[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42654-42655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-FY-2018; Docket No. CDC-2018-0063]


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: 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 prevention services to adult Hispanic/Latina 
transgender women at high risk for HIV infection.

DATES: CDC must receive written comments on or before October 22, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0063 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
    <bullet> 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 Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
<a href="/cdn-cgi/l/email-protection#224d4f40624146410c454d54"><span class="__cf_email__" data-cfemail="2f40424d6f4c4b4c01484059">[email protected]</span></a>.

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 
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: Evaluation of a

[[Page 42655]]

locally developed intervention--New--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 20-months of data collection 
entitled, ``HIV prevention among Latina transgender women: 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 five metropolitan areas in North 
Carolina: Ashville, NC; Charlotte, NC; Research Triangle (metropolitan 
area of Greensboro, Winston-Salem and High Point NC); Raleigh, NC; and 
Wilmington, NC. 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 to take 
approximately four minutes to complete. The assessment will take 60 
minutes (one hour) to complete and will be administered to 140 
participants a total of two times. 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 estimated annualized burden hours is 172.

                                                            Estimated Annualized Burden Hours
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                                                                                                     Number of        Average burden
             Type of respondents                         Form name                Number of        responses per     per response (in   Total burden (in
                                                                                 respondents         respondent           hours)             hours)
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General Public--Adults......................  Eligibility Screener..........                140                  1               3/60                  7
General Public--Adults......................  Contact Information...........                 70                  1               1/60                  2
General Public--Adults......................  Assessment....................                 70                  2                1.0                140
General Public--Adults......................  Interview.....................                 15                  1                1.5                 23
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...................................  ..............................  .................  .................  .................                172
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Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-18180 Filed 8-22-18; 8:45 am]
 BILLING CODE 4163-18-P


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