[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Notices]
[Pages 68696-68698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24919]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-23AQ; Docket No. CDC-2022-0129]


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 information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled Understanding HIV/STD Risk and Enhancing PrEP Implementation 
Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and 
Other Men Who Have Sex with Men in a Transformational Era (MIC-DROP). 
This project is a prospective cohort study to understand men who have 
sex with men's (MSM) strategies to prevent HIV and sexually transmitted 
infections (STIs), including pre-exposure prophylaxis (PrEP) use and 
adherence, condom use, sexual risk-taking behavior and substance-using 
behaviors.

DATES: CDC must receive written comments on or before January 17, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0129 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without

[[Page 68697]]

change, all relevant comments to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118; 
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;
    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; and
    5. Assess information collection costs.

Proposed Project

    Understanding HIV/STD Risk and Enhancing PrEP Implementation 
Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and 
Other Men Who Have Sex with Men in a Transformational Era (MIC-DROP)--
New--National Center for HIV, Viral Hepatitis, STD, and TB Prevention 
(NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The National Center for HIV, Viral Hepatitis, STD, and TB 
Prevention (NCHHSTP) is requesting approval for 36 months of data 
collection entitled Understanding HIV/STD Risk and Enhancing PrEP 
Implementation Messaging in a Diverse Community-Based Sample of Gay, 
Bisexual, and Other Men Who Have Sex with Men in a Transformational Era 
(MIC-DROP). The purpose of this study is to enroll a prospective cohort 
of men who have sex with men (MSM) in Atlanta, Detroit, and San Diego 
to understand men's strategies to prevent HIV and other STIs including 
PrEP use and adherence, condom use, sexual risk-taking behavior, and 
substance-using behaviors. This study also proposes to assess men's use 
and preferences for prevention modalities and assess men's awareness, 
knowledge, beliefs, and perceptions about HIV/STI prevention products.
    The information collected in this study will be used to: (1) 
describe real-world HIV and STI prevention strategies including PrEP 
use and adherence and condom use; (2) better understand men's use, 
preferences, knowledge, and perceptions about prevention modalities; 
(3) develop rapid reports that will allow for summary recommendations 
concerning gaps in prevention protection; and (4) provide timely new 
information to public health programs and decision makers.
    The study will be carried out in three cities, Atlanta, GA; 
Detroit, MI; and San Diego, CA. Participants will include 1275 HIV-
negative men ages 18 and older. Participants will identify as cisgender 
male; report male at birth; report sex with a man in the last six 
months; live in or near Atlanta, Detroit, or San Diego; own a cell 
phone with data service; be willing to download a health-related app as 
part of the study; be able to provide two or more means of contact; be 
fluent in written/spoken English or Spanish; and not currently be 
enrolled in another HIV prevention clinical trial. We will use 
purposive sampling to ensure that 60% of participants will be PrEP 
users at baseline, and 40% will not be using PrEP. We will also 
oversample Black and Hispanic MSM to ensure that a minimum of 30% each 
are represented in the cohort sample. Participants will be recruited 
using a combination of approaches including social media, referral, and 
in-person outreach.
    Quantitative and qualitative assessments will be used to collect 
information from participants. A quarterly quantitative survey will 
assess use of prevention modalities, awareness, knowledge, beliefs, and 
perceptions about HIV/STI prevention products and prevention messages. 
The SMaRT app study management platform allows for scheduling, 
reminders, survey administration, and communication by email and text 
messaging. HIV and STI test results will allow the study team to assess 
HIV and STI risk throughout the study period. A subset of the 
participants will be invited to further participate in qualitative data 
collection activities including focus groups and in-depth interviews. 
The focus groups will assess the participants' awareness of PREP 
messages, preferences for PrEP messages, and perceived impact/efficacy 
of HIV prevention and PrEP messages. The in-depth interviews will 
assess men's PrEP experiences, their preferences for PrEP and other HIV 
prevention products, and further explore their reactions to prevention 
messages.
    The screening process is estimated to take five minutes to 
complete. We estimate that the contact information gathering and the 
SMaRT app installation will take five minutes each to complete. The 
quantitative assessment is estimated to take 45 minutes to complete and 
will be delivered quarterly for a total eight times over the two-year 
follow up period. Participants will be asked to collect specimens for 
both HIV and STI testing at six-month intervals for a total of four 
times over the two-year follow up period. The specimen kit for HIV 
testing will take approximately 15 minutes to complete. The specimen 
kit for STI testing will take approximately 30 minutes to complete. A 
subset of the 1,275 enrolled participants will be invited to 
participate in qualitative data activities: 270 participants will 
engage in a focus group that is estimated to take 90 minutes to 
complete, and 30 participants will be invited to participate in three 
in-depth interviews to be delivered at six-month intervals over the 
two-year follow up period. The interviews will take approximately 90 
minutes to complete.
    CDC requests OMB approval for an estimated 2,214 annual burden 
hours. There are no costs to the respondents other than their time to 
participate.

[[Page 68698]]



                                        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 hr)         (in hr)
----------------------------------------------------------------------------------------------------------------
General Public--Adults........  Eligibility                  850               1            5/60              68
                                 Screener.
General Public--Adults........  Contact                      425               1            5/60              34
                                 Information.
General Public--Adults........  SMaRT App                    425               1            5/60              34
                                 Installation.
General Public--Adults........  Quantitative                 425               4           45/60           1,275
                                 Survey.
General Public--Adults........  Sample                       425               2           15/60             213
                                 Collection for
                                 HIV Test.
General Public--Adults........  Sample                       425               2           30/60             425
                                 Collection for
                                 STI Test.
General Public--Adults........  Focus Group                   90               1           90/60             135
                                 Guide.
General Public--Adults........  In-Depth                      10               2           90/60              30
                                 interview Guide.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           2,214
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-24919 Filed 11-15-22; 8:45 am]
BILLING CODE 4163-18-P