Federal Register / Vol. 87, No. 113 / Monday, June 13, 2022 / Notices 35781 

NIOSH ‘‘Training for Nurses on Shift 

Work and Long Work Hours.’’ Part 1 

will be a secondary analysis of preexisting CDC data from individuals who 

have received continuing professional 

licensing education credits following 

the NIOSH nurse training completion. 

There are no associated burden hours 

with Part 1 since data were previously 

collected by CDC. 

Part 2: Part 2 goal is to evaluate the 

effectiveness of the NIOSH nurse 

training on objective (i.e., sleep 

duration, efficiency, and timing with 

actigraphy watches) and subjective (i.e., 

sleep quality, daytime sleepiness) sleep 

health measures, and self-reported wellbeing. Part 2 will be a field study 

requiring recruitment of 50 RNs to 

volunteer to participate. Recruitment 

will take approximately three months 

through online platforms and with 

assistance of the nursing and health care 

connections through the NIOSH Health 

Care and Social Assistance Program, 

and NIOSH subject matter experts. 

During Part 2, NIOSH will collect data 

before and after RNs complete the 

NIOSH Training for Nurses. RNs 

enrolled in the Part 2 study will be 

asked to complete online surveys and 

wear an actigraphy watch during this 

study. Actigraphy watches are research 

grade sleep activity data collection 

instruments, similar to a wristwatch. 

Actigraphy watches will be supplied by 

NIOSH for participant use during the 

study. As part of baseline measures, RNs 

will be asked to complete an online 

survey with questions about 

demographics, workplace characteristics 

(i.e., job tenure, shift length), sleep 

quality, daytime sleepiness, and wellbeing. In addition, RNs will be asked to 

wear an actigraphy watch and complete 

online daily sleep diaries for seven 

days. 

One month after baseline measures, 

participants will be asked to take the 

NIOSH online nurse training. The 

training takes approximately 3.5 hours 

to complete and participants will have 

the opportunity to receive continuing 

education credits for professional 

licensure upon training completion. 

After the online nurse training, 

participants will answer four immediate 

post-training online questions regarding 

behavioral intention and feedback on 

the participant training experience. The 

participant will then be scheduled for 

the one-month post-training data 

collection period. 

At each post-training follow-up 

period, participants will be asked to 

follow the same sampling protocol they 

completed at baseline: online survey 

(i.e., sleep quality, daytime sleepiness, 

wellbeing) and seven-day actigraphy 

and sleep/wake diary. Participants will 

also be asked three open-ended 

questions about adopted behavior 

strategies to improve sleep, as well as 

facilitators and barriers to adoption. 

Data collected during Part 2 will 

allow us to compare sleep and wellbeing measures at baseline with 1-, 3-, 

and 6-months post-training. We will 

also examine the relationship between 

nurse characteristics (e.g., age, work 

tenure) and behavioral intention, and 

the relationship between behavioral 

intention and sleep health post-training 

at 1-month, 3-months, and 6-months. 

CDC requests OMB approval for an 

estimated 341 annual burden hours. 

There are no costs to respondents other 

than their time to participate. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Registered Nurses .......................................... Baseline Survey ............................................. 50 1 23/60 

Online Nurses Training .................................. 50 1 3.5 

Immediate Post-Training Survey .................... 50 1 7/60 

Post-Training (1-, 3-, and 6-month) Surveys 50 3 16/60 

Consensus Sleep Diary ................................. 50 4 21/60 

Actigraphy Watch Training ............................. 50 1 10/60 

Actigraphy Watch Fitting ................................ 50 4 7/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–12698 Filed 6–10–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–22–22FZ; Docket No. CDC–2022– 

0075] 

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 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 evidencebased 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 August 12, 2022. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2022– 

0075 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 


khammond on DSKJM1Z7X2PROD with NOTICES
35782 Federal Register / Vol. 87, No. 113 / Monday, June 13, 2022 / Notices 

(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 

(NCHHSTP) is requesting approval for 

36 months of data collection entitled, 

‘‘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 located in 

New York, NY (NYC) (two clinics) and 

Birmingham, AL (two clinics). 

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 threemonth study visit, participants using 

oral PrEP will receive the mChoice 

mobile phone application, an evidencebased 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 self-reported 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 


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Federal Register / Vol. 87, No. 113 / Monday, June 13, 2022 / Notices 35783 

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 

three-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 threeyear data collection period the 

estimated annual enrollment is 10. For 

Aim 3, total study enrollment is 20, over 

the three-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. 

The total number of burden hours is 

1,323 across 36 months of data 

collection. The total estimated 

annualized burden hours are 441. There 

are no costs to the participants other 

than their time to participate. 

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 

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 Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–12697 Filed 6–10–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10237 and 

CMS–10407] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 


khammond on DSKJM1Z7X2PROD with NOTICES