[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Notices]
[Pages 73402-73404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25677]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17AX; Docket No. CDC-2016-0100]


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 efforts 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 the proposed 
information collection project entitled ``Mobile Messaging Intervention 
to Present New HIV Prevention Options for Men who have Sex with Men 
(MSM) Study.'' The collect is part of a research study designed to 
evaluate the efficacy of smartphone-based platform for delivering 
sexual health and prevention messages to MSM.

DATES: Written comments will be received on or before December 27, 
2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0100 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted 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

[[Page 73403]]

proposed project or to obtain a copy of the information collection plan 
and instruments, contact the 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Mobile Messaging Intervention to Present New HIV Prevention Options 
for Men Who Have Sex with Men (MSM) Study--New--National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    The National Center for HIV/AIDS, Viral Hepatitis, STD and TB 
Prevention is requesting approval for two years of data collection 
entitled, ``Mobile Messaging Intervention to Present New HIV Prevention 
Options for MSM.'' The purpose of this study is to evaluate the 
efficacy of a smartphone-based HIV prevention intervention, known as 
M\3\, through a randomized controlled trial. The information collected 
through this study will be used to evaluate whether the M\3\ mobile-
messaging intervention is an effective HIV-prevention strategy, by 
assessing whether exposure to the message-delivery platform results in 
improvements in participants' self-reported sexual health and HIV 
prevention behaviors, beliefs and attitudes. The trial will assess 
whether intervention participants' behaviors significantly change from 
baseline to post-intervention when compared to participants in a 
waitlist control arm, and whether these changes are sustained at 6-
month and 9-month follow-ups.
    This study will be carried out in three metropolitan areas in the 
United States: Atlanta, Georgia, Detroit, Michigan and New York City, 
New York. These cities were selected not only because they have high 
rates of HIV, but also because significant disparities in HIV among men 
who have sex with men (MSM) have been observed by race/ethnicity and 
age.
    The study population will include 1,206 adult MSM living in 
Atlanta, Detroit, and New York City. Men recruited to the study will be 
at least 18 years in age, who have had anal sex with at least one man 
in the past 12 months, and who own and use an Android and iOS 
smartphone.
    Across the three sites, we will ensure that at least 40% of 
participants are people of color (non-white or Hispanic) by quota 
sampling. Participants will be recruited to the study through a 
combination of approaches, including online advertisement, traditional 
print advertisement, referral, in-person outreach, and through word of 
mouth.
    A quantitative assessment will be used to collect information for 
this study, which will be delivered at the time of study enrollment and 
again at 3-month, 6-month and 9-month follow-ups. The assessment will 
be used to measure changes in condom use behavior, number of sex 
partners, HIV testing, sexually transmitted disease (STD) testing, 
health care engagement, pre-exposure prophylaxis uptake and adherence, 
and antiretroviral therapy uptake and adherence following completion of 
the intervention. Participants will complete the assessment in-person 
at baseline and 9-months, using a computer in a private location, and 
remotely via their personal computer or tablet device at the 3-month 
and 6-month follow-ups.
    It is expected that 50% of men screened will meet study eligibility 
and provide contact information, that 75% will schedule and show up for 
an in-person appointment, and that 95% of these men will remain 
eligible after reverification. We expect the initial screening to take 
approximately four minutes to complete, that providing contact 
information will take one minute, and the rescreening prior to study 
enrollment to take another four minutes. The assessment will take 90 
minutes (1\1/2\ hour) to complete, and will be administered to 1,206 
men a total of four times. The total number of burden hours are 5,164.

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                                                                                      Average
                                                     Number of       Number of      burden per     Total  burden
      Type of respondent            Form name       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
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General Public--Adults........  Participant                1,356               1            4/60              90
                                 Screening
                                 (Eligibility).
General Public--Adults........  Contact                      678               1            1/60              11
                                 Information
                                 Form.
General Public--Adults........  Participant                  508               1            4/60              34
                                 Screening
                                 (Verification).
General Public--Adults........  Assessment......             482               4             1.5           2,892
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           3,027
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[[Page 73404]]

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. 2016-25677 Filed 10-24-16; 8:45 am]
 BILLING CODE 4163-18-P