Proposed Data Collection Submitted for Public Comment and Recommendations, 26688-26690 [2018-12372]
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26688
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
including awareness and use of the US
MEC, US SPR and QFP; (2) describing
current attitudes and practices among
family planning providers and clinics
related to recommendations included in
the US MEC, US SPR, and QFP and
assessing changes from previous data
collections; and (3) identifying training
needs in use of guidance and family
planning service delivery (e.g., provider
tools, continuing education modules).
As in previous phases of data
collection, CDC plans to administer
formatting, usability, and data quality.
OMB approval is requested for one year.
The estimated burden per response for
providers is 15 minutes and has not
changed since the previous OMB
approval. The estimated burden per
response for administrators will be
reduced from 40 minutes to 35 minutes.
The total burden for participants is
estimated at 1,916 hours. Participation
is voluntary and there are no costs to
respondents other than their time.
surveys to private and public sector
family planning providers and clinic
administrators in the United States. The
design, methodology, and analytic
approach that CDC plans to implement
are based on methods previously
approved for the 2013–2014 survey,
with different instruments being
administered to providers and clinic
administrators. Minor changes to survey
content will be made to eliminate
unnecessary questions, add new
questions of interest, and improve
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
Office-based physicians (private sector).
2018–2019 Survey of Health Care
Providers about Family Planning
Attitudes and Practices.
2018–2019 Survey of Health Care
Providers about Family Planning
Attitudes and Practices.
2018–2019 Survey of Health Care
Providers about Family Planning
Attitudes and Practices.
2018–2019 Survey of Administrators
of Health Centers that Provide
Family Planning.
2018–2019 Survey of Administrators
of Health Centers that Provide
Family Planning.
1,000
1
15/60
250
1,000
1
15/60
250
1,000
1
15/60
250
1,000
1
35/60
583
1,000
1
35/60
583
...........................................................
........................
........................
........................
1,916
Title X clinic providers (public sector)
Non-Title X publicly funded clinic
providers (public sector).
Title X clinic administrators (public
sector).
Non-Title X publicly funded clinic administrators (public sector).
Total ...........................................
Jeffrey M. Zirger,
Acting 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. 2018–12373 Filed 6–7–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–18ACN; Docket No. CDC–2018–
0042]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
amozie on DSK3GDR082PROD with NOTICES1
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
SUMMARY:
VerDate Sep<11>2014
16:53 Jun 07, 2018
Jkt 241001
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Undetermined cause of Serratia
marcescens infections—Multiple States,
2018. The goal of this investigation is to
identify potential risk factors leading to
an outbreak of Serratia marcescens
infections among U.S. healthcare
patients. Data will be used to identify a
cause of the infections and prevent
additional events from occurring.
DATES: CDC must receive written
comments on or before August 7, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0042 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, 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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
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:
omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
E:\FR\FM\08JNN1.SGM
08JNN1
26689
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Undetermined cause of Serratia
marcescens infections—Multiple States,
2018—New—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Serratia marcescens is a Gramnegative bacillus that can be found in
the environment and thrives in moist
environments. In healthcare settings, it
can be found on the hands of healthcare
workers and as a contaminant of
medical products and devices,
particularly aqueous products. It is a
known cause of healthcare-associated
infections, particularly urinary tract
infection, wound infections, and
bloodstream infections, and it is an
important opportunistic pathogen in
medical device or pharmaceutical
product) with widespread distribution,
broad case-finding efforts are needed.
Early investigations identified prefilled
normal saline syringes and prefilled
heparin flushes as common exposures,
however healthcare facility records
often provide an inadequate basis for
identifying the specific product or lot
number that was administered to a
particular patient, and only facility-level
information is available. The products
identified in common at this stage of the
investigation are widespread in
healthcare facilities across the United
States and incorrect identification as the
source of infections could reasonably be
anticipated to create panic in regards to
use of these products and limitations in
the safe care delivered to thousands of
patients.
Communications with the Food and
Drug Administration (FDA) and product
manufacturers indicate a nation-wide
shortage of saline following disruption
of manufacturing in Puerto Rico during
Hurricane Maria in September 2017.
FDA has stated that saline shortages in
the U.S. mean that alternatives to
prefilled saline are limited. In addition,
the products are manufactured and
subject to Current Good Manufacturing
Practice regulations including terminal
sterilization of many products using
steam sterilization, which reduce
opportunities for contamination.
This information is essential to the
CDC’s ability to identify a cause of these
events and prevent additional events
from occurring.
Nationwide case-finding has been
implemented through the Epi-X system.
The target audience of the case finding
will include, but not be limited to, state
and local health departments. They will
be asked to report any potential cases to
CDC. Information on each case will be
collected using a data collection form
that can be completed online or filled
out and returned to CDC. Depending on
the nature of each case, CDC may reach
out to relevant healthcare facilities or
healthcare staff for additional
information and recommendation of any
prevention measures.
neonatal and pediatric intensive care
units. Serratia marcescens has been
implicated previously in multistate
outbreaks of bloodstream infections
caused by intrinsic contamination of
prefilled syringes of heparin and
isotonic sodium chloride solution.
On March 27, 2018, the Colorado
Department of Public Health and
Environment (CDPHE) notified CDC of 4
cases of Serratia marcescens bacteremia
among pediatric patients with central
lines in an acute care hospital between
January 20 and March 23, 2018. This
cluster of cases was above the normal
baseline of 1–3 cases per year at that
facility. The facility examined
exposures including common staff and
medications and identified
commonalities related to the
maintenance and care of central lines as
well as several medical products
including prefilled normal saline
syringes and prefilled heparin flushes.
On March 28, CDPHE issued a call for
cases to other state and local health
departments through the Epidemic
Information Exchange (Epi-X) system.
On March 29, the Tennessee
Department of Health (TDH) notified
CDC of 3 cases of Serratia marcescens
bacteremia in pediatric patients with
central lines in a pediatric hospital
between March 6 and March 21, 2018;
initial examination of medications and
common products identified central
venous catheter line products as a
possible source of infections, including
prefilled heparin and normal saline
syringes.
CDC is currently conducting a
multistate investigation to support state
health departments. Currently, eight
state health departments have reported
a total of 26 cases to CDC. However,
since more than nine states are
ultimately expected to participate, CDC
is pursuing emergency OMB clearance
to collect patient-level information from
ten or more state/local health
departments.
Most identified patient infections are
bloodstream infections, but other body
sites (e.g., respiratory) have also been
described. Because these events could
be linked to a healthcare product (e.g.,
amozie on DSK3GDR082PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses
per
respondent
Average
burden per
response
(in hrs)
Total burden
(in hrs)
Type of respondents
Form name
Healthcare staff .................................
Case finding for data collection .......
25
2
25/50
100
Total ...........................................
...........................................................
........................
........................
........................
100
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16:53 Jun 07, 2018
Jkt 241001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
E:\FR\FM\08JNN1.SGM
08JNN1
26690
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
Jeffrey M. Zirger,
Acting 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. 2018–12372 Filed 6–7–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–18LQ]
amozie on DSK3GDR082PROD with NOTICES1
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Assessment of
Occupational Injury among Fire Fighters
Using a Follow-back Survey to the
Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on February 13, 2018 to obtain
comments from the public and affected
agencies. CDC received one comment
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
VerDate Sep<11>2014
16:53 Jun 07, 2018
Jkt 241001
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Assessment of Occupational Injury
among Fire Fighters Using a Followback Survey—New—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Studies have reported that fire fighters
have high rates of non-fatal injuries and
illnesses as compared to the general
worker population. As fire fighters
undertake many critical public safety
activities and are tasked with protecting
the safety and health of the public, it
follows that understanding and
preventing injuries and exposures
among fire fighters will have a benefit
reaching beyond the workers to the
general public.
As mandated in the Occupational
Safety and Health Act of 1970 (Pub. L.
91–596), the mission of NIOSH is to
conduct research and investigations on
occupational safety and health. Related
to this mission, the purpose of this
project is to conduct research that will
provide a detailed description of nonfatal occupational injuries and
exposures incurred by fire fighters. This
information will offer detailed insight
into events that lead to the largest
number of nonfatal injuries and
exposures among fire fighters. The
project will use two related data
sources. The first source is data
abstracted from medical records of fire
fighters treated in a nationally stratified
sample of emergency departments.
These data are routinely collected
through the occupational supplement to
the National Electronic Injury
Surveillance System (NEISS-Work). The
second data source, for which NIOSH is
seeking OMB approval for three years, is
responses to telephone interview
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
surveys of the injured and exposed fire
fighters identified within NEISS-Work.
The proposed telephone interview
surveys will supplement NEISS-Work
data with an extensive description of
fire fighter injuries and exposures,
including worker characteristics, injury
types, injury circumstances, injury
outcomes, and use of personal
protective equipment. Previous reports
describing occupational injuries and
exposures to fire fighters provide
limited details on specific regions or
sub-segments of the population. As
compared to these earlier studies, the
scope of the telephone interview data
will be broader as it includes sampled
cases nationwide and has no limitations
in regards to type of employment (i.e.,
volunteer versus career). Results from
the telephone interviews will be
weighted and reported as national
estimates.
The sample size for the telephone
interview survey is estimated to be
approximately 240 fire fighters annually
for the proposed three year duration of
the study. This is based on the number
of fire fighters identified in previous
years of NEISS-Work data and a 30 to
40% response rate that is comparable to
the rate of previously conducted
National Electronic Injury Surveillance
System telephone interview studies.
Each telephone interview will take
approximately 30 minutes to complete,
resulting in an annualized burden
estimate of 120 hours. Using the routine
NEISS-Work data, an analysis of all
identified EMS workers will be
performed to determine if there are
differences between the telephone
interview responder and non-responder
groups.
The Division of Safety Research (DSR)
within NIOSH is conducting this
project. DSR has a strong interest in
improving surveillance of fire fighter
injuries and exposures to provide the
information necessary for effectively
targeting and implementing prevention
efforts and, consequently, reducing
occupational injuries and exposures to
fire fighters. The Consumer Product
Safety Commission (CPSC) will also
contribute to this project, as they are
responsible for coordinating the
collection of all NEISS-Work data and
for overseeing the collection of all
telephone interview data. The estimated
annual Burden Hours are 120. There is
no cost to respondents other than their
time.
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26688-26690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12372]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-18-18ACN; Docket No. CDC-2018-0042]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Undetermined cause of Serratia
marcescens infections--Multiple States, 2018. The goal of this
investigation is to identify potential risk factors leading to an
outbreak of Serratia marcescens infections among U.S. healthcare
patients. Data will be used to identify a cause of the infections and
prevent additional events from occurring.
DATES: CDC must receive written comments on or before August 7, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0042 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Leroy A. 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].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed
[[Page 26689]]
extension of existing collection of information, and each reinstatement
of previously approved information collection before submitting the
collection to the OMB for approval. To comply with this requirement, we
are publishing this notice of a proposed data collection as described
below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses.
5. Assess information collection costs.
Proposed Project
Undetermined cause of Serratia marcescens infections--Multiple
States, 2018--New--National Center for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Serratia marcescens is a Gram-negative bacillus that can be found
in the environment and thrives in moist environments. In healthcare
settings, it can be found on the hands of healthcare workers and as a
contaminant of medical products and devices, particularly aqueous
products. It is a known cause of healthcare-associated infections,
particularly urinary tract infection, wound infections, and bloodstream
infections, and it is an important opportunistic pathogen in neonatal
and pediatric intensive care units. Serratia marcescens has been
implicated previously in multistate outbreaks of bloodstream infections
caused by intrinsic contamination of prefilled syringes of heparin and
isotonic sodium chloride solution.
On March 27, 2018, the Colorado Department of Public Health and
Environment (CDPHE) notified CDC of 4 cases of Serratia marcescens
bacteremia among pediatric patients with central lines in an acute care
hospital between January 20 and March 23, 2018. This cluster of cases
was above the normal baseline of 1-3 cases per year at that facility.
The facility examined exposures including common staff and medications
and identified commonalities related to the maintenance and care of
central lines as well as several medical products including prefilled
normal saline syringes and prefilled heparin flushes.
On March 28, CDPHE issued a call for cases to other state and local
health departments through the Epidemic Information Exchange (Epi-X)
system. On March 29, the Tennessee Department of Health (TDH) notified
CDC of 3 cases of Serratia marcescens bacteremia in pediatric patients
with central lines in a pediatric hospital between March 6 and March
21, 2018; initial examination of medications and common products
identified central venous catheter line products as a possible source
of infections, including prefilled heparin and normal saline syringes.
CDC is currently conducting a multistate investigation to support
state health departments. Currently, eight state health departments
have reported a total of 26 cases to CDC. However, since more than nine
states are ultimately expected to participate, CDC is pursuing
emergency OMB clearance to collect patient-level information from ten
or more state/local health departments.
Most identified patient infections are bloodstream infections, but
other body sites (e.g., respiratory) have also been described. Because
these events could be linked to a healthcare product (e.g., medical
device or pharmaceutical product) with widespread distribution, broad
case-finding efforts are needed. Early investigations identified
prefilled normal saline syringes and prefilled heparin flushes as
common exposures, however healthcare facility records often provide an
inadequate basis for identifying the specific product or lot number
that was administered to a particular patient, and only facility-level
information is available. The products identified in common at this
stage of the investigation are widespread in healthcare facilities
across the United States and incorrect identification as the source of
infections could reasonably be anticipated to create panic in regards
to use of these products and limitations in the safe care delivered to
thousands of patients.
Communications with the Food and Drug Administration (FDA) and
product manufacturers indicate a nation-wide shortage of saline
following disruption of manufacturing in Puerto Rico during Hurricane
Maria in September 2017. FDA has stated that saline shortages in the
U.S. mean that alternatives to prefilled saline are limited. In
addition, the products are manufactured and subject to Current Good
Manufacturing Practice regulations including terminal sterilization of
many products using steam sterilization, which reduce opportunities for
contamination.
This information is essential to the CDC's ability to identify a
cause of these events and prevent additional events from occurring.
Nationwide case-finding has been implemented through the Epi-X
system. The target audience of the case finding will include, but not
be limited to, state and local health departments. They will be asked
to report any potential cases to CDC. Information on each case will be
collected using a data collection form that can be completed online or
filled out and returned to CDC. Depending on the nature of each case,
CDC may reach out to relevant healthcare facilities or healthcare staff
for additional information and recommendation of any prevention
measures.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hrs)
respondent hrs)
----------------------------------------------------------------------------------------------------------------
Healthcare staff.............. Case finding for 25 2 25/50 100
data collection.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 100
----------------------------------------------------------------------------------------------------------------
[[Page 26690]]
Jeffrey M. Zirger,
Acting 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. 2018-12372 Filed 6-7-18; 8:45 am]
BILLING CODE 4163-18-P
