-completed
questionnaire completed by caregivers
after selected home visits; (5) a Rapid
Reflect self-completed questionnaire
completed by home visitors after
selected home visits; (6) a one-time
survey of home visitors; (7) a one-time
survey of program coordinators/
managers; (8) a one-time survey of
program directors; (9) a one-time survey
of local program evaluators; (10) a onetime survey for program managers on
program implementation, (11)
qualitative interviews of home visitors
Total
number of
respondents

Instrument

Caregiver Enrollment Form ..................................................
Caregiver Survey—Baseline ................................................
Caregiver Survey—6 & 12 Month Follow-up .......................
Rapid Reflect Self-Completed Home Visit Questionnaire
for Caregivers ...................................................................
Rapid Reflect Self Completed Home Visit Questionnaire
for Home Visitors ..............................................................
Home Visitor Survey ............................................................
Program Coordinator/Manager Survey ................................
Program Director Survey .....................................................
Local Program Evaluator Survey .........................................
Program Implementation Survey .........................................
Qualitative Interviews of Home Visitors ...............................
Qualitative Interviews of Program Coordinators/Managers
and Program Directors .....................................................
Qualitative Interviews of Local Program Evaluators ............
Qualitative Interviews of Caregivers ....................................
Implementation Logs ............................................................
Administrative Program Data ...............................................

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1 The

Annual
number of
respondents

at each site; (12) qualitative interviews
of program coordinators/managers and
program directors at each site; (13)
qualitative interviews of local program
evaluators at each site; (14) qualitative
interviews of caregivers receiving home
visiting services; (15) a log of
implementation activities completed by
program coordinators/managers on
training, family group activities, and
supervision; and 156 electronic
compilation and submission of
administrative program data.
All data collection will be used to
generate information about how tribal
home visiting program services are
planned and delivered, and about what
individual, organizational, community,
and external factors support successful
program implementation.
Respondents: Caregivers enrolled in
TMIECHV programs and TMIECHV
program staff (program directors,
program coordinators/managers, home
visitors, and local program evaluators).
Annual Burden Estimates: We will
request approval for three years, which
will accommodate an approximate 27
month data collection period and any
potential delays in the data collection
timeline.
Number of
responses
per
respondent

Average
burden hours
per response

Annual
burden hours

93
565
380

31
188
127

14
1
2

.08
.25
.50

35
47
127

1,136

1 568

6

.08

273

93
81
21
21
30
34
42

1 47

27
7
7
10
11
14

66
1
1
1
1
1
1

.2
1.17
1
.75
.5
.25
2

620
32
7
5
5
3
28

34
30
51
17
17

11
10
17
19
19

1
1
1
24
4

1.5
1.5
1
.67
24

17
15
17
145
864

annual number of respondents is annualized over 2 years for instruments that are completed by respondents on an ongoing basis.

Estimated Total Annual Burden
Hours: 2,240.
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

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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

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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:

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Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices
Desk Officer for the Administration for
Children and Families.
Emily B. Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–17121 Filed 8–9–18; 8:45 am]
BILLING CODE 4184–74–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Proposed Projects
Title: Supplemental Nutrition
Assistance Program (SNAP) Matching
Program Performance Outcomes.
OMB No. 0970–0464.
Description: State agencies
administering the Supplemental
Nutrition Assistance Program (SNAP)
are mandated to participate in a

computer matching program with the
federal Office of Child Support
Enforcement (OCSE). The matching
program compares SNAP applicant and
recipient information with employment
and wage information maintained in the
National Directory of New Hires
(NDNH). The outcomes of the compared
information help state SNAP agencies
with administering the program and
verifying and determining an
individual’s benefit eligibility. To
receive NDNH information, state
agencies enter into a computer matching
agreement and adhere to its terms and
conditions, including providing OCSE
with annual performance outcomes
attributable to the use of NDNH
information.
The Office of Management and Budget
(OMB) requires OCSE to periodically
report performance measurements
demonstrating how the use of
information in the NDNH supports
OCSE’s strategic mission, goals, and
objectives. OCSE will provide the

annual SNAP performance outcomes to
OMB.
The information collection activities
for the SNAP performance outcomes
reports are authorized by: (1) Subsection
453(j)(10) of the Social Security Act (42
U.S.C. 653(j)(10)), which allows the
Secretary of the U.S. Department of
Health and Human Services to disclose
information maintained in the NDNH to
state agencies administering SNAP
under the Nutrition Act of 2008, as
amended by the Agriculture Act of
2014; (2) the Privacy Act of 1974, as
amended by the Computer Matching
and Privacy Protection Act of 1988 (5
U.S.C. 552a), which sets forth the terms
and conditions of a computer matching
program; and, (3) the Government
Performance and Results Modernization
Act of 2010 (Pub. L. 111–352), which
requires agencies to report program
performance outcomes to the Office of
Management and Budget and for the
reports to be available to the public.
Respondents: State SNAP Agencies.

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ANNUAL BURDEN ESTIMATES
Information collection title

Number of
respondents

Number of
responses per
respondent

Average
burden hours
per response

Total
burden hours

SNAP Matching Program Performance Outcomes .........................................

53

1

1.92

101.76

Estimated Total Annual Burden
Hours: 101.76.
Additional Information: Copies of the
proposed collection may be obtained by
writing to The Administration for
Children and Families, Office of
Information Services, 330 C Street SW,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer.
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. 2018–17152 Filed 8–9–18; 8:45 am]
BILLING CODE 4184–41–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2582]

Human Dermal (Skin) Safety Testing
for Topical Drug Products: Regulatory
Utility and Evaluation; Public
Workshop; Request for Comments
AGENCY:

Food and Drug Administration,

HHS.
Notice of public workshop;
request for comments.

ACTION:

The Food and Drug
Administration (FDA, Agency, or we) is
announcing the following 1-day public
workshop entitled ‘‘Human Dermal
(Skin) Safety Testing for Topical Drug
Products: Regulatory Utility and
Evaluation.’’ The purpose of the public
workshop is to provide a forum to
discuss the current state and future
directions of the collection of human
data on the potential skin toxicity with
the use of medications applied
topically. The workshop will review
current approaches to the collection of
human data during the clinical
development of topical drug products.
The workshop will also address the

SUMMARY:

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impact of human skin toxicity studies
on drug labeling and consider
alternative approaches to providing
information about skin toxicity.
DATES: The public workshop will be
held on September 10, 2018, from 8:30
a.m. to 4 p.m. Eastern Time. Submit
either electronic or written comments
on this public workshop by October 10,
2018. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503, Section A), Silver Spring,
MD 20993–0002. Entrance for the public
workshop participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be 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 October 10, 2018. The

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