[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45444-45447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19382]


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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 November 6, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0042 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
    <bullet> 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: 
<a href="/cdn-cgi/l/email-protection#d2bdbfb092b1b6b1fcb5bda4"><span class="__cf_email__" data-cfemail="543b3936143730377a333b22">[email protected]</span></a>.

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

Proposed Project

    National Healthcare Safety Network (NHSN)--Revision--National 
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    NHSN is a public health surveillance system that collects, 
analyzes, reports, and makes available data for monitoring, measuring, 
and responding to healthcare associated infections (HAIs), 
antimicrobial use and resistance, blood transfusion safety events, and 
the extent to which healthcare facilities adhere to infection 
prevention practices and antimicrobial stewardship. The data collected 
will be used to inform and detect changes in the epidemiology of 
adverse events resulting from new and current medical therapies and 
changing risks. NHSN is comprised of six components: Patient Safety, 
Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility, 
Outpatient Procedure, and Dialysis.
    Changes were made to 33 data collection facility surveys with this 
new ICR. CDC revised three annual facility surveys for the Patient 
Safety component for Hospitals, Long-Term Acute Care Facilities, and 
Inpatient Rehabilitation Facilities. CDC's revisions clarify the 
reporting requirements for the data collected on fungal testing, 
facility locations, and laboratory testing locations. Additionally, 
corresponding response options for these questions have been revised to 
include updated testing methods used by facilities to capture current 
HAI specific data specification requirements for NHSN. New required 
questions have been added to all Patient Safety component surveys. The 
new questions are designed to provide data on surveillance processes, 
policies, and standards that are used by reporting facilities to ensure 
that when an event is detected, the facility has the appropriate 
mechanism to conduct complete reporting. The Hospital Annual Survey 
added new required questions to provide data about neonatal 
antimicrobial stewardship practices because the focus of stewardship 
efforts in neonatology differ from the focus in adult and pediatric 
practice. Questions were removed and replaced on all three

[[Page 45445]]

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

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

[[Page 45446]]

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

[[Page 45447]]

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


Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-19382 Filed 9-6-18; 8:45 am]
 BILLING CODE 4163-18-P?>


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