[Federal Register Volume 79, Number 212 (Monday, November 3, 2014)]
[Notices]
[Pages 65219-65221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day 15-15CK]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of 
its continuing effort to reduce public burden, 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. To request more information on the 
below proposed project or to obtain a copy of the information 
collection plan and instruments, call 404-639-7570 or send comments to 
Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or 
send an email to <a href="/cdn-cgi/l/email-protection#e08f8d82a0838483ce878f96"><span class="__cf_email__" data-cfemail="2f40424d6f4c4b4c01484059">[email protected]</span></a>.
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. 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 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. Written comments should be received within 60 
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

[[Page 65220]]

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). The ALA LPG is being co-
developed with the American Society of Hematologists (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 
data 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 survey. 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 2,668 out of 
3,335 potential respondents. 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 CMS Part B reimbursement 
claims for IHC testing. The response rate for the baseline IHC survey 
was approximately 70% but through more focused promotion the CAP hopes 
to increase participation. We have identified a total of 3,335 (2,885 
CAP-accredited + 450 non-CAP-accredited) laboratories that will be 
targeted by the IHC post-dissemination survey.
    CAP-accredited laboratories that are enrolled in IHC PT will 
receive surveys with their PT mailings. Non-CAP-accredited laboratories 
will be surveyed via the US postal system, with a fax-back mechanism.
    The CAP will need to collect both baseline and post-guideline 
dissemination data 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 data 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, who will be provided a link to 
the Qualtrics site that hosts the survey.
    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 non-CAP-
accredited laboratories by sending reminders through the US postal 
system. The CAP will also try to maximize response rates for the ALA 
survey by advertising it through various channels.
    For burden calculation, we assume one response per laboratory. We 
assume respondents for the IHC survey will 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 will include 
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 and the ALA baseline survey are also expected to 
take 15 minutes. Each survey will be pilot tested with nine or fewer 
respondents before deployment to assure that they require 15 minutes or 
less to complete. CDC is requesting a one-year OMB approval to collect 
the information. There are no costs to respondents other than their 
time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
        Type of respondent            Form name      Number of     responses per   per  response   Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Pathologist.......................  IHC                      834               1           15/60             209
                                    ALA                    1,045               2           15/60             523
Laboratory Directors..............  IHC                      834               1           15/60             209
Laboratory Managers...............  IHC                    1,667               1           15/60             417
Hematologist......................  ALA                       55               2           15/60              28
                                                 ---------------------------------------------------------------

[[Page 65221]]

 
    Total.........................  ............  ..............  ..............  ..............           1,386
----------------------------------------------------------------------------------------------------------------


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. 2014-26030 Filed 10-31-14; 8:45 am]
BILLING CODE 4163-18-P


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