[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Pages 24711-24714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11020]



[[Page 24711]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0666; Docket No. CDC-2017-0047]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the National 
Healthcare Safety Network (NHSN). NHSN is a system designed to 
accumulate, exchange, and integrate relevant information and resources 
among private and public stakeholders to support local and national 
efforts to protect patients and promote healthcare safety.

DATES: Written comments must be received on or before July 31, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0047 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted 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 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

National Healthcare Safety Network (NHSN) (OMB Control Number 0920-
0666, Expires--Revision--National Center for Emerging and Zoonotic 
Infection Diseases (NCEZID), Centers for Disease Control and Prevention 
(CDC)

Background and Brief Description
    The Centers for Disease Control and Prevention (CDC) is requesting 
a three-year approval of the National Healthcare Safety Network 
information collection project.
    The National Healthcare Safety Network (NHSN) is a system designed 
to accumulate, exchange, and integrate relevant information and 
resources among private and public stakeholders to support local and 
national efforts to protect patients and promote healthcare safety. 
Specifically, the data is used to determine the magnitude of various 
healthcare-associated adverse events and trends in the rates of these 
events among patients and healthcare workers with similar risks.
    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. The NHSN currently consists of five 
components: Patient Safety, Healthcare Personnel Safety, Biovigilance, 
Long-Term Care Facility (LTCF), and Dialysis. The Outpatient Procedure 
Component is on track to be released in NHSN in 2018. The development 
of this component has been previously delayed to obtain additional user 
feedback and support from outside partners.
    Changes were made to four facility surveys. Based on user feedback 
and internal reviews of the annual facility surveys it was determined 
that questions and response options be amended, removed, or added to 
fit the evolving uses of the annual facility surveys. Also, the surveys 
are being increasingly used to help intelligently interpret the other 
data elements reported into NHSN. Currently, the surveys are used to 
appropriately risk adjust the numerator and denominator data entered 
into NHSN while also guiding decisions on future division priorities 
for prevention.
    Further, two new forms were added to expand NHSN surveillance to 
enhance data collection by Ambulatory Surgical Centers to identify 
areas where prevention of SSIs may be improved. An additional 14 forms 
were modified within the Hemovigilance module to streamline data 
collection/entry for adverse reaction events.

[[Page 24712]]

    Overall, minor revisions have been made to a total of 38 forms 
within the package to clarify and/or update surveillance definitions, 
increase or decrease the number of reporting facilities, and adding new 
forms. The previously approved NHSN package included 70 individual 
collection forms; the current revision request includes a total of 72 
forms. The reporting burden will decrease by 811,985 hours, for a total 
of 5,922,953 hours.
    This collection of information is authorized by the Public Health 
Service Act (42 U.S.C. 242b, 242k, and 242m (d)). There is no cost to 
respondents other than the time to participate.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent         Form No. & name     Number of     responses per   per response    Total burden
                                                    respondents     respondent        (hours)         (hours)
----------------------------------------------------------------------------------------------------------------
Registered Nurse (Infection     57.100 NHSN                2,000               1            5/60             167
 Preventionist).                 Registration
                                 Form.
Registered Nurse (Infection     57.101 Facility            2,000               1           10/60             333
 Preventionist).                 Contact
                                 Information.
Registered Nurse (Infection     57.103 Patient             5,000               1           55/60           4,583
 Preventionist).                 Safety
                                 Component--Annu
                                 al Hospital
                                 Survey.
Registered Nurse (Infection     57.105 Group               1,000               1            5/60              83
 Preventionist).                 Contact
                                 Information.
Registered Nurse (Infection     57.106 Patient             6,000              12           15/60          18,000
 Preventionist).                 Safety Monthly
                                 Reporting Plan.
Registered Nurse (Infection     57.108 Primary             6,000              44           30/60         132,000
 Preventionist).                 Bloodstream
                                 Infection (BSI).
Registered Nurse (Infection     57.111 Pneumonia           6,000              72           30/60         216,000
 Preventionist).                 (PNEU).
Registered Nurse (Infection     57.112                     6,000             144           25/60         360,000
 Preventionist).                 Ventilator--Ass
                                 ociated Event.
Registered Nurse (Infection     57.113 Pediatric           2,000             120           25/60         100,000
 Preventionist).                 Ventilator--Ass
                                 ociated Event
                                 (PedVAE).
Registered Nurse (Infection     57.114 Urinary             6,000              40           20/60          80,000
 Preventionist).                 Tract Infection
                                 (UTI).
Registered Nurse (Infection     57.115 Custom              2,000              91           35/60         106,167
 Preventionist).                 Event.
Staff RN......................  57.116                     6,000              12               4         288,000
                                 Denominators
                                 for Neonatal
                                 Intensive Care
                                 Unit (NICU).
Staff RN......................  57.117                     6,000               9               5         270,000
                                 Denominators
                                 for Specialty
                                 Care Area (SCA)/
                                 Oncology (ONC).
Staff RN......................  57.118                     6,000              60               5       1,800,000
                                 Denominators
                                 for Intensive
                                 Care Unit (ICU)/
                                 Other locations
                                 (not NICU or
                                 SCA).
Registered Nurse (Infection     57.120 Surgical            6,000              36           35/60         126,000
 Preventionist).                 Site Infection
                                 (SSI).
Staff RN......................  57.121                     6,000             540           10/60         540,000
                                 Denominator for
                                 Procedure.
Laboratory Technician.........  57.123                     6,000              12            5/60           6,000
                                 Antimicrobial
                                 Use and
                                 Resistance
                                 (AUR)--Microbio
                                 logy Data
                                 Electronic
                                 Upload
                                 Specification
                                 Tables.
Pharmacist....................  57.124                     6,000              12            5/60           6,000
                                 Antimicrobial
                                 Use and
                                 Resistance
                                 (AUR)--Pharmacy
                                 Data Electronic
                                 Upload
                                 Specification
                                 Tables.
Registered Nurse (Infection     57.125 Central               100             100           25/60           4,167
 Preventionist).                 Line Insertion
                                 Practices
                                 Adherence
                                 Monitoring.
Registered Nurse (Infection     57.126 MDRO or             6,000              72           30/60         216,000
 Preventionist).                 CDI Infection
                                 Form.
Registered Nurse (Infection     57.127 MDRO and            6,000              24           15/60          36,000
 Preventionist).                 CDI Prevention
                                 Process and
                                 Outcome
                                 Measures
                                 Monthly
                                 Monitoring.
Registered Nurse (Infection     57.128                     6,000             240           20/60         480,000
 Preventionist).                 Laboratory-
                                 identified MDRO
                                 or CDI Event.
Registered Nurse (Infection     57.129 Adult                  50             250           25/60           5,208
 Preventionist).                 Sepsis.
Registered Nurse (Infection     57.137 Long-Term           2,600               1               2           5,200
 Preventionist).                 Care Facility
                                 Component--Annu
                                 al Facility
                                 Survey.
Registered Nurse (Infection     57.138                     2,600              12           15/60           7,800
 Preventionist).                 Laboratory-
                                 identified MDRO
                                 or CDI Event
                                 for LTCF.
Registered Nurse (Infection     57.139 MDRO and            2,600              12           10/60           5,200
 Preventionist).                 CDI Prevention
                                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 LTCF.
Registered Nurse (Infection     57.140 Urinary             2,600              14           30/60          18,200
 Preventionist).                 Tract Infection
                                 (UTI) for LTCF.

[[Page 24713]]

 
Registered Nurse (Infection     57.141 Monthly             2,600              12            5/60           2,600
 Preventionist).                 Reporting Plan
                                 for LTCF.
Registered Nurse (Infection     57.142                     2,600              12               4         124,800
 Preventionist).                 Denominators
                                 for LTCF
                                 Locations.
Registered Nurse (Infection     57.143                     2,600              12            5/60             600
 Preventionist).                 Prevention
                                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 LTCF.
Registered Nurse (Infection     57.150 LTAC                  400               1           55/60             367
 Preventionist).                 Annual Survey.
Registered Nurse (Infection     57.151 Rehab               1,000               1           55/60             917
 Preventionist).                 Annual Survey.
Occupational Health RN/         57.200                        50               1               8             400
 Specialist.                     Healthcare
                                 Personnel
                                 Safety
                                 Component
                                 Annual Facility
                                 Survey.
Occupational Health RN/         57.203                    17,000               1            5/60           1,417
 Specialist.                     Healthcare
                                 Personnel
                                 Safety Monthly
                                 Reporting Plan.
Occupational Health RN/         57.204                        50             200           20/60           3,333
 Specialist.                     Healthcare
                                 Worker
                                 Demographic
                                 Data.
Occupational Health RN/         57.205 Exposure               50              50               1           2,500
 Specialist.                     to Blood/Body
                                 Fluids.
Occupational Health RN/         57.206                        50              30           15/60             375
 Specialist.                     Healthcare
                                 Worker
                                 Prophylaxis/
                                 Treatment.
Laboratory Technician.........  57.207 Follow-Up              50              50           15/60             625
                                 Laboratory
                                 Testing.
Occupational Health RN/         57.210                        50              50           10/60             417
 Specialist.                     Healthcare
                                 Worker
                                 Prophylaxis/
                                 Treatment--Infl
                                 uenza.
Medical/Clinical Laboratory     57.300                       500               1               2           1,000
 Technologist.                   Hemovigilance
                                 Module Annual
                                 Survey.
Medical/Clinical Laboratory     57.301                       500              12            1/60             100
 Technologist.                   Hemovigilance
                                 Module Monthly
                                 Reporting Plan.
Medical/Clinical Laboratory     57.303                       500              12            1.17           7,020
 Technologist.                   Hemovigilance
                                 Module Monthly
                                 Reporting
                                 Denominators.
Medical/Clinical Laboratory     57.305                       500              10           10/60             833
 Technologist.                   Hemovigilance
                                 Incident.
Medical/Clinical Laboratory     57.306                       200               1           35/60             117
 Technologist.                   Hemovigilance
                                 Module Annual
                                 Survey--Non-
                                 acute care
                                 facility.
Medical/Clinical Laboratory     57.307                       500               4           20/60             667
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Acute
                                 Hemolytic
                                 Transfusion
                                 Reaction.
Medical/Clinical Laboratory     57.308                       500               4           20/60             667
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Aller
                                 gic Transfusion
                                 Reaction.
Medical/Clinical Laboratory     57.309                       500               1           20/60             167
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Delay
                                 ed Hemolytic
                                 Transfusion
                                 Reaction.
Medical/Clinical Laboratory     57.310                       500               2           20/60             333
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Delay
                                 ed Serologic
                                 Transfusion
                                 Reaction.
Medical/Clinical Laboratory     57.311                       500               4           20/60             667
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Febri
                                 le Non-
                                 hemolytic
                                 Transfusion
                                 Reaction.
Medical/Clinical Laboratory     57.312                       500               1           20/60             167
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Hypot
                                 ensive
                                 Transfusion
                                 Reaction.
Medical/Clinical Laboratory     57.313                       500               1           20/60             167
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Infec
                                 tion.
Medical/Clinical Laboratory     57.314                       500               1           20/60             167
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Post
                                 Transfusion
                                 Purpura.
Medical/Clinical Laboratory     57.315                       500               1           20/60             167
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Trans
                                 fusion
                                 Associated
                                 Dyspnea.
Medical/Clinical Laboratory     57.316                       500               1           20/60             167
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Trans
                                 fusion
                                 Associated
                                 Graft vs. Host
                                 Disease.
Medical/Clinical Laboratory     57.317                       500               1           20/60             167
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Trans
                                 fusion Related
                                 Acute Lung
                                 Injury.

[[Page 24714]]

 
Medical/Clinical Laboratory     57.318                       500               2           20/60             333
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Trans
                                 fusion
                                 Associated
                                 Circulatory
                                 Overload.
Medical/Clinical Laboratory     57.319                       500               1           20/60             167
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Unkno
                                 wn Transfusion
                                 Reaction.
Medical/Clinical Laboratory     57.320                       500               1           20/60             167
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction--Other
                                 Transfusion
                                 Reaction.
Medical/Clinical Laboratory     57.400                     5,000               1            5/60             417
 Technologist.                   Outpatient
                                 Procedure
                                 Component--Annu
                                 al Facility
                                 Survey.
Staff RN......................  57.401                     5,000              12           15/60          15,000
                                 Outpatient
                                 Procedure
                                 Component--Mont
                                 hly Reporting
                                 Plan.
Staff RN......................  57.402--Outpatie           5,000              25           40/60          83,333
                                 nt Procedure
                                 Component Same
                                 Day Outcome
                                 Measures &
                                 Prophylactic
                                 Intravenous(IV)
                                 Antibiotic
                                 Timing Event.
Staff RN......................  57.403--Outpatie           5,000              12           40/60          40,000
                                 nt Procedure
                                 Component--Mont
                                 hly
                                 Denominators
                                 for Same Day
                                 Outcome
                                 Measures &
                                 Prophylactic
                                 Intravenous(IV)
                                 Antibiotic
                                 Timing Event.
Staff RN......................  57.404                     5,000             540           10/60          450,00
                                 Outpatient
                                 Procedure
                                 Component--Annu
                                 al Facility
                                 Survey.
Registered Nurse (Infection     57.405                     5,000              36           35/60          105,00
 Preventionist).                 Outpatient
                                 Procedure
                                 Component--Surg
                                 ical Site (SSI)
                                 Event.
Staff RN......................  57.500                     7,000               1             2.0          14,000
                                 Outpatient
                                 Dialysis Center
                                 Practices
                                 Survey.
Registered Nurse (Infection     57.501 Dialysis            7,000              12            5/60           7,000
 Preventionist).                 Monthly
                                 Reporting Plan.
Staff RN......................  57.502 Dialysis            7,000              60           25/60         175,000
                                 Event.
Staff RN......................  57.503                     7,000              12           10/60          14,000
                                 Denominator for
                                 Outpatient
                                 Dialysis.
Staff RN......................  57.504                     2,000              12            1.25          30,000
                                 Prevention
                                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 Dialysis.
Staff RN......................  57.505 Dialysis              325              75           10/60           4,063
                                 Patient
                                 Influenza
                                 Vaccination.
Staff RN......................  57.506 Dialysis              325               5           10/60             271
                                 Patient
                                 Influenza
                                 Vaccination
                                 Denominator.
Staff RN......................  57.507 Home                  350               1           30/60             175
                                 Dialysis Center
                                 Practices
                                 Survey.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............        5922,953
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Leroy A. Richardson,
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. 2017-11020 Filed 5-26-17; 8:45 am]
BILLING CODE 4163-18-P