83_FR_22166 83 FR 22074 - Proposed Data Collection Submitted for Public Comment and Recommendations

83 FR 22074 - 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 92 (May 11, 2018)

Page Range22074-22077
FR Document2018-10094

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 92 (Friday, May 11, 2018)
[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22074-22077]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10094]


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

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 July 10, 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

[[Page 22075]]

options for these questions have been revised to include updated 
testing methods used by facilities to capture current HAI specific data 
specification requirements for NHSN. New required questions have been 
added to all Patient Safety component surveys. The new questions are 
designed to provide data on surveillance processes, policies, and 
standards that are used by reporting facilities to ensure that when an 
event is detected, the facility has the appropriate mechanism to 
conduct complete reporting. The Hospital Annual Survey added new 
required questions to provide data about neonatal antimicrobial 
stewardship practices because the focus of stewardship efforts in 
neonatology differ from the focus in adult and pediatric practice. 
Questions were removed and replaced on all three Patient Safety surveys 
to align better with the Core Elements of Hospital Antibiotic 
Stewardship Programs specified by CDC. The Core Elements defined by CDC 
are part of broad-based efforts by CDC and its healthcare and public 
health partners to combat the threat of antibiotic-resistant bacteria. 
The new Antibiotic Stewardship Program questions will provide 
additional data about operational features of the programs that 
hospitals have implemented, which in turn will enable CDC and its 
healthcare and public health partners to target their efforts to help 
invigorate and extend antibiotic stewardship.
    CDC is introducing a new optional survey form that is designed to 
be completed by state and local health departments that participate in 
HAI surveillance and prevention activities. This new form will provide 
data on legal and regulatory requirements that are pertinent to HAI 
reporting. CDC plans to include data the health department survey in 
its annual National and State Healthcare-Associated Infection Progress 
Report. The report helps identify the progress in HAI surveillance and 
prevention at the state and national levels. Data about the extent to 
which state health departments have validated HAI data that healthcare 
facilities in their jurisdiction report to NHSN and the extent of state 
and local health department HAI reporting requirements are important 
data for users of CDC's HAI Progress Report to consider when they are 
reviewing and interpreting data in the report.
    NHSN now includes a ventilator-associated event available for NICU 
locations, which requires additional denominator reporting, in which 
CDC has provided an option to accommodate facilities that are reporting 
requested data by updating the corresponding surveys. The Pediatric 
Ventilator-Associated Event (PedVAE) was removed from the survey 
because a single algorithm is used to detect PedVAE events.
    NHSN has made updates to the Antimicrobial Use and Resistance (AUR) 
data collection tools for the purposes of monitoring additional 
microorganisms and their antimicrobial susceptibility profiles. Use of 
these updates in AUR surveillance will provide important additional 
data for clinical and public health responses to mounting antibiotic 
resistance problems.
    The Long-term Care Facility Component (LTCF) will be updating three 
forms, two of which will include an update for facilities to document 
the ``CDI treatment start'' variable. Early CDI reporting data from 
nursing homes has shown exceptionally low event rates for many 
reporting facilities (e.g., zero events for six or more months). Since 
current CDI event detection is based on presence of a positive 
laboratory specimen, variability in the use of diagnostic testing as 
part of CDI management will have direct impact on the estimate of CDI 
burden in a facility (e.g., empiric treatment for CDI without 
confirmatory testing may result in the appearance of low disease 
burden). In order to determine whether low CDI event rates might be due 
to empiric CDI treatment practices, a new process measure will be 
incorporated into the monthly summary data on CDI for LTCFs. This 
measure, called ``CDI treatment starts,'' will allow providers to 
capture the number of residents started on antibiotic treatment for CDI 
that month based on clinical decisions (i.e., even those without a 
positive CDI test). This process measure should provide data on 
clinically-treated CDI in order to inform our understanding of CDI 
management practices and serve as a proxy for CDI burden in nursing 
homes.
    Overall, minor revisions have been made to a total of 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 Registration Form.........           2,000               1            5/60             167
                                                  57.101 Facility Contact Information...           2,000               1           10/60             333
                                                  57.103 Patient Safety Component--                6,000               1            1.17           7,500
                                                   Annual Hospital Survey.
                                                  57.105 Group Contact Information......           1,000               1            5/60              83
                                                  57.106 Patient Safety Monthly                    6,000              12           15/60          18,000
                                                   Reporting Plan.
                                                  57.108 Primary Bloodstream Infection             6,000              44           33/60         145,200
                                                   (BSI).
                                                  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             100             120           30/60           6,000
                                                   Event (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                 6,000              12               4         288,000
                                                   Intensive Care Unit (NICU).
                                                  57.117 Denominators for Specialty Care           2,000               9            5.03          90,600
                                                   Area (SCA)/Oncology (ONC).

[[Page 22076]]

 
                                                  57.118 Denominators for Intensive Care           6,000              60            5.03       1,812,000
                                                   Unit (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                    55               1           45/60              41
                                                   Health Department Survey.
                                                  57.123 Antimicrobial Use and                     1,000              12            5/60           1,000
                                                   Resistance (AUR)-Microbiology Data
                                                   Electronic Upload Specification
                                                   Tables.
                                                  57.124 Antimicrobial Use and                     2,000              12            5/60           2,000
                                                   Resistance (AUR)-Pharmacy Data
                                                   Electronic Upload Specification
                                                   Tables.
                                                  57.125 Central Line Insertion                      100             100           25/60           4,167
                                                   Practices Adherence Monitoring.
                                                  57.126 MDRO or CDI Infection Form.....           6,000              72           30/60         216,000
                                                  57.127 MDRO and CDI Prevention Process           6,000              24           15/60          36,000
                                                   and Outcome Measures Monthly
                                                   Monitoring.
                                                  57.128 Laboratory-identified MDRO or             6,000             240           20/60         480,000
                                                   CDI Event.
                                                  57.129 Adult Sepsis...................              50             250           25/60           5,208
                                                  57.137 Long-Term Care Facility                   2,600               1               2           5,200
                                                   Component--Annual.
                                                  Facility Survey:
                                                     57.138 Laboratory-identified MDRO             2,600              12           20/60          10,400
                                                      or CDI Event for LTCF.
                                                     57.139 MDRO and CDI Prevention                2,600              12           20/60          10,400
                                                      Process Measures Monthly
                                                      Monitoring for LTCF.
                                                     57.140 Urinary Tract Infection                2,600              14           35/60          18,200
                                                      (UTI) for LTCF.
                                                     57.141 Monthly Reporting Plan for             2,600              12            5/60           2,600
                                                      LTCF.
                                                     57.142 Denominators for LTCF                  2,600              12            4.17         130,000
                                                      Locations.
                                                     57.143 Prevention Process Measures            2,600              12            5/60           2,600
                                                      Monthly 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               50               1               8             400
                                                      Component Annual Facility Survey.
                                                     57.203 Healthcare Personnel Safety           19,500               1            5/60           1,625
                                                      Monthly Reporting Plan.
                                                     57.204 Healthcare Worker                         50             200           20/60           3,333
                                                      Demographic Data.
                                                     57.205 Exposure to Blood/Body                    50              50               1           2,500
                                                      Fluids.
                                                     57.206 Healthcare Worker                         50              30           15/60             375
                                                      Prophylaxis/Treatment.
                                                     57.207 Follow-Up Laboratory Testing              50              50           15/60             625
                                                     57.210 Healthcare Worker                         50              50           10/60             417
                                                      Prophylaxis/Treatment-Influenza.
                                                     57.300 Hemovigilance Module Annual              500               1            1.42             708
                                                      Survey.
                                                     57.301 Hemovigilance Module Monthly             500              12            1/60             100
                                                      Reporting Plan.
                                                     57.303 Hemovigilance Module Monthly             500              12            1.17           7,000
                                                      Reporting Denominators.
                                                     57.305 Hemovigilance Incident......             500              10           10/60             833
                                                     57.306 Hemovigilance Module Annual              200               1           35/60             117
                                                      Survey--Non-acute care facility.
                                                     57.307 Hemovigilance Adverse                    500               4           20/60             667
                                                      Reaction--Acute Hemolytic
                                                      Transfusion Reaction.
                                                     57.308 Hemovigilance Adverse                    500               4           20/60             667
                                                      Reaction--Allergic Transfusion
                                                      Reaction.
                                                     57.309 Hemovigilance Adverse                    500               1           20/60             167
                                                      Reaction--Delayed Hemolytic
                                                      Transfusion Reaction.
                                                     57.310 Hemovigilance Adverse                    500               2           20/60             333
                                                      Reaction--Delayed Serologic
                                                      Transfusion Reaction.

[[Page 22077]]

 
                                                     57.311 Hemovigilance Adverse                    500               4           20/60             667
                                                      Reaction--Febrile Non-hemolytic
                                                      Transfusion Reaction.
                                                     57.312 Hemovigilance Adverse                    500               1           20/60             167
                                                      Reaction--Hypotensive Transfusion
                                                      Reaction.
                                                     57.313 Hemovigilance Adverse                    500               1           20/60             167
                                                      Reaction--Infection.
                                                     57.314 Hemovigilance Adverse                    500               1           20/60             167
                                                      Reaction--Post Transfusion Purpura.
                                                     57.315 Hemovigilance Adverse                    500               1           20/60             167
                                                      Reaction--Transfusion Associated
                                                      Dyspnea.
                                                     57.316 Hemovigilance Adverse                    500               1           20/60             167
                                                      Reaction--Transfusion Associated
                                                      Graft vs. Host Disease.
                                                     57.317 Hemovigilance Adverse                    500               1           20/60             167
                                                      Reaction--Transfusion Related
                                                      Acute Lung Injury.
                                                     57.318 Hemovigilance Adverse                    500               2           20/60             333
                                                      Reaction--Transfusion Associated
                                                      Circulatory Overload.
                                                     57.319 Hemovigilance Adverse                    500               1           20/60             167
                                                      Reaction--Unknown Transfusion
                                                      Reaction.
                                                     57.320 Hemovigilance Adverse                    500               1           20/60             167
                                                      Reaction--Other Transfusion
                                                      Reaction.
                                                     57.400 Outpatient Procedure                   5,000               1           10/60             417
                                                      Component--Annual Facility Survey.
                                                     57.401 Outpatient Procedure                   5,000              12           20/60          15,000
                                                      Component--Monthly Reporting Plan.
                                                     57.402 Outpatient Procedure                   1,200              25           40/60          20,000
                                                      Component Same Day Outcome
                                                      Measures.
                                                     57.403 Outpatient Procedure                   1,200              12           40/60           9,600
                                                      Component--Monthly Denominators
                                                      for Same Day Outcome Measures.
                                                     57.404 Outpatient Procedure                   5,000             540           10/60         450,000
                                                      Component--SSI Denominator.
                                                     57.405 Outpatient Procedure                   5,000              36           35/60         105,000
                                                      Component--Surgical Site (SSI)
                                                      Event.
                                                     57.500 Outpatient Dialysis Center             7,000               1            2.12          14,817
                                                      Practices Survey.
                                                     57.501 Dialysis Monthly Reporting             7,000              12            5/60           7,000
                                                      Plan.
                                                     57.502 Dialysis Event..............           7,000              60           25/60         175,000
                                                     57.503 Denominator for Outpatient             7,000              12           10/60          14,000
                                                      Dialysis.
                                                     57.504 Prevention Process Measures            2,000              12            1.42          17,000
                                                      Monthly Monitoring for Dialysis.
                                                     57.505 Dialysis Patient Influenza               325              75           10/60           4,063
                                                      Vaccination.
                                                     57.506 Dialysis Patient Influenza               325               5           10/60             271
                                                      Vaccination Denominator.
                                                     57.507 Home Dialysis Center                     350               1           30/60             175
                                                      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. 2018-10094 Filed 5-10-18; 8:45 am]
 BILLING CODE 4163-18-P



                                                22074                            Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices

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

                                                EDN data entry staff at state and local health        The EDN Tuberculosis Follow-up Worksheet                         550              48          30/60
                                                 departments.                                           for Newly-Arrived Persons With Overseas
                                                                                                        Tuberculosis Classifications.



                                                Jeffrey Zirger,                                            • Federal eRulemaking Portal:                        2. Evaluate the accuracy of the
                                                Acting Chief, Information Collection Review             Regulations.gov. Follow the instructions              agency’s estimate of the burden of the
                                                Office, Office of Scientific Integrity, Office          for submitting comments.                              proposed collection of information,
                                                of the Associate Director for Science, Office              • Mail: Jeffrey M. Zirger, Information             including the validity of the
                                                of the Director, Centers for Disease Control            Collection Review Office, Centers for                 methodology and assumptions used;
                                                and Prevention.                                                                                                 3. Enhance the quality, utility, and
                                                                                                        Disease Control and Prevention, 1600
                                                [FR Doc. 2018–10064 Filed 5–10–18; 8:45 am]                                                                   clarity of the information to be
                                                                                                        Clifton Road NE, MS–D74, Atlanta,
                                                BILLING CODE 4163–18–P                                  Georgia 30329.                                        collected; and
                                                                                                           Instructions: All submissions received               4. Minimize the burden of the
                                                                                                        must include the agency name and                      collection of information on those who
                                                DEPARTMENT OF HEALTH AND                                                                                      are to respond, including through the
                                                                                                        Docket Number. CDC will post, without
                                                HUMAN SERVICES                                                                                                use of appropriate automated,
                                                                                                        change, all relevant comments to
                                                                                                        Regulations.gov.                                      electronic, mechanical, or other
                                                Centers for Disease Control and                                                                               technological collection techniques or
                                                Prevention                                                 Please note: Submit all comments
                                                                                                                                                              other forms of information technology,
                                                                                                        through the Federal eRulemaking portal                e.g., permitting electronic submissions
                                                [60Day–18–0666; Docket No. CDC–2018–
                                                                                                        (regulations.gov) or by U.S. mail to the              of responses.
                                                0042]                                                   address listed above.                                   5. Assess information collection costs.
                                                                                                        FOR FURTHER INFORMATION CONTACT: To
                                                Proposed Data Collection Submitted                      request more information on the                       Proposed Project
                                                for Public Comment and                                  proposed project or to obtain a copy of                 National Healthcare Safety Network
                                                Recommendations                                         the information collection plan and                   (NHSN)—Revision—National Center for
                                                                                                        instruments, contact Leroy A.                         Emerging and Zoonotic Infectious
                                                AGENCY: Centers for Disease Control and                                                                       Diseases (NCEZID), Centers for Disease
                                                                                                        Richardson, Information Collection
                                                Prevention (CDC), Department of Health                                                                        Control and Prevention (CDC).
                                                                                                        Review Office, Centers for Disease
                                                and Human Services (HHS).
                                                                                                        Control and Prevention, 1600 Clifton                  Background and Brief Description
                                                ACTION: Notice with comment period.                     Road NE, MS–D74, Atlanta, Georgia
                                                                                                        30329; phone: 404–639–7570; Email:                       NHSN is a public health surveillance
                                                SUMMARY:   The Centers for Disease                      omb@cdc.gov.                                          system that collects, analyzes, reports,
                                                Control and Prevention (CDC), as part of                                                                      and makes available data for
                                                                                                        SUPPLEMENTARY INFORMATION: Under the                  monitoring, measuring, and responding
                                                its continuing effort to reduce public
                                                burden and maximize the utility of                      Paperwork Reduction Act of 1995 (PRA)                 to healthcare associated infections
                                                government information, invites the                     (44 U.S.C. 3501–3520), Federal agencies               (HAIs), antimicrobial use and resistance,
                                                general public and other Federal                        must obtain approval from the Office of               blood transfusion safety events, and the
                                                agencies the opportunity to comment on                  Management and Budget (OMB) for each                  extent to which healthcare facilities
                                                a proposed and/or continuing                            collection of information they conduct                adhere to infection prevention practices
                                                information collection, as required by                  or sponsor. In addition, the PRA also                 and antimicrobial stewardship. The data
                                                the Paperwork Reduction Act of 1995.                    requires Federal agencies to provide a                collected will be used to inform and
                                                This notice invites comment on a                        60-day notice in the Federal Register                 detect changes in the epidemiology of
                                                proposed information collection project                 concerning each proposed collection of                adverse events resulting from new and
                                                titled National Healthcare Safety                       information, including each new                       current medical therapies and changing
                                                Network (NHSN). NHSN is a public                        proposed collection, each proposed                    risks. NHSN is comprised of six
                                                health surveillance system that collects,               extension of existing collection of                   components: Patient Safety, Healthcare
                                                analyzes, reports, and makes available                  information, and each reinstatement of                Personnel Safety, Biovigilance, Long-
                                                data for monitoring, measuring, and                     previously approved information                       Term Care Facility, Outpatient
                                                responding to healthcare associated                     collection before submitting the                      Procedure, and Dialysis.
                                                infections (HAIs), antimicrobial use and                collection to the OMB for approval. To                   Changes were made to 33 data
                                                resistance, blood transfusion safety                    comply with this requirement, we are                  collection facility surveys with this new
                                                events, and the extent to which                         publishing this notice of a proposed                  ICR. CDC revised three annual facility
                                                healthcare facilities adhere to infection               data collection as described below.                   surveys for the Patient Safety
                                                                                                           The OMB is particularly interested in              component for Hospitals, Long-Term
sradovich on DSK3GMQ082PROD with NOTICES




                                                prevention practices and antimicrobial
                                                stewardship.                                            comments that will help:                              Acute Care Facilities, and Inpatient
                                                                                                           1. Evaluate whether the proposed                   Rehabilitation Facilities. CDC’s
                                                DATES:  CDC must receive written                        collection of information is necessary                revisions clarify the reporting
                                                comments on or before July 10, 2018.                    for the proper performance of the                     requirements for the data collected on
                                                ADDRESSES: You may submit comments,                     functions of the agency, including                    fungal testing, facility locations, and
                                                identified by Docket No. CDC–2018–                      whether the information will have                     laboratory testing locations.
                                                0042 by any of the following methods:                   practical utility;                                    Additionally, corresponding response


                                           VerDate Sep<11>2014   19:21 May 10, 2018   Jkt 244001   PO 00000   Frm 00078   Fmt 4703   Sfmt 4703   E:\FR\FM\11MYN1.SGM   11MYN1


                                                                                    Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices                                                  22075

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

                                                                                                          ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                       Average
                                                                                                                                                                  Number of
                                                                                                                                                Number of                            burden per     Total burden
                                                   Type of respondents                                  Form name                                               responses per
                                                                                                                                               respondents                            response       (in hours)
                                                                                                                                                                  respondent          (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                                6,000                 1              1.17          7,500
                                                                                    Hospital 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
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                  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                            6,000                12                 4        288,000
                                                                                    Care Unit (NICU).
                                                                                  57.117 Denominators for Specialty Care Area                           2,000                 9              5.03         90,600
                                                                                    (SCA)/Oncology (ONC).



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                                                22076                            Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices

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

                                                                               57.118 Denominators for Intensive Care Unit                             6,000                60              5.03      1,812,000
                                                                                 (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 De-                                55                 1             45/60             41
                                                                                 partment Survey.
                                                                               57.123 Antimicrobial Use and Resistance                                 1,000                12              5/60          1,000
                                                                                 (AUR)-Microbiology Data Electronic Upload
                                                                                 Specification Tables.
                                                                               57.124 Antimicrobial Use and Resistance                                 2,000                12              5/60          2,000
                                                                                 (AUR)-Pharmacy Data Electronic Upload
                                                                                 Specification Tables.
                                                                               57.125 Central Line Insertion Practices Adher-                            100               100             25/60          4,167
                                                                                 ence Monitoring.
                                                                               57.126 MDRO or CDI Infection Form ..............                        6,000                72             30/60        216,000
                                                                               57.127 MDRO and CDI Prevention Process                                  6,000                24             15/60         36,000
                                                                                 and Outcome Measures Monthly Monitoring.
                                                                               57.128 Laboratory-identified MDRO or CDI                                6,000               240             20/60        480,000
                                                                                 Event.
                                                                               57.129 Adult Sepsis .........................................              50               250             25/60          5,208
                                                                               57.137 Long-Term Care Facility Component—                               2,600                 1                 2          5,200
                                                                                 Annual.
                                                                               Facility Survey:
                                                                                    57.138 Laboratory-identified MDRO or                               2,600                12             20/60         10,400
                                                                                       CDI Event for LTCF.
                                                                                    57.139 MDRO and CDI Prevention Proc-                               2,600                12             20/60         10,400
                                                                                       ess Measures Monthly Monitoring for
                                                                                       LTCF.
                                                                                    57.140 Urinary Tract Infection (UTI) for                           2,600                14             35/60         18,200
                                                                                       LTCF.
                                                                                    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                                 2,600                12              5/60          2,600
                                                                                       Monthly 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                  50                 1                 8            400
                                                                                       Component Annual Facility Survey.
                                                                                    57.203 Healthcare       Personnel             Safety              19,500                 1              5/60          1,625
                                                                                       Monthly Reporting Plan.
                                                                                    57.204 Healthcare Worker Demographic                                  50               200             20/60          3,333
                                                                                       Data.
                                                                                    57.205 Exposure to Blood/Body Fluids ....                             50                50                 1          2,500
                                                                                    57.206 Healthcare Worker Prophylaxis/                                 50                30             15/60            375
                                                                                       Treatment.
                                                                                    57.207 Follow-Up Laboratory Testing ......                            50                50             15/60            625
                                                                                    57.210 Healthcare Worker Prophylaxis/                                 50                50             10/60            417
                                                                                       Treatment-Influenza.
                                                                                    57.300 Hemovigilance Module Annual                                   500                 1              1.42            708
                                                                                       Survey.
                                                                                    57.301 Hemovigilance Module Monthly                                  500                12              1/60            100
                                                                                       Reporting Plan.
                                                                                    57.303 Hemovigilance Module Monthly                                  500                12              1.17          7,000
                                                                                       Reporting Denominators.
                                                                                    57.305 Hemovigilance Incident .................                      500                10             10/60            833
                                                                                    57.306 Hemovigilance Module Annual                                   200                 1             35/60            117
                                                                                       Survey—Non-acute care facility.
                                                                                    57.307 Hemovigilance Adverse Reac-                                   500                 4             20/60            667
                                                                                       tion—Acute Hemolytic Transfusion Reac-
                                                                                       tion.
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                    57.308 Hemovigilance Adverse Reac-                                   500                 4             20/60            667
                                                                                       tion—Allergic Transfusion Reaction.
                                                                                    57.309 Hemovigilance Adverse Reac-                                   500                 1             20/60            167
                                                                                       tion—Delayed Hemolytic Transfusion Re-
                                                                                       action.
                                                                                    57.310 Hemovigilance Adverse Reac-                                   500                 2             20/60            333
                                                                                       tion—Delayed Serologic Transfusion Re-
                                                                                       action.



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                                                                                     Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices                                                                                                 22077

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

                                                                                         57.311 Hemovigilance Adverse Reac-                                                          500                           4                    20/60                667
                                                                                           tion—Febrile Non-hemolytic Transfusion
                                                                                           Reaction.
                                                                                         57.312 Hemovigilance Adverse Reac-                                                          500                           1                    20/60                167
                                                                                           tion—Hypotensive Transfusion Reaction.
                                                                                         57.313 Hemovigilance Adverse Reac-                                                          500                           1                    20/60                167
                                                                                           tion—Infection.
                                                                                         57.314 Hemovigilance Adverse Reac-                                                          500                           1                    20/60                167
                                                                                           tion—Post Transfusion Purpura.
                                                                                         57.315 Hemovigilance Adverse Reac-                                                          500                            1                   20/60                167
                                                                                           tion—Transfusion Associated Dyspnea.
                                                                                         57.316 Hemovigilance Adverse Reac-                                                         500                             1                   20/60                167
                                                                                           tion—Transfusion Associated Graft vs.
                                                                                           Host Disease.
                                                                                         57.317 Hemovigilance Adverse Reac-                                                          500                            1                   20/60                167
                                                                                           tion—Transfusion Related Acute Lung In-
                                                                                           jury.
                                                                                         57.318 Hemovigilance Adverse Reac-                                                          500                            2                   20/60                333
                                                                                           tion—Transfusion Associated Circulatory
                                                                                           Overload.
                                                                                         57.319 Hemovigilance Adverse Reac-                                                          500                            1                   20/60                167
                                                                                           tion—Unknown Transfusion Reaction.
                                                                                         57.320 Hemovigilance Adverse Reac-                                                          500                            1                   20/60                167
                                                                                           tion—Other Transfusion Reaction.
                                                                                         57.400 Outpatient Procedure Compo-                                                       5,000                             1                   10/60                417
                                                                                           nent—Annual Facility Survey.
                                                                                         57.401 Outpatient Procedure Compo-                                                       5,000                           12                    20/60             15,000
                                                                                           nent—Monthly Reporting Plan.
                                                                                         57.402 Outpatient Procedure Component                                                    1,200                           25                    40/60             20,000
                                                                                           Same Day Outcome Measures.
                                                                                         57.403 Outpatient Procedure Compo-                                                       1,200                          12                     40/60              9,600
                                                                                           nent—Monthly Denominators for Same
                                                                                           Day Outcome Measures.
                                                                                         57.404 Outpatient Procedure Compo-                                                       5,000                        540                      10/60            450,000
                                                                                           nent—SSI Denominator.
                                                                                         57.405 Outpatient Procedure Compo-                                                       5,000                           36                    35/60            105,000
                                                                                           nent—Surgical Site (SSI) Event.
                                                                                         57.500 Outpatient Dialysis Center Prac-                                                  7,000                             1                     2.12            14,817
                                                                                           tices Survey.
                                                                                         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 Dialy-                                                 7,000                           12                    10/60             14,000
                                                                                           sis.
                                                                                         57.504 Prevention Process Measures                                                       2,000                           12                      1.42            17,000
                                                                                           Monthly Monitoring for Dialysis.
                                                                                         57.505 Dialysis Patient Influenza Vaccina-                                                 325                           75                    10/60              4,063
                                                                                           tion.
                                                                                         57.506 Dialysis Patient Influenza Vaccina-                                                  325                           5                    10/60                271
                                                                                           tion Denominator.
                                                                                         57.507 Home Dialysis Center Practices                                                       350                           1                    30/60                175
                                                                                           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
sradovich on DSK3GMQ082PROD with NOTICES




                                                and Prevention.
                                                [FR Doc. 2018–10094 Filed 5–10–18; 8:45 am]
                                                BILLING CODE 4163–18–P




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Document Created: 2018-11-02 09:49:07
Document Modified: 2018-11-02 09:49:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesCDC must receive written comments on or before July 10, 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 22074 

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