Notice2022-22025
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 11, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 195 (Tuesday, October 11, 2022)</title>
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[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61327-61329]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22025]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-22CX]
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 ``Preferences for Longer-Acting Preexposure
Prophylaxis (PrEP) Methods Among Persons in US Populations at Highest
Need: A Discrete Choice Experiment'' 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 March 2, 2022, to obtain comments from the
public and affected agencies. CDC did not receive 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
[[Page 61328]]
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
Preferences for Longer-Acting Preexposure Prophylaxis (PrEP)
Methods Among Persons in US Populations at Highest Need: A Discrete
Choice Experiment--New--National Center for HIV, Viral Hepatitis, STD,
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The 2022-2025 National HIV/AIDS Strategy includes a goal of
increasing PrEP coverage to 50% among persons with indications, from a
2017 baseline of 13.2%. Despite successes in development and scale up
of daily oral pre-exposure prophylaxis (PrEP) as a biomedical HIV
prevention product, studies consistently show obstacles to its uptake
and continuation. The Centers for Disease Control and Prevention (CDC)
and its partners must engage in early planning for the implementation
of longer-acting (LA)-PrEP agents to help achieve the U.S. Ending the
HIV Epidemic (EHE) goal of reducing incident HIV infections by 90% by
2030. Understanding providers' and priority populations' preferences
for different LA-PrEP agents and perceived advantages and disadvantages
of each product will be critical to estimating future uptake and market
share of the various products that are likely to come to market.
The goal of this study is to understand preferences for long-acting
pre-exposure prophylaxis (LA-PrEP) products for HIV prevention among
potential users and providers, including product characteristics and
other service delivery factors that may facilitate or hinder future
uptake of these products. RTI will collaborate with CDC to conduct a
discrete choice experiment (DCE) among providers and potential users of
LA-PrEP products to elicit their preferences for characteristics of LA-
PrEP and delivery programs to maximize uptake of LA-PrEP among people
in need of HIV prevention methods. Results from this experiment will be
used to identify factors key to adoption and implementation of each
product and increase implementation efficiency by identifying
strategies to support decision making and address potential use
challenges early on.
The study design is a cross-sectional, online survey comprised of a
DCE and additional questions to directly elicit participant preferences
and gather data on socioeconomic, behavioral, and attitudinal factors.
DCE methods are based on the principle that products or services are
evaluated through their multiple features or `attributes,' and that an
individual's choice of a product or service is a function of the
utility of each attribute option or `level.' Attributes and their
corresponding levels are chosen to represent the features of
medications, devices, and health care services that are relevant to a
health care decision.
The proposed information collection will include two separate DCE
surveys: one for priority populations; and one for clinicians. The
survey uses an experimental design to combine levels from each
attribute into hypothetical product profiles and to pair profiles into
choice tasks. The experimental design will be split into several blocks
or versions. Each equally sized block will have 11 questions, with one
question being repeated across blocks. Participants will be randomly
assigned to a block and will see only one block when completing the
survey instrument.
The study's target population includes clinical providers ages 18
and older who prescribe PrEP and the following priority population
groups who were selected because they have the highest rates of HIV
acquisition and are in need for HIV prevention services. To be eligible
for the study, potential participants in each of the priority
population groups must be 18 years of age and older, living without
HIV, and meet the U.S. Public Health Service (USPHS) indications for
offering PrEP as described in the 2021 USPHS Clinical Practice
Guidelines.
The study sample will be recruited from cities with high numbers of
annual HIV diagnoses within the 57 priority jurisdictions identified as
part of the Ending the HIV Epidemic (EHE) initiative. Data collection
will last approximately six months. Participants will be randomly
assigned to a block when they are sent their unique DCE survey link and
will only complete the set of choice tasks in that block. Throughout
the study, we will closely monitor recruitment and data collection to
ensure that screening criteria are being met, key demographic groups
are adequately represented, and survey completion rates are acceptable.
Participants will be reimbursed $20 upon completion of the DCE. A Visa
gift card will be sent electronically or mailed via the postal system
based on the participant's choice.
Participation is voluntary. For this study, CDC intends to screen
approximately 9,200 participants and enroll 1,840. CDC estimates that
approximately 15% of enrolled participants will be removed from the
analysis due to fraud or incomplete data, resulting in a final analysis
sample size of 1,600 participants. At 25 minutes per survey and 10
minutes per combined screener and consent, CDC requests OMB approval
for an estimated 2,282 annualized burden hours. There are no costs to
participants other than their time.
[[Page 61329]]
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 hours)
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Potential LA-PrEP users or Clients.... Client Screening Survey 8,050 1 10/60
& Consent Form.
C4P Client DCE Survey... 1,610 1 25/60
Clinical providers who prescribe PrEP, Provider Screening 1,150 1 10/60
in the United States. Survey & Consent Form.
C4P Provider DCE Survey. 230 1 20/60
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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. 2022-22025 Filed 10-7-22; 8:45 am]
BILLING CODE 4163-18-P
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