[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23297-23299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09190]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-1067]
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 projects or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice 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--College of American Pathologists (OMB Control
No. 0920-1067)--Revision--Center for Surveillance, Epidemiology and
[[Page 23298]]
Laboratory Services (CSELS), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC) funded the
College of American Pathologists (CAP) as one of three professional
organizations in 5-year cooperative agreement 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. 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.
One of the awardees is the College of American Pathologists (CAP).
This revision request concerns additional information collection
relating to the CAP's LPG for immunohistochemistry (IHC) testing, for
which a post dissemination survey was approved under OMB Control No.
0920-1067 and has been completed. We are requesting a revision to the
OMB-approved 0920-1067 package by adding two information collections:
Telephone interviews and focus groups as a follow-up to the completed
IHC LPG post survey to further explore the survey findings that are
being analyzed now. The questions to be used for the telephone
interviews and focus groups are based on the questions and results of
the IHC post survey, to help CAP and CDC better understand the
impediments and facilitators that affect uptake of the IHC LPG. The
intended participants in the proposed telephone interviews and focus
groups will be selected from the IHC post survey respondents which
include pathologists, pathology chairs, clinical laboratory directors,
laboratory managers overseeing the IHC staining department, laboratory
supervisors, and histotechnologists.
This revision request represents a decrease in burden. The proposed
telephone interviews 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 into two peer groups of pathologists (composed of
pathologists, pathology chairs, and laboratory directors) and non-
pathologist laboratory professionals (composed of laboratory managers,
laboratory supervisors, and histotechnologists 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.
For this request, the CAP will collect information via 40 telephone
interviews (20 pathologists, 10 laboratory directors, and 10 laboratory
managers). The telephone interview questions are scripted to be
completed within 20 minutes by each respondent (0.33 hour per
respondent or ~13 hours total). Because the CAP anticipates that
approximately 121 laboratory individuals (41 pathologists, 40
laboratory directors, and 40 laboratory managers) will 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 total burden for
individuals who decline participation is 81 minutes (1.35 hours).
In addition, the CAP will conduct two focus group sessions and
invite 12 participants to each of the sessions, composed of the
following respondent types: (4) Pathologists, (4) pathology chairs, (4)
laboratory directors, (4) laboratory managers, (4) laboratory
supervisors, and (4) histotechnologists. Each of the focus groups will
last no more than 60 minutes (1.0 hour) which is based on standard
focus group planning instructions, inclusive of time required to
complete informed consent (24 hours or 1,440 minutes total burden). It
is anticipated that 200 individuals will be contacted to determine
their availability to participate in one of the two focus group
sessions and each will take no longer than 5 minutes to read and
respond to the invitation letter (~17 hours or 1000 minutes total). The
200 individuals contacted will be composed of the following respondent
types: (34) Pathologists, (33) pathology chairs, (33) laboratory
directors, (34) laboratory managers, (33) laboratory supervisors, and
(33) histotechnologists.
This revision includes three types of laboratory professionals who
were not included in the original OMB-approved submission: Pathology
chairs, laboratory supervisors, and histotechnologists. Because the
OMB-approved IHC post-survey has been completed, this request for
approval of additional data collection (telephone interviews and focus
groups) is a reduction of burden. The total new burden for this
revision request will be ~58 hours which is a reduction of 1,512 hours
from the previously approved submission. A total of 321 respondents
(121 invited to take the telephone interview and 200 invited to
participate in focus groups), is a reduction of 4,114 respondents with
an approved burden of 1,570 hours and 4,435 respondents).
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Form name Type of respondent Number of responses per per response
respondents respondent (in hours)
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IHC telephone interview-contacted..... Pathologists............ 41 1 1/60
Laboratory Directors.... 40
Laboratory Managers..... 40
IHC telephone interview............... Pathologists............ 20 1 20/60
Laboratory Directors.... 10
Laboratory Managers..... 10
IHC focus group invitation............ Pathologists............ 34 1 5/60
[[Page 23299]]
Pathology Chairs........ 33
Laboratory Directors.... 33
Laboratory Managers..... 34
Laboratory Supervisors.. 33
Histotechnologists...... 33
IHC focus group....................... Pathologists............ 4 1 1
Pathology Chairs........ 4
Laboratory Directors.... 4
Laboratory Managers..... 4
Laboratory Supervisors.. 4
Histotechnologists...... 4
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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. 2016-09190 Filed 4-19-16; 8:45 am]
BILLING CODE 4163-18-P