Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Assessing Client Factors Associated With Detectable HIV Viral Loads and Models of Care and the Ryan White HIV/AIDS Program, 22838-22839 [2017-10060]
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Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Notices
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017–10061 Filed 5–17–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0906–xxxx–New]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Assessing
Client Factors Associated With
Detectable HIV Viral Loads and Models
of Care and the Ryan White HIV/AIDS
Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects the Paperwork Reduction Act of
1995, HRSA announces plans to submit
an Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). Prior
to submitting the ICR to OMB, HRSA
seeks comments from the public
regarding the burden estimate, below, or
any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than July 17, 2017.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Assessing Client Factors Associated
with Detectable HIV Viral Loads and
Models of Care and the Ryan White
HIV/AIDS Program OMB No. 0906–
xxxx–New.
Abstract: The Ryan White HIV/AIDS
Program (RWHAP), first authorized by
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
13:43 May 17, 2017
Jkt 241001
the U.S. Congress in 1990, is
administered by HRSA’s HIV/AIDS
Bureau (HAB). In 2015, 533,036 clients
received services from RWHAP-funded
providers; 97.0 percent were living with
HIV. This information collection request
covers two distinct evaluation studies
with RWHAP provider sites that will
share some data collection instruments.
The sharing of data collection
instruments will minimize the burden
on RWHAP provider sites related to data
collection, increase the sample size that
could be used for data analysis resulting
in greater generalizability of results, and
provide richer and more robust data that
may offer additional depth to the
findings of each study.
The first evaluation study, Assessing
Client Factors Associated with
Detectable HIV Viral Loads, will explore
clinical activities and barriers to
achieving and sustaining viral
suppression. Early and effective
treatment for HIV has been shown to
greatly reduce associated morbidity and
mortality. In spite of the known benefit
of treatment, many individuals remain
out of care or access care only
intermittently; the CDC estimated that,
in 2013, approximately 45 percent of
people living with HIV (PLWH) in the
United States were not virally
suppressed, indicating a significant gap
in the percentage of PLWH who are
being successfully engaged and retained
in care. In spite of the increased
attention on retention in care and the
overarching goal of viral suppression,
little data exist regarding the specific
individual factors that are associated
with sub-optimal viral suppression.
Such information would be valuable in
targeting programs to reach populations
that are currently not achieving viral
suppression.
The second evaluation study, Models
of Care and the Ryan White HIV/AIDS
Program, seeks to answer the critical
questions of what individual and
system-wide factors, including the
models of care employed among
RWHAP provider sites, contribute to
better health outcomes for PLWH. While
advances in treatment have improved
survival in patients with HIV, longer
lives are associated with increased
prevalence of adverse effects of HIV
infection and therapeutic complications,
concurrent with medical conditions
related to aging processes that would
occur in the absence of HIV. These longterm complications amplify chronic
disease management as a major issue for
the HIV population and a challenge for
the delivery of effective health care.
These studies will inform HAB about
how the method of health services
delivery (the ‘‘model of care’’)
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
contributes to better health outcomes,
including HIV-related outcomes.
Understanding the most effective
models of care will be important for HIV
specialists, primary care physicians, and
other clinicians who care for PLWH as
they design and coordinate a full array
of primary care and support services for
their HIV patients. These primary care
and support services have a direct
impact on viral suppression, which, in
turn, improves life expectancy and
quality of life, and prevents HIV
transmission.
The two studies inform each other in
that the degree to which clients are
virally suppressed may be attributed
partly to the model of care practiced at
their clinic. Likewise, the degree to
which its clients have achieved viral
suppression may drive a clinic to
practice a particular model of care. The
two studies will collect several identical
data elements through their individual
collection instruments, allowing data to
be aggregated across the two studies.
The aggregation of data across the two
studies will minimize the burden on
RWHAP provider sites related to data
collection, increase the sample size that
could be used for data analysis resulting
in greater generalizability of results, and
provide richer and more robust data that
may offer additional depth to the
findings of each study.
Need and Proposed Use of the
Information: The Assessing Client
Factors Associated with Detectable HIV
Viral Loads study will identify
characteristics of RWHAP clients and
health facilities that are associated with
the ability to achieve and sustain an
undetectable viral load as compared to
the characteristics that are associated
with sub-optimal viral suppression.
This study will enable the development
of better targeted services for improved
viral suppression rates. The Models of
Care and the Ryan White HIV/AIDS
Program study will compare HIV and
primary health outcomes across various
models of care to determine which are
most effective in responding to HIV to
improve health outcomes for people
living with HIV and to prevent HIV
transmissions. The results from this
study will enable improvements or
redesigns of effective delivery of HIV
care among Ryan White providers,
which will, in turn, improve HIV
clinical outcomes such as viral
suppression.
In both studies, an analysis of the
perceptions of providers and clients will
further support the understanding of the
impact of individual and system-wide
factors on achieving health outcomes.
The two studies will share data to
inform both studies’ objectives, allow
E:\FR\FM\18MYN1.SGM
18MYN1
22839
Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Notices
for a larger sample size from which to
generalize conclusions, and reduce the
overall burden of response on RWHAP
providers and clients. The objectives of
both studies will be achieved through
collection of the following data:
• RWHAP provider interviews—Site
staff interviewees (in person);
• RWHAP client surveys—Clients
with detectable and undetectable viral
load at each clinic;
• RWHAP client records
abstraction—Medical chart and
administrative records (e.g., service
utilization and health outcomes data);
• RWHAP site survey data—Site
Director responses; and
RWHAP client semi-structured
interviews—Clients with detectable and
undetectable viral load.
These studies will build upon and
complement HAB’s study focusing on
RWHAP outcomes within the context of
the changing health care landscape; and
will use the RWHAP site survey and
chart abstraction instruments that were
submitted as part of that study. The data
will be collected by a contractor
selected by HRSA.
Likely Respondents: RWHAP
Administrators, RWHAP Care Providers,
and RWHAP Clients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below. Both
research studies are included in the
table, with burden proportional to the
number of RWHAP provider sites from
which each study will collect data: 25
distinct facilities for Assessing Client
Factors Associated with Detectable HIV
Viral Loads and 50 distinct facilities for
Models of Care and the Ryan White
HIV/AIDS Program. The table below
provides the level of burden inclusive of
both studies.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Site Survey * .........................................................................
Medical Records Sample Selection Guide* .........................
Provider Interview Guide .....................................................
Focus Groups Guide ............................................................
Client Survey ........................................................................
Client semi-structured interview ...........................................
75
75
375
400
500
150
1
1
1
1
1
1
75
75
375
400
500
150
0.5
1
2
1.5
1
1
37.5
75
750
600
500
150
Total ..............................................................................
1,575
........................
1,575
........................
2112.5
* The site survey and medical records sample selection instruments were submitted in March 2017 for OMB review as part of the Ryan White
HIV/AIDS Program Outcomes and Expanded Insurance Coverage Information Collection Request.
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017–10060 Filed 5–17–17; 8:45 am]
BILLING CODE 4165–15–P
jstallworth on DSK7TPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
VerDate Sep<11>2014
13:43 May 17, 2017
Jkt 241001
hereby given of meetings of the Board of
Scientific Counselors for Basic Sciences,
National Cancer Institute.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Cancer Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors for Basic Sciences, National
Cancer Institute.
Date: July 10, 2017.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health, 31
Center Drive, Building 31, C-Wing, 6th Floor,
Conference Room 6, Bethesda, MD 20892.
Contact Person: Mehrdad Tondravi, Ph.D.,
Chief, Institute Review Office, Office of the
PO 00000
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Director, National Cancer Institute, National
Institutes of Health, 9609 Medical Center
Drive, Room 3W–302, Bethesda, MD 20892,
240–276–5664, tondravim@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: May 12, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–10021 Filed 5–17–17; 8:45 am]
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E:\FR\FM\18MYN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)]
[Notices]
[Pages 22838-22839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10060]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
[OMB No. 0906-xxxx-New]
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: Assessing
Client Factors Associated With Detectable HIV Viral Loads and Models of
Care and the Ryan White HIV/AIDS Program
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than July 17,
2017.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference, in compliance with Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995.
Information Collection Request Title: Assessing Client Factors
Associated with Detectable HIV Viral Loads and Models of Care and the
Ryan White HIV/AIDS Program OMB No. 0906-xxxx-New.
Abstract: The Ryan White HIV/AIDS Program (RWHAP), first authorized
by the U.S. Congress in 1990, is administered by HRSA's HIV/AIDS Bureau
(HAB). In 2015, 533,036 clients received services from RWHAP-funded
providers; 97.0 percent were living with HIV. This information
collection request covers two distinct evaluation studies with RWHAP
provider sites that will share some data collection instruments. The
sharing of data collection instruments will minimize the burden on
RWHAP provider sites related to data collection, increase the sample
size that could be used for data analysis resulting in greater
generalizability of results, and provide richer and more robust data
that may offer additional depth to the findings of each study.
The first evaluation study, Assessing Client Factors Associated
with Detectable HIV Viral Loads, will explore clinical activities and
barriers to achieving and sustaining viral suppression. Early and
effective treatment for HIV has been shown to greatly reduce associated
morbidity and mortality. In spite of the known benefit of treatment,
many individuals remain out of care or access care only intermittently;
the CDC estimated that, in 2013, approximately 45 percent of people
living with HIV (PLWH) in the United States were not virally
suppressed, indicating a significant gap in the percentage of PLWH who
are being successfully engaged and retained in care. In spite of the
increased attention on retention in care and the overarching goal of
viral suppression, little data exist regarding the specific individual
factors that are associated with sub-optimal viral suppression. Such
information would be valuable in targeting programs to reach
populations that are currently not achieving viral suppression.
The second evaluation study, Models of Care and the Ryan White HIV/
AIDS Program, seeks to answer the critical questions of what individual
and system-wide factors, including the models of care employed among
RWHAP provider sites, contribute to better health outcomes for PLWH.
While advances in treatment have improved survival in patients with
HIV, longer lives are associated with increased prevalence of adverse
effects of HIV infection and therapeutic complications, concurrent with
medical conditions related to aging processes that would occur in the
absence of HIV. These long-term complications amplify chronic disease
management as a major issue for the HIV population and a challenge for
the delivery of effective health care. These studies will inform HAB
about how the method of health services delivery (the ``model of
care'') contributes to better health outcomes, including HIV-related
outcomes. Understanding the most effective models of care will be
important for HIV specialists, primary care physicians, and other
clinicians who care for PLWH as they design and coordinate a full array
of primary care and support services for their HIV patients. These
primary care and support services have a direct impact on viral
suppression, which, in turn, improves life expectancy and quality of
life, and prevents HIV transmission.
The two studies inform each other in that the degree to which
clients are virally suppressed may be attributed partly to the model of
care practiced at their clinic. Likewise, the degree to which its
clients have achieved viral suppression may drive a clinic to practice
a particular model of care. The two studies will collect several
identical data elements through their individual collection
instruments, allowing data to be aggregated across the two studies. The
aggregation of data across the two studies will minimize the burden on
RWHAP provider sites related to data collection, increase the sample
size that could be used for data analysis resulting in greater
generalizability of results, and provide richer and more robust data
that may offer additional depth to the findings of each study.
Need and Proposed Use of the Information: The Assessing Client
Factors Associated with Detectable HIV Viral Loads study will identify
characteristics of RWHAP clients and health facilities that are
associated with the ability to achieve and sustain an undetectable
viral load as compared to the characteristics that are associated with
sub-optimal viral suppression. This study will enable the development
of better targeted services for improved viral suppression rates. The
Models of Care and the Ryan White HIV/AIDS Program study will compare
HIV and primary health outcomes across various models of care to
determine which are most effective in responding to HIV to improve
health outcomes for people living with HIV and to prevent HIV
transmissions. The results from this study will enable improvements or
redesigns of effective delivery of HIV care among Ryan White providers,
which will, in turn, improve HIV clinical outcomes such as viral
suppression.
In both studies, an analysis of the perceptions of providers and
clients will further support the understanding of the impact of
individual and system-wide factors on achieving health outcomes. The
two studies will share data to inform both studies' objectives, allow
[[Page 22839]]
for a larger sample size from which to generalize conclusions, and
reduce the overall burden of response on RWHAP providers and clients.
The objectives of both studies will be achieved through collection of
the following data:
RWHAP provider interviews--Site staff interviewees (in
person);
RWHAP client surveys--Clients with detectable and
undetectable viral load at each clinic;
RWHAP client records abstraction--Medical chart and
administrative records (e.g., service utilization and health outcomes
data);
RWHAP site survey data--Site Director responses; and
RWHAP client semi-structured interviews--Clients with detectable
and undetectable viral load.
These studies will build upon and complement HAB's study focusing
on RWHAP outcomes within the context of the changing health care
landscape; and will use the RWHAP site survey and chart abstraction
instruments that were submitted as part of that study. The data will be
collected by a contractor selected by HRSA.
Likely Respondents: RWHAP Administrators, RWHAP Care Providers, and
RWHAP Clients.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below. Both research studies are
included in the table, with burden proportional to the number of RWHAP
provider sites from which each study will collect data: 25 distinct
facilities for Assessing Client Factors Associated with Detectable HIV
Viral Loads and 50 distinct facilities for Models of Care and the Ryan
White HIV/AIDS Program. The table below provides the level of burden
inclusive of both studies.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Site Survey *................... 75 1 75 0.5 37.5
Medical Records Sample Selection 75 1 75 1 75
Guide*.........................
Provider Interview Guide........ 375 1 375 2 750
Focus Groups Guide.............. 400 1 400 1.5 600
Client Survey................... 500 1 500 1 500
Client semi-structured interview 150 1 150 1 150
-------------------------------------------------------------------------------
Total....................... 1,575 .............. 1,575 .............. 2112.5
----------------------------------------------------------------------------------------------------------------
* The site survey and medical records sample selection instruments were submitted in March 2017 for OMB review
as part of the Ryan White HIV/AIDS Program Outcomes and Expanded Insurance Coverage Information Collection
Request.
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017-10060 Filed 5-17-17; 8:45 am]
BILLING CODE 4165-15-P
