# Proposed Data Collection Submitted for Public Comment and Recommendations > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2016-12701 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** May 31, 2016 - **Citation:** 81 FR 34337 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-0666; Docket No. CDC-2016-0046] 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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Healthcare Safety Network (NHSN). 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 promote healthcare safety. DATES: Written comments must be received on or before August 1, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-0046 by any of the following methods: • Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments. • Mail: Leroy A. Richardson, 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. All relevant comments received will be posted without change to Regulations.gov , including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov . Please note: All public comment should be submitted 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 the Information Collection Review Office, 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 OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Proposed Project National Healthcare Safety Network (NHSN)—Revision—National Center for Emerging and Zoonotic Infection 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 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. The data will be used to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks. The NHSN currently consists of five components: Patient Safety, Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility (LTCF), and Dialysis. The Outpatient Procedure Component is on track to be released in NHSN in 2017/2018. The development of this component has been previously delayed to obtain additional user feedback and support from outside partners. Changes were made to six facility surveys and two new facility surveys were added. Based on user feedback and internal reviews of the annual facility surveys it was determined that questions and response options be amended, removed, or added to fit the evolving uses of the annual facility surveys. The surveys are being increasingly used to help intelligently interpret the other data elements reported into NHSN. Currently the surveys are used to appropriately risk adjust the numerator and denominator data entered into NHSN while also guiding decisions on future division priorities for prevention. Further, three new forms were added to expand NHSN surveillance to pediatric ventilator-associated events, adult sepsis, and custom HAI event surveillance. An additional 14 forms were added to the Hemovigilance Component to streamline data collection/entry for adverse reaction events. Additionally, minor revisions have been made to 22 forms within the package to clarify and/or update surveillance definitions. The previously approved NHSN package included 52 individual collection forms; the current revision request adds nineteen forms and removes one form for a total of 70 forms. The reporting burden will increase by 489,174 hours, for a total of 5,110,716 hours. Estimated Annualized Burden Hours Type of respondents Form name Number of respondents Number of responses per Respondent Avg. burden per response (in hrs.) Total burden (in hrs.) Registered Nurse (Infection Preventionist) 57.100 NHSN Registration Form 2,000 1 5/60 167 Registered Nurse (Infection Preventionist) 57.101 Facility Contact Information 2,000 1 10/60 333 Registered Nurse (Infection Preventionist) 57.103 Patient Safety Component—Annual Hospital Survey 5,000 1 55/60 4,583 Registered Nurse (Infection Preventionist) 57.105 Group Contact Information 1,000 1 5/60 83 Registered Nurse (Infection Preventionist) 57.106 Patient Safety Monthly Reporting Plan 6,000 12 15/60 18,000 Registered Nurse (Infection Preventionist) 57.108 Primary Bloodstream Infection (BSI) 6,000 44 30/60 132,000 Registered Nurse (Infection Preventionist) 57.111 Pneumonia (PNEU) 6,000 72 30/60 216,000 Registered Nurse (Infection Preventionist) 57.112 Ventilator-Associated Event 6,000 144 25/60 360,000 Registered Nurse (Infection Preventionist) 57.113 Pediatric Ventilator-Associated Event (PedVAE) 2,000 120 25/60 100,000 Registered Nurse (Infection Preventionist) 57.114 Urinary Tract Infection (UTI) 6,000 40 20/60 80,000 Registered Nurse (Infection Preventionist) 57.115 Custom Event 2,000 91 35/60 106,167 Staff RN 57.116 Denominators for Neonatal Intensive Care Unit (NICU) 6,000 9 3 162,000 Staff RN 57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC) 6,000 9 5 270,000 Staff RN 57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA) 6,000 60 5 1,800,000 Registered Nurse (Infection Preventionist) 57.120 Surgical Site Infection (SSI) 6,000 36 35/60 126,000 Staff RN 57.121 Denominator for Procedure 6,000 540 10/60 540,000 Laboratory Technician 57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables 6,000 12 5/60 6,000 Pharmacist 57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables 6,000 12 5/60 6,000 Registered Nurse (Infection Preventionist) 57.125 Central Line Insertion Practices Adherence Monitoring 1,000 100 25/60 41,667 Registered Nurse (Infection Preventionist) 57.126 MDRO or CDI Infection Form 6,000 72 30/60 216,000 Registered Nurse (Infection Preventionist) 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring 6,000 24 15/60 36,000 Registered Nurse (Infection Preventionist) 57.128 Laboratory-identified MDRO or CDI Event 6,000 240 20/60 480,000 Registered Nurse (Infection Preventionist) 57.129 Adult Sepsis 50 250 25/60 5,208 Registered Nurse (Infection Preventionist) 57.137 Long-Term Care Facility Component—Annual Facility Survey 350 1 1.08 378 Registered Nurse (Infection Preventionist) 57.138 Laboratory-identified MDRO or CDI Event for LTCF 350 12 15/60 1,050 Registered Nurse (Infection Preventionist) 57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF 350 12 10/60 700 Registered Nurse (Infection Preventionist) 57.140 Urinary Tract Infection (UTI) for LTCF 350 14 30/60 2,450 Registered Nurse (Infection Preventionist) 57.141 Monthly Reporting Plan for LTCF 350 12 5/60 350 Registered Nurse (Infection Preventionist) 57.142 Denominators for LTCF Locations 350 12 3.35 14,070 Registered Nurse (Infection Preventionist) 57.143 Prevention Process Measures Monthly Monitoring for LTCF 300 12 5/60 300 Registered Nurse (Infection Preventionist) 57.150 LTAC Annual Survey 400 1 55/60 367 Registered Nurse (Infection Preventionist) 57.151 Rehab Annual Survey 1,000 1 55/60 917 Occupational Health RN/Specialist 57.200 Healthcare Personnel Safety Component Annual Facility Survey 50 1 8 400 Occupational Health RN/Specialist 57.203 Healthcare Personnel Safety Monthly Reporting Plan 17,000 1 5/60 1,417 Occupational Health RN/Specialist 57.204 Healthcare Worker Demographic Data 50 200 20/60 3,333 Occupational Health RN/Specialist 57.205 Exposure to Blood/Body Fluids 50 50 1 2,500 Occupational Health RN/Specialist 57.206 Healthcare Worker Prophylaxis/Treatment 50 30 15/60 375 Laboratory Technician 57.207 Follow-Up Laboratory Testing 50 50 15/60 625 Occupational Health RN/Specialist 57.210 Healthcare Worker Prophylaxis/Treatment-Influenza 50 50 10/60 417 Medical/Clinical Laboratory Technologist 57.300 Hemovigilance Module Annual Survey 500 1 2 1,000 Medical/Clinical Laboratory Technologist 57.301 Hemovigilance Module Monthly Reporting Plan 500 12 1/60 100 Medical/Clinical Laboratory Technologist 57.303 Hemovigilance Module Monthly Reporting Denominators 500 12 1.17 7,020 Medical/Clinical Laboratory Technologist 57.305 Hemovigilance Incident 500 10 10/60 833 Medical/Clinical Laboratory Technologist 57.306 Hemovigilance Module Annual Survey—Non-acute care facility 200 1 35/60 117 Medical/Clinical Laboratory Technologist 57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction 500 4 25/60 833 Medical/Clinical Laboratory Technologist 57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction 500 4 25/60 833 Medical/Clinical Laboratory Technologist 57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction 500 2 25/60 417 Medical/Clinical Laboratory Technologist 57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction 500 4 25/60 833 Medical/Clinical Laboratory Technologist 57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.313 Hemovigilance Adverse Reaction—Infection 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload 500 2 25/60 417 Medical/Clinical Laboratory Technologist 57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.400 Patient Safety Component—Annual Facility Survey for Ambulatory Surgery Center (ASC) 5,000 1 5/60 417 Staff RN 57.401 Outpatient Procedure Component—Monthly Reporting Plan 5,000 12 15/60 15,000 Staff RN 57.402 Outpatient Procedure Component Event 5,000 25 40/60 83,333 Staff RN 57.403 Outpatient Procedure Component—Monthly Denominators and Summary 5,000 12 40/60 40,000 Staff RN 57.500 Outpatient Dialysis Center Practices Survey 6,500 1 2.0 13,000 Registered Nurse (Infection Preventionist) 57.501 Dialysis Monthly Reporting Plan 6,500 12 5/60 6,500 Staff RN 57.502 Dialysis Event 6,500 60 25/60 162,500 Staff RN 57.503 Denominator for Outpatient Dialysis 6,500 12 10/60 13,000 Staff RN 57.504 Prevention Process Measures Monthly Monitoring for Dialysis 1,500 12 1.25 22,500 Staff RN 57.505 Dialysis Patient Influenza Vaccination 325 75 10/60 4,063 Staff RN 57.506 Dialysis Patient Influenza Vaccination Denominator 325 5 10/60 271 Staff RN 57.507 Home Dialysis Center Practices Survey 600 1 25/60 250 Total 5,110,716 Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2016-12701 Filed 5-27-16; 8:45 am] BILLING CODE 4163-18-P --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2016-12701. Public record. Not legal advice.