[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62864-62866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26350]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-19BG; Docket No. CDC-2018-0102]


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 the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``Web-based approaches to reach 
black or African American and Hispanic/Latino MSM for HIV Testing and 
Prevention Services.''

DATES: CDC must receive written comments on or before February 4, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0102 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M.Zirger, Ph.D., 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;

[[Page 62865]]

    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

    Web-based approaches to reach black or African American and 
Hispanic/Latino MSM for HIV Testing and Prevention Services-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 goal of this study is to evaluate the effectiveness of mailing 
out rapid HIV home-testing kits and additional testing promotion 
components to increase HIV testing among black/African-American or 
Hispanic/Latino MSM. The findings from this research will assist local 
and state health departments, and community based organizations in 
making decisions on how to improve HIV testing and linkage to HIV 
prevention services for black/African American and Hispanic/Latino men 
who have sex with men.
    The research study is a randomized control trial and all survey 
data will be collected over the internet. There will not be any in-
person surveys. We will advertise the study on internet websites 
frequented by black and Hispanic MSM. People will click on a banner ad 
and will be taken to a study website that provides a brief overview of 
the study. Those who are interested in participating will complete a 
brief survey to determine their eligibility. Men who are eligible will 
complete registration information and then download a study phone app 
onto their smartphone. The app will allow them to complete a baseline 
survey. After completing the baseline survey, they will be randomized 
into one of three conditions.
    All participants will be sent a rapid HIV test kit and they will 
report their results to the study. Men assigned to all study arms will 
use the study app to complete study activities. All participants will 
have access to web-based HIV counseling upon request. Participants who 
report a positive HIV test result will be offered web-based HIV 
counseling if they have not previously requested counseling. Men 
assigned to the control arm will only have access to the study app and 
web-based counseling. Men assigned to one intervention arm will also be 
able to access another smartphone app (HealthMindr) that will allow 
them to engage in additional study activities. Men assigned to the 
second intervention arm will have access to a web-based forum 
(HealthEmpowerment) covering HIV prevention and not the HealthMindr 
app. At four months after enrollment, all participants will complete an 
online survey and will be offered additional HIV testing materials to 
complete.
    The subpopulation are individuals who: (1) Identify as African-
American/black or Hispanic/Latino; (2) report their HIV status as 
negative or report being unaware of their HIV status; (3) are not 
currently using PrEP or participating in other HIV testing prevention 
studies; (4) have had anal intercourse with another man in the past 12 
months; (5) reside in one of the study states; (6) Are 18 years or 
older; (7) born male; and (8) identify as male. We will evaluate the 
comparative effectiveness of the HIV home-testing kits and additional 
testing promotion components with respect to linkage of participants to 
appropriate services (HIV treatment, PrEP, STI testing, additional 
prevention and social services). These analyses will determine whether 
any such differences are significant within and across study arms, and 
by race/ethnicity.
    Depending on the study arm to which participants are assigned, 
filling out data collection forms, engaging with testing promotion 
components, and completing and submitting at-home HIV testing will 
require between 2 hours 53 minutes and 4 hours and 13 minutes of a 
participant's time over the course of the entire study period.
    The participation of respondents is voluntary. There is no cost to 
the respondents other than their time. The total estimated annual 
burden hours for the proposed project are 7,011 hours.

                                        Estimated Annualized Burden Hours
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                                                                     Number of
                                                     Number of     responses per  Average burden       Total
      Type of respondent            Form name       respondents   respondent per   per response   ResponseBurden
                                                                       year          (in Hrs)        (in Hrs)
----------------------------------------------------------------------------------------------------------------
Potential participant.........  Eligibility               10,000              18           10/60            1667
                                 Consent.
Potential participant.........  Eligibility               10,000               1            3/60             500
                                 Screener.
Potential participant.........  Study Consent...           4,000               1           10/60             667
Potential participant.........  Registration               3,800               7            5/60             317
                                 contact
                                 information.
Enrolled participant..........  Baseline Survey.           3,600             110           30/60           1,800
Enrolled participant..........  HIV Test Result            3,000              10            5/60             250
                                 Survey.
Enrolled participant..........  Follow-up Survey           3,000             120           30/60           1,500
Enrolled participant..........  HIV Test Result            3,000              10            5/60             250
                                 Survey
                                 (completion).
Enrolled participant..........  Product ordering           1,200               2            3/60              60
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           7,011
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[[Page 62866]]

Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2018-26350 Filed 12-4-18; 8:45 am]
 BILLING CODE 4163-18-P