[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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    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