Agency Forms Undergoing Paperwork Reduction Act Review, 78043-78045 [2023-25081]
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78043
Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form Name
Adult Household Member ...............................
Sample Adult ...................................................
Adult Family Member ......................................
Adult Family Member ......................................
Sample Child ...................................................
Adult Family Member ......................................
Household Roster ..........................................
Adult Questionnaire ........................................
Child Questionnaire ........................................
Methodological Projects .................................
NHIS-Teen .....................................................
Reinterview Survey ........................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–25084 Filed 11–13–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–24–22FZ]
Agency Forms Undergoing Paperwork
Reduction Act Review
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of Respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘mChoice:
Improving PrEP Uptake and Adherence
among Minority MSM through Provider
Training and Adherence Assistance in
Two High Priority Settings’’ 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 August 21, 2023, to obtain
comments from the public and affected
agencies. CDC received three 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
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,
VerDate Sep<11>2014
16:48 Nov 13, 2023
Jkt 262001
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
mChoice: Improving PrEP Uptake and
Adherence among Minority MSM
through Provider Training and
Adherence Assistance in Two High
Priority Settings—New—National
Center for HIV, Viral Hepatitis, STD, TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The CDC is requesting approval for
three years for a data collection titled
mChoice: Improving PrEP Uptake and
Adherence among Minority MSM
through Provider Training and
Adherence Assistance in Two High
PO 00000
Frm 00096
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
36,000
33,000
10,000
15,000
667
5,500
1
1
1
1
1
1
Average
burden per
response
(in hours)
4/60
50/60
22/60
20/60
15/60
5/60
Priority Settings. The purpose of the
information collection is to implement
and evaluate the effectiveness of
mChoice, a clinic-based intervention
designed to improve HIV preexposure
prophylaxis (PrEP) adherence and
persistence among young men who have
sex with men (YMSM). The intervention
targets both health providers and PrEP
patients by providing evidence-based
training for health providers to improve
clinical knowledge and enhance
provider communications with patients,
and CleverCap, an electronic medication
monitoring device and mobile phone
application that provides health
information and medication and
appointment reminders for patients
undergoing PrEP treatment.
Data collected through this study will
be used to evaluate the mChoice
intervention for YMSM. The
information collected in this study will
be used to: (1) describe real-world PrEP
use including factors influencing
selection and change of PrEP regimens;
(2) understand and describe barriers and
facilitators impacting the
implementation of new PrEP modalities
in clinical practice; (3) evaluate the
feasibility and acceptability of the
CleverCap mobile app among YMSM on
PrEP; and (4) evaluate the feasibility and
acceptability of implementing provider
PrEP training.
The study will be carried out in four
clinics in two locations, New York City,
NY (2), and Birmingham, AL (2). For the
cohort, convenience and referral-based
sampling techniques will be used to
identify and recruit participants.
Participants will be young men between
the ages of 18 and 39 who have sex with
men; are using or initiating PrEP; and
live in the New York City or
Birmingham, AL area. Recruitment
controls will ensure enrollment of at
least 50% Black or African American or
Hispanic or Latino men. Cohort
participants will be recruited using a
combination of approaches including
print media posted in clinic waiting
rooms, social media, referral, and inperson outreach.
E:\FR\FM\14NON1.SGM
14NON1
78044
Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
For the provider training,
convenience and referral-based
sampling techniques will be used to
identify and recruit a total of 20
healthcare providers from the four
participating clinics. Providers will
include, but are not limited to, medical
doctors, nurse practitioners, physician
associates, nurses, adherence
counselors, pharmacists, and social
workers. A provider can include any
employee who discusses PrEP treatment
with patients. Providers will be
recruited using email invitations and
flyers posted at the clinic sites.
To evaluate the effectiveness of the
mChoice clinic intervention to increase
PrEP adherence and persistence among
YMSM, we will conduct a hybrid type
II trial. Participants will be asked to
complete computer assisted surveys at
baseline and quarterly in-person visits.
The surveys will assess participant
attitudes, knowledge, behavior, and
experiences related to PrEP, and risk
factors for HIV acquisition. Participants
will be given a CleverCap device to
track medication dispensed from their
prescription PrEP bottle. Participants
will also be asked to download the
companion CleverCap smartphone
application. The application is designed
to support PrEP adherence by providing
health information, appointment
reminders, medication reminders and
other supportive information. Data
collected from the app will include
prescription adherence data from
CleverCap and paradata to describe
overall app use and use of app
components. Data will also be collected
from urine specimens and from
electronic health records to describe the
PrEP prescription regimen and any
changes in PrEP regimen, evaluate PrEP
adherence, and assess sexual risk
through HIV and STI test results. To
further examine the participant
experience and intervention
satisfaction, a subset of the cohort will
be invited to participate in in-depth
interviews. During the in-person
interviews, participants will be asked to
elaborate on intervention satisfaction;
communications with providers; PrEP
choices, switching and decision making;
CleverCap and app use and
acceptability; and PrEP knowledge.
CDC will also conduct a PrEP training
for 20 healthcare providers from the
four participating clinic sites. The
provider training will include education
on available PrEP modalities and will be
aligned with the most recent CDC PrEP
guidelines. To evaluate the training,
providers will complete computer
assisted self-administered pre- and posttraining assessments to identify the
potential impact of the training module
on PrEP knowledge, attitudes, and
practice. Six-months after completing
the training, providers will be asked to
complete a post-implementation
interview to assess the impact of the
intervention on the provider’s work and
interactions with their patients.
Information to be collected from the
interviews will include training
satisfaction and opinions about the
effect of the training on clinic
operations, staff procedures, and client/
patient responses; barriers to PrEP care;
and attitudes and perceptions about
PrEP. Healthcare providers will have the
option to complete their interview inperson or using a web-based HIPAAcompliant platform. In addition to the
training and provider-level assessments,
at six-month intervals, clinic staff at
each of the four participating clinic sites
will complete a computer assisted clinic
assessment to describe PrEP services
implementation at the facility level.
Information collected from the
assessments will include facility hours
and scheduling; patient services; PrEP
services; PrEP prescribing information;
and available PrEP options.
For the patient trial, we will enroll a
total of 400 YMSM; over the three-year
data collection period the estimated
annual enrollment will be 134. It is
expected that 50% of YMSM screened
will meet study eligibility criteria and
agree to join the study; therefore, we
expect to screen 267 YMSM annually.
The collection of initial screening
information will take approximately 10
minutes to complete. Once enrolled, the
collection of locator information will
take an additional 10 minutes to
complete. Participants will complete a
baseline assessment which will take
approximately 45 minutes to complete
Participants will also complete followup assessments at 3-, 6-, 9-, 12- and 18month time points. The follow-up
assessments will take approximately 45
minutes to complete. Participants will
receive their CleverCap and be asked to
install the CleverCap app on their
mobile phones. We estimate the
CleverCap onboarding process will take
approximately 10 minutes to complete.
Use of the app after the initial install
will be optional. A subset (30 total) of
the YMSM participants will be invited
to participate in an in-depth interview.
The interview will take approximately
90 minutes to complete.
For the healthcare provider training,
we will enroll a total of 20 healthcare
providers. Over the 3-year data
collection period, the estimated annual
enrollment will be seven providers. It is
expected that 50% of healthcare
providers screened will meet study
eligibility criteria and agree to join the
study. Thus, we expect to screen 14
providers annually. The collection of
initial screening information from the
14 providers will take approximately 10
minutes to complete. The collection of
locator information from enrolled
participants will take an additional 10
minutes to complete. Provider
participants will be asked to complete
an assessment before and after the PrEP
training. Each assessment will take
approximately 30 minutes to complete.
Providers will also be asked to take part
in a 60-minute interview.
To evaluate the impact of the
intervention at the facility level, every
six months during the 36-month data
collection period, each of the four
participating clinic sites will complete
the clinic assessment tool to describe
PrEP services implementation at the
facility level. The clinic assessment will
be completed by a single member of the
clinic staff at each clinic (four
respondents total). Clinic-level
assessments at baseline and study end
are estimated to take 120 minutes to
complete. Clinic-level assessments
conducted at six-month intervals
between the baseline and study end
points are expected to take 90 minutes
to complete.
CDC is requesting OMB approval for
2,210 total burden hours across three
years of data collection. Participation of
respondents is voluntary. There are no
costs to the respondents other than their
time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
General Public—Adults ...................................
General Public—Adults ...................................
General Public—Adults ...................................
Patient Screener ............................................
Patient Locator Form .....................................
Patient Baseline Assessment ........................
VerDate Sep<11>2014
16:48 Nov 13, 2023
Jkt 262001
PO 00000
Frm 00097
Fmt 4703
Sfmt 4703
E:\FR\FM\14NON1.SGM
Number of
responses per
respondent
267
134
134
14NON1
1
1
1
Average
burden per
response
10/60
10/60
45/60
78045
Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
General Public—Adults ...................................
General Public—Adults ...................................
General Public—Adults ...................................
Health Practitioners .........................................
Health Practitioners .........................................
Health Practitioners .........................................
Health Practitioners .........................................
Health Practitioners .........................................
Health Practitioners .........................................
Health Practitioners .........................................
Patient Quarterly Assessment .......................
CleverCap App Setup ....................................
Patient Interview Guide ..................................
Provider Screener ..........................................
Provider Locator Form ...................................
Provider Pre-Training Assessment ................
Provider Post-Training Assessment ...............
Provider Interview Guide ................................
Clinic Assessment Baseline and Final ...........
Clinic Assessment Every Six Months ............
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–25081 Filed 11–13–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–24–0109]
Agency Forms Undergoing Paperwork
Reduction Act Review
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Respiratory
Protective Devices—42 CFR part 84’’ 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 November 28, 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
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,
VerDate Sep<11>2014
16:48 Nov 13, 2023
Jkt 262001
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
Respiratory Protective Devices—42
CFR part 84 (OMB Control No. 0920–
0109, Exp. 03/31/2024)—Revision—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The regulatory authority for the
National Institute for Occupational
Safety and Health (NIOSH) certification
program for respiratory protective
devices is found in the Mine Safety and
PO 00000
Frm 00098
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
134
134
10
14
7
7
7
7
4
4
3
1
1
1
1
1
1
1
1
2
Average
burden per
response
45/60
10/60
90/60
10/90
10/90
30/60
30/60
60/60
120/60
90/60
Health Amendments Act of 1977 (30
U.S.C. 577a, 651 et seq., and 657(g)) and
the Occupational Safety and Health Act
of 1970 (30 U.S.C. 3, 5, 7, 811, 842(h),
844). These regulations have, as their
basis, the performance tests and criteria
for approval of respirators used by
millions of American construction
workers, miners, painters, asbestos
removal workers, fabric mill workers,
and fire fighters.
Regulations of the Environmental
Protection Agency (EPA) and the
Nuclear Regulatory Commission (NRC)
also require the use of NIOSH Approved
respirators. These regulations also
establish methods for respirator
manufacturers to submit respirators for
testing under the regulation and have
them certified as NIOSH Approved if
they meet the criteria given in the above
regulation. This data collection was
formerly named Respiratory Protective
Devices 30 CFR part 11 but in 1995, the
respirator standard was moved to 42
CFR part 84.
NIOSH, in accordance with 42 CFR
part 84: (1) issues certificates of
approval for respirators which have met
specified construction, performance,
and protection requirements; (2)
establishes procedures and
requirements to be met in filing
applications for approval; (3) specifies
minimum requirements and methods to
be employed by NIOSH and by
applicants in conducting inspections,
examinations, and tests to determine
effectiveness of respirators; (4)
establishes a schedule of fees to be
charged for testing and certification; and
(5) establishes approval labeling
requirements. Information is collected
from those who request services under
42 CFR part 84 in order to properly
establish the scope and intent of
request.
Information collected from requests
for respirator approval functions
includes contact information and
information about factors likely to affect
respirator performance and use. Such
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78043-78045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25081]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-22FZ]
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 ``mChoice: Improving PrEP Uptake and
Adherence among Minority MSM through Provider Training and Adherence
Assistance in Two High Priority Settings'' 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 August 21, 2023, to obtain comments from
the public and affected agencies. CDC received three 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 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
mChoice: Improving PrEP Uptake and Adherence among Minority MSM
through Provider Training and Adherence Assistance in Two High Priority
Settings--New--National Center for HIV, Viral Hepatitis, STD, TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The CDC is requesting approval for three years for a data
collection titled mChoice: Improving PrEP Uptake and Adherence among
Minority MSM through Provider Training and Adherence Assistance in Two
High Priority Settings. The purpose of the information collection is to
implement and evaluate the effectiveness of mChoice, a clinic-based
intervention designed to improve HIV preexposure prophylaxis (PrEP)
adherence and persistence among young men who have sex with men (YMSM).
The intervention targets both health providers and PrEP patients by
providing evidence-based training for health providers to improve
clinical knowledge and enhance provider communications with patients,
and CleverCap, an electronic medication monitoring device and mobile
phone application that provides health information and medication and
appointment reminders for patients undergoing PrEP treatment.
Data collected through this study will be used to evaluate the
mChoice intervention for YMSM. The information collected in this study
will be used to: (1) describe real-world PrEP use including factors
influencing selection and change of PrEP regimens; (2) understand and
describe barriers and facilitators impacting the implementation of new
PrEP modalities in clinical practice; (3) evaluate the feasibility and
acceptability of the CleverCap mobile app among YMSM on PrEP; and (4)
evaluate the feasibility and acceptability of implementing provider
PrEP training.
The study will be carried out in four clinics in two locations, New
York City, NY (2), and Birmingham, AL (2). For the cohort, convenience
and referral-based sampling techniques will be used to identify and
recruit participants. Participants will be young men between the ages
of 18 and 39 who have sex with men; are using or initiating PrEP; and
live in the New York City or Birmingham, AL area. Recruitment controls
will ensure enrollment of at least 50% Black or African American or
Hispanic or Latino men. Cohort participants will be recruited using a
combination of approaches including print media posted in clinic
waiting rooms, social media, referral, and in-person outreach.
[[Page 78044]]
For the provider training, convenience and referral-based sampling
techniques will be used to identify and recruit a total of 20
healthcare providers from the four participating clinics. Providers
will include, but are not limited to, medical doctors, nurse
practitioners, physician associates, nurses, adherence counselors,
pharmacists, and social workers. A provider can include any employee
who discusses PrEP treatment with patients. Providers will be recruited
using email invitations and flyers posted at the clinic sites.
To evaluate the effectiveness of the mChoice clinic intervention to
increase PrEP adherence and persistence among YMSM, we will conduct a
hybrid type II trial. Participants will be asked to complete computer
assisted surveys at baseline and quarterly in-person visits. The
surveys will assess participant attitudes, knowledge, behavior, and
experiences related to PrEP, and risk factors for HIV acquisition.
Participants will be given a CleverCap device to track medication
dispensed from their prescription PrEP bottle. Participants will also
be asked to download the companion CleverCap smartphone application.
The application is designed to support PrEP adherence by providing
health information, appointment reminders, medication reminders and
other supportive information. Data collected from the app will include
prescription adherence data from CleverCap and paradata to describe
overall app use and use of app components. Data will also be collected
from urine specimens and from electronic health records to describe the
PrEP prescription regimen and any changes in PrEP regimen, evaluate
PrEP adherence, and assess sexual risk through HIV and STI test
results. To further examine the participant experience and intervention
satisfaction, a subset of the cohort will be invited to participate in
in-depth interviews. During the in-person interviews, participants will
be asked to elaborate on intervention satisfaction; communications with
providers; PrEP choices, switching and decision making; CleverCap and
app use and acceptability; and PrEP knowledge.
CDC will also conduct a PrEP training for 20 healthcare providers
from the four participating clinic sites. The provider training will
include education on available PrEP modalities and will be aligned with
the most recent CDC PrEP guidelines. To evaluate the training,
providers will complete computer assisted self-administered pre- and
post-training assessments to identify the potential impact of the
training module on PrEP knowledge, attitudes, and practice. Six-months
after completing the training, providers will be asked to complete a
post-implementation interview to assess the impact of the intervention
on the provider's work and interactions with their patients.
Information to be collected from the interviews will include training
satisfaction and opinions about the effect of the training on clinic
operations, staff procedures, and client/patient responses; barriers to
PrEP care; and attitudes and perceptions about PrEP. Healthcare
providers will have the option to complete their interview in-person or
using a web-based HIPAA-compliant platform. In addition to the training
and provider-level assessments, at six-month intervals, clinic staff at
each of the four participating clinic sites will complete a computer
assisted clinic assessment to describe PrEP services implementation at
the facility level. Information collected from the assessments will
include facility hours and scheduling; patient services; PrEP services;
PrEP prescribing information; and available PrEP options.
For the patient trial, we will enroll a total of 400 YMSM; over the
three-year data collection period the estimated annual enrollment will
be 134. It is expected that 50% of YMSM screened will meet study
eligibility criteria and agree to join the study; therefore, we expect
to screen 267 YMSM annually. The collection of initial screening
information will take approximately 10 minutes to complete. Once
enrolled, the collection of locator information will take an additional
10 minutes to complete. Participants will complete a baseline
assessment which will take approximately 45 minutes to complete
Participants will also complete follow-up assessments at 3-, 6-, 9-,
12- and 18-month time points. The follow-up assessments will take
approximately 45 minutes to complete. Participants will receive their
CleverCap and be asked to install the CleverCap app on their mobile
phones. We estimate the CleverCap onboarding process will take
approximately 10 minutes to complete. Use of the app after the initial
install will be optional. A subset (30 total) of the YMSM participants
will be invited to participate in an in-depth interview. The interview
will take approximately 90 minutes to complete.
For the healthcare provider training, we will enroll a total of 20
healthcare providers. Over the 3-year data collection period, the
estimated annual enrollment will be seven providers. It is expected
that 50% of healthcare providers screened will meet study eligibility
criteria and agree to join the study. Thus, we expect to screen 14
providers annually. The collection of initial screening information
from the 14 providers will take approximately 10 minutes to complete.
The collection of locator information from enrolled participants will
take an additional 10 minutes to complete. Provider participants will
be asked to complete an assessment before and after the PrEP training.
Each assessment will take approximately 30 minutes to complete.
Providers will also be asked to take part in a 60-minute interview.
To evaluate the impact of the intervention at the facility level,
every six months during the 36-month data collection period, each of
the four participating clinic sites will complete the clinic assessment
tool to describe PrEP services implementation at the facility level.
The clinic assessment will be completed by a single member of the
clinic staff at each clinic (four respondents total). Clinic-level
assessments at baseline and study end are estimated to take 120 minutes
to complete. Clinic-level assessments conducted at six-month intervals
between the baseline and study end points are expected to take 90
minutes to complete.
CDC is requesting OMB approval for 2,210 total burden hours across
three years of data collection. Participation of respondents is
voluntary. There are no costs to the respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average
Type of respondents Form name Number of responses per burden per
respondents respondent response
----------------------------------------------------------------------------------------------------------------
General Public--Adults................ Patient Screener........ 267 1 10/60
General Public--Adults................ Patient Locator Form.... 134 1 10/60
General Public--Adults................ Patient Baseline 134 1 45/60
Assessment.
[[Page 78045]]
General Public--Adults................ Patient Quarterly 134 3 45/60
Assessment.
General Public--Adults................ CleverCap App Setup..... 134 1 10/60
General Public--Adults................ Patient Interview Guide. 10 1 90/60
Health Practitioners.................. Provider Screener....... 14 1 10/90
Health Practitioners.................. Provider Locator Form... 7 1 10/90
Health Practitioners.................. Provider Pre-Training 7 1 30/60
Assessment.
Health Practitioners.................. Provider Post-Training 7 1 30/60
Assessment.
Health Practitioners.................. Provider Interview Guide 7 1 60/60
Health Practitioners.................. Clinic Assessment 4 1 120/60
Baseline and Final.
Health Practitioners.................. Clinic Assessment Every 4 2 90/60
Six Months.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2023-25081 Filed 11-13-23; 8:45 am]
BILLING CODE 4163-18-P
