Notice2023-22271
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 6, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 193 (Friday, October 6, 2023)</title>
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[Federal Register Volume 88, Number 193 (Friday, October 6, 2023)]
[Notices]
[Pages 69638-69640]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hr)
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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
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