[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22074-22077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10094]


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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.

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