[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)
----------------------------------------------------------------------------------------------------------------
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