[Federal Register Volume 79, Number 215 (Thursday, November 6, 2014)]
[Notices]
[Pages 65967-65969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26354]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-15-15DA]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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
[[Page 65968]]
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
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.
Proposed Project
``Improving the Impact of Laboratory Practice Guidelines: A New
Paradigm for Metrics''--American Society for Microbiology--NEW--Center
for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers
for Disease Control and Prevention (CDC).
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 (ASM), the Clinical and Laboratory Standards
Institute, 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 ASM submission will be
described in this notice.
The ASM project will address four LPGs that are important to
clinical testing and have a high public health impact: Reducing blood
culture contamination (BCC), rapid diagnosis of blood stream infections
(BSI), proper collection and transport of urine (UT), and
microbiological practices to improve the diagnosis and management of
patients with Clostridium difficile (C. difficile) infection (CDI). The
BCC LPG was published and it includes recommendations for the use of:
(1) Venipuncture over catheters as the preferred technique for sample
collection in a clinical setting, and (2) phlebotomy teams over non-
phlebotomist staff for collecting blood for culture. The BSI report
examines the effectiveness of rapid diagnostic tests to promote more
accurate and timely administration of targeted antibiotic therapy for
patients with bloodstream infections. This report will be published and
recommendations will be developed based on additional information
collected. Practices related to the collection, storage and
preservation of urine for microbiological culture that improve the
diagnosis and management of patients with urinary tract infections were
analyzed and approved recommendations will be published.
Microbiological practices related to improving diagnosis and management
of patients with C. difficile infection will be collected and analyzed,
and recommendations will also be developed and published.
The intended respondents of ASM's surveys will include microbiology
supervisors, laboratory directors, and laboratory managers. For this
request for OMB approval of a new information collection, we will be
requesting approval to collect baseline and post-dissemination
information for the BCC LPG. Because the BSI, UT and CDI reports are
not yet published, ASM will conduct a baseline survey to determine
current practices prior to dissemination of the LPGs.
On behalf of the ASM and the CDC, the Laboratory Response Network
(LRN), which was founded by the CDC, will recruit laboratories that
perform the kinds of testing affected by these LPGs to take the
surveys. Messages regarding ASM surveys will be worded as an
invitation, not as a coercive request. Some states may opt not to
recruit LRN laboratory participation, but because the issues are
important to clinical and public health, we expect good participation
by most states. This mechanism will assure the best response rate of
all the options we considered.
The CDC LRN Coordinator will email a letter to the Laboratory
Director of the LRN Reference Laboratories, (i.e., 50 State Public
Health Laboratories, the New York City Public Health Laboratory and the
Los Angeles County Public Health Laboratory). These 52 LRN Reference
Laboratory Directors will be asked to then email the sentinel
laboratories, which include hospital and independent laboratories, in
their states, and provide a hyperlink to access the survey tool on-line
via a landing page provided by ASM through their Clinical Microbiology
portal. Survey Monkey will be used as the data collection instrument
and responses will be collected and maintained by ASM. We anticipate
that a maximum of 4,200 sentinel laboratories will be contacted and
asked to complete the survey on-line. ASM anticipates achieving an 80%
response rate with their information collections, or 3,360 out of
~4,200 aggregate responses for each of the 5 different surveys.
[[Page 65969]]
For burden calculations, we assume one respondent per laboratory
and we also assume respondents will include microbiology supervisors,
laboratory directors, and laboratory managers, approximately in a
50%:25%:25% distribution, respectively. According to ASM, the burden
hours per respondent who will be invited to participate in the BCC
baseline and post-dissemination surveys and the BSI, UT and CDI
baseline surveys will be 20 minutes. This time frame was specified
based on ASM's previous experiences conducting laboratory surveys. Each
survey will be pilot tested with 9 or fewer respondents before
dissemination to assure that completing the surveys does not extend
past 20 minutes.
CDC is requesting a three-year OMB approval to collect this
information. There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Microbiology Supervisors...... BCC............. 2,100 2 20/60 1,400
BSI............. 2,100 1 20/60 700
UT.............. 2,100 1 20/60 700
CDI............. 2,100 1 20/60 700
Laboratory Directors.......... BCC............. 1,050 2 20/60 700
BSI............. 1,050 1 20/60 350
UT.............. 1,050 1 20/60 350
CDI............. 1,050 1 20/60 350
Laboratory Managers........... BCC............. 1,050 2 20/60 700
BSI............. 1,050 1 20/60 350
UT.............. 1,050 1 20/60 350
CDI............. 1,050 1 20/60 350
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Total..................... .............. .............. .............. 7,000
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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.
[FR Doc. 2014-26354 Filed 11-5-14; 8:45 am]
BILLING CODE 4163-18-P