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, 40666-40667 [2020-14612]
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2 4—Continued
Number of
respondents 3
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Pretest .................
235 ............................
1 ................................
235 ............................
77.55
Survey screener ..
2,120 .........................
1 ................................
2,120 .........................
Survey .................
1,060 .........................
1 ................................
1,060 .........................
0.33 ...........................
(20 minutes) ..............
0.17 ...........................
(10 minutes) ..............
0.33 ...........................
(20 minutes) ..............
732 ............................
1 ................................
732 ............................
124.44
Pretests ...............
366 ............................
1 ................................
366 ............................
Main study
screener.
Main study ...........
2,120 .........................
1 ................................
2,120 .........................
1,060 .........................
1 ................................
1,060 .........................
0.17 ...........................
(10 minutes) ..............
0.33 ...........................
(20 minutes) ..............
0.17 ...........................
(10 minutes) ..............
0.33 ...........................
(20 minutes) ..............
Total .............
...................................
...................................
...................................
...................................
1,823.07
Activity
Phase 3:
Pretests screener
Total hours
360.40
349.80
120.78
360.40
349.80
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
total burden for project phases 2 and 3.
3 Includes 10 percent overage.
4 With online surveys, several participants may be in the process of completing the survey at the time that the total target sample is reached.
Those participants will be allowed to complete the survey, which can result in the number of valid completes exceeding the target number. With
this in mind, we have included an additional 10 percent over our target number of valid completes to account for some overage.
2 Includes
II. Reference
ACTION:
The following reference is on display
with the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
is not available electronically at https://
www.regulations.gov as this reference is
copyright protected.
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
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Sickle Cell Disease Treatment
Demonstration Regional Collaborative
Program, OMB No. 0906–xxxx—New.
1. Hwang, C.S., L.W. Turner, S.P.
Kruszewski, et al. ‘‘Primary Care Physicians’
Knowledge and Attitudes Regarding
Prescription Opioid Abuse and Diversion.’’
The Clinical Journal of Pain, 32(4), 279–284,
2016.
Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14516 Filed 7–6–20; 8:45 am]
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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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
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Notice.
SUMMARY:
PO 00000
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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
E:\FR\FM\07JYN1.SGM
07JYN1
40667
Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
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
Number of
respondents
Form name
Number of
responses per
respondent
per year
Total
responses
per year
Average
burden per
response
(hrs/yr)
Total burden
hours per year
SCDTDRCP .........................................................................
Quality Improvement Measures* .........................................
SCDTDRCP Performance Measures ..................................
55
305
4
1
220
305
13
1
2,860
305
Total ..............................................................................
360
........................
525
........................
3,165
* 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2020–14612 Filed 7–6–20; 8:45 am]
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Subject to COVID–19 Hoarding
Prevention Measures; Change in
Information Contact, Removal of
Chloroquine Phosphate and
Hydroxychloroquine HCl; Correction
Office of the Secretary (OS),
DHHS.
ACTION: Notice; correction.
AGENCY:
VerDate Sep<11>2014
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This document updates the
March 30, 2020, Federal Register Notice
entitled ‘‘Notice of Designation of
Scarce Materials or Threatened
Materials Subject to COVID–19
Hoarding Prevention Measures,’’ by
replacing the named contact and
updating the ‘‘Notice of Designation of
Scarce Materials or Threatened
Materials’’ section.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Paige Ezernack, Office of the Assistant
Secretary for Preparedness and
Response, Office of Strategy, Policy,
Planning, and Requirements, Suite
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
SCDTDRCP........................ 55 4 220 13 2,860
Quality Improvement Measures*...
SCDTDRCP Performance Measures... 305 1 305 1 305
-------------------------------------------------------------------------------
Total....................... 360 .............. 525 .............. 3,165
----------------------------------------------------------------------------------------------------------------
* 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]
BILLING CODE 4165-15-P
