83 FR 28232 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 117 (June 18, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 117 (June 18, 2018)
| Page Range | 28232-28233 | |
| FR Document | 2018-12971 |
[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)] [Notices] [Pages 28232-28233] From the Federal Register Online [www.thefederalregister.org] [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
![28232 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
disease. The advice provided by the functions of the agency, including Black and Hispanic MSM and
Committee will assist in ensuring whether the information will have transgender persons face obstacles in
scientific quality, timeliness, utility, and practical utility; seeking medical care and following
dissemination of credible appropriate (b) Evaluate the accuracy of the through with referrals or appointments,
messages and resource materials. agencies estimate of the burden of the including lack of health insurance.
Matters to be Considered: The agenda proposed collection of information, The intervention being evaluated in
will include discussions on current and including the validity of the this study (in-person health insurance
emerging topics related to breast cancer methodology and assumptions used; enrollment assistance) is not a new
in young women. These will include (c) Enhance the quality, utility, and activity. This study will evaluate
public health communication, breast clarity of the information to be whether moving the delivery of in-
cancer in young women digital and collected; person health insurance enrollment
social media campaign, CDC updates, (d) Minimize the burden of the assistance, from the first clinic visit after
and updates from the field. Agenda collection of information on those who receipt of an HIV test result, to earlier
items are subject to change as priorities are to respond, including, through the in the care continuum during the HIV
dictate. use of appropriate automated, testing event, will impact health
The Director, Management Analysis electronic, mechanical, or other outcomes. Because this study does not
and Services Office, has been delegated technological collection techniques or introduce new intervention activities,
the authority to sign Federal Register other forms of information technology, only reorders the sequence of delivery
notices pertaining to announcements of e.g., permitting electronic submission of of standard practice, the burden to the
meetings and other committee responses; and participant experience will be data
management activities, for both the (e) Assess information collection collection forms and research
Centers for Disease Control and costs. procedures only.
Prevention and the Agency for Toxic To request additional information on The goal of this study is to test
Substances and Disease Registry. the proposed project or to obtain a copy whether providing a point of care, in-
of the information collection plan and person assistance in enrolling in private
Elaine Baker, instruments, call (404) 639–7570 or health insurance or Medicaid for the
Director, Management Analysis and Services send an email to omb@cdc.gov. Direct first time, changing to a different
Office, Centers for Disease Control and written comments and/or suggestions insurance plan, or understanding how
Prevention. regarding the items contained in this to use current insurance policies
[FR Doc. 2018–13047 Filed 6–15–18; 8:45 am] notice to the Attention: CDC Desk following HIV testing will (1) increase
BILLING CODE 4163–19–P Officer, Office of Management and the proportion of participants who
Budget, 725 17th Street NW, obtain health insurance; (2) result in
Washington, DC 20503 or by fax to (202) better health outcomes among
DEPARTMENT OF HEALTH AND 395–5806. Provide written comments participants (e.g., achieving viral
HUMAN SERVICES within 30 days of notice publication. suppression, remaining HIV negative);
(3) improve the linkage and retention
Centers for Disease Control and Proposed Project rates for HIV care (i.e., HIV treatment,
Prevention Project NICE: Navigating Insurance Pre-exposure Prophylaxis (PrEP)) and
[30Day–18–17AUZ] Coverage Expansion—New—National other HIV-associated health services
Center for HIV/AIDS, Viral Hepatitis, (e.g., mental health counseling,
Agency Forms Undergoing Paperwork STD, and TB Prevention (NCHHSTP), substance use treatment) of participants,
Reduction Act Review Centers for Disease Control and especially those diagnosed with HIV;
Prevention (CDC). and (4) increase HIV care linkage and
In accordance with the Paperwork retention rates sufficiently to justify the
Reduction Act of 1995, the Centers for Background and Brief Description
cost of implementing the intervention
Disease Control and Prevention (CDC) CDC is requesting a three-year (cost-benefit analysis) among Black and
has submitted the information approval to evaluate the efficacy of an Hispanic MSM and transgender persons
collection request titled ‘‘Project NICE: in-person health insurance enrollment age 18 or older in the Chicago, Illinois
Navigating Insurance Coverage assistance intervention among 1,000 metropolitan area.
Expansion’’ to the Office of Management Black and Hispanic men who have sex This study is funded through a
and Budget (OMB) for review and with men (MSM) and transgender cooperative agreement between CDC
approval. CDC previously published a persons ages ≥18 years living in the and the University of Chicago Medicine.
‘‘Proposed Data Collection Submitted Chicago, Illinois metropolitan area. Three partner agencies will conduct the
for Public Comment and In 2013, MSM accounted for 81% of intervention: (1) University of Chicago
Recommendations’’ notice on November new HIV infections among males and Medicine (the lead partner agency), (2)
13, 2017, to obtain comments from the 65% of all new HIV infections. In 2010 Howard Brown Health, and (3) Chicago
public and affected agencies. CDC did African Americans comprised only 12% House and Social Service Agency
not receive comments related to the of the US population, but Black MSM (Chicago House). These three partner
previous notice. This notice serves to nearly equaled White MSM in numbers agencies currently provide in-person
allow an additional 30 days for public of new HIV infections (10,600 and health insurance enrollment assistance,
and affected agency comments. 11,200, respectively). In 2010 Hispanics linkage to care (HIV-related treatment,
CDC will accept all comments for this comprised 17% of the US population, primary care), and patient navigation
amozie on DSK3GDR082PROD with NOTICES1
proposed information collection project. and Hispanic MSM accounted for 22% services to the study population.
The Office of Management and Budget (6,700) of all new HIV infections. A This study uses a randomized
is particularly interested in comments 2008 systematic review found HIV rates controlled trial design, which will
that: among Black and Hispanic transgender enhance scientific validity and the
(a) Evaluate whether the proposed women to be 56% and 16%, policy impact of the intervention, and
collection of information is necessary respectively. Contributing to these help researchers assess the efficacy of
for the proper performance of the disproportionate HIV rates are that this intervention as an emerging
VerDate Sep<11>2014 18:00 Jun 15, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\18JNN1.SGM 18JNN1](https://thefederalregister.org/doc/83_FR_28349/page/1.svg)
![Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28233
practice. This study aligns with However, we have discussed the study individuals will need to be screened to
National HIV/AIDS Strategy 2020 and with HRSA/HAB and HHS/OD, and identify and enroll 1,000 eligible study
Healthy People 2020 objectives of plan to apprise CMS and HRSA of the participants. After an HIV testing
reducing new HIV infections, increasing project before implementation and session at an outreach event or clinic
access to care and improving health invite CMS and HRSA representatives to visit, partner agency staff will invite
outcomes for people living with HIV, serve as consultants. HHS may also individuals to participate in the study.
and reducing HIV-related health direct us to the CMS regional officer for If individuals are interested, staff will
disparities. This study also aligns with Chicago, Illinois. Additionally, there is screen individuals for eligibility using
the Office of Management and Budget’s the potential to have CMS grantee the Participant Eligibility Form
emphasis on application of behavioral navigators supplement partner agency (Attachment 5) which will take
insights in that it restructures the navigators during outreach HIV testing approximately 5 minutes to complete. If
context (i.e., after HIV testing) in which events. For this study, CDC is not they are determined eligible to
health-related decision-making (i.e., engaged in research, and therefore not
participate, and still interested in
health insurance enrollment) occurs in involved in data collection activities.
participating, the individual will
order to promote the selection of The grantee is responsible for
beneficial options (i.e., attending HIV- implementing the intervention and complete an Informed Consent Form
related medical care appointments). collecting data from the proposed 1,000 (Attachment 6), which will take
This proposed health insurance participants. Thus, CDC will not need approximately 10 minutes to complete,
enrollment assistance study has the an interagency data-sharing agreement if and the Participant Enrollment Form
potential for widespread health we do consult with HRSA or CMS. (Attachment 7), which will take
improvements for Black and Hispanic The study will enroll 1,000 approximately 35 minutes to complete.
MSM and transgender persons participants over 12 months to reach The total estimated annualized hourly
regardless of their HIV status. adequate power calculations (500 into burden anticipated for this study is 875
At this time, CDC is not partnering the intervention arm, and 500 into the hours. There is no cost to respondents
with other HHS agencies for this study. control arm). Approximately 1,500 other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden
Type of respondent Form name responses per
respondents per response
respondent (in hours)
Study participant ............................................. Participant Eligibility Form (Att 5) .................. 1,500 1 5/60
Study participant ............................................. Informed Consent Form (Att 6) ...................... 1,000 1 10/60
Study participant ............................................. Participant Enrollment Form (Att 7) ............... 1,000 1 35/60
Jeffrey M. Zirger, Submitted for Public Comment and technological collection techniques or
Acting Chief, Information Collection Review Recommendations’’ notice on February other forms of information technology,
Office, Office of Scientific Integrity, Office 20, 2018 to obtain comments from the e.g., permitting electronic submission of
of the Associate Director for Science, Office public and affected agencies. CDC did responses; and
of the Director, Centers for Disease Control not receive comments related to the (e) Assess information collection
and Prevention. previous notice. This notice serves to costs.
[FR Doc. 2018–12971 Filed 6–15–18; 8:45 am] allow an additional 30 days for public To request additional information on
BILLING CODE 4163–18–P and affected agency comments. the proposed project or to obtain a copy
CDC will accept all comments for this of the information collection plan and
proposed information collection project. instruments, call (404) 639–7570 or
DEPARTMENT OF HEALTH AND The Office of Management and Budget send an email to omb@cdc.gov. Direct
HUMAN SERVICES is particularly interested in comments written comments and/or suggestions
that: regarding the items contained in this
Centers for Disease Control and (a) Evaluate whether the proposed notice to the Attention: CDC Desk
Prevention collection of information is necessary Officer, Office of Management and
[30Day–18–0530] for the proper performance of the Budget, 725 17th Street NW,
functions of the agency, including Washington, DC 20503 or by fax to (202)
Agency Forms Undergoing Paperwork whether the information will have 395–5806. Provide written comments
Reduction Act Review practical utility; within 30 days of notice publication.
(b) Evaluate the accuracy of the
In accordance with the Paperwork agencies estimate of the burden of the Proposed Project
Reduction Act of 1995, the Centers for proposed collection of information, EEOICPA Dose Reconstruction
Disease Control and Prevention (CDC) including the validity of the Interviews and Forms, OMB No. 0920–
has submitted the information methodology and assumptions used; 0530, expires 04/30/2018—
collection request titled Energy (c) Enhance the quality, utility, and Reinstatement without change—
amozie on DSK3GDR082PROD with NOTICES1
Employees Occupational Illness clarity of the information to be National Institute for Occupational
Compensation Program Act of 2000 collected; Safety and Health (NIOSH), Centers for
(EEOICPA) Dose Reconstruction (d) Minimize the burden of the Disease Control and Prevention (CDC).
Interviews and Forms to the Office of collection of information on those who
Management and Budget (OMB) for are to respond, including, through the Background and Brief Description
review and approval. CDC previously use of appropriate automated, On October 30, 2000, the Energy
published a ‘‘Proposed Data Collection electronic, mechanical, or other Employees Occupational Illness
VerDate Sep<11>2014 18:00 Jun 15, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\18JNN1.SGM 18JNN1](https://thefederalregister.org/doc/83_FR_28349/page/2.svg)
Document Created: 2018-06-18 15:49:49
Document Modified: 2018-06-18 15:49:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 83 FR 28232 |
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