[Federal Register Volume 88, Number 193 (Friday, October 6, 2023)]
[Notices]
[Pages 69638-69640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22271]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-24-23AQ]


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 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)'' 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 November 16, 2022, to obtain comments from 
the public and affected agencies. CDC received two 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 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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 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, TB 
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC is requesting approval for three years for a data collection 
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).'' 
The purpose of the information collection is to understand men's 
strategies to prevent HIV and sexually transmitted infections (STIs), 
including preexposure prophylaxis (PrEP) use and adherence, condom use, 
sexual risk-taking behavior, and substance-using behaviors. This study 
will assess men's use and preferences for prevention modalities and 
their awareness, knowledge, beliefs, and perceptions about products 
that prevent the transmission of HIV and other sexually transmitted 
diseases (STD). This study will also conduct structured assessments to 
identify HIV prevention gaps and test prevention messages for men who 
have sex with men (MSM).
    The information collected in this study will be used to: (1) 
describe real-world HIV and STI prevention strategies including PrEP 
and condom use and

[[Page 69639]]

adherence; (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 message testing; and (4) provide timely new information 
to public health programs and decision makers. The study will be 
carried out in three cities: Atlanta, GA; Chicago, IL; and San Diego, 
CA. Participants will include 1,275 HIV-negative men ages 18 and older. 
Cohort participants will identify as cisgender male; report sex with a 
man in the last six months; and be fluent in written/spoken English or 
Spanish. We will use purposive sampling to ensure that 60% of 
participants will be PrEP users at baseline, and 40% will not be using 
PrEP at that point. We will also oversample Black/African American and 
Hispanic/Latino 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.
    A computer-assisted quantitative assessment will collect 
information about participants' use of prevention modalities, as well 
as their awareness, knowledge, beliefs, and perceptions about HIV/STI 
prevention products and prevention messages. The study will utilize the 
SMaRT (Study Management and Retention Toolkit) system, a study 
management platform for participant management that includes a HIPPA-
compliant companion mobile app that study participants install on their 
smart phones. The app supports several key functions of study 
participation including notifications of surveys available, 
administration of surveys, a messaging center, appointment scheduling, 
secure HIPPA-compliant document upload and return of laboratory 
results, and a HIPPA-compliant telehealth video conference platform. At 
six-month intervals starting at baseline, all participants will be 
mailed self-collection kits to provide samples for HIV and STI testing. 
Specimens for STI testing include urine, rectal, and pharyngeal swabs 
for gonorrhea and chlamydia and dried blood spot (DBS) for syphilis 
testing. HIV kits will collect DBS for 4th generation HIV testing. 
Tests will be shipped from, returned to, and processed by a CLIA-
certified laboratory. Participants will also have the option to self-
collect their specimens at a study site, where study staff will provide 
them with a self-collection kit and a private room in which to collect 
their specimens. A subset of the participant cohort 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. Participants 
will have the option to join virtual or in-person focus groups and 
interview sessions.
    Total study enrollment is 1,275 over the three-year data collection 
period. Based on screening and enrollment numbers from similar studies, 
we estimate we will need to screen 2,550 individuals (850 annually) to 
reach total enrollment. The screening process will take approximately 
five minutes to complete. Participants will be rescreened at the time 
of the enrollment visit. Contact information will be collected from 
1,275 participants (425 annually) and will take approximately five 
minutes to complete. The quantitative assessment will take 45 minutes 
to complete and will be delivered to 1,275 participants (850 annually) 
a total 8 times. The SMaRT app install will take 10 minutes to complete 
and will be completed by 1,275 participants (425 annually). The 
specimen kit for HIV testing will take approximately 20 minutes to 
complete and will be distributed to 1,275 participants (850 annually) a 
total of four times. The specimen kit for STI testing will take 
approximately 30 minutes to complete and will be distributed to 1,275 
participants (850 annually) a total of four times. A subset of the 
cohort participants will be invited to participate in qualitative data 
collection activities. A total of 144 participants (48 annually) will 
engage in a focus group that is estimated to take 90 minutes to 
complete, and 45 participants will be invited to participate in a 
series of three in-depth interviews to be administered at six-month 
intervals. The interviews will take approximately 60 minutes to 
complete.
    CDC is requesting 12,996 total burden hours across 3 years of data 
collection. The total estimated annualized burden hours are 4,332. 
Total burden for each activity has been rounded to the nearest whole 
hour. Participation of respondents is voluntary. There is no cost to 
participants other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondent                    Form name           respondents    responses per   response (in
                                                                                    respondent          hr)
----------------------------------------------------------------------------------------------------------------
General Public--Adults................  Eligibility Screener....             850               2            5/60
General Public--Adults................  Locator Form............             425               1            5/60
General Public--Adults................  Quarterly Assessment....             850               4           45/60
General Public--Adults................  SMaRT App Installation..             425               1           10/60
General Public--Adults................  Sample Collection for                850               2           20/60
                                         HIV Test.
General Public--Adults................  Sample Collection for                850               2           30/60
                                         STI Test.
General Public--Adults................  Focus Group.............              48               1           90/60
General Public--Adults................  In-Depth interview......              45               1           60/60
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[[Page 69640]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-22271 Filed 10-5-23; 8:45 am]
BILLING CODE 4163-18-P