[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28232-28233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-17AUZ]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled ``Project NICE: Navigating Insurance Coverage 
Expansion'' to the Office of Management and Budget (OMB) for review and 
approval. CDC previously published a ``Proposed Data Collection 
Submitted for Public Comment and Recommendations'' notice on November 
13, 2017, to obtain comments from the public and affected agencies. CDC 
did not receive comments related to the previous notice. This notice 
serves to allow an additional 30 days for public and affected agency 
comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) 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;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) 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 submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

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 is requesting a three-year approval to evaluate the efficacy of 
an in-person health insurance enrollment assistance intervention among 
1,000 Black and Hispanic men who have sex with men (MSM) and 
transgender persons ages >=18 years living in the Chicago, Illinois 
metropolitan area.
    In 2013, MSM accounted for 81% of new HIV infections among males 
and 65% of all new HIV infections. In 2010 African Americans comprised 
only 12% of the US population, but Black MSM nearly equaled White MSM 
in numbers of new HIV infections (10,600 and 11,200, respectively). In 
2010 Hispanics comprised 17% of the US population, and Hispanic MSM 
accounted for 22% (6,700) of all new HIV infections. A 2008 systematic 
review found HIV rates among Black and Hispanic transgender women to be 
56% and 16%, respectively. Contributing to these disproportionate HIV 
rates are that 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.
    The intervention being evaluated in this study (in-person health 
insurance enrollment assistance) is not a new activity. This study will 
evaluate whether moving the delivery of in-person health 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. Because this study does not 
introduce new intervention activities, only reorders the sequence of 
delivery of standard practice, the burden to the participant experience 
will be data collection forms and research procedures only.
    The goal of this study is to test whether providing a point of 
care, in-person assistance in enrolling in private health insurance or 
Medicaid for the first time, 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.
    This study is funded through a cooperative agreement between CDC 
and the University of Chicago Medicine. Three partner agencies will 
conduct the intervention: (1) University of Chicago Medicine (the lead 
partner agency), (2) Howard Brown Health, and (3) Chicago House and 
Social Service Agency (Chicago House). These three partner agencies 
currently provide in-person health insurance enrollment assistance, 
linkage to care (HIV-related treatment, primary care), and patient 
navigation services to the study population.
    This study uses a randomized controlled trial design, which will 
enhance scientific validity and the policy impact of the intervention, 
and help researchers assess the efficacy of this intervention as an 
emerging

[[Page 28233]]

practice. This study aligns with National HIV/AIDS Strategy 2020 and 
Healthy People 2020 objectives of reducing new HIV infections, 
increasing access to care and improving health outcomes for people 
living with HIV, and reducing HIV-related health disparities. This 
study also aligns with the Office of Management and Budget'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 (i.e., attending HIV-related 
medical care appointments). This proposed health insurance enrollment 
assistance study has the potential for widespread health improvements 
for Black and Hispanic MSM and transgender persons regardless of their 
HIV status.
    At this time, CDC is not partnering with other HHS agencies for 
this study. However, we have discussed the study with HRSA/HAB and HHS/
OD, and plan to apprise CMS and HRSA of the project before 
implementation and invite CMS and HRSA representatives to serve as 
consultants. HHS may also direct us to the CMS regional officer for 
Chicago, Illinois. Additionally, there is the potential to have CMS 
grantee navigators supplement partner agency navigators during outreach 
HIV testing events. For this study, CDC is not engaged in research, and 
therefore not involved in data collection activities. The grantee is 
responsible for implementing the intervention and collecting data from 
the proposed 1,000 participants. Thus, CDC will not need an interagency 
data-sharing agreement if we do consult with HRSA or CMS.
    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). Approximately 1,500 individuals will need to be 
screened to identify and enroll 1,000 eligible study participants. 
After an HIV testing session at an outreach event or clinic visit, 
partner agency staff will invite individuals to participate in the 
study. If individuals are interested, staff will screen individuals for 
eligibility using the Participant Eligibility Form (Attachment 5) which 
will take approximately 5 minutes to complete. If they are determined 
eligible to participate, and still interested in participating, the 
individual will complete an Informed Consent Form (Attachment 6), which 
will take approximately 10 minutes to complete, and the Participant 
Enrollment Form (Attachment 7), which will take approximately 35 
minutes to complete. The total estimated annualized hourly burden 
anticipated for this study is 875 hours. There is no cost to 
respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden  per
          Type of respondent                    Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Study participant.....................  Participant Eligibility            1,500               1            5/60
                                         Form (Att 5).
Study participant.....................  Informed Consent Form              1,000               1           10/60
                                         (Att 6).
Study participant.....................  Participant Enrollment             1,000               1           35/60
                                         Form (Att 7).
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting 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. 2018-12971 Filed 6-15-18; 8:45 am]
 BILLING CODE 4163-18-P