[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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4163-18-P