Draft Report on Carcinogens Monograph on Night Shift Work and Light at Night; Availability of Document; Request for Comments; Notice of Peer-Review Meeting, 41093-41095 [2018-17782]
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Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices
additional contact information is also
available here and on the OSP website
(www.osp.od.nih.gov). The NIH Director may
rescind the certification of a host-vector
system (see Section IV–C–1–b–(2)–(g), Minor
Actions). If certification is rescinded, NIH
will instruct investigators to transfer cloned
DNA into a different system or use the clones
at a higher level of physical containment
level, unless NIH determines that the already
constructed clones incorporate adequate
biological containment. Certification of a
host-vector system does not extend to
modifications of either the host or vector
component of that system. Such modified
systems shall be independently certified by
the NIH Director. If modifications are minor,
it may only be necessary for the investigator
to submit data showing that the
modifications have either improved or not
impaired the major phenotypic traits on
which the containment of the system
depends. Substantial modifications to a
certified host-vector system requires
submission of complete testing data.
Appendix I–II–B. Data To Be Submitted
for Certification
Appendix I–II–B–1. Host-Vector 1
Systems Other than Escherichia coli
K–12
containment and utility, including
information on yields of phage or plasmid
molecules, ease of DNA isolation, and ease of
transfection or transformation; and (vi) in
some cases, the investigator may be asked to
submit data on survival and vector
transmissibility from experiments in which
the host-vector is fed to laboratory animals or
one or more human subjects. Such in vivo
data may be required to confirm the validity
of predicting in vivo survival on the basis of
in vitro experiments. Data shall be submitted
to the Office of Science Policy, National
Institutes of Health, preferably by email to:
NIHGuidelines@od.nih.gov; additional
contact information is also available here and
on the OSP website (www.osp.od.nih.gov).
Investigators are encouraged to publish their
data on the construction, properties, and
testing of proposed Host Vector 2 systems
prior to consideration of the system by NIH.
Specific instructions concerning the
submission of data for proposed Escherichia
coli K–12 Host-Vector 2 system (EK2)
involving either plasmids or bacteriophage in
Escherichia coli K–12, are available from the
Office of Science Policy, National Institutes
of Health, preferably by submitting a request
for this information to: NIHGuidelines@
od.nih.gov; additional contact information is
also available here and on the OSP website
(www.osp.od.nih.gov).
Appendix L, GENE THERAPY
POLICY CONFERENCES (GTPCS), is
proposed to be deleted in its entirety.
Appendix M, Points to Consider in
the Design and Submission of Protocols
for the Transfer of Recombinant or
Synthetic Nucleic Acid Molecules into
One or More Human Research
Participants (Points to Consider), is
proposed to be deleted in its entirety.
Appendix I–II–B–2. Host-Vector 2
Systems
amozie on DSK3GDR082PROD with NOTICES1
The following types of data shall be
submitted, modified as appropriate for the
particular system under consideration: (i) A
description of the organism and vector; the
strain’s natural habitat and growth
requirements; its physiological properties,
particularly those related to its reproduction,
survival, and the mechanisms by which it
exchanges genetic information; the range of
organisms with which this organism
normally exchanges genetic information and
the type of information is exchanged; and
any relevant information about its
pathogenicity or toxicity; (ii) a description of
the history of the particular strains and
vectors to be used, including data on any
mutations which render this organism less
able to survive or transmit genetic
information; and (iii) a general description of
the range of experiments contemplated with
emphasis on the need for developing such an
Host-Vector 1 system.
National Institutes of Health
Investigators planning to request HostVector 2 systems certification may obtain
instructions from NIH OSP concerning data
to be submitted (see Appendices I–III–N and
O, Footnotes and References of Appendix I).
In general, the following types of data are
required: (i) Description of construction steps
with indication of source, properties, and
manner of introduction of genetic traits; (ii)
quantitative data on the stability of genetic
traits that contribute to the containment of
the system; (iii) data on the survival of the
host-vector system under non-permissive
laboratory conditions designed to represent
the relevant natural environment; (iv) data on
transmissibility of the vector and/or a cloned
DNA fragment under both permissive and
non-permissive conditions; (v) data on all
other properties of the system which affect
Center for Scientific Review; Notice of
Closed Meetings
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Dated: August 7, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
41093
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–17–
144: Limited Competition: National Primate
Research Centers (P51).
Date: September 11–14, 2018.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Vintage Portland, 422 SW
Broadway, Portland, OR 97205.
Contact Person: Brian H. Scott, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Bethesda, MD 20892, 301–
827–7490, brianscott@mail.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Pathophysiological Basis of Mental
Disorders and Addictions Study Section.
Date: September 13–14, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Orlando at SeaWorld,
6677 Sea Harbor Drive, Orlando, FL 32821.
Contact Person: Boris P. Sokolov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892, 301–408–
9115, bsokolov@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: August 13, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–17785 Filed 8–16–18; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2018–17760 Filed 8–16–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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National Institutes of Health
Draft Report on Carcinogens
Monograph on Night Shift Work and
Light at Night; Availability of
Document; Request for Comments;
Notice of Peer-Review Meeting
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Toxicology
Program (NTP) announces a meeting to
peer review the Draft Report on
Carcinogens Monograph on Night Shift
Work and Light at Night. NTP has
conducted a literature-based assessment
to determine whether night shift work
(e.g., working at least three hours
between 12 a.m. and 6 a.m.) and light
at night are cancer hazards and should
SUMMARY:
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41094
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices
be listed the Report on Carcinogens. The
peer-review meeting will be held at the
National Institute of Environmental
Health Sciences (NIEHS) in Research
Triangle Park, NC and is open to the
public. Registration is requested for
attendance at the meeting either inperson or by webcast and to present oral
comments. Information about the
meeting and registration is available at
https://ntp.niehs.nih.gov/go/36051.
DATES:
Meeting: Scheduled for October 5,
2018, 8:30 a.m. to adjournment at
approximately 5:00 p.m. Eastern
Daylight Time (EDT). The preliminary
agenda is available at https://
ntp.niehs.nih.gov/go/36051 and will be
updated one week before the meeting.
Document Availability: The draft RoC
monograph should be available by
August 24, 2018, at https://
ntp.niehs.nih.gov/go/36051.
Written Public Comment
Submissions: Deadline is September 21,
2018.
Registration for Oral Comments:
Deadline is September 21, 2018.
Registration To Attend Meeting InPerson or To View Webcast: Deadline is
October 5, 2018.
ADDRESSES:
Meeting Location: Rodbell
Auditorium, Rall Building, NIEHS, 111
T.W. Alexander Drive, Research
Triangle Park, NC 27709.
Meeting Web Page: The draft RoC
monograph, preliminary agenda,
registration, and other meeting materials
will be available at https://
ntp.niehs.nih.gov/go/36051.
Webcast: The URL for viewing the
peer-review meeting webcast will be
provided to registrants.
FOR FURTHER INFORMATION CONTACT: Kate
Helmick, ICF, 2635 Meridian Parkway,
Suite 200, Durham, NC, USA 27713.
Phone: (919) 293–1673, Fax: (919) 293–
1645, Email: NTP-Meetings@icf.com.
SUPPLEMENTARY INFORMATION:
Background: The invention of electric
light transformed society, from one in
which people’s activities and sleep
patterns were limited by the natural
light: Dark cycle to a culture in which
people now work, sleep, eat, and receive
goods or services throughout the 24hour day. Through lifestyle choices,
home location, and work schedule,
people are exposed to different patterns
and types of light, including electric
light at night (LAN), which may lead to
cancer and other adverse health effects.
These health effects may arise from
misalignment of daily physiological and
behavioral cycles (i.e., circadian
rhythms) with external stimuli or with
each other (i.e., circadian disruption).
VerDate Sep<11>2014
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Circadian rhythms can include
processes and behaviors like sleep-wake
cycles, eating, and body temperature,
among others.
NTP has conducted a literature-based
assessment and applied the Report on
Carcinogens (RoC) listing criteria to this
assessment to determine whether night
shift work (e.g., working at least three
hours between midnight and 6 a.m.) and
light at night are cancer hazards. As
circadian disruption is thought to be a
key intermediate step, NTP has also
reviewed the literature on this topic.
The monograph assesses the evidence
from cancer studies in humans and
experimental animals and mechanistic
data and provides NTP’s preliminary
recommendation regarding whether
night shift work and or light at night
should be listed in the Report on
Carcinogens, and if so, how the two
exposure scenarios should be defined.
The listing categories include known or
reasonably anticipated to be a human
carcinogen.
Meeting Attendance Registration: The
meeting is open to the public with time
set aside for oral public comment; inperson attendance at the NIEHS is
limited by the space available (∼100
attendees). Registration for in-person
attendance is on a first-come, firstserved basis. After the first 100
registrants, persons will be placed on a
wait list and notified should an opening
become available. Registration to attend
the meeting in-person or view the
webcast is by October 5, 2018, at https://
ntp.niehs.nih.gov/go/36051. The URL
for the webcast will be provided in the
email confirming registration. Visitor
and security information for those
attending in person is available at
https://www.niehs.nih.gov/about/
visiting/index.cfm. Individuals with
disabilities who need accommodation to
view the webcast should contact Kate
Helmick by phone: (919) 293–1673 or
email: NTP-Meetings@icf.com. TTY
users should contact the Federal TTY
Relay Service at (800) 877–8339.
Requests should be made at least five
business days in advance of the event.
Public Comment Registration: NTP
invites written and oral public
comments on the draft RoC monograph
that address scientific/technical issues.
Guidelines for public comments are
available at https://ntp.niehs.nih.gov/
ntp/about_ntp/guidelines_public_
comments_508.pdf.
The deadline for submission of
written comments is September 21,
2018. Written public comments should
be submitted through the meeting
website. Persons submitting written
comments should include name,
affiliation, mailing address, phone,
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email, and sponsoring organization (if
any). Written comments received in
response to this notice will be posted on
the NTP website and the submitter will
be identified by name, affiliation, and
sponsoring organization (if any).
Comments that address scientific/
technical issues will be forwarded to the
peer-review panel and NTP staff prior to
the meeting.
The agenda allows for one oral public
comment period (up to 12 commenters,
up to 5 min per speaker). Registration to
provide oral comments is September 21,
2018, at https://ntp.niehs.nih.gov/go/
36051. Registration is on a first-come,
first-served basis. Each organization is
allowed one time slot. Oral comments
may be presented in person at NIEHS or
by teleconference line. The access
number for the teleconference line will
be provided to registrants by email prior
to the meeting. Commenters will be
notified after September 21, 2018, the
deadline to register for oral public
comments, about the actual time
allotted per speaker.
If possible, oral public commenters
should send a copy of their slides and/
or statement or talking points to Kate
Helmick by email: NTP-Meetings@
icf.com by September 21, 2018.
Meeting Materials: The draft RoC
monograph and preliminary agenda will
be available on the NTP website at
https://ntp.niehs.nih.gov/go/36051. The
draft RoC monograph should be
available by August 24, 2018.
Additional information will be posted
when available or may be requested in
hardcopy, contact Kate Helmick by
phone: (919) 293–1673 or email: NTPMeetings@icf.com. The preliminary
meeting agenda will be available on the
meeting web page and will be updated
one week before the meeting.
Individuals are encouraged to access the
meeting web page to stay abreast of the
most current information regarding the
meeting.
Following the meeting, a report of the
peer review will be prepared and made
available on the NTP website.
Background Information on the RoC:
Published biennially, each edition of the
RoC is cumulative and consists of
substances newly reviewed in addition
to those listed in previous editions. For
each listed substance, the RoC contains
a substance profile, which provides
information on cancer studies that
support the listing—including those in
humans and animals and studies on
possible mechanisms of action,
information about potential sources of
exposure to humans, and current
Federal regulations to limit exposures.
The 14th RoC, the latest edition, was
published on November 3, 2016
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(available at https://ntp.niehs.nih.gov/
go/roc14).
Background Information on NTP PeerReview Panels: NTP panels are
technical, scientific advisory bodies
established on an ‘‘as needed’’ basis to
provide independent scientific peer
review and advise NTP on agents of
public health concern, new/revised
toxicological test methods, or other
issues. These panels help ensure
transparent, unbiased, and scientifically
rigorous input to the program for its use
in making credible decisions about
human hazard, setting research and
testing priorities, and providing
information to regulatory agencies about
alternative methods for toxicity
screening. NTP welcomes nominations
of scientific experts for upcoming
panels. Scientists interested in serving
on an NTP panel should provide their
current curriculum vitae to Kate
Helmick by email: NTP-Meetings@
icf.com. The authority for NTP panels is
provided by 42 U.S.C. 217a; section 222
of the Public Health Service Act, as
amended. The panel is governed by the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), which
sets forth standards for the formation
and use of advisory committees.
Dated: August 8, 2018.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2018–17782 Filed 8–16–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2018–0565]
Lifejacket Approval Harmonization
Coast Guard, DHS.
Notice and request for
comments.
AGENCY:
ACTION:
The Coast Guard announces
that it is harmonizing personal flotation
device (PFD) standards between the
United States and Canada by accepting
a new standard for approval of PFDs.
Specific elements of the new standard
are contained in a policy letter and
deregulatory savings analysis, on which
we are requesting public comment, and
are intended to promote the Coast
Guard’s maritime safety and
stewardship missions.
DATES: Comments must be submitted to
the online docket via https://
www.regulations.gov, or reach the
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SUMMARY:
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Docket Management Facility, on or
before October 16, 2018.
ADDRESSES: You may submit comments
identified by docket number USCG–
2018–0565 using the Federal
eRulemaking Portal at https://
www.regulations.gov. See the ‘‘Public
Participation and Comments’’ portion of
the SUPPLEMENTARY INFORMATION section
for further instructions on submitting
comments.
For
information about this document call or
email Jacqueline Yurkovich, Coast
Guard; telephone 202–372–1389, email
Jacqueline.M.Yurkovich@uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Public Participation and Comments
We encourage you to submit
comments on the lifejacket approval
harmonization policy letter entitled,
ADOPTION OF ANSI/CAN/UL 12402–5
AND –9, and the deregulatory savings
analysis entitled, ‘‘Approval for
Personal Floatation Devices/Adoption of
ANSI/CAN/UL 12402–5 and 9,’’ which
are available in the docket. The policy
letter is also available on the USCG
website, https://www.dco.uscg.mil/CGENG, listed as CG–ENG Policy 02–18.
We will consider all submissions and
may adjust our final action based on
your comments. If you submit a
comment, please include the docket
number for this notice, indicate the
specific section of the document to
which each comment applies, and
provide a reason for each suggestion or
recommendation.
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions. Documents
mentioned in this notice, and all public
comments, are in our online docket at
https://www.regulations.gov and can be
viewed by following that website’s
instructions. Additionally, if you go to
the online docket and sign up for email
alerts, you will be notified when
comments or other documents are
posted.
We accept anonymous comments. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided. For more about privacy and
the docket, you may review a Privacy
Act notice regarding the Federal Docket
Management System in the March 24,
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41095
2005, issue of the Federal Register (70
FR 15086).
Discussion
The United States Coast Guard
(USCG) has statutory authority under
Title 46, U.S. Code, Sections 3306(a)
and (b), 4102(a) and (b), 4302(a), and
4502(a) and (c)(2)(B) to prescribe
regulations for the design, construction,
performance, testing, carriage, use, and
inspection of lifesaving equipment on
commercial and recreational vessels.
Since 2008, the USCG has been working
closely with Transport Canada (TC) and
a diverse group of U.S. and Canadian
stakeholders to harmonize PFD
standards with the current international
standard (ISO 12402) to create a single
North American standard for PFD
approval. A single North American
standard will allow manufacturers the
opportunity to produce more innovative
equipment that meets the approval
requirements of both the United States
and Canada.
In 2015, Underwriters Laboratories
Inc. published bi-national standards 1 to
set forth performance requirements and
manufacturing standards for PFDs that
are being used when vessels are close to
shore, or where a rescue may be
imminent. UL 12402–5 sets forth the
performance requirements for PFDs and,
within UL 12402–5, there are two levels
of performance: Level 50 and Level 70.
A Level 70 PFD provides an equivalent
level of safety to a Type III PFD
currently approved under 46 CFR
160.064, 160.076, or 160.077–15, and
certified to UL 1123 (Marine Buoyant
Devices). A Level 50 PFD provides a
reduced level of performance, and is not
included in this policy. UL 12402–9 sets
forth the test methods for determining
compliance with UL 12402–5.
In April 2017, the USCG and TC
signed a Memorandum of
Understanding (MOU) outlining
intended cooperation for approval of
personal lifesaving appliances that
comply with mutually acceptable
standards, are tested by mutually
accepted conformity assessment bodies
or independent test laboratories, and are
covered by a mutually acceptable
follow-up program. In January 2018, TC
published a policy stating it will accept
UL 12402–5 as a substitute for its PFD
standards in support of the MOU. The
policy letter on which we are requesting
comment builds on the efforts described
above by establishing that the USCG
will accept Level 70 PFDs complying
1 ANSI/CAN/UL 12402–5, Standard for Personal
Flotation Devices—Part 5: Buoyancy Aids (Level
50)—Safety Requirements (UL 12402–5), and ANSI/
CAN/UL 12402–9, Standard for Personal Flotation
Devices—Part 9: Test Methods (UL12402–9).
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]]>Agencies
[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Pages 41093-41095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17782]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Draft Report on Carcinogens Monograph on Night Shift Work and
Light at Night; Availability of Document; Request for Comments; Notice
of Peer-Review Meeting
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Toxicology Program (NTP) announces a meeting to
peer review the Draft Report on Carcinogens Monograph on Night Shift
Work and Light at Night. NTP has conducted a literature-based
assessment to determine whether night shift work (e.g., working at
least three hours between 12 a.m. and 6 a.m.) and light at night are
cancer hazards and should
[[Page 41094]]
be listed the Report on Carcinogens. The peer-review meeting will be
held at the National Institute of Environmental Health Sciences (NIEHS)
in Research Triangle Park, NC and is open to the public. Registration
is requested for attendance at the meeting either in-person or by
webcast and to present oral comments. Information about the meeting and
registration is available at https://ntp.niehs.nih.gov/go/36051.
DATES:
Meeting: Scheduled for October 5, 2018, 8:30 a.m. to adjournment at
approximately 5:00 p.m. Eastern Daylight Time (EDT). The preliminary
agenda is available at https://ntp.niehs.nih.gov/go/36051 and will be
updated one week before the meeting.
Document Availability: The draft RoC monograph should be available
by August 24, 2018, at https://ntp.niehs.nih.gov/go/36051.
Written Public Comment Submissions: Deadline is September 21, 2018.
Registration for Oral Comments: Deadline is September 21, 2018.
Registration To Attend Meeting In-Person or To View Webcast:
Deadline is October 5, 2018.
ADDRESSES:
Meeting Location: Rodbell Auditorium, Rall Building, NIEHS, 111
T.W. Alexander Drive, Research Triangle Park, NC 27709.
Meeting Web Page: The draft RoC monograph, preliminary agenda,
registration, and other meeting materials will be available at https://ntp.niehs.nih.gov/go/36051.
Webcast: The URL for viewing the peer-review meeting webcast will
be provided to registrants.
FOR FURTHER INFORMATION CONTACT: Kate Helmick, ICF, 2635 Meridian
Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1673, Fax:
(919) 293-1645, Email: [email protected].
SUPPLEMENTARY INFORMATION:
Background: The invention of electric light transformed society,
from one in which people's activities and sleep patterns were limited
by the natural light: Dark cycle to a culture in which people now work,
sleep, eat, and receive goods or services throughout the 24-hour day.
Through lifestyle choices, home location, and work schedule, people are
exposed to different patterns and types of light, including electric
light at night (LAN), which may lead to cancer and other adverse health
effects. These health effects may arise from misalignment of daily
physiological and behavioral cycles (i.e., circadian rhythms) with
external stimuli or with each other (i.e., circadian disruption).
Circadian rhythms can include processes and behaviors like sleep-wake
cycles, eating, and body temperature, among others.
NTP has conducted a literature-based assessment and applied the
Report on Carcinogens (RoC) listing criteria to this assessment to
determine whether night shift work (e.g., working at least three hours
between midnight and 6 a.m.) and light at night are cancer hazards. As
circadian disruption is thought to be a key intermediate step, NTP has
also reviewed the literature on this topic.
The monograph assesses the evidence from cancer studies in humans
and experimental animals and mechanistic data and provides NTP's
preliminary recommendation regarding whether night shift work and or
light at night should be listed in the Report on Carcinogens, and if
so, how the two exposure scenarios should be defined. The listing
categories include known or reasonably anticipated to be a human
carcinogen.
Meeting Attendance Registration: The meeting is open to the public
with time set aside for oral public comment; in-person attendance at
the NIEHS is limited by the space available (~100 attendees).
Registration for in-person attendance is on a first-come, first-served
basis. After the first 100 registrants, persons will be placed on a
wait list and notified should an opening become available. Registration
to attend the meeting in-person or view the webcast is by October 5,
2018, at https://ntp.niehs.nih.gov/go/36051. The URL for the webcast
will be provided in the email confirming registration. Visitor and
security information for those attending in person is available at
https://www.niehs.nih.gov/about/visiting/index.cfm. Individuals with
disabilities who need accommodation to view the webcast should contact
Kate Helmick by phone: (919) 293-1673 or email: [email protected].
TTY users should contact the Federal TTY Relay Service at (800) 877-
8339. Requests should be made at least five business days in advance of
the event.
Public Comment Registration: NTP invites written and oral public
comments on the draft RoC monograph that address scientific/technical
issues. Guidelines for public comments are available at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
The deadline for submission of written comments is September 21,
2018. Written public comments should be submitted through the meeting
website. Persons submitting written comments should include name,
affiliation, mailing address, phone, email, and sponsoring organization
(if any). Written comments received in response to this notice will be
posted on the NTP website and the submitter will be identified by name,
affiliation, and sponsoring organization (if any). Comments that
address scientific/technical issues will be forwarded to the peer-
review panel and NTP staff prior to the meeting.
The agenda allows for one oral public comment period (up to 12
commenters, up to 5 min per speaker). Registration to provide oral
comments is September 21, 2018, at https://ntp.niehs.nih.gov/go/36051.
Registration is on a first-come, first-served basis. Each organization
is allowed one time slot. Oral comments may be presented in person at
NIEHS or by teleconference line. The access number for the
teleconference line will be provided to registrants by email prior to
the meeting. Commenters will be notified after September 21, 2018, the
deadline to register for oral public comments, about the actual time
allotted per speaker.
If possible, oral public commenters should send a copy of their
slides and/or statement or talking points to Kate Helmick by email:
[email protected] by September 21, 2018.
Meeting Materials: The draft RoC monograph and preliminary agenda
will be available on the NTP website at https://ntp.niehs.nih.gov/go/36051. The draft RoC monograph should be available by August 24, 2018.
Additional information will be posted when available or may be
requested in hardcopy, contact Kate Helmick by phone: (919) 293-1673 or
email: [email protected]. The preliminary meeting agenda will be
available on the meeting web page and will be updated one week before
the meeting. Individuals are encouraged to access the meeting web page
to stay abreast of the most current information regarding the meeting.
Following the meeting, a report of the peer review will be prepared
and made available on the NTP website.
Background Information on the RoC: Published biennially, each
edition of the RoC is cumulative and consists of substances newly
reviewed in addition to those listed in previous editions. For each
listed substance, the RoC contains a substance profile, which provides
information on cancer studies that support the listing--including those
in humans and animals and studies on possible mechanisms of action,
information about potential sources of exposure to humans, and current
Federal regulations to limit exposures. The 14th RoC, the latest
edition, was published on November 3, 2016
[[Page 41095]]
(available at https://ntp.niehs.nih.gov/go/roc14).
Background Information on NTP Peer-Review Panels: NTP panels are
technical, scientific advisory bodies established on an ``as needed''
basis to provide independent scientific peer review and advise NTP on
agents of public health concern, new/revised toxicological test
methods, or other issues. These panels help ensure transparent,
unbiased, and scientifically rigorous input to the program for its use
in making credible decisions about human hazard, setting research and
testing priorities, and providing information to regulatory agencies
about alternative methods for toxicity screening. NTP welcomes
nominations of scientific experts for upcoming panels. Scientists
interested in serving on an NTP panel should provide their current
curriculum vitae to Kate Helmick by email: [email protected]. The
authority for NTP panels is provided by 42 U.S.C. 217a; section 222 of
the Public Health Service Act, as amended. The panel is governed by the
Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which
sets forth standards for the formation and use of advisory committees.
Dated: August 8, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-17782 Filed 8-16-18; 8:45 am]
BILLING CODE 4140-01-P
