[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52066-52067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24400]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft Report on Carcinogens Monograph on Antimony Trioxide; 
Availability of Document; Request for Comments; Notice of Peer-Review 
Meeting

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Toxicology Program (NTP) announces a meeting to 
peer review the Draft Report on Carcinogens (RoC) Monograph on Antimony 
Trioxide. The Office of the Report on Carcinogens, Division of the 
National Toxicology Program (DNTP), National Institute of Environmental 
Health Sciences (NIEHS) prepared the monograph. This peer-review 
meeting is by webcast only and is open to the public. Registration is 
requested for oral comment and is required to access the webcast. 
Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/38853.

DATES: 
    Meeting: January 24, 2018, 8:30 a.m. to adjournment at 
approximately 4:00 p.m. Eastern Standard Time (EST). The meeting may 
end sooner or later than 4:00 p.m. EST.
    Document Availability: The draft monograph should be available by 
November 30, 2017, at https://ntp.niehs.nih.gov/go/38853.
    Written Public Comment Submissions: Deadline is January 10, 2018.
    Registration for Oral Comments: Deadline is January 10, 2018.
    Registration to View Webcast: Deadline is January 24, 2018. 
Registration to view the meeting webcast is required.

ADDRESSES: 
    Meeting Location: Webcast.
    Meeting Web page: The draft monograph, preliminary agenda, 
registration, and other meeting materials will be available at https://ntp.niehs.nih.gov/go/38853.
    Webcast: The URL for viewing the peer-review meeting webcast will 
be provided to registrants.

FOR FURTHER INFORMATION CONTACT: Canden Byrd, ICF, 2635 Meridian 
Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1660, Fax: 
(919) 293-1645, Email: [email protected].

SUPPLEMENTARY INFORMATION: 
    Background: The RoC is a congressionally mandated, science-based, 
public health report that identifies agents, substances, mixtures, or 
exposures (collectively called ``substances'') in our environment that 
pose a cancer hazard for people in the United States. NTP prepares the 
RoC on behalf of the Secretary of Health and Human Services.
    NTP follows an established, four-part process for preparing the RoC 
(https://ntp.niehs.nih.gov/pubhealth/roc/process/index.html). For each 
substance selected for review, a draft RoC monograph is prepared that 
presents (1) information on human exposure to the substance; (2) an 
assessment of the evidence from cancer studies in humans and 
experimental animals, mechanisms of carcinogenicity, and other data 
relevant for evaluating the substance's potential carcinogenicity; and 
(3) NTP's preliminary RoC listing recommendation. The draft monograph 
also contains a draft profile that provides NTP's preliminary listing 
recommendation for the substance and a summary of the scientific 
evidence considered key to reaching that recommendation.
    Antimony trioxide was selected for review following solicitation of 
public comment, review by the NTP Board of Scientific Counselors on 
December 14-15, 2016, and approval by the NTP Director (https://ntp.niehs.nih.gov/go/9741).
    Antimony trioxide is the most commercially significant form of 
antimony and is a high-production-volume chemical with a production 
volume exceeding one million pounds per year. Its major industrial use 
is as a synergist with halogenated flame-retardants in textiles, 
plastics, and rubber. The main exposures to antimony trioxide are from 
inhalation of airborne solid dust and for workers in facilities 
producing or using antimony trioxide. Exposures of the public to 
antimony trioxide are primarily from environmental exposures secondary 
to human activities. Antimony trioxide can form in the product life 
cycle of other antimony compounds, such as during the use of automobile 
brake containing antimony trisulfate, which can oxidize into antimony 
trioxide. The draft RoC monograph includes a cancer hazard assessment 
of antimony trioxide.
    Meeting and Registration: The meeting is open to the public with 
time set aside for oral public comment. Registration to view the 
webcast is by January 24, 2018, at https://ntp.niehs.nih.gov/go/38853. 
Registration is required to view the webcast; the URL for the webcast 
will be provided in the email confirming registration. Individuals with 
disabilities who need accommodation to view the webcast should contact 
Canden Byrd by phone: (919) 293-1660 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.
    Meeting Materials: The draft monograph and preliminary agenda will 
be available on the NTP Web site at https://ntp.niehs.nih.gov/go/38853. 
The draft monograph should be available by November 30, 2017. 
Additional information will be posted when available or may be 
requested in hardcopy, contact Canden Byrd by phone: (919) 293-1660 or 
email: [email protected].
    Following the meeting, a report of the peer review will be prepared 
and made available on the NTP Web site. Individuals are encouraged to 
access the meeting Web page to stay abreast of the most current 
information regarding the meeting.
    Request for Comments: NTP invites written and oral public comments 
on the draft monograph. The deadline for submission of written comments 
is January 10, 2018, to enable review by the peer-review panel and NTP 
staff prior to the meeting. Registration to provide oral comments is on 
or before January 10, 2018, at https://ntp.niehs.nih.gov/go/38853. 
Written public comments and any other correspondence on the draft 
monograph should be sent to Canden Byrd by email: [email protected]. 
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 Web site, and the submitter will be identified by name, 
affiliation, and sponsoring organization (if any). Guidelines for 
public comments are available at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
    Oral public comment at this meeting is welcome, with time set aside 
on January 24 for the presentation of oral remarks on the draft 
monograph. Public comments will be presented by teleconference line. 
Fifty (50) lines will be available for this call; availability is on a 
first-come, first-served basis. The lines will be open from 8:30 a.m. 
until

[[Page 52067]]

adjournment at approximately 4:00 p.m. EST on January 24, 2018 (meeting 
may end sooner or later than 4:00 p.m. EST). Oral comments will be 
received only during the formal public comment periods indicated on the 
preliminary agenda. The access number for the teleconference line will 
be provided to registrants by email prior to the meeting. Each 
organization is allowed one time slot. At least 7 minutes will be 
allotted to each time slot, and if time permits, the allotment may be 
extended to 10 minutes at the discretion of the chair. Please note: The 
time per speaker may be decreased if the number of commenters exceeds 
the total time allotted for public remarks. If the time per speaker 
changes, commenters would be notified after January 10, 2018, the 
deadline to register for oral public comments.
    Persons wishing to make an oral presentation are asked to register 
online at https://ntp.niehs.nih.gov/go/38853 by January 10, 2018. If 
possible, oral public commenters should send a copy of their slides 
and/or statement or talking points to Canden Byrd by email: 
[email protected] by January 10, 2018. Written statements may 
supplement and may expand the oral presentation.
    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 (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 Canden Byrd 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: November 1, 2017.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2017-24400 Filed 11-8-17; 8:45 am]
 BILLING CODE 4140-01-P