56834 Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Fire Chiefs ......................................... Survey .............................................. 4,500 1 18/60 1,350 

Company Officers ............................. Survey .............................................. 4,500 1 18/60 1,350 

Total ........................................... ........................................................... ........................ ........................ ........................ 4,050 

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. 2023–17926 Filed 8–18–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–23–22FZ; Docket No. CDC–2023– 

0072] 

Proposed Data Collection 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. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a proposed and/or continuing 

information collection, as required by 

the Paperwork Reduction Act of 1995. 

This notice invites comment on a 

proposed information collection project 

titled mChoice: Improving PrEP Uptake 

and Adherence among Minority MSM 

through Tailored Provider Training and 

Adherence Assistance in Two High 

Priority Settings. The collection is part 

of a research study designed to 

implement and evaluate the 

effectiveness of an intervention that 

utilizes evidence-based education and 

support tools to improve preexposure 

prophylaxis (PrEP) adherence among 

young men who have sex with men 

(YMSM). 

DATES: CDC must receive written 

comments on or before October 20, 

2023. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2023– 

0072 by either of the following methods: 

b Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting comments. 

b 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 

www.regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(www.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; 

Telephone: 404–639–7118; Email: omb@

cdc.gov. 

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 the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. The 

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 

mChoice: Improving PrEP Uptake and 

Adherence among Minority MSM 

through Tailored Provider Training and 

Adherence Assistance in Two High 

Priority Settings—New—National 

Center for HIV/AIDS, Viral Hepatitis, 

STD, and TB Prevention (NCHHSTP), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

The National Center for HIV/AIDS, 

Viral Hepatitis, STD and TB Prevention 

is requesting approval for 36 months of 

data collection titled, ‘‘mChoice: 

Improving PrEP Uptake and Adherence 

among Minority MSM through Tailored 

Provider Training and Adherence 

Assistance in Two High Priority 

Settings.’’ 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 

improve preexposure prophylaxis 

(PrEP) adherence among young men 

who have sex with men (YMSM). The 

goals of this research study are to: (1) 

improve the overall PrEP experience of 

providers and YMSM patients; and (2) 

increase our understanding of provider 

and patient factors that influence the 

choice of PrEP regimen by MSM in 

clinical settings. This study will be 

carried out in four clinics in New York, 

NY (two clinics) and Birmingham, AL 

(two clinics). 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices 56835 

Aim 1 of the study will enroll 400 

YMSM (ages 18–39) who identify as 

male, non-binary, or genderqueer; were 

assigned male sex at birth; are taking or 

initiating PrEP; own a smartphone; 

understand and read English or 

Spanish; have a self-reported history of 

sex with men in the past 12-months; 

and live in the NYC or Birmingham, AL 

areas. Participants may identify as any 

race or ethnicity, but to ensure a diverse 

sample comprised mainly of racial/ 

ethnic minority participants, the study 

will utilize recruitment controls to 

enroll at least 50% African American/ 

Black and/or Hispanic/Latino 

participants. Patient participants will be 

recruited to the study through a 

combination of approaches including 

flyers and social media, referral, inperson outreach, and through word of 

mouth. Rolling enrollment will continue 

until enrollment targets are reached; 

each Aim 1 participant will be followed 

for 12 months. All participants will 

receive PrEP clinical services congruent 

with CDC PrEP guidelines. Participants 

using oral PrEP will receive CleverCap, 

an electronic medication monitoring 

device, that will track and support 

medication adherence. At the 3-month 

study visit, participants using oral PrEP 

will receive the mChoice mobile phone 

application, an evidence-based 

intervention that supports PrEP use 

through medication monitoring, study 

staff interaction, and other resources. 

Aim 1 assessments include: a baseline 

survey of self-reported demographic 

factors, sexual and drug use behaviors, 

and potential cofactors of sexual and 

drug use behavior including attitudes, 

beliefs, knowledge, traits, and other 

psychosocial factors; follow-up surveys 

at 3-, 6-, 9-, and 12-month study visits 

which will assess experiences with 

PrEP, PrEP adherence, and behavioral 

and social factors; medication 

adherence data from CleverCap; 

participant use and voluntary selfreported adherence and HIV exposure 

risk-related data from the mChoice app; 

PrEP clinical care data from clinic 

electronic medical records; and urine 

studies assessing PrEP adherence. The 

information collected in Aim 1 will be 

used to evaluate the effectiveness of the 

mChoice intervention to improve PrEP 

adherence and persistence, and to 

increase understanding of PrEP 

experiences and factors that influence 

PrEP choices among MSM in clinical 

settings. 

Aim 2 of the study will enroll 30 

YMSM who participated in Aim 1; 15 

from New York and 15 from Alabama. 

Participants will be recruited at Aim 1 

study visits. Study staff will conduct indepth interviews with Aim 2 

participants exploring their experiences 

with PrEP, reasons for PrEP choices, and 

thoughts about the mChoice 

intervention. Data collected in Aim 2 

will contribute to the evaluation of the 

mChoice intervention, implementation, 

and contribute to understanding factors 

that influence PrEP choices by MSM in 

clinical settings. 

Aim 3 of the study will include 20 

health care providers (10 from New 

York and 10 from Alabama) involved in 

the direct delivery of PrEP services at 

participating clinical sites. Providers 

may include nurse practitioners, 

physicians, PrEP coordinators/ 

navigators, medical assistants, and other 

cross-trained coordinators from the 

participating clinics. Providers will be 

recruited via flyers, emails to clinic 

staff, and referrals. Providers will 

receive education and training designed 

to improve knowledge of PrEP options 

and clinical recommendations and 

enhance provider communications with 

patients. Aim 3 includes practice 

facilitation, an intervention that 

includes identification of a clinic 

champion who will engage other 

providers in embracing PrEP 

recommendations, as well as ongoing 

support from a practice coach who will 

offer tools, resources, hands-on 

guidance, and content expertise to assist 

the clinic team in developing strategies 

to improve clinical PrEP services. Aim 

3 assessments include notes from 

practice facilitation coaching sessions; 

in-depth interviews of participating 

providers exploring their experiences 

with the intervention and thoughts 

about providing PrEP clinical services; 

and a clinic assessment completed by 

clinic staff every six months to describe 

the current implementation of PrEP 

services at their clinical site. These data 

will inform ongoing practice 

improvement in PrEP clinical services 

and increase understanding of provider 

experiences with providing PrEP 

clinical services. 

It is expected that half of screened 

persons will meet study eligibility. For 

all aims we anticipate that screening 

and completion of the locator form will 

each take five minutes. Study staff will 

assist Aim 1 participants with 

onboarding the CleverCap device and 

mChoice app, a process that will take 20 

minutes. Aim 1 participants will 

complete the baseline survey once 

(anticipated 30 minutes completion 

time) and the follow-up survey four 

times (anticipated completion time 30 

minutes each) over their 12-month 

participation period. Total study 

enrollment for Aim 1 is 400, over the 3- 

year data collection period the 

estimated annual enrollment is 134. 

Aims 2 and 3 interviews will take 60 

minutes to complete. For Aim 2, total 

study enrollment is 30, over the 3-year 

data collection period the estimated 

annual enrollment is 10. For Aim 3, 

total study enrollment is 20, over the 3- 

year data collection period the 

estimated annual enrollment is seven. 

Additionally, a single Aim 3 participant 

at each of the four participating clinic 

sites will complete a clinic assessment 

form every six months throughout the 

study period. 

There are no costs to the participants 

other than their time. The total number 

of burden hours is 1,323 across 36 

months of data collection. The total 

estimated annualized burden hours are 

441. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hr) 

Total burden 

(in hr) 

Aim 1 participants—YMSM; General 

public, adults.

Aim 1 Participant Eligibility Screener 268 1 5/60 22 

Aim 1 participants—YMSM; General 

public, adults.

Aim 1 Participant Locator Form ....... 134 1 5/60 12 

Aim 1 participants—YMSM; General 

public, adults.

Aim 1 mChoice Onboarding Guide .. 134 1 20/60 45 

Aim 1 participants—YMSM; General 

public, adults.

Aim 1 Participant Baseline Survey .. 134 1 30/60 67 


ddrumheller on DSK120RN23PROD with NOTICES1
56836 Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hr) 

Total burden 

(in hr) 

Aim 1 participants—YMSM; General 

public, adults.

Aim 1 Participant Follow-up Survey 134 4 30/60 268 

Aim 2 participants—YMSM; General 

public, adults.

Aim 2 Participant Eligibility Screener 20 1 5/60 2 

Aim 2 participants—YMSM; General 

public, adults.

Aim 2 Participant Locator Form ....... 10 1 5/60 1 

Aim 2 participants—YMSM; General 

public, adults.

Aim 2 Participant Interview Guide ... 10 1 1.0 10 

Aim 3 participants—providers; General public, adults.Aim 3 Participant Eligibility Screener 14 1 5/60 2 

Aim 3 participants—providers; General public, adults.Aim 3 Participant Locator Form ....... 7 1 5/60 1 

Aim 3 participants—providers; General public, adults.Aim 3 Participant Interview Guide ... 7 1 1.0 7 

Aim 3 participant—clinic staff respondent, 1 per clinic site; General public, adults.Aim 3 Clinic Assessment ................. 4 2 30/60 4 

Total ........................................... ........................................................... ........................ ........................ ........................ 441 

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. 2023–17921 Filed 8–18–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–23–1319; Docket No. CDC–2023– 

0073] 

Proposed Data Collection 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. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a continuing information collection, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed information 

collection project titled National 

Surveillance of Community Water 

Systems and Corresponding Populations 

with the Recommended Fluoridation 

Level. This surveillance collects the 

fluoridation status of, and population 

served by the nation’s 52,000 

community water systems (CWS) which 

serve the 50 States and the District of 

Columbia. 

DATES: CDC must receive written 

comments on or before October 20, 

2023. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2023– 

0073 by either of the following methods: 

• Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS H21–8, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

www.regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(www.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; 

Telephone: 404–639–7570; Email: omb@

cdc.gov. 

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 the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The 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. 


ddrumheller on DSK120RN23PROD with NOTICES1