Att B - 60d FRN

2017-60 Day Notice.pdf

The National Healthcare Safety Network (NHSN)

Att B - 60d FRN

OMB: 0920-0666

Document [pdf]
Download: pdf | pdf
Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
instruments, contact Leroy Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: [email protected].

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0666; Docket No. CDC–2017–
0047]

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
safety.
DATES: Written comments must be
received on or before July 31, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0047 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment
should be submitted through the
Federal eRulemaking portal
(Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and

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SUMMARY:

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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.

SUPPLEMENTARY INFORMATION:

Proposed Data Collection Submitted
for Public Comment and
Recommendations

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Proposed Project
National Healthcare Safety Network
(NHSN) (OMB Control Number 0920–
0666, Expires—Revision—National
Center for Emerging and Zoonotic
Infection Diseases (NCEZID), Centers for
Disease Control and Prevention (CDC)
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) is requesting a threeyear approval of the National
Healthcare Safety Network information
collection project.
The National Healthcare Safety
Network (NHSN) is a system designed to
accumulate, exchange, and integrate
relevant information and resources
among private and public stakeholders
to support local and national efforts to
protect patients and promote healthcare
safety. Specifically, the data is used to
determine the magnitude of various
healthcare-associated adverse events
and trends in the rates of these events
among patients and healthcare workers
with similar risks.
The data collected will be used to
inform and detect changes in the
epidemiology of adverse events
resulting from new and current medical
therapies and changing risks. The NHSN
currently consists of five components:
Patient Safety, Healthcare Personnel
Safety, Biovigilance, Long-Term Care
Facility (LTCF), and Dialysis. The
Outpatient Procedure Component is on
track to be released in NHSN in 2018.
The development of this component has
been previously delayed to obtain
additional user feedback and support
from outside partners.
Changes were made to four facility
surveys. Based on user feedback and
internal reviews of the annual facility
surveys it was determined that
questions and response options be
amended, removed, or added to fit the
evolving uses of the annual facility
surveys. Also, the surveys are being
increasingly used to help intelligently
interpret the other data elements
reported into NHSN. Currently, the
surveys are used to appropriately risk
adjust the numerator and denominator
data entered into NHSN while also
guiding decisions on future division
priorities for prevention.
Further, two new forms were added to
expand NHSN surveillance to enhance
data collection by Ambulatory Surgical
Centers to identify areas where
prevention of SSIs may be improved. An
additional 14 forms were modified
within the Hemovigilance module to
streamline data collection/entry for
adverse reaction events.

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Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
This collection of information is
authorized by the Public Health Service
Act (42 U.S.C. 242b, 242k, and 242m
(d)). There is no cost to respondents
other than the time to participate.

previously approved NHSN package
included 70 individual collection forms;
the current revision request includes a
total of 72 forms. The reporting burden
will decrease by 811,985 hours, for a
total of 5,922,953 hours.

Overall, minor revisions have been
made to a total of 38 forms within the
package to clarify and/or update
surveillance definitions, increase or
decrease the number of reporting
facilities, and adding new forms. The

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Laboratory Technician ......................

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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

Registered
Nurse
Preventionist).

(Infection

VerDate Sep<11>2014

(Infection
(Infection

(Infection
(Infection

(Infection

19:59 May 26, 2017

Number of
respondents

Form No. & name

Number of
responses per
respondent

Average
burden per
response
(hours)

Total burden
(hours)

57.100

NHSN Registration Form ...

2,000

1

5/60

167

57.101

Facility Contact Information

2,000

1

10/60

333

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

57.106 Patient Safety Monthly Reporting Plan.
57.108 Primary Bloodstream Infection (BSI).
57.111 Pneumonia (PNEU) ...........

6,000

12

15/60

18,000

6,000

44

30/60

132,000

6,000

72

30/60

216,000

6,000

144

25/60

360,000

2,000

120

25/60

100,000

6,000

40

20/60

80,000

2,000

91

35/60

106,167

6,000

12

4

288,000

6,000

9

5

270,000

6,000

60

5

1,800,000

6,000

36

35/60

126,000

6,000
6,000

540
12

10/60
5/60

540,000
6,000

6,000

12

5/60

6,000

100

100

25/60

4,167

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

2,600

1

2

5,200

2,600

12

15/60

7,800

2,600

12

10/60

5,200

2,600

14

30/60

18,200

57.112 Ventilator—Associated
Event.
57.113 Pediatric Ventilator—Associated Event (PedVAE).
57.114 Urinary
Tract
Infection
(UTI).
57.115 Custom Event ....................
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).
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 .......................
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.

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Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form No. & name

Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Occupational Health RN/Specialist ...

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 .........

Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Laboratory Technician ......................
Occupational Health RN/Specialist ...

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Number of
respondents

Type of respondent

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.

Laboratory

Tech-

Laboratory

Tech-

Medical/Clinical
nologist.

Laboratory

Tech-

Medical/Clinical
nologist.

Laboratory

Tech-

Medical/Clinical
nologist.

Laboratory

Tech-

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19:59 May 26, 2017

Number of
responses per
respondent

Average
burden per
response
(hours)

Total burden
(hours)

2,600

12

5/60

2,600

2,600

12

4

124,800

2,600

12

5/60

600

400

1

55/60

367

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.
57.300 Hemovigilance Module Annual Survey.
57.301 Hemovigilance
Module
Monthly Reporting Plan.
57.303 Hemovigilance
Module
Monthly Reporting Denominators.
57.305 Hemovigilance Incident .....

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

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

20/60

667

500

4

20/60

667

500

1

20/60

167

500

2

20/60

333

500

4

20/60

667

500

1

20/60

167

500

1

20/60

167

500

1

20/60

167

500

1

20/60

167

500

1

20/60

167

500

1

20/60

167

57.151

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.

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Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent

Medical/Clinical
nologist.

Laboratory

Tech-

Medical/Clinical
nologist.

Laboratory

Tech-

Medical/Clinical
nologist.

Laboratory

Tech-

Medical/Clinical Laboratory Technologist.
Staff RN ............................................
Staff RN ............................................

Staff RN ............................................

Staff RN ............................................
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Total ...........................................

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 Outpatient Procedure Component—Annual Facility Survey.
57.401 Outpatient Procedure Component—Monthly Reporting Plan.
57.402—Outpatient Procedure Component Same Day Outcome
Measures & Prophylactic Intravenous(IV)
Antibiotic
Timing
Event.
57.403—Outpatient Procedure Component—Monthly
Denominators
for Same Day Outcome Measures
& Prophylactic Intravenous(IV)
Antibiotic Timing Event.
57.404 Outpatient Procedure Component—Annual Facility Survey.
57.405 Outpatient Procedure Component—Surgical Site (SSI) Event.
57.500 Outpatient Dialysis Center
Practices Survey.
57.501 Dialysis Monthly Reporting
Plan.
57.502 Dialysis Event ....................
57.503 Denominator for Outpatient
Dialysis.
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.
...........................................................

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–11020 Filed 5–26–17; 8:45 am]

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19:59 May 26, 2017

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2

20/60

333

500

1

20/60

167

500

1

20/60

167

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

5,000

540

10/60

450,00

5,000

36

35/60

105,00

7,000

1

2.0

14,000

7,000

12

5/60

7,000

7,000
7,000

60
12

25/60
10/60

175,000
14,000

2,000

12

1.25

30,000

325

75

10/60

4,063

325

5

10/60

271

350

1

30/60

175

........................

........................

........................

5922,953

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request

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Total burden
(hours)

500

Proposed Projects:
Title: Form ACF–196R, ‘‘TANF
Quarterly Financial Report.’’
OMB No.: 0970–0446.
Description: This information
collection is authorized under Section
411(a)(3) of the Social Security Act. This
request is for continued approval of
Form ACF–196R for quarterly financial
reporting under the Temporary

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burden per
response
(hours)

Number of
responses per
respondent

Number of
respondents

Form No. & name

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Assistance for Needy Families (TANF)
program. States participating in the
TANF program are required by statute to
report financial data on a quarterly
basis. The forms meet the legal standard
and provide essential data on the use of
federal TANF funds. Failure to collect
the data would seriously compromise
ACF’s ability to monitor program
expenditures, estimate funding needs,
and to prepare budget submissions and
annual reports required by Congress.
Financial reporting under the TANF
program is governed by 45 CFR part
265.
Respondents: State agencies
administering the TANF program.

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