60 Day FRN

73588

Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–29047 Filed 12–10–14; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Proposed Data Collections Submitted
for Public Comment and
Recommendations

Proposed Project
Improving the Impact of Laboratory
Practice Guidelines: A New Paradigm
for Metrics—Clinical and Laboratory
Standards Institute—NEW—Center for
Surveillance, Epidemiology and
Laboratory Services (CSELS), Centers for
Disease Control and Prevention (CDC).

The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. To
request more information on the below
proposed project or to obtain a copy of
the information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; (d) ways to
minimize the burden of the collection of
information on respondents, including
through the use of automated collection
techniques or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying

Background and Brief Description
The Centers for Disease Control and
Prevention is funding three 5-year
projects collectively entitled ‘‘Improving
the Impact of Laboratory Practice
Guidelines: A New Paradigm for
Metrics’’. An ‘‘LPG’’ is defined as
written recommendations for voluntary,
standardized approaches for medical
laboratory testing that takes into account
processes for test selection, sample
procurement and processing, analytical
methods, and results reporting for
effective diagnosis and management of
disease and health conditions. LPGs
may be disseminated to, and used by,
laboratorians and clinicians to assist
with test selection and test result
interpretation. The overall purpose of
these cooperative agreements is to
increase the effectiveness of LPGs by
defining measures and collecting
information to inform better LPG
creation, revision, dissemination,
promotion, uptake, and impact on
clinical testing and public health. The
project will explore how these processes
and their impediments and facilitators
differ among various intended users of
LPGs. Through this demonstration
project, CDC seeks to understand how to
customize LPG creation and promotion
to better serve these intended users of
LPGs. An important goal is to help
organizations that sponsor the
development of LPGs create a
sustainable approach for continuous
quality improvement to evaluate and
improve an LPG’s impact through better
collection of information.
The CDC selected three organizations
that currently create and disseminate
LPGs to support activities under a
cooperative agreement funding
mechanism to improve the impact of
their LPGs. The American Society for
Microbiology, the Clinical and
Laboratory Standards Institute (CLSI),

Centers for Disease Control and
Prevention
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information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.

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and the College of American
Pathologists, will each use their LPGs as
models to better understand how to
improve uptake and impact of these and
future LPGs. Only the CLSI submission
will be described in this notice.
Specifically, the CLSI project will
address two LPGs that are important to
clinical testing and have a high public
health impact: POCT12, Point-of-Care
Blood Glucose Testing in Acute and
Chronic Care Facilities and POCT13,
Glucose Monitoring in Settings without
Laboratory Support. These LPGs
provide guidance and recommendations
for personnel monitoring patient
glucose levels at sites that have access
to a hospital laboratory as well as
locations, such as physician offices or
nursing homes that do not have an onsite moderate or high complexity
laboratory. It is expected that as a result
of sustained improvements in the
process of creating and updating these
clinical LPGs, public health, which
depends upon accurate and appropriate
laboratory testing guided by the use of
LPGs, will also generally benefit. The
intended users of the CLSI’s POCT12
and POCT13 LPGs will include point-ofcare coordinators, clinical laboratory
directors, medical technologists, nurses,
and medical doctors.
The CLSI plans to collect information
using the same survey instrument,
‘‘Fingerstick Glucose Survey’’ (FGS), on
three separate occasions. During the first
information collection (FGS1), all
targeted respondents will be asked to
complete the survey. Respondents who
indicate that they are not familiar with
either POCT12 or POCT13 will be asked
to provide an email address and offered
a free copy of the applicable LPG. This
subset of respondents will be asked to
complete the same survey (FGS2) 4–6
months after receiving the free LPG.
After analysis of the information
collected during the first two surveys,
CLSI will make improvements to
POCT12 and POCT13, such as provision
of educational materials or helpful
products such as quality control logs,
and may also alter their marketing
campaigns to address issues related to
awareness and use of CLSI documents.
The third survey (FGS3) will then be
sent to all targeted respondents
approximately 2.5 years after the first
survey to obtain information that can be
used to evaluate the impact of these
improvements. Respondents that
received a free copy of POCT12 or
POCT13 following the first survey will
also be contacted by email and asked to
take the third survey.
A link to the survey will be
distributed to all targeted respondents
either by email or postcard. The CLSI

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Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices
will solicit participation from physician
office laboratories, Department of
Defense laboratories, and hospitals that
offer point-of-care glucose testing.
Participants will be recruited by COLA,
the Joint Commission and a Point-ofCare Coordinator network, who have
agreed to distribute links to the survey
through their membership mailing lists.
In addition, participants will also be
solicited through mailing lists
purchased by CLSI from Clinscan and
the American Hospital Association.
Clinical sites offering point-of-care
glucose testing in the Department of
Defense medical system will also be
asked to participate through the
Department of Defense Clinical
Laboratory Improvement Program
(CLIP). In order to obtain the needed
number of respondents for a statistically
valid study, additional laboratories,
selected at random from a database of
Clinical Laboratory Improvement
Amendment (CLIA) certificate holders,
will also be solicited. The survey will
contain instructions to direct it to the
individual in each laboratory
responsible for the development or

The third survey will measure the
impact of the modifications to the
documents and marketing strategy made
based on the data collected from the
first 2 surveys. The response rate for all
surveys will be maximized by repeated
reminders using the same channel that
will be used to distribute the survey. All
targeted laboratories will receive an
email or postcard approximately one
month before distribution of the survey.
This letter will describe the survey and
our purpose for collecting information.
Another email or post card with a link
to the survey will be sent to the same
targeted laboratories. We also plan to
resend the link to the survey to all
targeted laboratories approximately one
month later to remind them of the
survey.
The CLSI believes completion of the
survey will take approximately 15
minutes. The survey will be pilot tested
with 9 or fewer respondents before
deployment to assure that they require
15 minutes or less to take.
There are no costs to respondents
other than their time.

revision of procedures for fingerstick
glucose testing. Directing the survey to
the individual with this specific
responsibility will help to ensure that
only one response will be obtained from
each participating laboratory.
Respondents include point-of-care
coordinators, clinical laboratory
directors, managers, and supervisors,
medical technologists, nurses, and
medical doctors.
The CLSI hopes to achieve an 80%
response rate with their laboratory
information collections, or 24,000 out of
about 30,000 potential respondents. The
second survey will occur approximately
4–6 months after the initial survey and
will only target responders from the first
survey that received a complimentary
copy of one of the LPG documents. CLSI
anticipates that approximately 12,000
participants will be asked to take the
second survey. Approximately two and
a half years after the initial survey, the
same survey will be sent to the same
laboratories as the first survey (i.e. we
will solicit approximately 30,000
potential respondents and expect about
24,000 individuals to take the survey).

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

Form name

Point-of-Care Coordinators ....................................................
Laboratory Directors ...............................................................
Laboratory Managers .............................................................
Laboratory Supervisors ..........................................................
Medical Technologists ............................................................
Nurses ....................................................................................
Medical Doctors ......................................................................

FGS1
FGS2
FGS3
FGS1
FGS2
FGS3
FGS1
FGS2
FGS3
FGS1
FGS2
FGS3
FGS1
FGS2
FGS3
FGS1
FGS2
FGS3
FGS1
FGS2
FGS3

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Total ................................................................................

Number of
respondents

Number of
responses per
respondent

500
250
500
4,276
2,138
4,276
4,276
2,138
4,276
4,276
2,138
4,276
7,800
3,900
7,800
5,000
2,500
5,000
3,500
1,750
3,500

1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1

15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60

125
63
125
1,069
535
1,069
1,069
535
1,069
1,069
535
1,069
1,950
975
1,950
1,250
625
1,250
875
438
875

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

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

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

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

18,520

[FR Doc. 2014–29036 Filed 12–10–14; 8:45 am]
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Total burden
hours

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Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.

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burden per
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(in hours)

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