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)

Page Range		46585-46586
FR Document		2015-19114
Federal Register, Volume 80 Issue 150 (Wednesday, 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
----------------------------------------------------------------------------------------------------------------


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
Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices 46585

Obtaining Copies of Proposals: of the information collection plan and College of American Pathologists, will
Requesters may obtain a copy of the instruments, call (404) 639–7570 or each use their LPGs as models to better
information collection documents from send an email to omb@cdc.gov. Written understand how to improve uptake and
the General Services Administration, comments and/or suggestions regarding impact of these and future LPGs. Only
Regulatory Secretariat Division (MVCB), the items contained in this notice the ASM submission will be described
1800 F Street NW., Washington, DC should be directed to the Attention: in this notice.
20405, telephone 202–501–4755. Please CDC Desk Officer, Office of Management The ASM project will address four
cite OMB Control No. 3090–0252, and Budget, Washington, DC 20503 or LPGs that are important to clinical
Preparation, Submission, and by fax to (202) 395–5806. Written testing and have a high public health
Negotiation of Subcontracting Plans, in comments should be received within 30 impact: reducing blood culture
all correspondence. days of this notice. contamination (BCC), rapid diagnosis of
blood stream infections (BSI), proper
Dated: July 30, 2015. Proposed Project collection and transport of urine (UT),
Jeffrey A. Koses, Improving the Impact of Laboratory and microbiological practices to
Director, Office of Acquisition Policy, Senior Practice Guidelines (LPGs): A New improve the diagnosis and management
Procurement Executive. Paradigm for Metrics- American Society of patients with Clostridium difficile (C.
[FR Doc. 2015–19222 Filed 8–4–15; 8:45 am] for Microbiology—NEW—Center for difficile) infection (CDI). The BCC LPG
BILLING CODE 6820–61–P Surveillance, Epidemiology and was published and it includes
Laboratory Services (CSELS), Centers for recommendations for the use of: 1)
Disease Control and Prevention (CDC). venipuncture over catheters as the
DEPARTMENT OF HEALTH AND Background and Brief Description preferred technique for sample
HUMAN SERVICES collection in a clinical setting, and 2)
The Centers for Disease Control and phlebotomy teams over non-
Centers for Disease Control and Prevention is funding three 5-year phlebotomist staff for collecting blood
Prevention projects collectively entitled ‘‘Improving for culture. The BSI report examines the
the Impact of Laboratory Practice effectiveness of rapid diagnostic tests to
[30Day–15–15DA]
Guidelines: A New Paradigm for promote more accurate and timely
Agency Forms Undergoing Paperwork Metrics’’. An ‘‘LPG’’ is defined as administration of targeted antibiotic
Reduction Act Review written recommendations for voluntary, therapy for patients with bloodstream
standardized approaches for medical infections. This report will be published
The Centers for Disease Control and laboratory testing that takes into account and recommendations will be
Prevention (CDC) has submitted the processes for test selection, sample developed based on additional
following information collection request procurement and processing, analytical information collected. Practices related
to the Office of Management and Budget methods, and results reporting for to the collection, storage and
(OMB) for review and approval in effective diagnosis and management of preservation of urine for microbiological
accordance with the Paperwork disease and health conditions. LPGs culture that improve the diagnosis and
Reduction Act of 1995. The notice for may be disseminated to, and used by, management of patients with urinary
the proposed information collection is laboratorians and clinicians to assist tract infections were analyzed and
published to obtain comments from the with test selection and test result approved recommendations will be
public and affected agencies. interpretation. The overall purpose of published. Microbiological practices
Written comments and suggestions these cooperative agreements is to related to improving diagnosis and
from the public and affected agencies increase the effectiveness of LPGs by management of patients with C. difficile
concerning the proposed collection of defining measures and collecting infection will be collected and analyzed,
information are encouraged. Your information to inform better LPG and recommendations will also be
comments should address any of the creation, revision, dissemination, developed and published.
following: (a) Evaluate whether the promotion, uptake and impact on The intended respondents of ASM’s
proposed collection of information is clinical testing and public health. surveys will include microbiology
necessary for the proper performance of The project will explore how these supervisors, laboratory directors,
the functions of the agency, including processes and their impediments and laboratory managers, and medical
whether the information will have facilitators differ among various technologists. For this request for OMB
practical utility; (b) Evaluate the intended users of LPGs. Through this approval of a new information
accuracy of the agencies estimate of the demonstration project, CDC seeks to collection, we will be requesting
burden of the proposed collection of understand how to customize LPG approval to collect baseline and post-
information, including the validity of creation and promotion to better serve dissemination information for the BCC
the methodology and assumptions used; these intended users of LPGs. An LPG. Because the BSI, UT and CDI
(c) Enhance the quality, utility, and important goal is to help organizations reports are not yet published, ASM will
clarity of the information to be that sponsor the development of LPGs conduct a baseline survey to determine
collected; (d) Minimize the burden of create a sustainable approach for current practices prior to dissemination
the collection of information on those continuous quality improvement to of the LPGs.
who are to respond, including through evaluate and improve an LPG’s impact On behalf of the ASM and the CDC,
the use of appropriate automated, through better collection of information. the Laboratory Response Network
asabaliauskas on DSK5VPTVN1PROD with NOTICES

electronic, mechanical, or other The CDC selected three organizations (LRN), which was founded by the CDC,
technological collection techniques or that currently create and disseminate will recruit laboratories that perform the
other forms of information technology, LPGs to support activities under a kinds of testing affected by these LPGs
e.g., permitting electronic submission of cooperative agreement funding to take the surveys. Messages regarding
responses; and (e) Assess information mechanism to improve the impact of ASM surveys will be worded as an
collection costs. their LPGs. The American Society for invitation, not as a coercive request.
To request additional information on Microbiology (ASM), the Clinical and Some states may opt not to recruit LRN
the proposed project or to obtain a copy Laboratory Standards Institute, and the laboratory participation, but because the

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 46585
80 FR 46585 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

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

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