83_FR_46668 83 FR 46490 - Agency Forms Undergoing Paperwork Reduction Act Review

83 FR 46490 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 178 (September 13, 2018)

Page Range46490-46493
FR Document2018-19902

Federal Register, Volume 83 Issue 178 (Thursday, September 13, 2018)
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46490-46493]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19902]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-0666]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled National Healthcare Safety Network to the 
Office of Management and Budget (OMB) for review and approval. CDC 
previously published a ``Proposed Data Collection Submitted for Public 
Comment and Recommendations'' notice on May 11, 2018 to obtain comments 
from the public and affected agencies. CDC received one comment related 
to the previous notice. This notice serves to allow an additional 30 
days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. 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 (0920-0666, Expiration Date 1/
31/2021)--Revision--National Center for Emerging and Zoonotic 
Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    NHSN is a public health surveillance system that collects, 
analyzes, reports, and makes available data for monitoring, measuring, 
and responding to healthcare associated infections (HAIs), 
antimicrobial use and resistance, blood transfusion safety events, and 
the extent to which healthcare facilities adhere to infection 
prevention practices and antimicrobial stewardship. Specifically, 
resulting data estimates the magnitude of Healthcare Associated 
Infections (HAI), monitor HAI trends, and facilitate inter-facility and 
intra-facility comparisons with risk-adjusted data used for local 
quality improvement activities. 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 
six components: Patient Safety, Healthcare Personnel Safety, 
Biovigilance, Long-Term Care Facility (LTCF), Outpatient Procedure 
Component, and Dialysis.
    Changes were made to 34 data collection facility surveys with this 
revision ICR. CDC revised three annual facility surveys for the Patient 
Safety component for Hospitals, Long-Term Acute Care Facilities, and 
Inpatient Rehabilitation Facilities. CDC's revisions clarify the 
reporting requirements for the data collected on fungal testing, 
facility locations, and laboratory testing locations. Additionally, 
corresponding response

[[Page 46491]]

options for these questions have been revised to include updated 
testing methods used by facilities to capture current HAI specific data 
specification requirements for NHSN. New required questions have been 
added to all Patient Safety component surveys. The new questions are 
designed to provide data on surveillance processes, policies, and 
standards that are used by reporting facilities to ensure that when an 
event is detected, the facility has the appropriate mechanism to 
conduct complete reporting. The Hospital Annual Survey added new 
required questions to provide data about neonatal antimicrobial 
stewardship practices because the focus of stewardship efforts in 
neonatology differ from the focus in adult and pediatric practice. 
Questions were removed and replaced on all three Patient Safety surveys 
to align better with the Core Elements of Hospital Antibiotic 
Stewardship Programs specified by CDC. The Core Elements defined by CDC 
are part of broad-based efforts by CDC and its healthcare and public 
health partners to combat the threat of antibiotic-resistant bacteria. 
The new Antibiotic Stewardship Program questions will provide 
additional data about operational features of the programs that 
hospitals have implemented, which in turn will enable CDC and its 
healthcare and public health partners to target their efforts to help 
invigorate and extend antibiotic stewardship.
    CDC is introducing a new optional survey form that is designed to 
be completed by state and local health departments that participate in 
HAI surveillance and prevention activities. This new form will provide 
data on legal and regulatory requirements that are pertinent to HAI 
reporting. CDC plans to include data the health department survey in 
its annual National and State Healthcare-Associated Infection Progress 
Report. The report helps identify the progress in HAI surveillance and 
prevention at the state and national levels. Data about the extent to 
which state health departments have validated HAI data that healthcare 
facilities in their jurisdiction report to NHSN and the extent of state 
and local health department HAI reporting requirements are important 
data for users of CDC's HAI Progress Report to consider when they are 
reviewing and interpreting data in the report.
    NHSN now includes a ventilator-associated event available for NICU 
locations, which requires additional denominator reporting, in which 
CDC has provided an option to accommodate facilities that are reporting 
requested data by updating the corresponding surveys. The Pediatric 
Ventilator-Associated Event (PedVAE) was removed from the survey 
because a single algorithm is used to detect PedVAE events.
    NHSN has made updates to the Antimicrobial Use and Resistance (AUR) 
data collection tools for the purposes of monitoring additional 
microorganisms and their antimicrobial susceptibility profiles. Use of 
these updates in AUR surveillance will provide important additional 
data for clinical and public health responses to mounting antibiotic 
resistance problems.
    The Long-term Care Facility Component (LTCF) will be updating three 
forms, two of which will include an update for facilities to document 
the ``CDI treatment start'' variable. Early CDI reporting data from 
nursing homes has shown exceptionally low event rates for many 
reporting facilities (e.g., zero events for six or more months). Since 
current CDI event detection is based on presence of a positive 
laboratory specimen, variability in the use of diagnostic testing as 
part of CDI management will have direct impact on the estimate of CDI 
burden in a facility (e.g., empiric treatment for CDI without 
confirmatory testing may result in the appearance of low disease 
burden). In order to determine whether low CDI event rates might be due 
to empiric CDI treatment practices, a new process measure will be 
incorporated into the monthly summary data on CDI for LTCFs. This 
measure, called ``CDI treatment starts,'' will allow providers to 
capture the number of residents started on antibiotic treatment for CDI 
that month based on clinical decisions (i.e., even those without a 
positive CDI test). This process measure should provide data on 
clinically-treated CDI in order to inform our understanding of CDI 
management practices and serve as a proxy for CDI burden in nursing 
homes.
    Overall, minor revisions have been made to a total of 34 forms 
within the package to clarify and/or update surveillance definitions, 
increase or decrease the number of reporting facilities, and add new 
forms.
    Finally, NHSN has achieved significant burden reduction with this 
ICR due to a decrease in the number of respondents for the Specialty 
Care Area (SCA) and Oncology (ONC) facilities reporting to NHSN. NHSN 
re-evaluated these reporting facilities and determined that 
approximately 2,000 SCA and ONC facilities are reporting to NHSN 
compared to the estimated 6,000 that was estimated last year. 
Additionally, NHSN streamlined many response options, which also 
attributed to a reduction in the overall burden.
    The previously approved NHSN package included 72 individual 
collection forms; the current revision request includes a total of 73 
forms. The reporting burden will decrease by 109,745 hours, for a total 
of 5,393,725 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Healthcare facility................  57.100 NHSN Registration              2,000               1            5/60
                                      Form.
                                     57.101 Facility Contact               2,000               1           10/60
                                      Information.
                                     57.103 Patient Safety                 6,000               1           75/60
                                      Component--Annual Hospital
                                      Survey.
                                     57.105 Group Contact                  1,000               1            5/60
                                      Information.
                                     57.106 Patient Safety                 6,000              12           15/60
                                      Monthly Reporting Plan.
                                     57.108 Primary Bloodstream            6,000              44           33/60
                                      Infection (BSI).
                                     57.111 Pneumonia (PNEU)....           1,800              72           30/60
                                     57.112 Ventilator-                    6,000             144           28/60
                                      Associated Event.
                                     57.113 Pediatric Ventilator-            100             120           30/60
                                      Associated Event (PedVAE).
                                     57.114 Urinary Tract                  6,000              40           20/60
                                      Infection (UTI).
                                     57.115 Custom Event........             600              91           35/60
                                     57.116 Denominators for               6,000              12               4
                                      Neonatal Intensive Care
                                      Unit (NICU).

[[Page 46492]]

 
                                     57.117 Denominators for               2,000               9          302/60
                                      Specialty Care Area (SCA)/
                                      Oncology (ONC).
                                     57.118 Denominators for               6,000              60          302/60
                                      Intensive Care Unit (ICU)/
                                      Other locations (not NICU
                                      or SCA).
                                     57.120 Surgical Site                  6,000              36           35/60
                                      Infection (SSI).
                                     57.121 Denominator for                6,000             540           10/60
                                      Procedure.
                                     57.122 HAI Progress Report               55               1           45/60
                                      State Health Department
                                      Survey.
                                     57.123 Antimicrobial Use              1,000              12            5/60
                                      and Resistance (AUR)-
                                      Microbiology Data
                                      Electronic Upload
                                      Specification Tables.
                                     57.124 Antimicrobial Use              2,000              12            5/60
                                      and Resistance (AUR)-
                                      Pharmacy Data Electronic
                                      Upload Specification
                                      Tables.
                                     57.125 Central Line                     100             100           25/60
                                      Insertion Practices
                                      Adherence Monitoring.
                                     57.126 MDRO or CDI                    6,000              72           30/60
                                      Infection Form.
                                     57.127 MDRO and CDI                   6,000              24           15/60
                                      Prevention Process and
                                      Outcome Measures Monthly
                                      Monitoring.
                                     57.128 Laboratory-                    6,000             240           20/60
                                      identified MDRO or CDI
                                      Event.
                                     57.129 Adult Sepsis........              50             250           25/60
                                     57.137 Long-Term Care                 2,600               1               2
                                      Facility Component--Annual
                                      Facility Survey.
                                     57.138 Laboratory-                    2,600              12           20/60
                                      identified MDRO or CDI
                                      Event for LTCF.
                                     57.139 MDRO and CDI                   2,600              12           20/60
                                      Prevention Process
                                      Measures Monthly
                                      Monitoring for LTCF.
                                     57.140 Urinary Tract                  2,600              14           35/60
                                      Infection (UTI) for LTCF.
                                     57.141 Monthly Reporting              2,600              12            5/60
                                      Plan for LTCF.
                                     57.142 Denominators for               2,600              12          250/60
                                      LTCF Locations.
                                     57.143 Prevention Process             2,600              12            5/60
                                      Measures Monthly
                                      Monitoring for LTCF.
                                     57.150 LTAC Annual Survey..             400               1           70/60
                                     57.151 Rehab Annual Survey.           1,000               1           70/60
                                     57.200 Healthcare Personnel              50               1               8
                                      Safety Component Annual
                                      Facility Survey.
                                     57.203 Healthcare Personnel          19,500               1            5/60
                                      Safety Monthly Reporting
                                      Plan.
                                     57.204 Healthcare Worker                 50             200           20/60
                                      Demographic Data.
                                     57.205 Exposure to Blood/                50              50               1
                                      Body Fluids.
                                     57.206 Healthcare Worker                 50              30           15/60
                                      Prophylaxis/Treatment.
                                     57.207 Follow-Up Laboratory              50              50           15/60
                                      Testing.
                                     57.210 Healthcare Worker                 50              50           10/60
                                      Prophylaxis/Treatment-
                                      Influenza.
                                     57.300 Hemovigilance Module             500               1           85/60
                                      Annual Survey.
                                     57.301 Hemovigilance Module             500              12            1/60
                                      Monthly Reporting Plan.
                                     57.303 Hemovigilance Module             500              12           70/60
                                      Monthly Reporting
                                      Denominators.
                                     57.305 Hemovigilance                    500              10           10/60
                                      Incident.
                                     57.306 Hemovigilance Module             200               1           35/60
                                      Annual Survey--Non-acute
                                      care facility.
                                     57.307 Hemovigilance                    500               4           20/60
                                      Adverse Reaction--Acute
                                      Hemolytic Transfusion
                                      Reaction.
                                     57.308 Hemovigilance                    500               4           20/60
                                      Adverse Reaction--Allergic
                                      Transfusion Reaction.
                                     57.309 Hemovigilance                    500               1           20/60
                                      Adverse Reaction--Delayed
                                      Hemolytic Transfusion
                                      Reaction.
                                     57.310 Hemovigilance                    500               2           20/60
                                      Adverse Reaction--Delayed
                                      Serologic Transfusion
                                      Reaction.
                                     57.311 Hemovigilance                    500               4           20/60
                                      Adverse Reaction--Febrile
                                      Non-hemolytic Transfusion
                                      Reaction.
                                     57.312 Hemovigilance                    500               1           20/60
                                      Adverse Reaction--
                                      Hypotensive Transfusion
                                      Reaction.
                                     57.313 Hemovigilance                    500               1           20/60
                                      Adverse Reaction--
                                      Infection.
                                     57.314 Hemovigilance                    500               1           20/60
                                      Adverse Reaction--Post
                                      Transfusion Purpura.
                                     57.315 Hemovigilance                    500               1           20/60
                                      Adverse Reaction--
                                      Transfusion Associated
                                      Dyspnea.
                                     57.316 Hemovigilance                    500               1           20/60
                                      Adverse Reaction--
                                      Transfusion Associated
                                      Graft vs. Host Disease.
                                     57.317 Hemovigilance                    500               1           20/60
                                      Adverse Reaction--
                                      Transfusion Related Acute
                                      Lung Injury.
                                     57.318 Hemovigilance                    500               2           20/60
                                      Adverse Reaction--
                                      Transfusion Associated
                                      Circulatory Overload.

[[Page 46493]]

 
                                     57.319 Hemovigilance                    500               1           20/60
                                      Adverse Reaction--Unknown
                                      Transfusion Reaction.
                                     57.320 Hemovigilance                    500               1           20/60
                                      Adverse Reaction--Other
                                      Transfusion Reaction.
                                     57.400 Outpatient Procedure           5,000               1           10/60
                                      Component--Annual Facility
                                      Survey.
                                     57.401 Outpatient Procedure           5,000              12           20/60
                                      Component--Monthly
                                      Reporting Plan.
                                     57.402 Outpatient Procedure           1,200              25           40/60
                                      Component Same Day Outcome
                                      Measures.
                                     57.403 Outpatient Procedure           1,200              12           40/60
                                      Component--Monthly
                                      Denominators for Same Day
                                      Outcome Measures.
                                     57.404 Outpatient Procedure           5,000             540           10/60
                                      Component--SSI Denominator.
                                     57.405 Outpatient Procedure           5,000              36           35/60
                                      Component--Surgical Site
                                      (SSI) Event.
                                     57.500 Outpatient Dialysis            7,000               1          127/60
                                      Center Practices Survey.
                                     57.501 Dialysis Monthly               7,000              12            5/60
                                      Reporting Plan.
                                     57.502 Dialysis Event......           7,000              60           25/60
                                     57.503 Denominator for                7,000              12           10/60
                                      Outpatient Dialysis.
                                     57.504 Prevention Process             2,000              12           85/60
                                      Measures Monthly
                                      Monitoring for Dialysis.
                                     57.505 Dialysis Patient                 325              75           10/60
                                      Influenza Vaccination.
                                     57.506 Dialysis Patient                 325               5           10/60
                                      Influenza Vaccination
                                      Denominator.
                                     57.507 Home Dialysis Center             350               1           30/60
                                      Practices Survey.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
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. 2018-19902 Filed 9-12-18; 8:45 am]
 BILLING CODE 4163-18-P



                                               46490                            Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices

                                               research activities in the health field.                                monitoring of goals for the Year 2000,                                          There is no cost to respondents other
                                               Historically, data have been used                                       2010, and 2020 Healthy People                                                 than their time to participate. The total
                                               extensively in the development and                                      Objectives.                                                                   annualized burden is 7,080 hours.

                                                                                                                      ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                   Number of                     Average                  Total
                                                                                                                                                                        Number of                   responses                  burden per
                                                         Type of respondents                                                Form name                                                                                                                    burden
                                                                                                                                                                       respondents                     per                      response               (in hours)
                                                                                                                                                                                                   respondent                   (in hours)

                                               Hospital Director of Health Informa-                     Initial Hospital Intake Questionnaire                                          150                             1                          1            150
                                                 tion Management (DHIM) or Direc-
                                                 tor of Health Information Tech-
                                                 nology (DHIT).
                                               Hospital Chief Executive Officer                         Recruitment Survey Presentation ....                                            150                           1                           1            150
                                                 (CEO)/Chief     Financial     Officer
                                                 (CFO).
                                               Hospital DHIM or DHIT .....................              Prepare and transmit UB–04 or                                                  399                           12                          1            4,788
                                                                                                          State File for Inpatient and Ambu-
                                                                                                          latory.
                                               Hospital DHIM or DHIT .....................              Prepare and transmit EHR for Inpa-                                              199                            4                         1             796
                                                                                                          tient and Ambulatory.
                                               Hospital CEO/CFO ............................            Annual Hospital Interview ................                                      598                            1                         2            1,196

                                                    Total ...........................................   ...........................................................   ........................   ........................   ........................          7,080



                                               Jeffrey M. Zirger,                                                        (a) Evaluate whether the proposed                                           Emerging and Zoonotic Infectious
                                               Acting Chief, Information Collection Review                             collection of information is necessary                                        Diseases (NCEZID), Centers for Disease
                                               Office, Office of Scientific Integrity, Office                          for the proper performance of the                                             Control and Prevention (CDC).
                                               of the Associate Director for Science, Office                           functions of the agency, including
                                               of the Director, Centers for Disease Control                                                                                                          Background and Brief Description
                                                                                                                       whether the information will have
                                               and Prevention.                                                         practical utility;                                                               NHSN is a public health surveillance
                                               [FR Doc. 2018–19901 Filed 9–12–18; 8:45 am]                               (b) Evaluate the accuracy of the                                            system that collects, analyzes, reports,
                                               BILLING CODE 4163–18–P                                                  agencies estimate of the burden of the                                        and makes available data for
                                                                                                                       proposed collection of information,                                           monitoring, measuring, and responding
                                                                                                                       including the validity of the                                                 to healthcare associated infections
                                               DEPARTMENT OF HEALTH AND                                                methodology and assumptions used;                                             (HAIs), antimicrobial use and resistance,
                                               HUMAN SERVICES                                                            (c) Enhance the quality, utility, and                                       blood transfusion safety events, and the
                                                                                                                       clarity of the information to be                                              extent to which healthcare facilities
                                               Centers for Disease Control and                                         collected;                                                                    adhere to infection prevention practices
                                               Prevention                                                                (d) Minimize the burden of the                                              and antimicrobial stewardship.
                                                                                                                       collection of information on those who                                        Specifically, resulting data estimates the
                                               [30Day–18–0666]                                                         are to respond, including, through the                                        magnitude of Healthcare Associated
                                                                                                                       use of appropriate automated,                                                 Infections (HAI), monitor HAI trends,
                                               Agency Forms Undergoing Paperwork                                       electronic, mechanical, or other                                              and facilitate inter-facility and intra-
                                               Reduction Act Review                                                    technological collection techniques or                                        facility comparisons with risk-adjusted
                                                                                                                       other forms of information technology,                                        data used for local quality improvement
                                                  In accordance with the Paperwork                                                                                                                   activities. The data will be used to
                                                                                                                       e.g., permitting electronic submission of
                                               Reduction Act of 1995, the Centers for                                                                                                                detect changes in the epidemiology of
                                                                                                                       responses; and
                                               Disease Control and Prevention (CDC)                                      (e) Assess information collection                                           adverse events resulting from new and
                                               has submitted the information                                           costs.                                                                        current medical therapies and changing
                                               collection request titled National                                        To request additional information on                                        risks. The NHSN currently consists of
                                               Healthcare Safety Network to the Office                                 the proposed project or to obtain a copy                                      six components: Patient Safety,
                                               of Management and Budget (OMB) for                                      of the information collection plan and                                        Healthcare Personnel Safety,
                                               review and approval. CDC previously                                     instruments, call (404) 639–7570 or                                           Biovigilance, Long-Term Care Facility
                                               published a ‘‘Proposed Data Collection                                  send an email to omb@cdc.gov. Direct                                          (LTCF), Outpatient Procedure
                                               Submitted for Public Comment and                                        written comments and/or suggestions                                           Component, and Dialysis.
                                               Recommendations’’ notice on May 11,                                     regarding the items contained in this                                            Changes were made to 34 data
                                               2018 to obtain comments from the                                        notice to the Attention: CDC Desk                                             collection facility surveys with this
                                               public and affected agencies. CDC                                       Officer, Office of Management and                                             revision ICR. CDC revised three annual
                                               received one comment related to the                                     Budget, 725 17th Street, NW,                                                  facility surveys for the Patient Safety
                                               previous notice. This notice serves to                                  Washington, DC 20503 or by fax to (202)                                       component for Hospitals, Long-Term
daltland on DSKBBV9HB2PROD with NOTICES




                                               allow an additional 30 days for public                                  395–5806. Provide written comments                                            Acute Care Facilities, and Inpatient
                                               and affected agency comments.                                           within 30 days of notice publication.                                         Rehabilitation Facilities. CDC’s
                                                  CDC will accept all comments for this                                                                                                              revisions clarify the reporting
                                               proposed information collection project.                                Proposed Project                                                              requirements for the data collected on
                                               The Office of Management and Budget                                       National Healthcare Safety Network                                          fungal testing, facility locations, and
                                               is particularly interested in comments                                  (0920–0666, Expiration Date 1/31/                                             laboratory testing locations.
                                               that:                                                                   2021)—Revision—National Center for                                            Additionally, corresponding response


                                          VerDate Sep<11>2014       19:20 Sep 12, 2018        Jkt 244001       PO 00000        Frm 00015        Fmt 4703        Sfmt 4703      E:\FR\FM\13SEN1.SGM               13SEN1


                                                                            Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices                                                          46491

                                               options for these questions have been                          Associated Infection Progress Report.                           management will have direct impact on
                                               revised to include updated testing                             The report helps identify the progress in                       the estimate of CDI burden in a facility
                                               methods used by facilities to capture                          HAI surveillance and prevention at the                          (e.g., empiric treatment for CDI without
                                               current HAI specific data specification                        state and national levels. Data about the                       confirmatory testing may result in the
                                               requirements for NHSN. New required                            extent to which state health                                    appearance of low disease burden). In
                                               questions have been added to all Patient                       departments have validated HAI data                             order to determine whether low CDI
                                               Safety component surveys. The new                              that healthcare facilities in their                             event rates might be due to empiric CDI
                                               questions are designed to provide data                         jurisdiction report to NHSN and the                             treatment practices, a new process
                                               on surveillance processes, policies, and                       extent of state and local health                                measure will be incorporated into the
                                               standards that are used by reporting                           department HAI reporting requirements                           monthly summary data on CDI for
                                               facilities to ensure that when an event                        are important data for users of CDC’s                           LTCFs. This measure, called ‘‘CDI
                                               is detected, the facility has the                              HAI Progress Report to consider when                            treatment starts,’’ will allow providers
                                               appropriate mechanism to conduct                               they are reviewing and interpreting data                        to capture the number of residents
                                               complete reporting. The Hospital                               in the report.                                                  started on antibiotic treatment for CDI
                                               Annual Survey added new required                                  NHSN now includes a ventilator-                              that month based on clinical decisions
                                               questions to provide data about neonatal                       associated event available for NICU                             (i.e., even those without a positive CDI
                                               antimicrobial stewardship practices                            locations, which requires additional                            test). This process measure should
                                               because the focus of stewardship efforts                       denominator reporting, in which CDC                             provide data on clinically-treated CDI in
                                               in neonatology differ from the focus in                        has provided an option to accommodate                           order to inform our understanding of
                                               adult and pediatric practice. Questions                        facilities that are reporting requested                         CDI management practices and serve as
                                               were removed and replaced on all three                         data by updating the corresponding                              a proxy for CDI burden in nursing
                                               Patient Safety surveys to align better                         surveys. The Pediatric Ventilator-                              homes.
                                               with the Core Elements of Hospital                             Associated Event (PedVAE) was                                      Overall, minor revisions have been
                                               Antibiotic Stewardship Programs                                removed from the survey because a                               made to a total of 34 forms within the
                                               specified by CDC. The Core Elements                            single algorithm is used to detect                              package to clarify and/or update
                                               defined by CDC are part of broad-based                         PedVAE events.                                                  surveillance definitions, increase or
                                               efforts by CDC and its healthcare and                             NHSN has made updates to the
                                                                                                                                                                              decrease the number of reporting
                                               public health partners to combat the                           Antimicrobial Use and Resistance
                                                                                                                                                                              facilities, and add new forms.
                                               threat of antibiotic-resistant bacteria.                       (AUR) data collection tools for the
                                                                                                              purposes of monitoring additional                                  Finally, NHSN has achieved
                                               The new Antibiotic Stewardship                                                                                                 significant burden reduction with this
                                                                                                              microorganisms and their antimicrobial
                                               Program questions will provide                                                                                                 ICR due to a decrease in the number of
                                                                                                              susceptibility profiles. Use of these
                                               additional data about operational                                                                                              respondents for the Specialty Care Area
                                                                                                              updates in AUR surveillance will
                                               features of the programs that hospitals                                                                                        (SCA) and Oncology (ONC) facilities
                                                                                                              provide important additional data for
                                               have implemented, which in turn will                                                                                           reporting to NHSN. NHSN re-evaluated
                                                                                                              clinical and public health responses to
                                               enable CDC and its healthcare and                                                                                              these reporting facilities and determined
                                                                                                              mounting antibiotic resistance
                                               public health partners to target their                                                                                         that approximately 2,000 SCA and ONC
                                                                                                              problems.
                                               efforts to help invigorate and extend                             The Long-term Care Facility                                  facilities are reporting to NHSN
                                               antibiotic stewardship.                                        Component (LTCF) will be updating                               compared to the estimated 6,000 that
                                                  CDC is introducing a new optional                           three forms, two of which will include                          was estimated last year. Additionally,
                                               survey form that is designed to be                             an update for facilities to document the                        NHSN streamlined many response
                                               completed by state and local health                            ‘‘CDI treatment start’’ variable. Early CDI                     options, which also attributed to a
                                               departments that participate in HAI                            reporting data from nursing homes has                           reduction in the overall burden.
                                               surveillance and prevention activities.                        shown exceptionally low event rates for                            The previously approved NHSN
                                               This new form will provide data on                             many reporting facilities (e.g., zero                           package included 72 individual
                                               legal and regulatory requirements that                         events for six or more months). Since                           collection forms; the current revision
                                               are pertinent to HAI reporting. CDC                            current CDI event detection is based on                         request includes a total of 73 forms. The
                                               plans to include data the health                               presence of a positive laboratory                               reporting burden will decrease by
                                               department survey in its annual                                specimen, variability in the use of                             109,745 hours, for a total of 5,393,725
                                               National and State Healthcare-                                 diagnostic testing as part of CDI                               hours.

                                                                                                             ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                Average
                                                                                                                                                                                                Number of
                                                                                                                                                                              Number of                       burden per
                                                     Type of respondents                                                 Form name                                                            responses per
                                                                                                                                                                             respondents                       response
                                                                                                                                                                                                respondent     (in hours)

                                               Healthcare facility ...................   57.100 NHSN Registration Form ...........................................                  2,000                1            5/60
                                                                                         57.101 Facility Contact Information .......................................                2,000                1           10/60
                                                                                         57.103 Patient Safety Component—Annual Hospital Survey                                     6,000                1           75/60
                                                                                         57.105 Group Contact Information .........................................                 1,000                1            5/60
                                                                                         57.106 Patient Safety Monthly Reporting Plan ......................                        6,000               12           15/60
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                                                                                         57.108 Primary Bloodstream Infection (BSI) .........................                       6,000               44           33/60
                                                                                         57.111 Pneumonia (PNEU) ....................................................               1,800               72           30/60
                                                                                         57.112 Ventilator-Associated Event .......................................                 6,000              144           28/60
                                                                                         57.113 Pediatric Ventilator-Associated Event (PedVAE) .......                                100              120           30/60
                                                                                         57.114 Urinary Tract Infection (UTI) ......................................                6,000               40           20/60
                                                                                         57.115 Custom Event .............................................................            600               91           35/60
                                                                                         57.116 Denominators for Neonatal Intensive Care Unit                                       6,000               12               4
                                                                                           (NICU).



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                                               46492                    Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices

                                                                                               ESTIMATED ANNUALIZED BURDEN HOURS—Continued
                                                                                                                                                                                                              Average
                                                                                                                                                                                              Number of
                                                                                                                                                                            Number of                       burden per
                                                    Type of respondents                                               Form name                                                             responses per
                                                                                                                                                                           respondents                       response
                                                                                                                                                                                              respondent     (in hours)

                                                                                     57.117 Denominators for Specialty Care Area (SCA)/Oncol-                                     2,000                 9         302/60
                                                                                       ogy (ONC).
                                                                                     57.118 Denominators for Intensive Care Unit (ICU)/Other lo-                                  6,000                60         302/60
                                                                                       cations (not NICU or SCA).
                                                                                     57.120 Surgical Site Infection (SSI) .......................................                 6,000               36           35/60
                                                                                     57.121 Denominator for Procedure ........................................                    6,000              540           10/60
                                                                                     57.122 HAI Progress Report State Health Department Sur-                                         55                1           45/60
                                                                                       vey.
                                                                                     57.123 Antimicrobial Use and Resistance (AUR)-Microbi-                                       1,000                12           5/60
                                                                                       ology Data Electronic Upload Specification Tables.
                                                                                     57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy                                       2,000                12           5/60
                                                                                       Data Electronic Upload Specification Tables.
                                                                                     57.125 Central Line Insertion Practices Adherence Moni-                                       100               100           25/60
                                                                                       toring.
                                                                                     57.126 MDRO or CDI Infection Form ....................................                       6,000                72          30/60
                                                                                     57.127 MDRO and CDI Prevention Process and Outcome                                           6,000                24          15/60
                                                                                       Measures Monthly Monitoring.
                                                                                     57.128 Laboratory-identified MDRO or CDI Event ................                              6,000              240           20/60
                                                                                     57.129 Adult Sepsis ...............................................................             50              250           25/60
                                                                                     57.137 Long-Term Care Facility Component—Annual Facil-                                       2,600                1               2
                                                                                       ity Survey.
                                                                                     57.138 Laboratory-identified MDRO or CDI Event for LTCF                                      2,600                12          20/60
                                                                                     57.139 MDRO and CDI Prevention Process Measures                                              2,600                12          20/60
                                                                                       Monthly Monitoring for LTCF.
                                                                                     57.140 Urinary Tract Infection (UTI) for LTCF .......................                        2,600                14          35/60
                                                                                     57.141 Monthly Reporting Plan for LTCF ..............................                        2,600                12           5/60
                                                                                     57.142 Denominators for LTCF Locations .............................                         2,600                12         250/60
                                                                                     57.143 Prevention Process Measures Monthly Monitoring                                        2,600                12           5/60
                                                                                       for LTCF.
                                                                                     57.150 LTAC Annual Survey .................................................                    400                 1          70/60
                                                                                     57.151 Rehab Annual Survey ................................................                  1,000                 1          70/60
                                                                                     57.200 Healthcare Personnel Safety Component Annual Fa-                                         50                 1              8
                                                                                       cility Survey.
                                                                                     57.203 Healthcare Personnel Safety Monthly Reporting Plan                                   19,500                1            5/60
                                                                                     57.204 Healthcare Worker Demographic Data ......................                                50              200           20/60
                                                                                     57.205 Exposure to Blood/Body Fluids ..................................                         50               50               1
                                                                                     57.206 Healthcare Worker Prophylaxis/Treatment ................                                 50               30           15/60
                                                                                     57.207 Follow-Up Laboratory Testing ....................................                        50               50           15/60
                                                                                     57.210 Healthcare Worker Prophylaxis/Treatment-Influenza                                        50               50           10/60
                                                                                     57.300 Hemovigilance Module Annual Survey ......................                               500                1           85/60
                                                                                     57.301 Hemovigilance Module Monthly Reporting Plan ........                                    500               12            1/60
                                                                                     57.303 Hemovigilance Module Monthly Reporting Denomi-                                          500               12           70/60
                                                                                       nators.
                                                                                     57.305 Hemovigilance Incident ..............................................                  500                 10          10/60
                                                                                     57.306 Hemovigilance Module Annual Survey—Non-acute                                           200                  1          35/60
                                                                                       care facility.
                                                                                     57.307 Hemovigilance Adverse Reaction—Acute Hemolytic                                         500                  4          20/60
                                                                                       Transfusion Reaction.
                                                                                     57.308 Hemovigilance Adverse Reaction—Allergic Trans-                                         500                  4          20/60
                                                                                       fusion Reaction.
                                                                                     57.309 Hemovigilance Adverse Reaction—Delayed Hemo-                                           500                  1          20/60
                                                                                       lytic Transfusion Reaction.
                                                                                     57.310 Hemovigilance Adverse Reaction—Delayed Sero-                                           500                  2          20/60
                                                                                       logic Transfusion Reaction.
                                                                                     57.311 Hemovigilance Adverse Reaction—Febrile Non-he-                                         500                  4          20/60
                                                                                       molytic Transfusion Reaction.
                                                                                     57.312 Hemovigilance Adverse Reaction—Hypotensive                                             500                  1          20/60
                                                                                       Transfusion Reaction.
                                                                                     57.313 Hemovigilance Adverse Reaction—Infection .............                                 500                  1          20/60
                                                                                     57.314 Hemovigilance Adverse Reaction—Post Transfusion                                        500                  1          20/60
                                                                                       Purpura.
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                                                                                     57.315 Hemovigilance Adverse Reaction—Transfusion As-                                         500                  1          20/60
                                                                                       sociated Dyspnea.
                                                                                     57.316 Hemovigilance Adverse Reaction—Transfusion As-                                         500                  1          20/60
                                                                                       sociated Graft vs. Host Disease.
                                                                                     57.317 Hemovigilance Adverse Reaction—Transfusion Re-                                         500                  1          20/60
                                                                                       lated Acute Lung Injury.
                                                                                     57.318 Hemovigilance Adverse Reaction—Transfusion As-                                         500                  2          20/60
                                                                                       sociated Circulatory Overload.



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                                                                        Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices                                                            46493

                                                                                               ESTIMATED ANNUALIZED BURDEN HOURS—Continued
                                                                                                                                                                                                              Average
                                                                                                                                                                                              Number of
                                                                                                                                                                            Number of                       burden per
                                                    Type of respondents                                               Form name                                                             responses per
                                                                                                                                                                           respondents                       response
                                                                                                                                                                                              respondent     (in hours)

                                                                                     57.319 Hemovigilance Adverse Reaction—Unknown Trans-                                          500                  1          20/60
                                                                                       fusion Reaction.
                                                                                     57.320 Hemovigilance Adverse Reaction—Other Trans-                                            500                  1          20/60
                                                                                       fusion Reaction.
                                                                                     57.400 Outpatient Procedure Component—Annual Facility                                        5,000                 1          10/60
                                                                                       Survey.
                                                                                     57.401 Outpatient Procedure Component—Monthly Report-                                        5,000                12          20/60
                                                                                       ing Plan.
                                                                                     57.402 Outpatient Procedure Component Same Day Out-                                          1,200                25          40/60
                                                                                       come Measures.
                                                                                     57.403 Outpatient Procedure Component—Monthly Denomi-                                        1,200                12          40/60
                                                                                       nators for Same Day Outcome Measures.
                                                                                     57.404 Outpatient Procedure Component—SSI Denomi-                                            5,000              540           10/60
                                                                                       nator.
                                                                                     57.405 Outpatient Procedure Component—Surgical Site                                          5,000                36          35/60
                                                                                       (SSI) Event.
                                                                                     57.500 Outpatient Dialysis Center Practices Survey .............                             7,000                 1         127/60
                                                                                     57.501 Dialysis Monthly Reporting Plan ................................                      7,000                12           5/60
                                                                                     57.502 Dialysis Event .............................................................          7,000                60          25/60
                                                                                     57.503 Denominator for Outpatient Dialysis ..........................                        7,000                12          10/60
                                                                                     57.504 Prevention Process Measures Monthly Monitoring                                        2,000                12          85/60
                                                                                       for Dialysis.
                                                                                     57.505 Dialysis Patient Influenza Vaccination .......................                         325                 75          10/60
                                                                                     57.506 Dialysis Patient Influenza Vaccination Denominator                                     325                  5          10/60
                                                                                     57.507 Home Dialysis Center Practices Survey ....................                             350                  1          30/60



                                               Jeffrey M. Zirger,                                          response to the notice. This notice                              third party may not wish to be posted,
                                               Acting Chief, Information Collection Review                 solicits comments on the information                             such as medical information, your or
                                               Office, Office of Scientific Integrity, Office              collection associated with the Food                              anyone else’s Social Security number, or
                                               of the Associate Director for Science, Office               Contact Substance Notification Program.                          confidential business information, such
                                               of the Director, Centers for Disease Control                                                                                 as a manufacturing process. Please note
                                                                                                           DATES: Submit either electronic or
                                               and Prevention.                                                                                                              that if you include your name, contact
                                                                                                           written comments on the collection of
                                               [FR Doc. 2018–19902 Filed 9–12–18; 8:45 am]                                                                                  information, or other information that
                                                                                                           information by November 13, 2018.
                                               BILLING CODE 4163–18–P
                                                                                                           ADDRESSES: You may submit comments
                                                                                                                                                                            identifies you in the body of your
                                                                                                           as follows. Please note that late,                               comments, that information will be
                                                                                                           untimely filed comments will not be                              posted on https://www.regulations.gov.
                                               DEPARTMENT OF HEALTH AND                                                                                                       • If you want to submit a comment
                                               HUMAN SERVICES                                              considered. Electronic comments must
                                                                                                                                                                            with confidential information that you
                                                                                                           be submitted on or before November 13,
                                                                                                                                                                            do not wish to be made available to the
                                               Food and Drug Administration                                2018. The https://www.regulations.gov
                                                                                                                                                                            public, submit the comment as a
                                                                                                           electronic filing system will accept                             written/paper submission and in the
                                               [Docket No. FDA–2012–N–0294]
                                                                                                           comments until midnight Eastern Time                             manner detailed (see ‘‘Written/Paper
                                               Agency Information Collection                               at the end of November 13, 2018.                                 Submissions’’ and ‘‘Instructions’’).
                                               Activities; Proposed Collection;                            Comments received by mail/hand
                                               Comment Request; Food Contact                               delivery/courier (for written/paper                              Written/Paper Submissions
                                               Substance Notification Program                              submissions) will be considered timely                             Submit written/paper submissions as
                                                                                                           if they are postmarked or the delivery                           follows:
                                               AGENCY:    Food and Drug Administration,                    service acceptance receipt is on or                                • Mail/Hand Delivery/Courier (for
                                               HHS.                                                        before that date.                                                written/paper submissions): Dockets
                                               ACTION:   Notice.                                           Electronic Submissions                                           Management Staff (HFA–305), Food and
                                                                                                                                                                            Drug Administration, 5630 Fishers
                                               SUMMARY:   The Food and Drug                                  Submit electronic comments in the                              Lane, Rm. 1061, Rockville, MD 20852.
                                               Administration (FDA or Agency) is                           following way:                                                     • For written/paper comments
                                               announcing an opportunity for public                          • Federal eRulemaking Portal:                                  submitted to the Dockets Management
                                               comment on the proposed collection of                       https://www.regulations.gov. Follow the                          Staff, FDA will post your comment, as
                                               certain information by the Agency.                          instructions for submitting comments.                            well as any attachments, except for
                                               Under the Paperwork Reduction Act of                        Comments submitted electronically,                               information submitted, marked and
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                                               1995 (PRA), Federal Agencies are                            including attachments, to https://                               identified, as confidential, if submitted
                                               required to publish notice in the                           www.regulations.gov will be posted to                            as detailed in ‘‘Instructions.’’
                                               Federal Register concerning each                            the docket unchanged. Because your                                 Instructions: All submissions received
                                               proposed collection of information,                         comment will be made public, you are                             must include the Docket No. FDA–
                                               including each proposed extension of an                     solely responsible for ensuring that your                        2012–N–0294 for ‘‘Agency Information
                                               existing collection of information, and                     comment does not include any                                     Collection Activities; Proposed
                                               to allow 60 days for public comment in                      confidential information that you or a                           Collection; Comment Request; Food


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Document Created: 2018-09-13 01:02:07
Document Modified: 2018-09-13 01:02:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation83 FR 46490 

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