60d FRN published 25FEB2021

Att 2 60 day FRN Published 2-25-2021.pdf

HIV prevention among Latina transgender women who have sex with men: Evaluation of a locally developed intervention

60d FRN published 25FEB2021

OMB: 0920-1266

Document [pdf]

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Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices
participate in the survey. We anticipate
that approximately 20% of SSPs will
decline to complete the survey, yielding
approximately 320 completed surveys
per year. However, given that this is the
first survey of SSPs funded by CDC and
that the COVID–19 pandemic makes it
challenging to predict future response
rates, we are requesting enough burden
hours to allow 100% of SSPs to respond
to the survey. We estimate that it will
take 35 minutes to complete the survey,
regardless of how the respondent

described above, we are requesting
enough burden hours to allow 100% of
SSPs to respond to this question. We
estimate that it will take two minutes to
respond to this question.
OMB approval is requested for three
years. The survey will be administered
annually using the most updated
national directory of SSPs during each
survey administration. Participation is
voluntary and there are no costs to
respondents other than their time.

chooses to complete it (i.e., selfadministered online or intervieweradministered by phone or
videoconferencing). SSPs that do not
respond to the initial survey invitation
will be given reminders to complete the
survey over the duration of the survey
implementation period. The final
reminder will include a link to a single
question for SSPs that choose not to
complete the survey about why they
declined to complete the survey. Given
the uncertainties in response rates

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Number of
respondents

Average
burden per
response
(in hours)

Total burden
(in hours)

Type of respondent

Form

All participating SSPs .......................

400

35/60

233

Non-responding SSPs ......................

National Syringe Services Program
Evaluation Survey.
Non-Response Survey Item .............

400

2/60

Total ...........................................

...........................................................

........................

246

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–03924 Filed 2–24–21; 8:45 am]
BILLING CODE 4163–18–P

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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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

SUMMARY:

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17:04 Feb 24, 2021

Jkt 253001

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]

PO 00000

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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

SUPPLEMENTARY INFORMATION:

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25FEN1

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Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices

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 preexposure 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-

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.

(baseline) and post-intervention (sixmonth) 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 Spanishspeaking transgender women.
Participants will be adults, at least 18
years of age, self-identify as male-tofemale 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

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

General
General
General
General
General

Public—Adults
Public—Adults
Public—Adults
Public—Adults
Public—Adults

Number
of respondents

Form name

Number of
responses
per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

.....................................
.....................................
.....................................
.....................................
.....................................

Eligibility Screener ............................................
Contact Information ..........................................
Baseline Assessment ........................................
Follow-up Assessment ......................................
Interview ............................................................

140
70
70
70
15

1
1
1
1
1

3/60
1/60
1.0
45/60
1.5

7
2
70
53
23

Total ............................................................

...........................................................................