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Proposed Data Collections Submitted for Public Comment and Recommendations

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In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-7570 or send comments to Kimberly S. Lane, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to

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; and (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. Written comments should be received within 60 days of this notice.

Proposed Project

National Healthcare Safety Network (NHSN) (OMB No. 0920-0666), exp. 12/31/2015—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 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 consists of six components: Patient Safety, Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility (LTCF), Dialysis, and Outpatient Procedure.

The new Dialysis Component was developed in order to separate reporting of dialysis events from the Patient Safety Component. The new component will tailor the NHSN user interface for dialysis users to simplify their data entry and analyses processes as well as provide options for expanding the Dialysis Component in the future to include dialysis surveillance in settings other than outpatient facilities.

The new Outpatient Procedure Component was developed to gather data on the impact of infections and other outcomes related to outpatient procedures that are performed in settings such as Ambulatory Surgery Centers (ASCs), Hospital Outpatient Departments (HOPDs), and physicians' offices. Three event types will be monitored in this new component: Same Day Outcome Measures, Prophylactic Intravenous (IV) Antibiotic Timing, and Surgical Site Infections (SSI).

This revision submission includes two new NHSN components and their corresponding forms. The Dialysis Component consists of changes to three previously approved forms and the addition of four new forms. These new forms include component specific monthly reporting plan, prevention process measures monthly monitoring, patient influenza vaccination, and patient influenza vaccination denominator forms. The Outpatient Procedure Component consists of four new forms: component specific annual survey, monthly reporting plan, event, and monthly denominators and summary forms.

Further, the breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Significant changes were made to the NHSN Biovigilance Component forms as a result of a subject matter expert and stakeholder working groups. This includes the removal of the monthly incident summary form. A brand new form was added (Form 57.600—State Health Department Validation Record) to collect aggregate validation results that will be gathered by state health departments when conducting facility-level validation of NHSN healthcare-associated infection (HAI) data within their jurisdictions using the CDC/NHSN Validation Guidance and Toolkits.

Additionally, minor revisions have been made to 17 other forms within the package to clarify and/or update surveillance definitions.

The previously approved NSHN package included 48 individual collection forms; the current revision request adds nine new forms and removes one form for a total of 56 forms. The reporting burden will increase by 542,123 hours, for a total of 4,104,776 hours.Start Printed Page 37225

Estimated Annualized Burden Hours

Type of respondentsForm number and nameNumber of respondentsNumber of responses per respondentAverage burden per response (in hrs.)Total burden (in hrs.)
Registered Nurse (Infection Preventionist)57.100: NHSN Registration Form2,00015/60167
Registered Nurse (Infection Preventionist)57.101: Facility Contact Information2,000110/60333
Registered Nurse (Infection Preventionist)57.103: Patient Safety Component—Annual Hospital Survey6,000130/603,000
Registered Nurse (Infection Preventionist)57.105: Group Contact Information6,00015/60500
Registered Nurse (Infection Preventionist)57.106: Patient Safety Monthly Reporting Plan6,0001235/6042,000
Registered Nurse (Infection Preventionist)57.108: Primary Bloodstream Infection (BSI)6,0003632/60115,200
Registered Nurse (Infection Preventionist)57.111: Pneumonia (PNEU)6,0007229/60208,800
Registered Nurse (Infection Preventionist)57.112: Ventilator-Associated Event6,00014422/60316,800
Infection Preventionist57.114: Urinary Tract Infection (UTI)6,0002729/6078,300
Staff RN57.116: Denominators for Neonatal Intensive Care Unit (NICU)6,00093162,000
Staff RN57.117: Denominators for Specialty Care Area (SCA)/Oncology (ONC)6,00095270,000
Staff RN57.118: Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)6,0005451,620,000
Registered Nurse (Infection Preventionist)57.120: Surgical Site Infection (SSI)6,0003629/60104,400
Staff RN57.121: Denominator for Procedure6,0005405/60270,000
Laboratory Technician57.123: Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables6,000125/606,000
Pharmacy Technician57.124: Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables6,000125/606,000
Registered Nurse (Infection Preventionist)57.125: Central Line Insertion Practices Adherence Monitoring1,0001005/608,333
Registered Nurse (Infection Preventionist)57.126: MDRO or CDI Infection Form6,0007229/60208,800
Registered Nurse (Infection Preventionist)57.127: MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring6,0002412/6028,800
Registered Nurse (Infection Preventionist)57.128: Laboratory-identified MDRO or CDI Event6,00024015/60360,000
Registered Nurse (Infection Preventionist)57.130: Vaccination Monthly Monitoring Form-Summary Method1005147,000
Registered Nurse (Infection Preventionist)57.131: Vaccination Monthly Monitoring Form-Patient-Level Method100521,000
Registered Nurse (Infection Preventionist)57.133: Patient Vaccination10025010/604,167
Registered Nurse (Infection Preventionist)57.137: Long-Term Care Facility Component—Annual Facility Survey250145/60188
Registered Nurse (Infection Preventionist)57.138: Laboratory-identified MDRO or CDI Event for LTCF250815/60500
Registered Nurse (Infection Preventionist)57.139: MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF250125/60250
Registered Nurse (Infection Preventionist)57.140: Urinary Tract Infection (UTI) for LTCF250927/601,013
Registered Nurse (Infection Preventionist)57.141: Monthly Reporting Plan for LTCF250125/60250
Registered Nurse (Infection Preventionist)57.142: Denominators for LTCF Locations2501239,000
Registered Nurse (Infection Preventionist)57.143: Prevention Process Measures Monthly Monitoring for LTCF250125/60250
Registered Nurse (Infection Preventionist)57.150: LTAC Annual Survey400130/60200
Registered Nurse (Infection Preventionist)57.151: Rehab Annual Survey1,000125/60417
Occupational Health RN/Specialist57.200: Healthcare Personnel Safety Component Annual Facility Survey5018400
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Occupational Health RN/Specialist57.203: Healthcare Personnel Safety Monthly Reporting Plan50910/6075
Occupational Health RN/Specialist57.204: Healthcare Worker Demographic Data5020020/603,333
Occupational Health RN/Specialist57.205: Exposure to Blood/Body Fluids505012,500
Occupational Health RN/Specialist57.206: Healthcare Worker Prophylaxis/Treatment503015/60375
Laboratory Technician57.207: Follow-Up Laboratory Testing505015/60625
Occupational Health RN/Specialist57.210: Healthcare Worker Prophylaxis/Treatment-Influenza505010/60417
Medical/Clinical Laboratory Technologist57.300: Hemovigilance Module Annual Survey500121,000
Medical/Clinical Laboratory Technologist57.301: Hemovigilance Module Monthly Reporting Plan500121/60100
Medical/Clinical Laboratory Technologist57.303: Hemovigilance Module Monthly Reporting Denominators5001216,000
Medical/Clinical Laboratory Technologist57.304: Hemovigilance Adverse Reaction5004815/606,000
Medical/Clinical Laboratory Technologist57.305: Hemovigilance Incident5001210/601,000
Staff RN57.400: Outpatient Procedure Component—Annual Facility Survey5,00015/60417
Staff RN57.401: Outpatient Procedure Component—Monthly Reporting Plan5,0001215/6015,000
Staff RN57.402: Outpatient Procedure Component Event5,0002540/6083,333
Staff RN57.403: Outpatient Procedure Component—Monthly Denominators and Summary5,0001240/6040,000
Registered Nurse (Infection Preventionist)57.500: Outpatient Dialysis Center Practices Survey6,00011.7510,500
Staff RN57.501: Dialysis Monthly Reporting Plan6,000125/606,000
Staff RN57.502: Dialysis Event6,0006013/6078,000
Staff RN57.503: Denominator for Outpatient Dialysis6,000126/607,200
Staff RN57.504: Prevention Process Measures Monthly Monitoring for Dialysis6001230/603,600
Staff RN57.505: Dialysis Patient Influenza Vaccination2507510/603,125
Staff RN57.506: Dialysis Patient Influenza Vaccination Denominator250510/60208
Epidemiologist57.600: State Health Department Validation Record1525015/601,900
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Ron A. Otten,

Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director.

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[FR Doc. 2013-14752 Filed 6-19-13; 8:45 am]