[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37265-37268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-0666; Docket No. CDC-2015-0048]


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

[[Page 37266]]

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 August 31, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0048 by any of the following methods:
     Federal eRulemaking Portal: Regulation.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 the 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)--Revision--National 
Center for Emerging and Zoonotic Infection Diseases (NCEZID), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    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 will be used to 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 2016/2017. The development of this component has 
been previously delayed to obtain additional user feedback and support 
from outside partners.
    Changes were made to seven 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. 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.
    Additionally, minor revisions have been made to 27 forms within the 
package to clarify and/or update surveillance definitions. Two forms 
are being removed as those forms will no longer be added to the NHSN 
system. The previously approved NHSN package included 54 individual 
collection forms; the current revision request removes two forms for a 
total of 52 forms. The reporting burden will increase by 583,825 hours, 
for a total of 4,861,542 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)
----------------------------------------------------------------------------------------------------------------
Registered Nurse (Infection     NHSN                       2,000               1            5/60             167
 Preventionist).                 Registration
                                 Form.
Registered Nurse (Infection     Facility Contact           2,000               1           10/60             333
 Preventionist).                 Information.
Registered Nurse (Infection     Patient Safety             5,000               1           50/60           4,167
 Preventionist).                 Component--Annu
                                 al Hospital
                                 Survey.

[[Page 37267]]

 
Registered Nurse (Infection     Group Contact              1,000               1            5/60              83
 Preventionist).                 Information.
Registered Nurse (Infection     Patient Safety             6,000              12           15/60          18,000
 Preventionist).                 Monthly
                                 Reporting Plan.
Registered Nurse (Infection     Primary                    6,000              44           30/60         132,000
 Preventionist).                 Bloodstream
                                 Infection (BSI).
Registered Nurse (Infection     Pneumonia (PNEU)           6,000              72           30/60         216,000
 Preventionist).
Registered Nurse (Infection     Ventilator-                6,000             144           25/60         360,000
 Preventionist).                 Associated
                                 Event.
Registered Nurse (Infection     Urinary Tract              6,000              40           20/60          80,000
 Preventionist).                 Infection (UTI).
Staff RN......................  Denominators for           6,000               9               3         162,000
                                 Neonatal
                                 Intensive Care
                                 Unit (NICU).
Staff RN......................  Denominators for           6,000               9               5         270,000
                                 Specialty Care
                                 Area (SCA)/
                                 Oncology (ONC).
Staff RN......................  Denominators for           6,000              60               5       1,800,000
                                 Intensive Care
                                 Unit (ICU)/
                                 Other locations
                                 (not NICU or
                                 SCA).
Registered Nurse (Infection     Surgical Site              6,000              36           35/60         126,000
 Preventionist).                 Infection (SSI).
Staff RN......................  Denominator for            6,000             540            5/60         270,000
                                 Procedure.
Laboratory Technician.........  Antimicrobial              6,000              12            5/60           6,000
                                 Use and
                                 Resistance
                                 (AUR)-
                                 Microbiology
                                 Data Electronic
                                 Upload
                                 Specification
                                 Tables.
Pharmacy Technician...........  Antimicrobial              6,000              12            5/60           6,000
                                 Use and
                                 Resistance
                                 (AUR)-Pharmacy
                                 Data Electronic
                                 Upload
                                 Specification
                                 Tables.
Registered Nurse (Infection     Central Line               1,000             100           25/60          41,667
 Preventionist).                 Insertion
                                 Practices
                                 Adherence
                                 Monitoring.
Registered Nurse (Infection     MDRO or CDI                6,000              72           30/60         216,000
 Preventionist).                 Infection Form.
Registered Nurse (Infection     MDRO and CDI               6,000              24           15/60          36,000
 Preventionist).                 Prevention
                                 Process and
                                 Outcome
                                 Measures
                                 Monthly
                                 Monitoring.
Registered Nurse (Infection     Laboratory-                6,000             240           30/60         720,000
 Preventionist).                 identified MDRO
                                 or CDI Event.
Registered Nurse (Infection     Long-Term Care               250               1               1             250
 Preventionist).                 Facility
                                 Component--Annu
                                 al Facility
                                 Survey.
Registered Nurse (Infection     Laboratory-                  250               8           15/60             500
 Preventionist).                 identified MDRO
                                 or CDI Event
                                 for LTCF.
Registered Nurse (Infection     MDRO and CDI                 250              12            5/60             250
 Preventionist).                 Prevention
                                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 LTCF.
Registered Nurse (Infection     Urinary Tract                250               9           30/60           1,125
 Preventionist).                 Infection (UTI)
                                 for LTCF.
Registered Nurse (Infection     Monthly                      250              12            5/60             250
 Preventionist).                 Reporting Plan
                                 for LTCF.
Registered Nurse (Infection     Denominators for             250              12            3.25           9,750
 Preventionist).                 LTCF Locations.
Registered Nurse (Infection     Prevention                   250              12            5/60             250
 Preventionist).                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 LTCF.
Registered Nurse (Infection     LTAC Annual                  400               1           50/60             333
 Preventionist).                 Survey.
Registered Nurse (Infection     Rehab Annual               1,000               1           50/60             833
 Preventionist).                 Survey.
Occupational Health RN/         Healthcare                    50               1               8             400
 Specialist.                     Personnel
                                 Safety
                                 Component
                                 Annual Facility
                                 Survey.
Occupational Health RN/         Healthcare                17,000               1            5/60           1,417
 Specialist.                     Personnel
                                 Safety Monthly
                                 Reporting Plan.
Occupational Health RN/         Healthcare                    50             200           20/60           3,333
 Specialist.                     Worker
                                 Demographic
                                 Data.
Occupational Health RN/         Exposure to                   50              50               1           2,500
 Specialist.                     Blood/Body
                                 Fluids.
Occupational Health RN/         Healthcare                    50              30           15/60             375
 Specialist.                     Worker
                                 Prophylaxis/
                                 Treatment.
Laboratory Technician.........  Follow-Up                     50              50           15/60             625
                                 Laboratory
                                 Testing.
Occupational Health RN/         Healthcare                    50              50           10/60             417
 Specialist.                     Worker
                                 Prophylaxis/
                                 Treatment-
                                 Influenza.

[[Page 37268]]

 
Medical/Clinical Laboratory     Hemovigilance                500               1               2           1,000
 Technologist.                   Module Annual
                                 Survey.
Medical/Clinical Laboratory     Hemovigilance                500              12            1/60             100
 Technologist.                   Module Monthly
                                 Reporting Plan.
Medical/Clinical Laboratory     Hemovigilance                500              12               1           6,000
 Technologist.                   Module Monthly
                                 Reporting
                                 Denominators.
Medical/Clinical Laboratory     Hemovigilance                500              48           15/60           6,000
 Technologist.                   Adverse
                                 Reaction.
Medical/Clinical Laboratory     Hemovigilance                500              10           10/60             833
 Technologist.                   Incident.
Staff RN......................  Patient Safety             5,000               1            5/60             417
                                 Component--Annu
                                 al Facility
                                 Survey for
                                 Ambulatory
                                 Surgery Center
                                 (ASC).
Staff RN......................  Outpatient                 5,000              12           15/60          15,000
                                 Procedure
                                 Component--Mont
                                 hly Reporting
                                 Plan.
Staff RN......................  Outpatient                 5,000              25           40/60          83,333
                                 Procedure
                                 Component Event.
Staff RN......................  Outpatient                 5,000              12           40/60          40,000
                                 Procedure
                                 Component--Mont
                                 hly
                                 Denominators
                                 and Summary.
Registered Nurse (Infection     Outpatient                 6,500               1             2.0          13,000
 Preventionist).                 Dialysis Center
                                 Practices
                                 Survey.
Staff RN......................  Dialysis Monthly           6,500              12            5/60           6,500
                                 Reporting Plan.
Staff RN......................  Dialysis Event..           6,500              60           25/60         162,500
Staff RN......................  Denominators for           6,500              12           10/60          13,000
                                 Dialysis Event
                                 Surveillance.
Staff RN......................  Prevention                 1,500              12            1.25          22,500
                                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 Dialysis.
Staff RN......................  Dialysis Patient             325              75           10/60           4,063
                                 Influenza
                                 Vaccination.
Staff RN......................  Dialysis Patient             325               5           10/60             271
                                 Influenza
                                 Vaccination
                                 Denominator.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............       4,861,542
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Maryam I. Daneshvar,
Deputy Director, Office of Scientific Integrity, Office of the 
Associate Director for Science, Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2015-16028 Filed 6-29-15; 8:45 am]
 BILLING CODE 4163-18-P