82 FR 52066 - Draft Report on Carcinogens Monograph on Antimony Trioxide; Availability of Document; Request for Comments; Notice of Peer-Review Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 216 (November 9, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 216 (November 9, 2017)
| Page Range | 52066-52067 | |
| FR Document | 2017-24400 |
[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)] [Notices] [Pages 52066-52067] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24400] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![52066 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices
Dated: November 6, 2017. Parkway, Suite 200, Durham, NC, USA set aside for oral public comment.
Melanie J. Pantoja, 27713. Phone: (919) 293–1660, Fax: Registration to view the webcast is by
Program Analyst, Office of Federal Advisory (919) 293–1645, Email: canden.byrd@ January 24, 2018, at https://
Committee Policy. icf.com. ntp.niehs.nih.gov/go/38853. Registration
[FR Doc. 2017–24402 Filed 11–8–17; 8:45 am] SUPPLEMENTARY INFORMATION:
is required to view the webcast; the URL
BILLING CODE 4140–01–P Background: The RoC is a for the webcast will be provided in the
congressionally mandated, science- email confirming registration.
based, public health report that Individuals with disabilities who need
DEPARTMENT OF HEALTH AND identifies agents, substances, mixtures, accommodation to view the webcast
HUMAN SERVICES or exposures (collectively called should contact Canden Byrd by phone:
‘‘substances’’) in our environment that (919) 293–1660 or email: canden.byrd@
National Institutes of Health icf.com. TTY users should contact the
pose a cancer hazard for people in the
United States. NTP prepares the RoC on Federal TTY Relay Service at (800) 877–
Draft Report on Carcinogens 8339. Requests should be made at least
Monograph on Antimony Trioxide; behalf of the Secretary of Health and
five business days in advance of the
Availability of Document; Request for Human Services.
NTP follows an established, four-part event.
Comments; Notice of Peer-Review Meeting Materials: The draft
Meeting process for preparing the RoC (https://
monograph and preliminary agenda will
ntp.niehs.nih.gov/pubhealth/roc/
AGENCY: National Institutes of Health, be available on the NTP Web site at
process/index.html). For each substance https://ntp.niehs.nih.gov/go/38853. The
HHS. selected for review, a draft RoC
ACTION: Notice. draft monograph should be available by
monograph is prepared that presents (1) November 30, 2017. Additional
SUMMARY: The National Toxicology information on human exposure to the information will be posted when
Program (NTP) announces a meeting to substance; (2) an assessment of the available or may be requested in
peer review the Draft Report on evidence from cancer studies in humans hardcopy, contact Canden Byrd by
Carcinogens (RoC) Monograph on and experimental animals, mechanisms phone: (919) 293–1660 or email:
Antimony Trioxide. The Office of the of carcinogenicity, and other data canden.byrd@icf.com.
Report on Carcinogens, Division of the relevant for evaluating the substance’s Following the meeting, a report of the
National Toxicology Program (DNTP), potential carcinogenicity; and (3) NTP’s peer review will be prepared and made
National Institute of Environmental preliminary RoC listing available on the NTP Web site.
Health Sciences (NIEHS) prepared the recommendation. The draft monograph Individuals are encouraged to access the
monograph. This peer-review meeting is also contains a draft profile that meeting Web page to stay abreast of the
by webcast only and is open to the provides NTP’s preliminary listing most current information regarding the
public. Registration is requested for oral recommendation for the substance and meeting.
comment and is required to access the a summary of the scientific evidence Request for Comments: NTP invites
webcast. Information about the meeting considered key to reaching that written and oral public comments on
and registration is available at https:// recommendation. the draft monograph. The deadline for
ntp.niehs.nih.gov/go/38853. Antimony trioxide was selected for submission of written comments is
DATES:
review following solicitation of public January 10, 2018, to enable review by
Meeting: January 24, 2018, 8:30 a.m. comment, review by the NTP Board of the peer-review panel and NTP staff
to adjournment at approximately 4:00 Scientific Counselors on December 14– prior to the meeting. Registration to
p.m. Eastern Standard Time (EST). The 15, 2016, and approval by the NTP provide oral comments is on or before
meeting may end sooner or later than Director (https://ntp.niehs.nih.gov/go/ January 10, 2018, at https://
4:00 p.m. EST. 9741). ntp.niehs.nih.gov/go/38853. Written
Document Availability: The draft Antimony trioxide is the most public comments and any other
monograph should be available by commercially significant form of correspondence on the draft monograph
November 30, 2017, at https:// antimony and is a high-production- should be sent to Canden Byrd by email:
ntp.niehs.nih.gov/go/38853. volume chemical with a production canden.byrd@icf.com. Persons
Written Public Comment volume exceeding one million pounds submitting written comments should
Submissions: Deadline is January 10, per year. Its major industrial use is as a include name, affiliation, mailing
2018. synergist with halogenated flame- address, phone, email, and sponsoring
Registration for Oral Comments: retardants in textiles, plastics, and organization (if any). Written comments
Deadline is January 10, 2018. rubber. The main exposures to antimony received in response to this notice will
Registration to View Webcast: trioxide are from inhalation of airborne be posted on the NTP Web site, and the
Deadline is January 24, 2018. solid dust and for workers in facilities submitter will be identified by name,
Registration to view the meeting producing or using antimony trioxide. affiliation, and sponsoring organization
webcast is required. Exposures of the public to antimony (if any). Guidelines for public comments
ADDRESSES: trioxide are primarily from are available at https://
Meeting Location: Webcast. environmental exposures secondary to ntp.niehs.nih.gov/ntp/about_ntp/
Meeting Web page: The draft human activities. Antimony trioxide can guidelines_public_comments_508.pdf.
monograph, preliminary agenda, form in the product life cycle of other Oral public comment at this meeting
registration, and other meeting materials antimony compounds, such as during is welcome, with time set aside on
sradovich on DSK3GMQ082PROD with NOTICES
will be available at https:// the use of automobile brake containing January 24 for the presentation of oral
ntp.niehs.nih.gov/go/38853. antimony trisulfate, which can oxidize remarks on the draft monograph. Public
Webcast: The URL for viewing the into antimony trioxide. The draft RoC comments will be presented by
peer-review meeting webcast will be monograph includes a cancer hazard teleconference line. Fifty (50) lines will
provided to registrants. assessment of antimony trioxide. be available for this call; availability is
FOR FURTHER INFORMATION CONTACT: Meeting and Registration: The on a first-come, first-served basis. The
Canden Byrd, ICF, 2635 Meridian meeting is open to the public with time lines will be open from 8:30 a.m. until
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![Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52067
adjournment at approximately 4:00 p.m. on an NTP panel should provide their National Institutes of Health, 31 Center
EST on January 24, 2018 (meeting may current curriculum vitae to Canden Drive, Room 2A18, Bethesda, Maryland,
end sooner or later than 4:00 p.m. EST). Byrd by email: canden.byrd@icf.com. 20892 or call non-toll-free number (301)
Oral comments will be received only The authority for NTP panels is 496–1877 or Email your request,
during the formal public comment provided by 42 U.S.C. 217a; section 222 including your address to:
periods indicated on the preliminary of the Public Health Service Act, as Jennifer.guimond@nih.gov.
agenda. The access number for the amended. The panel is governed by the SUPPLEMENTARY INFORMATION: This
teleconference line will be provided to Federal Advisory Committee Act, as proposed information collection was
registrants by email prior to the meeting. amended (5 U.S.C. Appendix 2), which previously published in the Federal
Each organization is allowed one time sets forth standards for the formation Register on August 28, 2017, page 40778
slot. At least 7 minutes will be allotted and use of advisory committees. (82 FR 40778) and allowed 60 days for
to each time slot, and if time permits, Dated: November 1, 2017. public comment. No public comments
the allotment may be extended to 10 were received. The purpose of this
John R. Bucher,
minutes at the discretion of the chair. notice is to allow an additional 30 days
Please note: The time per speaker may Associate Director, National Toxicology
Program. for public comment.
be decreased if the number of The Eunice Kennedy Shriver National
commenters exceeds the total time [FR Doc. 2017–24400 Filed 11–8–17; 8:45 am]
Institute of Child Health and Human
allotted for public remarks. If the time BILLING CODE 4140–01–P
Development (NICHD), National
per speaker changes, commenters would Institutes of Health, may not conduct or
be notified after January 10, 2018, the sponsor, and the respondent is not
deadline to register for oral public DEPARTMENT OF HEALTH AND
HUMAN SERVICES required to respond to, an information
comments. collection that has been extended,
Persons wishing to make an oral
National Institutes of Health revised, or implemented on or after
presentation are asked to register online
October 1, 1995, unless it displays a
at https://ntp.niehs.nih.gov/go/38853 by Submission for OMB Review; 30-Day currently valid OMB control number.
January 10, 2018. If possible, oral public Comment Request; Generic Clearance In compliance with section
commenters should send a copy of their for the Collection of Qualitative 3507(a)(1)(D) of the Paperwork
slides and/or statement or talking points Feedback on Agency Service Delivery Reduction Act of 1995, the National
to Canden Byrd by email: canden.byrd@ (Eunice Kennedy Shriver National
icf.com by January 10, 2018. Written Institutes of Health (NIH) has submitted
Institute of Child Health and Human to the Office of Management and Budget
statements may supplement and may Development)
expand the oral presentation. (OMB) a request for review and
Background Information on the RoC: AGENCY: National Institutes of Health, approval of the information collection
Published biennially, each edition of the HHS. listed below.
RoC is cumulative and consists of Proposed Collection: Generic
ACTION: Notice. Clearance for the Collection of
substances newly reviewed in addition
to those listed in previous editions. For SUMMARY: In compliance with the Qualitative Feedback on Agency Service
each listed substance, the RoC contains Paperwork Reduction Act of 1995, the Delivery–0925–0643, Expiration Date
a substance profile, which provides National Institutes of Health (NIH) has 10/31/2014, REINSTATEMENT
information on cancer studies that submitted to the Office of Management WITHOUT CHANGE, Eunice Kennedy
support the listing—including those in and Budget (OMB) a request for review Shriver National Institute of Child
humans and animals and studies on and approval of the information Health and Human Development
possible mechanisms of action, collection listed below. (NICHD), National Institutes of Health
information about potential sources of DATES: Comments regarding this
(NIH).
exposure to humans, and current information collection are best assured Need and Use of Information
Federal regulations to limit exposures. of having their full effect if received Collection: The proposed information
The 14th RoC, the latest edition, was within 30-days of the date of this collection activity provides a means to
published on November 3, 2016 publication. garner qualitative customer and
(available at https://ntp.niehs.nih.gov/ stakeholder feedback in an efficient,
go/roc14). ADDRESSES: Written comments and/or timely manner, in accordance with the
Background Information on NTP Peer- suggestions regarding the item(s) Administration’s commitment to
Review Panels: NTP panels are contained in this notice, especially improving service delivery. By
technical, scientific advisory bodies regarding the estimated public burden qualitative feedback we mean
established on an ‘‘as needed’’ basis to and associated response time, should be information that provides useful
provide independent scientific peer directed to the: Office of Management insights on perceptions and opinions,
review and advise NTP on agents of and Budget, Office of Regulatory Affairs, but are not statistical surveys that yield
public health concern, new/revised OIRA_submission@omb.eop.gov or by quantitative results that can be
toxicological test methods, or other fax to 202–395–6974, Attention: Desk generalized to the population of study.
issues. These panels help ensure Officer for NIH. This feedback will provide information
transparent, unbiased, and scientifically FOR FURTHER INFORMATION CONTACT: To about the NICHD’s customer or
rigorous input to the program for its use request more information on the stakeholder perceptions, experiences
in making credible decisions about proposed project or to obtain a copy of and expectations, provide an early
sradovich on DSK3GMQ082PROD with NOTICES
human hazard, setting research and the data collection plans and warning of issues with service, or focus
testing priorities, and providing instruments, contact: Dr. Jennifer attention on areas where
information to regulatory agencies about Guimond, Project Clearance Liaison, communication, training or changes in
alternative methods for toxicity Office of Science Policy, Reporting, and operations might improve delivery of
screening. NTP welcomes nominations Program Analysis, Eunice Kennedy products or services. These collections
of scientific experts for upcoming Shriver National Institute of Child will allow for ongoing, collaborative and
panels. Scientists interested in serving Health and Human Development, actionable communications between the
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Document Created: 2018-10-25 10:30:16
Document Modified: 2018-10-25 10:30:16
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| Contact | Canden Byrd, ICF, 2635 Meridian Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1660, Fax: (919) 293-1645, Email: [email protected] | |
| FR Citation | 82 FR 52066 |
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