Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices 78043 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of Respondents Form Name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Adult Household Member ............................... Household Roster .......................................... 36,000 1 4/60 

Sample Adult ................................................... Adult Questionnaire ........................................ 33,000 1 50/60 

Adult Family Member ...................................... Child Questionnaire ........................................ 10,000 1 22/60 

Adult Family Member ...................................... Methodological Projects ................................. 15,000 1 20/60

Sample Child ................................................... NHIS-Teen ..................................................... 667 1 15/60 

Adult Family Member ...................................... Reinterview Survey ........................................ 5,500 1 5/60

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 

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 inperson outreach. 


khammond on DSKJM1Z7X2PROD with NOTICES
78044 Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / 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 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

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

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 Assessment ........................ 134 1 45/60 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices 78045 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

General Public—Adults ................................... Patient Quarterly Assessment ....................... 134 3 45/60 

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 Assessment ................ 7 1 30/60 

Health Practitioners ......................................... Provider Post-Training Assessment ............... 7 1 30/60 

Health Practitioners ......................................... Provider Interview Guide ................................ 7 1 60/60 

Health Practitioners ......................................... Clinic Assessment Baseline and Final ........... 4 1 120/60 

Health Practitioners ......................................... Clinic Assessment Every Six Months ............ 4 2 90/60 

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 

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, 

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 

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 


khammond on DSKJM1Z7X2PROD with NOTICES