35778 Federal Register / Vol. 87, No. 113 / Monday, June 13, 2022 / Notices 

individuals with technical expertise on 

health care quality, system functions, 

privacy, security, and on the electronic 

exchange and use of health information, 

including the use standards for such 

activity. GAO is now accepting 

nominations for HITAC appointments 

that will be effective January 1, 2023. 

Members serve 3-year terms, with the 

terms subject to renewal, for a total not 

to exceed 6 years of service on the 

committee. From these nominations, 

GAO expects to appoint at least 4 new 

HITAC members, focusing especially on 

patients or consumers, health care 

providers, ancillary health care workers, 

and individuals with technical expertise 

on health care quality, system functions, 

privacy, security, and on the electronic 

exchange and use of health information. 

Nominations should be sent to the email 

address listed below. 

DATES: Letters of nomination and 

resumes should be submitted no later 

than July 22, 2022, to ensure adequate 

opportunity for review and 

consideration of nominees prior to 

appointment. 

ADDRESSES: Submit letters of 

nomination and resumes to 

HITCommittee@gao.gov. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Legeer at (202) 512–3197 or 

legeers@gao.gov if you do not receive an 

acknowledgment within a week of 

submission or need additional 

information. For general information, 

contact GAO’s Office of Public Affairs, 

(202) 512–4800. 

Authority: Pub. L. 114–255, sec. 

4003(e) (2016), 42 U.S.C. 300jj–12. 

Gene L. Dodaro, 

Comptroller General of the United States. 

[FR Doc. 2022–12499 Filed 6–10–22; 8:45 am] 

BILLING CODE 1610–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–22–22GA; Docket No. CDC–2022– 

0076] 

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 Expanding PrEP 

in Communities of Color (EPICC). The 

proposed study is designed to deliver 

training to health providers 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, and to test 

the effectiveness of the EPICC 

intervention. 

DATES: CDC must receive written 

comments on or before August 12, 2022. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2022– 

0076 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: 404–639–7118; 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 

Expanding PrEP in Communities of 

Color (EPICC)—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 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). 

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. For Aim 2a, 

the study will initiate an effectivenessimplementation trial with 400 YMSM to 

test the effectiveness of the EPICC+ 

intervention package in increasing PrEP 

adherence and persistence among 

YMSM. The intervention will also 


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Federal Register / Vol. 87, No. 113 / Monday, June 13, 2022 / Notices 35779 

utilize a mobile app-based platform, 

HealthMPowerment (HMP) to support 

ongoing participant engagement and 

monitoring, as well as to provide 

additional adherence support. In Aim 

2b the study team will conduct focus 

groups with providers to gather 

feedback on overall perceptions of the 

barriers and facilitators to 

implementation of evidence-based tools 

(EBT) within their clinical site. 

The information collected in this 

study will be used to: (1) describe realworld 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 will be carried out in 10 

clinics located in Chicago, IL; New York 

City, NY; Philadelphia, PA; Charlotte, 

NC; Raleigh, NC; Tuscaloosa, AL; 

Montgomery, AL; Tampa, FL; Orlando, 

FL; and Houston, TX. Aim 1 will 

include 30 health care providers from 

the 10 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. 

Aim 2a participants will include 400 

YMSM ages 18–39. Participants will 

identify as a cisgender male; report sex 

with a man in the past 12 months; have 

an active prescription for PrEP; receive 

care at one of the 10 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. 

Quantitative and qualitative 

assessments will be used to collect 

information from providers and YMSM 

participants. For the Aim 1 provider 

training, assessments will include pre, 

post, 3-month, and 6-month surveys to 

evaluate provider information retention. 

Providers will also be asked to complete 

a brief survey at baseline, 3- and 6- 

months to assess their new patient 

interaction skills. For Aim 2a, YMSM 

participants will be asked to complete a 

baseline assessment and quarterly 

assessments at 3–, 6–, 9–, 12–, 15–, and 

18-months to assess PrEP adherence; 

PrEP knowledge, usage and choice; 

sexual risk behaviors; HIV status of 

partners; and substance use assessment. 

A subset of YMSM participants from 

Aim 2a will be asked to complete an 

exit interview that will focus on 

understanding factors that influenced 

participants’ selection of PrEP regimens, 

changes and/or discontinuations, as 

well as perceptions of the counseling 

they received by providers at PrEP 

initiation and follow-up, receipt of tools 

or materials that influenced choice and 

feasibility/acceptability of the HMP app. 

We will also conduct focus groups with 

providers in Aim 2b to gather feedback 

on overall perceptions of the barriers 

and facilitators to EBT implementation 

within their clinical site. The study will 

also collect data through from electronic 

health records; biological specimens 

collected at quarterly intervals; and a 

clinic assessment tool delivered every 

six months. 

For the Aim 1 provider training, we 

estimate the collection of contact 

information will take five minutes. Pretraining, baseline and follow up surveys 

at 3- and 6-months will take 

approximately 15 minutes each to 

complete. Patient interaction 

assessments delivered at baseline, 3-, 

and 6-months will take approximately 

15 minutes each to complete. For Aim 

2a, the effectiveness-implementation 

trail, it is expected that 50% of YMSM 

screened will meet study eligibility. The 

initial screening will take five minutes 

to complete and the collection of 

contact information to take five minutes. 

The baseline assessment will take 

approximately 45 minutes to complete. 

The follow-up assessments will take 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 to setup the HMP app, a 

process that will take 30 minutes. The 

patient exit interview takes 

approximately 60 minutes to complete 

and will be delivered one time to a 

subset of 48 YMSM participants. For the 

Aim 2b provider focus groups, we 

estimate it will take approximately 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. 

Total study enrollment for Aim 1 is 

30, over the three-year study period the 

estimated annual enrollment is 10. Total 

enrollment for aim 2a is 400, over the 

three-year study period the estimated 

annual enrollment is 134. For the Aim 

2a exit interview, 45 will participate for 

an annual enrollment of 15. For Aim 2b, 

total study enrollment is 48 and the 

estimated annual enrollment is 16. 

Additionally, a clinic staff member at 

each of the ten participating clinic sites 

will complete a clinic assessment form 

every six months throughout the study 

period. 

The total number of burden hours is 

2,055 across 36 months of data 

collection. The total estimated 

annualized burden hours are 685. There 

are no costs to the participant 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) 

General Public—Adults ..................... Aim 1 Provider Contact Information 10 1 5/60 1 

General Public—Adults ..................... Aim 1 Provider Training Survey ....... 10 4 15/60 10 

General Public—Adults ..................... Aim 1 Patient Interaction Assessment.10 3 15/60 8 

General Public—Adults ..................... Aim 2a Participant Eligibility Screener.268 1 5/60 23 

General Public—Adults ..................... Aim 2a Participant Contact Information.134 1 5/60 12 

General Public—Adults ..................... Aim 2a Baseline Assessment .......... 134 1 45/60 101 

General Public—Adults ..................... Aim 2a Quarterly Assessments ....... 134 4 45/60 402 

General Public—Adults ..................... Aim 2a HMP App Setup ................... 134 1 30/60 67 


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35780 Federal Register / Vol. 87, No. 113 / Monday, June 13, 2022 / 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) 

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

General Public—Adults ..................... Aim 2b Provider Focus Group Contact Information.16 1 5/60 2 

General Public—Adults ..................... Aim 2b Provider Focus Group Survey.16 1 5/60 2 

General Public—Adults ..................... Aim 2b Provider Focus Group Guide 16 1 2 32 

General Public—Adults ..................... Clinic Assessment ............................ 10 2 30/60 10 

Total ........................................... ........................................................... ........................ ........................ ........................ 685 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–12699 Filed 6–10–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–22–21FC] 

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 ‘‘Nurse FatigueMitigation Education: Does it Change 

Nurse Sleep Behavior?’’ 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 14, 

2021 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 

Nurse Fatigue-Mitigation Education: 

Does it Change Nurse Sleep Behavior?— 

New—National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Many nurses in the United States 

work in around-the-clock healthcare 

facilities, providing necessary care to 

patients and the public. Providing these 

services requires nurses to work 

nonstandard hours, including shift work 

(e.g. early mornings, over-nights, 

rotating between days and nights) and 

long work hours. These work 

organizational characteristics are 

primary factors contributing to sleeprelated fatigue, and decreased health 

and well-being for nurses. Studies have 

found 36% of healthcare workers 

(including nurses) report sleeping less 

than the recommended 7–9 hours of 

sleep/24 hours, with prevalence rates 

climbing to a little over 50% for those 

working night shift. This is concerning, 

as insufficient sleep not only increases 

the risk for a patient care error to occur 

but can also jeopardize the health of 

nurses. 

In 2015, the National Institutes for 

Occupational Safety and Health 

(NIOSH) published a free, publicly 

available, online resource to address the 

risks associated with shift work and 

other nonstandard work hours. This 

program, ‘‘Training for Nurses on Shift 

Work and Long Work Hours’’ provides 

information to nurses, nurse managers 

and other interested healthcare workers 

on the health and safety risks associated 

with nonstandard work hours. In 

addition, the training provides strategies 

for improving sleep and reducing 

fatigue-related risks when working shift 

work in the healthcare setting. 

Over five years have passed since the 

training was published online. Since 

then, the nursing workforce has faced a 

changing healthcare landscape. In 

response, the two studies in this project 

have been designed to evaluate the 

effectiveness of the NIOSH Training for 

Nurses at improving nurses’ sleep and 

well-being, as well as assess the reach 

of training dissemination. This 

evaluation project will help NIOSH 

determine gaps in training distribution, 

identify needs to enhance training 

content and ensure the training is 

meeting its purpose. 

This evaluation project consists of 2 

studies. 

Part 1: Part 1 goal is to provide a 

description of the registered nurses 

(RNs) who have already completed the 


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