Proposed Data Collection Submitted for Public Comment and Recommendations, 73188-73190 [2015-29867]
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73188
Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices
confirm receipt of your comment(s),
please check www.regulations.gov,
approximately two to three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT: Mr.
Kenneth Goldman, GSA, at telephone
202–779–2265.
SUPPLEMENTARY INFORMATION:
Please cite OMB Control No. 3090–
XXXX, Simplifying Federal Award
Reporting, in all correspondence.
A. Purpose
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The President’s Management Agenda
includes objectives for creating a
twenty-first century government that
delivers better results to the American
people in a more efficient manner.
Leveraging information technology
capabilities to reduce reporting burden
is key to achieving these goals. Section
5 of the Digital Accountability and
Transparency Act (Pub. L. 113–101)
requires a pilot program to develop
recommendations for standardizing
reporting, eliminating unnecessary
duplication, and reducing compliance
costs for recipients of Federal awards.
The pilot participants are required to
provide requested reports as well as the
cost to collect the data via the pilot. The
proposed pilot program will provide an
alternative submission method for
existing Federal Acquisition Regulation
(FAR) requirements, and assess the pilot
results against the existing FARrequired method.
B. Annual Reporting Burden
Respondents: 720.
Responses per Respondent: 3 each
week.
Total Annual Responses: 2,160.
Hours per Response: .5.
Total Burden Hours: 56,160.
mstockstill on DSK4VPTVN1PROD with NOTICES
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information will have practical utility;
whether our estimate of the public
burden of this collection of information
is accurate, and based on valid
assumptions and methodology; ways to
enhance the quality, utility, and clarity
of the information to be collected; and
ways in which we can minimize the
burden of the collection of information
on those who are to respond, through
the use of appropriate technological
collection techniques or other forms of
information technology.
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.
VerDate Sep<11>2014
17:20 Nov 23, 2015
Jkt 238001
Dated: November 18, 2015.
David A. Shive,
Chief Information Officer.
[FR Doc. 2015–29896 Filed 11–23–15; 8:45 am]
BILLING CODE 6820–61–P
[60Day–16–1067; Docket No. CDC–2015–
0106]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS)
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, 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. This notice invites
comment on a proposed revision of the
information collection entitled
Improving the Impact of Laboratory
Practice Guidelines: A New Paradigm
for Metrics—College of American
Pathologists, which will allow for a
fuller exploration of the factors that
underlie the reasons why laboratorians
adhere to the College of American
Pathologists’ laboratory practice
guideline for immunohistochemistry
test validation.
DATES: Written comments must be
received on or before January 25, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0106 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
SUMMARY:
Frm 00027
Fmt 4703
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
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
FOR FURTHER INFORMATION CONTACT:
Centers for Disease Control and
Prevention
PO 00000
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Sfmt 4703
E:\FR\FM\24NON1.SGM
24NON1
Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
Proposed Project
Improving the Impact of Laboratory
Practice Guidelines (LPGs): A New
Paradigm for Metrics—College of
American Pathologists, REVISION
(OMB Control No. 0920–1067,
Expiration 05/31/16)—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, the Clinical and
Laboratory Standards Institute, and the
College of American Pathologists (CAP),
will each use their LPGs as models to
VerDate Sep<11>2014
17:20 Nov 23, 2015
Jkt 238001
better understand how to improve
uptake and impact of these and future
LPGs. Only the CAP submission will be
described in this notice.
The CAP project will address two
LPGs that are important to clinical
testing: immunohistochemistry test
validation (IHC) and an algorithm for
diagnosing acute leukemia (ALA). As
part of the completed survey collections
that was conducted under OMB Control
Number 0920–1067, the intended users
of the CAP’s IHC LPG included
pathologists, clinical laboratory
directors, and laboratory managers
overseeing the IHC staining department;
the intended users of the CAP’s ALA
LPG were pathologists and
hematologists overseeing testing for
acute leukemia. For this revision
request, CDC is proposing information
collections to conduct qualitative
studies of the survey respondents of the
IHC post-survey with the intent to
include representation from the
laboratory professionals who submitted
the IHC post-survey results
(pathologists, clinical laboratory
directors, and laboratory managers).
Prior to entering into this cooperative
agreement project with the CDC, the
CAP had already completed a baseline
IHC LPG information collection from
laboratories that used IHC testing.
Because of this prior baseline
assessment, the CAP only needed to
collect post-dissemination data. This
has been completed using the
information approved under OMB
Control Number 0920–1067. Similarly,
the CAP also completed an ALA
baseline survey under this clearance.
We are submitting a revision request
to allow for a fuller exploration of the
factors that underlie the reasons why
laboratorians adhere to the College of
American Pathologists’ laboratory
practice guideline for IHC. We propose
to conduct telephone interviews that
will explore the impediments and
facilitators that affect uptake and use of
the CAP IHC LPG, both generally and
concerning specific recommendations.
This will be followed by two focus
groups, arranged by peer group of
pathologists and non-pathologists
(referred to as laboratory directors and
managers for the purpose of estimating
burden), which will allow us to collect
information on the current usage of
CAP’s tools and resources (toolkit) to
facilitate implementation of the IHC
guideline for its future improvement. To
the extent possible, we will include
non-adopters of the CAP’s IHC LPG, but
this fraction won’t be known until the
information collection occurs. We
propose to collect information for the
telephone interviews and focus groups
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
73189
combined, from 64 of the IHC postsurvey respondents which include
pathologists and non-pathologist
laboratory directors and laboratory
managers.
For this request, the CAP will collect
information via telephone interviews
from 40 laboratorians. The time it will
take each respondent to complete the
interview is 20 minutes. Because the
CAP anticipates that as many as 121
individuals may need to be contacted to
reach 40 individuals who will
voluntarily participate, and the burden
for those individuals who will not go on
to participate (81) in the telephone
interview is one minute, the anticipated
total burden for individuals who decline
participation is 1.35 hours (81 minutes).
The telephone interview respondents
will be targeted from two primary
segments: (1) Laboratories exclusively
using CAP Proficiency Testing (PT)
products, and (2) laboratories identified
by Centers for Medicare and Medicaid
Services billing codes that perform IHC
testing but are not enrolled in CAP PT
products. The telephone interview
respondents will be randomly sampled
from the submitted post-survey results
and will be cross-checked for
appropriate distribution of laboratory
type and size. Because there are fewer
of them, all of the non-CAP PT customer
respondents will be included. The CAP
estimates that the individuals who
complete the telephone interview will
be comprised of 20 pathologists, 10
laboratory directors, and 10 laboratory
managers and will each take 20 minutes
and the 40 respondents combined will
take approximately 13 hours (800
minutes) total burden.
The two in-person focus group
sessions will include some of the probe
questions from the telephone interview
survey and a specific subset
concentrating on evaluating CAP’s
current tools and resources (toolkit). It
is anticipated that 200 individuals will
be contacted to determine their
availability to participate in one of two
focus group sessions and each will take
no longer than five minutes to read and
respond to the invitation letter (∼17
hours or 1,000 minutes total). Among
the 200 individuals contacted, only the
24 who are selected to participate in a
focus group session will each be asked
to read and submit a signed consent
form prior to the session (5 minutes
each) (2 hours or 120 minutes total).
Twelve participants will be selected to
participate in each of the two focus
groups (pathologist peers and laboratory
director/manager peers) and will last no
more than 90 minutes each (36 hours or
2,160 minutes total). Thus, the total
E:\FR\FM\24NON1.SGM
24NON1
73190
Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices
burden for the focus group is estimated
to be ∼55 hours (3,280 minutes) total.
Including both telephone interviews
and focus group sessions, the total new
burden for this revision request will be
an additional ∼68 hours (321
individuals) at $4,421 total, compared
with the original OMB approved burden
of 1,570 hours (4,435 individuals) at
$97,460 total.
There are no costs to respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Pathologist .......................................
Laboratory Directors ........................
Laboratory Managers .......................
Total ..........................................
IHC
IHC
IHC
IHC
IHC
IHC
IHC
IHC
IHC
IHC
IHC
IHC
IHC
IHC
IHC
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
20/60
1/60
1.50
5/60
5/60
20/60
1/60
1.50
5/60
5/60
20/60
1/60
1.50
5/60
5/60
7
0.45
18
8
1
3
0.45
9
4
0.50
3
0.45
9
4
0.50
..........................................................
........................
........................
........................
68.00
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–16–0968; Docket No. CDC–2015–
0104]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, 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. This notice invites
comment on a proposed information
collection entitled ‘‘Monitoring and
Reporting System for DELTA FOCUS
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Total burden
(in hours)
20
27
12
100
12
10
27
6
50
6
10
27
6
50
6
[FR Doc. 2015–29867 Filed 11–23–15; 8:45 am]
17:20 Nov 23, 2015
Average
burden per
response
(in hours)
Number of
responses per
respondent
telephone interview ..................
telephone interview—contacted
focus group ..............................
focus group—invitation ............
focus group—consent form ......
telephone interview ..................
telephone interview—contacted
focus group ..............................
focus group—invitation ............
focus group—consent form ......
telephone interview ..................
telephone interview—contacted
focus group ..............................
focus group—invitation ............
focus group—consent form ......
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.
VerDate Sep<11>2014
Number of
respondents
Form name
Jkt 238001
Awardees’’. CDC will use the
information collected to monitor
cooperative agreement awardees and to
identify challenges to program
implementation and achievement of
outcomes.
DATES: Written comments must be
received on or before January 25, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0104 by any of the following methods:
Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
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,
E:\FR\FM\24NON1.SGM
24NON1
]]>Agencies
[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Notices]
[Pages 73188-73190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29867]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-16-1067; Docket No. CDC-2015-0106]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS)
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, 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. This notice invites comment on a proposed
revision of the information collection entitled Improving the Impact of
Laboratory Practice Guidelines: A New Paradigm for Metrics--College of
American Pathologists, which will allow for a fuller exploration of the
factors that underlie the reasons why laboratorians adhere to the
College of American Pathologists' laboratory practice guideline for
immunohistochemistry test validation.
DATES: Written comments must be received on or before January 25, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0106 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the
instructions for submitting comments.
Mail: Leroy A. Richardson, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE., MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.
Please note: All public comment should be submitted through the
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact the Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
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
[[Page 73189]]
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.
Proposed Project
Improving the Impact of Laboratory Practice Guidelines (LPGs): A
New Paradigm for Metrics--College of American Pathologists, REVISION
(OMB Control No. 0920-1067, Expiration 05/31/16)--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, the Clinical and Laboratory Standards
Institute, and the College of American Pathologists (CAP), will each
use their LPGs as models to better understand how to improve uptake and
impact of these and future LPGs. Only the CAP submission will be
described in this notice.
The CAP project will address two LPGs that are important to
clinical testing: immunohistochemistry test validation (IHC) and an
algorithm for diagnosing acute leukemia (ALA). As part of the completed
survey collections that was conducted under OMB Control Number 0920-
1067, the intended users of the CAP's IHC LPG included pathologists,
clinical laboratory directors, and laboratory managers overseeing the
IHC staining department; the intended users of the CAP's ALA LPG were
pathologists and hematologists overseeing testing for acute leukemia.
For this revision request, CDC is proposing information collections to
conduct qualitative studies of the survey respondents of the IHC post-
survey with the intent to include representation from the laboratory
professionals who submitted the IHC post-survey results (pathologists,
clinical laboratory directors, and laboratory managers).
Prior to entering into this cooperative agreement project with the
CDC, the CAP had already completed a baseline IHC LPG information
collection from laboratories that used IHC testing. Because of this
prior baseline assessment, the CAP only needed to collect post-
dissemination data. This has been completed using the information
approved under OMB Control Number 0920-1067. Similarly, the CAP also
completed an ALA baseline survey under this clearance.
We are submitting a revision request to allow for a fuller
exploration of the factors that underlie the reasons why laboratorians
adhere to the College of American Pathologists' laboratory practice
guideline for IHC. We propose to conduct telephone interviews that will
explore the impediments and facilitators that affect uptake and use of
the CAP IHC LPG, both generally and concerning specific
recommendations. This will be followed by two focus groups, arranged by
peer group of pathologists and non-pathologists (referred to as
laboratory directors and managers for the purpose of estimating
burden), which will allow us to collect information on the current
usage of CAP's tools and resources (toolkit) to facilitate
implementation of the IHC guideline for its future improvement. To the
extent possible, we will include non-adopters of the CAP's IHC LPG, but
this fraction won't be known until the information collection occurs.
We propose to collect information for the telephone interviews and
focus groups combined, from 64 of the IHC post-survey respondents which
include pathologists and non-pathologist laboratory directors and
laboratory managers.
For this request, the CAP will collect information via telephone
interviews from 40 laboratorians. The time it will take each respondent
to complete the interview is 20 minutes. Because the CAP anticipates
that as many as 121 individuals may need to be contacted to reach 40
individuals who will voluntarily participate, and the burden for those
individuals who will not go on to participate (81) in the telephone
interview is one minute, the anticipated total burden for individuals
who decline participation is 1.35 hours (81 minutes). The telephone
interview respondents will be targeted from two primary segments: (1)
Laboratories exclusively using CAP Proficiency Testing (PT) products,
and (2) laboratories identified by Centers for Medicare and Medicaid
Services billing codes that perform IHC testing but are not enrolled in
CAP PT products. The telephone interview respondents will be randomly
sampled from the submitted post-survey results and will be cross-
checked for appropriate distribution of laboratory type and size.
Because there are fewer of them, all of the non-CAP PT customer
respondents will be included. The CAP estimates that the individuals
who complete the telephone interview will be comprised of 20
pathologists, 10 laboratory directors, and 10 laboratory managers and
will each take 20 minutes and the 40 respondents combined will take
approximately 13 hours (800 minutes) total burden.
The two in-person focus group sessions will include some of the
probe questions from the telephone interview survey and a specific
subset concentrating on evaluating CAP's current tools and resources
(toolkit). It is anticipated that 200 individuals will be contacted to
determine their availability to participate in one of two focus group
sessions and each will take no longer than five minutes to read and
respond to the invitation letter (~17 hours or 1,000 minutes total).
Among the 200 individuals contacted, only the 24 who are selected to
participate in a focus group session will each be asked to read and
submit a signed consent form prior to the session (5 minutes each) (2
hours or 120 minutes total). Twelve participants will be selected to
participate in each of the two focus groups (pathologist peers and
laboratory director/manager peers) and will last no more than 90
minutes each (36 hours or 2,160 minutes total). Thus, the total
[[Page 73190]]
burden for the focus group is estimated to be ~55 hours (3,280 minutes)
total.
Including both telephone interviews and focus group sessions, the
total new burden for this revision request will be an additional ~68
hours (321 individuals) at $4,421 total, compared with the original OMB
approved burden of 1,570 hours (4,435 individuals) at $97,460 total.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Pathologist................... IHC telephone 20 1 20/60 7
interview.
IHC telephone 27 1 1/60 0.45
interview--cont
acted.
IHC focus group. 12 1 1.50 18
IHC focus group-- 100 1 5/60 8
invitation.
IHC focus group-- 12 1 5/60 1
consent form.
Laboratory Directors.......... IHC telephone 10 1 20/60 3
interview.
IHC telephone 27 1 1/60 0.45
interview--cont
acted.
IHC focus group. 6 1 1.50 9
IHC focus group-- 50 1 5/60 4
invitation.
IHC focus group-- 6 1 5/60 0.50
consent form.
Laboratory Managers........... IHC telephone 10 1 20/60 3
interview.
IHC telephone 27 1 1/60 0.45
interview--cont
acted.
IHC focus group. 6 1 1.50 9
IHC focus group-- 50 1 5/60 4
invitation.
IHC focus group-- 6 1 5/60 0.50
consent form.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 68.00
----------------------------------------------------------------------------------------------------------------
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. 2015-29867 Filed 11-23-15; 8:45 am]
BILLING CODE 4163-18-P
