Notice2022-24919
Proposed Data Collection Submitted for Public Comment and Recommendations
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
November 16, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 220 (Wednesday, November 16, 2022)</title>
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[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Notices]
[Pages 68696-68698]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#e08f8d82a0838483ce878f96"><span class="__cf_email__" data-cfemail="0966646b496a6d6a276e667f">[email protected]</span></a>.
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)
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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.
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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
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