[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Pages 11533-11534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03925]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-1266; Docket No. CDC-2021-0014]


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 and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``HIV prevention among Latina 
transgender women who have sex with men: Evaluation of a locally 
developed intervention''. The collection is part of a research study 
designed to evaluate the efficacy of a locally developed and culturally 
congruent two-session Spanish-language small-group intervention, ChiCAS 
(Chicas Creando Acceso a la Salud [Chicas: Girls Creating Access to 
Health]), which provides combination HIV prention services to adult 
Hispanic/Latina transgender women at high risk for HIV infection.

DATES: CDC must receive written comments on or before April 26, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2121-
0014 by any of the following methods:
     Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (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-D74, Atlanta, Georgia 30329; phone: 404-639-7570; 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; and
    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

[[Page 11534]]

other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

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, STED, 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 is requesting approval for a two-year extension of a 
currently approved ICR, 0920-1266 entitled, ``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 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 the assessment at baseline and again at 
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.
    We 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 (one hour) to complete and 
will be administered to 140 participants. The follow up assessment will 
take 45 minutes (0.75 hours) to complete and will be administered to 
140 participants one time. The interview will take 90 minutes (one and 
one-half hours) 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 number of burden hours is 310 across 39-months of data 
collection. The total estimated annualized burden hours are 155.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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General Public--Adults........  Eligibility                  140               1            3/60               7
                                 Screener.
General Public--Adults........  Contact                       70               1            1/60               2
                                 Information.
General Public--Adults........  Baseline                      70               1             1.0              70
                                 Assessment.
General Public--Adults........  Follow-up                     70               1           45/60              53
                                 Assessment.
General Public--Adults........  Interview.......              15               1             1.5              23
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             155
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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. 2021-03925 Filed 2-24-21; 8:45 am]
BILLING CODE 4163-18-P