Revised Draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials, 47174-47175 [2018-20169]
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Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices
Much of CDC’s health communication
takes place within campaigns that have
fairly lengthy planning periods—
timeframes that accommodate the
standard Federal process for approving
data collections. Short term qualitative
interviewing and cognitive research
techniques have previously proven
invaluable in the development of
scientifically valid and populationappropriate methods, interventions, and
instruments.
This request includes studies
investigating the utility and
acceptability of proposed sampling and
recruitment methods, intervention
contents and delivery, questionnaire
domains, individual questions, and
interactions with project staff or
electronic data collection equipment.
These activities will also provide
information about how respondents
answer questions and ways in which
question response bias and error can be
reduced. This request also includes
collection of information from public
health programs to assess needs related
to initiation of a new program activity,
or expansion or changes in scope, or
implementation of existing program
activities to adapt them to current
needs. The information collected will be
used to advise programs and provide
capacity-building assistance tailored to
identified needs.
Overall, these development activities
are intended to provide information that
will increase the success of the
surveillance or research projects
through increasing response rates and
decreasing response error, thereby
decreasing future data collection burden
to the public. The studies that will be
covered under this request will include
one or more of the following
investigational modalities: (1)
Structured and qualitative interviewing
for surveillance, research, interventions
and material development, (2) cognitive
interviewing for development of specific
data collection instruments, (3)
methodological research, (4) usability
testing of technology-based instruments
and materials, (5) field testing of new
methodologies and materials, (6)
investigation of mental models for
health decision-making, to inform
health communication messages, and (7)
organizational needs assessments to
support development of capacity.
Respondents who will participate in
individual and group interviews
(qualitative, cognitive, and computer
assisted development activities) are
selected purposively from those who
respond to recruitment advertisements.
In addition to utilizing advertisements
for recruitment, respondents who will
participate in research on survey
methods may be selected purposively or
systematically from within an ongoing
surveillance or research project. The
total burden hours for this collection is
46,516. Participation of respondents is
voluntary. There is no cost to
participants other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
General public .................................................
Health care providers ......................................
General public .................................................
Health care providers ......................................
General public .................................................
Health care providers ......................................
General public .................................................
Health care providers ......................................
General public .................................................
Health care providers ......................................
Screener .........................................................
Screener .........................................................
Consent Forms ...............................................
Consent Forms ...............................................
Individual Interview .........................................
Individual Interview .........................................
Focus Group Interview ...................................
Focus Group Interview ...................................
Survey of Individual ........................................
Survey of Individual ........................................
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–20245 Filed 9–17–18; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[CDC–2016–0001; Docket Number NIOSH
260–A]
Revised Draft NIOSH Current
Intelligence Bulletin: Health Effects of
Occupational Exposure to Silver
Nanomaterials
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
AGENCY:
VerDate Sep<11>2014
19:14 Sep 17, 2018
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of draft document
available for public comment and online
public meeting.
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC)
announces the availability of the
following draft document for public
comment titled Current Intelligence
Bulletin: Health Effects of Occupational
Exposure to Silver Nanomaterials. To
view the notice, document and related
materials, visit https://
www.regulations.gov and enter CDC–
2016–0001 in the search field and click
‘‘Search’’.
DATES: The public online meeting will
be held on October 30, 2018, 1 p.m.–
4:30 p.m., Eastern Time, or until the last
public commenter has spoken,
SUMMARY:
BILLING CODE 4163–18–P
daltland on DSKBBV9HB2PROD with NOTICES
Number of
respondents
Type of respondent
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56,840
24,360
28,420
12,180
4,620
1,980
2,800
1,200
21,000
9,000
Number of
responses per
respondent
Average hours
per response
1
1
1
1
1
1
1
1
1
1
10/60
10/60
5/60
5/60
1
1
2
2
30/60
30/60
whichever occurs first. The public
online meeting will be a web-based
event available only by remote access.
Members of the public who wish to
provide public comments should plan
to login to the meeting at the start time
listed. Members of the public who
register with the NIOSH Docket Office,
niocindocket@cdc.gov to attend the
public meeting will be provided the
login information prior to the meeting.
ADDRESSES: Written comments
submitted to the docket must be
received by November 30, 2018. Written
comments may be submitted by either of
the following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: NIOSH Docket Office, 1090
Tusculum Avenue, MS C–34,
Cincinnati, Ohio 45226–1998.
FOR FURTHER INFORMATION CONTACT:
Charles Geraci, NIOSH/EID/NTRC,
Robert A. Taft Laboratories, 1090
E:\FR\FM\18SEN1.SGM
18SEN1
daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices
Tusculum Avenue, Cincinnati, OH
45226, (513) 533–8339 (not a toll free
number).
SUPPLEMENTARY INFORMATION:
Background: In response to public
and peer review comments on the
NIOSH draft document titled Current
Intelligence Bulletin: Health Effects of
Occupational Exposure to Silver
Nanomaterials, NIOSH has developed a
revised draft document and released it
for public comment [https://
www.regulations.gov]. Regarding the
previous draft document, notices of a
public meeting and comment period
were published on January 21, 2016 [81
FR 342], and February 10, 2016 [81 FR
7124]. A public meeting was held on
March 23, 2016, and members of the
public, stakeholders, and scientific
peers were given the opportunity to
provide comments by April 22, 2016. In
the interest of completeness and
transparency, NIOSH is making
available the public and peer reviewer
comments received on the previous
draft document and the NIOSH
responses to those comments at [https://
www.regulations.gov]. NIOSH has
carefully considered the review
comments on the previous draft in
developing the current draft document.
For the current review, NIOSH is
requesting comments on the August
2018 draft NIOSH document only.
This revised draft document provides
an updated scientific literature review
of information pertaining to
occupational exposure to silver
nanomaterials. This literature review
includes studies on the toxicological
effects of exposure to silver
nanomaterials in experimental animal
and cellular systems, the effect of
particle size and other properties on the
toxicological effects of silver, and
NIOSH recommendations on the
measurement and control of
occupational exposures to silver and
silver nanomaterials. NIOSH assessed
the potential health risks of
occupational exposure to silver
nanomaterials by evaluating the
scientific literature. Studies in animals
have shown adverse lung and liver
effects associated with exposure to
silver nanoparticles. Based on an
assessment of these data, NIOSH
developed a recommended exposure
limit (REL) for silver nanomaterials.
This new draft REL applies to processes
that produce or use silver
nanomaterials. In addition, NIOSH
continues to recommend its existing
REL for total silver (metal dust and
soluble compounds, as Ag)
[www.cdc.gov/niosh/npg/
npgd0557.html].
VerDate Sep<11>2014
19:14 Sep 17, 2018
Jkt 244001
NIOSH further recommends the use of
workplace exposure assessments,
engineering controls, safe work
procedures, training and education, and
established medical surveillance
approaches to prevent potential adverse
health effects from exposure to silver
nanomaterials. NIOSH proposes
research needs to fill remaining data
gaps on the potential adverse health
effects of occupational exposure to
silver nanomaterials.
The purpose of the public review of
the draft document is to obtain
comments on whether the proposed
NIOSH draft document (1) adequately
and clearly describes the scientific
literature on the potential adverse
health effects of silver nanomaterials,
and (2) demonstrates that the NIOSH
recommendations on occupational
exposure to silver nanomaterials are
consistent with current scientific
knowledge.
Purpose of Public Meeting
To discuss and obtain comments on
the revised August 2018 draft NIOSH
document, ‘‘Current Intelligence
Bulletin: Health Effects of Occupational
Exposure to Silver Nanomaterials’’.
Special emphasis will be placed on
discussion of the following questions for
reviewers:
(1) Does the draft document
accurately identify and characterize the
health hazards of exposures to silver
and silver nanomaterials based on the
available scientific literature?
(2) Are the risk assessment and
dosimetry modeling methods presented
in the draft document consistent with
current scientific knowledge and
practice?
(3) Is the relationship between
exposure to silver nanomaterials and
biological activity (toxicity) accurately
portrayed in the draft document?
(4) Is the available scientific evidence
fully described regarding the human
health relevance of the adverse health
endpoints observed in rats associated
with exposure to silver nanomaterials?
(5) Is the proposed recommended
exposure limit (REL) well-supported by
the scientific data presented in the
document?
(6) Are the sampling and analytical
methods proposed for silver
nanomaterials adequate to measure
worker exposure?
(7) Are the recommended strategies
for controlling exposure to silver and
silver nanomaterials (e.g., engineering
controls, work practices, personal
protective equipment) reasonable?
(8) Are the important data gaps and
future research needs complete and
clearly described?
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47175
Online Public Meeting
The meeting is open to the public,
limited only by the number of logins
available. The Adobe Connect license
accommodates approximately 500
people. In addition, there will be an
audio conference for those who cannot
login through a computer. There is no
registration fee to attend this public
online meeting. However, those wishing
to attend are encouraged to register via
email to NIOSH Docket Office
niocindocket@cdc.gov by October 23,
2018. Registrants will be provided with
the public meeting login information
prior to the meeting. Individuals
wishing to speak during the meeting
may sign up when registering. Those
who have not signed up to present in
advance may be allowed to present at
the meeting if time allows. Persons
wanting to provide oral comments will
be permitted up to 20 minutes. If
additional time becomes available,
presenters will be notified. Oral
comments given at the meeting may also
be submitted to the docket in writing to
assure they are accurately recorded by
the Agency.
Priority for attendance will be given
to those providing oral comments. Other
requests to attend the meeting will then
be accommodated on a first-come basis.
Unreserved attendees will be admitted
as login space allows.
Instructions: All material submitted to
the Agency should reference the agency
name and docket number [CDC–2016–
0001; NIOSH 260–A]. Each person
making a comment will be asked to give
his or her name and affiliation, and all
comments (including their name and
affiliation) will be posted without
change to https://www.regulations.gov.
All information received in response to
this notice will be available for public
examination and copying at the NIOSH
Docket Office, Room 155, 1150
Tusculum Avenue, Cincinnati, Ohio
45226–1998.
Dated: September 12, 2018.
Frank J. Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.
[FR Doc. 2018–20169 Filed 9–17–18; 8:45 am]
BILLING CODE 4163–19–P
E:\FR\FM\18SEN1.SGM
18SEN1
]]>Agencies
[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Notices]
[Pages 47174-47175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20169]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[CDC-2016-0001; Docket Number NIOSH 260-A]
Revised Draft NIOSH Current Intelligence Bulletin: Health Effects
of Occupational Exposure to Silver Nanomaterials
AGENCY: National Institute for Occupational Safety and Health (NIOSH)
of the Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of draft document available for public comment and
online public meeting.
-----------------------------------------------------------------------
SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC)
announces the availability of the following draft document for public
comment titled Current Intelligence Bulletin: Health Effects of
Occupational Exposure to Silver Nanomaterials. To view the notice,
document and related materials, visit https://www.regulations.gov and
enter CDC-2016-0001 in the search field and click ``Search''.
DATES: The public online meeting will be held on October 30, 2018, 1
p.m.-4:30 p.m., Eastern Time, or until the last public commenter has
spoken, whichever occurs first. The public online meeting will be a
web-based event available only by remote access. Members of the public
who wish to provide public comments should plan to login to the meeting
at the start time listed. Members of the public who register with the
NIOSH Docket Office, [email protected] to attend the public meeting
will be provided the login information prior to the meeting.
ADDRESSES: Written comments submitted to the docket must be received by
November 30, 2018. Written comments may be submitted by either of the
following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34,
Cincinnati, Ohio 45226-1998.
FOR FURTHER INFORMATION CONTACT: Charles Geraci, NIOSH/EID/NTRC, Robert
A. Taft Laboratories, 1090
[[Page 47175]]
Tusculum Avenue, Cincinnati, OH 45226, (513) 533-8339 (not a toll free
number).
SUPPLEMENTARY INFORMATION:
Background: In response to public and peer review comments on the
NIOSH draft document titled Current Intelligence Bulletin: Health
Effects of Occupational Exposure to Silver Nanomaterials, NIOSH has
developed a revised draft document and released it for public comment
[https://www.regulations.gov]. Regarding the previous draft document,
notices of a public meeting and comment period were published on
January 21, 2016 [81 FR 342], and February 10, 2016 [81 FR 7124]. A
public meeting was held on March 23, 2016, and members of the public,
stakeholders, and scientific peers were given the opportunity to
provide comments by April 22, 2016. In the interest of completeness and
transparency, NIOSH is making available the public and peer reviewer
comments received on the previous draft document and the NIOSH
responses to those comments at [https://www.regulations.gov]. NIOSH has
carefully considered the review comments on the previous draft in
developing the current draft document. For the current review, NIOSH is
requesting comments on the August 2018 draft NIOSH document only.
This revised draft document provides an updated scientific
literature review of information pertaining to occupational exposure to
silver nanomaterials. This literature review includes studies on the
toxicological effects of exposure to silver nanomaterials in
experimental animal and cellular systems, the effect of particle size
and other properties on the toxicological effects of silver, and NIOSH
recommendations on the measurement and control of occupational
exposures to silver and silver nanomaterials. NIOSH assessed the
potential health risks of occupational exposure to silver nanomaterials
by evaluating the scientific literature. Studies in animals have shown
adverse lung and liver effects associated with exposure to silver
nanoparticles. Based on an assessment of these data, NIOSH developed a
recommended exposure limit (REL) for silver nanomaterials. This new
draft REL applies to processes that produce or use silver
nanomaterials. In addition, NIOSH continues to recommend its existing
REL for total silver (metal dust and soluble compounds, as Ag)
[www.cdc.gov/niosh/npg/npgd0557.html].
NIOSH further recommends the use of workplace exposure assessments,
engineering controls, safe work procedures, training and education, and
established medical surveillance approaches to prevent potential
adverse health effects from exposure to silver nanomaterials. NIOSH
proposes research needs to fill remaining data gaps on the potential
adverse health effects of occupational exposure to silver
nanomaterials.
The purpose of the public review of the draft document is to obtain
comments on whether the proposed NIOSH draft document (1) adequately
and clearly describes the scientific literature on the potential
adverse health effects of silver nanomaterials, and (2) demonstrates
that the NIOSH recommendations on occupational exposure to silver
nanomaterials are consistent with current scientific knowledge.
Purpose of Public Meeting
To discuss and obtain comments on the revised August 2018 draft
NIOSH document, ``Current Intelligence Bulletin: Health Effects of
Occupational Exposure to Silver Nanomaterials''. Special emphasis will
be placed on discussion of the following questions for reviewers:
(1) Does the draft document accurately identify and characterize
the health hazards of exposures to silver and silver nanomaterials
based on the available scientific literature?
(2) Are the risk assessment and dosimetry modeling methods
presented in the draft document consistent with current scientific
knowledge and practice?
(3) Is the relationship between exposure to silver nanomaterials
and biological activity (toxicity) accurately portrayed in the draft
document?
(4) Is the available scientific evidence fully described regarding
the human health relevance of the adverse health endpoints observed in
rats associated with exposure to silver nanomaterials?
(5) Is the proposed recommended exposure limit (REL) well-supported
by the scientific data presented in the document?
(6) Are the sampling and analytical methods proposed for silver
nanomaterials adequate to measure worker exposure?
(7) Are the recommended strategies for controlling exposure to
silver and silver nanomaterials (e.g., engineering controls, work
practices, personal protective equipment) reasonable?
(8) Are the important data gaps and future research needs complete
and clearly described?
Online Public Meeting
The meeting is open to the public, limited only by the number of
logins available. The Adobe Connect license accommodates approximately
500 people. In addition, there will be an audio conference for those
who cannot login through a computer. There is no registration fee to
attend this public online meeting. However, those wishing to attend are
encouraged to register via email to NIOSH Docket Office
[email protected] by October 23, 2018. Registrants will be provided
with the public meeting login information prior to the meeting.
Individuals wishing to speak during the meeting may sign up when
registering. Those who have not signed up to present in advance may be
allowed to present at the meeting if time allows. Persons wanting to
provide oral comments will be permitted up to 20 minutes. If additional
time becomes available, presenters will be notified. Oral comments
given at the meeting may also be submitted to the docket in writing to
assure they are accurately recorded by the Agency.
Priority for attendance will be given to those providing oral
comments. Other requests to attend the meeting will then be
accommodated on a first-come basis. Unreserved attendees will be
admitted as login space allows.
Instructions: All material submitted to the Agency should reference
the agency name and docket number [CDC-2016-0001; NIOSH 260-A]. Each
person making a comment will be asked to give his or her name and
affiliation, and all comments (including their name and affiliation)
will be posted without change to https://www.regulations.gov. All
information received in response to this notice will be available for
public examination and copying at the NIOSH Docket Office, Room 155,
1150 Tusculum Avenue, Cincinnati, Ohio 45226-1998.
Dated: September 12, 2018.
Frank J. Hearl,
Chief of Staff, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2018-20169 Filed 9-17-18; 8:45 am]
BILLING CODE 4163-19-P
