[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Notices]
[Pages 43985-43988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-0666]


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. CDC previously published a 
``Proposed Data Collection Submitted for Public Comment and 
Recommendations'' notice on May 30, 2017 to obtain comments from the 
public and affected agencies. CDC received one comment related to the 
first notice. The purpose of this notice is to allow an additional 30 
days for public comments.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. The Office of Management and Budget is particularly 
interested in comments that:
    (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]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW., Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    National Healthcare Safety Network (NHSN) (OMB No. 0920-0666), exp. 
11/30/2019--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, CDC uses the data to

[[Page 43986]]

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. CDC will use the data 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. CDC will release the NHSN ``Outpatient Procedure 
Component'' in 2018. CDC's request for additional user feedback and 
support from outside partners delayed development of this component.
    After receiving user feedback and internal review feedback, CDC 
made changes to six facility surveys. For the annual facility surveys, 
CDC amended, removed, or added questions and response options to fit 
the survey's evolving uses. In addition, CDC and its partners use the 
surveys 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. CDC modified an 
additional 14 forms within the Hemovigilance module to streamline data 
collection/entry for adverse reaction events.
    Overall, CDC has made minor revisions to a total of 44 forms within 
the package to clarify and/or update surveillance definitions, increase 
or decrease the number of reporting facilities, and adding 2 new forms. 
The previously approved NHSN information collection package included 70 
individual collection forms; the current revision request includes 72 
forms. The reporting burden will increase by 811,985 hours, for a total 
of 5,922,953 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                 Form No. & name         Number of     responses per   per response
                                                                    respondents     respondent        (hours)
----------------------------------------------------------------------------------------------------------------
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.
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                     6,000              44           30/60
 Preventionist).                         Bloodstream 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                   2,000             120           25/60
 Preventionist).                         Ventilator-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              12               4
                                         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                  100             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              2,600               1               2
 Preventionist).                         Facility Component--
                                         Annual Facility Survey.

[[Page 43987]]

 
Registered Nurse (Infection             57.138 Laboratory-                 2,600              12           15/60
 Preventionist).                         identified MDRO or CDI
                                         Event for LTCF.
Registered Nurse (Infection             57.139 MDRO and CDI                2,600              12           10/60
 Preventionist).                         Prevention Process
                                         Measures Monthly
                                         Monitoring for LTCF.
Registered Nurse (Infection             57.140 Urinary Tract               2,600              14           30/60
 Preventionist).                         Infection (UTI) for
                                         LTCF.
Registered Nurse (Infection             57.141 Monthly Reporting           2,600              12            5/60
 Preventionist).                         Plan for LTCF.
Registered Nurse (Infection             57.142 Denominators for            2,600              12               4
 Preventionist).                         LTCF Locations.
Registered Nurse (Infection             57.143 Prevention                  2,600              12            5/60
 Preventionist).                         Process Measures
                                         Monthly Monitoring for
                                         LTCF.
Registered Nurse (Infection             57.150 LTAC Annual                   400               1           55/60
 Preventionist).                         Survey.
Registered Nurse (Infection             57.151 Rehab Annual                1,000               1           55/60
 Preventionist).                         Survey.
Occupational Health RN/Specialist.....  57.200 Healthcare                     50               1               8
                                         Personnel Safety
                                         Component Annual
                                         Facility Survey.
Occupational Health RN/Specialist.....  57.203 Healthcare                 17,000               1            5/60
                                         Personnel 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                      50              50           15/60
                                         Laboratory Testing.
Occupational Health RN/Specialist.....  57.210 Healthcare Worker              50              50           10/60
                                         Prophylaxis/Treatment-
                                         Influenza.
Medical/Clinical Laboratory             57.300 Hemovigilance                 500               1               2
 Technologist.                           Module Annual Survey.
Medical/Clinical Laboratory             57.301 Hemovigilance                 500              12            1/60
 Technologist.                           Module Monthly
                                         Reporting Plan.
Medical/Clinical Laboratory             57.303 Hemovigilance                 500              12            1.17
 Technologist.                           Module Monthly
                                         Reporting Denominators.
Medical/Clinical Laboratory             57.305 Hemovigilance                 500              10           10/60
 Technologist.                           Incident.
Medical/Clinical Laboratory             57.306 Hemovigilance                 200               1           35/60
 Technologist.                           Module Annual Survey--
                                         Non-acute care facility.
Medical/Clinical Laboratory             57.307 Hemovigilance                 500               4           20/60
 Technologist.                           Adverse Reaction--Acute
                                         Hemolytic Transfusion
                                         Reaction.
Medical/Clinical Laboratory             57.308 Hemovigilance                 500               4           20/60
 Technologist.                           Adverse Reaction--
                                         Allergic Transfusion
                                         Reaction.
Medical/Clinical Laboratory             57.309 Hemovigilance                 500               1           20/60
 Technologist.                           Adverse Reaction--
                                         Delayed Hemolytic
                                         Transfusion Reaction.
Medical/Clinical Laboratory             57.310 Hemovigilance                 500               2           20/60
 Technologist.                           Adverse Reaction--
                                         Delayed Serologic
                                         Transfusion Reaction.
Medical/Clinical Laboratory             57.311 Hemovigilance                 500               4           20/60
 Technologist.                           Adverse Reaction--
                                         Febrile Non-hemolytic
                                         Transfusion Reaction.
Medical/Clinical Laboratory             57.312 Hemovigilance                 500               1           20/60
 Technologist.                           Adverse Reaction--
                                         Hypotensive Transfusion
                                         Reaction.
Medical/Clinical Laboratory             57.313 Hemovigilance                 500               1           20/60
 Technologist.                           Adverse Reaction--
                                         Infection.
Medical/Clinical Laboratory             57.314 Hemovigilance                 500               1           20/60
 Technologist.                           Adverse Reaction--Post
                                         Transfusion Purpura.
Medical/Clinical Laboratory             57.315 Hemovigilance                 500               1           20/60
 Technologist.                           Adverse Reaction--
                                         Transfusion Associated
                                         Dyspnea.
Medical/Clinical Laboratory             57.316 Hemovigilance                 500               1           20/60
 Technologist.                           Adverse Reaction--
                                         Transfusion Associated
                                         Graft vs. Host Disease.
Medical/Clinical Laboratory             57.317 Hemovigilance                 500               1           20/60
 Technologist.                           Adverse Reaction--
                                         Transfusion Related
                                         Acute Lung Injury.
Medical/Clinical Laboratory             57.318 Hemovigilance                 500               2           20/60
 Technologist.                           Adverse Reaction--
                                         Transfusion Associated
                                         Circulatory Overload.
Medical/Clinical Laboratory             57.319 Hemovigilance                 500               1           20/60
 Technologist.                           Adverse Reaction--
                                         Unknown Transfusion
                                         Reaction.
Medical/Clinical Laboratory             57.320 Hemovigilance                 500               1           20/60
 Technologist.                           Adverse Reaction--Other
                                         Transfusion Reaction.
Medical/Clinical Laboratory             57.400 Patient Safety              5,000               1            5/60
 Technologist.                           Component--Annual
                                         Facility Survey.

[[Page 43988]]

 
Staff RN..............................  57.401 Outpatient                  5,000              12           15/60
                                         Procedure Component--
                                         Monthly Reporting Plan.
Staff RN..............................  57.402 Outpatient                  5,000              25           40/60
                                         Procedure Component--
                                         Same Day Outcome
                                         Measures & Prophylactic
                                         Intravenous (IV)
                                         Antibiotic Timing Event.
Staff RN..............................  57.403 Outpatient                  5,000              12           40/60
                                         Procedure Component--
                                         Monthly Denominators
                                         for Same Day Outcome
                                         Measures & Prophylactic
                                         Intravenous (IV)
                                         Antibiotic Timing Event.
Staff RN..............................  57.404 Outpatient                  5,000             540           10/60
                                         Procedure Component--
                                         Annual Facility Survey.
Registered Nurse (Infection             57.405 Outpatient                  5,000              36           35/60
 Preventionist).                         Procedure Component--
                                         Surgical Site (SSI)
                                         Event.
Staff RN..............................  57.500 Outpatient                  7,000               1             2.0
                                         Dialysis Center
                                         Practices Survey.
Registered Nurse (Infection             57.501 Dialysis Monthly            7,000              12            5/60
 Preventionist).                         Reporting Plan.
Staff RN..............................  57.502 Dialysis Event...           7,000              60           25/60
Staff RN..............................  57.503 Denominator for             7,000              12           10/60
                                         Outpatient Dialysis.
Staff RN..............................  57.504 Prevention                  2,000              12            1.25
                                         Process 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                 350               1           30/60
                                         Center Practices Survey.
----------------------------------------------------------------------------------------------------------------


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. 2017-20009 Filed 9-19-17; 8:45 am]
 BILLING CODE 4163-18-P