[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Notices]
[Page 9699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02988]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-12PZ]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to 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

    Proficiency Testing in US Clinical Laboratories: Perception, 
Practices and Potential for Expanded Utility--NEW--The Office of 
Surveillance, Epidemiology and Laboratory Services (OSELS), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The primary focus of this project is to conduct a systematic 
analysis in order to understand which types of laboratories follow 
Proficiency Testing (PT) and Good Laboratory Practices (GLPs), to 
identify ways that PT and GLPs could be better promoted, and to 
identify populations that would benefit from receiving information on 
PT GLPs. The Association of Public Health Laboratories (APHL) and 
Centers for Disease Control and Prevention (CDC) hope to learn more 
about the perceived benefits and burden of performing PT. This 
information may be helpful to the CDC as the Clinical Laboratory 
Improvement Amendments (CLIA) regulations for PT are revised. Our 
survey population frame is 20,500 Certificate of Compliance 
laboratories and 16,800 Certificate of Accreditation laboratories. All 
of these laboratories are required to perform PT in accordance with 
CLIA. Many of these laboratories also use their PT results internally 
to further improve laboratory quality at no additional cost.
    The first phase of this project was conducted by the APHL through 
focus group research in 2011. The research explored how clinical and 
public health laboratories perceived commercial PT programs and 
explored the ways in which the laboratories used PT to assure and 
improve the quality of their testing. This second phase of the project 
will be administration of a survey to build on the preliminary findings 
from the focus group research and help identify the types of 
laboratories that would benefit from learning about additional uses for 
PT. This information will be helpful to disseminate PT and GLPs to 
laboratories in a strategic and targeted way based on findings from 
this survey.
    The goal is to achieve an 80% response rate (29,840 out of 37,300 
laboratories). APHL and CDC will strive to ensure a high response rate 
by promoting the survey through advertisements in laboratory trade 
publications, at professional meetings, and possibly through programs 
and laboratory accreditation organizations.
    The cohort of laboratories surveyed will be all Certificate of 
Compliance and Certificate of Accreditation laboratories listed in the 
Centers for Medicare and Medicaid Services (CMS) Online Survey, 
Certification and Reporting (OSCAR) database. The OSCAR database 
contains demographic information and relevant characteristics including 
laboratory specialty and laboratory type for each laboratory.
    The survey will be administered through a web-based survey system, 
specifically Survey Monkey. APHL will send each laboratory a postmarked 
letter explaining the survey and provide them with a link to log in to 
the survey with a unique identifier on their address label. Two weeks 
afterwards, APHL will follow-up with a postcard reminder which will 
also include that unique identifier.
    There are no costs to respondents other than their time.
    The annualized estimated burden is 9,947 hours.
    Estimated Annualized Burden Hours:

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                                                                                   Number of      Average burden
         Type of respondent                  Form name            Number of      responses per     per response
                                                                 respondents       respondent        (in hrs)
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Laboratorians.......................  Laboratory Practices...          29,840                1            20/60
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    Dated: February 5, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2013-02988 Filed 2-8-13; 8:45 am]
BILLING CODE 4163-18-P