Proposed Data Collection Submitted for Public Comment and Recommendations, 42654-42655 [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
[FR Doc. 2018–18168 Filed 8–22–18; 8:45 am]
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
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Jkt 244001
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: 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.
You may submit comments,
identified by Docket No. CDC–2018–
0063 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
ADDRESSES:
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
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:
omb@cdc.gov.
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
E:\FR\FM\23AUN1.SGM
23AUN1
42655
Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
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 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(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 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 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 healthcare access,
community attachment and social
support will also be measured. All
participants will complete the
assessment at baseline and again at sixmonth 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
Type of respondents
General
General
General
General
Public—Adults
Public—Adults
Public—Adults
Public—Adults
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total burden
(in hours)
........
........
........
........
Eligibility Screener ................
Contact Information ..............
Assessment ..........................
Interview ...............................
140
70
70
15
1
1
2
1
3/60
1/60
1.0
1.5
7
2
140
23
Total ...............................
...............................................
..............................
..............................
..............................
172
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.
daltland on DSKBBV9HB2PROD with NOTICES
Number of
respondents
Form name
[FR Doc. 2018–18180 Filed 8–22–18; 8:45 am]
19:43 Aug 22, 2018
Centers for Disease Control and
Prevention
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
BILLING CODE 4163–18–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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PO 00000
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provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Public
Law 92–463. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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 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:
[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
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response (in Total burden (in
respondents respondent hours) hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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]
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