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]

Download as PDF 40666 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] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES jbell on DSKJLSW7X2PROD with NOTICES 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: VerDate Sep<11>2014 16:59 Jul 06, 2020 Jkt 250001 Notice. SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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] jbell on DSKJLSW7X2PROD with NOTICES BILLING CODE 4165–15–P Office of the Secretary Notice of Designation of Scarce Materials or Threatened Materials 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 16:59 Jul 06, 2020 Jkt 250001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 E:\FR\FM\07JYN1.SGM 07JYN1

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]


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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.

-----------------------------------------------------------------------

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