Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Sickle Cell Disease Treatment Demonstration Regional Collaborative Program, OMB No. 0906-xxxx-New
| Published date | 07 July 2020 |
| Citation | 85 FR 40666 |
| Record Number | 2020-14612 |
| Section | Notices |
| Court | Health Resources And Services Administration |
Federal Register, Volume 85 Issue 130 (Tuesday, July 7, 2020)
[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40666-40667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14612]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; 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 of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. OMB may act on HRSA's ICR only after the
30-day comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than August 6,
2020.
ADDRESSES: Written 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 Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION: 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 by the Sickle Cell
Disease and Other Heritable Blood Disorders Research, Surveillance,
Prevention, and Treatment Act of 2018 (Pub. L. 115-327), which added
section 1106 of the Public Health Service Act, 42 U.S.C. 300b-5. The
purpose of the proposed Quality Improvement (QI) and Performance
Measures (N) data collection is to evaluate the effectiveness of the
SCDTDRCP and how the program can improve the coordination of service
delivery for individuals with sickle cell disease (SCD), train health
professionals to increase access to quality care and collaborate with
various stakeholders to optimize health outcomes for individuals with
SCD. The goals of the SCDTDRCP are to improve health outcomes in
individuals with SCD; reduce morbidity and mortality caused by SCD;
reduce the number of individuals with SCD receiving care only in
emergency departments; and improve the quality of coordinated and
comprehensive services to individuals with SCD and their families. The
program funds five grantees to establish regional networks to provide
leadership and support for regional and statewide activities in SCD.
The grantees develop and establish systemic mechanisms to improve the
treatment of SCD, by: (1) Increasing the number of providers treating
individuals with SCD using the National Heart, Lung and Blood
[[Page 40667]]
Institute Evidence-Based Management of SCD 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. Per the statutory requirement, the data
collected will be used to evaluate the program and will be published in
a report to Congress.
A 60-day notice published in the Federal Register on January 23,
2020, vol. 85, No. 15; pp. 3935-37. There were no public comments.
Need and Proposed Use of the Information: The purpose of the
proposed QI and PM data collection is to evaluate the effectiveness of
the SCDTDRCP and how the program can improve the coordination of
service delivery for individuals with sickle cell disease, train health
professionals to increase access to quality care and collaborate with
various stakeholders to optimize health outcomes for individuals with
sickle cell disease. Pursuant to 42 U.S.C. 300b-5(b)(3)(B), the
National Coordinating Center (NCC) will work with the grantees to
gather data and prepare a Report to Congress at the conclusion of the
program.
Quality Improvement
All five SCDTDRCP grantees are required to conduct QI initiatives
to improve quality of SCD treatment and access to care. Each grantee
also works with and supports local sites (i.e., university, medical
center, etc.) that provide SCD care within their region to implement QI
initiatives. All the grantees and local sites are required to implement
initiatives to increase the hydroxyurea use and conduct one or more
additional QI initiatives on the following topics: pneumococcal
vaccinations, Transcranial Doppler screening, and transition planning.
The grantees and local sites will collect data on a quarterly basis on
applicable measures depending on which QI initiatives they are
undertaking. The data will be extracted from patients' charts either
via chart reviews or electronic health records. The local sites will
send their data to the grantees using an excel spreadsheet or by
entering data into a database form of their choice developed by the
grantee. The grantees will aggregate their own data and the data
received from the local sites and submit the aggregate data to the NCC.
Performance Measures
In order to understand SCD care provided and the reach of the
SCDTDRCP activities across regions, seven PM have been established
(e.g. number of SCD patients seen by a provider in the past year). The
five SCDTDRCP grantees will send a survey once a year to providers they
work with within their region who provide care to SCD patients to
collect PM data. Once the providers complete the survey, the grantees
will aggregate the individual responses and submit the PM data to the
NCC.
Likely Respondents: For QI data, the five SCDTDRCP grantees and
local sites that provide SCD care that the grantees work with. For PM
data, the five SCDTDRCP grantees and providers the grantees work with
within their region who provide care to SCD patients.
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:
Total Estimated Annualized Burden--Hours
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Number of Average
Number of responses per Total burden per Total burden
Form name respondents respondent per responses per response (hrs/ hours per year
year year yr)
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SCDTDRCP........................ 55 4 220 13 2,860
Quality Improvement Measures*...
SCDTDRCP Performance Measures... 305 1 305 1 305
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Total....................... 360 .............. 525 .............. 3,165
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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 of the respondents may not be collecting data all QI initiatives.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-14612 Filed 7-6-20; 8:45 am]
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