73588 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 

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. 2014–29047 Filed 12–10–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–15–15GE] 

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 omb@cdc.gov. 

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: A New Paradigm 

for Metrics—Clinical and Laboratory 

Standards Institute—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 

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 (CLSI), 

and the College of American 

Pathologists, will each use their LPGs as 

models to better understand how to 

improve uptake and impact of these and 

future LPGs. Only the CLSI submission 

will be described in this notice. 

Specifically, the CLSI project will 

address two LPGs that are important to 

clinical testing and have a high public 

health impact: POCT12, Point-of-Care 

Blood Glucose Testing in Acute and 

Chronic Care Facilities and POCT13, 

Glucose Monitoring in Settings without 

Laboratory Support. These LPGs 

provide guidance and recommendations 

for personnel monitoring patient 

glucose levels at sites that have access 

to a hospital laboratory as well as 

locations, such as physician offices or 

nursing homes that do not have an onsite moderate or high complexity 

laboratory. It is expected that as a result 

of sustained improvements in the 

process of creating and updating these 

clinical LPGs, public health, which 

depends upon accurate and appropriate 

laboratory testing guided by the use of 

LPGs, will also generally benefit. The 

intended users of the CLSI’s POCT12 

and POCT13 LPGs will include point-ofcare coordinators, clinical laboratory 

directors, medical technologists, nurses, 

and medical doctors. 

The CLSI plans to collect information 

using the same survey instrument, 

‘‘Fingerstick Glucose Survey’’ (FGS), on 

three separate occasions. During the first 

information collection (FGS1), all 

targeted respondents will be asked to 

complete the survey. Respondents who 

indicate that they are not familiar with 

either POCT12 or POCT13 will be asked 

to provide an email address and offered 

a free copy of the applicable LPG. This 

subset of respondents will be asked to 

complete the same survey (FGS2) 4–6 

months after receiving the free LPG. 

After analysis of the information 

collected during the first two surveys, 

CLSI will make improvements to 

POCT12 and POCT13, such as provision 

of educational materials or helpful 

products such as quality control logs, 

and may also alter their marketing 

campaigns to address issues related to 

awareness and use of CLSI documents. 

The third survey (FGS3) will then be 

sent to all targeted respondents 

approximately 2.5 years after the first 

survey to obtain information that can be 

used to evaluate the impact of these 

improvements. Respondents that 

received a free copy of POCT12 or 

POCT13 following the first survey will 

also be contacted by email and asked to 

take the third survey. 

A link to the survey will be 

distributed to all targeted respondents 

either by email or postcard. The CLSI 

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Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 73589 

will solicit participation from physician 

office laboratories, Department of 

Defense laboratories, and hospitals that 

offer point-of-care glucose testing. 

Participants will be recruited by COLA, 

the Joint Commission and a Point-ofCare Coordinator network, who have 

agreed to distribute links to the survey 

through their membership mailing lists. 

In addition, participants will also be 

solicited through mailing lists 

purchased by CLSI from Clinscan and 

the American Hospital Association. 

Clinical sites offering point-of-care 

glucose testing in the Department of 

Defense medical system will also be 

asked to participate through the 

Department of Defense Clinical 

Laboratory Improvement Program 

(CLIP). In order to obtain the needed 

number of respondents for a statistically 

valid study, additional laboratories, 

selected at random from a database of 

Clinical Laboratory Improvement 

Amendment (CLIA) certificate holders, 

will also be solicited. The survey will 

contain instructions to direct it to the 

individual in each laboratory 

responsible for the development or 

revision of procedures for fingerstick 

glucose testing. Directing the survey to 

the individual with this specific 

responsibility will help to ensure that 

only one response will be obtained from 

each participating laboratory. 

Respondents include point-of-care 

coordinators, clinical laboratory 

directors, managers, and supervisors, 

medical technologists, nurses, and 

medical doctors. 

The CLSI hopes to achieve an 80% 

response rate with their laboratory 

information collections, or 24,000 out of 

about 30,000 potential respondents. The 

second survey will occur approximately 

4–6 months after the initial survey and 

will only target responders from the first 

survey that received a complimentary 

copy of one of the LPG documents. CLSI 

anticipates that approximately 12,000 

participants will be asked to take the 

second survey. Approximately two and 

a half years after the initial survey, the 

same survey will be sent to the same 

laboratories as the first survey (i.e. we 

will solicit approximately 30,000 

potential respondents and expect about 

24,000 individuals to take the survey). 

The third survey will measure the 

impact of the modifications to the 

documents and marketing strategy made 

based on the data collected from the 

first 2 surveys. The response rate for all 

surveys will be maximized by repeated 

reminders using the same channel that 

will be used to distribute the survey. All 

targeted laboratories will receive an 

email or postcard approximately one 

month before distribution of the survey. 

This letter will describe the survey and 

our purpose for collecting information. 

Another email or post card with a link 

to the survey will be sent to the same 

targeted laboratories. We also plan to 

resend the link to the survey to all 

targeted laboratories approximately one 

month later to remind them of the 

survey. 

The CLSI believes completion of the 

survey will take approximately 15 

minutes. The survey will be pilot tested 

with 9 or fewer respondents before 

deployment to assure that they require 

15 minutes or less to take. 

There are no costs to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Point-of-Care Coordinators .................................................... FGS1 ........... 500 1 15/60 125 

FGS2 ........... 250 1 15/60 63 

FGS3 ........... 500 1 15/60 125 

Laboratory Directors ............................................................... FGS1 ........... 4,276 1 15/60 1,069 

FGS2 ........... 2,138 1 15/60 535 

FGS3 ........... 4,276 1 15/60 1,069 

Laboratory Managers ............................................................. FGS1 ........... 4,276 1 15/60 1,069 

FGS2 ........... 2,138 1 15/60 535 

FGS3 ........... 4,276 1 15/60 1,069 

Laboratory Supervisors .......................................................... FGS1 ........... 4,276 1 15/60 1,069 

FGS2 ........... 2,138 1 15/60 535 

FGS3 ........... 4,276 1 15/60 1,069 

Medical Technologists ............................................................ FGS1 ........... 7,800 1 15/60 1,950 

FGS2 ........... 3,900 1 15/60 975 

FGS3 ........... 7,800 1 15/60 1,950 

Nurses .................................................................................... FGS1 ........... 5,000 1 15/60 1,250 

FGS2 ........... 2,500 1 15/60 625 

FGS3 ........... 5,000 1 15/60 1,250 

Medical Doctors ...................................................................... FGS1 ........... 3,500 1 15/60 875 

FGS2 ........... 1,750 1 15/60 438 

FGS3 ........... 3,500 1 15/60 875 

Total ................................................................................ ..................... ........................ ........................ ........................ 18,520 

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. 2014–29036 Filed 12–10–14; 8:45 am] 

BILLING CODE 4163–18–P 

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