[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34337-34341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12701]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0666; Docket No. CDC-2016-0046]


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 August 1, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0046 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

[[Page 34338]]

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 2017/2018. The development of this component has 
been previously delayed to obtain additional user feedback and support 
from outside partners.
    Changes were made to six facility surveys and two new facility 
surveys were added. 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.
    Further, three new forms were added to expand NHSN surveillance to 
pediatric ventilator-associated events, adult sepsis, and custom HAI 
event surveillance. An additional 14 forms were added to the 
Hemovigilance Component to streamline data collection/entry for adverse 
reaction events.
    Additionally, minor revisions have been made to 22 forms within the 
package to clarify and/or update surveillance definitions. The 
previously approved NHSN package included 52 individual collection 
forms; the current revision request adds nineteen forms and removes one 
form for a total of 70 forms. The reporting burden will increase by 
489,174 hours, for a total of 5,110,716 hours.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of      Avg. burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     Respondent       (in hrs.)       (in hrs.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registered Nurse (Infection Preventionist).....  57.100 NHSN Registration Form..........           2,000               1            5/60             167
Registered Nurse (Infection Preventionist).....  57.101 Facility Contact Information....           2,000               1           10/60             333
Registered Nurse (Infection Preventionist).....  57.103 Patient Safety Component--Annual           5,000               1           55/60           4,583
                                                  Hospital Survey.
Registered Nurse (Infection Preventionist).....  57.105 Group Contact Information.......           1,000               1            5/60              83
Registered Nurse (Infection Preventionist).....  57.106 Patient Safety Monthly Reporting           6,000              12           15/60          18,000
                                                  Plan.
Registered Nurse (Infection Preventionist).....  57.108 Primary Bloodstream Infection              6,000              44           30/60         132,000
                                                  (BSI).
Registered Nurse (Infection Preventionist).....  57.111 Pneumonia (PNEU)................           6,000              72           30/60         216,000
Registered Nurse (Infection Preventionist).....  57.112 Ventilator-Associated Event.....           6,000             144           25/60         360,000
Registered Nurse (Infection Preventionist).....  57.113 Pediatric Ventilator-Associated            2,000             120           25/60         100,000
                                                  Event (PedVAE).

[[Page 34339]]

 
Registered Nurse (Infection Preventionist).....  57.114 Urinary Tract Infection (UTI)...           6,000              40           20/60          80,000
Registered Nurse (Infection Preventionist).....  57.115 Custom Event....................           2,000              91           35/60         106,167
Staff RN.......................................  57.116 Denominators for Neonatal                  6,000               9               3         162,000
                                                  Intensive Care Unit (NICU).
Staff RN.......................................  57.117 Denominators for Specialty Care            6,000               9               5         270,000
                                                  Area (SCA)/Oncology (ONC).
Staff RN.......................................  57.118 Denominators for Intensive Care            6,000              60               5       1,800,000
                                                  Unit (ICU)/Other locations (not NICU
                                                  or SCA).
Registered Nurse (Infection Preventionist).....  57.120 Surgical Site Infection (SSI)...           6,000              36           35/60         126,000
Staff RN.......................................  57.121 Denominator for Procedure.......           6,000             540           10/60         540,000
Laboratory Technician..........................  57.123 Antimicrobial Use and Resistance           6,000              12            5/60           6,000
                                                  (AUR)-Microbiology Data Electronic
                                                  Upload Specification Tables.
Pharmacist.....................................  57.124 Antimicrobial Use and Resistance           6,000              12            5/60           6,000
                                                  (AUR)-Pharmacy Data Electronic Upload
                                                  Specification Tables.
Registered Nurse (Infection Preventionist).....  57.125 Central Line Insertion Practices           1,000             100           25/60          41,667
                                                  Adherence Monitoring.
Registered Nurse (Infection Preventionist).....  57.126 MDRO or CDI Infection Form......           6,000              72           30/60         216,000
Registered Nurse (Infection Preventionist).....  57.127 MDRO and CDI Prevention Process            6,000              24           15/60          36,000
                                                  and Outcome Measures Monthly
                                                  Monitoring.
Registered Nurse (Infection Preventionist).....  57.128 Laboratory-identified MDRO or              6,000             240           20/60         480,000
                                                  CDI Event.
Registered Nurse (Infection Preventionist).....  57.129 Adult Sepsis....................              50             250           25/60           5,208
Registered Nurse (Infection Preventionist).....  57.137 Long-Term Care Facility                      350               1            1.08             378
                                                  Component--Annual Facility Survey.
Registered Nurse (Infection Preventionist).....  57.138 Laboratory-identified MDRO or                350              12           15/60           1,050
                                                  CDI Event for LTCF.
Registered Nurse (Infection Preventionist).....  57.139 MDRO and CDI Prevention Process              350              12           10/60             700
                                                  Measures Monthly Monitoring for LTCF.
Registered Nurse (Infection Preventionist).....  57.140 Urinary Tract Infection (UTI)                350              14           30/60           2,450
                                                  for LTCF.
Registered Nurse (Infection Preventionist).....  57.141 Monthly Reporting Plan for LTCF.             350              12            5/60             350
Registered Nurse (Infection Preventionist).....  57.142 Denominators for LTCF Locations.             350              12            3.35          14,070
Registered Nurse (Infection Preventionist).....  57.143 Prevention Process Measures                  300              12            5/60             300
                                                  Monthly Monitoring for LTCF.
Registered Nurse (Infection Preventionist).....  57.150 LTAC Annual Survey..............             400               1           55/60             367
Registered Nurse (Infection Preventionist).....  57.151 Rehab Annual Survey.............           1,000               1           55/60             917
Occupational Health RN/Specialist..............  57.200 Healthcare Personnel Safety                   50               1               8             400
                                                  Component Annual Facility Survey.
Occupational Health RN/Specialist..............  57.203 Healthcare Personnel Safety               17,000               1            5/60           1,417
                                                  Monthly Reporting Plan.
Occupational Health RN/Specialist..............  57.204 Healthcare Worker Demographic                 50             200           20/60           3,333
                                                  Data.
Occupational Health RN/Specialist..............  57.205 Exposure to Blood/Body Fluids...              50              50               1           2,500
Occupational Health RN/Specialist..............  57.206 Healthcare Worker Prophylaxis/                50              30           15/60             375
                                                  Treatment.
Laboratory Technician..........................  57.207 Follow-Up Laboratory Testing....              50              50           15/60             625
Occupational Health RN/Specialist..............  57.210 Healthcare Worker Prophylaxis/                50              50           10/60             417
                                                  Treatment-Influenza.

[[Page 34340]]

 
Medical/Clinical Laboratory Technologist.......  57.300 Hemovigilance Module Annual                  500               1               2           1,000
                                                  Survey.
Medical/Clinical Laboratory Technologist.......  57.301 Hemovigilance Module Monthly                 500              12            1/60             100
                                                  Reporting Plan.
Medical/Clinical Laboratory Technologist.......  57.303 Hemovigilance Module Monthly                 500              12            1.17           7,020
                                                  Reporting Denominators.
Medical/Clinical Laboratory Technologist.......  57.305 Hemovigilance Incident..........             500              10           10/60             833
Medical/Clinical Laboratory Technologist.......  57.306 Hemovigilance Module Annual                  200               1           35/60             117
                                                  Survey--Non-acute care facility.
Medical/Clinical Laboratory Technologist.......  57.307 Hemovigilance Adverse Reaction--             500               4           25/60             833
                                                  Acute Hemolytic Transfusion Reaction.
Medical/Clinical Laboratory Technologist.......  57.308 Hemovigilance Adverse Reaction--             500               4           25/60             833
                                                  Allergic Transfusion Reaction.
Medical/Clinical Laboratory Technologist.......  57.309 Hemovigilance Adverse Reaction--             500               1           25/60             208
                                                  Delayed Hemolytic Transfusion Reaction.
Medical/Clinical Laboratory Technologist.......  57.310 Hemovigilance Adverse Reaction--             500               2           25/60             417
                                                  Delayed Serologic Transfusion Reaction.
Medical/Clinical Laboratory Technologist.......  57.311 Hemovigilance Adverse Reaction--             500               4           25/60             833
                                                  Febrile Non-hemolytic Transfusion
                                                  Reaction.
Medical/Clinical Laboratory Technologist.......  57.312 Hemovigilance Adverse Reaction--             500               1           25/60             208
                                                  Hypotensive Transfusion Reaction.
Medical/Clinical Laboratory Technologist.......  57.313 Hemovigilance Adverse Reaction--             500               1           25/60             208
                                                  Infection.
Medical/Clinical Laboratory Technologist.......  57.314 Hemovigilance Adverse Reaction--             500               1           25/60             208
                                                  Post Transfusion Purpura.
Medical/Clinical Laboratory Technologist.......  57.315 Hemovigilance Adverse Reaction--             500               1           25/60             208
                                                  Transfusion Associated Dyspnea.
Medical/Clinical Laboratory Technologist.......  57.316 Hemovigilance Adverse Reaction--             500               1           25/60             208
                                                  Transfusion Associated Graft vs. Host
                                                  Disease.
Medical/Clinical Laboratory Technologist.......  57.317 Hemovigilance Adverse Reaction--             500               1           25/60             208
                                                  Transfusion Related Acute Lung Injury.
Medical/Clinical Laboratory Technologist.......  57.318 Hemovigilance Adverse Reaction--             500               2           25/60             417
                                                  Transfusion Associated Circulatory
                                                  Overload.
Medical/Clinical Laboratory Technologist.......  57.319 Hemovigilance Adverse Reaction--             500               1           25/60             208
                                                  Unknown Transfusion Reaction.
Medical/Clinical Laboratory Technologist.......  57.320 Hemovigilance Adverse Reaction--             500               1           25/60             208
                                                  Other Transfusion Reaction.
Medical/Clinical Laboratory Technologist.......  57.400 Patient Safety Component--Annual           5,000               1            5/60             417
                                                  Facility Survey for Ambulatory Surgery
                                                  Center (ASC).
Staff RN.......................................  57.401 Outpatient Procedure Component--           5,000              12           15/60          15,000
                                                  Monthly Reporting Plan.
Staff RN.......................................  57.402 Outpatient Procedure Component             5,000              25           40/60          83,333
                                                  Event.
Staff RN.......................................  57.403 Outpatient Procedure Component--           5,000              12           40/60          40,000
                                                  Monthly Denominators and Summary.
Staff RN.......................................  57.500 Outpatient Dialysis Center                 6,500               1             2.0          13,000
                                                  Practices Survey.
Registered Nurse (Infection Preventionist).....  57.501 Dialysis Monthly Reporting Plan.           6,500              12            5/60           6,500
Staff RN.......................................  57.502 Dialysis Event..................           6,500              60           25/60         162,500
Staff RN.......................................  57.503 Denominator for Outpatient                 6,500              12           10/60          13,000
                                                  Dialysis.

[[Page 34341]]

 
Staff RN.......................................  57.504 Prevention Process Measures                1,500              12            1.25          22,500
                                                  Monthly Monitoring for Dialysis.
Staff RN.......................................  57.505 Dialysis Patient Influenza                   325              75           10/60           4,063
                                                  Vaccination.
Staff RN.......................................  57.506 Dialysis Patient Influenza                   325               5           10/60             271
                                                  Vaccination Denominator.
Staff RN.......................................  57.507 Home Dialysis Center Practices               600               1           25/60             250
                                                  Survey.
Total..........................................  .......................................       5,110,716
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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. 2016-12701 Filed 5-27-16; 8:45 am]
 BILLING CODE 4163-18-P