[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45442-45443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19378]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-17AZI]


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 Understanding Decisions and Barriers about 
PrEP Use and Uptake Among Men Who Have Sex With Men 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 October 10, 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

[[Page 45443]]

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 <a href="/cdn-cgi/l/email-protection#6c03010e2c0f080f420b031a"><span class="__cf_email__" data-cfemail="533c3e31133037307d343c25">[email protected]</span></a>. 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

    Understanding Decisions and Barriers about PrEP Use and Uptake 
Among Men Who Have Sex With Men--New--National Center for HIV/AIDS, 
Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    This project involves original, formative research toward improving 
the uptake and adherence necessary to achieve efficacious levels of 
protection offered by pre-exposure prophylaxis (PrEP) among the most 
highly affected population. HIV incidence and prevalence are higher 
among gay, bisexual, and other men who have sex with men (MSM) than any 
other risk group in the U.S. Approximately half of all diagnosed HIV 
infections are among gay, bisexual, and other MSM. The FDA-approved 
PrEP regimen, daily Tenofovir/emtricitabine (aka Truvada[supreg]), has 
shown greater than 90% efficacy in reducing HIV infections among MSM 
when taken in accordance with its prescribed daily schedule. In 2014, 
CDC published clinical practice guidelines for the use of PrEP in high-
risk populations, and began national promotion of PrEP as an effective 
HIV prevention strategy for MSM. While hailed as an HIV-prevention 
``game-changer,'' in reality PrEP uptake has been slow. Some studies 
report a wide range in the percentages of MSM (28-81%) interested in 
PrEP. In addition, other studies indicate that specific cities have 
alarmingly low rates of PrEP uptake (for example, the estimate for 
Atlanta is 2%). Moreover, recent survey findings have shown that less 
than 1 in 10 MSM on PrEP are adherent to their PrEP regimen; adherence 
is necessary to optimize efficacy.
    In order to develop effective programs that increase PrEP uptake 
among MSM at greatest risk for HIV, studies are needed to better 
understand the decisions men make about their HIV prevention needs. 
Qualitative methods will be used to explore in-depth the ``Whys'' and 
``How's'' of MSM's decisions to refuse or use PrEP, and barriers and 
challenges to successfully undertake a PrEP medication regimen. 
Quantitative methods will be used to understand the HIV risk behavior 
context, attitudes towards PrEP, health seeking behavior, and 
acceptability of new modes of PrEP delivery (that differ from current 
recommendation of daily PrEP and that are in development or discussion) 
and emerging biomedical HIV prevention options.
    The purpose of this research is to explore decisions, barriers, and 
facilitators about PrEP use among MSM: (1) Who were offered PrEP but 
refused it; (2) who were interested in or started a PrEP regimen but 
did not follow through; and (3) who are eligible for PrEP per CDC 
guidelines (report condomless anal sex within last three months) but 
not currently on PrEP.
    This study will provide insight on individual and community level 
PrEP-related decision-making, and identify barriers and facilitators to 
successful PrEP initiation and PrEP acceptability. Findings will 
improve programming, in line with the CDC Division of HIV/AIDS 
Prevention goal of high-impact prevention to reduce HIV infections in 
the U.S. Findings will assist the CDC and frontline public health 
programs in identifying and designing programs and intervention 
approaches that encourage, support, and maintain appropriate PrEP 
uptake among eligible MSM and anticipate future HIV prevention needs, 
including anticipated changes in PrEP delivery.
    The total annual burden hours are 335. There are no other costs to 
the respondents other than their time to participate.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
General Public--Adults................  Screener................             600               1            5/60
General Public--Adults................  Contact Information Form             300               1            1/60
General Public--Adults................  In-Depth Interview Guide              60               1           45/60
General Public--Adults................  Focus Group Moderator                 60               1               1
                                         Guide.
General Public--Adults................  Eligibility verification             300               1            5/60
                                         (verification of
                                         continuing eligibility).
General Public--Adults................  Structured response self-            300               1           30/60
                                         administered behavioral
                                         assessment.
----------------------------------------------------------------------------------------------------------------


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. 2018-19378 Filed 9-6-18; 8:45 am]
BILLING CODE 4163-18-P


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