[Federal Register Volume 85, Number 40 (Friday, February 28, 2020)]
[Notices]
[Pages 11988-11990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04081]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-20-20IT; Docket No. CDC-2020-0022]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Understanding Long-term
Respiratory Morbidity in Former Styrene-Exposed Workers. The purpose of
the interviews and medical testing is to determine the prevalence of
respiratory symptoms and lung function abnormalities among a cohort of
former styrene-exposed workers with different exposure levels to
evaluate the long-term impacts of styrene exposure on the respiratory
system.
DATES: CDC must receive written comments on or before April 28, 2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0022 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all Federal comments through the Federal
eRulemaking portal (regulations.gov) or by U.S. mail to the address
listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office,
[[Page 11989]]
Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses.
5. Assess information collection costs.
Proposed Project
Understanding Long-term Respiratory Morbidity in Former Styrene-
Exposed Workers--New--National Institute for Occupational Safety and
Health (NIOSH), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Styrene is used in the production of automobile parts, boats,
computer housings, food containers, wind energy components, and many
other products. An estimated 90,000 U.S. workers are potentially
exposed to styrene at more than 5,000 U.S. manufacturing plants.
Occupational exposure to styrene has been associated with deleterious
health effects, including changes in color vision, mucous membrane
irritation, hearing loss, and neurocognitive impairment. Workplace
exposure to styrene has also been associated with cases of non-
malignant respiratory disease (NMRD), including COPD and obliterative
bronchiolitis. However, little is understood about the long-term
respiratory effects on styrene-exposed workers. NIOSH is requesting a
three year OMB approval.
The goal of this project is to understand the prevalence of long-
term respiratory morbidity in styrene-exposed workers. The objectives
of the proposed study are: (1) To characterize work exposures by
acquiring job histories and comparing with historical exposure levels
obtained from a past industrial hygiene survey, (2) to examine
prevalence of respiratory morbidity by duration and level of styrene
exposure and other characteristics, (3) to apply research biomarkers of
lung injury to a styrene-exposed workforce, and (4) to describe the
prevalence of color vision impairment with the presence of respiratory
morbidity. Our hypothesis is that workers previously exposed to high
concentrations of styrene (>=5 ppm), even those with short tenure (<1
year), will have a higher prevalence of respiratory symptoms and lung
function abnormalities compared with workers exposed to low
concentration of styrene (<5 ppm).
We will conduct face-to-face interviews with members of a cohort of
workers from two reinforced plastic boatbuilding plants that closed in
1989 and 1993. The purpose of the interviews is to collect demographic
information, detailed job history during and after the worker's tenure
at the boatbuilding plant, upper and lower respiratory symptoms,
physician diagnoses of respiratory diseases, cigarette smoking history,
and medication use. A NIOSH employee will conduct the interviews. We
will also conduct several lung function tests including: Exhaled nitric
oxide, impulse oscillometry, multiple-breath washout, spirometry,
bronchodilator reversibility testing, and high-resolution computed
tomography (HRCT) scan.
The purpose of the lung function testing is to identify small and
large airway abnormalities that are consistent with NMRD. With the
exception of the HRCT scans, NIOSH technicians will perform the lung
function testing. An accredited imaging center will be hired to perform
the HRCT scans. We will collect blood to analyze for biomarkers
associated with lung injury caused by obliterative bronchiolitis. A
NIOSH phlebotomist will collect the blood samples. Finally, we will
assess cohort members for color vision abnormalities using the Lanthony
D-15 Color Test. Color vision assessment will be completed by a NIOSH
technician. The total estimated burden hours are 1,449. 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 Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Boatbuilder Cohort Members.... Questionnaire 676 1 15/60 169
and medical
survey consent
form.
Boatbuilder Cohort Members.... Questionnaire... 676 1 45/60 507
Boatbuilder Cohort Members.... Exhaled Nitric 676 1 5/60 56
Oxide--no form.
Boatbuilder Cohort Members.... Impulse 676 1 10/60 113
Oscillometry--n
o form.
Boatbuilder Cohort Members.... Spirometry--no 676 1 10/60 113
form.
Boatbuilder Cohort Members.... Bronchodilator 50 1 20/60 17
Test--no form.
Boatbuilder Cohort Members.... Multiple-Breath 676 1 30/60 338
Washout--no
form.
Boatbuilder Cohort Members.... Color vision 676 1 5/60 56
test--no form.
Boatbuilder Cohort Members.... Blood test--no 676 1 5/60 56
form.
Boatbuilder Cohort Members.... HRCT consent 70 1 5/60 6
form.
Boatbuilder Cohort Members.... HRCT Imaging--no 70 1 15/60 18
form.
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[[Page 11990]]
Total..................... ................ .............. .............. .............. 1,449
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-04081 Filed 2-27-20; 8:45 am]
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