Agency Forms Undergoing Paperwork Reduction Act Review, 74064-74066 [2011-30832]

Download as PDF emcdonald on DSK5VPTVN1PROD with NOTICES 74064 Federal Register / Vol. 76, No. 230 / Wednesday, November 30, 2011 / Notices Review Officers (MROs) and HHS approval of entities that certify MROs. Subpart M—Medical Review Officer (MRO), Section 13.1(b), ‘‘Who may serve as an MRO?’’ states as follows: ‘‘Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug testing results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual objective review of the qualifications and content of the examination, the Secretary shall publish a list in the Federal Register of those entities and boards that have been approved.’’ HHS has completed its review of entities that train and certify MROs, in accordance with requests submitted by such entities to HHS. (1) The HHS Secretary approves the following MRO certifying entities that offer both MRO training and certification through examination: American Association of Medical Review Officers (AAMRO), P.O. Box 12873, Research Triangle Park, NC 27709, Phone: (800) 489–1839, Fax: (919) 490–1010, Email: cferrell@ aamro.com, Web site: https://www. aamro.com/. Medical Review Officer Certification Council (MROCC), 836 Arlington Heights Road, #327, Elk Grove Village, IL 60007, Phone: (847) 631– 0599, Fax: (847) 483–1282, Email: mrocc@mrocc.org, Web site: https:// www.mrocc.org/. (2) The HHS Secretary lists the following entities that offer MRO training as a prerequisite for MRO certification: American College of Occupational and Environmental Medicine (ACOEM), 25 Northwest Point Boulevard, Suite 700, Elk Grove Village, IL 60007– 1030, Phone: (847) 818–1800, Fax: (847) 818–9266, Contact Form: https:// www.acoem.org/contactacoem.aspx, Web site: https://www.acoem.org/. American Society of Addiction Medicine (ASAM), 4601 N. Park Avenue, Upper Arcade #101, Chevy Chase, MD 20815, Phone: (301) 656– 3920, Fax: (301) 656–3815, Email: email@asam.org, Web site: https:// www.asam.org/. DATES: HHS approval is effective November 30, 2011. FOR FURTHER INFORMATION CONTACT: Jennifer Fan, Pharm.D., J.D., Division of Workplace Programs (DWP), Center for Substance Abuse Prevention (CSAP), Substance Abuse and Mental Health Services Administration (SAMHSA), 1 VerDate Mar<15>2010 17:30 Nov 29, 2011 Jkt 226001 Choke Cherry Road, Room 2–1031, Rockville, MD 20857; Telephone: (240) 276–1759; Email: jennifer.fan@ samhsa.hhs.gov. Dated: November 21, 2011. Kathleen Sebelius, Secretary. [FR Doc. 2011–30846 Filed 11–29–11; 8:45 am] BILLING CODE ;P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30-Day–12–0666] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project National Healthcare Safety Network (NHSN) (OMB No. 0920–0666 exp. 3/31/2012)—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description The National Healthcare Safety Network (NHSN) is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and to promote healthcare safety. Specifically, the data is used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare workers with similar risks. Healthcare institutions that participate in NHSN voluntarily report their data to CDC using a web browser based technology for data entry and data management. Data are collected by trained surveillance personnel using written standardized protocols. The data will be used to detect changes in the PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 epidemiology of adverse events resulting from new and current medical therapies and changing risks. This revision submission includes an amended Assurance of Confidentiality, which required an update of the Assurance of Confidentiality language on all forms included in the NHSN surveillance system. The scope of NHSN dialysis surveillance is being expanded to include all outpatient dialysis centers so that the existing Dialysis Annual Survey can be used to facilitate prevention objectives set forth in the HHS HAI tier 2 Action Plan and to assess national practices in all Medicare-certified dialysis centers if CMS re-establishes this survey method (as expected). The Patient Safety (PS) Component is being expanded to include long term care facilities to facilitate HAI surveillance in this setting, for which no standardized reporting methodology or mechanism currently exists. Four new forms are proposed for this purpose. A new form is proposed to be added to the Healthcare Personnel Safety (HPS) Component to facilitate summary reporting of influenza vaccination in healthcare workers, which is anticipated to be required by CMS in the near future. In addition to this new form, the scope of the HPS Annual Facility Survey is being expanded to include all acute care facilities that would enroll if CMS does implement this requirement. The NHSN Antimicrobial Use and Resistance module is transitioning from manual web entry to electronic data upload only, which results in a significant decrease to the reporting burden for this package. Finally, there are many updates, clarifications, and data collection revisions proposed in this submission. CDC is requesting to delete four currently approved forms that are no longer needed by the NHSN and add five new forms The previously-approved NHSN package included 47 individual data collection forms. If all proposed revisions are approved, the reporting burden will decrease by 1,258,119 hours, for a total estimated burden of 3,914,125 hours and 48 total data collection tools. Participating institutions must have a computer capable of supporting an Internet service provider (ISP) and access to an ISP. There is no cost to respondents other than their time. The total estimated annual burden hours are 3,914,125. E:\FR\FM\30NON1.SGM 30NON1 74065 Federal Register / Vol. 76, No. 230 / Wednesday, November 30, 2011 / Notices ESTIMATE OF ANNUALIZED BURDEN HOURS Number of respondents Responses per respondent Burden per response (hours) Respondents Form name Infection Preventionist ................... NHSN Registration Form ................................................. Facility Contact Information ............................................. Patient Safety Component—Annual Facility Survey ....... Patient Safety Component—Outpatient Dialysis Center Practices Survey. Group Contact Information ............................................... Patient Safety Monthly Reporting Plan ............................ Primary Bloodstream Infection (BSI) ............................... Dialysis Event ................................................................... Pneumonia (PNEU) .......................................................... Urinary Tract Infection (UTI) ............................................ Denominators for Neonatal Intensive Care Unit (NICU) 6,000 ................................................................................ 6,000 6,000 6,000 5,500 1 1 1 1 5/60 10/60 40/60 1 6,000 6,000 6,000 500 6,000 6,000 6,000 9 1 9 36 75 72 27 9 5 5/60 35/60 32/60 15/60 32/60 32/60 4 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA). Denominator for Outpatient Dialysis ................................ Surgical Site Infection (SSI) ............................................. Denominator for Procedure .............................................. Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables. Antimicrobial Use and Resistance (AUR)—Pharmacy Data Electronic Upload Specification Tables. Central Line Insertion Practices Adherence Monitoring .. MDRO or CDI Infection Form .......................................... MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring. Laboratory-identified MDRO or CDI Event ...................... Vaccination Monthly Monitoring Form–Summary Method Vaccination Monthly Monitoring Form–Patient-Level Method. Patient Vaccination .......................................................... Patient Safety Component—Annual Facility Survey for LTCF. Laboratory-identified MDRO or CDI Event for LTCF ....... MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF. Urinary Tract Infection (UTI) for LTCF ............................. Healthcare Personnel Safety Component Annual Facility Survey. Healthcare Worker Survey ............................................... Healthcare Personnel Safety Monthly Reporting Plan .... Healthcare Worker Demographic Data ............................ Exposure to Blood/Body Fluids ........................................ Healthcare Worker Prophylaxis/Treatment ...................... Follow-Up Laboratory Testing .......................................... Healthcare Worker Vaccination History ........................... Healthcare Worker Influenza Vaccination ........................ Healthcare Worker Prophylaxis/Treatment-Influenza ...... Pre-season Survey on Influenza Vaccination Programs for Healthcare Personnel. Post-season Survey on Influenza Vaccination Programs for Healthcare Personnel. Healthcare Personnel Influenza Vaccination Monthly Summary. Hemovigilance Module Annual Survey ............................ Hemovigilance Module Monthly Reporting Plan .............. Hemovigilance Module Monthly Incident Summary ......... Hemovigilance Module Monthly Reporting Denominators Hemovigilance Adverse Reaction .................................... Hemovigilance Incident .................................................... 6,000 18 5 500 6,000 6,000 6,000 12 27 540 12 5/60 32/60 10/60 5/60 6,000 12 5/60 6,000 6,000 6,000 100 72 24 5/60 32/60 10/60 6,000 6,000 2,000 240 5 5 25/60 14 2 2,000 250 250 1 10/60 25/60 250 250 8 3 30/60 7/60 250 6,000 9 1 30/60 8 600 600 600 600 600 600 600 600 600 600 100 9 200 50 10 100 300 500 50 1 10/60 10/60 20/60 1 15/60 15/60 10/60 10/60 10/60 10/60 600 1 10/60 6,000 6 2 500 500 500 500 500 500 1 12 12 12 120 72 2 2/60 2 30/60 10/60 10/60 Staff RN ........................................ Denominators for Specialty Care Area (SCA). Staff RN ........................................ Infection Preventionist ................... Staff RN ........................................ Laboratory Technician .................. Pharmacy Technician ................... Infection Preventionist ................... Occ Health RN .............................. Laboratory Technician .................. Occ Health RN .............................. Occ Health RN .............................. emcdonald on DSK5VPTVN1PROD with NOTICES Clinical Laboratory Technologist ... VerDate Mar<15>2010 17:30 Nov 29, 2011 Jkt 226001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\30NON1.SGM 30NON1 74066 Federal Register / Vol. 76, No. 230 / Wednesday, November 30, 2011 / Notices Dated: November 22, 2011 Daniel Holcomb, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2011–30832 Filed 11–29–11; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30-Day–12–11IR] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Evaluation of Core Violence and Injury Prevention Program (Core VIPP)—New—National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC). Background and Brief Description Injuries and their consequences, including unintentional and violencerelated injuries, are the leading cause of death for the first four decades of life, regardless of gender, race, or socioeconomic status. More than 179,000 individuals in the United States die each year as a result of unintentional injuries and violence, more than 29 million others suffer non-fatal injuries and over one-third of all emergency department (ED) visits each year are due to injuries. In 2000, injuries and violence ultimately cost the United States $406 billion, with over $80 billion in medical costs and the remainder lost in productivity.1 Most events that result in injury and/or death from injury could be prevented if evidence-based public health strategies, practices, and policies were used throughout the nation. CDC’s National Center for Injury Prevention and Control (NCIPC) is committed to working with their partners to promote action that reduces injuries, violence, and disabilities by providing leadership in identifying priorities, promoting tools, and monitoring effectiveness of injury and violence prevention and to promote effective strategies for the prevention of injury and violence, and their consequences. One tool NCIPC will use to accomplish this is the Core Violence and Injury Prevention Program (VIPP). This program funds state health departments to build effective delivery systems for dissemination, implementation and evaluation of evidence based/best practice programs and policies. Core VIPP also focuses on the integration of unintentional injury and violence prevention. Unintentional injury and violence prevention have many common risk and protective factors for children. In an endeavor to promote efforts to prevent child maltreatment, a NCIPC priority, CDC is collaborating with the Health Resources and Services Administration (HRSA) regarding the new Affordable Care Act (ACA) Maternal, Infant, and Early Childhood Home Visiting Program. The state health departments funded by the Core VIPP will be required to partner with the state agency responsible for administration of the State Home Visiting program. CDC requests OMB approval to collect program evaluation data for Core VIPP over a three-year period. Specifically, CDC will use the Safe States Alliance State of the States (SOTS) survey as the template for annual evaluation surveys and an annual follow-up telephone interview. Both the SOTS and the telephone interviews will be conducted with state Violence and Injury Prevention programs directors and staff. This approach provides a means to collect standardized, systematic data from the Core VIPP grantees for program evaluation and improvement. Topics for data collection include: Program evaluation, state injury and violence prevention program (IVP) infrastructure, IVP strategies and partners, policy strategies, injury surveillance, quality of surveillance, and regional network leaders. Part of the requirement for receiving Core VIPP funding is for State Injury and Violence Programs (SIVPs) to develop and maintain their own evaluation capacity and data systems; thus, this data collection is not expected to entail significant burdens to respondents. Estimates of burden for the survey are based on previous experience with evaluation data collections conducted by the evaluation staff. The State of the States (SOTS) web-based survey assessment will be completed by 28 Core Funded State Health Departments (SHDs) and 22 Non-Funded SHDs, taking 3 hours to complete. The SOTS Financial Module will also be completed by the 28 Core Funded and 22 Non-Funded SHD, taking 1 hour to complete. The telephone interviews will take 1.5 hours to conclude and will be completed by the 28 Core Funded States. We expect that each of the 28 Core Funded states will complete three web-based surveys and three telephone interviews during the first three years of Core funding. It is anticipated that up to 22 unfunded states will complete three web-based surveys during the first three years of Core funding. There are no costs to respondents other than their time. The total estimated annual burden hours are 242. ESTIMATED ANNUALIZED BURDEN HOURS emcdonald on DSK5VPTVN1PROD with NOTICES Type of respondent Core VIPP funded Core VIPP funded Core VIPP funded Non-funded SHD ment and staff. Non-funded SHD ment and staff. VerDate Mar<15>2010 Number of respondents Form name Number of responses per respondent Average burden per response (in hours) SVIP directors and staff ... SVIP directors and staff ... VIP directors and staff ...... Injury Program manage- State of the States Survey (SOTS) ............... SOTS Financial Module ................................. Telephone interview ....................................... SOTS .............................................................. 28 28 28 22 1 1 1 1 3 1 1.5 3 Injury Program manage- SOTS Financial Module ................................. 22 1 1 17:30 Nov 29, 2011 Jkt 226001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\30NON1.SGM 30NON1

Agencies

[Federal Register Volume 76, Number 230 (Wednesday, November 30, 2011)]
[Notices]
[Pages 74064-74066]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30832]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-12-0666]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an email to 
omb@cdc.gov. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-5806. 
Written comments should be received within 30 days of this notice.

Proposed Project

    National Healthcare Safety Network (NHSN) (OMB No. 0920-0666 exp. 
3/31/2012)--Revision--National Center for Emerging and Zoonotic 
Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The National Healthcare Safety Network (NHSN) is a system designed 
to accumulate, exchange, and integrate relevant information and 
resources among private and public stakeholders to support local and 
national efforts to protect patients and to promote healthcare safety. 
Specifically, the data is used to determine the magnitude of various 
healthcare-associated adverse events and trends in the rates of these 
events among patients and healthcare workers with similar risks. 
Healthcare institutions that participate in NHSN voluntarily report 
their data to CDC using a web browser based technology for data entry 
and data management. Data are collected by trained surveillance 
personnel using written standardized protocols. The data will be used 
to detect changes in the epidemiology of adverse events resulting from 
new and current medical therapies and changing risks.
    This revision submission includes an amended Assurance of 
Confidentiality, which required an update of the Assurance of 
Confidentiality language on all forms included in the NHSN surveillance 
system. The scope of NHSN dialysis surveillance is being expanded to 
include all outpatient dialysis centers so that the existing Dialysis 
Annual Survey can be used to facilitate prevention objectives set forth 
in the HHS HAI tier 2 Action Plan and to assess national practices in 
all Medicare-certified dialysis centers if CMS re-establishes this 
survey method (as expected). The Patient Safety (PS) Component is being 
expanded to include long term care facilities to facilitate HAI 
surveillance in this setting, for which no standardized reporting 
methodology or mechanism currently exists. Four new forms are proposed 
for this purpose. A new form is proposed to be added to the Healthcare 
Personnel Safety (HPS) Component to facilitate summary reporting of 
influenza vaccination in healthcare workers, which is anticipated to be 
required by CMS in the near future. In addition to this new form, the 
scope of the HPS Annual Facility Survey is being expanded to include 
all acute care facilities that would enroll if CMS does implement this 
requirement. The NHSN Antimicrobial Use and Resistance module is 
transitioning from manual web entry to electronic data upload only, 
which results in a significant decrease to the reporting burden for 
this package. Finally, there are many updates, clarifications, and data 
collection revisions proposed in this submission.
    CDC is requesting to delete four currently approved forms that are 
no longer needed by the NHSN and add five new forms
    The previously-approved NHSN package included 47 individual data 
collection forms. If all proposed revisions are approved, the reporting 
burden will decrease by 1,258,119 hours, for a total estimated burden 
of 3,914,125 hours and 48 total data collection tools.
    Participating institutions must have a computer capable of 
supporting an Internet service provider (ISP) and access to an ISP. 
There is no cost to respondents other than their time. The total 
estimated annual burden hours are 3,914,125.

[[Page 74065]]



                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                    Burden per
            Respondents                       Form name              Number of     Responses per     response
                                                                    respondents     respondent        (hours)
----------------------------------------------------------------------------------------------------------------
Infection Preventionist............  NHSN Registration Form.....           6,000               1            5/60
                                     Facility Contact                      6,000               1           10/60
                                      Information.
                                     Patient Safety Component--            6,000               1           40/60
                                      Annual Facility Survey.
                                     Patient Safety Component--            5,500               1               1
                                      Outpatient Dialysis Center
                                      Practices Survey.
                                     Group Contact Information..           6,000               1            5/60
                                     Patient Safety Monthly                6,000               9           35/60
                                      Reporting Plan.
                                     Primary Bloodstream                   6,000              36           32/60
                                      Infection (BSI).
                                     Dialysis Event.............             500              75           15/60
                                     Pneumonia (PNEU)...........           6,000              72           32/60
                                     Urinary Tract Infection               6,000              27           32/60
                                      (UTI).
Staff RN...........................  Denominators for Neonatal             6,000               9               4
                                      Intensive Care Unit (NICU).
Denominators for Specialty Care      6,000......................               9               5
 Area (SCA).
                                     Denominators for Intensive            6,000              18               5
                                      Care Unit (ICU)/Other
                                      locations (not NICU or
                                      SCA).
Staff RN...........................  Denominator for Outpatient              500              12            5/60
                                      Dialysis.
Infection Preventionist............  Surgical Site Infection               6,000              27           32/60
                                      (SSI).
Staff RN...........................  Denominator for Procedure..           6,000             540           10/60
Laboratory Technician..............  Antimicrobial Use and                 6,000              12            5/60
                                      Resistance (AUR)-
                                      Microbiology Data
                                      Electronic Upload
                                      Specification Tables.
Pharmacy Technician................  Antimicrobial Use and                 6,000              12            5/60
                                      Resistance (AUR)--Pharmacy
                                      Data Electronic Upload
                                      Specification Tables.
Infection Preventionist............  Central Line Insertion                6,000             100            5/60
                                      Practices Adherence
                                      Monitoring.
                                     MDRO or CDI Infection Form.           6,000              72           32/60
                                     MDRO and CDI Prevention               6,000              24           10/60
                                      Process and Outcome
                                      Measures Monthly
                                      Monitoring.
                                     Laboratory-identified MDRO            6,000             240           25/60
                                      or CDI Event.
                                     Vaccination Monthly                   6,000               5              14
                                      Monitoring Form-Summary
                                      Method.
                                     Vaccination Monthly                   2,000               5               2
                                      Monitoring Form-Patient-
                                      Level Method.
                                     Patient Vaccination........           2,000             250           10/60
                                     Patient Safety Component--              250               1           25/60
                                      Annual Facility Survey for
                                      LTCF.
                                     Laboratory-identified MDRO              250               8           30/60
                                      or CDI Event for LTCF.
                                     MDRO and CDI Prevention                 250               3            7/60
                                      Process Measures Monthly
                                      Monitoring for LTCF.
                                     Urinary Tract Infection                 250               9           30/60
                                      (UTI) for LTCF.
Occ Health RN......................  Healthcare Personnel Safety           6,000               1               8
                                      Component Annual Facility
                                      Survey.
                                     Healthcare Worker Survey...             600             100           10/60
                                     Healthcare Personnel Safety             600               9           10/60
                                      Monthly Reporting Plan.
                                     Healthcare Worker                       600             200           20/60
                                      Demographic Data.
                                     Exposure to Blood/Body                  600              50               1
                                      Fluids.
                                     Healthcare Worker                       600              10           15/60
                                      Prophylaxis/Treatment.
Laboratory Technician..............  Follow-Up Laboratory                    600             100           15/60
                                      Testing.
Occ Health RN......................  Healthcare Worker                       600             300           10/60
                                      Vaccination History.
Occ Health RN......................  Healthcare Worker Influenza             600             500           10/60
                                      Vaccination.
                                     Healthcare Worker                       600              50           10/60
                                      Prophylaxis/Treatment-
                                      Influenza.
                                     Pre-season Survey on                    600               1           10/60
                                      Influenza Vaccination
                                      Programs for Healthcare
                                      Personnel.
                                     Post-season Survey on                   600               1           10/60
                                      Influenza Vaccination
                                      Programs for Healthcare
                                      Personnel.
                                     Healthcare Personnel                  6,000               6               2
                                      Influenza Vaccination
                                      Monthly Summary.
Clinical Laboratory Technologist...  Hemovigilance Module Annual             500               1               2
                                      Survey.
                                     Hemovigilance Module                    500              12            2/60
                                      Monthly Reporting Plan.
                                     Hemovigilance Module                    500              12               2
                                      Monthly Incident Summary.
                                     Hemovigilance Module                    500              12           30/60
                                      Monthly Reporting
                                      Denominators.
                                     Hemovigilance Adverse                   500             120           10/60
                                      Reaction.
                                     Hemovigilance Incident.....             500              72           10/60
----------------------------------------------------------------------------------------------------------------



[[Page 74066]]

    Dated: November 22, 2011
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-30832 Filed 11-29-11; 8:45 am]
BILLING CODE 4163-18-P
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