[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