Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 62793 

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] 

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 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 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Health Practitioners ......................................... Aim 1 Provider Training Screener ................. 20 1 2 

Health Practitioners ......................................... Aim 1 Provider Training Contact Information 10 1 1 

Health Practitioners ......................................... Aim 1 Provider Pre-Training Survey .............. 10 1 3 

Health Practitioners ......................................... Aim 1 Provider Post-Training Survey ............ 10 1 3 

Health Practitioners ......................................... Aim 1 Provider Patient Interaction ................. 10 2 5 

General Public—Adults ................................... Aim 2a Cohort Screener ................................ 267 1 22 

General Public—Adults ................................... Aim 2a Cohort Contact Information ............... 134 1 11 

General Public—Adults ................................... Aim 2a Cohort HIPAA Form .......................... 134 1 11 

General Public—Adults ................................... Aim 2a Cohort Baseline Survey ..................... 134 1 101 

General Public—Adults ................................... Aim 2a Cohort Follow-Up Survey .................. 134 3 302 

General Public—Adults ................................... Aim 2a Cohort App Setup .............................. 134 1 67 

General Public—Adults ................................... Aim 2a Cohort Blood Collection Instructions 134 2 134 

General Public—Adults ................................... Aim 2a Cohort Exit Interview ......................... 15 1 15 

Health Practitioners ......................................... Aim 2b Provider Focus Group Screener ....... 32 1 3 

Health Practitioners ......................................... Aim 2b Provider Focus Group Contact Information.16 1 1 

Health Practitioners ......................................... Aim 2b Provider Pre-Focus Group Survey .... 16 1 1 

Health Practitioners ......................................... Aim 2b Provider Focus Group Guide ............ 16 1 32 

Health Practitioners ......................................... Aims 1&2 Clinic Assessment (Baseline and 

Final).

9 1 18 

Health Practitioners ......................................... Aims 1&2 Clinic Assessment (every 6 

months).

9 2 27 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 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 

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). 

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. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1