Agency Forms Undergoing Paperwork Reduction Act Review, 46585-46586 [2015-19114]
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Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control No. 3090–0252,
Preparation, Submission, and
Negotiation of Subcontracting Plans, in
all correspondence.
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. 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.
Dated: July 30, 2015.
Jeffrey A. Koses,
Director, Office of Acquisition Policy, Senior
Procurement Executive.
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).
[FR Doc. 2015–19222 Filed 8–4–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
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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
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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
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46585
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 nonphlebotomist 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 postdissemination 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
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05AUN1
46586
Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices
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®
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® 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® surveys.
Moreover, the ASM will email the same
letter containing the SurveyMonkey®
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
Number of
respondents
Type of respondents
Form name
Microbiology Supervisors ................................
BCC-baseline .................................................
BCC-post ........................................................
BSI-baseline ...................................................
UT-baseline ....................................................
CDI-baseline ...................................................
BCC-baseline .................................................
BCC-post ........................................................
BSI-baseline ...................................................
UT-baseline ....................................................
CDI-baseline ...................................................
BCC-baseline .................................................
BCC-post ........................................................
BSI-baseline ...................................................
UT-baseline ....................................................
CDI-baseline ...................................................
BCC-baseline .................................................
BCC-post ........................................................
BSI-baseline ...................................................
UT-baseline ....................................................
CDI-baseline ...................................................
Laboratory Directors .......................................
Laboratory Managers ......................................
Medical Technologists ....................................
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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[FR Doc. 2015–19114 Filed 8–4–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Small Business
Innovation Research Program—Phase
II
National Institute on Disability,
Independent Living and Rehabilitation,
Administration for Community Living
(ACL), HHS.
AGENCY:
ACTION:
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2,463
2,463
2,463
2,463
2,463
3,115
3,115
3,115
3,115
3,115
1,413
1,413
1,413
1,413
1,413
960
960
960
960
960
Number of
responses
per
respondent
Average
burden per
response
(in hrs.)
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
35/60
35/60
20/60
20/60
20/60
35/60
20/60
20/60
20/60
20/60
35/60
35/60
20/60
20/60
20/60
35/60
20/60
20/60
20/60
20/60
The Administration for
Community Living (ACL), National
Institute on Disability, Independent
Living, and Rehabilitation Research
(NIDLRR) is announcing an opportunity
for public comment on the proposed
collection of certain information. Under
the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required
to publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Notices]
[Pages 46585-46586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19114]
=======================================================================
-----------------------------------------------------------------------
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 omb@cdc.gov. 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
