Agency Forms Undergoing Paperwork Reduction Act Review, 13344-13345 [2013-04508]
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13344
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–13–0852]
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 (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Prevalence Survey of HealthcareAssociated Infections (HAIs) in Acute
Care Hospitals in the United States—
Extension—(0920–0852 exp.5/31/13)—
National Center for Emerging and
Zoonotic Infectious Diseases, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Preventing healthcare-associated
infections (HAIs) is a CDC priority. An
essential step in reducing the
occurrence of HAIs is to estimate
accurately the burden of these infections
in U.S. hospitals, and to describe the
types of HAIs and causative organisms.
The scope and magnitude of HAIs in the
United States were last directly
estimated in the 1970s by CDC’s Study
on the Efficacy of Nosocomial Infection
Control (SENIC), in which
comprehensive data were collected from
a sample of 338 hospitals; 5% of
hospitalized patients acquired an
infection not present at the time of
admission. Because of the substantial
resources necessary to conduct hospitalwide surveillance in an ongoing
manner, most of the more than 4,500
hospitals now reporting to the CDC’s
current HAI surveillance system, the
National Healthcare Safety Network
(NHSN 0920–0666 expires 1/31/15),
focus instead on device-associated and
procedure-associated infections in a
selected patient locations, and do not
report data on all types of HAIs
occurring hospital-wide. Periodic
assessments of the magnitude and types
of HAIs occurring in all patient
populations within acute care hospitals
are needed to inform decisions by local
and national policy makers and by
hospital infection control personnel
regarding appropriate targets and
strategies for HAI prevention. Such
assessments can be obtained in periodic
national prevalence surveys, such as
those that have been conducted in
several European countries.
In 2008–2009, CDC developed a pilot
protocol for a HAI point prevalence
survey, conducted over a 1-day period
at each of 9 acute care hospitals in one
U.S. city. This pilot phase was followed
in 2010 by a phase 2, limited roll-out
HAI and antimicrobial use prevalence
survey, conducted during July and
August in 22 hospitals across 10
Emerging Infections Program sites (in
California, Colorado, Connecticut,
Georgia, Maryland, Minnesota, New
Mexico, New York, Oregon, and
Tennessee). Experience gained in the
phase 1 and phase 2 surveys was used
to conduct a full-scale, phase 3 survey
in 2011, involving 183 hospitals in the
10 EIP sites. Over 11,000 patients were
surveyed, and analysis of HAI and
antimicrobial use data is ongoing at this
time. Preliminary HAI prevalence
results were presented at the 52nd
Interscience Conference on
Antimicrobial Agents and
Chemotherapy (San Francisco, CA,
September 8–12, 2012) and preliminary
antimicrobial use results were presented
at the 2012 IDWeek conference (San
Diego, CA, October 17–21, 2012).
An extension of the prevalence
survey’s existing OMB approval is
sought, to allow a repeat HAI and
antimicrobial use prevalence survey to
be performed in 2014. A repeat survey
will allow further refinement of survey
methodology and assessment of changes
over time in prevalence, HAI
distribution, and pathogen distribution.
It will also allow for a re-assessment of
the burden of antimicrobial use, at a
time when antimicrobial stewardship is
an area of active engagement in many
acute care hospitals. The 2014 survey
will be performed in a sample of up to
500 acute care hospitals, drawn from the
acute care hospital populations in each
of the 10 EIP sites (and including
participation from many hospitals that
participated in prior phases of the
survey). Infection prevention personnel
in participating hospitals and EIP site
personnel will collect demographic and
clinical data from the medical records of
a sample of eligible patients in their
hospitals on a single day in 2014, to
identify CDC-defined HAIs. The surveys
will provide data for CDC to make
estimates of the prevalence of HAIs
across this sample of U.S. hospitals as
well as the distribution of infection
types and causative organisms. These
data can be used to work toward
reducing and eliminating healthcareassociated infections—a DHHS Healthy
People 2020 objective (https://
www.healthypeople.gov/2020/
topicsobjectives2020/
overview.aspx?topicid=17). This survey
project also supports the CDC Winnable
Battle goal of improving national
surveillance for healthcare-associated
infections (https://www.cdc.gov/
winnablebattles/Goals.html).
The total burden is 9,375 hours,
which represents an increase of 250
hours over the previously approved
burden. The increase is requested
because the median number of
responses per respondent in the 2011
phase 3 survey was 75. Previously, we
had estimated 73 responses per
respondent. There are no costs to
respondents. The total estimated
annualized burden is 9,375.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
in hours
Infection Prevention Personnel in Participating Hospitals ...........................................................
erowe on DSK2VPTVN1PROD with NOTICES
Respondents
500
75
15/60
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13345
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
*Assumptions: One respondent per
hospital, collection of data on median of
75 patients per hospital, average data
collection time of 15 minutes per
patient.
Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013–04508 Filed 2–26–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–13–0263]
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 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Requirements for the Importation of
Nonhuman Primates into the United
States (formerly Requirements for a
Special Permit to Import Cynomolgus,
African Green, or Rhesus Monkeys into
the United States) (OMB Control No.
0920–0263 Exp.6/30/2014)—Revision—
National Center Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Since May 1990, CDC has monitored
the arrival and/or uncrating of certain
shipments of non-human primates
imported into the United States under a
special permit program specific to
Cynomolgus, African Green, or Rhesus
Monkeys. CDC has monitored
compliance with this special permit
through the collection of information
focused on determining whether or not
importers conduct adequate disease
control practices. Importers were
required to renew their special permit
every 180 days.
In February 2013, CDC promulgated
two regulations pertaining to the
importation of nonhuman primates. The
first rule rule, Requirements for
Importers of Nonhuman Primates (2/15/
2013, Vol. 78, No. 32/p. 11522)
consolidates into 42 CFR 71.53 the
requirements previously found in 42
CFR part 71.53 with those found in the
Special Permit to Import Cynomolgus,
African Green, or Rhesus Monkeys into
the United States. It also extended the
time period for registration/permit
renewal from 180 days to 2 years. The
Special Permit has been withdrawn. The
requirements found therein are now
incorporated into the revised final rule
for 42 CFR 71.53. The second rule,
Establishment of User Fees for Filovirus
Testing of Nonhuman Primate Liver
Samples (2/12/2013, Vol.78, No. 29,
p.9828), outlines a process by which
importers can send liver tissues to CDC
from primates that die during
importation from reasons other than
trauma. CDC performs these tests due to
the absence of a private sector option.
CDC feels these regulatory changes
balance the public health risks posed by
the importation of nonhuman primates
with the burden imposed on regulating
their importation.
These rule changes have prompted
CDC to modify how it administers the
information collected from the public in
the enforcement of nonhuman primate
regulations. CDC is requesting the
following changes:
1. CDC requests that this information
collection request be re-named
‘‘Requirements for the Importation of
Nonhuman Primates into the United
States’’ to more accurately reflect the
type of information that is requested
from respondents.
2. To streamline administration of this
information collection request, CDC
requests that CDC form 75.10A
Application for Registration as an
Importer of Nonhuman Primates and the
Recordkeeping requirement currently
approved under OMB Control Number
0920–0134 Foreign Quarantine
Regulations, be moved and included in
this revision to OMB Control Number
0920–0263. This action places all
nonhuman primate information
collection requirements and requests
into one information collection request
administered by CDC.
3. CDC is renaming the different
portions of the information collected in
this information collection to more
accurately list the types of forms and
documentation CDC collects from
importers of nonhuman primates.
Therefore, the former information
categories of Businesses (limited
permit), Businesses (extended permit),
and Organizations (extended permit) are
being renamed and reorganized. The
information contained in these
categories will now be accounted for in
the Documentation sections of the
burden table. This categorization will
more accurately reflect CDC’s
interaction with the importers.
4. CDC also requests additional
burden hours to account for notification
to CDC from importers of shipment
arrivals and requests for release from
quarantine.
5. CDC further requests the addition
of the Filovirus Diagnostic Specimen
Submission Form for Non-human
Primate Materials, which will be used to
collect all of the necessary information
from nonhuman primate importers to
test nonhuman primate liver samples for
filovirus and communicate the results of
this test. This action adds
approximately 50 hours of burden to
this information collection request.
This information collection involves
minimal personally identifiable
information and should have limited
impact on an individual’s privacy.
There are no costs to respondents other
than their time.
The total burden requested for this
information collection is 146.
erowe on DSK2VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Nonhuman Primate Importer ..........................
Nonhuman Primate Importer ..........................
VerDate Mar<15>2010
15:18 Feb 26, 2013
Jkt 229001
71.53(g)
New
Importer
Nonhuman Primates.
71.53(g)
Importer
ReNonhuman Primates.
PO 00000
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Number of
responses per
respondent
Number of
respondents
Form name/CFR reference
Average
burden per
response
(in hours)
Registration—
1
1
10/60
Registration—
12
1
10/60
Sfmt 4703
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27FEN1
]]>Agencies
[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13344-13345]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04508]
[[Page 13344]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-13-0852]
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
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC
20503 or by fax to (202) 395-5806. Written comments should be received
within 30 days of this notice.
Proposed Project
Prevalence Survey of Healthcare-Associated Infections (HAIs) in
Acute Care Hospitals in the United States--Extension--(0920-0852 exp.5/
31/13)--National Center for Emerging and Zoonotic Infectious Diseases,
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Preventing healthcare-associated infections (HAIs) is a CDC
priority. An essential step in reducing the occurrence of HAIs is to
estimate accurately the burden of these infections in U.S. hospitals,
and to describe the types of HAIs and causative organisms. The scope
and magnitude of HAIs in the United States were last directly estimated
in the 1970s by CDC's Study on the Efficacy of Nosocomial Infection
Control (SENIC), in which comprehensive data were collected from a
sample of 338 hospitals; 5% of hospitalized patients acquired an
infection not present at the time of admission. Because of the
substantial resources necessary to conduct hospital-wide surveillance
in an ongoing manner, most of the more than 4,500 hospitals now
reporting to the CDC's current HAI surveillance system, the National
Healthcare Safety Network (NHSN 0920-0666 expires 1/31/15), focus
instead on device-associated and procedure-associated infections in a
selected patient locations, and do not report data on all types of HAIs
occurring hospital-wide. Periodic assessments of the magnitude and
types of HAIs occurring in all patient populations within acute care
hospitals are needed to inform decisions by local and national policy
makers and by hospital infection control personnel regarding
appropriate targets and strategies for HAI prevention. Such assessments
can be obtained in periodic national prevalence surveys, such as those
that have been conducted in several European countries.
In 2008-2009, CDC developed a pilot protocol for a HAI point
prevalence survey, conducted over a 1-day period at each of 9 acute
care hospitals in one U.S. city. This pilot phase was followed in 2010
by a phase 2, limited roll-out HAI and antimicrobial use prevalence
survey, conducted during July and August in 22 hospitals across 10
Emerging Infections Program sites (in California, Colorado,
Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York,
Oregon, and Tennessee). Experience gained in the phase 1 and phase 2
surveys was used to conduct a full-scale, phase 3 survey in 2011,
involving 183 hospitals in the 10 EIP sites. Over 11,000 patients were
surveyed, and analysis of HAI and antimicrobial use data is ongoing at
this time. Preliminary HAI prevalence results were presented at the
52nd Interscience Conference on Antimicrobial Agents and Chemotherapy
(San Francisco, CA, September 8-12, 2012) and preliminary antimicrobial
use results were presented at the 2012 IDWeek conference (San Diego,
CA, October 17-21, 2012).
An extension of the prevalence survey's existing OMB approval is
sought, to allow a repeat HAI and antimicrobial use prevalence survey
to be performed in 2014. A repeat survey will allow further refinement
of survey methodology and assessment of changes over time in
prevalence, HAI distribution, and pathogen distribution. It will also
allow for a re-assessment of the burden of antimicrobial use, at a time
when antimicrobial stewardship is an area of active engagement in many
acute care hospitals. The 2014 survey will be performed in a sample of
up to 500 acute care hospitals, drawn from the acute care hospital
populations in each of the 10 EIP sites (and including participation
from many hospitals that participated in prior phases of the survey).
Infection prevention personnel in participating hospitals and EIP site
personnel will collect demographic and clinical data from the medical
records of a sample of eligible patients in their hospitals on a single
day in 2014, to identify CDC-defined HAIs. The surveys will provide
data for CDC to make estimates of the prevalence of HAIs across this
sample of U.S. hospitals as well as the distribution of infection types
and causative organisms. These data can be used to work toward reducing
and eliminating healthcare-associated infections--a DHHS Healthy People
2020 objective (https://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=17). This survey project also supports the CDC
Winnable Battle goal of improving national surveillance for healthcare-
associated infections (https://www.cdc.gov/winnablebattles/Goals.html).
The total burden is 9,375 hours, which represents an increase of
250 hours over the previously approved burden. The increase is
requested because the median number of responses per respondent in the
2011 phase 3 survey was 75. Previously, we had estimated 73 responses
per respondent. There are no costs to respondents. The total estimated
annualized burden is 9,375.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response
respondents respondent in hours
----------------------------------------------------------------------------------------------------------------
Infection Prevention Personnel in Participating Hospitals.... 500 75 15/60
----------------------------------------------------------------------------------------------------------------
[[Page 13345]]
*Assumptions: One respondent per hospital, collection of data on
median of 75 patients per hospital, average data collection time of 15
minutes per patient.
Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2013-04508 Filed 2-26-13; 8:45 am]
BILLING CODE 4163-18-P
