Notice2022-04190
Proposed Data Collections 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
March 1, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 40 (Tuesday, March 1, 2022)</title>
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[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
[Notices]
[Pages 11445-11446]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">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 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:
<a href="/cdn-cgi/l/email-protection#ea858788aa898e89c48d859c"><span class="__cf_email__" data-cfemail="7d12101f3d1e191e531a120b">[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 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:
<bullet> Gay, bisexual, and other men who have sex with men
subdivided by race/ethnicity:
[cir] Black/African American,
[cir] Hispanic/Latino, or
[cir] White;
<bullet> Black/African American heterosexual persons subdivided by
biological sex:
[cir] Men or
[cir] Women;
<bullet> Transgender women; and
<bullet> 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..........
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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
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