Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Sickle Cell Disease Treatment Demonstration Regional Collaborative Program, OMB No. 0906-xxxx-New
| Published date | 23 January 2020 |
| Citation | 85 FR 3935 |
| Record Number | 2020-01075 |
| Section | Notices |
| Court | Health Resources And Services Administration |
Federal Register, Volume 85 Issue 15 (Thursday, January 23, 2020)
[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3935-3937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01075]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: Sickle
Cell Disease Treatment Demonstration Regional Collaborative Program,
OMB No. 0906-xxxx-New
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
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SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of 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 March 23,
2020.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 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 Lisa Wright-
Solomon, 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.
Information Collection Request Title: Sickle Cell Disease Treatment
Demonstration Regional Collaborative Program.
OMB No.: 0906-xxxx-New.
Abstract: The Sickle Cell Disease Treatment Demonstration Regional
Collaborative Program (SCDTDRCP) was reauthorized and amended in 2018
by the Sickle Cell Disease and Other Heritable Blood Disorders
Research, Surveillance, Prevention, and Treatment Act (Pub. L. 115-
327), 42 U.S.C. 300b-5. The purpose of the proposed data collection is
to monitor the progress of the SCDTDRCP in improving health outcomes in
individuals living with sickle cell disease.
The goals of the program are to improve health outcomes in
individuals with sickle cell disease; reduce morbidity and mortality
caused by
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sickle cell disease; reduce the number of individuals with sickle cell
receiving care only in emergency departments; and improve the quality
of coordinated and comprehensive services to individuals with sickle
cell and their families. The program funds five grantees to establish
regional networks to provide leadership and support for regional and
statewide activities in sickle cell disease. The grantees develop and
establish systemic mechanisms to improve the treatment of sickle cell
disease, by: (1) Increasing the number of providers treating
individuals with sickle cell disease using the National Heart, Lung and
Blood Institute (NHLBI) Evidence-Based Management of Sickle Cell
Disease Expert Panel Report; (2) using tele-mentoring, telemedicine and
other provider support strategies to increase the number of providers
administering evidence-based sickle cell care; and (3) developing and
implementing strategies to improve access to quality care with emphasis
on individual and family engagement/partnership, adolescent transitions
to adult life, and care in a medical home. The SCDTDRCP is designed to
improve access to services for individuals with sickle cell disease,
improve and expand patient and provider education, and improve and
expand the continuity and coordination of service delivery for
individuals with sickle cell disease and sickle cell trait. Per the
statutory requirement, the data collected will be used to evaluate the
program and will be published in a report to Congress.
Need and Proposed Use of the Information: The purpose of the
proposed data collection is to monitor the progress of the SCDTDRCP in
improving care and health outcomes for individuals living with sickle
cell disease/trait and monitor grantee progress in meeting the goals of
the program. Each regional grantee will conduct one quality improvement
initiative for hydroxyurea utilization among individuals with sickle
cell disease. Grantees must conduct an additional quality improvement
initiative on one of these topics: (1) Pneumococcal vaccinations, (2)
Transcranial Doppler Ultrasound (TCD) screening, or (3) transition
planning. Grantees are encouraged to conduct additional clinical
outcome quality improvement (QI) initiatives according to their
ability. The regional grantees will also survey providers annually to
assess provider comfort with treating individuals with sickle cell
disease, awareness of the guidelines and involvement in Project ECHO
(Extension of Community Health Outcomes) and other program activities.
Pursuant to 42 U.S.C. 300b-5(b)(3)(B), the Sickle Cell Disease
Treatment Demonstration Regional Collaborative Program's National
Coordinating Center (NCC) will work with the grantees to gather data
and prepare a Report to Congress at the conclusion of the program.
Additional information regarding the data collection activities is
below:
Provider Survey
Regional grantees will administer the Provider Survey annually to
providers within their region. The Provider Survey is a 13 item
questionnaire that collects information on the provider type, their
utilization of telementoring, and aggregate de-identified patient-level
data. The number of states participating within a region may range from
5 to 17 states. Data from the Provider Survey will be aggregated by the
regional grantee and submitted to the NCC.
Quality Improvement
As part of the requirement for funding under the grant, each
regional grantee is required to conduct at least two quality
improvement initiatives within their region. All grantees are required
to conduct a quality improvement initiative on increasing the use of
hydroxyurea. Grantees must conduct an additional quality improvement
initiative on one of these topics: (1) Pneumococcal vaccinations, (2)
TCD screening, or (3) transition planning. Each regional grantee will
collect QI data from participating providers and medical centers within
their region and aggregate the data for submission to the NCC. Specific
quality improvement data will be extracted from patients' charts
quarterly, either manually or via electronic health records (EHR). This
will require an initial set-up time in year 1 to develop data
collection and reporting protocols for manual or electronic collection
for the quality improvement project(s) that each regional grantee
decides to measure. This initial set-up time has been included in the
burden estimates listed in the chart.
Likely Respondents: Providers who treat individuals with sickle
cell disease will complete the Provider Survey. The five regional
grantees will aggregate these data and submit to the NCC. The grantees
will also aggregate data from medical record extraction for the quality
improvement initiatives.
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 purposes 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 tables below:
Provider Survey and QI Measures
Total Annual Burden Estimate Hours
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Number of Average
Number of responses per Total burden per Total burden
Form name respondents respondent responses per response (hrs/ hours per
per year year yr) year
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SCDTDP Provider Survey, 70 1 70 1 70
participant responses..........
SCDTDP.......................... 50 4 200 22 4,400
QI Measures *...................
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Total....................... 120 .............. 270 .............. 4,470
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* Note: Total burden hours per year shown represents the maximum number of estimated hours. Actual hours may be
lower since many teams will not be assessing all four QI initiatives.
[[Page 3937]]
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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-01075 Filed 1-22-20; 8:45 am]
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