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)

Page Range		73188-73190
FR Document		2015-29867

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 Issue 226 (Tuesday, November 24, 2015)

[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.

-----------------------------------------------------------------------

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: omb@cdc.gov.

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

73188 Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices

confirm receipt of your comment(s), Please cite OMB Control No. 3090– personal information provided. For
please check www.regulations.gov, XXXX, Simplifying Federal Award access to the docket to read background
approximately two to three days after Reporting, in all correspondence. documents or comments received, go to
submission to verify posting (except Dated: November 18, 2015. Regulations.gov.
allow 30 days for posting of comments David A. Shive, Please note: All public comment should be
submitted by mail). submitted through the Federal eRulemaking
Chief Information Officer.
FOR FURTHER INFORMATION CONTACT: Mr. portal (Regulations.gov) or by U.S. mail to the
[FR Doc. 2015–29896 Filed 11–23–15; 8:45 am] address listed above.
Kenneth Goldman, GSA, at telephone
BILLING CODE 6820–61–P
202–779–2265. FOR FURTHER INFORMATION CONTACT: To
SUPPLEMENTARY INFORMATION: request more information on the
DEPARTMENT OF HEALTH AND proposed project or to obtain a copy of
A. Purpose
HUMAN SERVICES the information collection plan and
The President’s Management Agenda instruments, contact the Information
includes objectives for creating a Centers for Disease Control and Collection Review Office, Centers for
twenty-first century government that Prevention Disease Control and Prevention, 1600
delivers better results to the American Clifton Road NE., MS–D74, Atlanta,
people in a more efficient manner. [60Day–16–1067; Docket No. CDC–2015– Georgia 30329; phone: 404–639–7570;
0106] Email: omb@cdc.gov.
Leveraging information technology
capabilities to reduce reporting burden Proposed Data Collection Submitted SUPPLEMENTARY INFORMATION: Under the
is key to achieving these goals. Section for Public Comment and Paperwork Reduction Act of 1995 (PRA)
5 of the Digital Accountability and Recommendations (44 U.S.C. 3501–3520), Federal agencies
Transparency Act (Pub. L. 113–101) must obtain approval from the Office of
requires a pilot program to develop AGENCY: Centers for Disease Control and Management and Budget (OMB) for each
recommendations for standardizing Prevention (CDC), Department of Health collection of information they conduct
reporting, eliminating unnecessary and Human Services (HHS) or sponsor. In addition, the PRA also
duplication, and reducing compliance ACTION: Notice with comment period. requires Federal agencies to provide a
costs for recipients of Federal awards. 60-day notice in the Federal Register
The pilot participants are required to SUMMARY: The Centers for Disease concerning each proposed collection of
provide requested reports as well as the Control and Prevention (CDC), as part of information, including each new
cost to collect the data via the pilot. The its continuing efforts to reduce public proposed collection, each proposed
proposed pilot program will provide an burden and maximize the utility of extension of existing collection of
alternative submission method for government information, invites the information, and each reinstatement of
existing Federal Acquisition Regulation general public and other Federal previously approved information
(FAR) requirements, and assess the pilot agencies to take this opportunity to collection before submitting the
results against the existing FAR- comment on proposed and/or collection to OMB for approval. To
required method. continuing information collections, as comply with this requirement, we are
required by the Paperwork Reduction publishing this notice of a proposed
B. Annual Reporting Burden Act of 1995. This notice invites data collection as described below.
Respondents: 720. comment on a proposed revision of the Comments are invited on: (a) Whether
Responses per Respondent: 3 each information collection entitled the proposed collection of information
week. Improving the Impact of Laboratory is necessary for the proper performance
Total Annual Responses: 2,160. Practice Guidelines: A New Paradigm of the functions of the agency, including
Hours per Response: .5. for Metrics—College of American whether the information shall have
Total Burden Hours: 56,160. Pathologists, which will allow for a practical utility; (b) the accuracy of the
fuller exploration of the factors that agency’s estimate of the burden of the
C. Public Comments underlie the reasons why laboratorians proposed collection of information; (c)
Public comments are particularly adhere to the College of American ways to enhance the quality, utility, and
invited on: Whether this collection of Pathologists’ laboratory practice clarity of the information to be
information will have practical utility; guideline for immunohistochemistry collected; (d) ways to minimize the
whether our estimate of the public test validation. burden of the collection of information
burden of this collection of information DATES: Written comments must be on respondents, including through the
is accurate, and based on valid received on or before January 25, 2016. use of automated collection techniques
assumptions and methodology; ways to ADDRESSES: You may submit comments, or other forms of information
enhance the quality, utility, and clarity identified by Docket No. CDC–2015– technology; and (e) estimates of capital
of the information to be collected; and 0106 by any of the following methods: or start-up costs and costs of operation,
ways in which we can minimize the • Federal eRulemaking Portal: maintenance, and purchase of services
burden of the collection of information Regulation.gov. Follow the instructions to provide information. Burden means
on those who are to respond, through for submitting comments. the total time, effort, or financial
the use of appropriate technological • Mail: Leroy A. Richardson, resources expended by persons to
collection techniques or other forms of Information Collection Review Office, generate, maintain, retain, disclose or
mstockstill on DSK4VPTVN1PROD with NOTICES

information technology. Centers for Disease Control and provide information to or for a Federal
Obtaining Copies of Proposals: Prevention, 1600 Clifton Road NE., MS– agency. This includes the time needed
Requesters may obtain a copy of the D74, Atlanta, Georgia 30329. to review instructions; to develop,
information collection documents from Instructions: All submissions received acquire, install and utilize technology
the General Services Administration, must include the agency name and and systems for the purpose of
Regulatory Secretariat Division (MVCB), Docket Number. All relevant comments collecting, validating and verifying
1800 F Street NW., Washington, DC received will be posted without change information, processing and
20405, telephone 202–501–4755. to Regulations.gov, including any maintaining information, and disclosing

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73190 Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices

burden for the focus group is estimated burden for this revision request will be of 1,570 hours (4,435 individuals) at
to be ∼55 hours (3,280 minutes) total. an additional ∼68 hours (321 $97,460 total.
Including both telephone interviews individuals) at $4,421 total, compared There are no costs to respondents
and focus group sessions, the total new with the original OMB approved burden other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)

Pathologist ....................................... IHC telephone interview .................. 20 1 20/60 7
IHC telephone interview—contacted 27 1 1/60 0.45
IHC focus group .............................. 12 1 1.50 18
IHC focus group—invitation ............ 100 1 5/60 8
IHC focus group—consent form ...... 12 1 5/60 1
Laboratory Directors ........................ IHC telephone interview .................. 10 1 20/60 3
IHC telephone interview—contacted 27 1 1/60 0.45
IHC focus group .............................. 6 1 1.50 9
IHC focus group—invitation ............ 50 1 5/60 4
IHC focus group—consent form ...... 6 1 5/60 0.50
Laboratory Managers ....................... IHC telephone interview .................. 10 1 20/60 3
IHC telephone interview—contacted 27 1 1/60 0.45
IHC focus group .............................. 6 1 1.50 9
IHC focus group—invitation ............ 50 1 5/60 4
IHC focus group—consent form ...... 6 1 5/60 0.50

Total .......................................... .......................................................... ........................ ........................ ........................ 68.00

Leroy A. Richardson, Awardees’’. CDC will use the Clifton Road NE., MS–D74, Atlanta,
Chief, Information Collection Review Office, information collected to monitor Georgia 30329; phone: 404–639–7570;
Office of Scientific Integrity, Office of the cooperative agreement awardees and to Email: omb@cdc.gov.
Associate Director for Science, Office of the identify challenges to program SUPPLEMENTARY INFORMATION: Under the
Director, Centers for Disease Control and implementation and achievement of Paperwork Reduction Act of 1995 (PRA)
Prevention.
outcomes. (44 U.S.C. 3501–3520), Federal agencies
[FR Doc. 2015–29867 Filed 11–23–15; 8:45 am]
DATES: Written comments must be must obtain approval from the Office of
BILLING CODE 4163–18–P
received on or before January 25, 2016. Management and Budget (OMB) for each
ADDRESSES: You may submit comments,
collection of information they conduct
identified by Docket No. CDC–2015– or sponsor. In addition, the PRA also
DEPARTMENT OF HEALTH AND
0104 by any of the following methods: requires Federal agencies to provide a
HUMAN SERVICES
Federal eRulemaking Portal: 60-day notice in the Federal Register
Centers for Disease Control and Regulation.gov. Follow the instructions concerning each proposed collection of
Prevention for submitting comments. information, including each new
Mail: Leroy A. Richardson, proposed collection, each proposed
[60 Day–16–0968; Docket No. CDC–2015– extension of existing collection of
0104] Information Collection Review Office,
Centers for Disease Control and information, and each reinstatement of
Prevention, 1600 Clifton Road NE., MS– previously approved information
Proposed Data Collection Submitted
D74, Atlanta, Georgia 30329. collection before submitting the
for Public Comment and
Instructions: All submissions received collection to OMB for approval. To
Recommendations
must include the agency name and comply with this requirement, we are
AGENCY: Centers for Disease Control and Docket Number. All relevant comments publishing this notice of a proposed
Prevention (CDC), Department of Health received will be posted without change data collection as described below.
and Human Services (HHS). to Regulations.gov, including any Comments are invited on: (a) Whether
ACTION: Notice with comment period. personal information provided. For the proposed collection of information
access to the docket to read background is necessary for the proper performance
SUMMARY: The Centers for Disease of the functions of the agency, including
documents or comments received, go to
Control and Prevention (CDC), as part of whether the information shall have
Regulations.gov.
its continuing efforts to reduce public practical utility; (b) the accuracy of the
burden and maximize the utility of Please note: All public comment should be agency’s estimate of the burden of the
government information, invites the submitted through the Federal eRulemaking proposed collection of information; (c)
portal (Regulations.gov) or by U.S. mail to the
general public and other Federal ways to enhance the quality, utility, and
address listed above.
mstockstill on DSK4VPTVN1PROD with NOTICES

agencies to take this opportunity to clarity of the information to be
comment on proposed and/or FOR FURTHER INFORMATION CONTACT: To collected; (d) ways to minimize the
continuing information collections, as request more information on the burden of the collection of information
required by the Paperwork Reduction proposed project or to obtain a copy of on respondents, including through the
Act of 1995. This notice invites the information collection plan and use of automated collection techniques
comment on a proposed information instruments, contact the Information or other forms of information
collection entitled ‘‘Monitoring and Collection Review Office, Centers for technology; and (e) estimates of capital
Reporting System for DELTA FOCUS Disease Control and Prevention, 1600 or start-up costs and costs of operation,

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Document Created: 2015-12-14 14:08:58
Document Modified: 2015-12-14 14:08:58

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before January 25, 2016.
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]
FR Citation		80 FR 73188

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

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

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