Att 2_60d FRN

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Project NICE: Navigating Insurance Coverage Expansion

Att 2_60d FRN

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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices

clinical linkages. Through this
initiative, DCPC intends to help address
the public health needs of cancer
survivors. To facilitate evidenceinformed policymaking and quality
improvement of federal programs, CDC
needs a comprehensive evaluation to
characterize survivorship interventions
and document outcomes.
CDC seeks to request OMB approval
to collect information needed for this
evaluation. The proposed information
collection will focus on how each
grantee has expanded their knowledge
of cancer survivor needs, increased
utilization of surveillance data to inform
program planning by providers and
coalition members, and enhanced
partnerships to facilitate and broaden
program reach. CDC will also collect
data on challenges encountered and
addressed, factors that facilitated
implementation, and lessons learned
along the way. The requested
information does not currently exist for
organizations and entities working to
improve cancer survivorship needs.
With this data, CDC will gain critical
insights for improving achieving
immediate strategic efforts and goals to
improve the public health needs of
cancer survivors.
CDC plans to collect information
during two cycles of the program using
a Web-based Grantee survey of NCCCP
DP15–1501 grantee program directors
and program managers, a Web-based
Partner Survey of grantees’ self-

CDC intends to also seek OMB
approval to conduct semi-structured
interviews by telephone with a
purposive sample of one program
director and one program manager for
each of the six grantee sites (12
respondents total). CDC will conduct
the semi-structured interviews with the
same respondents at two time points for
a total estimated burden of 36 hours.
CDC will ask the respondents to
provide information on the following:
(1) Administration of the Behavioral
Risk Factor Surveillance System Cancer
Survivorship Module; (2)
communication, education, and training
activities to support the implementation
of cancer survivorship interventions; (3)
community clinical linkage strategies to
support cancer survivors, knowledge
regarding best practices for survivorship
care; partnership engagement; (4)
dissemination of evidence-based
survivorship interventions; and (5)
recommendations for improving the
implementation of evidence-based
survivorship interventions.
CDC will analyze the collected
information and use in aggregate to
inform future efforts to support cancer
survivors and to initiate evidenceinformed program decisions when
rolling this initiative out to all NCCCP
grantees. Without this data collection,
CDC will not be able to provide tailored
technical assistance to its grantees and
communicate program efforts.

identified key partners (e.g., coalition
members, providers, patient navigators),
and semi-structured telephone
interviews with NCCCP DP15–1501
grantee program directors and program
managers. The data from the survey and
semi-structured interviews will provide
additional insight into program efforts.
CDC is requesting OMB approval to
conduct a Web-based Grantee survey
using Survey Gizmo to a purposive
sample of one program director and one
program manager for each of the six
grantee sites (12 respondents total) and
to conduct a Web-based Partner Survey
of 10 self-identified key partners in each
of 6 grantees for a total of 60
respondents. CDC will administer the
Web-based surveys to the same
respondents at two time points for a
total estimated burden of 8 hours for the
Web-based Grantee Survey and 40 hours
for the Web-based Partner Survey.
CDC will ask the respondents to
provide information regarding the type
of respondent; their use of surveillance
data to inform survivorship
interventions; communication,
education, and training activities to
support the implementation of
survivorship interventions; partnership
engagement; challenges and facilitators
regarding the implementation of
evidence-based cancer survivorship
strategies; reach of cancer survivorship
interventions; and respondent
background information.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

Form name

NCCCP Grantee Program Director ..
NCCCP Grantee Partner ..................

Web-based Grantee survey .............
Semi-structured telephone interview
Web-based Partner survey ..............

12
12
60

2
2
2

20/60
1.50
20/60

8
36
40

Total ...........................................

...........................................................

........................

........................

........................

84

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2017–24523 Filed 11–9–17; 8:45 am]

[60Day–17–17AUZ; Docket No. CDC–2017–
0065]

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Number of
respondents

Type of respondent

Centers for Disease Control and
Prevention

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on ‘‘Project NICE: Navigating
Insurance Coverage Expansion’’. Project
NICE will evaluate the efficacy of an inperson health insurance enrollment
assistance intervention among Black
and Hispanic men who have sex with

SUMMARY:

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asabaliauskas on DSKBBXCHB2PROD with NOTICES

Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
men (MSM) and Transgender persons
living in the Chicago, Illinois
metropolitan area.
DATES: CDC must receive written
comments on or before January 12,
2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0065 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE., MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
[email protected].
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. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,

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including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Project NICE: Navigating Insurance
Coverage Expansion—New—National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC seeks to request a three-year
OMB approval to evaluate the efficacy
of an in-person health insurance
enrollment assistance intervention
among 1,000 Black and Hispanic MSM
and Transgender persons ages ≥18 years
living in the Chicago, Illinois
metropolitan area. CDC will invite
individuals attending HIV testing
outreach events, or seeking care in
select clinics in Chicago to participate
in the study after an HIV testing session.
Researchers will collect study
participants’ sociodemographic, risk
behavior, and insurance coverage
information as part of study enrollment.
Each quarter, researchers will abstract
outcome evaluation data (linkage to and
retention in HIV-related care, referrals
for mental health or substance use, and
other health outcomes) from study
participant’s electronic medical records
(EMRs). Researchers will also assess
intervention cost-effectiveness.
CDC funded this study through a
cooperative agreement with the
University of Chicago Medicine (UCM).
Three partner agencies will conduct the
intervention: (1) University of Chicago
Medicine (UCM) (the lead partner
agency), (2) Howard Brown Health, and
(3) Chicago House and Social Service
Agency (Chicago House). The three
partner agencies each have a history of
providing clinical care, HIV testing
outreach, and in-person health
insurance enrollment assistance for
Chicago’s MSM and Transgender
communities.
As part of this study, CDC will
evaluate the in-person health insurance
enrollment assistance. Specifically,
researchers will evaluate whether
moving the delivery of in-person health

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insurance enrollment assistance, from
the first clinic visit after receipt of an
HIV test result, to earlier in the care
continuum, during the HIV testing
event, will impact health outcomes.
Therefore, this study does not introduce
new intervention activities or burden on
the participants or the agency staff; it
reorders the sequence of delivery of
standard practice. Only the addition of
data collection forms and procedures
will be new, and the additional burden
will be to partner agency staff workload
and participant experience.
In 2013, MSM accounted for 81% of
new HIV infections among males and
65% of all new HIV infections. In 2010,
health officials reported 10,600 new HIV
infections for African-American (Black)
MSM, 11,200 for White MSM, and 6,700
for Hispanic MSM. Through a 2008
systematic review, researchers found
HIV rates among Black and Hispanic
Transgender women to be 56% and
16%, respectively.
Black and Hispanic MSM and
Transgender persons face obstacles in
seeking medical care and following
through with referrals or appointments,
including lack of health insurance.
This study will implement a
structural intervention. The goal of this
study is to test whether providing inperson assistance for first-time private
health insurance or Medicaid
enrollment, changing to a different
insurance plan, or understanding how
to use current insurance policies
following HIV testing will: (1) Increase
the proportion of participants who
obtain health insurance; (2) result in
better health outcomes among
participants (e.g., achieving viral
suppression, remaining HIV negative);
(3) improve the linkage and retention
rates for HIV care (i.e., HIV treatment,
Pre-exposure Prophylaxis (PrEP)) and
other HIV-associated health services
(e.g., mental health counseling,
substance use treatment) of participants,
especially those diagnosed with HIV;
and (4) increase HIV care linkage and
retention rates sufficiently to justify the
cost of implementing the intervention
(cost-benefit analysis) among Black and
Hispanic MSM and Transgender
persons age 18 or older in the Chicago,
Illinois metropolitan area.
Randomized controlled trials (RCTs)
of structural interventions are rare.
Nevertheless, CDC will use a RCT
design to enhance scientific validity and
the policy impact of the intervention,
and help researchers assess the efficacy
of this intervention as an emerging
practice prior to dissemination to HIV
prevention service providers
nationwide.

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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices

This project aligns with National HIV/
AIDS Strategy 2020 and Health People
2020 objectives. This structural
intervention aligns with the OMB’s
emphasis on application of behavioral
insights in that it restructures the
context (i.e., after HIV testing) in which
health-related decision-making (i.e.,
health insurance enrollment) occurs in
order to promote the selection of
beneficial options. The proposed health
insurance enrollment assistance project
has the potential for widespread health
improvements for Black and Hispanic
MSM and Transgender persons
regardless of their HIV status.

If eligible and interested in
participating, individuals will complete
the Participant Enrollment Form, which
will take approximately 35 minutes to
complete. Researchers then will offer inperson health insurance enrollment to
randomized intervention arm
participants. This enrollment will take a
maximum of 60 minutes to complete.
The study’s in-person health insurance
enrollment assistance will take the same
amount of time as standard practice
health insurance enrollment assistance.
The total estimated annualized hourly
burden anticipated for this study is
1,458 hours.

The study will enroll 1,000
participants over 12 months to reach
adequate power calculations (500 into
the intervention arm, and 500 into the
control arm).
After an HIV testing session at an
outreach event or clinic visit, a partneragency staff person will invite an
individual to participate in the study. If
interested, participants will complete a
consent form. Staff will screen
individuals using the Eligibility Form,
which will take approximately five
minutes to complete. Researchers would
need to screen approximately 1,500
individuals in order to identify and
enroll 1,000 eligible study participants.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
hours

Form name

Study participant ................................
Study participant ................................
Study participant ................................
Study participant (Intervention arm
ONLY).

Consent Form ..................................
Eligibility Form .................................
Participant Enrollment Form ............
ACTIVITY: In-person health insurance enrollment assistance.

1,500
1,500
1,000
500

1
1
1
1

10/60
5/60
35/60
1

250
125
583
500

Total ...........................................

..........................................................

........................

........................

........................

1,458

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–24473 Filed 11–9–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–48 and
CMS–10421]

Agency Information Collection
Activities: Proposed Collection;
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 (the
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

SUMMARY:
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Number of
respondents

Type of respondent

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collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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.
DATES: Comments must be received by
January 12, 2018.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to http://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,

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Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number __, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
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’ Web site address at
http://www.cms.hhs.gov/
PaperworkReductionActof1995.
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 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–R–48 Hospital Conditions of
Participation and Supporting
Regulations
CMS–10421 Fee-for-Service Recovery
Audit Prepayment Review

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