[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Notices]
[Pages 68694-68695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24918]



[[Page 68694]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-23AP; Docket No. CDC-2022-0128]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: 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 new proposed information collection project 
titled TRANSCEND: Transgender status-neutral community-to-clinic models 
to end the HIV epidemic. This project is designed to collect 
standardized program evaluation data from the clinics and community-
based organizations who receive federal funds for HIV prevention and 
care activities.

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

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0128 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 (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: [email protected].

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

    TRANSCEND: Transgender status-neutral community-to-clinic models to 
end the HIV epidemic--New--National Center for HIV, Viral Hepatitis, 
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    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. Among TG persons, 92% reported 
that they were aware of pre-exposure prophylaxis (PrEP) but only 32% 
had used it. In 2019, viral suppression among persons with diagnosed 
HIV was 67% among TGW. Large proportions of 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 healthcare 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 develop and 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 deidentified data will allow CDC to assist TG 
clinics and CBOs in monitoring and evaluating their programs and to 
identify best practices for 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 clinic's electronic health record (EHR) and a 
database shared between clinic and CBOs, and additional program 
evaluation data will be collected through client surveys.
    CDC requests OMB approval for an estimated 329 annual burden hours 
for the recipients to collect, enter or upload, and report client 
demographic and behavioral characteristics, client data from the EHR, 
and client surveys. There are no other costs to respondents other than 
their time to participate.

[[Page 68695]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
TRANSCEND Recipient Data        Electronic                     4               2               8              64
 Manager.                        Health Record
                                 Data Form.
TRANSCEND Recipient Data        Client Info Form               4               2               2              16
 Manager.
                                                 ---------------------------------------------------------------
TRANSCEND Clients.............  Client Info Form           1,000               1            5/60              83
TRANSCEND CBO Staff...........  Client Info Form               8             100            5/60              67
TRANSCEND Clients.............  Client Program             1,000               1            5/60              83
                                 Evaluation
                                 Survey.
TRANSCEND Recipient Data        Client Program                 4               2               2              16
 Manager.                        Evaluation
                                 Survey.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             329
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-24918 Filed 11-15-22; 8:45 am]
BILLING CODE 4163-18-P