83_FR_45618 83 FR 45444 - Proposed Data Collection Submitted for Public Comment and Recommendations

83 FR 45444 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 83, Issue 174 (September 7, 2018)

Page Range45444-45447
FR Document2018-19382

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Healthcare Safety Network (NHSN). 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.

Federal Register, Volume 83 Issue 174 (Friday, September 7, 2018)
[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45444-45447]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19382]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0666; Docket No. CDC-2018-0042]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled National Healthcare Safety 
Network (NHSN). 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.

DATES: CDC must receive written comments on or before November 6, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0042 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    National Healthcare Safety Network (NHSN)--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. The data collected 
will be used to inform and detect changes in the epidemiology of 
adverse events resulting from new and current medical therapies and 
changing risks. NHSN is comprised of six components: Patient Safety, 
Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility, 
Outpatient Procedure, and Dialysis.
    Changes were made to 33 data collection facility surveys with this 
new 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 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

[[Page 45445]]

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 33 forms 
within the package to clarify and/or update surveillance definitions, 
increase or decrease the number of reporting facilities, and add new 
forms.
    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    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Healthcare facility.........  57.100 NHSN                  2,000               1            5/60             167
                               Registration Form.
                              57.101 Facility              2,000               1           10/60             333
                               Contact
                               Information.
                              57.103 Patient               6,000               1            1.17           7,500
                               Safety Component--
                               Annual Hospital
                               Survey.
                              57.105 Group                 1,000               1            5/60              83
                               Contact
                               Information.
                              57.106 Patient               6,000              12           15/60          18,000
                               Safety Monthly
                               Reporting Plan.
                              57.108 Primary               6,000              44           33/60         145,200
                               Bloodstream
                               Infection (BSI).
                              57.111 Pneumonia             1,800              72           30/60          64,800
                               (PNEU).
                              57.112 Ventilator--          6,000             144           28/60         403,200
                               Associated Event.
                              57.113 Pediatric               100             120           30/60           6,000
                               Ventilator--Assoc
                               iated Event
                               (PedVAE).
                              57.114 Urinary               6,000              40           20/60          80,000
                               Tract Infection
                               (UTI).
                              57.115 Custom                  600              91           35/60          31,850
                               Event.
                              57.116                       6,000              12               4         288,000
                               Denominators for
                               Neonatal
                               Intensive Care
                               Unit (NICU).
                              57.117                       2,000               9            5.03          90,600
                               Denominators for
                               Specialty Care
                               Area (SCA)/
                               Oncology (ONC).
                              57.118                       6,000              60            5.03       1,812,000
                               Denominators for
                               Intensive Care
                               Unit (ICU)/Other
                               locations (not
                               NICU or SCA).
                              57.120 Surgical              6,000              36           35/60         126,000
                               Site Infection
                               (SSI).
                              57.121 Denominator           6,000             540           10/60         540,000
                               for Procedure.
                              57.122 HAI                      55               1           45/60              41
                               Progress Report
                               State Health
                               Department Survey.
                              57.123                       1,000              12            5/60           1,000
                               Antimicrobial Use
                               and Resistance
                               (AUR)--Microbiolo
                               gy Data
                               Electronic Upload
                               Specification
                               Tables.

[[Page 45446]]

 
                              57.124                       2,000              12            5/60           2,000
                               Antimicrobial Use
                               and Resistance
                               (AUR)--Pharmacy
                               Data Electronic
                               Upload
                               Specification
                               Tables.
                              57.125 Central                 100             100           25/60           4,167
                               Line Insertion
                               Practices
                               Adherence
                               Monitoring.
                              57.126 MDRO or CDI           6,000              72           30/60         216,000
                               Infection Form.
                              57.127 MDRO and              6,000              24           15/60          36,000
                               CDI Prevention
                               Process and
                               Outcome Measures
                               Monthly
                               Monitoring.
                              57.128 Laboratory-           6,000             240           20/60         480,000
                               identified MDRO
                               or CDI Event.
                              57.129 Adult                    50             250           25/60           5,208
                               Sepsis.
                              57.137 Long-Term             2,600               1               2           5,200
                               Care Facility
                               Component--Annual
                               Facility Survey.
                              57.138 Laboratory-           2,600              12           20/60          10,400
                               identified MDRO
                               or CDI Event for
                               LTCF.
                              57.139 MDRO and              2,600              12           20/60          10,400
                               CDI Prevention
                               Process Measures
                               Monthly
                               Monitoring for
                               LTCF.
                              57.140 Urinary               2,600              14           35/60          18,200
                               Tract Infection
                               (UTI) for LTCF.
                              57.141 Monthly               2,600              12            5/60           2,600
                               Reporting Plan
                               for LTCF.
                              57.142                       2,600              12            4.17         130,000
                               Denominators for
                               LTCF Locations.
                              57.143 Prevention            2,600              12            5/60           2,600
                               Process Measures
                               Monthly
                               Monitoring for
                               LTCF.
                              57.150 LTAC Annual             400               1            1.17             467
                               Survey.
                              57.151 Rehab                 1,000               1            1.17           1,167
                               Annual Survey.
                              57.200 Healthcare               50               1               8             400
                               Personnel Safety
                               Component Annual
                               Facility Survey.
                              57.203 Healthcare           19,500               1            5/60           1,625
                               Personnel Safety
                               Monthly Reporting
                               Plan.
                              57.204 Healthcare               50             200           20/60           3,333
                               Worker
                               Demographic Data.
                              57.205 Exposure to              50              50               1           2,500
                               Blood/Body Fluids.
                              57.206 Healthcare               50              30           15/60             375
                               Worker
                               Prophylaxis/
                               Treatment.
                              57.207 Follow-Up                50              50           15/60             625
                               Laboratory
                               Testing.
                              57.210 Healthcare               50              50           10/60             417
                               Worker
                               Prophylaxis/
                               Treatment--Influe
                               nza.
                              57.300                         500               1            1.42             708
                               Hemovigilance
                               Module Annual
                               Survey.
                              57.301                         500              12            1/60             100
                               Hemovigilance
                               Module Monthly
                               Reporting Plan.
                              57.303                         500              12            1.17           7,000
                               Hemovigilance
                               Module Monthly
                               Reporting
                               Denominators.
                              57.305                         500              10           10/60             833
                               Hemovigilance
                               Incident.
                              57.306                         200               1           35/60             117
                               Hemovigilance
                               Module Annual
                               Survey--Non-acute
                               care facility.
                              57.307                         500               4           20/60             667
                               Hemovigilance
                               Adverse Reaction--
                               Acute Hemolytic
                               Transfusion
                               Reaction.
                              57.308                         500               4           20/60             667
                               Hemovigilance
                               Adverse Reaction--
                               Allergic
                               Transfusion
                               Reaction.
                              57.309                         500               1           20/60             167
                               Hemovigilance
                               Adverse Reaction--
                               Delayed Hemolytic
                               Transfusion
                               Reaction.
                              57.310                         500               2           20/60             333
                               Hemovigilance
                               Adverse Reaction--
                               Delayed Serologic
                               Transfusion
                               Reaction.
                              57.311                         500               4           20/60             667
                               Hemovigilance
                               Adverse Reaction--
                               Febrile Non-
                               hemolytic
                               Transfusion
                               Reaction.
                              57.312                         500               1           20/60             167
                               Hemovigilance
                               Adverse Reaction--
                               Hypotensive
                               Transfusion
                               Reaction.
                              57.313                         500               1           20/60             167
                               Hemovigilance
                               Adverse Reaction--
                               Infection.
                              57.314                         500               1           20/60             167
                               Hemovigilance
                               Adverse Reaction--
                               Post Transfusion
                               Purpura.
                              57.315                         500               1           20/60             167
                               Hemovigilance
                               Adverse Reaction--
                               Transfusion
                               Associated
                               Dyspnea.
                              57.316                         500               1           20/60             167
                               Hemovigilance
                               Adverse Reaction--
                               Transfusion
                               Associated Graft
                               vs. Host Disease.
                              57.317                         500               1           20/60             167
                               Hemovigilance
                               Adverse Reaction--
                               Transfusion
                               Related Acute
                               Lung Injury.
                              57.318                         500               2           20/60             333
                               Hemovigilance
                               Adverse Reaction--
                               Transfusion
                               Associated
                               Circulatory
                               Overload.
                              57.319                         500               1           20/60             167
                               Hemovigilance
                               Adverse Reaction--
                               Unknown
                               Transfusion
                               Reaction.
                              57.320                         500               1           20/60             167
                               Hemovigilance
                               Adverse Reaction--
                               Other Transfusion
                               Reaction.

[[Page 45447]]

 
                              57.400 Outpatient            5,000               1           10/60             417
                               Procedure
                               Component--Annual
                               Facility Survey.
                              57.401 Outpatient            5,000              12           20/60          15,000
                               Procedure
                               Component--Monthl
                               y Reporting Plan.
                              57.402 Outpatient            1,200              25           40/60          20,000
                               Procedure
                               Component Same
                               Day Outcome
                               Measures.
                              57.403 Outpatient            1,200              12           40/60           9,600
                               Procedure
                               Component--Monthl
                               y Denominators
                               for Same Day
                               Outcome Measures.
                              57.404 Outpatient            5,000             540           10/60         450,000
                               Procedure
                               Component--SSI
                               Denominator.
                              57.405 Outpatient            5,000              36           35/60         105,000
                               Procedure
                               Component--Surgic
                               al Site (SSI)
                               Event.
                              57.500 Outpatient            7,000               1            2.12          14,817
                               Dialysis Center
                               Practices Survey.
                              57.501 Dialysis              7,000              12            5/60           7,000
                               Monthly Reporting
                               Plan.
                              57.502 Dialysis              7,000              60           25/60         175,000
                               Event.
                              57.503 Denominator           7,000              12           10/60          14,000
                               for Outpatient
                               Dialysis.
                              57.504 Prevention            2,000              12            1.42          17,000
                               Process Measures
                               Monthly
                               Monitoring for
                               Dialysis.
                              57.505 Dialysis                325              75           10/60           4,063
                               Patient Influenza
                               Vaccination.
                              57.506 Dialysis                325               5           10/60             271
                               Patient Influenza
                               Vaccination
                               Denominator.
                              57.507 Home                    350               1           30/60             175
                               Dialysis Center
                               Practices Survey.
                                                 ---------------------------------------------------------------
    Total...................  ..................  ..............  ..............  ..............       5,393,725
----------------------------------------------------------------------------------------------------------------


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. 2018-19382 Filed 9-6-18; 8:45 am]
 BILLING CODE 4163-18-P?>



                                               45444                       Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices

                                               Centers for Disease Control and                         ADDRESSES:    You may submit comments,                are to respond, including through the
                                               Prevention, 1600 Clifton Road NE, MS–                   identified by Docket No. CDC–2018–                    use of appropriate automated,
                                               D74, Atlanta, Georgia 30329; phone:                     0042 by any of the following methods:                 electronic, mechanical, or other
                                               404–639–7570; email: omb@cdc.gov.                          • Federal eRulemaking Portal:                      technological collection techniques or
                                               SUPPLEMENTARY INFORMATION: On August                    Regulations.gov. Follow the instructions              other forms of information technology,
                                               22, 2018 CDC published a notice in the                  for submitting comments.                              e.g., permitting electronic submissions
                                               Federal Register titled ‘‘Information                      • Mail: Jeffrey M. Zirger, Information             of responses.
                                               Collection for Tuberculosis Data from                   Collection Review Office, Centers for                   5. Assess information collection costs.
                                               Panel Physicians’’ (Vol. 83, No. 163                    Disease Control and Prevention, 1600
                                                                                                       Clifton Road NE, MS–D74, Atlanta,                     Proposed Project
                                               Docket No. CDC–2018–0049, Pages
                                                                                                       Georgia 30329.                                          National Healthcare Safety Network
                                               42502–542503). This notice was
                                                                                                          Instructions: All submissions received             (NHSN)—Revision—National Center for
                                               published inadvertently. The notice is
                                                                                                       must include the agency name and                      Emerging and Zoonotic Infectious
                                               being withdrawn immediately for public                                                                        Diseases (NCEZID), Centers for Disease
                                                                                                       Docket Number. CDC will post, without
                                               comment.                                                                                                      Control and Prevention (CDC).
                                                                                                       change, all relevant comments to
                                               Jeffrey M. Zirger,                                      Regulations.gov.
                                                                                                                                                             Background and Brief Description
                                               Acting Chief, Information Collection Review                Please note: Submit all comments
                                               Office, Office of Scientific Integrity, Office          through the Federal eRulemaking portal                   NHSN is a public health surveillance
                                               of the Associate Director for Science, Office           (regulations.gov) or by U.S. mail to the              system that collects, analyzes, reports,
                                               of the Director, Centers for Disease Control            address listed above.                                 and makes available data for
                                               and Prevention.                                         FOR FURTHER INFORMATION CONTACT: To                   monitoring, measuring, and responding
                                               [FR Doc. 2018–19383 Filed 9–6–18; 8:45 am]              request more information on the                       to healthcare associated infections
                                               BILLING CODE 4163–18–P                                  proposed project or to obtain a copy of               (HAIs), antimicrobial use and resistance,
                                                                                                       the information collection plan and                   blood transfusion safety events, and the
                                                                                                       instruments, contact Leroy A.                         extent to which healthcare facilities
                                               DEPARTMENT OF HEALTH AND                                Richardson, Information Collection                    adhere to infection prevention practices
                                               HUMAN SERVICES                                          Review Office, Centers for Disease                    and antimicrobial stewardship. The data
                                                                                                       Control and Prevention, 1600 Clifton                  collected will be used to inform and
                                               Centers for Disease Control and                         Road NE, MS–D74, Atlanta, Georgia                     detect changes in the epidemiology of
                                               Prevention                                              30329; phone: 404–639–7570; Email:                    adverse events resulting from new and
                                               [60Day–18–0666; Docket No. CDC–2018–                    omb@cdc.gov.                                          current medical therapies and changing
                                               0042]                                                   SUPPLEMENTARY INFORMATION: Under the
                                                                                                                                                             risks. NHSN is comprised of six
                                                                                                       Paperwork Reduction Act of 1995 (PRA)                 components: Patient Safety, Healthcare
                                               Proposed Data Collection Submitted                      (44 U.S.C. 3501–3520), Federal agencies               Personnel Safety, Biovigilance, Long-
                                               for Public Comment and                                  must obtain approval from the Office of               Term Care Facility, Outpatient
                                               Recommendations                                         Management and Budget (OMB) for each                  Procedure, and Dialysis.
                                                                                                       collection of information they conduct                   Changes were made to 33 data
                                               AGENCY: Centers for Disease Control and                                                                       collection facility surveys with this new
                                               Prevention (CDC), Department of Health                  or sponsor. In addition, the PRA also
                                                                                                       requires Federal agencies to provide a                ICR. CDC revised three annual facility
                                               and Human Services (HHS).                                                                                     surveys for the Patient Safety
                                                                                                       60-day notice in the Federal Register
                                               ACTION: Notice with comment period.                                                                           component for Hospitals, Long-Term
                                                                                                       concerning each proposed collection of
                                                                                                       information, including each new                       Acute Care Facilities, and Inpatient
                                               SUMMARY:   The Centers for Disease                                                                            Rehabilitation Facilities. CDC’s
                                               Control and Prevention (CDC), as part of                proposed collection, each proposed
                                                                                                       extension of existing collection of                   revisions clarify the reporting
                                               its continuing effort to reduce public                                                                        requirements for the data collected on
                                               burden and maximize the utility of                      information, and each reinstatement of
                                                                                                       previously approved information                       fungal testing, facility locations, and
                                               government information, invites the                                                                           laboratory testing locations.
                                               general public and other Federal                        collection before submitting the
                                                                                                       collection to the OMB for approval. To                Additionally, corresponding response
                                               agencies the opportunity to comment on                                                                        options for these questions have been
                                               a proposed and/or continuing                            comply with this requirement, we are
                                                                                                       publishing this notice of a proposed                  revised to include updated testing
                                               information collection, as required by                                                                        methods used by facilities to capture
                                               the Paperwork Reduction Act of 1995.                    data collection as described below.
                                                                                                          The OMB is particularly interested in              current HAI specific data specification
                                               This notice invites comment on a                                                                              requirements for NHSN. New required
                                               proposed information collection project                 comments that will help:
                                                                                                          1. Evaluate whether the proposed                   questions have been added to all Patient
                                               titled National Healthcare Safety                                                                             Safety component surveys. The new
                                               Network (NHSN). NHSN is a public                        collection of information is necessary
                                                                                                       for the proper performance of the                     questions are designed to provide data
                                               health surveillance system that collects,                                                                     on surveillance processes, policies, and
                                               analyzes, reports, and makes available                  functions of the agency, including
                                                                                                       whether the information will have                     standards that are used by reporting
                                               data for monitoring, measuring, and                                                                           facilities to ensure that when an event
                                               responding to healthcare associated                     practical utility;
                                                                                                          2. Evaluate the accuracy of the                    is detected, the facility has the
                                               infections (HAIs), antimicrobial use and                                                                      appropriate mechanism to conduct
                                                                                                       agency’s estimate of the burden of the
                                               resistance, blood transfusion safety                                                                          complete reporting. The Hospital
                                                                                                       proposed collection of information,
daltland on DSKBBV9HB2PROD with NOTICES




                                               events, and the extent to which                                                                               Annual Survey added new required
                                                                                                       including the validity of the
                                               healthcare facilities adhere to infection                                                                     questions to provide data about neonatal
                                                                                                       methodology and assumptions used;
                                               prevention practices and antimicrobial                                                                        antimicrobial stewardship practices
                                                                                                          3. Enhance the quality, utility, and
                                               stewardship.                                                                                                  because the focus of stewardship efforts
                                                                                                       clarity of the information to be
                                               DATES:CDC must receive written                          collected; and                                        in neonatology differ from the focus in
                                               comments on or before November 6,                          4. Minimize the burden of the                      adult and pediatric practice. Questions
                                               2018.                                                   collection of information on those who                were removed and replaced on all three


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                                                                            Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices                                                 45445

                                               Patient Safety surveys to align better                     are important data for users of CDC’s                   specimen, variability in the use of
                                               with the Core Elements of Hospital                         HAI Progress Report to consider when                    diagnostic testing as part of CDI
                                               Antibiotic Stewardship Programs                            they are reviewing and interpreting data                management will have direct impact on
                                               specified by CDC. The Core Elements                        in the report.                                          the estimate of CDI burden in a facility
                                               defined by CDC are part of broad-based                        NHSN now includes a ventilator-                      (e.g., empiric treatment for CDI without
                                               efforts by CDC and its healthcare and                      associated event available for NICU                     confirmatory testing may result in the
                                               public health partners to combat the                       locations, which requires additional                    appearance of low disease burden). In
                                               threat of antibiotic-resistant bacteria.                   denominator reporting, in which CDC                     order to determine whether low CDI
                                               The new Antibiotic Stewardship                             has provided an option to accommodate                   event rates might be due to empiric CDI
                                               Program questions will provide                             facilities that are reporting requested                 treatment practices, a new process
                                               additional data about operational                          data by updating the corresponding                      measure will be incorporated into the
                                               features of the programs that hospitals                    surveys. The Pediatric Ventilator-                      monthly summary data on CDI for
                                               have implemented, which in turn will                       Associated Event (PedVAE) was                           LTCFs. This measure, called ‘‘CDI
                                               enable CDC and its healthcare and                          removed from the survey because a                       treatment starts,’’ will allow providers
                                               public health partners to target their                     single algorithm is used to detect                      to capture the number of residents
                                               efforts to help invigorate and extend                      PedVAE events.                                          started on antibiotic treatment for CDI
                                               antibiotic stewardship.                                       NHSN has made updates to the                         that month based on clinical decisions
                                                  CDC is introducing a new optional                       Antimicrobial Use and Resistance                        (i.e., even those without a positive CDI
                                               survey form that is designed to be                         (AUR) data collection tools for the                     test). This process measure should
                                               completed by state and local health                        purposes of monitoring additional                       provide data on clinically-treated CDI in
                                               departments that participate in HAI                        microorganisms and their antimicrobial                  order to inform our understanding of
                                               surveillance and prevention activities.                    susceptibility profiles. Use of these                   CDI management practices and serve as
                                               This new form will provide data on                         updates in AUR surveillance will                        a proxy for CDI burden in nursing
                                               legal and regulatory requirements that                     provide important additional data for                   homes.
                                               are pertinent to HAI reporting. CDC                        clinical and public health responses to
                                               plans to include data the health                           mounting antibiotic resistance                             Overall, minor revisions have been
                                               department survey in its annual                            problems.                                               made to a total of 33 forms within the
                                               National and State Healthcare-                                The Long-term Care Facility                          package to clarify and/or update
                                               Associated Infection Progress Report.                      Component (LTCF) will be updating                       surveillance definitions, increase or
                                               The report helps identify the progress in                  three forms, two of which will include                  decrease the number of reporting
                                               HAI surveillance and prevention at the                     an update for facilities to document the                facilities, and add new forms.
                                               state and national levels. Data about the                  ‘‘CDI treatment start’’ variable. Early CDI                The previously approved NHSN
                                               extent to which state health                               reporting data from nursing homes has                   package included 72 individual
                                               departments have validated HAI data                        shown exceptionally low event rates for                 collection forms; the current revision
                                               that healthcare facilities in their                        many reporting facilities (e.g., zero                   request includes a total of 73 forms. The
                                               jurisdiction report to NHSN and the                        events for six or more months). Since                   reporting burden will decrease by
                                               extent of state and local health                           current CDI event detection is based on                 109,745 hours, for a total of 5,393,725
                                               department HAI reporting requirements                      presence of a positive laboratory                       hours.

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

                                               Healthcare facility ....   57.100 NHSN Registration Form ............................                    2,000                 1             5/60            167
                                                                          57.101 Facility Contact Information ........................                  2,000                 1            10/60            333
                                                                          57.103 Patient Safety Component—Annual Hos-                                   6,000                 1             1.17          7,500
                                                                            pital Survey.
                                                                          57.105 Group Contact Information ..........................                   1,000                1              5/60            83
                                                                          57.106 Patient Safety Monthly Reporting Plan .......                          6,000               12             15/60        18,000
                                                                          57.108 Primary Bloodstream Infection (BSI) ..........                         6,000               44             33/60       145,200
                                                                          57.111 Pneumonia (PNEU) .....................................                 1,800               72             30/60        64,800
                                                                          57.112 Ventilator—Associated Event ......................                     6,000              144             28/60       403,200
                                                                          57.113 Pediatric Ventilator—Associated Event                                    100              120             30/60         6,000
                                                                            (PedVAE).
                                                                          57.114 Urinary Tract Infection (UTI) .......................                  6,000               40             20/60        80,000
                                                                          57.115 Custom Event ..............................................              600               91             35/60        31,850
                                                                          57.116 Denominators for Neonatal Intensive Care                               6,000               12                 4       288,000
                                                                            Unit (NICU).
                                                                          57.117 Denominators for Specialty Care Area                                   2,000                 9             5.03        90,600
                                                                            (SCA)/Oncology (ONC).
                                                                          57.118 Denominators for Intensive Care Unit                                   6,000               60              5.03     1,812,000
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                                                                            (ICU)/Other locations (not NICU or SCA).
                                                                          57.120 Surgical Site Infection (SSI) ........................                 6,000               36             35/60       126,000
                                                                          57.121 Denominator for Procedure .........................                    6,000              540             10/60       540,000
                                                                          57.122 HAI Progress Report State Health Depart-                                  55                1             45/60            41
                                                                            ment Survey.
                                                                          57.123 Antimicrobial Use and Resistance (AUR)—                                1,000               12              5/60          1,000
                                                                            Microbiology Data Electronic Upload Specification
                                                                            Tables.



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                                               45446                       Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices

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

                                                                         57.124 Antimicrobial Use and Resistance (AUR)—                                  2,000               12              5/60          2,000
                                                                           Pharmacy Data Electronic Upload Specification
                                                                           Tables.
                                                                         57.125 Central Line Insertion Practices Adherence                                 100              100             25/60          4,167
                                                                           Monitoring.
                                                                         57.126 MDRO or CDI Infection Form .....................                         6,000               72             30/60       216,000
                                                                         57.127 MDRO and CDI Prevention Process and                                      6,000               24             15/60        36,000
                                                                           Outcome Measures Monthly Monitoring.
                                                                         57.128 Laboratory-identified MDRO or CDI Event                                  6,000              240             20/60       480,000
                                                                         57.129 Adult Sepsis ................................................               50              250             25/60         5,208
                                                                         57.137 Long-Term Care Facility Component—An-                                    2,600                1                 2         5,200
                                                                           nual Facility Survey.
                                                                         57.138 Laboratory-identified MDRO or CDI Event                                  2,600               12             20/60        10,400
                                                                           for LTCF.
                                                                         57.139 MDRO and CDI Prevention Process Meas-                                    2,600               12             20/60        10,400
                                                                           ures Monthly Monitoring for LTCF.
                                                                         57.140 Urinary Tract Infection (UTI) for LTCF ........                          2,600               14             35/60        18,200
                                                                         57.141 Monthly Reporting Plan for LTCF ...............                          2,600               12              5/60         2,600
                                                                         57.142 Denominators for LTCF Locations ..............                           2,600               12              4.17       130,000
                                                                         57.143 Prevention Process Measures Monthly                                      2,600               12              5/60         2,600
                                                                           Monitoring for LTCF.
                                                                         57.150 LTAC Annual Survey ..................................                      400                 1             1.17            467
                                                                         57.151 Rehab Annual Survey .................................                    1,000                 1             1.17          1,167
                                                                         57.200 Healthcare Personnel Safety Component                                       50                 1                8            400
                                                                           Annual Facility Survey.
                                                                         57.203 Healthcare Personnel Safety Monthly Re-                                 19,500                 1             5/60          1,625
                                                                           porting Plan.
                                                                         57.204 Healthcare Worker Demographic Data .......                                  50              200             20/60          3,333
                                                                         57.205 Exposure to Blood/Body Fluids ...................                           50               50                 1          2,500
                                                                         57.206 Healthcare Worker Prophylaxis/Treatment                                     50               30             15/60            375
                                                                         57.207 Follow-Up Laboratory Testing .....................                          50               50             15/60            625
                                                                         57.210 Healthcare Worker Prophylaxis/Treat-                                        50               50             10/60            417
                                                                           ment—Influenza.
                                                                         57.300 Hemovigilance Module Annual Survey .......                                 500                1              1.42           708
                                                                         57.301 Hemovigilance Module Monthly Reporting                                     500               12              1/60           100
                                                                           Plan.
                                                                         57.303 Hemovigilance Module Monthly Reporting                                     500               12              1.17          7,000
                                                                           Denominators.
                                                                         57.305 Hemovigilance Incident ...............................                     500               10             10/60           833
                                                                         57.306 Hemovigilance Module Annual Survey—                                        200                1             35/60           117
                                                                           Non-acute care facility.
                                                                         57.307 Hemovigilance Adverse Reaction—Acute                                       500                 4            20/60           667
                                                                           Hemolytic Transfusion Reaction.
                                                                         57.308 Hemovigilance Adverse Reaction—Allergic                                    500                 4            20/60           667
                                                                           Transfusion Reaction.
                                                                         57.309 Hemovigilance Adverse Reaction—Delayed                                     500                 1            20/60           167
                                                                           Hemolytic Transfusion Reaction.
                                                                         57.310 Hemovigilance Adverse Reaction—Delayed                                     500                 2            20/60           333
                                                                           Serologic Transfusion Reaction.
                                                                         57.311 Hemovigilance Adverse Reaction—Febrile                                     500                 4            20/60           667
                                                                           Non-hemolytic Transfusion Reaction.
                                                                         57.312 Hemovigilance Adverse Reaction—                                            500                 1            20/60           167
                                                                           Hypotensive Transfusion Reaction.
                                                                         57.313 Hemovigilance Adverse Reaction—Infec-                                      500                 1            20/60           167
                                                                           tion.
                                                                         57.314 Hemovigilance Adverse Reaction—Post                                        500                 1            20/60           167
                                                                           Transfusion Purpura.
                                                                         57.315 Hemovigilance Adverse Reaction—Trans-                                      500                 1            20/60           167
                                                                           fusion Associated Dyspnea.
                                                                         57.316 Hemovigilance Adverse Reaction—Trans-                                      500                 1            20/60           167
                                                                           fusion Associated Graft vs. Host Disease.
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                                                                         57.317 Hemovigilance Adverse Reaction—Trans-                                      500                 1            20/60           167
                                                                           fusion Related Acute Lung Injury.
                                                                         57.318 Hemovigilance Adverse Reaction—Trans-                                      500                 2            20/60           333
                                                                           fusion Associated Circulatory Overload.
                                                                         57.319 Hemovigilance Adverse Reaction—Un-                                         500                 1            20/60           167
                                                                           known Transfusion Reaction.
                                                                         57.320 Hemovigilance Adverse Reaction—Other                                       500                 1            20/60           167
                                                                           Transfusion Reaction.



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                                                                                Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices                                                                                                45447

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

                                                                              57.400 Outpatient Procedure Component—Annual                                                          5,000                             1                   10/60               417
                                                                                Facility Survey.
                                                                              57.401 Outpatient Procedure Component—Month-                                                          5,000                           12                    20/60            15,000
                                                                                ly Reporting Plan.
                                                                              57.402 Outpatient Procedure Component Same                                                            1,200                           25                    40/60            20,000
                                                                                Day Outcome Measures.
                                                                              57.403 Outpatient Procedure Component—Month-                                                          1,200                           12                    40/60              9,600
                                                                                ly Denominators for Same Day Outcome Meas-
                                                                                ures.
                                                                              57.404 Outpatient Procedure Component—SSI                                                             5,000                         540                     10/60           450,000
                                                                                Denominator.
                                                                              57.405 Outpatient Procedure Component—Sur-                                                            5,000                           36                    35/60           105,000
                                                                                gical Site (SSI) Event.
                                                                              57.500 Outpatient Dialysis Center Practices Sur-                                                      7,000                             1                     2.12           14,817
                                                                                vey.
                                                                              57.501 Dialysis Monthly Reporting Plan .................                                              7,000                           12                     5/60             7,000
                                                                              57.502 Dialysis Event ..............................................                                  7,000                           60                    25/60           175,000
                                                                              57.503 Denominator for Outpatient Dialysis ...........                                                7,000                           12                    10/60            14,000
                                                                              57.504 Prevention Process Measures Monthly                                                            2,000                           12                     1.42            17,000
                                                                                Monitoring for Dialysis.
                                                                              57.505 Dialysis Patient Influenza Vaccination ........                                                   325                          75                    10/60              4,063
                                                                              57.506 Dialysis Patient Influenza Vaccination De-                                                        325                           5                    10/60                271
                                                                                nominator.
                                                                              57.507 Home Dialysis Center Practices Survey .....                                                       350                            1                   30/60               175

                                                    Total .................   ....................................................................................   ........................   ........................   ........................     5,393,725



                                               Jeffrey M. Zirger,                                                     ADDRESSES:   The CPSTF Meeting will be                                        identified could result in the inability to
                                               Acting Chief, Information Collection Review                            held at the CDC Edward R. Roybal                                              attend the CPSTF meeting in person.
                                               Office, Office of Scientific Integrity, Office                         Campus, Centers for Disease Control                                              Those unable to attend the meeting in
                                               of the Associate Director for Science, Office                          and Prevention Headquarters (Building                                         person are able to do so via Webcast.
                                               of the Director, Centers for Disease Control                           19), 1600 Clifton Road NE, Atlanta, GA                                        CDC will send the Webcast URL to
                                               and Prevention.                                                        30329. You should be aware that the                                           registrants upon receipt of their
                                               [FR Doc. 2018–19382 Filed 9–6–18; 8:45 am]                             meeting location is in a Federal                                              registration. All meeting attendees must
                                               BILLING CODE 4163–18–P?≤                                               government building; therefore, Federal                                       register by October 11, 2018 to receive
                                                                                                                      security measures are applicable. For                                         the webcast information. CDC will email
                                                                                                                      additional information, please see                                            webcast information from the CPSTF@
                                               DEPARTMENT OF HEALTH AND                                               Roybal Campus Security Guidelines                                             cdc.gov mailbox.
                                               HUMAN SERVICES                                                         under SUPPLEMENTARY INFORMATION.                                                 To register for the meeting, whether in
                                                                                                                      Information regarding meeting logistics                                       person or via webcast, individuals
                                               Centers for Disease Control and
                                                                                                                      will be available on the Community                                            should send an email to CPSTF@cdc.gov
                                               Prevention
                                                                                                                      Guide website (www.thecommunity                                               and include the following information:
                                               Meeting of the Community Preventive                                    guide.org) closer to the date of the                                          name, title, organization name,
                                               Services Task Force (CPSTF)                                            meeting.                                                                      organization address, phone, email, and
                                                                                                                      FOR FURTHER INFORMATION CONTACT:                                              whether attending in person or via
                                               AGENCY: Centers for Disease Control and                                Onslow Smith, Center for Surveillance,                                        webcast.
                                               Prevention (CDC), Department of Health                                 Epidemiology and Laboratory Services;                                            Public Comment: A public comment
                                               and Human Services (HHS).                                              Centers for Disease Control and                                               period, limited to three minutes per
                                                                                                                      Prevention, 1600 Clifton Road NE, MS–                                         person, will follow the CPSTF’s
                                               ACTION:    Notice of meeting.
                                                                                                                      E–69, Atlanta, GA 30329, phone: (404)                                         discussion of each systematic review.
                                                                                                                      498–6778, email: CPSTF@cdc.gov.                                               Individuals wishing to make public
                                               SUMMARY:  The Centers for Disease                                                                                                                    comments must indicate their desire to
                                                                                                                      SUPPLEMENTARY INFORMATION:
                                               Control and Prevention (CDC) within                                                                                                                  do so with their registration by
                                                                                                                         Meeting Accessibility: This space-
                                               the Department of Health and Human                                                                                                                   providing their name, organizational
                                                                                                                      limited meeting is open to the public.
                                               Services announces the next meeting of                                                                                                               affiliation, and the topic to be addressed
                                                                                                                      All meeting attendees must register. To
                                               the Community Preventive Services                                                                                                                    (if known). Public comments will
                                                                                                                      ensure completion of required security
daltland on DSKBBV9HB2PROD with NOTICES




                                               Task Force (CPSTF) on October 17–18,                                                                                                                 become part of the meeting summary.
                                                                                                                      procedures and access to the CDC’s
                                               2018, in Atlanta, Georgia.                                                                                                                           Public comment is not possible via
                                                                                                                      Global Communications Center, U.S.
                                               DATES:  The meeting will be held on                                    citizens intending to attend in person                                        Webcast.
                                               Wednesday, October 17, 2018, from 8:30                                 must register by October 10, 2018, and                                           Background on the CPSTF: The
                                               a.m. to 6:00 p.m. EDT and Thursday,                                    non-U.S. citizens intending to attend in                                      CPSTF is an independent, nonfederal
                                               October 18, 2018, from 8:30 a.m. to 1:00                               person must register by September 19,                                         panel whose members are appointed by
                                               p.m. EDT.                                                              2018. Failure to register by the dates                                        the CDC Director. CPSTF members


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Document Created: 2018-09-07 00:15:33
Document Modified: 2018-09-07 00:15:33
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
ActionNotice with comment period.
DatesCDC must receive written comments on or before November 6, 2018.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation83 FR 45444 

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