[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 [email protected] 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 [email protected] 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