Proposed Data Collection Submitted for Public Comment and Recommendations, 11533-11534 [2021-03925]
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11533
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
1
35/60
233
Non-responding SSPs ......................
National Syringe Services Program
Evaluation Survey.
Non-Response Survey Item .............
400
1
2/60
13
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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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: omb@cdc.gov
PO 00000
Frm 00039
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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:
E:\FR\FM\25FEN1.SGM
25FEN1
11534
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 ............................................................
...........................................................................
........................
........................
........................
155
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
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
