Proposed Data Collections Submitted for Public Comment and Recommendations, 56458-56461 [2011-23302]
Download as PDF
<![CDATA[
56458
Federal Register / Vol. 76, No. 177 / Tuesday, September 13, 2011 / Notices
The purpose of this analysis is to
facilitate public comment on the
Consent Agreement, and it is not
intended to constitute an official
interpretation of the proposed Decision
and Order or the Order to Maintain
Assets, or to modify their terms in any
way.
By direction of the Commission.
Donald S. Clark
Secretary.
[FR Doc. 2011–23305 Filed 9–12–11; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Assistant Secretary for
Planning and Evaluation; Meeting of
the Advisory Council on Alzheimer’s
Research, Care, and Services
This notice announces public
meetings of the Advisory Council on
Alzheimer’s Research, Care, and
Services (Advisory Council). Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)(1) and
(a)(2)). The Advisory Council on
Alzheimer’s Research, Care, and
Services will provide advice on how to
prevent or reduce the burden of
Alzheimer’s disease and related
dementias on people with the disease
and their caregivers. Representatives
from the Department of Health and
Human Services (HHS) will present
inventories of Federal activities related
to Alzheimer’s disease and related
dementias in three areas: research,
clinical care, and long-term services and
support. The representatives will also
identify gaps and opportunities in these
areas. The Advisory Council will
discuss the inventories, gaps, and
opportunities, and make
recommendations to the Secretary for
priority areas and actions for a national
plan to address Alzheimer’s disease and
related dementias.
Meeting Date: September 27, 2011,
9:30 a.m. to 4 p.m.
ADDRESSES: The meeting will be held at
Administration on Aging headquarters
at 1 Massachusetts Ave., NW.,
Washington, DC, 20001, Room 5604/
5403.
Comments: Time is allocated on the
agenda to hear public comments at the
end of the meeting. In lieu of oral
comments, formal written comments
may be submitted for the record to
mstockstill on DSK4VPTVN1PROD with NOTICES
VerDate Mar<15>2010
19:22 Sep 12, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Proposed Data Collections Submitted
for Public Comment and
Recommendations
Helen Lamont (202) 690–7996,
helen.lamont@hhs.gov Note: Although
the meeting is open to the public,
procedures governing security and the
entrance to Federal buildings may
change without notice. Those wishing to
attend the meeting must call or e-mail
Dr. Lamont by Thursday September 22,
2011, so that their name may be put on
a list of expected attendees and
forwarded to the security officers at the
Administration on Aging. Space is
limited to 40 participants.
Topics of
the Meeting: The Advisory Council will
hear presentations and provide feedback
on inventories of Federal activities to
address Alzheimer’s disease and related
dementias, gaps that can be addressed,
and opportunities for collaboration. The
Advisory Council is specifically charged
with discussing and making
recommendations to the Secretary on
priorities for a national plan to address
Alzheimer’s disease and related
dementias.
Procedure and Agenda: This meeting
is open to the public. Representatives of
HHS will present the inventories of
Federal activities related to Alzheimer’s
disease and related dementias to the
Advisory Council. The representatives
will also identify gaps and opportunities
in these areas. After each presentation,
the Advisory Council will openly
discuss the inventory and the findings.
Interested persons may observe the
discussion, but the Advisory Council
will not hear public comments during
this time. The Advisory Council will
allow an open public session for any
attendee to address issues specific to the
inventories or topics that should be
addressed by a national plan.
SUPPLEMENTARY INFORMATION:
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
SUMMARY:
Helen Lamont, OASPE, 200
Independence Ave., SW., Washington,
DC 20201, Room 424E. Those
submitting written comments should
identify themselves and any relevant
organizational affiliations.
Authority: 42 U.S.C. 11225; Section 2(e)(3)
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Dated: September 8, 2011.
Sherry Glied,
Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2011–23465 Filed 9–9–11; 11:15 am]
BILLING CODE 4150–05–P
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Centers for Disease Control and
Prevention
[60Day–11–0666]
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Daniel Holcomb, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an e-mail to omb@cdc.gov.
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; and (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. Written comments should
be received within 60 days of this
notice.
Proposed Project
National Healthcare Safety Network
(NHSN) (OMB No. 0920–0666) exp. 05/
31/2014—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
E:\FR\FM\13SEN1.SGM
13SEN1
56459
Federal Register / Vol. 76, No. 177 / Tuesday, September 13, 2011 / Notices
adverse events resulting from new and
current medical therapies and changing
risks. The NHSN previously consisted of
four components: Patient Safety,
Healthcare Personnel Safety,
Biovigilance, and eSurveillance. In
addition, a fifth component, Long Term
Care Facilities (LTCF) is included in
this revision. In general, the data
reported under the Patient Safety
Component protocols are used to (1)
determine the magnitude of the
healthcare-associated adverse events
under study, trends in the rates of
events, in the distribution of pathogens,
and in the adherence to prevention
practices, and (2) to detect changes in
the epidemiology of adverse events
resulting from new medical therapies
and changing patient risks.
Additionally, reported data will be used
to describe the epidemiology of
antimicrobial use and resistance and to
understand the relationship of
antimicrobial therapy to this growing
problem. Under the Healthcare
Personnel Safety Component protocols,
data on events—both positive and
adverse—are used to determine (1) the
magnitude of adverse events in
healthcare personnel and (2)
compliance with immunization and
sharps injuries safety guidelines. Under
the Biovigilance Component, data on
adverse reactions and incidents
associated with blood transfusions are
A CMS ruling states that these specific
hospital types must begin reporting HAI
surveillance. Therefore, in order to
accurately capture data relevant to those
specific facility types, separate annual
facility surveys were created. Also
within the Patient Safety Component, a
new form will be added, Streamlined
Ventilator-Associated Pneumonia, to
provide a streamlined, objective
definition via which NHSN users may
detect and report cases of ventilatorassociated pneumonia in adult patients
only. Finally there are many updates,
clarifications, and data collection
revisions proposed in this submission.
The previously approved NSHN
package included 48 individual
collection forms; the current revision
request includes six new forms for a
total of 54 forms. The reporting burden
will increase by 64,050 hours, for a total
of 3,978,175 hours.
Healthcare institutions that
participate in NHSN voluntarily report
their data to CDC using a Web browser
based technology for data entry and data
management. Data are collected by
trained surveillance personnel using
written standardized protocols.
Participating institutions must have a
computer capable of supporting an
Internet service provider (ISP) and
access to an ISP. There is no cost to
respondents other than their time.
used to provide national estimates of
adverse reactions and incidents. The
Long-Term Care Facility (LTCF)
Component will be used to more
specifically and appropriately capture
data from the residents of skilled
nursing facilities. In order to facilitate
this reporting, seven LTCF forms were
created by using forms from the Patient
Safety Component as a base, with
modifications to specifically address the
nuances of LTC residents.
This revision submission includes the
remaining three LTCF Component forms
needed to facilitate healthcareassociated infection (HAI) surveillance
in this setting, for which no
standardized reporting methodology or
mechanism currently exists. The three
submitted LTCF forms along with the
four previously approved LTCF forms
will complete the LTCF Component.
The scope of NHSN dialysis
surveillance is being expanded to
include all outpatient dialysis centers,
so that the existing Dialysis Annual
Survey can be used to facilitate
prevention objectives set forth in the
HHS HAI tier 2 Action Plan and to
assess national practices in all
Medicare-certified dialysis centers if
CMS re-establishes this survey method
(as expected). In addition, two new
annual facility surveys will be added for
Long-term Acute Care Hospitals (LTAC)
and Rehabilitation Hospitals (REHAB).
ESTIMATE OF ANNUALIZED BURDEN HOURS
Form number and name
57.100: NHSN Registration Form .....
57.101: Facility Contact Information
57.103: Patient Safety Component—
Annual Facility Survey.
57.104: Patient Safety Component—
Outpatient Dialysis Center Practices Survey.
57.105: Group Contact Information ...
mstockstill on DSK4VPTVN1PROD with NOTICES
57.106: Patient Safety Monthly Reporting Plan.
57.108: Primary Bloodstream Infection (BSI).
57.109: Dialysis Event .......................
57.111: Pneumonia (PNEU) ..............
57.112: Streamlined Ventilator-Associated Pneumonia.
57.114: Urinary Tract Infection (UTI)
57.116: Denominators for Neonatal
Intensive Care Unit (NICU).
57.117: Denominators for Specialty
Care Area (SCA).
57.118: Denominators for Intensive
Care Unit (ICU)/Other locations
(not NICU or SCA).
VerDate Mar<15>2010
19:22 Sep 12, 2011
Number of
respondents
Type of respondents
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Number of
responses per
respondent
Avg. burden
per response
(in hours)
Total burden
(in hours)
(Infection
6,000
1
5/60
500
(Infection
6,000
1
10/60
1,000
(Infection
6,000
1
30/60
3,000
(Infection
5,500
1
1
5,500
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Staff RN ...........................................
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Staff RN ...........................................
6,000
1
5/60
500
6,000
9
35/60
31,500
6,000
36
33/60
118,800
5,500
6,000
75
72
16/60
32/60
110,000
230,400
6,000
144
25/60
360,000
6,000
27
32/60
86,400
6,000
9
3
162,000
Staff RN ...........................................
6,000
9
5
270,000
Staff RN ...........................................
6,000
18
5
540,000
Jkt 223001
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
E:\FR\FM\13SEN1.SGM
13SEN1
56460
Federal Register / Vol. 76, No. 177 / Tuesday, September 13, 2011 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Number of
responses per
respondent
Avg. burden
per response
(in hours)
Total burden
(in hours)
Form number and name
Type of respondents
57.119: Denominator for Outpatient
Dialysis.
57.120: Surgical Site Infection (SSI)
Staff RN ...........................................
5,500
12
6/60
6,600
Registered
Nurse
(Infection
Preventionist).
Staff RN ...........................................
Laboratory Technician .....................
6,000
36
32/60
115,200
6,000
6,000
540
12
8/60
5/60
432,000
6,000
Pharmacy Technician ......................
6,000
12
5/60
6,000
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
(Infection
1,000
100
5/60
8,333
(Infection
6,000
72
32/60
230,400
(Infection
6,000
24
10/60
24,000
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
(Infection
6,000
240
15/60
360,000
(Infection
6,000
5
14
420,000
(Infection
2,000
5
2
20,000
(Infection
2,000
250
10/60
83,333
(Infection
250
1
25/60
104
(Infection
250
8
15/60
500
(Infection
250
3
5/60
63
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 ..
250
9
30/60
1,125
250
12
5/60
250
250
12
3
9,000
250
12
5/60
250
400
1
30/60
200
1,000
1
25/60
417
6,000
1
8
48,000
Occupational Health RN/Specialist ..
Occupational Health RN/Specialist ..
600
600
100
9
10/60
10/60
10,000
900
Occupational Health RN/Specialist ..
600
200
20/60
40,000
Occupational Health RN/Specialist ..
600
50
1
30,000
Occupational Health RN/Specialist ..
600
10
15/60
1,500
Laboratory Technician .....................
600
100
15/60
15,000
Occupational Health RN/Specialist ..
600
300
10/60
30,000
Occupational Health RN/Specialist ..
600
500
10/60
50,000
Occupational Health RN/Specialist ..
600
50
10/60
5,000
Occupational Health RN/Specialist ..
600
1
10/60
100
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.
57.130: Vaccination Monthly Monitoring Form—Summary Method.
57.131: Vaccination Monthly Monitoring Form—Patient-Level Method.
57.133: Patient Vaccination ..............
57.137: Patient Safety Component—
Annual Facility Survey for LTCF.
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 ...........
mstockstill on DSK4VPTVN1PROD with NOTICES
57.151: Rehab Annual Survey ..........
57.200: Healthcare Personnel Safety
Component Annual Facility Survey.
57.202: Healthcare Worker 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.
57.208: Healthcare Worker Vaccination History.
57.209: Healthcare Worker Influenza
Vaccination.
57.210: Healthcare Worker Prophylaxis/Treatment—Influenza.
57.211: Pre-season Survey on Influenza Vaccination Programs for
Healthcare Personnel.
VerDate Mar<15>2010
19:22 Sep 12, 2011
Jkt 223001
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
E:\FR\FM\13SEN1.SGM
13SEN1
56461
Federal Register / Vol. 76, No. 177 / Tuesday, September 13, 2011 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Number of
responses per
respondent
Avg. burden
per response
(in hours)
Total burden
(in hours)
Form number and name
Type of respondents
57.212: Post-season Survey on Influenza Vaccination Programs for
Healthcare Personnel.
57.213: Healthcare Personnel Influenza Vaccination Monthly Summary.
57.300: Hemovigilance Module Annual Survey.
57.301:
Hemovigilance
Module
Monthly Reporting Plan.
57.302:
Hemovigilance
Module
Monthly Incident Summary.
57.303:
Hemovigilance
Module
Monthly Reporting Denominators.
57.304: Hemovigilance Adverse Reaction.
57.305: Hemovigilance Incident ........
Occupational Health RN/Specialist ..
600
1
10/60
100
Occupational Health RN/Specialist ..
6,000
6
2
72,000
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Total Est Annual Burden Hours:
3,978,175
Dated: September 6, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–23302 Filed 9–12–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below
concerns Emerging Infections Programs,
Funding Opportunity Announcement
(FOA), CK12–1202, initial review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 8 a.m.–5 p.m., November
9, 2011 (Closed).
Laboratory
Tech-
500
1
2
1,000
Laboratory
Tech-
500
12
2/60
200
Laboratory
Tech-
500
12
2
12,000
Laboratory
Tech-
500
12
30/60
3,000
Laboratory
Tech-
500
120
10/60
10,000
Laboratory
Tech-
500
72
10/60
6,000
Place: Holiday Inn Decatur Conference
Plaza, 130 Clairemont Avenue, Decatur,
Georgia 30030, Telephone: (404) 371–0204.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Emerging Infections Programs,
FOA CK12–1202.’’
Contact Person for More Information: Amy
Yang, Ph.D., Scientific Review Officer, CDC,
1600 Clifton Road, NE., Mailstop E60,
Atlanta, Georgia 30333, Telephone: (404)
498–2733.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: August 31, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–23300 Filed 9–12–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Family Violence Prevention and
Services: Grants to States; Native
American Tribes and Alaskan Native
Villages; and State Domestic Violence
Coalitions.
OMB No.: 0970–0280.
Description: The Family Violence
Prevention and Services Act (FVPSA),
42 U.S.C. 10401 et seq., authorizes the
Department of Health and Human
Services to award grants to States,
Territories, Tribes or Tribal
Organizations, and State Domestic
Violence Coalitions for family violence
prevention and intervention activities.
The proposed information collection
activities will be used to make grant
award decisions and to monitor grant
performance.
Respondents: State Agencies and
Territories Administering FVPSA
Grants; Tribal Governments and Tribal
Organizations; and State Domestic
Violence Coalitions.
mstockstill on DSK4VPTVN1PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
State Grant Application ....................................................................................
Tribal Grant Application ...................................................................................
State Domestic Violence Coalition Application ................................................
State and Territory FVPSA Grant Performance Progress Report ..................
Tribal FVPSA Grant Performance Progress Report ........................................
VerDate Mar<15>2010
19:22 Sep 12, 2011
Jkt 223001
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
53
200
56
57
200
E:\FR\FM\13SEN1.SGM
1
1
1
1
1
13SEN1
Average
burden hours
per response
10
5
10
10
15
Total burden
hours
530
1,000
560
570
3,000
]]>Agencies
[Federal Register Volume 76, Number 177 (Tuesday, September 13, 2011)]
[Notices]
[Pages 56458-56461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23302]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-11-0666]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Daniel Holcomb, CDC Reports Clearance Officer,
1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to
omb@cdc.gov.
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; and (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. Written comments should be received
within 60 days of this notice.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB No. 0920-0666) exp.
05/31/2014--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
[[Page 56459]]
adverse events resulting from new and current medical therapies and
changing risks. The NHSN previously consisted of four components:
Patient Safety, Healthcare Personnel Safety, Biovigilance, and
eSurveillance. In addition, a fifth component, Long Term Care
Facilities (LTCF) is included in this revision. In general, the data
reported under the Patient Safety Component protocols are used to (1)
determine the magnitude of the healthcare-associated adverse events
under study, trends in the rates of events, in the distribution of
pathogens, and in the adherence to prevention practices, and (2) to
detect changes in the epidemiology of adverse events resulting from new
medical therapies and changing patient risks. Additionally, reported
data will be used to describe the epidemiology of antimicrobial use and
resistance and to understand the relationship of antimicrobial therapy
to this growing problem. Under the Healthcare Personnel Safety
Component protocols, data on events--both positive and adverse--are
used to determine (1) the magnitude of adverse events in healthcare
personnel and (2) compliance with immunization and sharps injuries
safety guidelines. Under the Biovigilance Component, data on adverse
reactions and incidents associated with blood transfusions are used to
provide national estimates of adverse reactions and incidents. The
Long-Term Care Facility (LTCF) Component will be used to more
specifically and appropriately capture data from the residents of
skilled nursing facilities. In order to facilitate this reporting,
seven LTCF forms were created by using forms from the Patient Safety
Component as a base, with modifications to specifically address the
nuances of LTC residents.
This revision submission includes the remaining three LTCF
Component forms needed to facilitate healthcare-associated infection
(HAI) surveillance in this setting, for which no standardized reporting
methodology or mechanism currently exists. The three submitted LTCF
forms along with the four previously approved LTCF forms will complete
the LTCF Component. The scope of NHSN dialysis surveillance is being
expanded to include all outpatient dialysis centers, so that the
existing Dialysis Annual Survey can be used to facilitate prevention
objectives set forth in the HHS HAI tier 2 Action Plan and to assess
national practices in all Medicare-certified dialysis centers if CMS
re-establishes this survey method (as expected). In addition, two new
annual facility surveys will be added for Long-term Acute Care
Hospitals (LTAC) and Rehabilitation Hospitals (REHAB). A CMS ruling
states that these specific hospital types must begin reporting HAI
surveillance. Therefore, in order to accurately capture data relevant
to those specific facility types, separate annual facility surveys were
created. Also within the Patient Safety Component, a new form will be
added, Streamlined Ventilator-Associated Pneumonia, to provide a
streamlined, objective definition via which NHSN users may detect and
report cases of ventilator-associated pneumonia in adult patients only.
Finally there are many updates, clarifications, and data collection
revisions proposed in this submission.
The previously approved NSHN package included 48 individual
collection forms; the current revision request includes six new forms
for a total of 54 forms. The reporting burden will increase by 64,050
hours, for a total of 3,978,175 hours.
Healthcare institutions that participate in NHSN voluntarily report
their data to CDC using a Web browser based technology for data entry
and data management. Data are collected by trained surveillance
personnel using written standardized protocols. Participating
institutions must have a computer capable of supporting an Internet
service provider (ISP) and access to an ISP. There is no cost to
respondents other than their time.
Estimate of Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Form number and name Type of respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
57.100: NHSN Registration Form................. Registered Nurse (Infection 6,000 1 5/60 500
Preventionist).
57.101: Facility Contact Information........... Registered Nurse (Infection 6,000 1 10/60 1,000
Preventionist).
57.103: Patient Safety Component--Annual Registered Nurse (Infection 6,000 1 30/60 3,000
Facility Survey. Preventionist).
57.104: Patient Safety Component--Outpatient Registered Nurse (Infection 5,500 1 1 5,500
Dialysis Center Practices Survey. Preventionist).
57.105: Group Contact Information.............. Registered Nurse (Infection 6,000 1 5/60 500
Preventionist).
57.106: Patient Safety Monthly Reporting Plan.. Registered Nurse (Infection 6,000 9 35/60 31,500
Preventionist).
57.108: Primary Bloodstream Infection (BSI).... Registered Nurse (Infection 6,000 36 33/60 118,800
Preventionist).
57.109: Dialysis Event......................... Staff RN............................... 5,500 75 16/60 110,000
57.111: Pneumonia (PNEU)....................... Registered Nurse (Infection 6,000 72 32/60 230,400
Preventionist).
57.112: Streamlined Ventilator-Associated Registered Nurse (Infection 6,000 144 25/60 360,000
Pneumonia. Preventionist).
57.114: Urinary Tract Infection (UTI).......... Registered Nurse (Infection 6,000 27 32/60 86,400
Preventionist).
57.116: Denominators for Neonatal Intensive Staff RN............................... 6,000 9 3 162,000
Care Unit (NICU).
57.117: Denominators for Specialty Care Area Staff RN............................... 6,000 9 5 270,000
(SCA).
57.118: Denominators for Intensive Care Unit Staff RN............................... 6,000 18 5 540,000
(ICU)/Other locations (not NICU or SCA).
[[Page 56460]]
57.119: Denominator for Outpatient Dialysis.... Staff RN............................... 5,500 12 6/60 6,600
57.120: Surgical Site Infection (SSI).......... Registered Nurse (Infection 6,000 36 32/60 115,200
Preventionist).
57.121: Denominator for Procedure.............. Staff RN............................... 6,000 540 8/60 432,000
57.123: Antimicrobial Use and Resistance (AUR)-- Laboratory Technician.................. 6,000 12 5/60 6,000
Microbiology Data Electronic Upload
Specification Tables.
57.124: Antimicrobial Use and Resistance (AUR)-- Pharmacy Technician.................... 6,000 12 5/60 6,000
Pharmacy Data Electronic Upload Specification
Tables.
57.125: Central Line Insertion Practices Registered Nurse (Infection 1,000 100 5/60 8,333
Adherence Monitoring. Preventionist).
57.126: MDRO or CDI Infection Form............. Registered Nurse (Infection 6,000 72 32/60 230,400
Preventionist).
57.127: MDRO and CDI Prevention Process and Registered Nurse (Infection 6,000 24 10/60 24,000
Outcome Measures Monthly Monitoring. Preventionist).
57.128: Laboratory-identified MDRO or CDI Event Registered Nurse (Infection 6,000 240 15/60 360,000
Preventionist).
57.130: Vaccination Monthly Monitoring Form-- Registered Nurse (Infection 6,000 5 14 420,000
Summary Method. Preventionist).
57.131: Vaccination Monthly Monitoring Form-- Registered Nurse (Infection 2,000 5 2 20,000
Patient-Level Method. Preventionist).
57.133: Patient Vaccination.................... Registered Nurse (Infection 2,000 250 10/60 83,333
Preventionist).
57.137: Patient Safety Component--Annual Registered Nurse (Infection 250 1 25/60 104
Facility Survey for LTCF. Preventionist).
57.138: Laboratory-identified MDRO or CDI Event Registered Nurse (Infection 250 8 15/60 500
for LTCF. Preventionist).
57.139: MDRO and CDI Prevention Process Registered Nurse (Infection 250 3 5/60 63
Measures Monthly Monitoring for LTCF. Preventionist).
57.140: Urinary Tract Infection (UTI) for LTCF. Registered Nurse (Infection 250 9 30/60 1,125
Preventionist).
57.141: Monthly Reporting Plan for LTCF........ Registered Nurse (Infection 250 12 5/60 250
Preventionist).
57.142: Denominators for LTCF Locations........ Registered Nurse (Infection 250 12 3 9,000
Preventionist).
57.143: Prevention Process Measures Monthly Registered Nurse (Infection 250 12 5/60 250
Monitoring for LTCF. Preventionist).
57.150: LTAC Annual Survey..................... Registered Nurse (Infection 400 1 30/60 200
Preventionist).
57.151: Rehab Annual Survey.................... Registered Nurse (Infection 1,000 1 25/60 417
Preventionist).
57.200: Healthcare Personnel Safety Component Occupational Health RN/Specialist...... 6,000 1 8 48,000
Annual Facility Survey.
57.202: Healthcare Worker Survey............... Occupational Health RN/Specialist...... 600 100 10/60 10,000
57.203: Healthcare Personnel Safety Monthly Occupational Health RN/Specialist...... 600 9 10/60 900
Reporting Plan.
57.204: Healthcare Worker Demographic Data..... Occupational Health RN/Specialist...... 600 200 20/60 40,000
57.205: Exposure to Blood/Body Fluids.......... Occupational Health RN/Specialist...... 600 50 1 30,000
57.206: Healthcare Worker Prophylaxis/Treatment Occupational Health RN/Specialist...... 600 10 15/60 1,500
57.207: Follow-Up Laboratory Testing........... Laboratory Technician.................. 600 100 15/60 15,000
57.208: Healthcare Worker Vaccination History.. Occupational Health RN/Specialist...... 600 300 10/60 30,000
57.209: Healthcare Worker Influenza Vaccination Occupational Health RN/Specialist...... 600 500 10/60 50,000
57.210: Healthcare Worker Prophylaxis/ Occupational Health RN/Specialist...... 600 50 10/60 5,000
Treatment--Influenza.
57.211: Pre-season Survey on Influenza Occupational Health RN/Specialist...... 600 1 10/60 100
Vaccination Programs for Healthcare Personnel.
[[Page 56461]]
57.212: Post-season Survey on Influenza Occupational Health RN/Specialist...... 600 1 10/60 100
Vaccination Programs for Healthcare Personnel.
57.213: Healthcare Personnel Influenza Occupational Health RN/Specialist...... 6,000 6 2 72,000
Vaccination Monthly Summary.
57.300: Hemovigilance Module Annual Survey..... Medical/Clinical Laboratory 500 1 2 1,000
Technologist.
57.301: Hemovigilance Module Monthly Reporting Medical/Clinical Laboratory 500 12 2/60 200
Plan. Technologist.
57.302: Hemovigilance Module Monthly Incident Medical/Clinical Laboratory 500 12 2 12,000
Summary. Technologist.
57.303: Hemovigilance Module Monthly Reporting Medical/Clinical Laboratory 500 12 30/60 3,000
Denominators. Technologist.
57.304: Hemovigilance Adverse Reaction......... Medical/Clinical Laboratory 500 120 10/60 10,000
Technologist.
57.305: Hemovigilance Incident................. Medical/Clinical Laboratory 500 72 10/60 6,000
Technologist.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Est Annual Burden Hours: 3,978,175
Dated: September 6, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-23302 Filed 9-12-11; 8:45 am]
BILLING CODE 4163-18-P
