81 FR 52434 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 152 (August 8, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 152 (August 8, 2016)
| Page Range | 52434-52436 | |
| FR Document | 2016-18710 |
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)] [Notices] [Pages 52434-52436] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18710] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-0666] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) 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 submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project National Healthcare Safety Network (NHSN) (OMB No. 0920-0666, Exp. 12/31/2018)--Revision--National Center for Emerging and Zoonotic Infectious 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 ---------------------------------------------------------------------------------------------------------------- Number of Avg. burden Type of respondents Form name Number of responses per per response respondents respondent (in hrs.) ---------------------------------------------------------------------------------------------------------------- Registered Nurse (Infection 57.100 NHSN Registration 2,000 1 5/60 Preventionist). Form. Registered Nurse (Infection 57.101 Facility Contact 2,000 1 10/60 Preventionist). Information. [[Page 52435]] Registered Nurse (Infection 57.103 Patient Safety 5,000 1 55/60 Preventionist). Component--Annual Hospital Survey. Registered Nurse (Infection 57.105 Group Contact 1,000 1 5/60 Preventionist). Information. Registered Nurse (Infection 57.106 Patient Safety 6,000 12 15/60 Preventionist). Monthly Reporting Plan. Registered Nurse (Infection 57.108 Primary Bloodstream 6,000 44 30/60 Preventionist). Infection (BSI). Registered Nurse (Infection 57.111 Pneumonia (PNEU).... 6,000 72 30/60 Preventionist). Registered Nurse (Infection 57.112 Ventilator- 6,000 144 25/60 Preventionist). Associated Event. Registered Nurse (Infection 57.113 Pediatric Ventilator- 2,000 120 25/60 Preventionist). Associated Event (PedVAE). Registered Nurse (Infection 57.114 Urinary Tract 6,000 40 20/60 Preventionist). Infection (UTI). Registered Nurse (Infection 57.115 Custom Event........ 2,000 91 35/60 Preventionist). Staff RN........................... 57.116 Denominators for 6,000 9 3 Neonatal Intensive Care Unit (NICU). Staff RN........................... 57.117 Denominators for 6,000 9 5 Specialty Care Area (SCA)/ Oncology (ONC). Staff RN........................... 57.118 Denominators for 6,000 60 5 Intensive Care Unit (ICU)/ Other locations (not NICU or SCA). Registered Nurse (Infection 57.120 Surgical Site 6,000 36 35/60 Preventionist). Infection (SSI). Staff RN........................... 57.121 Denominator for 6,000 540 10/60 Procedure. Laboratory Technician.............. 57.123 Antimicrobial Use 6,000 12 5/60 and Resistance (AUR)-- Microbiology Data Electronic Upload Specification Tables. Pharmacist......................... 57.124 Antimicrobial Use 6,000 12 5/60 and Resistance (AUR)-- Pharmacy Data Electronic Upload Specification Tables. Registered Nurse (Infection 57.125 Central Line 1,000 100 25/60 Preventionist). Insertion Practices Adherence Monitoring. Registered Nurse (Infection 57.126 MDRO or CDI 6,000 72 30/60 Preventionist). Infection Form. Registered Nurse (Infection 57.127 MDRO and CDI 6,000 24 15/60 Preventionist). Prevention Process and Outcome Measures Monthly Monitoring. Registered Nurse (Infection 57.128 Laboratory- 6,000 240 20/60 Preventionist). identified MDRO or CDI Event. Registered Nurse (Infection 57.129 Adult Sepsis........ 50 250 25/60 Preventionist). Registered Nurse (Infection 57.137 Long-Term Care 350 1 1.08 Preventionist). Facility Component--Annual Facility Survey. Registered Nurse (Infection 57.138 Laboratory- 350 12 15/60 Preventionist). identified MDRO or CDI Event for LTCF. Registered Nurse (Infection 57.139 MDRO and CDI 350 12 10/60 Preventionist). Prevention Process Measures Monthly Monitoring for LTCF. Registered Nurse (Infection 57.140 Urinary Tract 350 14 30/60 Preventionist). Infection (UTI) for LTCF. Registered Nurse (Infection 57.141 Monthly Reporting 350 12 5/60 Preventionist). Plan for LTCF. Registered Nurse (Infection 57.142 Denominators for 350 12 3.35 Preventionist). LTCF Locations. Registered Nurse (Infection 57.143 Prevention Process 300 12 5/60 Preventionist). Measures Monthly Monitoring for LTCF. Registered Nurse (Infection 57.150 LTAC Annual Survey.. 400 1 55/60 Preventionist). Registered Nurse (Infection 57.151 Rehab Annual Survey. 1,000 1 55/60 Preventionist). Occupational Health RN/Specialist.. 57.200 Healthcare Personnel 50 1 8 Safety Component Annual Facility Survey. Occupational Health RN/Specialist.. 57.203 Healthcare Personnel 17,000 1 5/60 Safety Monthly Reporting Plan. Occupational Health RN/Specialist.. 57.204 Healthcare Worker 50 200 20/60 Demographic Data. Occupational Health RN/Specialist.. 57.205 Exposure to Blood/ 50 50 1 Body Fluids. Occupational Health RN/Specialist.. 57.206 Healthcare Worker 50 30 15/60 Prophylaxis/Treatment. Laboratory Technician.............. 57.207 Follow-Up Laboratory 50 50 15/60 Testing. Occupational Health RN/Specialist.. 57.210 Healthcare Worker 50 50 10/60 Prophylaxis/Treatment-- Influenza. Medical/Clinical Laboratory 57.300 Hemovigilance Module 500 1 2 Technologist. Annual Survey. Medical/Clinical Laboratory 57.301 Hemovigilance Module 500 12 1/60 Technologist. Monthly Reporting Plan. Medical/Clinical Laboratory 57.303 Hemovigilance Module 500 12 1.17 Technologist. Monthly Reporting Denominators. Medical/Clinical Laboratory 57.305 Hemovigilance 500 10 10/60 Technologist. Incident. Medical/Clinical Laboratory 57.306 Hemovigilance Module 200 1 35/60 Technologist. Annual Survey--Non-acute care facility. [[Page 52436]] Medical/Clinical Laboratory 57.307 Hemovigilance 500 4 25/60 Technologist. Adverse Reaction--Acute Hemolytic Transfusion Reaction. Medical/Clinical Laboratory 57.308 Hemovigilance 500 4 25/60 Technologist. Adverse Reaction--Allergic Transfusion Reaction. Medical/Clinical Laboratory 57.309 Hemovigilance 500 1 25/60 Technologist. Adverse Reaction--Delayed Hemolytic Transfusion Reaction. Medical/Clinical Laboratory 57.310 Hemovigilance 500 2 25/60 Technologist. Adverse Reaction--Delayed Serologic Transfusion Reaction. Medical/Clinical Laboratory 57.311 Hemovigilance 500 4 25/60 Technologist. Adverse Reaction--Febrile Non-hemolytic Transfusion Reaction. Medical/Clinical Laboratory 57.312 Hemovigilance 500 1 25/60 Technologist. Adverse Reaction-- Hypotensive Transfusion Reaction. Medical/Clinical Laboratory 57.313 Hemovigilance 500 1 25/60 Technologist. Adverse Reaction-- Infection. Medical/Clinical Laboratory 57.314 Hemovigilance 500 1 25/60 Technologist. Adverse Reaction--Post Transfusion Purpura. Medical/Clinical Laboratory 57.315 Hemovigilance 500 1 25/60 Technologist. Adverse Reaction-- Transfusion Associated Dyspnea. Medical/Clinical Laboratory 57.316 Hemovigilance 500 1 25/60 Technologist. Adverse Reaction-- Transfusion Associated Graft vs. Host Disease. Medical/Clinical Laboratory 57.317 Hemovigilance 500 1 25/60 Technologist. Adverse Reaction-- Transfusion Related Acute Lung Injury. Medical/Clinical Laboratory 57.318 Hemovigilance 500 2 25/60 Technologist. Adverse Reaction-- Transfusion Associated Circulatory Overload. Medical/Clinical Laboratory 57.319 Hemovigilance 500 1 25/60 Technologist. Adverse Reaction--Unknown Transfusion Reaction. Medical/Clinical Laboratory 57.320 Hemovigilance 500 1 25/60 Technologist. Adverse Reaction--Other Transfusion Reaction. Medical/Clinical Laboratory 57.400 Patient Safety 5,000 1 5/60 Technologist. Component--Annual Facility Survey for Ambulatory Surgery Center (ASC). Staff RN........................... 57.401 Outpatient Procedure 5,000 12 15/60 Component--Monthly Reporting Plan. Staff RN........................... 57.402 Outpatient Procedure 5,000 25 40/60 Component Event. Staff RN........................... 57.403 Outpatient Procedure 5,000 12 40/60 Component--Monthly Denominators and Summary. Staff RN........................... 57.500 Outpatient Dialysis 6,500 1 2.0 Center Practices Survey. Registered Nurse (Infection 57.501 Dialysis Monthly 6,500 12 5/60 Preventionist). Reporting Plan. Staff RN........................... 57.502 Dialysis Event...... 6,500 60 25/60 Staff RN........................... 57.503 Denominator for 6,500 12 10/60 Outpatient Dialysis. Staff RN........................... 57.504 Prevention Process 1,500 12 1.25 Measures Monthly Monitoring for Dialysis. Staff RN........................... 57.505 Dialysis Patient 325 75 10/60 Influenza Vaccination. Staff RN........................... 57.506 Dialysis Patient 325 5 10/60 Influenza Vaccination Denominator. Staff RN........................... 57.507 Home Dialysis Center 600 1 25/60 Practices Survey. ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Health Scientist, 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. 2016-18710 Filed 8-5-16; 8:45 am] BILLING CODE 4163-18-P
![52434 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
writing on the standards enumerated in accordance with the Paperwork to support local and national efforts to
the BHC Act (12 U.S.C. 1842(c)). If the Reduction Act of 1995. The notice for protect patients and promote healthcare
proposal also involves the acquisition of the proposed information collection is safety. Specifically, the data is used to
a nonbanking company, the review also published to obtain comments from the determine the magnitude of various
includes whether the acquisition of the public and affected agencies. healthcare-associated adverse events
nonbanking company complies with the Written comments and suggestions and trends in the rates of these events
standards in section 4 of the BHC Act from the public and affected agencies among patients and healthcare workers
(12 U.S.C. 1843). Unless otherwise concerning the proposed collection of with similar risks. The data will be used
noted, nonbanking activities will be information are encouraged. Your to detect changes in the epidemiology of
conducted throughout the United States. comments should address any of the adverse events resulting from new and
Unless otherwise noted, comments following: (a) Evaluate whether the current medical therapies and changing
regarding each of these applications proposed collection of information is risks. The NHSN currently consists of
must be received at the Reserve Bank necessary for the proper performance of five components: Patient Safety,
indicated or the offices of the Board of the functions of the agency, including Healthcare Personnel Safety,
Governors not later than September 2, whether the information will have Biovigilance, Long-Term Care Facility
2016. practical utility; (b) Evaluate the (LTCF), and Dialysis. The Outpatient
A. Federal Reserve Bank of Kansas accuracy of the agencies estimate of the Procedure Component is on track to be
City (Dennis Denney, Assistant Vice burden of the proposed collection of released in NHSN in 2017/2018. The
President) 1 Memorial Drive, Kansas information, including the validity of development of this component has
City, Missouri 64198–0001: the methodology and assumptions used; been previously delayed to obtain
1. Equity Bancshares, Inc., Wichita, (c) Enhance the quality, utility, and additional user feedback and support
Kansas, to acquire 100 percent of the clarity of the information to be from outside partners.
voting shares of Community First collected; (d) Minimize the burden of Changes were made to six facility
Bancshares, Inc., and thereby indirectly the collection of information on those surveys and two new facility surveys
acquire control of Community First who are to respond, including through were added. Based on user feedback and
Bank, both of Harrison, Arkansas. the use of appropriate automated,
B. Federal Reserve Bank of Chicago internal reviews of the annual facility
electronic, mechanical, or other surveys it was determined that
(Colette A. Fried, Assistant Vice technological collection techniques or
President) 230 South LaSalle Street, questions and response options be
other forms of information technology, amended, removed, or added to fit the
Chicago, Illinois 60690–1414: e.g., permitting electronic submission of
1. United Community Bancorp, Inc., evolving uses of the annual facility
responses; and (e) Assess information surveys. The surveys are being
Chatham, Illinois; for prior approval to collection costs.
acquire Illini Corporation, Springfield, increasingly used to help intelligently
To request additional information on interpret the other data elements
Illinois and thereby indirectly acquire the proposed project or to obtain a copy
Illini Bank, Springfield, Illinois and reported into NHSN. Currently the
of the information collection plan and surveys are used to appropriately risk
Farmers State Bank of Camp Point, instruments, call (404) 639–7570 or
Camp Point, Illinois. adjust the numerator and denominator
send an email to omb@cdc.gov. Written data entered into NHSN while also
Board of Governors of the Federal Reserve comments and/or suggestions regarding guiding decisions on future division
System, August 2, 2016. the items contained in this notice priorities for prevention.
Michele T. Fennell, should be directed to the Attention:
Further, three new forms were added
Assistant Secretary of the Board. CDC Desk Officer, Office of Management
to expand NHSN surveillance to
[FR Doc. 2016–18691 Filed 8–5–16; 8:45 am] and Budget, Washington, DC 20503 or
pediatric ventilator-associated events,
BILLING CODE 6210–01–P by fax to (202) 395–5806. Written
adult sepsis, and custom HAI event
comments should be received within 30
surveillance. An additional 14 forms
days of this notice.
were added to the Hemovigilance
DEPARTMENT OF HEALTH AND Proposed Project Component to streamline data
HUMAN SERVICES collection/entry for adverse reaction
National Healthcare Safety Network
(NHSN) (OMB No. 0920–0666, Exp. 12/ events.
Centers for Disease Control and
Prevention 31/2018)—Revision—National Center Additionally, minor revisions have
for Emerging and Zoonotic Infectious been made to 22 forms within the
[30Day–16–0666] package to clarify and/or update
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC). surveillance definitions. The previously
Agency Forms Undergoing Paperwork
approved NHSN package included 52
Reduction Act Review Background and Brief Description individual collection forms; the current
The Centers for Disease Control and The National Healthcare Safety revision request adds nineteen forms
Prevention (CDC) has submitted the Network (NHSN) is a system designed to and removes one form for a total of 70
following information collection request accumulate, exchange, and integrate forms. The reporting burden will
to the Office of Management and Budget relevant information and resources increase by 489,174 hours, for a total of
(OMB) for review and approval in among private and public stakeholders 5,110,716 hours.
mstockstill on DSK3G9T082PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Avg. burden
Number of
Type of respondents Form name responses per per response
respondents respondent (in hrs.)
Registered Nurse (Infection Preventionist) ..... 57.100 NHSN Registration Form ................... 2,000 1 5/60
Registered Nurse (Infection Preventionist) ..... 57.101 Facility Contact Information ............... 2,000 1 10/60
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![52436 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of Avg. burden
Number of
Type of respondents Form name responses per per response
respondents respondent (in hrs.)
Medical/Clinical Laboratory Technologist ....... 57.307 Hemovigilance Adverse Reaction— 500 4 25/60
Acute Hemolytic Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.308 Hemovigilance Adverse Reaction— 500 4 25/60
Allergic Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.309 Hemovigilance Adverse Reaction— 500 1 25/60
Delayed Hemolytic Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.310 Hemovigilance Adverse Reaction— 500 2 25/60
Delayed Serologic Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.311 Hemovigilance Adverse Reaction— 500 4 25/60
Febrile Non-hemolytic Transfusion Reac-
tion.
Medical/Clinical Laboratory Technologist ....... 57.312 Hemovigilance Adverse Reaction— 500 1 25/60
Hypotensive Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.313 Hemovigilance Adverse Reaction— 500 1 25/60
Infection.
Medical/Clinical Laboratory Technologist ....... 57.314 Hemovigilance Adverse Reaction— 500 1 25/60
Post Transfusion Purpura.
Medical/Clinical Laboratory Technologist ....... 57.315 Hemovigilance Adverse Reaction— 500 1 25/60
Transfusion Associated Dyspnea.
Medical/Clinical Laboratory Technologist ....... 57.316 Hemovigilance Adverse Reaction— 500 1 25/60
Transfusion Associated Graft vs. Host Dis-
ease.
Medical/Clinical Laboratory Technologist ....... 57.317 Hemovigilance Adverse Reaction— 500 1 25/60
Transfusion Related Acute Lung Injury.
Medical/Clinical Laboratory Technologist ....... 57.318 Hemovigilance Adverse Reaction— 500 2 25/60
Transfusion Associated Circulatory Over-
load.
Medical/Clinical Laboratory Technologist ....... 57.319 Hemovigilance Adverse Reaction— 500 1 25/60
Unknown Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.320 Hemovigilance Adverse Reaction— 500 1 25/60
Other Transfusion Reaction.
Medical/Clinical Laboratory Technologist ....... 57.400 Patient Safety Component—Annual 5,000 1 5/60
Facility Survey for Ambulatory Surgery
Center (ASC).
Staff RN .......................................................... 57.401 Outpatient Procedure Component— 5,000 12 15/60
Monthly Reporting Plan.
Staff RN .......................................................... 57.402 Outpatient Procedure Component 5,000 25 40/60
Event.
Staff RN .......................................................... 57.403 Outpatient Procedure Component— 5,000 12 40/60
Monthly Denominators and Summary.
Staff RN .......................................................... 57.500 Outpatient Dialysis Center Practices 6,500 1 2.0
Survey.
Registered Nurse (Infection Preventionist) ..... 57.501 Dialysis Monthly Reporting Plan ........ 6,500 12 5/60
Staff RN .......................................................... 57.502 Dialysis Event .................................... 6,500 60 25/60
Staff RN .......................................................... 57.503 Denominator for Outpatient Dialysis .. 6,500 12 10/60
Staff RN .......................................................... 57.504 Prevention Process Measures Month- 1,500 12 1.25
ly Monitoring for Dialysis.
Staff RN .......................................................... 57.505 Dialysis Patient Influenza Vaccination 325 75 10/60
Staff RN .......................................................... 57.506 Dialysis Patient Influenza Vaccination 325 5 10/60
Denominator.
Staff RN .......................................................... 57.507 Home Dialysis Center Practices Sur- 600 1 25/60
vey.
Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND to the Office of Management and Budget
Health Scientist, Acting Chief, Information HUMAN SERVICES (OMB) for review and approval in
Collection Review Office, Office of Scientific accordance with the Paperwork
Integrity, Office of the Associate Director for Centers for Disease Control and Reduction Act of 1995. The notice for
Science, Office of the Director, Centers for Prevention the proposed information collection is
Disease Control and Prevention. published to obtain comments from the
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–18710 Filed 8–5–16; 8:45 am] [30Day–16–0010] public and affected agencies.
BILLING CODE 4163–18–P
Agency Forms Undergoing Paperwork Written comments and suggestions
Reduction Act Review from the public and affected agencies
concerning the proposed collection of
The Centers for Disease Control and information are encouraged. Your
Prevention (CDC) has submitted the comments should address any of the
following information collection request following: (a) Evaluate whether the
VerDate Sep<11>2014 22:23 Aug 05, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1](https://thefederalregister.org/doc/81_FR_52586/page/3.svg)
Document Created: 2016-08-06 03:08:27
Document Modified: 2016-08-06 03:08:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 81 FR 52434 |
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