Proposed Data Collection Submitted for Public Comment and Recommendations, 36207-36211 [2020-12809]

Download as PDF 36207 Federal Register / Vol. 85, No. 115 / Monday, June 15, 2020 / Notices Proposed Project DOP Cross-Site Evaluation of Overdose Data to Action Program– New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description Overdose Data to Action Program (OD2A) is a comprehensive, national overdose prevention program developed by CDC’s NCIPC. The purpose of the OD2A program is to support funded jurisdictions in obtaining high quality, complete, and timely data on opioid prescribing and overdoses, and to use those data to inform prevention and response efforts. The OD2A (CDC–RFA– CE19–1904) funds a total of 66 recipients (state and local health jurisdictions. The outcome evaluation will assess short term (e.g., increased awareness and coordination of linkages to care) and intermediate (e.g., increased provider, health system, and payer awareness of and supports for guidelineconcordant opioid prescribing, nonopioid medications, and nonpharmacological treatments) outcomes. Data collected from this evaluation will be used by the CDC to obtain valid information regarding how recipients operationalized and implemented their chosen prevention activities, assess the impact of OD2A and different components of OD2A on the trajectory of the opioid epidemic, and through the provision of these data back to the recipients, improve the implementation and impact of further OD2A prevention activities. departments) to implement surveillance and prevention strategies, through a three-year cooperative agreement. OD2A funded recipients consist of 47 state-, 16 city/county-, and three district/territorylevel jurisdictions. The purpose of this information collection is to assess the implementation and the effectiveness of the OD2A program activities and identify the conditions under which these activities are most effective. Activities include key informant interviews (KII) and focus groups (FG), and are focused on the tools needed to evaluate the unique OD2A program. The implementation evaluation will identify the barriers and facilitators associated with deploying several prevention activities targeting specific populations within specific ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Average burden per response Total burden (hours) Form name Jurisdictions implementing OD2A program (e.g., PMs, PIs, SSLs, PSLs, Partners, or Stakeholders). Key Informant Interview Guides ....... Focus Group Guides ........................ 288 252 1 1 60 90 288 378 Permission to be recorded ............... Interview Recruitment Email ............ Focus Group Recruitment Email ...... Interview Recruitment Reminder Email. Focus Group Recruitment Reminder Email. Post-information Collection Follow up Email. 540 288 252 288 1 1 1 1 5 5 5 5 45 24 21 24 252 1 5 21 540 1 5 45 ........................................................... ........................ ........................ ........................ 846 Total ........................................... Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–12808 Filed 6–12–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–20–0666; Docket No. CDC–2020– 0065] Proposed Data Collection Submitted for Public Comment and Recommendations jbell on DSKJLSW7X2PROD with NOTICES Number of respondents Type of respondent Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: The Centers for Disease Control and Prevention (CDC), as part of SUMMARY: VerDate Sep<11>2014 17:04 Jun 12, 2020 Jkt 250001 its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the CDC’s National Healthcare Safety Network (NHSN). NHSN is a public health surveillance system that collects, analyzes, reports, and makes available data for monitoring, measuring, and responding to healthcare associated infections (HAIs), antimicrobial use and resistance, blood transfusion safety events, and the extent to which healthcare facilities adhere to infection prevention practices and antimicrobial stewardship. CDC must receive written comments on or before August 14, 2020. DATES: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 You may submit comments, identified by Docket No. CDC–2020– 0065 by any of the following methods: • Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. • Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS–D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, ADDRESSES: E:\FR\FM\15JNN1.SGM 15JNN1 36208 Federal Register / Vol. 85, No. 115 / Monday, June 15, 2020 / Notices Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS– D74, Atlanta, Georgia 30329; phone: 404–639–7570; Email: omb@cdc.gov. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. 5. Assess information collection costs. jbell on DSKJLSW7X2PROD with NOTICES Proposed Project National Healthcare Safety Network (NHSN) (OMB Control No. 0920– 0666)—Revision—National Center for Emerging and Zoonotic Infection Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Division of Healthcare Quality Promotion (DHQP), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) collects data from healthcare facilities in the National Healthcare Safety Network (NHSN) under OMB Control Number 0920–0666. NHSN provides facilities, VerDate Sep<11>2014 17:04 Jun 12, 2020 Jkt 250001 states, regions, and the nation with data necessary to identify problem areas, measure the progress of prevention efforts, and ultimately eliminate healthcare-associated infections (HAIs) nationwide. NHSN allows healthcare facilities to track blood safety errors and various healthcare-associated infection prevention practice methods such as healthcare personnel influenza vaccine status and corresponding infection control adherence rates. NHSN currently has six components: Patient Safety (PS), Healthcare Personnel Safety (HPS), Biovigilance (BV), Long-Term Care Facility (LTCF), Outpatient Procedure (OPC), and the Dialysis Component. NHSN’s planned Neonatal Component is expected to launch during the winter of 2020/2021. This component will focus on premature neonates and the healthcareassociated events that occur as a result of their prematurity. This component will be released with one module, which includes Late Onset-Sepsis and Meningitis. Late-onset sepsis (LOS) and Meningitis are common complications of extreme prematurity. These infections are usually serious, causing a prolongation of hospital stay, increased cost, and risk of morbidity and mortality. The data for this module will be electronically submitted, and manual data entry will not be available. This will allow more hospital personnel to be available to care for patients and will reduce annual burden across healthcare facilities. Additionally, LOS data will be utilized for prevention initiatives. Data reported under the Patient Safety Component are used to determine the magnitude of the healthcare-associated adverse events and trends in the rates of the events, in the distribution of pathogens, and in the adherence to prevention practices. Data will help detect changes in the epidemiology of adverse events resulting from new medical therapies and changing patient risks. Additionally, reported data is being used to describe the epidemiology of antimicrobial use and resistance and to better understand the relationship of antimicrobial therapy to this rising problem. Approved as a New Emergency ICR (National Healthcare Safety Network (NHSN) Patient Impact Module for Coronavirus (COVID–19) Surveillance in Healthcare Facilities, OMB Control No. 0920–1290), NHSN launched a COVID–19 Module in the Patient Safety Component on March 27th, 2020. This Module is designed to collect facilitylevel COVID–19 data on cases, deaths, capacity, healthcare worker staffing shortages, and personal protective equipment and supplies from hospitals PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 on a daily basis. Facility-level data collected through NSHN as part of the COVID–19 Module are being made available to a broader set of Federal, state, and local agency data users than data typically collected by NHSN. Specifically, COVID–19 data at the state, county, territory, and facility level submitted to NHSN will continue to be used for public health emergency response activities by CDC’s emergency COVID–19 response, by the U.S. Department of Health and Human Services’ (HHS’) COVID–19 tracking system maintained in the Office of the Assistant Secretary of Preparedness and Response as part of the National Response Coordination Center at the Federal Emergency Management Agency (FEMA), and by the White House Coronavirus Task Force. Under the Healthcare Personnel Safety Component, protocols and data on events—both positive and adverse— are used to determine (1) the magnitude of adverse events in healthcare personnel, and (2) compliance with immunization and sharps injuries safety guidelines. Under the Biovigilance Component, data on adverse reactions and incidents associated with blood transfusions are reported and analyzed to provide national estimates of adverse reactions and incidents. Under the Long-Term Care Facility Component, data is captured from skilled nursing facilities. Reporting methods under the LTCF component have been created by using forms from the PS Component as a model with modifications to specifically address the specific characteristics of LTCF residents and the unique data needs of these facilities reporting into NHSN. A new form has been introduced for field testingRespiratory Tract Infection (RTI)—not to be used by NHSN users, but as part of an EIP project with 4 EIP sites. Form title will be Denominators for Healthcare Associated Infections (HAIs): Respiratory Tract Infections. The purpose of this form is to allow testing prior to introducing a new module and forms to NHSN users. The CDC’s Epidemiology Research & Innovations Branch (ERIB) team will use the form to perform field testing of variables to explore the utilization, applicability, and data collection burden associated with these variables. This process will inform areas of improvement prior to incorporating the new module, including protocol, forms, and instructions into NHSN. The estimated burden for this form is 20 minutes, which is based on a similar denominator form. Also approved under New Emergency ICR 0920–1290, NHSN E:\FR\FM\15JNN1.SGM 15JNN1 36209 Federal Register / Vol. 85, No. 115 / Monday, June 15, 2020 / Notices launched a COVID–19 Module in the Long-Term Care Component April 27th, 2020. As with the COVID–19 Module in the PS Component, the LTC COVID–19 Module is designed to collect facilitylevel COVID–19 data on cases, deaths, capacity, healthcare worker staffing shortages, and personal protective equipment and supplies from long-term care facilities on at least a weekly basis. Facility-level data collected through NSHN as part of the COVID–19 Module are being made available to a broader set of Federal, state, and local agency data users than data typically collected by NHSN. Specifically, COVID–19 data at the state, county, territory, and facility level submitted to NHSN will continue to be used for public health emergency response activities by CDC’s emergency COVID–19 response, by the U.S. Department of Health and Human Services’ (HHS’) COVID–19 tracking system maintained in the Office of the Assistant Secretary of Preparedness and Response as part of the National Response Coordination Center at the Federal Emergency Management Agency (FEMA), and by the White House Coronavirus Task Force. The Dialysis Component offers a simplified user interface for dialysis users to streamline their data entry and analyses processes as well as provide options for expanding in the future to include dialysis surveillance in settings other than outpatient facilities. The Outpatient Procedure Component (OPC) gathers data on the impact of infections and outcomes related to operative procedures performed in Ambulatory Surgery Centers (ASCs). The OPC is used to monitor two event types: Same Day Outcome Measures and Surgical Site Infections (SSIs). NHSN has increasingly served as the operating system for HAI reporting compliance mandate. Facilities that fail to report quality measure data are subject to partial payment reduction in the applicable Medicare Fee-for-Service payment system. CMS links their quality reporting to payment for Medicare-eligible acute care hospitals, inpatient rehabilitation facilities, longterm acute care facilities, oncology hospitals, inpatient psychiatric facilities, dialysis facilities, and ambulatory surgery centers. Facilities report HAI data and healthcare personnel influenza vaccination summary data to CMS via NHSN as part of CMS’s quality reporting programs to receive full payment. Still, many healthcare facilities, even in states without HAI reporting legislation, submit limited HAI data to NHSN voluntarily. NHSN’s data collection updates continue to support the incentive programs managed by CMS. For example, survey questions support requirements for CMS’ quality reporting programs. Additionally, CDC has collaborated with CMS on a voluntary National Nursing Home Quality Collaborative, which focuses on recruiting nursing homes to report HAI data to NHSN and to retain their continued participation. This project has resulted in a significant increase in long-term care facilities reporting to NHSN. The ICR previously approved in December of 2019 for 5,352,360 responses; 3,113,631 burden hours. The proposed changes in this new ICR include revisions to eight data collection forms and the addition of ten new forms for a total of 86 proposed data collection forms. In this Revision, CDC requests OMB approval for an estimated 2,365,743 annual burden hours. through legislation established by the states. As of April 2020, 36 states, the District of Columbia and the City of Philadelphia, Pennsylvania have opted to use NHSN as their primary system for mandated reporting. Reporting compliance is completed by healthcare facilities in their respective jurisdictions, with emphasis on those states and municipalities acquiring varying consequences for failure to use NHSN. Additionally, healthcare facilities in five U.S. territories (Puerto Rico, American Samoa, the U.S. Virgin Islands, Guam, and the Northern Mariana Islands) are voluntarily reporting to NHSN. Additional territories are projected to follow with similar use of NHSN for reporting purposes. NHSN’s data is used to aid in the tracking of HAIs and guide infection prevention activities/practices that protect patients. The Centers for Medicare and Medicaid Services (CMS) and other payers use these data to determine incentives for performance at healthcare facilities across the US and surrounding territories, and members of the public may use some protected data to inform their selection among available providers. Each of these parties is dependent on the completeness and accuracy of the data. CDC and CMS work closely and are fully committed to ensuring complete and accurate reporting, which are critical for protecting patients and guiding national, state, and local prevention priorities. CMS collects some HAI data and healthcare personnel influenza vaccination summary data, which is done on a voluntary basis as part of its Fee-for-Service Medicare quality reporting programs, while others may report data required by a federal ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents jbell on DSKJLSW7X2PROD with NOTICES Form No. & name 57.100 NHSN Registration Form ..................................................................... 57.101 Facility Contact Information ................................................................. 57.103 Patient Safety Component—Annual Hospital Survey ......................... 57.105 Group Contact Information .................................................................. 57.106 Patient Safety Monthly Reporting Plan ............................................... 57.108 Primary Bloodstream Infection (BSI) ................................................... 57.111 Pneumonia (PNEU) ............................................................................. 57.112 Ventilator-Associated Event ................................................................ 57.113 Pediatric Ventilator-Associated Event (PedVAE) ................................ 57.114 Urinary Tract Infection (UTI) ................................................................ 57.115 Custom Event ...................................................................................... 57.116 Denominators for Neonatal Intensive Care Unit (NICU) ..................... 57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC) ......... 57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA) .............................................................................................. 57.120 Surgical Site Infection (SSI) ................................................................ VerDate Sep<11>2014 17:04 Jun 12, 2020 Jkt 250001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden per response (min./hour) Total burden (hours) 2,000 2,000 6,765 1,000 7,821 5,775 1,800 5,463 334 6,000 600 1,100 500 1 1 1 1 12 5 2 8 1 5 91 12 12 5/60 10/60 55/60 5/60 15/60 38/60 30/60 28/60 30/60 20/60 35/60 4/60 5/60 167 333 6,201 83 23,463 18,288 18,288 20,395 167 10,000 31,850 880 503 5,500 6,000 60 9 5/60 35/60 27,665 31,500 E:\FR\FM\15JNN1.SGM 15JNN1 36210 Federal Register / Vol. 85, No. 115 / Monday, June 15, 2020 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents jbell on DSKJLSW7X2PROD with NOTICES Form No. & name 57.121 Denominator for Procedure ................................................................. 57.122 HAI Progress Report State Health Department Survey ...................... 57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables .............................................................. 57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables ........................................................................ 57.125 Central Line Insertion Practices Adherence Monitoring ...................... 57.126 MDRO or CDI Infection Form .............................................................. 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring ................................................................................................. 57.128 Laboratory-identified MDRO or CDI Event .......................................... 57.129 Adult Sepsis ......................................................................................... 57.130 COVID–19 Module: Patient Impact and Hospital Capacity ................. 57.131 COVID–19 Module: Healthcare Worker Staffing ................................. 57.132 COVID–19 Module: Supplies .............................................................. 57.135 Late Onset Sepsis/Meningitis Denominator Form: Data Table for monthly electronic upload ............................................................................ 57.136 Late Onset Sepsis/Meningitis Event Form: Data Table for Monthly Electronic Upload ......................................................................................... 57.137 Long-Term Care Facility Component—Annual Facility Survey ........... 57.138 Laboratory-identified MDRO or CDI Event for LTCF .......................... 57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF ....................................................................................................... 57.140 Urinary Tract Infection (UTI) for LTCF ................................................ 57.141 Monthly Reporting Plan for LTCF ........................................................ 57.142 Denominators for LTCF Locations ...................................................... 57.143 Prevention Process Measures Monthly Monitoring for LTCF ............. 57.144 LTCF COVID–19 Module: Resident Impact and Facility Capacity ..... 57.145 LTCF COVID–19 Module: Staff and Personnel Impact ...................... 57.146 LTCF COVID–19 Module: Supplies and PPE ..................................... 57.147 LTCF COVID–19 Module: Ventilator Capacity and Supplies .............. 57.150 LTAC Annual Survey ........................................................................... 57.151 Rehab Annual Survey ......................................................................... 57.200 Healthcare Personnel Safety Component Annual Facility Survey ...... 57.203 Healthcare Personnel Safety Monthly Reporting Plan ........................ 57.204 Healthcare Worker Demographic Data ............................................... 57.205 Exposure to Blood/Body Fluids ........................................................... 57.206 Healthcare Worker Prophylaxis/Treatment .......................................... 57.207 Follow-Up Laboratory Testing ............................................................. 57.210 Healthcare Worker Prophylaxis/Treatment-Influenza .......................... 57.300 Hemovigilance Module Annual Survey ................................................ 57.301 Hemovigilance Module Monthly Reporting Plan ................................. 57.303 Hemovigilance Module Monthly Reporting Denominators .................. 57.305 Hemovigilance Incident ....................................................................... 57.306 Hemovigilance Module Annual Survey—Non-acute care facility ........ 57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction ............................................................................................................ 57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction ..... 57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction ....................................................................................................... 57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction ....................................................................................................... 57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction ............................................................................................ 57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction ................................................................................................................ 57.313 Hemovigilance Adverse Reaction—Infection ...................................... 57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura ........... 57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea 57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease ................................................................................................ 57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury ............................................................................................................. 57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload ......................................................................................... 57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction .. 57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction ........ 57.400 Outpatient Procedure Component—Annual Facility Survey ............... 57.401 Outpatient Procedure Component—Monthly Reporting Plan ............. VerDate Sep<11>2014 17:04 Jun 12, 2020 Jkt 250001 PO 00000 Frm 00027 Fmt 4703 Number of responses per respondent Average burden per response (min./hour) Total burden (hours) 6,000 55 602 1 10/60 28/60 602,000 26 2,500 12 5/60 1,500 2,000 500 720 12 213 12 5/60 25/60 30/60 2,000 44,375 3,960 5,500 4,800 50 3,117 3,117 3,117 29 79 250 540 540 540 15/60 20/60 25/60 25/60 25/60 25/60 39,875 126,400 5,208 701,325 701,325 701,325 300 12 5/60 300 300 3,079 1,998 4 1 24 5/60 1/60 12/60 100 51 9,590 1,998 339 2,011 339 130 14,674 14,674 14,674 14,674 620 1,340 50 ........................ 50 50 50 50 50 500 500 500 500 500 12 12 12 12 12 26 26 26 26 1 1 1 1 200 50 30 50 50 1 12 12 10 1 12/60 12/60 12/60 250/60 12/60 20/60 15/60 5/60 5/60 10/60 10/60 480/60 5/60 20/60 60/60 15/60 15/60 10/60 85/60 1/60 70/60 10/60 35/60 4,795 814 4,826 814 312 127,175 95,381 31,794 31,794 10 625 400 ........................ 3,333 2,500 375 625 417 708 100 7,000 833 292 500 500 4 4 20/60 20/60 667 667 500 1 20/60 167 500 2 20/60 333 500 4 20/60 667 500 500 500 500 1 1 1 1 20/60 20/60 20/60 20/60 167 167 167 167 500 1 20/60 167 500 1 20/60 167 500 500 500 700 700 2 1 1 1 12 20/60 20/60 20/60 10/60 15/60 333 167 167 117 2,100 Sfmt 4703 E:\FR\FM\15JNN1.SGM 15JNN1 36211 Federal Register / Vol. 85, No. 115 / Monday, June 15, 2020 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Average burden per response (min./hour) Total burden (hours) 57.402 Outpatient Procedure Component Same Day Outcome Measures .... 57.403 Outpatient Procedure Component—Monthly Denominators for Same Day Outcome Measures .............................................................................. 57.404 Outpatient Procedure Component—SSI Denominator ........................ 57.405 Outpatient Procedure Component—Surgical Site (SSI) Event ........... 57.500 Outpatient Dialysis Center Practices Survey ...................................... 57.501 Dialysis Monthly Reporting Plan .......................................................... 57.502 Dialysis Event ...................................................................................... 57.503 Denominator for Outpatient Dialysis .................................................... 57.504 Prevention Process Measures Monthly Monitoring for Dialysis .......... 57.505 Dialysis Patient Influenza Vaccination ................................................. 57.506 Dialysis Patient Influenza Vaccination Denominator ........................... 57.507 Home Dialysis Center Practices Survey ............................................. 200 1 40/60 133 200 700 700 7,200 7,200 7,200 7,200 1,730 615 615 430 400 100 5 1 12 30 30 12 50 5 1 40/60 40/60 40/60 127/60 5/60 25/60 10/60 75/60 10/60 10/60 30/60 53,333 46,667 2,333 15,240 7,200 90,000 14,400 25,950 5,125 513 215 Total .......................................................................................................... ........................ ........................ ........................ 2,365,743 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–12809 Filed 6–12–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-20–1186] Agency Forms Undergoing Paperwork Reduction Act Review jbell on DSKJLSW7X2PROD with NOTICES Number of responses per respondent Number of respondents Form No. & name In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Information Collection for Tuberculosis Data from Referring Entities to CureTB to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on December 23, 2019 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including VerDate Sep<11>2014 17:04 Jun 12, 2020 Jkt 250001 whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570. 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 30-day Review—Open for Public Comments’’ or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project Information Collection for Tuberculosis Data from Referring Entities to CureTB (OMB Control No. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 0920–1186, Exp. 06/30/2020)— Revision—National Center for Emerging Zoonotic and Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description CureTB at the Centers for Disease Control and Prevention (CDC) works with domestic and international programs to protect the U.S. public by preventing tuberculosis (TB) disease transmission domestically and internationally, as well as preventing the development of drug resistant TB. These goals are accomplished through CureTB referral and continuity of care services for mobile TB patients. Lack of treatment adherence and inappropriate selection of medications are prime reasons for the continued emergence and spread of resistant strains of tuberculosis. To combat this, CureTB ensures that patients understand how to remain adherent to treatment regimens, despite moving between nations. CureTB also provides information to the health care team that will be continuing care about each patient’s TB strain and tailored medication regimen. CureTB gathers demographic and clinical information for each patient and connects that individual to appropriate clinical care. This information is also provided on a real-time basis to medical providers and public health authorities in receiving nations so that follow-up with the patient can be expedited. The respondents are local health departments (LHD) or Immigration and Customs Enforcement (ICE) detention centers within the United States and foreign national TB programs or healthcare facilities in other countries that provide diagnostic and treatment services to individuals affected by TB. E:\FR\FM\15JNN1.SGM 15JNN1

Agencies

[Federal Register Volume 85, Number 115 (Monday, June 15, 2020)]
[Notices]
[Pages 36207-36211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12809]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-0666; Docket No. CDC-2020-0065]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the CDC's 
National Healthcare Safety Network (NHSN). NHSN is a public health 
surveillance system that collects, analyzes, reports, and makes 
available data for monitoring, measuring, and responding to healthcare 
associated infections (HAIs), antimicrobial use and resistance, blood 
transfusion safety events, and the extent to which healthcare 
facilities adhere to infection prevention practices and antimicrobial 
stewardship.

DATES: CDC must receive written comments on or before August 14, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0065 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office,

[[Page 36208]]

Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    National Healthcare Safety Network (NHSN) (OMB Control No. 0920-
0666)--Revision--National Center for Emerging and Zoonotic Infection 
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Division of Healthcare Quality Promotion (DHQP), National 
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers 
for Disease Control and Prevention (CDC) collects data from healthcare 
facilities in the National Healthcare Safety Network (NHSN) under OMB 
Control Number 0920-0666. NHSN provides facilities, states, regions, 
and the nation with data necessary to identify problem areas, measure 
the progress of prevention efforts, and ultimately eliminate 
healthcare-associated infections (HAIs) nationwide. NHSN allows 
healthcare facilities to track blood safety errors and various 
healthcare-associated infection prevention practice methods such as 
healthcare personnel influenza vaccine status and corresponding 
infection control adherence rates.
    NHSN currently has six components: Patient Safety (PS), Healthcare 
Personnel Safety (HPS), Biovigilance (BV), Long-Term Care Facility 
(LTCF), Outpatient Procedure (OPC), and the Dialysis Component. NHSN's 
planned Neonatal Component is expected to launch during the winter of 
2020/2021. This component will focus on premature neonates and the 
healthcare-associated events that occur as a result of their 
prematurity. This component will be released with one module, which 
includes Late Onset-Sepsis and Meningitis. Late-onset sepsis (LOS) and 
Meningitis are common complications of extreme prematurity. These 
infections are usually serious, causing a prolongation of hospital 
stay, increased cost, and risk of morbidity and mortality. The data for 
this module will be electronically submitted, and manual data entry 
will not be available. This will allow more hospital personnel to be 
available to care for patients and will reduce annual burden across 
healthcare facilities. Additionally, LOS data will be utilized for 
prevention initiatives.
    Data reported under the Patient Safety Component are used to 
determine the magnitude of the healthcare-associated adverse events and 
trends in the rates of the events, in the distribution of pathogens, 
and in the adherence to prevention practices. Data will help detect 
changes in the epidemiology of adverse events resulting from new 
medical therapies and changing patient risks. Additionally, reported 
data is being used to describe the epidemiology of antimicrobial use 
and resistance and to better understand the relationship of 
antimicrobial therapy to this rising problem.
    Approved as a New Emergency ICR (National Healthcare Safety Network 
(NHSN) Patient Impact Module for Coronavirus (COVID-19) Surveillance in 
Healthcare Facilities, OMB Control No. 0920-1290), NHSN launched a 
COVID-19 Module in the Patient Safety Component on March 27th, 2020. 
This Module is designed to collect facility-level COVID-19 data on 
cases, deaths, capacity, healthcare worker staffing shortages, and 
personal protective equipment and supplies from hospitals on a daily 
basis. Facility-level data collected through NSHN as part of the COVID-
19 Module are being made available to a broader set of Federal, state, 
and local agency data users than data typically collected by NHSN. 
Specifically, COVID-19 data at the state, county, territory, and 
facility level submitted to NHSN will continue to be used for public 
health emergency response activities by CDC's emergency COVID-19 
response, by the U.S. Department of Health and Human Services' (HHS') 
COVID-19 tracking system maintained in the Office of the Assistant 
Secretary of Preparedness and Response as part of the National Response 
Coordination Center at the Federal Emergency Management Agency (FEMA), 
and by the White House Coronavirus Task Force.
    Under the Healthcare Personnel Safety Component, protocols and data 
on events--both positive and adverse--are used to determine (1) the 
magnitude of adverse events in healthcare personnel, and (2) compliance 
with immunization and sharps injuries safety guidelines. Under the 
Biovigilance Component, data on adverse reactions and incidents 
associated with blood transfusions are reported and analyzed to provide 
national estimates of adverse reactions and incidents. Under the Long-
Term Care Facility Component, data is captured from skilled nursing 
facilities. Reporting methods under the LTCF component have been 
created by using forms from the PS Component as a model with 
modifications to specifically address the specific characteristics of 
LTCF residents and the unique data needs of these facilities reporting 
into NHSN. A new form has been introduced for field testing- 
Respiratory Tract Infection (RTI)--not to be used by NHSN users, but as 
part of an EIP project with 4 EIP sites. Form title will be 
Denominators for Healthcare Associated Infections (HAIs): Respiratory 
Tract Infections. The purpose of this form is to allow testing prior to 
introducing a new module and forms to NHSN users. The CDC's 
Epidemiology Research & Innovations Branch (ERIB) team will use the 
form to perform field testing of variables to explore the utilization, 
applicability, and data collection burden associated with these 
variables. This process will inform areas of improvement prior to 
incorporating the new module, including protocol, forms, and 
instructions into NHSN. The estimated burden for this form is 20 
minutes, which is based on a similar denominator form. Also approved 
under New Emergency ICR 0920-1290, NHSN

[[Page 36209]]

launched a COVID-19 Module in the Long-Term Care Component April 27th, 
2020. As with the COVID-19 Module in the PS Component, the LTC COVID-19 
Module is designed to collect facility-level COVID-19 data on cases, 
deaths, capacity, healthcare worker staffing shortages, and personal 
protective equipment and supplies from long-term care facilities on at 
least a weekly basis. Facility-level data collected through NSHN as 
part of the COVID-19 Module are being made available to a broader set 
of Federal, state, and local agency data users than data typically 
collected by NHSN. Specifically, COVID-19 data at the state, county, 
territory, and facility level submitted to NHSN will continue to be 
used for public health emergency response activities by CDC's emergency 
COVID-19 response, by the U.S. Department of Health and Human Services' 
(HHS') COVID-19 tracking system maintained in the Office of the 
Assistant Secretary of Preparedness and Response as part of the 
National Response Coordination Center at the Federal Emergency 
Management Agency (FEMA), and by the White House Coronavirus Task 
Force.
    The Dialysis Component offers a simplified user interface for 
dialysis users to streamline their data entry and analyses processes as 
well as provide options for expanding in the future to include dialysis 
surveillance in settings other than outpatient facilities. The 
Outpatient Procedure Component (OPC) gathers data on the impact of 
infections and outcomes related to operative procedures performed in 
Ambulatory Surgery Centers (ASCs). The OPC is used to monitor two event 
types: Same Day Outcome Measures and Surgical Site Infections (SSIs). 
NHSN has increasingly served as the operating system for HAI reporting 
compliance through legislation established by the states. As of April 
2020, 36 states, the District of Columbia and the City of Philadelphia, 
Pennsylvania have opted to use NHSN as their primary system for 
mandated reporting. Reporting compliance is completed by healthcare 
facilities in their respective jurisdictions, with emphasis on those 
states and municipalities acquiring varying consequences for failure to 
use NHSN. Additionally, healthcare facilities in five U.S. territories 
(Puerto Rico, American Samoa, the U.S. Virgin Islands, Guam, and the 
Northern Mariana Islands) are voluntarily reporting to NHSN. Additional 
territories are projected to follow with similar use of NHSN for 
reporting purposes.
    NHSN's data is used to aid in the tracking of HAIs and guide 
infection prevention activities/practices that protect patients. The 
Centers for Medicare and Medicaid Services (CMS) and other payers use 
these data to determine incentives for performance at healthcare 
facilities across the US and surrounding territories, and members of 
the public may use some protected data to inform their selection among 
available providers. Each of these parties is dependent on the 
completeness and accuracy of the data. CDC and CMS work closely and are 
fully committed to ensuring complete and accurate reporting, which are 
critical for protecting patients and guiding national, state, and local 
prevention priorities.
    CMS collects some HAI data and healthcare personnel influenza 
vaccination summary data, which is done on a voluntary basis as part of 
its Fee-for-Service Medicare quality reporting programs, while others 
may report data required by a federal mandate. Facilities that fail to 
report quality measure data are subject to partial payment reduction in 
the applicable Medicare Fee-for-Service payment system. CMS links their 
quality reporting to payment for Medicare-eligible acute care 
hospitals, inpatient rehabilitation facilities, long-term acute care 
facilities, oncology hospitals, inpatient psychiatric facilities, 
dialysis facilities, and ambulatory surgery centers. Facilities report 
HAI data and healthcare personnel influenza vaccination summary data to 
CMS via NHSN as part of CMS's quality reporting programs to receive 
full payment. Still, many healthcare facilities, even in states without 
HAI reporting legislation, submit limited HAI data to NHSN voluntarily. 
NHSN's data collection updates continue to support the incentive 
programs managed by CMS. For example, survey questions support 
requirements for CMS' quality reporting programs. Additionally, CDC has 
collaborated with CMS on a voluntary National Nursing Home Quality 
Collaborative, which focuses on recruiting nursing homes to report HAI 
data to NHSN and to retain their continued participation. This project 
has resulted in a significant increase in long-term care facilities 
reporting to NHSN.
    The ICR previously approved in December of 2019 for 5,352,360 
responses; 3,113,631 burden hours. The proposed changes in this new ICR 
include revisions to eight data collection forms and the addition of 
ten new forms for a total of 86 proposed data collection forms. In this 
Revision, CDC requests OMB approval for an estimated 2,365,743 annual 
burden hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                 Form No. & name                     Number of     responses per   per response    Total burden
                                                    respondents     respondent      (min./hour)       (hours)
----------------------------------------------------------------------------------------------------------------
57.100 NHSN Registration Form...................           2,000               1            5/60             167
57.101 Facility Contact Information.............           2,000               1           10/60             333
57.103 Patient Safety Component--Annual Hospital           6,765               1           55/60           6,201
 Survey.........................................
57.105 Group Contact Information................           1,000               1            5/60              83
57.106 Patient Safety Monthly Reporting Plan....           7,821              12           15/60          23,463
57.108 Primary Bloodstream Infection (BSI)......           5,775               5           38/60          18,288
57.111 Pneumonia (PNEU).........................           1,800               2           30/60          18,288
57.112 Ventilator-Associated Event..............           5,463               8           28/60          20,395
57.113 Pediatric Ventilator-Associated Event                 334               1           30/60             167
 (PedVAE).......................................
57.114 Urinary Tract Infection (UTI)............           6,000               5           20/60          10,000
57.115 Custom Event.............................             600              91           35/60          31,850
57.116 Denominators for Neonatal Intensive Care            1,100              12            4/60             880
 Unit (NICU)....................................
57.117 Denominators for Specialty Care Area                  500              12            5/60             503
 (SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit                5,500              60            5/60          27,665
 (ICU)/Other locations (not NICU or SCA)........
57.120 Surgical Site Infection (SSI)............           6,000               9           35/60          31,500

[[Page 36210]]

 
57.121 Denominator for Procedure................           6,000             602           10/60         602,000
57.122 HAI Progress Report State Health                       55               1           28/60              26
 Department Survey..............................
57.123 Antimicrobial Use and Resistance (AUR)-             2,500              12            5/60           1,500
 Microbiology Data Electronic Upload
 Specification Tables...........................
57.124 Antimicrobial Use and Resistance (AUR)-             2,000              12            5/60           2,000
 Pharmacy Data Electronic Upload Specification
 Tables.........................................
57.125 Central Line Insertion Practices                      500             213           25/60          44,375
 Adherence Monitoring...........................
57.126 MDRO or CDI Infection Form...............             720              12           30/60           3,960
57.127 MDRO and CDI Prevention Process and                 5,500              29           15/60          39,875
 Outcome Measures Monthly Monitoring............
57.128 Laboratory-identified MDRO or CDI Event..           4,800              79           20/60         126,400
57.129 Adult Sepsis.............................              50             250           25/60           5,208
57.130 COVID-19 Module: Patient Impact and                 3,117             540           25/60         701,325
 Hospital Capacity..............................
57.131 COVID-19 Module: Healthcare Worker                  3,117             540           25/60         701,325
 Staffing.......................................
57.132 COVID-19 Module: Supplies................           3,117             540           25/60         701,325
57.135 Late Onset Sepsis/Meningitis Denominator              300              12            5/60             300
 Form: Data Table for monthly electronic upload.
57.136 Late Onset Sepsis/Meningitis Event Form:              300               4            5/60             100
 Data Table for Monthly Electronic Upload.......
57.137 Long-Term Care Facility Component--Annual           3,079               1            1/60              51
 Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event             1,998              24           12/60           9,590
 for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures            1,998              12           12/60           4,795
 Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF...             339              12           12/60             814
57.141 Monthly Reporting Plan for LTCF..........           2,011              12           12/60           4,826
57.142 Denominators for LTCF Locations..........             339              12          250/60             814
57.143 Prevention Process Measures Monthly                   130              12           12/60             312
 Monitoring for LTCF............................
57.144 LTCF COVID-19 Module: Resident Impact and          14,674              26           20/60         127,175
 Facility Capacity..............................
57.145 LTCF COVID-19 Module: Staff and Personnel          14,674              26           15/60          95,381
 Impact.........................................
57.146 LTCF COVID-19 Module: Supplies and PPE...          14,674              26            5/60          31,794
57.147 LTCF COVID-19 Module: Ventilator Capacity          14,674              26            5/60          31,794
 and Supplies...................................
57.150 LTAC Annual Survey.......................             620               1           10/60              10
57.151 Rehab Annual Survey......................           1,340               1           10/60             625
57.200 Healthcare Personnel Safety Component                  50               1          480/60             400
 Annual Facility Survey.........................
57.203 Healthcare Personnel Safety Monthly        ..............               1            5/60  ..............
 Reporting Plan.................................
57.204 Healthcare Worker Demographic Data.......              50             200           20/60           3,333
57.205 Exposure to Blood/Body Fluids............              50              50           60/60           2,500
57.206 Healthcare Worker Prophylaxis/Treatment..              50              30           15/60             375
57.207 Follow-Up Laboratory Testing.............              50              50           15/60             625
57.210 Healthcare Worker Prophylaxis/Treatment-               50              50           10/60             417
 Influenza......................................
57.300 Hemovigilance Module Annual Survey.......             500               1           85/60             708
57.301 Hemovigilance Module Monthly Reporting                500              12            1/60             100
 Plan...........................................
57.303 Hemovigilance Module Monthly Reporting                500              12           70/60           7,000
 Denominators...................................
57.305 Hemovigilance Incident...................             500              10           10/60             833
57.306 Hemovigilance Module Annual Survey--Non-              500               1           35/60             292
 acute care facility............................
57.307 Hemovigilance Adverse Reaction--Acute                 500               4           20/60             667
 Hemolytic Transfusion Reaction.................
57.308 Hemovigilance Adverse Reaction--Allergic              500               4           20/60             667
 Transfusion Reaction...........................
57.309 Hemovigilance Adverse Reaction--Delayed               500               1           20/60             167
 Hemolytic Transfusion Reaction.................
57.310 Hemovigilance Adverse Reaction--Delayed               500               2           20/60             333
 Serologic Transfusion Reaction.................
57.311 Hemovigilance Adverse Reaction--Febrile               500               4           20/60             667
 Non-hemolytic Transfusion Reaction.............
57.312 Hemovigilance Adverse Reaction--                      500               1           20/60             167
 Hypotensive Transfusion Reaction...............
57.313 Hemovigilance Adverse Reaction--Infection             500               1           20/60             167
57.314 Hemovigilance Adverse Reaction--Post                  500               1           20/60             167
 Transfusion Purpura............................
57.315 Hemovigilance Adverse Reaction--                      500               1           20/60             167
 Transfusion Associated Dyspnea.................
57.316 Hemovigilance Adverse Reaction--                      500               1           20/60             167
 Transfusion Associated Graft vs. Host Disease..
57.317 Hemovigilance Adverse Reaction--                      500               1           20/60             167
 Transfusion Related Acute Lung Injury..........
57.318 Hemovigilance Adverse Reaction--                      500               2           20/60             333
 Transfusion Associated Circulatory Overload....
57.319 Hemovigilance Adverse Reaction--Unknown               500               1           20/60             167
 Transfusion Reaction...........................
57.320 Hemovigilance Adverse Reaction--Other                 500               1           20/60             167
 Transfusion Reaction...........................
57.400 Outpatient Procedure Component--Annual                700               1           10/60             117
 Facility Survey................................
57.401 Outpatient Procedure Component--Monthly               700              12           15/60           2,100
 Reporting Plan.................................

[[Page 36211]]

 
57.402 Outpatient Procedure Component Same Day               200               1           40/60             133
 Outcome Measures...............................
57.403 Outpatient Procedure Component--Monthly               200             400           40/60          53,333
 Denominators for Same Day Outcome Measures.....
57.404 Outpatient Procedure Component--SSI                   700             100           40/60          46,667
 Denominator....................................
57.405 Outpatient Procedure Component--Surgical              700               5           40/60           2,333
 Site (SSI) Event...............................
57.500 Outpatient Dialysis Center Practices                7,200               1          127/60          15,240
 Survey.........................................
57.501 Dialysis Monthly Reporting Plan..........           7,200              12            5/60           7,200
57.502 Dialysis Event...........................           7,200              30           25/60          90,000
57.503 Denominator for Outpatient Dialysis......           7,200              30           10/60          14,400
57.504 Prevention Process Measures Monthly                 1,730              12           75/60          25,950
 Monitoring for Dialysis........................
57.505 Dialysis Patient Influenza Vaccination...             615              50           10/60           5,125
57.506 Dialysis Patient Influenza Vaccination                615               5           10/60             513
 Denominator....................................
57.507 Home Dialysis Center Practices Survey....             430               1           30/60             215
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............       2,365,743
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-12809 Filed 6-12-20; 8:45 am]
 BILLING CODE 4163-18-P


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