[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68780-68782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27835]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-13-13BF]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570
and send comments to Ron Otten, at CDC 1600 Clifton Road, MS-D74,
Atlanta, GA 30333 or send an email to omb@cdc.gov.
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; and (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. Written comments should be received
within 60 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
The mission of the National Institute for Occupational Safety and
Health (NIOSH) is to promote safety and health at work for all people
through research
[[Page 68781]]
and prevention. The Occupational Safety and Health Act, Public Law 91-
596 (section 20[a][1]), authorizes NIOSH to conduct research to advance
the health and safety of workers. NIOSH is proposing to conduct a study
characterizing the nature of restrictive lung disease occurring in
flavoring and microwave popcorn workers.
Preliminary evidence suggests that flavorings exposures may be
associated with restrictive lung disease in exposed workers. In two
previous NIOSH health hazard evaluations, we found excesses of
restrictive spirometry among workers in a flavoring manufacturing plant
and a flavoring-exposed food production plant. There was virtually no
obstructive lung disease in either of these health hazard evaluations.
Over the course of eight cross-sectional studies at a microwave popcorn
plant, we also found strong relationships between decreases in FEV1 and
cumulative exposure estimates, without differentiating between
obstructive and restrictive abnormalities.
NIOSH requests OMB approval to collect additional information on a
subset of participants from previous NIOSH studies to determine if
restrictive lung disease is occurring among flavoring and popcorn
workers. Diagnostic methods for restrictive lung disease will be
applied in field settings. This will include spirometry, lung volume
testing such as total lung capacity (TLC) and diffusing capacity of the
lung to carbon monoxide (DLCO), as well as high resolution computed
tomography (HRCT), which can detect lung abnormalities consistent with
interstitial lung disease. These medical tests are critical to
establishing lung disease of a fibrotic or inflammatory nature in
persons with spirometric restriction.
Recent literature has demonstrated that bronchiolitis obliterans
and obstructive lung disease are related to flavoring exposures in an
exposure-dependent way. However, secondary prevention of further
impairment among flavoring workers with spirometric restriction and
excessive declines in lung function of a restrictive nature is not
occurring. Flavoring workers with restrictive abnormalities are not
identified as having possible occupational lung disease, are not
removed from further flavorings exposure, are not counseled about
respiratory protection and work practices, and are unlikely to be
successful in claims for work-related lung disease and medical
expenses. These cases of restrictive spirometric abnormality do not
motivate employers to implement controls to prevent lung injury to co-
workers or to enhance medical surveillance programs.
Results from this study will benefit many stakeholders, including
physicians who can appropriately manage workers with restrictive lung
disease with consideration of enhanced respiratory protection or
reassignment; workers who can make decisions regarding continued
exposures and apply for compensation if warranted; companies who can
set data driven priorities for preventive interventions; and policy
makers who can recommend measures to prevent flavoring-related lung
diseases.
For this study, we will recruit participants from two study
populations: approximately 100 workers from a flavorings plant for whom
we have spirometry data and 130 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 during the
summer of 2013 for the microwave popcorn workers and for the flavorings
workers in the summer of 2014. Both study populations will be offered a
questionnaire, spirometry, TLC test, DLCO, and HRCT of the chest. Those
with abnormal spirometry will also be offered a bronchodilator test.
Testing is expected to take between 3 to 3.25 hours per respondent. All
testing will be conducted by trained NIOSH personnel, except for the
HRCT chest scan, which will be done at a local hospital or radiology
clinic. Participants will receive a letter which will explain their
testing results. All study results will be stored at NIOSH.
The total estimated burden for the one-time collection of data is
822 hours. This is an overestimate of the actual burden to account for
any possible waiting at the radiology clinic. Participation in this
study is voluntary, and there are no costs to respondents other than
their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Testing Number of responses per per response Total burden
respondents respondent (in hours) hours
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Popcorn workers with normal Questionnaire 30 1 3 90
spirometry. Spirometry DLCO
TLC HRCT.
Popcorn workers with abnormal Questionnaire 130 1 3.25 423
spirometry. Spirometry DLCO
TLC HRCT
Bronchodilator
test.
Flavoring workers with normal Questionnaire 64 1 3 192
spirometry. Spirometry DLCO
TLC HRCT.
Flavoring workers with Questionnaire 36 1 3.25 117
abnormal spirometry. Spirometry DLCO
TLC HRCT
Bronchodilator
test.
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Total..................... ................ .............. .............. .............. 822
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[[Page 68782]]
Dated:November 2, 2012.
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. 2012-27835 Filed 11-15-12; 8:45 am]
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