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Agency Forms Undergoing Paperwork Reduction Act Review

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The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (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 or send an email to Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: 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

National Healthcare Safety Network (NHSN) (OMB No. 0920-0666, Exp. 12/31/2018)—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 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 respondentsForm nameNumber of respondentsNumber of responses per respondentAvg. burden per response (in hrs.)
Registered Nurse (Infection Preventionist)57.100 NHSN Registration Form2,00015/60
Registered Nurse (Infection Preventionist)57.101 Facility Contact Information2,000110/60
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Registered Nurse (Infection Preventionist)57.103 Patient Safety Component—Annual Hospital Survey5,000155/60
Registered Nurse (Infection Preventionist)57.105 Group Contact Information1,00015/60
Registered Nurse (Infection Preventionist)57.106 Patient Safety Monthly Reporting Plan6,0001215/60
Registered Nurse (Infection Preventionist)57.108 Primary Bloodstream Infection (BSI)6,0004430/60
Registered Nurse (Infection Preventionist)57.111 Pneumonia (PNEU)6,0007230/60
Registered Nurse (Infection Preventionist)57.112 Ventilator-Associated Event6,00014425/60
Registered Nurse (Infection Preventionist)57.113 Pediatric Ventilator-Associated Event (PedVAE)2,00012025/60
Registered Nurse (Infection Preventionist)57.114 Urinary Tract Infection (UTI)6,0004020/60
Registered Nurse (Infection Preventionist)57.115 Custom Event2,0009135/60
Staff RN57.116 Denominators for Neonatal Intensive Care Unit (NICU)6,00093
Staff RN57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC)6,00095
Staff RN57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)6,000605
Registered Nurse (Infection Preventionist)57.120 Surgical Site Infection (SSI)6,0003635/60
Staff RN57.121 Denominator for Procedure6,00054010/60
Laboratory Technician57.123 Antimicrobial Use and Resistance (AUR)—Microbiology Data Electronic Upload Specification Tables6,000125/60
Pharmacist57.124 Antimicrobial Use and Resistance (AUR)—Pharmacy Data Electronic Upload Specification Tables6,000125/60
Registered Nurse (Infection Preventionist)57.125 Central Line Insertion Practices Adherence Monitoring1,00010025/60
Registered Nurse (Infection Preventionist)57.126 MDRO or CDI Infection Form6,0007230/60
Registered Nurse (Infection Preventionist)57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring6,0002415/60
Registered Nurse (Infection Preventionist)57.128 Laboratory-identified MDRO or CDI Event6,00024020/60
Registered Nurse (Infection Preventionist)57.129 Adult Sepsis5025025/60
Registered Nurse (Infection Preventionist)57.137 Long-Term Care Facility Component—Annual Facility Survey35011.08
Registered Nurse (Infection Preventionist)57.138 Laboratory-identified MDRO or CDI Event for LTCF3501215/60
Registered Nurse (Infection Preventionist)57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF3501210/60
Registered Nurse (Infection Preventionist)57.140 Urinary Tract Infection (UTI) for LTCF3501430/60
Registered Nurse (Infection Preventionist)57.141 Monthly Reporting Plan for LTCF350125/60
Registered Nurse (Infection Preventionist)57.142 Denominators for LTCF Locations350123.35
Registered Nurse (Infection Preventionist)57.143 Prevention Process Measures Monthly Monitoring for LTCF300125/60
Registered Nurse (Infection Preventionist)57.150 LTAC Annual Survey400155/60
Registered Nurse (Infection Preventionist)57.151 Rehab Annual Survey1,000155/60
Occupational Health RN/Specialist57.200 Healthcare Personnel Safety Component Annual Facility Survey5018
Occupational Health RN/Specialist57.203 Healthcare Personnel Safety Monthly Reporting Plan17,00015/60
Occupational Health RN/Specialist57.204 Healthcare Worker Demographic Data5020020/60
Occupational Health RN/Specialist57.205 Exposure to Blood/Body Fluids50501
Occupational Health RN/Specialist57.206 Healthcare Worker Prophylaxis/Treatment503015/60
Laboratory Technician57.207 Follow-Up Laboratory Testing505015/60
Occupational Health RN/Specialist57.210 Healthcare Worker Prophylaxis/Treatment—Influenza505010/60
Medical/Clinical Laboratory Technologist57.300 Hemovigilance Module Annual Survey50012
Medical/Clinical Laboratory Technologist57.301 Hemovigilance Module Monthly Reporting Plan500121/60
Medical/Clinical Laboratory Technologist57.303 Hemovigilance Module Monthly Reporting Denominators500121.17
Medical/Clinical Laboratory Technologist57.305 Hemovigilance Incident5001010/60
Medical/Clinical Laboratory Technologist57.306 Hemovigilance Module Annual Survey—Non-acute care facility200135/60
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Medical/Clinical Laboratory Technologist57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction500425/60
Medical/Clinical Laboratory Technologist57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction500425/60
Medical/Clinical Laboratory Technologist57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction500125/60
Medical/Clinical Laboratory Technologist57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction500225/60
Medical/Clinical Laboratory Technologist57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction500425/60
Medical/Clinical Laboratory Technologist57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction500125/60
Medical/Clinical Laboratory Technologist57.313 Hemovigilance Adverse Reaction—Infection500125/60
Medical/Clinical Laboratory Technologist57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura500125/60
Medical/Clinical Laboratory Technologist57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea500125/60
Medical/Clinical Laboratory Technologist57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease500125/60
Medical/Clinical Laboratory Technologist57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury500125/60
Medical/Clinical Laboratory Technologist57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload500225/60
Medical/Clinical Laboratory Technologist57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction500125/60
Medical/Clinical Laboratory Technologist57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction500125/60
Medical/Clinical Laboratory Technologist57.400 Patient Safety Component—Annual Facility Survey for Ambulatory Surgery Center (ASC)5,00015/60
Staff RN57.401 Outpatient Procedure Component—Monthly Reporting Plan5,0001215/60
Staff RN57.402 Outpatient Procedure Component Event5,0002540/60
Staff RN57.403 Outpatient Procedure Component—Monthly Denominators and Summary5,0001240/60
Staff RN57.500 Outpatient Dialysis Center Practices Survey6,50012.0
Registered Nurse (Infection Preventionist)57.501 Dialysis Monthly Reporting Plan6,500125/60
Staff RN57.502 Dialysis Event6,5006025/60
Staff RN57.503 Denominator for Outpatient Dialysis6,5001210/60
Staff RN57.504 Prevention Process Measures Monthly Monitoring for Dialysis1,500121.25
Staff RN57.505 Dialysis Patient Influenza Vaccination3257510/60
Staff RN57.506 Dialysis Patient Influenza Vaccination Denominator325510/60
Staff RN57.507 Home Dialysis Center Practices Survey600125/60
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Jeffrey M. Zirger,

Health Scientist, Acting 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.

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[FR Doc. 2016-18710 Filed 8-5-16; 8:45 am]