60 Day FRN

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

Registered Nurses ..........................................

Baseline Survey .............................................
Online Nurses Training ..................................
Immediate Post-Training Survey ....................
Post-Training (1-, 3-, and 6-month) Surveys
Consensus Sleep Diary .................................
Actigraphy Watch Training .............................
Actigraphy Watch Fitting ................................

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

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Number of
respondents

Type of respondents

[60Day–22–22FZ; Docket No. CDC–2022–
0075]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

Notice with comment period.

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

SUMMARY:

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50
50
50
50
50
50
50

Number of
responses per
respondent
1
1
1
3
4
1
4

Average
burden per
response
(in hours)
23/60
3.5
7/60
16/60
21/60
10/60
7/60

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

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(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),

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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

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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
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 three-

year 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
Number of
responses per
respondent

Number of
respondents

Total burden
(in hr)

Form name

Aim 1 participants—YMSM General
public, adults.
Aim 1 participants—YMSM General
public, adults.
Aim 1 participants—YMSM General
public, adults.
Aim 1 participants—YMSM General
public, adults.
Aim 1 participants—YMSM General
public, adults.
Aim 2 participants—YMSM General
public, adults.
Aim 2 participants—YMSM General
public, adults.
Aim 2 participants—YMSM General
public, adults.
Aim 3 participants—providers General public, adults.
Aim 3 participants—providers General public, adults.
Aim 3 participants—providers General public, adults.
Aim 3 participant—clinic staff respondent, 1 per clinic site General
public, adults.

Aim 1 Participant Eligibility Screener

268

1

5/60

22

Aim 1 Participant Locator Form .......

134

1

5/60

12

Aim 1 mChoice Onboarding Guide ..

134

1

20/60

45

Aim 1 Participant Baseline Survey ..

134

1

30/60

67

Aim 1 Participant Follow-up Survey

134

4

30/60

268

Aim 2 Participant Eligibility Screener

20

1

5/60

2

Aim 2 Participant Locator Form .......

10

1

5/60

1

Aim 2 Participant Interview Guide ...

10

1

1.0

10

Aim 3 Participant Eligibility Screener

14

1

5/60

2

Aim 3 Participant Locator Form .......

7

1

5/60

1

Aim 3 Participant Interview Guide ...

7

1

1.0

7

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]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services

BILLING CODE 4163–18–P

[Document Identifiers: CMS–10237 and
CMS–10407]
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Average
burden per
response
(in hr)

Type of respondent

Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).

AGENCY:

ACTION:

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Notice.

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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

SUMMARY:

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