[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52434-52436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0666]


Agency Forms Undergoing Paperwork Reduction Act Review

    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 [email protected]. 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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of      Avg. burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Registered Nurse (Infection          57.100 NHSN Registration              2,000               1            5/60
 Preventionist).                      Form.
Registered Nurse (Infection          57.101 Facility Contact               2,000               1           10/60
 Preventionist).                      Information.

[[Page 52435]]

 
Registered Nurse (Infection          57.103 Patient Safety                 5,000               1           55/60
 Preventionist).                      Component--Annual Hospital
                                      Survey.
Registered Nurse (Infection          57.105 Group Contact                  1,000               1            5/60
 Preventionist).                      Information.
Registered Nurse (Infection          57.106 Patient Safety                 6,000              12           15/60
 Preventionist).                      Monthly Reporting Plan.
Registered Nurse (Infection          57.108 Primary Bloodstream            6,000              44           30/60
 Preventionist).                      Infection (BSI).
Registered Nurse (Infection          57.111 Pneumonia (PNEU)....           6,000              72           30/60
 Preventionist).
Registered Nurse (Infection          57.112 Ventilator-                    6,000             144           25/60
 Preventionist).                      Associated Event.
Registered Nurse (Infection          57.113 Pediatric Ventilator-          2,000             120           25/60
 Preventionist).                      Associated Event (PedVAE).
Registered Nurse (Infection          57.114 Urinary Tract                  6,000              40           20/60
 Preventionist).                      Infection (UTI).
Registered Nurse (Infection          57.115 Custom Event........           2,000              91           35/60
 Preventionist).
Staff RN...........................  57.116 Denominators for               6,000               9               3
                                      Neonatal Intensive Care
                                      Unit (NICU).
Staff RN...........................  57.117 Denominators for               6,000               9               5
                                      Specialty Care Area (SCA)/
                                      Oncology (ONC).
Staff RN...........................  57.118 Denominators for               6,000              60               5
                                      Intensive Care Unit (ICU)/
                                      Other locations (not NICU
                                      or SCA).
Registered Nurse (Infection          57.120 Surgical Site                  6,000              36           35/60
 Preventionist).                      Infection (SSI).
Staff RN...........................  57.121 Denominator for                6,000             540           10/60
                                      Procedure.
Laboratory Technician..............  57.123 Antimicrobial Use              6,000              12            5/60
                                      and Resistance (AUR)--
                                      Microbiology Data
                                      Electronic Upload
                                      Specification Tables.
Pharmacist.........................  57.124 Antimicrobial Use              6,000              12            5/60
                                      and Resistance (AUR)--
                                      Pharmacy Data Electronic
                                      Upload Specification
                                      Tables.
Registered Nurse (Infection          57.125 Central Line                   1,000             100           25/60
 Preventionist).                      Insertion Practices
                                      Adherence Monitoring.
Registered Nurse (Infection          57.126 MDRO or CDI                    6,000              72           30/60
 Preventionist).                      Infection Form.
Registered Nurse (Infection          57.127 MDRO and CDI                   6,000              24           15/60
 Preventionist).                      Prevention Process and
                                      Outcome Measures Monthly
                                      Monitoring.
Registered Nurse (Infection          57.128 Laboratory-                    6,000             240           20/60
 Preventionist).                      identified MDRO or CDI
                                      Event.
Registered Nurse (Infection          57.129 Adult Sepsis........              50             250           25/60
 Preventionist).
Registered Nurse (Infection          57.137 Long-Term Care                   350               1            1.08
 Preventionist).                      Facility Component--Annual
                                      Facility Survey.
Registered Nurse (Infection          57.138 Laboratory-                      350              12           15/60
 Preventionist).                      identified MDRO or CDI
                                      Event for LTCF.
Registered Nurse (Infection          57.139 MDRO and CDI                     350              12           10/60
 Preventionist).                      Prevention Process
                                      Measures Monthly
                                      Monitoring for LTCF.
Registered Nurse (Infection          57.140 Urinary Tract                    350              14           30/60
 Preventionist).                      Infection (UTI) for LTCF.
Registered Nurse (Infection          57.141 Monthly Reporting                350              12            5/60
 Preventionist).                      Plan for LTCF.
Registered Nurse (Infection          57.142 Denominators for                 350              12            3.35
 Preventionist).                      LTCF Locations.
Registered Nurse (Infection          57.143 Prevention Process               300              12            5/60
 Preventionist).                      Measures Monthly
                                      Monitoring for LTCF.
Registered Nurse (Infection          57.150 LTAC Annual Survey..             400               1           55/60
 Preventionist).
Registered Nurse (Infection          57.151 Rehab Annual Survey.           1,000               1           55/60
 Preventionist).
Occupational Health RN/Specialist..  57.200 Healthcare Personnel              50               1               8
                                      Safety Component Annual
                                      Facility Survey.
Occupational Health RN/Specialist..  57.203 Healthcare Personnel          17,000               1            5/60
                                      Safety Monthly Reporting
                                      Plan.
Occupational Health RN/Specialist..  57.204 Healthcare Worker                 50             200           20/60
                                      Demographic Data.
Occupational Health RN/Specialist..  57.205 Exposure to Blood/                50              50               1
                                      Body Fluids.
Occupational Health RN/Specialist..  57.206 Healthcare Worker                 50              30           15/60
                                      Prophylaxis/Treatment.
Laboratory Technician..............  57.207 Follow-Up Laboratory              50              50           15/60
                                      Testing.
Occupational Health RN/Specialist..  57.210 Healthcare Worker                 50              50           10/60
                                      Prophylaxis/Treatment--
                                      Influenza.
Medical/Clinical Laboratory          57.300 Hemovigilance Module             500               1               2
 Technologist.                        Annual Survey.
Medical/Clinical Laboratory          57.301 Hemovigilance Module             500              12            1/60
 Technologist.                        Monthly Reporting Plan.
Medical/Clinical Laboratory          57.303 Hemovigilance Module             500              12            1.17
 Technologist.                        Monthly Reporting
                                      Denominators.
Medical/Clinical Laboratory          57.305 Hemovigilance                    500              10           10/60
 Technologist.                        Incident.
Medical/Clinical Laboratory          57.306 Hemovigilance Module             200               1           35/60
 Technologist.                        Annual Survey--Non-acute
                                      care facility.

[[Page 52436]]

 
Medical/Clinical Laboratory          57.307 Hemovigilance                    500               4           25/60
 Technologist.                        Adverse Reaction--Acute
                                      Hemolytic Transfusion
                                      Reaction.
Medical/Clinical Laboratory          57.308 Hemovigilance                    500               4           25/60
 Technologist.                        Adverse Reaction--Allergic
                                      Transfusion Reaction.
Medical/Clinical Laboratory          57.309 Hemovigilance                    500               1           25/60
 Technologist.                        Adverse Reaction--Delayed
                                      Hemolytic Transfusion
                                      Reaction.
Medical/Clinical Laboratory          57.310 Hemovigilance                    500               2           25/60
 Technologist.                        Adverse Reaction--Delayed
                                      Serologic Transfusion
                                      Reaction.
Medical/Clinical Laboratory          57.311 Hemovigilance                    500               4           25/60
 Technologist.                        Adverse Reaction--Febrile
                                      Non-hemolytic Transfusion
                                      Reaction.
Medical/Clinical Laboratory          57.312 Hemovigilance                    500               1           25/60
 Technologist.                        Adverse Reaction--
                                      Hypotensive Transfusion
                                      Reaction.
Medical/Clinical Laboratory          57.313 Hemovigilance                    500               1           25/60
 Technologist.                        Adverse Reaction--
                                      Infection.
Medical/Clinical Laboratory          57.314 Hemovigilance                    500               1           25/60
 Technologist.                        Adverse Reaction--Post
                                      Transfusion Purpura.
Medical/Clinical Laboratory          57.315 Hemovigilance                    500               1           25/60
 Technologist.                        Adverse Reaction--
                                      Transfusion Associated
                                      Dyspnea.
Medical/Clinical Laboratory          57.316 Hemovigilance                    500               1           25/60
 Technologist.                        Adverse Reaction--
                                      Transfusion Associated
                                      Graft vs. Host Disease.
Medical/Clinical Laboratory          57.317 Hemovigilance                    500               1           25/60
 Technologist.                        Adverse Reaction--
                                      Transfusion Related Acute
                                      Lung Injury.
Medical/Clinical Laboratory          57.318 Hemovigilance                    500               2           25/60
 Technologist.                        Adverse Reaction--
                                      Transfusion Associated
                                      Circulatory Overload.
Medical/Clinical Laboratory          57.319 Hemovigilance                    500               1           25/60
 Technologist.                        Adverse Reaction--Unknown
                                      Transfusion Reaction.
Medical/Clinical Laboratory          57.320 Hemovigilance                    500               1           25/60
 Technologist.                        Adverse Reaction--Other
                                      Transfusion Reaction.
Medical/Clinical Laboratory          57.400 Patient Safety                 5,000               1            5/60
 Technologist.                        Component--Annual Facility
                                      Survey for Ambulatory
                                      Surgery Center (ASC).
Staff RN...........................  57.401 Outpatient Procedure           5,000              12           15/60
                                      Component--Monthly
                                      Reporting Plan.
Staff RN...........................  57.402 Outpatient Procedure           5,000              25           40/60
                                      Component Event.
Staff RN...........................  57.403 Outpatient Procedure           5,000              12           40/60
                                      Component--Monthly
                                      Denominators and Summary.
Staff RN...........................  57.500 Outpatient Dialysis            6,500               1             2.0
                                      Center Practices Survey.
Registered Nurse (Infection          57.501 Dialysis Monthly               6,500              12            5/60
 Preventionist).                      Reporting Plan.
Staff RN...........................  57.502 Dialysis Event......           6,500              60           25/60
Staff RN...........................  57.503 Denominator for                6,500              12           10/60
                                      Outpatient Dialysis.
Staff RN...........................  57.504 Prevention Process             1,500              12            1.25
                                      Measures Monthly
                                      Monitoring for Dialysis.
Staff RN...........................  57.505 Dialysis Patient                 325              75           10/60
                                      Influenza Vaccination.
Staff RN...........................  57.506 Dialysis Patient                 325               5           10/60
                                      Influenza Vaccination
                                      Denominator.
Staff RN...........................  57.507 Home Dialysis Center             600               1           25/60
                                      Practices Survey.
----------------------------------------------------------------------------------------------------------------


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.
[FR Doc. 2016-18710 Filed 8-5-16; 8:45 am]
 BILLING CODE 4163-18-P