Agency Forms Undergoing Paperwork Reduction Act Review, 62793-62795 [2023-19706]
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Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices
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. 2023–19708 Filed 9–12–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–22GA]
ddrumheller on DSK120RN23PROD with NOTICES1
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 ‘‘Expanding
PrEP in Communities of Color (EPICC)’’
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 June 13, 2022, to obtain
comments from the public and affected
agencies. CDC received four 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
VerDate Sep<11>2014
17:37 Sep 12, 2023
Jkt 259001
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
Expanding PrEP in Communities of
Color (EPICC)—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 36
months for a data collection titled,
Expanding PrEP in Communities of
Color (EPICC). The purpose of this study
is to implement and evaluate the
effectiveness of a clinic-based
intervention that utilizes evidencebased education and support tools to:
(1) increase provider knowledge of and
comfort with preexposure prophylaxis
(PrEP) modalities in clinical practice;
and (2) improve PrEP adherence among
young men who have sex with men
(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 EPICC+ mobile app among YMSM
on PrEP; and (4) evaluate the feasibility
and acceptability of implementing a
provider training.
This study has two aims: In Aim 1,
the study team will deliver training to
health providers that will focus on
implementation of evidence-based tools
to enhance the providers’ ability to
engage in PrEP screening, counseling,
initiation and to provide support for
adherence and persistence. The study
will utilize web-based computerassisted surveys to measure healthcare
provider knowledge both pre- and posttraining. Post-training and at three
months, providers will complete a
patient interaction assessment via
teleconference and receive personalized
PO 00000
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62793
feedback to assess and enhance their
tailored motivational interviewing
skills.
For Aim 2a, the study will initiate an
effectiveness-implementation trial with
400 YMSM to test the effectiveness of
the EPICC+ intervention package in
increasing PrEP adherence and
persistence among YMSM. The
intervention will utilize a mobile appbased platform, EPICC+, to support
ongoing participant engagement and
monitoring, as well as to provide
additional adherence support. YMSM
participants will complete quarterly
web-based computerized assessments
during the 18-month follow up period.
The assessments will measure PrEP
knowledge, usage, and choice, and
gather information about sexual
behaviors, HIV status of partners, and
substance use. YMSM participants will
be mailed four dried blood spot
collection kits to measure PrEP
metabolites (baseline, six, 12, and 18
months). To further examine the
participant experience and intervention
satisfaction, a subset of YMSM
participants (45) will be invited to
participate in a web-based exit
interview at the close of the follow up
period (18 months). Additionally, study
staff will collect data to measure mobile
app use and conduct medical record
abstractions three times during the
follow up period (six, 12, and 18
months).
In Aim 2b, the study team will
conduct focus groups with health
providers from the participating clinics
to gather feedback on overall
perceptions about the effectiveness of
the intervention and the barriers and
facilitators to implementation of the
evidence-based tools (EBT) within their
clinical site. Providers will complete a
short web-based computer-assisted prefocus group survey prior to the virtual
two-hour focus group. To describe PrEP
services implementation at the facility
level, each participating clinic will
complete a web-based computerassisted clinic assessment at six-month
intervals during the three-year data
collection period (baseline, six, 12, 18,
24, 30, and 36 months).
This study will be carried out in nine
clinics located in Chicago, IL; Bronx,
New York City, NY; Philadelphia, PA;
Charlotte, NC; Raleigh, NC; Tuscaloosa,
AL; Tampa, FL; Orlando, FL; and
Houston, TX. Aim 1 will include
healthcare providers from the nine
clinic sites, all involved in the direct
delivery of PrEP services. Providers may
include but are not limited to medical
doctors, nurses, adherence counselors,
pharmacists, and social workers. Health
providers will be recruited via staff
E:\FR\FM\13SEN1.SGM
13SEN1
62794
Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices
emails. Aim 2a participants will include
YMSM ages 18–39, inclusive.
Participants will identify as a cisgender
male; report sex with a man in the past
12 month; have an active prescription
for PrEP; receive care at one of the nine
participating study sites; provide a
mailing address within the 50 states
where packages can be received; have
daily smartphone access; and be fluent
in written/spoken English or Spanish.
We will use purposive sampling to
ensure at least 60% patient sample is
African American or Black or Hispanic/
Latino/Latinx. Patient participants will
be recruited to the study using a
combination of approaches including
social media, referral and in-person
outreach. Aim 2b will include
healthcare providers from the nine
clinic sites, all involved in the direct
delivery of PrEP services. Providers may
include but are not limited to medical
doctors, nurses, adherence counselors,
pharmacists, and social workers. Health
providers will be recruited via staff
emails.
Overall, this study will enroll up to
487 participants. Total study enrollment
for Aim 1 is 30 healthcare providers;
over the three-year study period
(estimated annual enrollment is 10).
Total enrollment for Aim 2a is 400
YMSM; over the three-year study period
(estimated annual enrollment is 134).
For Aim 2b, total study enrollment is 48
healthcare providers (estimated annual
enrollment is 16). Additionally, a clinic
staff member at each of the nine
participating clinic sites will complete a
clinic assessment form every six months
throughout the study period.
For the Aim 1 provider training, it is
expected that 50% of providers
screened will meet eligibility and
decide to enroll in the study. We
estimate that screening and the
collection of contact information will
each take five minutes. Pre-training and
post-training surveys will take
approximately 15 minutes each to
complete. Patient interaction
assessments delivered at baseline and
three months will take approximately 15
minutes each to complete.
For Aim 2a, the effectivenessimplementation trial, it is expected that
50% of YMSM screened will meet study
eligibility. The initial screening will
take approximately five minutes to
complete. The collection of contact
information and the completion of the
HIPAA form will take approximately
five minutes each to complete. The
baseline assessment will take
approximately 45 minutes to complete.
The follow-up assessments will take
approximately 45 minutes to complete
and will be administered quarterly for a
total of six times during the 18-month
follow up period. Study staff will assist
participants during the EPICC+ app
setup, a process that will take 30
minutes. The app setup is required of all
participants but app use after the setup
is voluntary. Participants will be mailed
a dried blood spot (DBS) specimen
collection kit that will take
approximately 30 minutes to read,
collect the specimen, and ship. The
patient exit interview takes
approximately 60 minutes to complete
and will be delivered one time to a
subset (45) of YMSM participants. For
the Aim 2b provider focus groups, it is
expected that 50% of providers
screened will meet eligibility and
decide to enroll in the study. We
estimate it will take approximately five
minutes to conduct the screening, five
minutes to collect contact information,
and another five minutes to conduct the
pre-focus group survey. Providers will
attend one focus group that is expected
to take 120 minutes to complete. Cliniclevel assessments will be completed by
clinic staff. The baseline and study end
assessments are estimated to take 120
minutes to complete. The assessments
conducted at six-month intervals
between the baseline and study end
points are expected to take 90 minute to
complete.
CDC is requesting 3,535 total burden
hours across 36-months of data
collection. The total estimated
annualized burden hours are 759.
Participation of respondents is
voluntary. There is no cost to
participants other than their time.
ddrumheller on DSK120RN23PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Health Practitioners .........................................
Health Practitioners .........................................
Health Practitioners .........................................
Health Practitioners .........................................
Health Practitioners .........................................
General Public—Adults ...................................
General Public—Adults ...................................
General Public—Adults ...................................
General Public—Adults ...................................
General Public—Adults ...................................
General Public—Adults ...................................
General Public—Adults ...................................
General Public—Adults ...................................
Health Practitioners .........................................
Health Practitioners .........................................
Aim 1 Provider Training Screener .................
Aim 1 Provider Training Contact Information
Aim 1 Provider Pre-Training Survey ..............
Aim 1 Provider Post-Training Survey ............
Aim 1 Provider Patient Interaction .................
Aim 2a Cohort Screener ................................
Aim 2a Cohort Contact Information ...............
Aim 2a Cohort HIPAA Form ..........................
Aim 2a Cohort Baseline Survey .....................
Aim 2a Cohort Follow-Up Survey ..................
Aim 2a Cohort App Setup ..............................
Aim 2a Cohort Blood Collection Instructions
Aim 2a Cohort Exit Interview .........................
Aim 2b Provider Focus Group Screener .......
Aim 2b Provider Focus Group Contact Information.
Aim 2b Provider Pre-Focus Group Survey ....
Aim 2b Provider Focus Group Guide ............
Aims 1&2 Clinic Assessment (Baseline and
Final).
Aims 1&2 Clinic Assessment (every 6
months).
Health Practitioners .........................................
Health Practitioners .........................................
Health Practitioners .........................................
Health Practitioners .........................................
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Number of
responses per
respondent
Number of
respondents
Type of respondents
E:\FR\FM\13SEN1.SGM
Average
burden per
response
(in hours)
20
10
10
10
10
267
134
134
134
134
134
134
15
32
16
1
1
1
1
2
1
1
1
1
3
1
2
1
1
1
2
1
3
3
5
22
11
11
101
302
67
134
15
3
1
16
16
9
1
1
1
1
32
18
9
2
27
13SEN1
Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices
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. 2023–19706 Filed 9–12–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–23EH]
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 ‘‘Public Health
Emergency Management Capacity
Assessment Tool (PHEM Tool)’’ 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 May 1, 2023 to obtain
comments from the public and affected
agencies. CDC received one comment
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
Public Health Emergency
Management Capacity Assessment Tool
(PHEM Tool)—New—Office of
Readiness and Response (ORR), Centers
for Disease Control and Prevention
(CDC).
62795
Background and Brief Description
The Centers for Disease Control and
Prevention’s (CDC) Global Emergency
Management Capacity Development
(GEMCD) team strengthens emergency
management capacity development
globally. It helps countries to prepare
for, anticipate, and respond to all forms
of public health threats. GEMCD’s
mission is to build resilient Public
Health Emergency Management (PHEM)
programs throughout the world.
The GEMCD team’s Emergency
Management Technical Advisors
(EMTAs) will use the PHEM Tool to
guide an in-person interview with
GHSA countries Ministry of Health,
Public Health Emergency Operations
Center (PHEOC) Manager and optional
additional staff, to characterize the
country’s PHEM program and
capabilities. EMTAs will document
responses in an excel based form that
will be entered into and maintained in
the CDCReady data base. Collected data
will identify strengths and weaknesses,
capabilities, and gaps in PHEM
programs and PHEOCs in GHSA
countries. Findings will guide GEMCD
team program planning initiatives and
determine appropriate technical
assistance (TA) for GHSA countries.
Data will be analyzed to identify the
presence or absence of specific PHEM
and PHEOC requirements, such as
plans, policies, and procedures, etc.
Additional analysis will focus upon the
status of PHEM and PHEOC plans,
policies, and procedures, e.g., date of
publication, relevance, etc. The survey
will be conducted annually to identify
progress and document changes from
one year to the next in terms of PHEM
program and PHEOC capabilities.
OMB approval is sought for three
years. The estimated annualized burden
for this information collection is 72
hours. There is no cost to respondents
other than their time.
ddrumheller on DSK120RN23PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Ministry of Health personnel responsible for Public Health
Emergency Management (PHEM) Program in participating GHSA countries.
PHEM Tool ............................
12
1
6
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. 2023–19707 Filed 9–12–23; 8:45 am]
BILLING CODE 4163–18–P
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13SEN1
]]>Agencies
[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Pages 62793-62795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19706]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-22GA]
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 ``Expanding PrEP in Communities of Color
(EPICC)'' 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 June 13,
2022, to obtain comments from the public and affected agencies. CDC
received four 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
Expanding PrEP in Communities of Color (EPICC)--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 36 months for a data collection
titled, Expanding PrEP in Communities of Color (EPICC). The purpose of
this study is to implement and evaluate the effectiveness of a clinic-
based intervention that utilizes evidence-based education and support
tools to: (1) increase provider knowledge of and comfort with
preexposure prophylaxis (PrEP) modalities in clinical practice; and (2)
improve PrEP adherence among young men who have sex with men (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 EPICC+
mobile app among YMSM on PrEP; and (4) evaluate the feasibility and
acceptability of implementing a provider training.
This study has two aims: In Aim 1, the study team will deliver
training to health providers that will focus on implementation of
evidence-based tools to enhance the providers' ability to engage in
PrEP screening, counseling, initiation and to provide support for
adherence and persistence. The study will utilize web-based computer-
assisted surveys to measure healthcare provider knowledge both pre- and
post-training. Post-training and at three months, providers will
complete a patient interaction assessment via teleconference and
receive personalized feedback to assess and enhance their tailored
motivational interviewing skills.
For Aim 2a, the study will initiate an effectiveness-implementation
trial with 400 YMSM to test the effectiveness of the EPICC+
intervention package in increasing PrEP adherence and persistence among
YMSM. The intervention will utilize a mobile app-based platform,
EPICC+, to support ongoing participant engagement and monitoring, as
well as to provide additional adherence support. YMSM participants will
complete quarterly web-based computerized assessments during the 18-
month follow up period. The assessments will measure PrEP knowledge,
usage, and choice, and gather information about sexual behaviors, HIV
status of partners, and substance use. YMSM participants will be mailed
four dried blood spot collection kits to measure PrEP metabolites
(baseline, six, 12, and 18 months). To further examine the participant
experience and intervention satisfaction, a subset of YMSM participants
(45) will be invited to participate in a web-based exit interview at
the close of the follow up period (18 months). Additionally, study
staff will collect data to measure mobile app use and conduct medical
record abstractions three times during the follow up period (six, 12,
and 18 months).
In Aim 2b, the study team will conduct focus groups with health
providers from the participating clinics to gather feedback on overall
perceptions about the effectiveness of the intervention and the
barriers and facilitators to implementation of the evidence-based tools
(EBT) within their clinical site. Providers will complete a short web-
based computer-assisted pre-focus group survey prior to the virtual
two-hour focus group. To describe PrEP services implementation at the
facility level, each participating clinic will complete a web-based
computer-assisted clinic assessment at six-month intervals during the
three-year data collection period (baseline, six, 12, 18, 24, 30, and
36 months).
This study will be carried out in nine clinics located in Chicago,
IL; Bronx, New York City, NY; Philadelphia, PA; Charlotte, NC; Raleigh,
NC; Tuscaloosa, AL; Tampa, FL; Orlando, FL; and Houston, TX. Aim 1 will
include healthcare providers from the nine clinic sites, all involved
in the direct delivery of PrEP services. Providers may include but are
not limited to medical doctors, nurses, adherence counselors,
pharmacists, and social workers. Health providers will be recruited via
staff
[[Page 62794]]
emails. Aim 2a participants will include YMSM ages 18-39, inclusive.
Participants will identify as a cisgender male; report sex with a man
in the past 12 month; have an active prescription for PrEP; receive
care at one of the nine participating study sites; provide a mailing
address within the 50 states where packages can be received; have daily
smartphone access; and be fluent in written/spoken English or Spanish.
We will use purposive sampling to ensure at least 60% patient sample is
African American or Black or Hispanic/Latino/Latinx. Patient
participants will be recruited to the study using a combination of
approaches including social media, referral and in-person outreach. Aim
2b will include healthcare providers from the nine clinic sites, all
involved in the direct delivery of PrEP services. Providers may include
but are not limited to medical doctors, nurses, adherence counselors,
pharmacists, and social workers. Health providers will be recruited via
staff emails.
Overall, this study will enroll up to 487 participants. Total study
enrollment for Aim 1 is 30 healthcare providers; over the three-year
study period (estimated annual enrollment is 10). Total enrollment for
Aim 2a is 400 YMSM; over the three-year study period (estimated annual
enrollment is 134). For Aim 2b, total study enrollment is 48 healthcare
providers (estimated annual enrollment is 16). Additionally, a clinic
staff member at each of the nine participating clinic sites will
complete a clinic assessment form every six months throughout the study
period.
For the Aim 1 provider training, it is expected that 50% of
providers screened will meet eligibility and decide to enroll in the
study. We estimate that screening and the collection of contact
information will each take five minutes. Pre-training and post-training
surveys will take approximately 15 minutes each to complete. Patient
interaction assessments delivered at baseline and three months will
take approximately 15 minutes each to complete.
For Aim 2a, the effectiveness-implementation trial, it is expected
that 50% of YMSM screened will meet study eligibility. The initial
screening will take approximately five minutes to complete. The
collection of contact information and the completion of the HIPAA form
will take approximately five minutes each to complete. The baseline
assessment will take approximately 45 minutes to complete. The follow-
up assessments will take approximately 45 minutes to complete and will
be administered quarterly for a total of six times during the 18-month
follow up period. Study staff will assist participants during the
EPICC+ app setup, a process that will take 30 minutes. The app setup is
required of all participants but app use after the setup is voluntary.
Participants will be mailed a dried blood spot (DBS) specimen
collection kit that will take approximately 30 minutes to read, collect
the specimen, and ship. The patient exit interview takes approximately
60 minutes to complete and will be delivered one time to a subset (45)
of YMSM participants. For the Aim 2b provider focus groups, it is
expected that 50% of providers screened will meet eligibility and
decide to enroll in the study. We estimate it will take approximately
five minutes to conduct the screening, five minutes to collect contact
information, and another five minutes to conduct the pre-focus group
survey. Providers will attend one focus group that is expected to take
120 minutes to complete. Clinic-level assessments will be completed by
clinic staff. The baseline and study end assessments are estimated to
take 120 minutes to complete. The assessments conducted at six-month
intervals between the baseline and study end points are expected to
take 90 minute to complete.
CDC is requesting 3,535 total burden hours across 36-months of data
collection. The total estimated annualized burden hours are 759.
Participation of respondents is voluntary. There is no cost to
participants other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Health Practitioners.................. Aim 1 Provider Training 20 1 2
Screener.
Health Practitioners.................. Aim 1 Provider Training 10 1 1
Contact Information.
Health Practitioners.................. Aim 1 Provider Pre- 10 1 3
Training Survey.
Health Practitioners.................. Aim 1 Provider Post- 10 1 3
Training Survey.
Health Practitioners.................. Aim 1 Provider Patient 10 2 5
Interaction.
General Public--Adults................ Aim 2a Cohort Screener.. 267 1 22
General Public--Adults................ Aim 2a Cohort Contact 134 1 11
Information.
General Public--Adults................ Aim 2a Cohort HIPAA Form 134 1 11
General Public--Adults................ Aim 2a Cohort Baseline 134 1 101
Survey.
General Public--Adults................ Aim 2a Cohort Follow-Up 134 3 302
Survey.
General Public--Adults................ Aim 2a Cohort App Setup. 134 1 67
General Public--Adults................ Aim 2a Cohort Blood 134 2 134
Collection Instructions.
General Public--Adults................ Aim 2a Cohort Exit 15 1 15
Interview.
Health Practitioners.................. Aim 2b Provider Focus 32 1 3
Group Screener.
Health Practitioners.................. Aim 2b Provider Focus 16 1 1
Group Contact
Information.
Health Practitioners.................. Aim 2b Provider Pre- 16 1 1
Focus Group Survey.
Health Practitioners.................. Aim 2b Provider Focus 16 1 32
Group Guide.
Health Practitioners.................. Aims 1&2 Clinic 9 1 18
Assessment (Baseline
and Final).
Health Practitioners.................. Aims 1&2 Clinic 9 2 27
Assessment (every 6
months).
----------------------------------------------------------------------------------------------------------------
[[Page 62795]]
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. 2023-19706 Filed 9-12-23; 8:45 am]
BILLING CODE 4163-18-P
