[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Notices]
[Pages 55258-55259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-13-13OE]


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

    Image-Assisted Cytology Workload Assessment and Measure--New--
Office of Surveillance, Epidemiology, and Laboratory Services (OSELS), 
Centers for Disease Control and Prevention (CDC).

[[Page 55259]]

Background and Brief Description

    CDC provides technical guidance to the Department of Health and 
Human Services (HHS) in coordination with the Centers for Medicare & 
Medicaid Services (CMS) and the Food and Drug Administration (FDA) for 
the implementation of the Clinical Laboratory Improvement Amendments 
(CLIA). The Clinical Laboratory Improvement Amendments of 1988 (CLIA) 
directed the Secretary of Health and Human Services to establish the 
maximum number of cytology slides that any individual may screen in a 
24 hour period; to establish certain quality assurance standards; to 
set personnel standards; and to provide for periodic proficiency 
testing of cytotechnologists and pathologists involved in screening and 
interpreting cytological preparations.
    The regulations implementing CLIA, published in the Federal 
Register of February 28, 1992, established that the maximum number of 
slides examined by an individual in each 24 hour period was not to 
exceed 100 slides and could not be examined in less than an eight hour 
day. The regulation further established that the technical supervisor 
is required to evaluate the performance of cytotechnologists at least 
every six months and determine their individual maximum daily workload 
limit. In 1992, when the regulation was published, all Pap slides were 
conventional ``Pap smears.'' In a conventional Pap smear, samples are 
smeared directly onto a glass microscope slide after collection. The 
cells are often obscured by blood or the smear may be too thick and 
contain contaminating artifacts. Today, almost all Pap tests in the 
U.S. are collected with a liquid-based method. Instead of ``smearing'' 
cervical cells directly onto a glass microscope slide, the cells are 
sent to the laboratory in a liquid preservative and processed by an 
automated processor. This processor disperses a uniform thickness 
representative sample on the slide that is free of obscuring blood, 
mucus, and non-diagnostic debris in a circle that covers less than one 
half of the slide.
    CLIA's Federal Advisory Committee, the Clinical Laboratory 
Improvement Advisory Committee (CLIAC), has discussed cytology workload 
on numerous occasions from 1996 until present. On August 29, 2011 the 
American Society of Cytopathology's (ASC) Executive Board approved an 
ASC task force recommendation that the average laboratory 
cytotechnologist productivity should not exceed 70 slides and that an 
individual's screening time should not exceed seven (7) hours in a 24 
hour period.
    Each laboratory will receive an advance request to participate in 
the Image-Assisted Cytology Workload Practices Survey from a DLSS 
contractor that has been selected to collect the survey data and 
conduct the time measure study. Respondents will be cytology 
supervisors from the 1,245 cytology laboratories in the Unites States. 
Since a response to this survey is voluntary we would expect an 80% 
response rate or approximately 996 laboratories. Responses would be 
submitted in written format. The estimated burden per response is one 
half hour. In addition, individual cytotechnologists working in the 
laboratory will be asked to complete the Image-Assisted Cytology 
Workload Assessment Survey. There are 6,064 cytotechnologists in the 
United States. Response to this survey is voluntary, so we would expect 
an 80% response rate or approximately 4,581 cytotechnologists. 
Responses would be submitted in written format. The estimated burden 
per response is one half hour. CDC requests OMB approval to collect 
information for one year.
    There are no costs to respondents other than their time.
    The total estimated annual burden hours are 2,789.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
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Cytology Supervisor...................  Image-Assisted Cytology              996               1           30/60
                                         Workload Practices.
Cytotechnologists.....................  Image-Assisted Cytology            4,581               1           30/60
                                         Workload Assessment.
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Leroy 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. 2013-21911 Filed 9-9-13; 8:45 am]
BILLING CODE 4163-18-P