Agency Forms Undergoing Paperwork Reduction Act Review, 28232-28233 [2018-12971]
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Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
disease. The advice provided by the
Committee will assist in ensuring
scientific quality, timeliness, utility, and
dissemination of credible appropriate
messages and resource materials.
Matters to be Considered: The agenda
will include discussions on current and
emerging topics related to breast cancer
in young women. These will include
public health communication, breast
cancer in young women digital and
social media campaign, CDC updates,
and updates from the field. Agenda
items are subject to change as priorities
dictate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2018–13047 Filed 6–15–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Centers for Disease Control and
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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 ‘‘Project NICE:
Navigating Insurance Coverage
Expansion’’ 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 November
13, 2017, to obtain comments from the
public and affected agencies. CDC did
not receive comments 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
VerDate Sep<11>2014
18:00 Jun 15, 2018
Jkt 244001
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 or
send an email to omb@cdc.gov. 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
Project NICE: Navigating Insurance
Coverage Expansion—New—National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC is requesting a three-year
approval to evaluate the efficacy of an
in-person health insurance enrollment
assistance intervention among 1,000
Black and Hispanic men who have sex
with men (MSM) and transgender
persons ages ≥18 years living in the
Chicago, Illinois metropolitan area.
In 2013, MSM accounted for 81% of
new HIV infections among males and
65% of all new HIV infections. In 2010
African Americans comprised only 12%
of the US population, but Black MSM
nearly equaled White MSM in numbers
of new HIV infections (10,600 and
11,200, respectively). In 2010 Hispanics
comprised 17% of the US population,
and Hispanic MSM accounted for 22%
(6,700) of all new HIV infections. A
2008 systematic review found HIV rates
among Black and Hispanic transgender
women to be 56% and 16%,
respectively. Contributing to these
disproportionate HIV rates are that
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Black and Hispanic MSM and
transgender persons face obstacles in
seeking medical care and following
through with referrals or appointments,
including lack of health insurance.
The intervention being evaluated in
this study (in-person health insurance
enrollment assistance) is not a new
activity. This study will evaluate
whether moving the delivery of inperson health insurance enrollment
assistance, from the first clinic visit after
receipt of an HIV test result, to earlier
in the care continuum during the HIV
testing event, will impact health
outcomes. Because this study does not
introduce new intervention activities,
only reorders the sequence of delivery
of standard practice, the burden to the
participant experience will be data
collection forms and research
procedures only.
The goal of this study is to test
whether providing a point of care, inperson assistance in enrolling in private
health insurance or Medicaid for the
first time, changing to a different
insurance plan, or understanding how
to use current insurance policies
following HIV testing will (1) increase
the proportion of participants who
obtain health insurance; (2) result in
better health outcomes among
participants (e.g., achieving viral
suppression, remaining HIV negative);
(3) improve the linkage and retention
rates for HIV care (i.e., HIV treatment,
Pre-exposure Prophylaxis (PrEP)) and
other HIV-associated health services
(e.g., mental health counseling,
substance use treatment) of participants,
especially those diagnosed with HIV;
and (4) increase HIV care linkage and
retention rates sufficiently to justify the
cost of implementing the intervention
(cost-benefit analysis) among Black and
Hispanic MSM and transgender persons
age 18 or older in the Chicago, Illinois
metropolitan area.
This study is funded through a
cooperative agreement between CDC
and the University of Chicago Medicine.
Three partner agencies will conduct the
intervention: (1) University of Chicago
Medicine (the lead partner agency), (2)
Howard Brown Health, and (3) Chicago
House and Social Service Agency
(Chicago House). These three partner
agencies currently provide in-person
health insurance enrollment assistance,
linkage to care (HIV-related treatment,
primary care), and patient navigation
services to the study population.
This study uses a randomized
controlled trial design, which will
enhance scientific validity and the
policy impact of the intervention, and
help researchers assess the efficacy of
this intervention as an emerging
E:\FR\FM\18JNN1.SGM
18JNN1
28233
Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
practice. This study aligns with
National HIV/AIDS Strategy 2020 and
Healthy People 2020 objectives of
reducing new HIV infections, increasing
access to care and improving health
outcomes for people living with HIV,
and reducing HIV-related health
disparities. This study also aligns with
the Office of Management and Budget’s
emphasis on application of behavioral
insights in that it restructures the
context (i.e., after HIV testing) in which
health-related decision-making (i.e.,
health insurance enrollment) occurs in
order to promote the selection of
beneficial options (i.e., attending HIVrelated medical care appointments).
This proposed health insurance
enrollment assistance study has the
potential for widespread health
improvements for Black and Hispanic
MSM and transgender persons
regardless of their HIV status.
At this time, CDC is not partnering
with other HHS agencies for this study.
However, we have discussed the study
with HRSA/HAB and HHS/OD, and
plan to apprise CMS and HRSA of the
project before implementation and
invite CMS and HRSA representatives to
serve as consultants. HHS may also
direct us to the CMS regional officer for
Chicago, Illinois. Additionally, there is
the potential to have CMS grantee
navigators supplement partner agency
navigators during outreach HIV testing
events. For this study, CDC is not
engaged in research, and therefore not
involved in data collection activities.
The grantee is responsible for
implementing the intervention and
collecting data from the proposed 1,000
participants. Thus, CDC will not need
an interagency data-sharing agreement if
we do consult with HRSA or CMS.
The study will enroll 1,000
participants over 12 months to reach
adequate power calculations (500 into
the intervention arm, and 500 into the
control arm). Approximately 1,500
individuals will need to be screened to
identify and enroll 1,000 eligible study
participants. After an HIV testing
session at an outreach event or clinic
visit, partner agency staff will invite
individuals to participate in the study.
If individuals are interested, staff will
screen individuals for eligibility using
the Participant Eligibility Form
(Attachment 5) which will take
approximately 5 minutes to complete. If
they are determined eligible to
participate, and still interested in
participating, the individual will
complete an Informed Consent Form
(Attachment 6), which will take
approximately 10 minutes to complete,
and the Participant Enrollment Form
(Attachment 7), which will take
approximately 35 minutes to complete.
The total estimated annualized hourly
burden anticipated for this study is 875
hours. There is no cost to respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Study participant .............................................
Study participant .............................................
Study participant .............................................
Participant Eligibility Form (Att 5) ..................
Informed Consent Form (Att 6) ......................
Participant Enrollment Form (Att 7) ...............
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. 2018–12971 Filed 6–15–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–0530]
amozie on DSK3GDR082PROD with NOTICES1
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 Energy
Employees Occupational Illness
Compensation Program Act of 2000
(EEOICPA) Dose Reconstruction
Interviews and Forms to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
VerDate Sep<11>2014
18:00 Jun 15, 2018
Jkt 244001
Submitted for Public Comment and
Recommendations’’ notice on February
20, 2018 to obtain comments from the
public and affected agencies. CDC did
not receive comments 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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
1,500
1,000
1,000
Number of
responses per
respondent
Average
burden
per response
(in hours)
1
1
1
5/60
10/60
35/60
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 or
send an email to omb@cdc.gov. 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
EEOICPA Dose Reconstruction
Interviews and Forms, OMB No. 0920–
0530, expires 04/30/2018—
Reinstatement without change—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
On October 30, 2000, the Energy
Employees Occupational Illness
E:\FR\FM\18JNN1.SGM
18JNN1
]]>Agencies
[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28232-28233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12971]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-17AUZ]
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 ``Project NICE: Navigating Insurance Coverage
Expansion'' 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 November
13, 2017, to obtain comments from the public and affected agencies. CDC
did not receive comments 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 or send an email to [email protected]. 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
Project NICE: Navigating Insurance Coverage Expansion--New--
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
CDC is requesting a three-year approval to evaluate the efficacy of
an in-person health insurance enrollment assistance intervention among
1,000 Black and Hispanic men who have sex with men (MSM) and
transgender persons ages >=18 years living in the Chicago, Illinois
metropolitan area.
In 2013, MSM accounted for 81% of new HIV infections among males
and 65% of all new HIV infections. In 2010 African Americans comprised
only 12% of the US population, but Black MSM nearly equaled White MSM
in numbers of new HIV infections (10,600 and 11,200, respectively). In
2010 Hispanics comprised 17% of the US population, and Hispanic MSM
accounted for 22% (6,700) of all new HIV infections. A 2008 systematic
review found HIV rates among Black and Hispanic transgender women to be
56% and 16%, respectively. Contributing to these disproportionate HIV
rates are that Black and Hispanic MSM and transgender persons face
obstacles in seeking medical care and following through with referrals
or appointments, including lack of health insurance.
The intervention being evaluated in this study (in-person health
insurance enrollment assistance) is not a new activity. This study will
evaluate whether moving the delivery of in-person health insurance
enrollment assistance, from the first clinic visit after receipt of an
HIV test result, to earlier in the care continuum during the HIV
testing event, will impact health outcomes. Because this study does not
introduce new intervention activities, only reorders the sequence of
delivery of standard practice, the burden to the participant experience
will be data collection forms and research procedures only.
The goal of this study is to test whether providing a point of
care, in-person assistance in enrolling in private health insurance or
Medicaid for the first time, changing to a different insurance plan, or
understanding how to use current insurance policies following HIV
testing will (1) increase the proportion of participants who obtain
health insurance; (2) result in better health outcomes among
participants (e.g., achieving viral suppression, remaining HIV
negative); (3) improve the linkage and retention rates for HIV care
(i.e., HIV treatment, Pre-exposure Prophylaxis (PrEP)) and other HIV-
associated health services (e.g., mental health counseling, substance
use treatment) of participants, especially those diagnosed with HIV;
and (4) increase HIV care linkage and retention rates sufficiently to
justify the cost of implementing the intervention (cost-benefit
analysis) among Black and Hispanic MSM and transgender persons age 18
or older in the Chicago, Illinois metropolitan area.
This study is funded through a cooperative agreement between CDC
and the University of Chicago Medicine. Three partner agencies will
conduct the intervention: (1) University of Chicago Medicine (the lead
partner agency), (2) Howard Brown Health, and (3) Chicago House and
Social Service Agency (Chicago House). These three partner agencies
currently provide in-person health insurance enrollment assistance,
linkage to care (HIV-related treatment, primary care), and patient
navigation services to the study population.
This study uses a randomized controlled trial design, which will
enhance scientific validity and the policy impact of the intervention,
and help researchers assess the efficacy of this intervention as an
emerging
[[Page 28233]]
practice. This study aligns with National HIV/AIDS Strategy 2020 and
Healthy People 2020 objectives of reducing new HIV infections,
increasing access to care and improving health outcomes for people
living with HIV, and reducing HIV-related health disparities. This
study also aligns with the Office of Management and Budget's emphasis
on application of behavioral insights in that it restructures the
context (i.e., after HIV testing) in which health-related decision-
making (i.e., health insurance enrollment) occurs in order to promote
the selection of beneficial options (i.e., attending HIV-related
medical care appointments). This proposed health insurance enrollment
assistance study has the potential for widespread health improvements
for Black and Hispanic MSM and transgender persons regardless of their
HIV status.
At this time, CDC is not partnering with other HHS agencies for
this study. However, we have discussed the study with HRSA/HAB and HHS/
OD, and plan to apprise CMS and HRSA of the project before
implementation and invite CMS and HRSA representatives to serve as
consultants. HHS may also direct us to the CMS regional officer for
Chicago, Illinois. Additionally, there is the potential to have CMS
grantee navigators supplement partner agency navigators during outreach
HIV testing events. For this study, CDC is not engaged in research, and
therefore not involved in data collection activities. The grantee is
responsible for implementing the intervention and collecting data from
the proposed 1,000 participants. Thus, CDC will not need an interagency
data-sharing agreement if we do consult with HRSA or CMS.
The study will enroll 1,000 participants over 12 months to reach
adequate power calculations (500 into the intervention arm, and 500
into the control arm). Approximately 1,500 individuals will need to be
screened to identify and enroll 1,000 eligible study participants.
After an HIV testing session at an outreach event or clinic visit,
partner agency staff will invite individuals to participate in the
study. If individuals are interested, staff will screen individuals for
eligibility using the Participant Eligibility Form (Attachment 5) which
will take approximately 5 minutes to complete. If they are determined
eligible to participate, and still interested in participating, the
individual will complete an Informed Consent Form (Attachment 6), which
will take approximately 10 minutes to complete, and the Participant
Enrollment Form (Attachment 7), which will take approximately 35
minutes to complete. The total estimated annualized hourly burden
anticipated for this study is 875 hours. There is no cost to
respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Study participant..................... Participant Eligibility 1,500 1 5/60
Form (Att 5).
Study participant..................... Informed Consent Form 1,000 1 10/60
(Att 6).
Study participant..................... Participant Enrollment 1,000 1 35/60
Form (Att 7).
----------------------------------------------------------------------------------------------------------------
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. 2018-12971 Filed 6-15-18; 8:45 am]
BILLING CODE 4163-18-P
