Proposed Data Collection Submitted for Public Comment and Recommendations, 34337-34341 [2016-12701]
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Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
Committee (Committee or DAC). The
meeting is open to the public. During
this meeting, members of the Committee
will receive and discuss summaries of
activities and recommendations from its
subcommittees.
DATES: The Committee’s next meeting
will take place on Thursday, June 16,
2016, from 9:00 a.m. to 3:30 p.m. (EST).
ADDRESSES: Federal Communications
Commission, 445 12th Street SW.,
Washington, DC 20554, in the
Commission Meeting Room.
FOR FURTHER INFORMATION CONTACT:
Elaine Gardner, Consumer and
Governmental Affairs Bureau: 202–418–
0581 (voice); email: DAC@fcc.gov; or
Suzy Rosen Singleton, Alternate DAC
Designated Federal Officer, Consumer
and Governmental Affairs Bureau: 202–
510–9446 (VP/voice), at the same email
address: DAC@fcc.gov.
SUPPLEMENTARY INFORMATION: The
Committee was established in December
2014 to make recommendations to the
Commission on a wide array of
disability matters within the jurisdiction
of the Commission, and to facilitate the
participation of people with disabilities
in proceedings before the Commission.
The Committee is organized under, and
operated in accordance with, the
provisions of the Federal Advisory
Committee Act (FACA). The Committee
held its first meeting on March 17, 2015.
At its June 16, 2016 meeting, the
Committee is expected to receive and
consider a report on the activities of its
Communications Subcommittee; a
report and recommendation from its
Emergency Communications
Subcommittee regarding proposed DAC
comments on the Commission’s Notice
of Proposed Rulemaking on Wireless
Emergency Alerts; a report on the
activities of its Relay & Equipment
Distribution Subcommittee; a report and
recommendation from its Technology
Transitions Subcommittee regarding the
benefits of HD Voice and ways to
address the transition to HD Voice; and
a report and possible recommendation
from its Video Programming
Subcommittee regarding appropriate
capitalization of offline captioning of
video programming. The Committee
will also (1) hear presentations from
Commission staff on recent activities;
(2) hear reports from various FCC
bureaus, including: A report from the
FCC Wireline Competition Bureau on
the modernization of the Lifeline
program; a report from FCC Media
Bureau on the commercial availability
of set top boxes and the expansion of
video description; and an update on the
ACE Direct project; and (3) discuss new
issues for its consideration.
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A limited amount of time may be
available on the agenda for comments
and inquiries from the public. The
public may comment or ask questions of
presenters via the email address
livequestions@fcc.gov.
The meeting site is fully accessible to
people using wheelchairs or other
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and Governmental Affairs Bureau at
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(TTY). Last minute requests will be
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audio format), send an email to fcc504@
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Governmental Affairs Bureau at (202)
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(TTY).
34337
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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
Federal Communications Commission.
safety.
Karen Peltz Strauss,
DATES: Written comments must be
received on or before August 1, 2016.
Deputy Chief, Consumer and Governmental
Affairs Bureau.
ADDRESSES: You may submit comments,
[FR Doc. 2016–12710 Filed 5–27–16; 8:45 am]
identified by Docket No. CDC–2016–
BILLING CODE 6712–01–P
0046 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
FEDERAL ELECTION COMMISSION
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Sunshine Act Meetings
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
AGENCY: Federal Election Commission
D74, Atlanta, Georgia 30329.
DATE & TIME: Thursday, May 26, 2016 At
Instructions: All submissions received
10:00 a.m.
must include the agency name and
PLACE: 999 E Street NW., Washington,
Docket Number. All relevant comments
DC (Ninth Floor)
received will be posted without change
STATUS: This meeting will be open to the to Regulations.gov, including any
personal information provided. For
public.
access to the docket to read background
Federal Register Notice of Previous
documents or comments received, go to
Anouncement—81 FR 32753
Regulations.gov.
CHANGE IN THE MEETING: The May 26,
Please note: All public comment should be
2016 meeting was cancelled.
submitted through the Federal eRulemaking
PERSON TO CONTACT FOR INFORMATION:
portal (Regulations.gov) or by U.S. mail to the
Judith Ingram, Press Officer, Telephone: address listed above.
(202) 694–1220.
FOR FURTHER INFORMATION CONTACT: To
Shelley E. Garr,
request more information on the
Deputy Secretary of the Commission.
proposed project or to obtain a copy of
[FR Doc. 2016–12820 Filed 5–26–16; 11:15 am]
the information collection plan and
instruments, contact the Information
BILLING CODE 6715–01–P
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SUMMARY:
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Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road, NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
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
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.
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,
ESTIMATED ANNUALIZED BURDEN HOURS
sradovich on DSK3TPTVN1PROD with NOTICES
Type of respondents
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
VerDate Sep<11>2014
Number of
respondents
Form name
Number of
responses per
Respondent
Avg. burden
per response
(in hrs.)
Total burden
(in hrs.)
(Infection
57.100 NHSN Registration Form .....
2,000
1
5/60
167
(Infection
57.101 Facility Contact Information
2,000
1
10/60
333
(Infection
57.103 Patient Safety Component—
Annual Hospital Survey.
57.105 Group Contact Information ..
5,000
1
55/60
4,583
1,000
1
5/60
83
6,000
12
15/60
18,000
6,000
44
30/60
132,000
(Infection
57.106 Patient Safety Monthly Reporting Plan.
57.108 Primary Bloodstream Infection (BSI).
57.111 Pneumonia (PNEU) .............
6,000
72
30/60
216,000
(Infection
57.112 Ventilator-Associated Event
6,000
144
25/60
360,000
(Infection
57.113 Pediatric Ventilator-Associated Event (PedVAE).
2,000
120
25/60
100,000
(Infection
(Infection
(Infection
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Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Number of
responses per
Respondent
Avg. burden
per response
(in hrs.)
Total burden
(in hrs.)
Type of respondents
Form name
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Staff RN .............................................
57.114 Urinary Tract Infection (UTI)
6,000
40
20/60
80,000
57.115 Custom Event ......................
2,000
91
35/60
106,167
57.116 Denominators for Neonatal
Intensive Care Unit (NICU).
57.117 Denominators for Specialty
Care
Area
(SCA)/Oncology
(ONC).
57.118 Denominators for Intensive
Care Unit (ICU)/Other locations
(not NICU or SCA).
57.120 Surgical Site Infection (SSI)
6,000
9
3
162,000
6,000
9
5
270,000
6,000
60
5
1,800,000
6,000
36
35/60
126,000
57.121 Denominator for Procedure
57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data
Electronic Upload Specification
Tables.
57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data
Electronic Upload Specification
Tables.
57.125 Central Line Insertion Practices Adherence Monitoring.
57.126 MDRO or CDI Infection
Form.
57.127 MDRO and CDI Prevention
Process and Outcome Measures
Monthly Monitoring.
57.128 Laboratory-identified MDRO
or CDI Event.
57.129 Adult Sepsis .........................
6,000
6,000
540
12
10/60
5/60
540,000
6,000
6,000
12
5/60
6,000
1,000
100
25/60
41,667
6,000
72
30/60
216,000
6,000
24
15/60
36,000
6,000
240
20/60
480,000
50
250
25/60
5,208
57.137 Long-Term Care Facility
Component—Annual Facility Survey.
57.138 Laboratory-identified MDRO
or CDI Event for LTCF.
57.139 MDRO and CDI Prevention
Process Measures Monthly Monitoring for LTCF.
57.140 Urinary Tract Infection (UTI)
for LTCF.
57.141 Monthly Reporting Plan for
LTCF.
57.142 Denominators for LTCF Locations.
57.143 Prevention Process Measures Monthly Monitoring for LTCF.
57.150 LTAC Annual Survey ...........
350
1
1.08
378
350
12
15/60
1,050
350
12
10/60
700
350
14
30/60
2,450
350
12
5/60
350
350
12
3.35
14,070
300
12
5/60
300
400
1
55/60
367
57.151 Rehab Annual Survey .........
1,000
1
55/60
917
57.200 Healthcare Personnel Safety
Component Annual Facility Survey.
57.203 Healthcare Personnel Safety
Monthly Reporting Plan.
57.204 Healthcare Worker Demographic Data.
57.205 Exposure to Blood/Body
Fluids.
57.206 Healthcare Worker Prophylaxis/Treatment.
57.207 Follow-Up Laboratory Testing.
57.210 Healthcare Worker Prophylaxis/Treatment-Influenza.
50
1
8
400
17,000
1
5/60
1,417
50
200
20/60
3,333
50
50
1
2,500
50
30
15/60
375
50
50
15/60
625
50
50
10/60
417
Staff RN .............................................
Staff RN .............................................
Registered
Nurse
(Infection
Preventionist).
Staff RN .............................................
Laboratory Technician .......................
Pharmacist .........................................
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
(Infection
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
(Infection
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
(Infection
(Infection
(Infection
(Infection
(Infection
(Infection
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
sradovich on DSK3TPTVN1PROD with NOTICES
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Laboratory Technician .......................
Occupational Health RN/Specialist ...
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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Laboratory
Tech-
Laboratory
Tech-
Laboratory
Tech-
Laboratory
Tech-
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Laboratory
Tech-
Laboratory
Tech-
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Medical/Clinical
nologist.
Laboratory
Tech-
Staff RN .............................................
Staff RN .............................................
sradovich on DSK3TPTVN1PROD with NOTICES
Staff RN .............................................
Staff RN .............................................
Registered
Nurse
(Infection
Preventionist).
Staff RN .............................................
Staff RN .............................................
VerDate Sep<11>2014
20:07 May 27, 2016
Number of
respondents
Form name
57.300 Hemovigilance Module Annual Survey.
57.301
Hemovigilance
Module
Monthly Reporting Plan.
57.303
Hemovigilance
Module
Monthly Reporting Denominators.
57.305 Hemovigilance Incident .......
57.306 Hemovigilance Module Annual Survey—Non-acute care facility.
57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction.
57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction.
57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction.
57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction.
57.311 Hemovigilance Adverse Reaction—Febrile
Non-hemolytic
Transfusion Reaction.
57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion
Reaction.
57.313 Hemovigilance Adverse Reaction—Infection.
57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura.
57.315 Hemovigilance Adverse Reaction—Transfusion
Associated
Dyspnea.
57.316 Hemovigilance Adverse Reaction—Transfusion
Associated
Graft vs. Host Disease.
57.317 Hemovigilance Adverse Reaction—Transfusion
Related
Acute Lung Injury.
57.318 Hemovigilance Adverse Reaction—Transfusion
Associated
Circulatory Overload.
57.319 Hemovigilance Adverse Reaction—Unknown
Transfusion
Reaction.
57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction.
57.400 Patient Safety Component—
Annual Facility Survey for Ambulatory Surgery Center (ASC).
57.401 Outpatient Procedure Component—Monthly Reporting Plan.
57.402 Outpatient Procedure Component Event.
57.403 Outpatient Procedure Component—Monthly
Denominators
and Summary.
57.500 Outpatient Dialysis Center
Practices Survey.
57.501 Dialysis Monthly Reporting
Plan.
57.502 Dialysis Event ......................
57.503 Denominator for Outpatient
Dialysis.
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Number of
responses per
Respondent
Avg. burden
per response
(in hrs.)
Total burden
(in hrs.)
500
1
2
1,000
500
12
1/60
100
500
12
1.17
7,020
500
10
10/60
833
200
1
35/60
117
500
4
25/60
833
500
4
25/60
833
500
1
25/60
208
500
2
25/60
417
500
4
25/60
833
500
1
25/60
208
500
1
25/60
208
500
1
25/60
208
500
1
25/60
208
500
1
25/60
208
500
1
25/60
208
500
2
25/60
417
500
1
25/60
208
500
1
25/60
208
5,000
1
5/60
417
5,000
12
15/60
15,000
5,000
25
40/60
83,333
5,000
12
40/60
40,000
6,500
1
2.0
13,000
6,500
12
5/60
6,500
6,500
6,500
60
12
25/60
10/60
162,500
13,000
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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondents
Form name
Staff RN .............................................
57.504 Prevention Process Measures Monthly Monitoring for Dialysis.
57.505 Dialysis Patient Influenza
Vaccination.
57.506 Dialysis Patient Influenza
Vaccination Denominator.
57.507 Home Dialysis Center Practices Survey.
..........................................................
Staff RN .............................................
Staff RN .............................................
Staff RN .............................................
Total ...................................................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day-16–16TM]
sradovich on DSK3TPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
20:07 May 27, 2016
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1.25
22,500
325
75
10/60
4,063
325
5
10/60
271
600
1
25/60
250
5,110,716
Background and Brief Description
Preventing healthcare-associated
infections (HAI) and encouraging
appropriate use of antimicrobials are
priorities of both the U.S. Department of
Health and Human Services and the
Centers for Disease Control and
Prevention. The burden and
epidemiology of HAIs and antimicrobial
use in U.S. nursing homes is currently
unknown. Understanding the scope and
magnitude of all types of HAIs in
patient populations across the spectrum
of U.S. healthcare facilities is essential
to the development of effective
prevention and control strategies and
policies.
HAI prevalence and antimicrobial use
estimates can be obtained through
prevalence surveys in which data are
Fmt 4703
Sfmt 4703
Total burden
(in hrs.)
12
Proposed Project
Prevalence Survey of HealthcareAssociated Infections and Antimicrobial
Use in U.S. Nursing Homes—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Frm 00033
Avg. burden
per response
(in hrs.)
1,500
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 omb@cdc.gov. 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.
PO 00000
Number of
responses per
Respondent
collected in healthcare facilities during
a short, specified time period. Essential
steps in reducing the occurrence of
HAIs and the prevalence of resistant
pathogens include estimating the
burden, types, and causative organisms
of HAIs; assessing the nature and extent
of antimicrobial use in U.S. healthcare
facilities; and assessing the nature and
extent of antimicrobial use.
Prevalence surveys, in which data are
collected in healthcare facilities during
a short, specified time period represent
an efficient and cost-effective alternative
to prospective studies of HAI and
antimicrobial use incidence. Given the
absence of existing HAI and
antimicrobial use data collection
mechanisms for nursing homes,
prevalence surveys represent a robust
method for obtaining the surveillance
data required to identify HAIs and
antibiotic use practices that should be
targeted for more intensive surveillance
and to guide and evaluate prevention
efforts.
The methods for the data collection
are based on those used in CDC hospital
prevalence surveys and informed by a
CDC pilot survey conducted in nine
U.S. nursing homes. The survey will be
performed by the CDC through the
Emerging Infections Program (EIP), a
collaboration with CDC and 10 state
health departments with experience in
HAI surveillance and data collection.
Respondents are nursing homes
certified by the Centers for Medicare &
Medicare Services in EIP states. Nursing
homes will be randomly selected for
participation. The EIP will recruit 20
nursing homes in each of the 10 EIP
sites. Nursing home participation is
voluntary.
OMB approval is requested for three
years. Participation is voluntary and
there are no costs to respondents other
than their time. The total estimated
annual burden hours are 5,217.
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[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.
-----------------------------------------------------------------------
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: omb@cdc.gov.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
