Published 60 Day FRN

Attachment B-CNT-60-d-FRN_09-20-2012.pdf

Exposure Assessment and Epidemiological Study of U.S. Workers Exposed to Carbon Nanotubes and Nanofibers

Published 60 Day FRN

OMB: 0920-0973

Document [pdf]
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58396

Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
ESTIMATES OF ANNUALIZED BURDEN HOURS
Number of
respondents

Average
burden per
response
(in hours)

Total
burden hours

Form name

Parent Group 1 .................................

Parent Groups 1, 2, 3, and 4 ............

Focus Group Guide ..........................
Focus group recruitment letter .........
Interviewer guide ..............................
Interview recruitment letter ...............
Survey ..............................................

36
50
35
50
230

1
1
1
1
1

1.5
5/60
1
5/60
10/60

54
4
35
4
38

Total Burden Hours ...................

...........................................................

........................

........................

........................

135

Parent Groups 2 and 3 .....................

Dated: September 14, 2012.
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. 2012–23197 Filed 9–19–12; 8:45 am]
BILLING CODE 4163–18–P

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–12–12RS]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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Number of
responses per
respondent

Parent category

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.

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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

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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 crosssectional 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

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Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
and CNF and these biomarkers of early
effect, considering potential
confounding factors such as smoking,
age, gender, and workplace coexposures, including non-engineered
ultrafine particles.
The proposed project supports the
NIOSH legislatively mandated
industrywide studies program that
conducts epidemiological and exposure

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).

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

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
(in hours)

Nanomaterials Workers ...................................................................................

100

1

22/60

37

Total ..........................................................................................................

........................

........................

........................

37

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Healthcare Infection Control Practices
Advisory Committee (HICPAC)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting for the
aforementioned committee:

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Number of
responses per
respondent

Number of
respondents

Respondents

Times and Dates: 9:00 a.m.–5:00 p.m.,
October 11, 2012; 9:00 a.m.–12:00 p.m.,
October 12, 2012
Place: Renaissance Washington, DC
Dupont Circle Hotel, City Center Ballroom,
1143 New Hampshire Avenue NW.,
Washington, District of Columbia 20037.
Status: Open to the public, limited only by
the space available. Please register for the
meeting at www.cdc.gov/hicpac.
Purpose: The Committee is charged with
providing advice and guidance to the
Secretary, Department of Health and Human
Services (HHS); the Director, Centers for
Disease Control and Prevention (CDC); the
Deputy Director, Office of Infectious Diseases
(OID), CDC; and the Director, National Center
for Emerging and Zoonotic Infectious Disease
(NCEZID), CDC, regarding (1) the practice of
infection control; (2) strategies for
surveillance, prevention, and control of
healthcare-associated infections (e.g.,
nosocomial infections) antimicrobial
resistance and related events in settings
where healthcare is provided, including

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hospitals, ambulatory and long-term care
facilities, and home health agencies; and (3)
periodic updating of existing guidelines,
development of new guidelines, guideline
evaluation; and other policy statements
regarding the prevention of healthcareassociated infections an healthcare-related
conditions.
Matters To Be Discussed: The agenda will
include updates on CDC’s activities for
healthcare associated infections (HAI), an
update on the draft guideline for prevention
of infections among patients in neonatal
intensive care units (NICU), draft guideline
for the prevention of surgical site infections,
draft guidance for facility adjudication of
infection data, and an update from the
HICPAC surveillance working group.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Erin
Stone, M.S., HICPAC, Division of Healthcare
Quality Promotion, NCEZID, CDC, l600
Clifton Road, NE., Mailstop A–07, Atlanta,
Georgia 30333 Telephone (404) 639–4045.
Email: [email protected]
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: September 12, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–23193 Filed 9–19–12; 8:45 am]
BILLING CODE 4163–18–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention—Ethics Subcommittee (ES)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned subcommittee:
Time and Date: 8:30 a.m.–2:30 p.m., EDT,
Thursday, October 11, 2012.
Place: CDC, Thomas R. Harkin Global
Communications Center, Distance Learning
Auditorium, 1600 Clifton Road, NE., Atlanta,
GA 30333. This meeting is also available by
teleconference. Please dial (877) 928–1204
and enter code 4305992.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 60 people. To
accommodate public participation in the
meeting, a conference telephone line will be
available. The public is welcome to
participate during the public comment
period. The public comment period is
tentatively scheduled for 2 p.m.–2:10 p.m.
Purpose: The ES will provide counsel to
the ACD, CDC, regarding a broad range of
public health ethics questions and issues
arising from programs, scientists and
practitioners.
Matters To Be Discussed: Agenda items
will include the following topics: Ethical
considerations relating to use of travel
restrictions for the control of communicable
diseases; addition of ethics standards to the
accreditation process for public health
departments; approaches for evaluating the
impact of public health ethics activities;
progress on developing practical tools to
assist state, tribal, local, and territorial health
departments in their efforts to address public
health ethics challenges; and strategies for

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