[Federal Register Volume 78, Number 106 (Monday, June 3, 2013)]
[Notices]
[Pages 33096-33097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-13BF]


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

    Spectrum of Flavoring Chemical-Related Lung Disease--New--National 
Institute for Occupational Safety and Health (NIOSH), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    This project involves a questionnaire, along with clinical testing, 
to investigate and characterize the nature of lung disease occurring in 
popcorn and flavoring workers. Since publication of the 60-day Federal 
Register Notice, the annual burden estimate has been revised. We added 
the inclusion of job and medication forms to be completed by the 
participant prior to the testing session. We also included the time 
needed to review the informed consent. The overall burden hours is now 
estimated to be 115 hours.
    The purpose of this study is to investigate the spectrum of lung 
disease occurring in flavoring and microwave popcorn workers. A 
secondary aim is to study the natural history of lung disease. For this 
study, we plan on interviewing and conducting clinical testing on 
participants from a previously investigated flavoring plant and 
microwave popcorn plant.
    For this study, we will recruit participants from two study 
populations: Approximately 112 workers from a flavorings plant for whom 
we have spirometry data and 132 workers that had abnormal spirometry on 
any test from a previous NIOSH health hazard evaluation at a microwave 
popcorn plant. Thirty additional workers from the microwave popcorn 
plant who had normal spirometry on their last test also will be chosen 
at random.
    NIOSH anticipates that information collection will begin in the 
2013 fiscal year for the microwave popcorn workers and for the 
flavorings workers in fiscal year 2014. Prior to the testing, 
participants will be mailed a copy of the informed consent to review 
and asked to complete a job history form and current medication form. 
This will take no more than 25 minutes (total) to review and complete. 
On the day of testing, a NIOSH staff member will review the consent 
form with the participant, which will take about 5 minutes. 
Participants will then be given a NIOSH-administered questionnaire 
which will take approximately 20 minutes to complete. All study results 
will be stored at NIOSH.
    Participation in all components of the study is completely 
voluntary. There are no costs to the respondents other than their time. 
The total estimated annual burden hours are 115.

                                        Estimated Annualized Burden Hours
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                                                                                Number of       Average  burden
       Type of respondents               Form name           Number of        responses per    per response  (in
                                                            respondents         respondent           hours)
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Popcorn workers..................  Informed consent....                 81                  1              15/60
                                   Medication form.....                 81                  1               5/60
                                   Job history form....                 81                  1              10/60
                                   Questionnaire.......                 81                  1              20/60
Flavoring workers................  Informed consent....                 56                  1              15/60
                                   Medication form.....                 56                  1               5/60
                                   Job history form....                 56                  1              10/60
                                   Questionnaire.......                 56                  1              20/60
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[[Page 33097]]

Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2013-12978 Filed 5-31-13; 8:45 am]
BILLING CODE 4163-18-P