Notice2021-13436
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 24, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33297-33298]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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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
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