[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)]
[Notices]
[Pages 46996-46997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17AZI; Docket No. CDC-2017-0075]


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 a proposed study 
titled ``Understanding Decisions and Barriers about PrEP Use and Uptake 
among Men Who Have Sex with Men.'' 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.

DATES: CDC must receive written comments on or before December 11, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0075 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 Federal 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

    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 (NCHHSTP), 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 
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 3 months).

[[Page 46997]]

    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 Unite States. Findings will also 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 costs to the 
respondents other than their time, travel costs, and the total 
estimated annual burden hours.

                                        Estimated Annualized Burden Hours
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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........  Screener #1.....             600               1            5/60              50
General Public--Adults........  Consent Forms...             300               1            1/60               5
General Public--Adults........  In-depth                      60               1           45/60              45
                                 Interview Guide.
General Public--Adults........  Focus Group                   60               1               1              60
                                 Moderator Guide.
General Public--Adults........  Eligibility                  300               1            5/60              25
                                 verification
                                 (verification
                                 of continuing
                                 eligibility).
General Public--Adults........  Behavioral                   300               1           30/60             150
                                 Assessment.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             335
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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. 2017-21750 Filed 10-6-17; 8:45 am]
BILLING CODE 4163-18-P