Agency Forms Undergoing Paperwork Reduction Act Review, 12119-12121 [2011-4946]
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Federal Register / Vol. 76, No. 43 / Friday, March 4, 2011 / Notices
that have the potential for use as agents
of bioterrorism, inflicting significant
morbidity and mortality on susceptible
populations.
In light of current terrorism concerns
and the significant NIH grant monies
directed toward Select Agent research,
CDC receives hundreds of requests for
Select Agents from researchers. The
approximately 900 applicants are
required to complete an application
form in which they identify themselves
and their institution, provide a
Curriculum Vitae or biographical
sketch, a summary of their research
proposal, and sign indemnification and
material transfer agreement statements.
In this request, CDC is requesting
approval for approximately 450 hours;
no change from the currently approved
12119
burden. The only correction to this data
collection request is updating the name
of the National Center on the
application form. A user fee will be
collected to recover costs for materials,
handling and shipping (except for
public health laboratories). The cost to
the respondent will vary based on
which agent is requested.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Respondent
Number of respondents
Number of responses per
respondent
Average burden per response
(in hours)
Researcher ......................................................................................................
Total ..........................................................................................................
900
........................
1
........................
30/60
........................
Dated: February 25, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2011–4948 Filed 3–3–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–11–0666]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
jlentini on DSKJ8SOYB1PROD with NOTICES
Proposed Project
National Healthcare Safety Network
(NHSN) (OMB No. 0920–0666 exp.
3/31/2012)—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
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19:16 Mar 03, 2011
Jkt 223001
accumulate, exchange, and integrate
relevant information and resources
among private and public stakeholders
to support local and national efforts to
protect patients and to 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. 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. The data will be
used to detect changes in the
epidemiology of adverse events
resulting from new and current medical
therapies and changing risks.
This revision submission includes an
amended Assurance of Confidentiality,
which required an update of the
Assurance of Confidentiality language
on all forms included in the NHSN
surveillance system. 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). The Patient Safety (PS)
Component is being expanded to
include long term care facilities to
facilitate HAI surveillance in this
setting, for which no standardized
reporting methodology or mechanism
currently exists. Four new forms are
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
Total burden
(in hours)
450
450
proposed for this purpose. A new form
is proposed to be added to the
Healthcare Personnel Safety (HPS)
Component to facilitate summary
reporting of influenza vaccination in
healthcare workers, which is anticipated
to be required by CMS in the near
future. In addition to this new form, the
scope of the HPS Annual Facility
Survey is being expanded to include all
acute care facilities that would enroll if
CMS does implement this requirement.
The NHSN Antimicrobial Use and
Resistance module is transitioning from
manual web entry to electronic data
upload only, which results in a
significant decrease to the reporting
burden for this package. Finally, there
are many updates, clarifications, and
data collection revisions proposed in
this submission.
CDC is requesting to delete four
currently approved forms that are no
longer needed by the NHSN and add
five new forms
The previously-approved NHSN
package included 47 individual data
collection forms. If all proposed
revisions are approved, the reporting
burden will decrease by 1,258,119
hours, for a total estimated burden of
3,914,125 hours and 48 total data
collection tools.
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. The
total estimated annual burden hours are
3,914,125.
E:\FR\FM\04MRN1.SGM
04MRN1
12120
Federal Register / Vol. 76, No. 43 / Friday, March 4, 2011 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Form name
Infection Preventionist ............
NHSN Registration Form .......................................................
Facility Contact Information ....................................................
Patient Safety Component—Annual Facility Survey ..............
Patient Safety Component—Outpatient Dialysis Center
Practices Survey.
Group Contact Information .....................................................
Patient Safety Monthly Reporting Plan ..................................
Primary Bloodstream Infection (BSI) ......................................
Dialysis Event .........................................................................
Pneumonia (PNEU) ................................................................
Urinary Tract Infection (UTI) ..................................................
Denominators for Neonatal Intensive Care Unit (NICU) ........
Denominators for Specialty Care Area (SCA) .......................
Denominators for Intensive Care Unit (ICU)/Other locations
(not NICU or SCA).
Denominator for Outpatient Dialysis ......................................
Surgical Site Infection (SSI) ...................................................
Denominator for Procedure ....................................................
Antimicrobial Use and Resistance (AUR)-Microbiology Data
Electronic Upload Specification Tables.
Antimicrobial Use and Resistance (AUR)-Pharmacy Data
Electronic Upload Specification Tables.
Central Line Insertion Practices Adherence Monitoring ........
MDRO or CDI Infection Form ................................................
MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring.
Laboratory-identified MDRO or CDI Event ............................
Vaccination Monthly Monitoring Form—Summary Method ...
Vaccination Monthly Monitoring Form—Patient-Level Method.
Patient Vaccination .................................................................
Patient Safety Component—Annual Facility Survey for
LTCF.
Laboratory-identified MDRO or CDI Event for LTCF .............
MDRO and CDI Prevention Process Measures Monthly
Monitoring for LTCF.
Urinary Tract Infection (UTI) for LTCF ...................................
Healthcare Personnel Safety Component Annual Facility
Survey.
Healthcare Worker Survey .....................................................
Healthcare Personnel Safety Monthly Reporting Plan ..........
Healthcare Worker Demographic Data ..................................
Exposure to Blood/Body Fluids ..............................................
Healthcare Worker Prophylaxis/Treatment ............................
Follow-Up Laboratory Testing ................................................
Healthcare Worker Vaccination History .................................
Healthcare Worker Influenza Vaccination ..............................
Healthcare Worker Prophylaxis/Treatment-Influenza ............
Pre-season Survey on Influenza Vaccination Programs for
Healthcare Personnel.
Post-season Survey on Influenza Vaccination Programs for
Healthcare Personnel.
Healthcare Personnel Influenza Vaccination Monthly Summary.
Hemovigilance Module Annual Survey ..................................
Staff RN ..................................
Staff RN ..................................
Infection Preventionist ............
Staff RN ..................................
Laboratory Technician ............
Pharmacy Technician .............
Infection Preventionist ............
Occ Health RN ........................
Laboratory Technician ............
Occ Health RN ........................
Occ Health RN ........................
Clinical Laboratory Technologist.
jlentini on DSKJ8SOYB1PROD with NOTICES
Hemovigilance
Hemovigilance
Hemovigilance
Hemovigilance
Hemovigilance
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Module Monthly Reporting Plan ....................
Module Monthly Incident Summary ...............
Module Monthly Reporting Denominators .....
Adverse Reaction ..........................................
Incident ..........................................................
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Fmt 4703
Sfmt 4703
E:\FR\FM\04MRN1.SGM
Responses
per respondent
Burden per
response
(hours)
6,000
6,000
6,000
5,500
1
1
1
1
5/60
10/60
40/60
1
6,000
6,000
6,000
500
6,000
6,000
6,000
6,000
6,000
1
9
36
75
72
27
9
9
18
5/60
35/60
32/60
15/60
32/60
32/60
4
5
5
500
6,000
6,000
6,000
12
27
540
12
5/60
32/60
10/60
5/60
6,000
12
5/60
6,000
6,000
6,000
100
72
24
5/60
32/60
10/60
6,000
6,000
2,000
240
5
5
25/60
14
2
2,000
250
250
1
10/60
25/60
250
250
8
3
30/60
7/60
250
6,000
9
1
30/60
8
600
600
600
600
600
600
600
600
600
600
100
9
200
50
10
100
300
500
50
1
10/60
10/60
20/60
1
15/60
15/60
10/60
10/60
10/60
10/60
600
1
10/60
6,000
6
2
500
1
2
500
500
500
500
500
12
12
12
120
72
2/60
2
30/60
10/60
10/60
04MRN1
12121
Federal Register / Vol. 76, No. 43 / Friday, March 4, 2011 / Notices
Dated: February 25, 2011.
Catina Conner,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2011–4946 Filed 3–3–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–11–0770]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
e-mail to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
National HIV Behavioral Surveillance
System (NHBS) 0920–0770 (exp. 03/31/
2011)—Revision-National Center for
HIV, Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The purpose of this data collection is
to monitor behaviors related to human
immunodeficiency virus (HIV) infection
among persons at high risk for infection
in the United States. The primary
objectives of NHBS are to obtain data
from samples of persons at risk to: (a)
Describe the prevalence and trends in
risk behaviors; (b) describe the
prevalence of and trends in HIV testing
and HIV infection; (c) describe the
prevalence of and trends in use of HIV
prevention services; (d) identify met and
unmet needs for HIV prevention
services in order to inform health
departments, community-based
organizations, community planning
groups and other stakeholders. This
project addresses the goals of CDC’s HIV
prevention strategic plan, specifically
the goal of strengthening the national
capacity to monitor the HIV epidemic to
better direct and evaluate prevention
efforts.
For the proposed data collection, CDC
has revised the interview data collection
instruments. A few questions were
added (related to health care access and
utilization, use of pre-exposure
prophylaxis, homophobia, HIV stigma,
and discrimination), some were
removed, and others were revised from
the previously approved instrument to
make them easier for respondents to
understand and respond appropriately.
The project activities and methods will
remain the same as those used in the
previously approved collection.
Data are collected through
anonymous, in-person interviews
conducted with persons systematically
selected from 25 Metropolitan Statistical
Areas (MSAs) throughout the United
States; these 25 MSAs were chosen
based on having high AIDS prevalence.
Persons at risk for HIV infection to be
interviewed for NHBS include men who
have sex with men (MSM), injecting
drug users (IDUs), and heterosexuals at
increased risk of HIV (HET). A brief
screening interview will be used to
determine eligibility for participation in
the behavioral assessment. The data
from the behavioral assessment will
provide estimates of behavior related to
the risk of HIV and other sexually
transmitted diseases, prior testing for
HIV, and use of HIV prevention
services. All persons interviewed will
also be offered an HIV test and will
participate in a pre-test counseling
session. No other Federal agency
systematically collects this type of
information from persons at risk for HIV
infection. These data have substantial
impact on prevention program
development and monitoring at the
local, State, and national levels.
CDC estimates that NHBS will
involve, per year in each of the 25
MSAs, eligibility screening for 50 to 200
persons and eligibility screening plus
the survey with 500 eligible
respondents, resulting in a total of
37,500 eligible survey respondents and
7,500 ineligible screened persons during
a 3-year period. Data collection will
rotate such that interviews will be
conducted among one group per year:
MSM in year 1, IDU in year 2, and HET
in year 3. The type of data collected for
each group will vary slightly due to
different sampling methods and risk
characteristics of the group.
This request is for a revision and an
approval for an additional 3 years of
data collection. Participation of
respondents is voluntary and there is no
cost to the respondents other than their
time. The total estimated annualized
burden hours are 9,931.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Responses
per respondent
Average
burden per
response (in
hours)
Screener ...............................
Survey ...................................
17,500
12,500
1
1
5/60
30/60
Screener ...............................
Survey ...................................
Recruiter Debriefing ..............
13,750
12,500
6,250
1
1
1
5/60
54/60
2/60
Screener ...............................
Survey ...................................
Recruiter Debriefing ..............
13,750
12,500
6,250
1
1
1
5/60
39/60
2/60
jlentini on DSKJ8SOYB1PROD with NOTICES
Type of respondent
Form name
Year 1 (MSM):
Persons Screened .........................................................................
Eligible Participants .......................................................................
Year 2 (IDU).
Persons Referred by Peer Recruiters ...........................................
Eligible Participants .......................................................................
Peer Recruiters .............................................................................
Year 3 (HET):
Persons Referred by Peer Recruiters ...........................................
Eligible Participants .......................................................................
Peer Recruiters .............................................................................
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19:16 Mar 03, 2011
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E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 76, Number 43 (Friday, March 4, 2011)]
[Notices]
[Pages 12119-12121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4946]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-11-0666]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-5806.
Written comments should be received within 30 days of this notice.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB No. 0920-0666 exp.
3/31/2012)--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 to 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.
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. The data will be used
to detect changes in the epidemiology of adverse events resulting from
new and current medical therapies and changing risks.
This revision submission includes an amended Assurance of
Confidentiality, which required an update of the Assurance of
Confidentiality language on all forms included in the NHSN surveillance
system. 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). The Patient Safety (PS) Component is being
expanded to include long term care facilities to facilitate HAI
surveillance in this setting, for which no standardized reporting
methodology or mechanism currently exists. Four new forms are proposed
for this purpose. A new form is proposed to be added to the Healthcare
Personnel Safety (HPS) Component to facilitate summary reporting of
influenza vaccination in healthcare workers, which is anticipated to be
required by CMS in the near future. In addition to this new form, the
scope of the HPS Annual Facility Survey is being expanded to include
all acute care facilities that would enroll if CMS does implement this
requirement. The NHSN Antimicrobial Use and Resistance module is
transitioning from manual web entry to electronic data upload only,
which results in a significant decrease to the reporting burden for
this package. Finally, there are many updates, clarifications, and data
collection revisions proposed in this submission.
CDC is requesting to delete four currently approved forms that are
no longer needed by the NHSN and add five new forms
The previously-approved NHSN package included 47 individual data
collection forms. If all proposed revisions are approved, the reporting
burden will decrease by 1,258,119 hours, for a total estimated burden
of 3,914,125 hours and 48 total data collection tools.
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. The total
estimated annual burden hours are 3,914,125.
[[Page 12120]]
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Burden per
Respondents Form name Number of Responses per response
respondents respondent (hours)
----------------------------------------------------------------------------------------------------------------
Infection Preventionist............ NHSN Registration Form..... 6,000 1 5/60
Facility Contact 6,000 1 10/60
Information.
Patient Safety Component-- 6,000 1 40/60
Annual Facility Survey.
Patient Safety Component-- 5,500 1 1
Outpatient Dialysis Center
Practices Survey.
Group Contact Information.. 6,000 1 5/60
Patient Safety Monthly 6,000 9 35/60
Reporting Plan.
Primary Bloodstream 6,000 36 32/60
Infection (BSI).
Dialysis Event............. 500 75 15/60
Pneumonia (PNEU)........... 6,000 72 32/60
Urinary Tract Infection 6,000 27 32/60
(UTI).
Staff RN........................... Denominators for Neonatal 6,000 9 4
Intensive Care Unit (NICU).
Denominators for Specialty 6,000 9 5
Care Area (SCA).
Denominators for Intensive 6,000 18 5
Care Unit (ICU)/Other
locations (not NICU or
SCA).
Staff RN........................... Denominator for Outpatient 500 12 5/60
Dialysis.
Infection Preventionist............ Surgical Site Infection 6,000 27 32/60
(SSI).
Staff RN........................... Denominator for Procedure.. 6,000 540 10/60
Laboratory Technician.............. Antimicrobial Use and 6,000 12 5/60
Resistance (AUR)-
Microbiology Data
Electronic Upload
Specification Tables.
Pharmacy Technician................ Antimicrobial Use and 6,000 12 5/60
Resistance (AUR)-Pharmacy
Data Electronic Upload
Specification Tables.
Infection Preventionist............ Central Line Insertion 6,000 100 5/60
Practices Adherence
Monitoring.
MDRO or CDI Infection Form. 6,000 72 32/60
MDRO and CDI Prevention 6,000 24 10/60
Process and Outcome
Measures Monthly
Monitoring.
Laboratory-identified MDRO 6,000 240 25/60
or CDI Event.
Vaccination Monthly 6,000 5 14
Monitoring Form--Summary
Method.
Vaccination Monthly 2,000 5 2
Monitoring Form--Patient-
Level Method.
Patient Vaccination........ 2,000 250 10/60
Patient Safety Component-- 250 1 25/60
Annual Facility Survey for
LTCF.
Laboratory-identified MDRO 250 8 30/60
or CDI Event for LTCF.
MDRO and CDI Prevention 250 3 7/60
Process Measures Monthly
Monitoring for LTCF.
Urinary Tract Infection 250 9 30/60
(UTI) for LTCF.
Occ Health RN...................... Healthcare Personnel Safety 6,000 1 8
Component Annual Facility
Survey.
Healthcare Worker Survey... 600 100 10/60
Healthcare Personnel Safety 600 9 10/60
Monthly Reporting Plan.
Healthcare Worker 600 200 20/60
Demographic Data.
Exposure to Blood/Body 600 50 1
Fluids.
Healthcare Worker 600 10 15/60
Prophylaxis/Treatment.
Laboratory Technician.............. Follow-Up Laboratory 600 100 15/60
Testing.
Occ Health RN...................... Healthcare Worker 600 300 10/60
Vaccination History.
Occ Health RN...................... Healthcare Worker Influenza 600 500 10/60
Vaccination.
Healthcare Worker 600 50 10/60
Prophylaxis/Treatment-
Influenza.
Pre-season Survey on 600 1 10/60
Influenza Vaccination
Programs for Healthcare
Personnel.
Post-season Survey on 600 1 10/60
Influenza Vaccination
Programs for Healthcare
Personnel.
Healthcare Personnel 6,000 6 2
Influenza Vaccination
Monthly Summary.
Clinical Laboratory Technologist... Hemovigilance Module Annual 500 1 2
Survey.
Hemovigilance Module 500 12 2/60
Monthly Reporting Plan.
Hemovigilance Module 500 12 2
Monthly Incident Summary.
Hemovigilance Module 500 12 30/60
Monthly Reporting
Denominators.
Hemovigilance Adverse 500 120 10/60
Reaction.
Hemovigilance Incident..... 500 72 10/60
----------------------------------------------------------------------------------------------------------------
[[Page 12121]]
Dated: February 25, 2011.
Catina Conner,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2011-4946 Filed 3-3-11; 8:45 am]
BILLING CODE 4163-18-P
