[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
[Notices]
[Pages 11445-11446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04190]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-22CX; Docket No. CDC-2022-0031]


Proposed Data Collections 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), in the 
Department of Health and Human Services (HHS), as part of its 
continuing effort to reduce public burden, invites the general public 
and other federal agencies to take this opportunity to comment on 
proposed and/or continuing information collections, as required by the 
Paperwork Reduction Act of 1995. This notice invites comment on a 
proposed information collection project titled Preferences for Longer-
Acting Preexposure Prophylaxis (LA-PrEP) Methods Among Persons in U.S. 
Populations at Highest Need: A Discrete Choice Experiment. The proposed 
project is designed to understand preferences for LA-PrEP products for 
HIV prevention among potential users and providers.

DATES: CDC must receive written comments on or before May 2, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0031, by either of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     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 change, all relevant comments 
to regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) 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; phone: 404-639-7118; Email: 
[email protected].

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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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

    Preferences for Longer-Acting Preexposure Prophylaxis (LA-PrEP) 
Methods Among Persons in U.S. 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 pre-exposure prophylaxis (PrEP) coverage to 50 percent among 
persons with indications, from a 2017 baseline of 13.2 percent. Despite 
successes in development and scale up of daily oral 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 PrEP (LA-PrEP) agents to help achieve 
the U.S. Ending the HIV Epidemic (EHE) goal of reducing incident HIV 
infections by 90 percent 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 use of the various products that are 
recently or soon likely to become available for prescription.
    The goal of this study is to understand preferences for 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. In 
cooperation with partners, CDC will 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 challenges.
    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

[[Page 11446]]

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 healthcare services that are relevant to a 
healthcare 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 8-12 questions, and 
questions will not be 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 persons ages 18 and older 
who either (1) prescribe PrEP or (2) are in the following priority 
population groups selected because they have the highest rates of HIV 
acquisition and are in need for HIV prevention services:
     Gay, bisexual, and other men who have sex with men 
subdivided by race/ethnicity:
    [cir] Black/African American,
    [cir] Hispanic/Latino, or
    [cir] White;
     Black/African American heterosexual persons subdivided by 
biological sex:
    [cir] Men or
    [cir] Women;
     Transgender women; and
     Persons who inject drugs.
    To be eligible for the study, potential participants in each of the 
priority population groups must be 18 years of age or 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 EHE initiative. 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.
    Participation is voluntary. For this study, CDC intends to screen 
approximately 9,200 participants and enroll 1,840 participants. CDC 
estimates that approximately 15 percent 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 screening and consent, CDC 
requests approval for an estimated 2,341 annualized burden hours. There 
are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
     (Type of) respondents          Form name       respondents   responses  per   response  (in    (in hours)
                                                                     respondent       hours)
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Black/African American,         Screening &                3,450               1           10/60             587
 Hispanic/Latino, or White men   Consent.                    690               1           25/60             290
 who are gay, bisexual or have  Survey..........
 sex with men, ages 18+ in the
 United States.
Black/African American          Screening &                2,300               1           10/60             391
 Heterosexual Cisgender Men or   Consent.                    460               1           25/60             194
 Women, ages 18+, in the        Survey..........
 United States.
Transgender Women, ages 18+,    Screening &                1,150               1           10/60             196
 in the United States.           Consent.                    230               1           25/60              97
                                Survey..........
Persons who inject drugs, ages  Screening &                1,150               1           10/60             196
 18+, in the United States.      Consent.                    230               1           25/60              97
                                Survey..........
Clinical providers who          Screening &                1,150               1           10/60             196
 prescribe PrEP, in the United   Consent.                    230               1           25/60              97
 States.                        Survey..........
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           2,341
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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. 2022-04190 Filed 2-28-22; 8:45 am]
BILLING CODE 4163-18-P