[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33297-33298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-21-1266]


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 prevention among Latina transgender 
women who have sex with men: Evaluation of a locally developed 
intervention'' 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 
25, 2021 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, 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 prevention among Latina transgender women who have sex with 
men: Evaluation of a locally developed intervention (OMB Control No. 
0920-1266, Exp. 6/30/2021)--Revision--National Center for HIV/AIDS, 
Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    The National Center for HIV/AIDS, Viral Hepatitis, STD and TB 
Prevention (NCHHSTP) is requesting approval for a two-year extension of 
a currently approved ICR (OMB Control No. 0920-1266), titled ``HIV 
prevention among Latina transgender women who have sex with men: 
Evaluation of a locally developed intervention.'' The goal of this 
study is to evaluate the efficacy of ChiCAS (Chicas Creando Acceso a la 
Salud [Chicas: Girls Creating Access to Health]), a locally developed 
and culturally congruent two-session Spanish-language small-group 
combination intervention, designed to promote consistent condom use, 
and access to, and participation in, pre-exposure prophylaxis (PrEP) 
and medically supervised hormone therapy by HIV seronegative Hispanic/
Latina transgender women who have sex with men.
    The information collected through this study will be used to 
evaluate whether the ChiCAS intervention is an effective HIV-prevention 
strategy by assessing whether exposure to the intervention results in 
improvements in participants' health and HIV prevention behaviors. The 
study will compare pre- (baseline) and post-intervention (six-month) 
levels of HIV risk among participants who have received the 
intervention and participants who have not yet received the 
intervention (delayed-intervention group).
    This study will be carried out in metropolitan areas in and around 
North Carolina, including Ashville, NC; Charlotte, NC; Research 
Triangle (metropolitan area of Greensboro, Winston-Salem and High Point 
NC); Raleigh, NC; Wilmington, NC; and Greenville, SC. The study 
population will include 140 HIV-negative Spanish-speaking transgender 
women. Participants will be adults, at least 18 years of age, self-
identify as male-to-female transgender or report having been born male 
and identifying as female, and report having sex with at least one man 
in the past six months. We anticipate participants will be comprised 
mainly of racial/ethnic minority participants under 35 years of age, 
consistent with the epidemiology of HIV infection among transgender 
women.
    Intervention participants will be recruited to the study through a 
combination of approaches, including traditional print advertisement, 
referral, in-person outreach, and through word of mouth. A quantitative 
assessment will be used to collect information for this study, which 
will be delivered at the time of study enrollment, and again at a six-
month follow up. The assessment will be used to measure differences in 
sexual risk knowledge, perceptions and behaviors including condom use, 
PrEP use, and use of medically supervised hormone therapy. Intervention 
mediators, including healthcare provider trust and communication 
skills, self-reported health status and healthcare access, community 
attachment and social support will also be measured. All participants 
will complete an assessment at baseline and

[[Page 33298]]

again at a six-month follow-up, after enrolling in the study. The 
intervention group will participate in ChiCAS after completing the 
baseline assessment and the delayed intervention group will participate 
in ChiCAS after completing the six-month follow up assessment.
    CDC will also examine intervention experiences through in-depth 
interviews with 30 intervention group participants. The interviews will 
capture participants' general experiences with the ChiCAS intervention, 
as well as their experiences and perceptions specific to the main study 
outcomes: PrEP knowledge, awareness, interest and use; condom skills 
and use; and hormone therapy knowledge, awareness, interest and use.
    It is expected that 50% of transgender women screened will meet 
study eligibility. We expect the initial screening and contact 
information gathering to take approximately four minutes to complete. 
The baseline assessment will take 60 minutes to complete and will be 
administered to 140 participants. The follow up assessment will take 45 
minutes to complete and will be administered to 140 participants one 
time. The interview will take 90 minutes to complete and will be 
administered to 30 participants from the intervention group one time.
    There are no costs to the respondents other than their time. The 
total estimated annualized burden hours are 155.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
General Public--Adults................  Eligibility Screener....             140               1            3/60
General Public--Adults................  Contact Information.....              70               1            1/60
General Public--Adults................  Baseline Assessment.....              70               1           60/60
General Public--Adults................  Follow-up Assessment....              70               1           45/60
General Public--Adults................  Interview...............              15               1           90/60
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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. 2021-13436 Filed 6-23-21; 8:45 am]
BILLING CODE 4163-18-P