[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61327-61329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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

    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)
----------------------------------------------------------------------------------------------------------------
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