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Notice

Proposed Data Collection Submitted for Public Comment and Recommendations

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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 July 31, 2017.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2017-0047 by any of the following methods:

  • Federal eRulemaking Portal: Regulations.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.

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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 Leroy Richardson, 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.

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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) (OMB Control Number 0920-0666, Expires—Revision—National Center for Emerging and Zoonotic Infection Diseases (NCEZID), Centers for Disease Control and Prevention (CDC)

Background and Brief Description

The Centers for Disease Control and Prevention (CDC) is requesting a three-year approval of the National Healthcare Safety Network information collection project.

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 collected will be used to inform and 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 2018. The development of this component has been previously delayed to obtain additional user feedback and support from outside partners.

Changes were made to four facility surveys. 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. Also, 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, two new forms were added to expand NHSN surveillance to enhance data collection by Ambulatory Surgical Centers to identify areas where prevention of SSIs may be improved. An additional 14 forms were modified within the Hemovigilance module to streamline data collection/entry for adverse reaction events.Start Printed Page 24712

Overall, minor revisions have been made to a total of 38 forms within the package to clarify and/or update surveillance definitions, increase or decrease the number of reporting facilities, and adding new forms. The previously approved NHSN package included 70 individual collection forms; the current revision request includes a total of 72 forms. The reporting burden will decrease by 811,985 hours, for a total of 5,922,953 hours.

This collection of information is authorized by the Public Health Service Act (42 U.S.C. 242b, 242k, and 242m (d)). There is no cost to respondents other than the time to participate.

Estimated Annualized Burden Hours

Type of respondentForm No. & nameNumber of respondentsNumber of responses per respondentAverage burden per response (hours)Total burden (hours)
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 Survey5,000155/604,583
Registered Nurse (Infection Preventionist)57.105 Group Contact Information1,00015/6083
Registered Nurse (Infection Preventionist)57.106 Patient Safety Monthly Reporting Plan6,0001215/6018,000
Registered Nurse (Infection Preventionist)57.108 Primary Bloodstream Infection (BSI)6,0004430/60132,000
Registered Nurse (Infection Preventionist)57.111 Pneumonia (PNEU)6,0007230/60216,000
Registered Nurse (Infection Preventionist)57.112 Ventilator—Associated Event6,00014425/60360,000
Registered Nurse (Infection Preventionist)57.113 Pediatric Ventilator—Associated Event (PedVAE)2,00012025/60100,000
Registered Nurse (Infection Preventionist)57.114 Urinary Tract Infection (UTI)6,0004020/6080,000
Registered Nurse (Infection Preventionist)57.115 Custom Event2,0009135/60106,167
Staff RN57.116 Denominators for Neonatal Intensive Care Unit (NICU)6,000124288,000
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)6,0006051,800,000
Registered Nurse (Infection Preventionist)57.120 Surgical Site Infection (SSI)6,0003635/60126,000
Staff RN57.121 Denominator for Procedure6,00054010/60540,000
Laboratory Technician57.123 Antimicrobial Use and Resistance (AUR)—Microbiology Data Electronic Upload Specification Tables6,000125/606,000
Pharmacist57.124 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 Monitoring10010025/604,167
Registered Nurse (Infection Preventionist)57.126 MDRO or CDI Infection Form6,0007230/60216,000
Registered Nurse (Infection Preventionist)57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring6,0002415/6036,000
Registered Nurse (Infection Preventionist)57.128 Laboratory-identified MDRO or CDI Event6,00024020/60480,000
Registered Nurse (Infection Preventionist)57.129 Adult Sepsis5025025/605,208
Registered Nurse (Infection Preventionist)57.137 Long-Term Care Facility Component—Annual Facility Survey2,600125,200
Registered Nurse (Infection Preventionist)57.138 Laboratory-identified MDRO or CDI Event for LTCF2,6001215/607,800
Registered Nurse (Infection Preventionist)57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF2,6001210/605,200
Registered Nurse (Infection Preventionist)57.140 Urinary Tract Infection (UTI) for LTCF2,6001430/6018,200
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Registered Nurse (Infection Preventionist)57.141 Monthly Reporting Plan for LTCF2,600125/602,600
Registered Nurse (Infection Preventionist)57.142 Denominators for LTCF Locations2,600124124,800
Registered Nurse (Infection Preventionist)57.143 Prevention Process Measures Monthly Monitoring for LTCF2,600125/60600
Registered Nurse (Infection Preventionist)57.150 LTAC Annual Survey400155/60367
Registered Nurse (Infection Preventionist)57.151 Rehab Annual Survey1,000155/60917
Occupational Health RN/Specialist57.200 Healthcare Personnel Safety Component Annual Facility Survey5018400
Occupational Health RN/Specialist57.203 Healthcare Personnel Safety Monthly Reporting Plan17,00015/601,417
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 Denominators500121.177,020
Medical/Clinical Laboratory Technologist57.305 Hemovigilance Incident5001010/60833
Medical/Clinical Laboratory Technologist57.306 Hemovigilance Module Annual Survey—Non-acute care facility200135/60117
Medical/Clinical Laboratory Technologist57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction500420/60667
Medical/Clinical Laboratory Technologist57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction500420/60667
Medical/Clinical Laboratory Technologist57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction500120/60167
Medical/Clinical Laboratory Technologist57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction500220/60333
Medical/Clinical Laboratory Technologist57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction500420/60667
Medical/Clinical Laboratory Technologist57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction500120/60167
Medical/Clinical Laboratory Technologist57.313 Hemovigilance Adverse Reaction—Infection500120/60167
Medical/Clinical Laboratory Technologist57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura500120/60167
Medical/Clinical Laboratory Technologist57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea500120/60167
Medical/Clinical Laboratory Technologist57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease500120/60167
Medical/Clinical Laboratory Technologist57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury500120/60167
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Medical/Clinical Laboratory Technologist57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload500220/60333
Medical/Clinical Laboratory Technologist57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction500120/60167
Medical/Clinical Laboratory Technologist57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction500120/60167
Medical/Clinical Laboratory Technologist57.400 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 Same Day Outcome Measures & Prophylactic Intravenous(IV) Antibiotic Timing Event5,0002540/6083,333
Staff RN57.403—Outpatient Procedure Component—Monthly Denominators for Same Day Outcome Measures & Prophylactic Intravenous(IV) Antibiotic Timing Event5,0001240/6040,000
Staff RN57.404 Outpatient Procedure Component—Annual Facility Survey5,00054010/60450,00
Registered Nurse (Infection Preventionist)57.405 Outpatient Procedure Component—Surgical Site (SSI) Event5,0003635/60105,00
Staff RN57.500 Outpatient Dialysis Center Practices Survey7,00012.014,000
Registered Nurse (Infection Preventionist)57.501 Dialysis Monthly Reporting Plan7,000125/607,000
Staff RN57.502 Dialysis Event7,0006025/60175,000
Staff RN57.503 Denominator for Outpatient Dialysis7,0001210/6014,000
Staff RN57.504 Prevention Process Measures Monthly Monitoring for Dialysis2,000121.2530,000
Staff RN57.505 Dialysis Patient Influenza Vaccination3257510/604,063
Staff RN57.506 Dialysis Patient Influenza Vaccination Denominator325510/60271
Staff RN57.507 Home Dialysis Center Practices Survey350130/60175
Total5922,953
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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.

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[FR Doc. 2017-11020 Filed 5-26-17; 8:45 am]

BILLING CODE 4163-18-P