[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Notices]
[Pages 52302-52304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

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


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: 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 in-person health insurance enrollment assistance 
intervention among Black and Hispanic men who have sex with

[[Page 52303]]

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, 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 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 in-person 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.

[[Page 52304]]

    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.
    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 partner-agency 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. 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 in-person 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.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
               Type of respondent                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)         hours
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Study participant..............................  Consent Form...........................           1,500               1           10/60             250
Study participant..............................  Eligibility Form.......................           1,500               1            5/60             125
Study participant..............................  Participant Enrollment Form............           1,000               1           35/60             583
Study participant (Intervention arm ONLY)......  ACTIVITY: In-person health insurance                500               1               1             500
                                                  enrollment assistance.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           1,458
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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]
BILLING CODE 4163-18-P