Notice2023-11266
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 26, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 102 (Friday, May 26, 2023)</title>
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[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Pages 34158-34159]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11266]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-23AP]
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
community-to-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.
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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 status-neutral 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 status-neutral 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 gender-affirming 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-
serving community-based organizations (CBOs) will work collaboratively
to evaluate community-to-clinic models to provide integrated status-
neutral HIV prevention and care services, gender-affirming 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-to-clinic 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-
to-clinic 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.
[[Page 34159]]
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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TRANSCEND Recipient Data Manager...... Electronic Health Record 4 2 8
Data Form.
TRANSCEND Recipient Data Manager...... Client Intake Form...... 4 2 2
TRANSCEND Clients..................... Client Intake Form...... 800 1 8/60
TRANSCEND Clients..................... Client Satisfaction 400 1 15/60
Survey.
TRANSCEND Recipient Data Manager...... Client Satisfaction 4 1 2
Survey.
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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. 2023-11266 Filed 5-25-23; 8:45 am]
BILLING CODE 4163-18-P
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