80 FR 46585 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 150 (August 5, 2015)

[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Notices]
[Pages 46585-46586]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19114]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-15DA]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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, 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 [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: 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

    Improving the Impact of Laboratory Practice Guidelines (LPGs): 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, laboratory managers, and medical 
technologists. 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

[[Page 46586]]

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. SurveyMonkey[supreg] will host the online survey and be used as 
the information collection instrument and responses will be collected 
and maintained by ASM.
    We anticipate that approximately 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 approximately 4,200 aggregate responses for each of the 
five different surveys.
    In addition, the ASM will also recruit, by emailing a letter 
containing the SurveyMonkey[supreg] hyperlinks for the five surveys to 
each of their ClinMicroNet and DivCNet listervs inviting ~828 and ~1470 
subscribers (comprised of laboratory directors as well as medical 
technologists in a 99%:1% and 60%:40%), respectively, to take each of 
the five SurveyMonkey[supreg] surveys. Moreover, the ASM will email the 
same letter containing the SurveyMonkey[supreg] hyperlinks for the 5 
surveys to ~1453 ASM Clinical Microbiology Issues Update newsletter 
subscribers, which include microbiology supervisors, laboratory 
directors, laboratory managers, and medical technologists in a 25 
percent:25 percent: 25 percent: 25 percent ratio, to invite them to 
participate.
    For burden calculations, respondents will include microbiology 
supervisors, laboratory directors, laboratory managers, and medical 
technologists. According to ASM, the burden hours per respondent who 
will be invited to participate in each of the BCC baseline and post-
dissemination surveys will not exceed 35 minutes and each of 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 was pilot tested with 9 or fewer respondents 
before dissemination.
    The total estimated annualized burden hours for this collection is 
17,225. There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents   responses  per   response (in
                                                                                     respondent        hrs.)
----------------------------------------------------------------------------------------------------------------
Microbiology Supervisors..............  BCC-baseline............           2,463               1           35/60
                                        BCC-post................           2,463               1           35/60
                                        BSI-baseline............           2,463               1           20/60
                                        UT-baseline.............           2,463               1           20/60
                                        CDI-baseline............           2,463               1           20/60
Laboratory Directors..................  BCC-baseline............           3,115               1           35/60
                                        BCC-post................           3,115               1           20/60
                                        BSI-baseline............           3,115               1           20/60
                                        UT-baseline.............           3,115               1           20/60
                                        CDI-baseline............           3,115               1           20/60
Laboratory Managers...................  BCC-baseline............           1,413               1           35/60
                                        BCC-post................           1,413               1           35/60
                                        BSI-baseline............           1,413               1           20/60
                                        UT-baseline.............           1,413               1           20/60
                                        CDI-baseline............           1,413               1           20/60
Medical Technologists.................  BCC-baseline............             960               1           35/60
                                        BCC-post................             960               1           20/60
                                        BSI-baseline............             960               1           20/60
                                        UT-baseline.............             960               1           20/60
                                        CDI-baseline............             960               1           20/60
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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. 2015-19114 Filed 8-4-15; 8:45 am]
 BILLING CODE 4163-18-P