Agency Forms Undergoing Paperwork Reduction Act Review, 34156-34158 [2023-11264]
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34156
Federal Register / Vol. 88, No. 102 / Friday, May 26, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–1301]
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 ‘‘Templates for
Extramural Data Management Plans’’ 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 4, 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.
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
Proposed Project
Templates for Extramural Data
Management Plans (OMB Control No.
0920–1301, Exp. 6/30/2023)—
Extension—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
This Information Collection Request
(ICR) seeks continued approval for Data
Management Plan (DMP) templates.
DMPs are required annually of entities
using CDC funds to collect or generate
public health data. They are submitted
to CDC by grant and cooperative
agreement applicants and awardees for
assessment to verify that they are
compliant with CDC’s data sharing
policy. Having templates makes it easier
for CDC awardees to create complete
and compliant DMPs and easier for CDC
project officers to assess them. Several
CDC Centers have created customized
templates. For this proposed Extension,
some of the templates will undergo
minor changes to increase utility and
ease of use and the annual burden hour
estimate has been updated based on the
experience of the past three years and
planned future use.
CDC requests OMB approval for an
estimated from 1450 annual burden
hours. There is no cost 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)
Applicants and Award Recipients ..................
DMP Template ..............................................
1450
1
60/60
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. 2023–11265 Filed 5–25–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ddrumheller on DSK120RN23PROD with NOTICES1
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.
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.
Centers for Disease Control and
Prevention
[30Day–23–1080]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
VerDate Sep<11>2014
18:14 May 25, 2023
Jkt 259001
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘HIV
Outpatient Study (HOPS)’’ 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 February
17, 2023 to obtain comments from the
public and affected agencies. CDC
received one comment 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:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
(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:\FR\FM\26MYN1.SGM
26MYN1
34157
Federal Register / Vol. 88, No. 102 / Friday, May 26, 2023 / Notices
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
HIV Outpatient Study (HOPS) (OMB
Control No. 0920–1080, Exp. 2/29/
2024)—Extension—National Center for
HIV, Viral Hepatitis, STD, TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
ddrumheller on DSK120RN23PROD with NOTICES1
The Centers for Disease Control and
Prevention (CDC) requests OMB
approval to continue collecting
information for HIV Outpatient Study
(HOPS). The study is based on a
prospective longitudinal cohort of
adults with HIV in outpatient care at
eight well-established private HIV care
practices and university-based clinics in
the U.S. The HOPS study sites are
located in six cities: Tampa, Florida;
Washington, DC; Stony Brook, New
York; Chicago, Illinois; Denver,
Colorado; and Philadelphia,
Pennsylvania. The study currently
collects information on a maximum of
2,700 outpatients per year. A portion of
HOPS participants are lost to follow-up
each year (most due to transferring out
of the HOPS clinics), and our target goal
is to enroll up to 450 new participants
(50–60 per site) annually. Patients are
approached during one of their routine
clinic visits and invited to participate in
the HOPS.
There are two sources of information
for the HOPS. First, clinical data are
abstracted on an ongoing basis from the
medical records of study participants.
Medical records provide data in five
general categories: demographics and
risk behaviors for HIV infection;
symptoms; diagnosed conditions
(definitive and presumptive);
medications prescribed (including dose,
duration, and reasons for stopping); and
all laboratory values, including CD4+ T
lymphocyte (CD4+) cell counts, plasma
HIV–RNA determinations, and
genotype, phenotype, and trophile
results. Clinic charts also provide data
about visit frequency, AIDS, and death.
Medical records abstraction is
conducted by trained study staff and
does not impose ongoing burden on
HOPS participants. However, CDC does
account for burden associated with the
initial study consent and orientation
process. The estimated burden per
response is 15 minutes.
The second source of HOPS
information is the annual behavioral
assessment, an optional activity
scheduled in conjunction with the
participant’s annual clinic visit. For
convenience, the behavioral assessment
can be completed in either of two
modes: a brief Telephone AudioComputer Assisted Self-Interview (T–
ACASI) survey or an identical Webbased Audio-Computer Assisted SelfInterview (W–ACASI). Data collection
includes: age, sex at birth, use of alcohol
and drugs, cigarette smoking, adherence
to antiretroviral medications, types of
Form name
HOPS Study Patients .....................................
HOPS Study Patients .....................................
Behavioral survey ...........................................
Consent form ..................................................
18:14 May 25, 2023
Jkt 259001
PO 00000
Frm 00032
Fmt 4703
Sfmt 9990
Estimated Annualized Burden Hours
Number of
respondents
Type of respondents
VerDate Sep<11>2014
sexual intercourse, condom use, and
disclosure of HIV status to partners. The
estimated burden per response is seven
minutes.
The core areas of HOPS research
extending through the present HIV
treatment era include: (i) investigating
and characterizing (new) problems
associated with long-term HIV infection
and its treatments using the longitudinal
cohort data; (ii) monitoring death rates
and causes of death; (iii) characterizing
the optimal patient management
strategies to reduce HIV related
morbidity and mortality (e.g.,
effectiveness of antiretroviral therapies
and other clinical interventions); (iv)
assessing sexual and drug use behaviors
and other patient reported outcomes
that supplement data from chart
abstraction; and (v) investigating
disparities in the HIV care continuum
by various demographic factors. In
recent years, the HOPS has been
instrumental in bringing attention to
emerging issues in chronic HIV
infection with actionable opportunities
for prevention, including cardiovascular
disease, fragility fractures, renal and
hepatic disease, and cancers. The HOPS
remains an important source for multiyear trend data concerning conditions
and behaviors for which data are not
readily available elsewhere, including:
rates of opportunistic illnesses, rates of
comorbid conditions (e.g., hypertension,
obesity, diabetes) and antiretroviral drug
resistance.
OMB approval is requested for three
years. The estimated number of
participants in the annual behavioral
assessment is 2,700 respondents. There
are no changes to the information
collection forms or methods.
Participation is voluntary and there are
no costs to respondents other than their
time. The total estimated annualized
burden is 428 hours.
E:\FR\FM\26MYN1.SGM
Number of
responses per
respondent
2,700
450
26MYN1
1
1
Average
burden
per response
(in hours)
7/60
15/60
34158
Federal Register / Vol. 88, No. 102 / Friday, May 26, 2023 / Notices
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. 2023–11264 Filed 5–25–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–23AP]
ddrumheller on DSK120RN23PROD with NOTICES1
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 ‘‘TRANSCEND:
Transgender status-neutral communityto-clinic models to end the HIV
epidemic’’ 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
16, 2022 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.
VerDate Sep<11>2014
18:14 May 25, 2023
Jkt 259001
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
TRANSCEND: Transgender statusneutral community-to-clinic models to
end the HIV epidemic—New—National
Center for HIV, Viral Hepatitis, STD, TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The CDC requesting public comment
and OMB approval on a New
information collection request (ICR) for
the demonstration project titled
‘‘TRANSCEND: Transgender statusneutral community-to-clinic models to
end the HIV epidemic.’’
Transgender (TG) persons, especially
transgender women (TGW), have a high
prevalence of HIV and lifetime risk of
acquiring HIV. In the 2019–2020
National HIV Behavioral Surveillance
Trans cycle, 42% of TGW tested
positive for HIV. Racial/ethnic
disparities were also found, with HIV
positivity rates of 62% among Black/
African American TGW and 35% among
Hispanic/Latina TGW compared to 17%
among White TGW. Despite the
disproportionate burden of HIV among
TGW, receipt of HIV prevention and
care services have been suboptimal.
Many TG persons experience poverty,
homelessness, abuse, and have
substance use or mental health
disorders, which impact access to and
utilization of HIV prevention and care
services. Many TG persons seek genderaffirming care, including hormone
therapy, at transgender health care
organizations (TG clinics), and these
encounters provide opportunities for
HIV testing and status-neutral HIV
services.
In the proposed demonstration
project, TG clinics and transgender-
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
serving community-based organizations
(CBOs) will work collaboratively to
evaluate community-to-clinic models to
provide integrated status-neutral HIV
prevention and care services, genderaffirming services including hormone
therapy, and primary healthcare, as well
as to ensure access to mental health,
substance use, and social support
services. All services will be culturally
and linguistically responsive for TG
persons to ensure that they feel
welcomed, heard, and cared for. The
recipients will also participate in a
national learning collaborative to share
lessons learned and best practices for
TG clinic and TG CBO partnerships to
provide status-neutral, community-toclinic services for TG persons.
This collection of data, which
involves creation of a unique identifier
so that CDC does not receive any
personally identifiable information (PII),
will allow CDC to assist TG clinics and
CBOs in monitoring and evaluating their
programs providing status-neutral HIV
services and comprehensive healthcare
for TG persons and for community-toclinic models of service provision.
Longitudinal person-level data
collection will occur through the
clinics’ electronic health record (EHR
Data Form) and the Client Intake Form,
and additional program evaluation data
will be collected through client surveys
(Client Satisfaction Survey).
The clients will complete the Client
Intake Form once when they first join
the program, with expected 800 clients
per year for a total burden of 107 hours
annually. A sample of 100 clients per
site (400 total) will respond to the Client
Satisfaction Survey once per year, for a
total burden of 100 hours annually. The
four data managers will extract data
from the EHR, perform quality checks,
code the data with a unique identifier,
and transmit the deidentified data to
CDC two times per year, for a total of 64
hours per year. The four data managers
will also compile, link, deidentify, and
report data from the Client Intake Forms
two times per year, with an estimated
burden of 16 hours annually. The four
data managers will compile and report
data from the Satisfaction Survey once
per year, with an estimated burden of
eight hours annually.
OMB approval is requested for three
years. Participation of the funded
recipients’ data managers is required,
and participation from the clients is
voluntary. There is no cost to
participants other than their time. The
total estimated annualized burden is
295 hours.
E:\FR\FM\26MYN1.SGM
26MYN1
]]>Agencies
[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Pages 34156-34158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11264]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-1080]
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 ``HIV Outpatient Study (HOPS)'' 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 February 17, 2023 to obtain comments from
the public and affected agencies. CDC received one comment 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,
[[Page 34157]]
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
HIV Outpatient Study (HOPS) (OMB Control No. 0920-1080, Exp. 2/29/
2024)--Extension--National Center for HIV, Viral Hepatitis, STD, TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC) requests OMB
approval to continue collecting information for HIV Outpatient Study
(HOPS). The study is based on a prospective longitudinal cohort of
adults with HIV in outpatient care at eight well-established private
HIV care practices and university-based clinics in the U.S. The HOPS
study sites are located in six cities: Tampa, Florida; Washington, DC;
Stony Brook, New York; Chicago, Illinois; Denver, Colorado; and
Philadelphia, Pennsylvania. The study currently collects information on
a maximum of 2,700 outpatients per year. A portion of HOPS participants
are lost to follow-up each year (most due to transferring out of the
HOPS clinics), and our target goal is to enroll up to 450 new
participants (50-60 per site) annually. Patients are approached during
one of their routine clinic visits and invited to participate in the
HOPS.
There are two sources of information for the HOPS. First, clinical
data are abstracted on an ongoing basis from the medical records of
study participants. Medical records provide data in five general
categories: demographics and risk behaviors for HIV infection;
symptoms; diagnosed conditions (definitive and presumptive);
medications prescribed (including dose, duration, and reasons for
stopping); and all laboratory values, including CD4+ T lymphocyte
(CD4+) cell counts, plasma HIV-RNA determinations, and genotype,
phenotype, and trophile results. Clinic charts also provide data about
visit frequency, AIDS, and death. Medical records abstraction is
conducted by trained study staff and does not impose ongoing burden on
HOPS participants. However, CDC does account for burden associated with
the initial study consent and orientation process. The estimated burden
per response is 15 minutes.
The second source of HOPS information is the annual behavioral
assessment, an optional activity scheduled in conjunction with the
participant's annual clinic visit. For convenience, the behavioral
assessment can be completed in either of two modes: a brief Telephone
Audio-Computer Assisted Self-Interview (T-ACASI) survey or an identical
Web-based Audio-Computer Assisted Self-Interview (W-ACASI). Data
collection includes: age, sex at birth, use of alcohol and drugs,
cigarette smoking, adherence to antiretroviral medications, types of
sexual intercourse, condom use, and disclosure of HIV status to
partners. The estimated burden per response is seven minutes.
The core areas of HOPS research extending through the present HIV
treatment era include: (i) investigating and characterizing (new)
problems associated with long-term HIV infection and its treatments
using the longitudinal cohort data; (ii) monitoring death rates and
causes of death; (iii) characterizing the optimal patient management
strategies to reduce HIV related morbidity and mortality (e.g.,
effectiveness of antiretroviral therapies and other clinical
interventions); (iv) assessing sexual and drug use behaviors and other
patient reported outcomes that supplement data from chart abstraction;
and (v) investigating disparities in the HIV care continuum by various
demographic factors. In recent years, the HOPS has been instrumental in
bringing attention to emerging issues in chronic HIV infection with
actionable opportunities for prevention, including cardiovascular
disease, fragility fractures, renal and hepatic disease, and cancers.
The HOPS remains an important source for multi-year trend data
concerning conditions and behaviors for which data are not readily
available elsewhere, including: rates of opportunistic illnesses, rates
of comorbid conditions (e.g., hypertension, obesity, diabetes) and
antiretroviral drug resistance.
OMB approval is requested for three years. The estimated number of
participants in the annual behavioral assessment is 2,700 respondents.
There are no changes to the information collection forms or methods.
Participation is voluntary and there are no costs to respondents other
than their time. The total estimated annualized burden is 428 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
HOPS Study Patients................... Behavioral survey....... 2,700 1 7/60
HOPS Study Patients................... Consent form............ 450 1 15/60
----------------------------------------------------------------------------------------------------------------
[[Page 34158]]
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. 2023-11264 Filed 5-25-23; 8:45 am]
BILLING CODE 4163-18-P
