60 Day FRN

Att 2a_60 Day FRN Pub11-16-2022.pdf

[NCHHSTP] Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era

60 Day FRN

OMB: 0920-1421

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68696

Federal Register / Vol. 87, No. 220 / Wednesday, November 16, 2022 / Notices

general populations and specifically
those at highest risk of stroke events,
and reduce disparities in access to
quality care for high burden
populations.
When Congress directed CDC to
establish the Paul Coverdell National
Acute Stroke Program (PCNASP) in
2001, CDC intended to monitor trends
in stroke and stroke care, with the
ultimate mission of improving the
quality of care for stroke patients in the
United States. Since 2021, CDC has
funded and provided technical
assistance to 13 recipients to develop
comprehensive stroke systems of care. A
comprehensive system of care improves
quality of care by creating seamless
transitions for individuals experiencing
stroke. In such a system, pre-hospital
providers, in-hospital providers, and
early post-hospital providers coordinate
patient hand-offs and ensure continuity
of care. While PCNASP has existed
since 2001, the goal and mission of the
program has evolved with each funding
cycle. The 2021–2024 funding cycle is
the first such initiative to focus on
addressing health equity specifically
and understanding efforts to impact
stroke outcomes for those at highest risk
of stroke. CDC contracted with RTI
International to conduct a national

evaluation to assess program
implementation as well as short term
and intermediate outcomes of the 13
funded recipients.
CDC and RTI International propose to
collect information from all PCNASP
recipients to gain insight into the
effectiveness of implementation
approaches, including linking and using
data, using team-based approaches to
coordinate stroke care, and providing
community resources in order to reach
the general population and those at
highest risk of stroke events, and reduce
disparities in access to quality care for
high burden populations. The
information collection will focus on
describing PCNASP specific
contributions to effective state-based
stroke systems of care and the costs
associated with this work. Two
components of the information
collection include: (1) program
implementation cost data collection
from program recipients using a cost
collection tool; and (2) interviews using
Zoom, Skype, Teams or a similar
technology with key program and
partner staff. Cost data collection will
focus on recipients’ cumulative
spending to support PCNASP activities,
spending by reporting period, and
spending associated with specific

PCNASP strategies related to building
comprehensive state-wide stroke
systems of care and strategies focusing
on high-risk populations. Interview
questions will focus on how each
recipient implemented its strategies to
increase access to and quality of
healthcare overall as well as for patients
at highest risk of stroke events. The data
collection will identify challenges
encountered and how they were
overcome, factors that facilitated
implementation, lessons learned along
the way, and observed outcomes and
improvements. The information to be
collected does not currently exist for
large scale, statewide programs that
employ multiple combinations of
strategies to build comprehensive stroke
systems of care. The insights to be
gained from this data collection will be
critical to improving immediate efforts
and achieving the goals of spreading
and replicating state-level strategies that
are proven programmatically and are
cost-effective in contributing to a higher
quality of care for stroke patients.
OMB approval is requested for two
years. The total estimated annualized
burden hours are 117. There are no costs
to the respondents other than their time
to participate.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Program Manager ..............................
Program Director ................................
Quality Improvement Specialist .........
Partner Staff .......................................

Cost Collection Tool ....................................................
Interviews using Zoom, Skype, Teams .......................
Interviews using Zoom, Skype, Teams .......................
Interviews using Zoom, Skype, Teams .......................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–24917 Filed 11–15–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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Number of
respondents

Type of respondents

[60Day–23–23AQ; Docket No. CDC–2022–
0129]

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 Understanding
HIV/STD Risk and Enhancing PrEP
Implementation Messaging in a Diverse
Community-Based Sample of Gay,
Bisexual, and Other Men Who Have Sex
with Men in a Transformational Era
(MIC–DROP). This project is a
prospective cohort study to understand
men who have sex with men’s (MSM)
strategies to prevent HIV and sexually

SUMMARY:

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Number of
responses per
respondent

13
13
13
52

Average
burden per
response
(in hours)

1
1
1
1

2
1
1
1

transmitted infections (STIs), including
pre-exposure prophylaxis (PrEP) use
and adherence, condom use, sexual risktaking behavior and substance-using
behaviors.
CDC must receive written
comments on or before January 17,
2023.

DATES:

You may submit comments,
identified by Docket No. CDC–2022–
0129 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

ADDRESSES:

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khammond on DSKJM1Z7X2PROD with NOTICES

Federal Register / Vol. 87, No. 220 / Wednesday, November 16, 2022 / Notices
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
Understanding HIV/STD Risk and
Enhancing PrEP Implementation
Messaging in a Diverse Community-

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Based Sample of Gay, Bisexual, and
Other Men Who Have Sex with Men in
a Transformational Era (MIC–DROP)—
New—National Center for HIV, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Center for HIV, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP) is requesting approval for
36 months of data collection entitled
Understanding HIV/STD Risk and
Enhancing PrEP Implementation
Messaging in a Diverse CommunityBased Sample of Gay, Bisexual, and
Other Men Who Have Sex with Men in
a Transformational Era (MIC–DROP).
The purpose of this study is to enroll a
prospective cohort of men who have sex
with men (MSM) in Atlanta, Detroit,
and San Diego to understand men’s
strategies to prevent HIV and other STIs
including PrEP use and adherence,
condom use, sexual risk-taking
behavior, and substance-using
behaviors. This study also proposes to
assess men’s use and preferences for
prevention modalities and assess men’s
awareness, knowledge, beliefs, and
perceptions about HIV/STI prevention
products.
The information collected in this
study will be used to: (1) describe realworld HIV and STI prevention strategies
including PrEP use and adherence and
condom use; (2) better understand
men’s use, preferences, knowledge, and
perceptions about prevention
modalities; (3) develop rapid reports
that will allow for summary
recommendations concerning gaps in
prevention protection; and (4) provide
timely new information to public health
programs and decision makers.
The study will be carried out in three
cities, Atlanta, GA; Detroit, MI; and San
Diego, CA. Participants will include
1275 HIV-negative men ages 18 and
older. Participants will identify as
cisgender male; report male at birth;
report sex with a man in the last six
months; live in or near Atlanta, Detroit,
or San Diego; own a cell phone with
data service; be willing to download a
health-related app as part of the study;
be able to provide two or more means
of contact; be fluent in written/spoken
English or Spanish; and not currently be
enrolled in another HIV prevention
clinical trial. We will use purposive
sampling to ensure that 60% of
participants will be PrEP users at
baseline, and 40% will not be using
PrEP. We will also oversample Black
and Hispanic MSM to ensure that a
minimum of 30% each are represented
in the cohort sample. Participants will

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68697

be recruited using a combination of
approaches including social media,
referral, and in-person outreach.
Quantitative and qualitative
assessments will be used to collect
information from participants. A
quarterly quantitative survey will assess
use of prevention modalities, awareness,
knowledge, beliefs, and perceptions
about HIV/STI prevention products and
prevention messages. The SMaRT app
study management platform allows for
scheduling, reminders, survey
administration, and communication by
email and text messaging. HIV and STI
test results will allow the study team to
assess HIV and STI risk throughout the
study period. A subset of the
participants will be invited to further
participate in qualitative data collection
activities including focus groups and indepth interviews. The focus groups will
assess the participants’ awareness of
PREP messages, preferences for PrEP
messages, and perceived impact/efficacy
of HIV prevention and PrEP messages.
The in-depth interviews will assess
men’s PrEP experiences, their
preferences for PrEP and other HIV
prevention products, and further
explore their reactions to prevention
messages.
The screening process is estimated to
take five minutes to complete. We
estimate that the contact information
gathering and the SMaRT app
installation will take five minutes each
to complete. The quantitative
assessment is estimated to take 45
minutes to complete and will be
delivered quarterly for a total eight
times over the two-year follow up
period. Participants will be asked to
collect specimens for both HIV and STI
testing at six-month intervals for a total
of four times over the two-year follow
up period. The specimen kit for HIV
testing will take approximately 15
minutes to complete. The specimen kit
for STI testing will take approximately
30 minutes to complete. A subset of the
1,275 enrolled participants will be
invited to participate in qualitative data
activities: 270 participants will engage
in a focus group that is estimated to take
90 minutes to complete, and 30
participants will be invited to
participate in three in-depth interviews
to be delivered at six-month intervals
over the two-year follow up period. The
interviews will take approximately 90
minutes to complete.
CDC requests OMB approval for an
estimated 2,214 annual burden hours.
There are no costs to the respondents
other than their time to participate.

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Federal Register / Vol. 87, No. 220 / Wednesday, November 16, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

General
General
General
General
General
General
General
General

Public—Adults
Public—Adults
Public—Adults
Public—Adults
Public—Adults
Public—Adults
Public—Adults
Public—Adults

Total burden
(in hr)

.....................
.....................
.....................
.....................
.....................
.....................
.....................
.....................

Eligibility Screener ............................
Contact Information ..........................
SMaRT App Installation ...................
Quantitative Survey ..........................
Sample Collection for HIV Test .......
Sample Collection for STI Test ........
Focus Group Guide ..........................
In-Depth interview Guide .................

850
425
425
425
425
425
90
10

1
1
1
4
2
2
1
2

5/60
5/60
5/60
45/60
15/60
30/60
90/60
90/60

68
34
34
1,275
213
425
135
30

Total ...........................................

...........................................................

........................

........................

........................

2,214

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–24919 Filed 11–15–22; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
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 continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled the National
Death Index (NDI). The goal of NDI and
the services it provides allows NCHS to
collect mortality data to support
epidemiological research and to furnish
mortality information to approved
public health and medical investigators.

SUMMARY:

CDC must receive written
comments on or before January 17,
2023.

DATES:

You may submit comments,
identified by Docket No. CDC–2022–
0131 by either of the following methods:

ADDRESSES:

VerDate Sep<11>2014

17:27 Nov 15, 2022

Jkt 259001

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:
FOR FURTHER INFORMATION CONTACT:

AGENCY:

ACTION:

• 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.

[60Day–23–0215; Docket No. CDC–2022–
0131]

khammond on DSKJM1Z7X2PROD with NOTICES

Average
burden per
response
(in hr)

Number of
responses per
respondent

Number of
respondents

Form name

PO 00000

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Fmt 4703

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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
Application Form and Related Forms
for the Operation of the National Death
Index (NDI) (OMB Control No. 0920–
0215, Exp. 3/31/2023)—Revision—
National Center for Health Statistics
(NCHS), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C.), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability of the population
of the United States. The National Death
Index (NDI) is a database containing
identifying death record information
submitted annually to NCHS by all the
jurisdiction (states and territories) vital
statistics offices, beginning with deaths
in 1979. Searches against the NDI file
provide the jurisdictions and dates of

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