[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58396-58397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23194]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-12-12RS]


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 or 
send comments to Kimberly S. Lane, at 1600 Clifton Road, MS-D74, 
Atlanta, GA 30333 or send an email to [email protected].
    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

    Exposure Assessment and Epidemiological Study of U.S. Workers 
Exposed to Carbon Nanotubes and Carbon Nanofibers--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 and prevention. The Occupational Safety and Health Act 
of 1970, Public Law 91-596 (Section 20[a][1] authorizes NIOSH to 
conduct research to advance the health and safety of workers. In this 
capacity, NIOSH will conduct an exposure assessment and epidemiological 
study of U.S. carbon nanotube (CNT) and carbon nanofiber (CNF) workers.
    At present, because of the newness of the technology, much of the 
occupational exposure to engineered nanomaterials occurs at the 
research and development (R&D) or pilot scale. There have been few 
reliable surveys of the size of the workforce exposed to nanomaterials. 
Health effects from exposure to nanomaterials are uncertain, but may be 
more severe than from larger-sized particles of the same material. This 
is due to the small size, high surface area per unit mass (i.e., 
specific surface area) or (in some cases) high aspect ratio of 
nanomaterials. Carbon nanotubes and nanofibers are among the 
nanomaterials of greatest interest from a public health perspective 
because of their potentially asbestiform properties (e.g., high aspect 
ratio) and toxicological evidence of possible fibrogenic, inflammatory, 
and clastogenic damage resulting from exposures at occupationally 
relevant levels. In addition, the useful properties of CNT and CNF have 
rendered them among the first nanomaterials to be commercially 
exploited in manufacturing settings. Thus, an epidemiologic study to 
determine whether early or late health effects occur from occupational 
exposure to CNT and CNF is warranted.
    The proposed research is a cross-sectional study of the small 
current U.S. workforce involved with CNT and CNF in manufacturing and 
distribution, to be conducted in the following phases: 1) Industrywide 
exposure assessment study to evaluate worker exposure and further 
develop and refine measurement methods for CNT and CNF. This component 
will refine sampling and analysis protocols previously developed for 
the detection and quantification of CNT and CNF in US workplaces. 2) A 
cross-sectional study relating the best metrics of CNT and CNF exposure 
to markers of early pulmonary or cardiovascular health effects. After 
the sampling and analysis protocols have been established to measure 
CNT and CNF, an industrywide study of the association between exposure 
and health effects will be conducted. Medical examinations will be 
conducted and several biomarkers of early effect (for pulmonary 
fibrosis, cardiovascular disease, and genetic damage) will be measured 
in blood and sputum for workers exposed to a range of CNT and CNF 
levels.
    The study will include a questionnaire with a three-fold purpose: 
(1) To determine whether study participants have any contraindications 
for certain medical procedures to be conducted (spirometry and sputum 
induction), (2) to assist in interpretation of the biomarker results, 
and (3) to inquire about current and past exposure to CNT, CNF, and 
other chemicals, dusts, and fumes. The questionnaire will be given by 
NIOSH personnel as a computer-assisted personal interview (CAPI). After 
administration of the CAPI, medical examinations will be conducted to 
evaluate pulmonary function (via spirometry) and blood pressure, and 
sputum and blood will be collected. Statistical analyses will be 
conducted to determine the nature of the relation between exposure to 
CNT

[[Page 58397]]

and CNF and these biomarkers of early effect, considering potential 
confounding factors such as smoking, age, gender, and workplace co-
exposures, including non-engineered ultrafine particles.
    The proposed project supports the NIOSH legislatively mandated 
industrywide studies program that conducts epidemiological and exposure 
assessment research studies to identify the occupational causes of 
disease in the working population and their offspring and to 
effectively communicate study results to workers, scientists, industry, 
and the public.
    The questionnaire will be administered one time only, at the 
worksite, to 100 workers involved in the production and use of CNT or 
CNT. The study will be carried out during the participants' regular 
work shift. There is no cost to respondents or their employers other 
than their time. We estimate that the average burden per response to be 
22 minutes, and that the total burden to all respondents will be 37 
hours (see table below).

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                   Respondents                      respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Nanomaterials Workers...........................             100               1           22/60              37
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............              37
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    Dated: September 14, 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. 2012-23194 Filed 9-19-12; 8:45 am]
BILLING CODE 4163-18-P