[Federal Register Volume 80, Number 38 (Thursday, February 26, 2015)]
[Notices]
[Pages 10489-10491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03985]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-15CK]


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- College of American Pathologists--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

[[Page 10490]]

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 (CLSI), 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). The ALA LPG is being co-
developed with the American Society of Hematology (ASH). The intended 
users of the CAP's IHC LPGs will include pathologists, clinical 
laboratory directors, and laboratory managers overseeing the IHC 
staining department. For the CAP's ALA LPG the intended users are 
pathologists and hematologists overseeing testing for acute leukemia. 
Thus, all these professionals will be surveyed by CAP.
    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. Subsequent to this 
information collection, the CAP created and disseminated an IHC LPG in 
a peer reviewed journal. Because of this prior baseline assessment, the 
CAP will only need to collect post-dissemination data. For their ALA 
LPG CAP/ASH Algorithm for Initial Work-Up of Acute Leukemia, the CAP 
will conduct both a baseline and a post-dissemination evaluation using 
a survey and/or focus group. Because there are uncertainties concerning 
the specific focus group probes for the IHC LPG and the ALA LPG, this 
notice only provides a description of our collection of post-
dissemination information for the IHC LPG and the baseline ALA LPG.
    The CAP hopes to achieve an 80% response rate, or 2668 out of 3335 
potential respondents for the IHC LPG. This represents laboratories 
known to be currently performing IHC testing based upon their 
participation in CAP's IHC proficiency testing (PT) program and 450 
additional laboratories identified by CDC using previous Centers for 
Medicare and Medicaid Services Part B reimbursement claims for IHC 
testing. The response rate for the baseline IHC survey was 
approximately 70% and more focused promotion is planned. We have 
identified a total of 3335 (2885 CAP-PT customers + 450 non-CAP-PT 
customers) laboratories that will be targeted by the IHC post-
dissemination survey. Both populations represent laboratories that are 
CAP-accredited and non-CAP-accredited.
    Laboratories that are enrolled in CAP IHC PT programs will receive 
surveys with their PT mailings. Non-CAP-PT-customer laboratories will 
be surveyed via the US postal system, with a fax-back mechanism. Only 
one response per laboratory will be accepted.
    The CAP will need to collect both baseline and post-guideline 
dissemination information for the ALA LPG. CAP will allow only one 
response per computer internet protocol address. The CAP has a database 
of pathologists who have indicated specialization in hematopathology; 
these hematopathologists will be invited to participate. The CAP hopes 
to achieve an 80% response rate with their individual information 
collections, or 880 (80% x 1100 pathologists listed in the CAP 
database).
    The baseline survey for the ALA guideline includes questions about 
individual practices for diagnosing various types of acute leukemia and 
individual and laboratory reporting practices. The link to the baseline 
survey for the ALA guideline will be disseminated via email to 
hematopathologists in CAP's database. The online survey will be hosted 
by Survey Monkey.
    The CAP and CDC will strive to ensure a high response rate for 
their IHC and ALA surveys. CAP plans to advertise both surveys. 
Similarly, the CAP plans to maximize response rates for CAP-PT customer 
laboratories by sending reminders through the PT program. The CAP will 
also try to maximize response rates for the ALA survey by advertising 
it through various channels and sending an email reminder.
    For burden calculation, we assume one response per laboratory for 
the IHC survey to include (1) pathologists, (2) laboratory directors, 
and (3) other laboratory managers of IHC laboratories, which may 
consist of graduate level scientists (Ph.D.s and Masters level), 
approximately in a 25%:25%:50% distribution, respectively. We assume 
respondents for the ALA surveys may include multiple responses within a 
laboratory of pathologists and hematologists that sign out cases, 
approximately in a 95%:5% distribution, respectively.
    The IHC baseline survey, which was conducted prior to this CAP-CDC 
cooperative agreement, took 15 minutes to complete. The IHC post-
dissemination survey is expected to take 20 minutes to complete. The 
ALA baseline survey is expected to take an average of 25 minutes to 
complete. The maximum times observed during pilot testing were 30 and 
45 minutes, respectively. Results from the pilot tests were used to 
revise both surveys.
    The total Estimated Annualized Burden Hours for this ICR is 1,570. 
There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                     Avgerage
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response (in
                                                                                    respondent         hrs.)
----------------------------------------------------------------------------------------------------------------
Pathologists..........................  IHC.....................             834               1           20/60
                                        ALA.....................           1,045               1           25/60
Laboratory Directors..................  IHC.....................             834               1           20/60
Laboratory Managers...................  IHC.....................           1,667               1           20/60
Hematologists.........................  ALA.....................              55               1           25/60
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[[Page 10491]]

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. 2015-03985 Filed 2-25-15; 8:45 am]
BILLING CODE 4163-18-P