[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Pages 34158-34159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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