80 FR 73188 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 226 (November 24, 2015)

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.

[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Notices]
[Pages 73188-73190]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29867]


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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.

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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: [email protected].

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