Proposed Data Collection Submitted for Public Comment and Recommendations, 30958-30960 [2020-10999]
Download as PDF
<![CDATA[
30958
Federal Register / Vol. 85, No. 99 / Thursday, May 21, 2020 / Notices
The Report and Order directed that
eligible space station operators that
choose to clear on the accelerated
timeframe in exchange for an
accelerated relocation payment must do
so via a written commitment by filing an
Accelerated Relocation Election in GN
Docket No. 18–122. Such elections are
public and irrevocable. Pursuant to the
Report and Order, WTB prescribes the
following format for filing an
Accelerated Relocation Election: The
election must state that the eligible
space station operator elects to perform
an accelerated relocation, understands
and accepts the commitments made
when filing an Accelerated Relocation
Election, and understands and accepts
the reduction in payments for missing
deadlines as outlined in the Report and
Order. The election must be signed by
a company officer of the eligible space
station operator with authority to bind
the company. The election must
acknowledge the Commission’s
authority to adopt the accelerated
relocation payment and the reduction in
payments for missing deadlines. The
election must acknowledge that
sufficient eligible space station
operators must elect accelerated
relocation such that at least 80% of the
total possible accelerated relocation
payments are accepted for the
Commission to accept elections and
require overlay licensees to pay
accelerated relocation payments.
The information collection
requirements were approved by OMB on
May 5, 2020 under OMB control number
3060–1272.
If an eligible space station operator
elects not to make an Accelerated
Relocation Election, that operator will
forfeit its eligibility to receive
accelerated relocation payments, even if
it completes all tasks by the Accelerated
Relocation Deadlines and files a
Certification of Accelerated Relocation.
Federal Communications Commission.
Katherine Harris,
Deputy Chief, Mobility Division, Wireless
Telecommunications Bureau.
[FR Doc. 2020–11004 Filed 5–20–20; 8:45 am]
BILLING CODE 6712–01–P
FEDERAL RETIREMENT THRIFT
INVESTMENT
Board Member Meeting
May 27, 2020—10:00 a.m., Telephonic
Open Session
1. Approval of the Minutes of the April
27, 2020 Board Meeting
2. Monthly Reports
(a) Participant Activity Report
VerDate Sep<11>2014
17:18 May 20, 2020
Jkt 250001
(b) Investment Performance
(c) Legislative Report
3. Quarterly Reports
(d) Metrics
4. Internal Audit Report
Executive Session
Information covered under 5 U.S.C.
552b(c)(7).
CONTACT PERSON FOR MORE INFORMATION:
Kimberly Weaver, Director, Office of
External Affairs, (202) 942–1640.
SUPPLEMENTARY INFORMATION:
Dial-in (listen only) information:
Number: 1–877–446–3914, Code:
5962888.
Kimberly Weaver, Director, Office of
External Affairs, (202) 942–1640.
Dated: May 18, 2020.
Megan Grumbine,
General Counsel, Federal Retirement Thrift
Investment Board.
[FR Doc. 2020–11003 Filed 5–20–20; 8:45 am]
BILLING CODE 6760–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-20–20NT; Docket No. CDC–2020–
0054]
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 Using Real-time Prescription and
Insurance Claims Data to Support the
HIV Care Continuum which will collect
data to evaluate the efficacy of using
administrative insurance and
prescription claims (billing) data to
identify and intervene upon persons
with HIV who fail to fill antiretroviral
(ARV) prescriptions.
DATES: CDC must receive written
comments on or before July 20, 2020.
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
You may submit comments,
identified by Docket No. CDC–2020–
0054 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.
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
ADDRESSES:
E:\FR\FM\21MYN1.SGM
21MYN1
Federal Register / Vol. 85, No. 99 / Thursday, May 21, 2020 / Notices
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
Using Real-time Prescription and
Insurance Claims Data to Support the
HIV Care Continuum—New—National
Center for HIV/AIDS, Viral Hepatitis,
STD and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Use of HIV surveillance data to
identify out-of-care persons is one
strategy for identifying and re-engaging
out-of-care persons and is called Datato-Care or ‘‘D2C.’’ Data-to-Care uses
laboratory reports (i.e., CD4 and HIV
viral load test results) received by a
health department’s HIV surveillance
program as markers of HIV care. In the
current D2C model, there is a delay in
the identification of out-of-care persons
due to the time interval between
recommended monitoring tests (i.e.,
every three to six months) and the
subsequent reporting of these tests to
surveillance.
Insurance and prescription
administrative claims (billing) data can
be used to identify persons who fail to
fill antiretroviral (ARV) prescriptions
and who are at risk for becoming out of
care. Because most ARVs are prescribed
as a 30-day supply of medication,
prescription claims can be used to
identify persons who are not filling ARV
prescriptions on a monthly basis.
Tracking ARV refill data can, therefore,
be a more real-time indicator of poor
adherence and can act as a harbinger of
potential poor retention in care. Using
real time insurance and prescription
claims data to identify persons who fail
to fill ARV prescriptions, and to
intervene, could have a significant
impact on ARV therapy adherence, viral
suppression and potentially on
retention in care.
The purpose of the Antiretroviral
Improvement among Medicaid Enrollees
(AIMS) study is to develop, implement
and evaluate a D2C strategy that uses
Medicaid insurance and prescription
claims data to identify (1) persons with
VerDate Sep<11>2014
17:18 May 20, 2020
Jkt 250001
HIV who have never been prescribed
ARV therapy and (2) persons with HIV
who fail to pick up prescribed ARV
medications in a timely manner and to
target these individuals for adherence
interventions.
A validated HIV case identification
algorithm will be applied to the Virginia
Medicaid database to identify persons
with HIV who have either never filled
an ARV prescription or have not filled
an ARV prescription within >30 to <90
days of the expected fill date.
Deterministic and probabilistic methods
will be used to link this list to Virginia
Department of Health’s (VDH) Care
Markers (an extract of the VDH HIV
surveillance database) database.
Individuals that are matched across the
two databases (indicating that the
persons are both enrolled in Medicaid
and confirmed HIV positive) are eligible
for study participation. Additional
eligibility criteria include age 19–64
years and continuous enrollment in
Virginia Medicaid for the preceding 12
months.
Once identified, individuals will be
randomized to receive either an
intervention or usual care. Participants
in the intervention arm will be assigned
to receive either a provider-level
intervention or a patient-level
intervention, depending on need;
providers of study eligible participants
who have never been prescribed ARV
therapy (ART) will receive a providerlevel intervention and participants who
are >30 to <90 days late filling their
ARV prescriptions will receive a
patient-level intervention. Potential
participants will be contacted by a VDH
Linkage Coordinator or Study
Coordinator to explain the study and
obtain consent for participation.
The provider-level intervention will
consist of a peer-to-peer clinician
consultation delivered by members of
Virginia Department of Health’s AIDS
Drug Assistance Program (ADAP)
Advisory Committee. The peer-to-peer
clinician consultations will involve
introduction or reinforcement of HIV
clinical guidelines for ART initiation,
strategies to optimize ART adherence,
and resources for supporting adherence
for people with HIV. The consultation
will be tailored to the needs of the
provider.
The patient-level intervention has two
phases. In Phase I, a Linkage
Coordinator will contact participants to
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
30959
discuss the participants’ adherence
barriers. Once the participant’s
adherence barriers are identified, the
participant will be referred to
appropriate resources to assist them in
overcoming their adherence barrier(s).
Phase II is intended for patients who
were enrolled in Phase I but who failed
to fill their ARV prescriptions in the
subsequent 30 days of the Phase I
consultation, and for participants who
are >60 to <90 days late at the time the
participant was determined to be study
eligible. In Phase II, the Linkage
Coordinator will lead a similar
consultation as in Phase I but will probe
for more complex adherence barriers
(e.g., mental health concerns) and
referrals will be made accordingly. The
participant will also be offered
PositiveLinks, an evidence-informed
mobile application (‘‘app’’) which is
designed to support ART adherence and
retention in care. PositiveLinks provides
daily queries of stress, mood, and
medication adherence; weekly quizzes
on general and HIV-specific
understanding; appointment and
medication reminders, curated
resources, a community message board,
direct messaging with the Linkage
Coordinator, and contact information for
participants’ providers.
All analyses will be conducted at the
patient level. Persons within the
intervention and control arms will be
followed for 12 months to compare the
primary study outcome of HIV viral
suppression (HIV RNA < 200 copies/
mL).
CDC requests OMB approval to collect
standardized information, from 500
AIMS study participants (including 460
patients and 40 providers) and 500
controls over the three year project
period. Secondary data will be
abstracted from the Virginia Medicaid
and Virginia Department of Health Care
Marker databases to determine study
eligibility, to conduct the patient- and
provider-level interventions, and to
determine study outcomes. During the
patient-level intervention data will be
collected on participants’ adherence
barriers; this information will be used to
refer participants to appropriate
resources to assist their adherence to
ART. During the provider-level
intervention data will be collected to
inform the peer-to-peer clinician
consultation.
E:\FR\FM\21MYN1.SGM
21MYN1
30960
Federal Register / Vol. 85, No. 99 / Thursday, May 21, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Linkage Coordinator ..........................
Study Coordinator .............................
Linkage Coordinator ..........................
Verbal consent (patient) ...................
Verbal consent (provider) .................
PositiveLinks Program and Services
Agreement.
Medicaid data abstraction ................
Care Marker data abstraction ..........
Phase I interview and Phase I data
elements.
Phase II interview and Phase II data
elements.
PositiveLinks data abstraction .........
Clinician consultation and Clinician
consultation data elements.
VCU Data Manager ..........................
VDH Surveillance Epidemiologist .....
Linkage Coordinator ..........................
Linkage Coordinator ..........................
Linkage Coordinator ..........................
ADAP Advisory Committee member
Total ...........................................
...........................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–10999 Filed 5–20–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–20DV]
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 ‘‘Chronic Q
Fever in the United States: Enhanced
Clinical Surveillance’’ 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 December
23, 2019 to obtain comments from the
public and affected agencies. CDC
received one comment 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;
VerDate Sep<11>2014
17:18 May 20, 2020
Jkt 250001
1
1
1
15/60
15/60
60/60
115
10
100
1
1
460
12
12
1
60/60
60/60
30/60
12
12
230
100
1
30/60
50
1
40
4
1
15/60
30/60
1
20
........................
........................
........................
550
Proposed Project
Chronic Q Fever in the United States:
Enhanced Clinical Surveillance – New –
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Frm 00036
Fmt 4703
Total burden
hours
460
40
100
(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.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. 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.
PO 00000
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Respondents
Sfmt 4703
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Q fever is a worldwide zoonosis
caused by Coxiella burnetii with acute
and chronic disease presentations.
Chronic Q fever can manifest months to
years after the primary infection and is
rare, occurring in <5% of persons with
an acute infection. Chronic Q fever can
take on several clinical forms, including
endocarditis, chronic hepatitis, chronic
vascular infections, osteomyelitis, and
osteoarthritis. In the United States, Q
fever cases are reported via the National
Notifiable Disease Surveillance System;
however, limited information is
collected the various clinical
manifestation of chronic Q fever or
patients pre-existing risk factors. Data
on outcomes other than death or
hospitalizations are not collected by the
current surveillance. Because of this
lack of data, the true burden and
proportion of cases exhibiting
endocarditis and other forms of chronic
Q fever in the United States is
unknown. We plan to establish an
enhanced medical surveillance for
chronic Q fever by working with
consulting clinicians to gather
additional and more specific clinical
data not otherwise collected during the
course of routine public health
surveillance for chronic Q fever. This
information will allow for better
characterization of the clinical
presentation and risk factors of chronic
Q fever in the United States. The results
will help characterize an underrecognized disease and provide valuable
data to educate physicians on
identifying and diagnosing these cases.
The survey will take approximately
20 minutes per individual. CDC requests
E:\FR\FM\21MYN1.SGM
21MYN1
]]>Agencies
[Federal Register Volume 85, Number 99 (Thursday, May 21, 2020)]
[Notices]
[Pages 30958-30960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10999]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-20-20NT; Docket No. CDC-2020-0054]
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 Using Real-time Prescription and
Insurance Claims Data to Support the HIV Care Continuum which will
collect data to evaluate the efficacy of using administrative insurance
and prescription claims (billing) data to identify and intervene upon
persons with HIV who fail to fill antiretroviral (ARV) prescriptions.
DATES: CDC must receive written comments on or before July 20, 2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0054 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
[[Page 30959]]
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
Using Real-time Prescription and Insurance Claims Data to Support
the HIV Care Continuum--New--National Center for HIV/AIDS, Viral
Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Use of HIV surveillance data to identify out-of-care persons is one
strategy for identifying and re-engaging out-of-care persons and is
called Data-to-Care or ``D2C.'' Data-to-Care uses laboratory reports
(i.e., CD4 and HIV viral load test results) received by a health
department's HIV surveillance program as markers of HIV care. In the
current D2C model, there is a delay in the identification of out-of-
care persons due to the time interval between recommended monitoring
tests (i.e., every three to six months) and the subsequent reporting of
these tests to surveillance.
Insurance and prescription administrative claims (billing) data can
be used to identify persons who fail to fill antiretroviral (ARV)
prescriptions and who are at risk for becoming out of care. Because
most ARVs are prescribed as a 30-day supply of medication, prescription
claims can be used to identify persons who are not filling ARV
prescriptions on a monthly basis. Tracking ARV refill data can,
therefore, be a more real-time indicator of poor adherence and can act
as a harbinger of potential poor retention in care. Using real time
insurance and prescription claims data to identify persons who fail to
fill ARV prescriptions, and to intervene, could have a significant
impact on ARV therapy adherence, viral suppression and potentially on
retention in care.
The purpose of the Antiretroviral Improvement among Medicaid
Enrollees (AIMS) study is to develop, implement and evaluate a D2C
strategy that uses Medicaid insurance and prescription claims data to
identify (1) persons with HIV who have never been prescribed ARV
therapy and (2) persons with HIV who fail to pick up prescribed ARV
medications in a timely manner and to target these individuals for
adherence interventions.
A validated HIV case identification algorithm will be applied to
the Virginia Medicaid database to identify persons with HIV who have
either never filled an ARV prescription or have not filled an ARV
prescription within >30 to <90 days of the expected fill date.
Deterministic and probabilistic methods will be used to link this list
to Virginia Department of Health's (VDH) Care Markers (an extract of
the VDH HIV surveillance database) database. Individuals that are
matched across the two databases (indicating that the persons are both
enrolled in Medicaid and confirmed HIV positive) are eligible for study
participation. Additional eligibility criteria include age 19-64 years
and continuous enrollment in Virginia Medicaid for the preceding 12
months.
Once identified, individuals will be randomized to receive either
an intervention or usual care. Participants in the intervention arm
will be assigned to receive either a provider-level intervention or a
patient-level intervention, depending on need; providers of study
eligible participants who have never been prescribed ARV therapy (ART)
will receive a provider-level intervention and participants who are >30
to <90 days late filling their ARV prescriptions will receive a
patient-level intervention. Potential participants will be contacted by
a VDH Linkage Coordinator or Study Coordinator to explain the study and
obtain consent for participation.
The provider-level intervention will consist of a peer-to-peer
clinician consultation delivered by members of Virginia Department of
Health's AIDS Drug Assistance Program (ADAP) Advisory Committee. The
peer-to-peer clinician consultations will involve introduction or
reinforcement of HIV clinical guidelines for ART initiation, strategies
to optimize ART adherence, and resources for supporting adherence for
people with HIV. The consultation will be tailored to the needs of the
provider.
The patient-level intervention has two phases. In Phase I, a
Linkage Coordinator will contact participants to discuss the
participants' adherence barriers. Once the participant's adherence
barriers are identified, the participant will be referred to
appropriate resources to assist them in overcoming their adherence
barrier(s). Phase II is intended for patients who were enrolled in
Phase I but who failed to fill their ARV prescriptions in the
subsequent 30 days of the Phase I consultation, and for participants
who are >60 to <90 days late at the time the participant was determined
to be study eligible. In Phase II, the Linkage Coordinator will lead a
similar consultation as in Phase I but will probe for more complex
adherence barriers (e.g., mental health concerns) and referrals will be
made accordingly. The participant will also be offered PositiveLinks,
an evidence-informed mobile application (``app'') which is designed to
support ART adherence and retention in care. PositiveLinks provides
daily queries of stress, mood, and medication adherence; weekly quizzes
on general and HIV-specific understanding; appointment and medication
reminders, curated resources, a community message board, direct
messaging with the Linkage Coordinator, and contact information for
participants' providers.
All analyses will be conducted at the patient level. Persons within
the intervention and control arms will be followed for 12 months to
compare the primary study outcome of HIV viral suppression (HIV RNA <
200 copies/mL).
CDC requests OMB approval to collect standardized information, from
500 AIMS study participants (including 460 patients and 40 providers)
and 500 controls over the three year project period. Secondary data
will be abstracted from the Virginia Medicaid and Virginia Department
of Health Care Marker databases to determine study eligibility, to
conduct the patient- and provider-level interventions, and to determine
study outcomes. During the patient-level intervention data will be
collected on participants' adherence barriers; this information will be
used to refer participants to appropriate resources to assist their
adherence to ART. During the provider-level intervention data will be
collected to inform the peer-to-peer clinician consultation.
[[Page 30960]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Respondents Form name respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Linkage Coordinator........... Verbal consent 460 1 15/60 115
(patient).
Study Coordinator............. Verbal consent 40 1 15/60 10
(provider).
Linkage Coordinator........... PositiveLinks 100 1 60/60 100
Program and
Services
Agreement.
VCU Data Manager.............. Medicaid data 1 12 60/60 12
abstraction.
VDH Surveillance Care Marker data 1 12 60/60 12
Epidemiologist. abstraction.
Linkage Coordinator........... Phase I 460 1 30/60 230
interview and
Phase I data
elements.
Linkage Coordinator........... Phase II 100 1 30/60 50
interview and
Phase II data
elements.
Linkage Coordinator........... PositiveLinks 1 4 15/60 1
data
abstraction.
ADAP Advisory Committee member Clinician 40 1 30/60 20
consultation
and Clinician
consultation
data elements.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 550
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-10999 Filed 5-20-20; 8:45 am]
BILLING CODE 4163-18-P
