Draft Report on Carcinogens Monograph on Antimony Trioxide; Availability of Document; Request for Comments; Notice of Peer-Review Meeting, 52066-52067 [2017-24400]

Download as PDF 52066 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices Dated: November 6, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293–1660, Fax: (919) 293–1645, Email: canden.byrd@ icf.com. [FR Doc. 2017–24402 Filed 11–8–17; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4140–01–P Background: The RoC is a congressionally mandated, sciencebased, 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/). 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-productionvolume chemical with a production volume exceeding one million pounds per year. Its major industrial use is as a synergist with halogenated flameretardants 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 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. 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 sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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: canden.byrd@ 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. 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: canden.byrd@icf.com. 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: canden.byrd@icf.com. 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 E:\FR\FM\09NON1.SGM 09NON1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 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: canden.byrd@ icf.com 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 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 VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 on an NTP panel should provide their current curriculum vitae to Canden Byrd by email: canden.byrd@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: 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (Eunice Kennedy Shriver National Institute of Child Health and Human Development) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. SUMMARY: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Jennifer Guimond, Project Clearance Liaison, Office of Science Policy, Reporting, and Program Analysis, Eunice Kennedy Shriver National Institute of Child Health and Human Development, ADDRESSES: PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 52067 National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland, 20892 or call non-toll-free number (301) 496–1877 or Email your request, including your address to: Jennifer.guimond@nih.gov. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on August 28, 2017, page 40778 (82 FR 40778) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery–0925–0643, Expiration Date 10/31/2014, REINSTATEMENT WITHOUT CHANGE, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: The proposed information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration’s commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide information about the NICHD’s customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the E:\FR\FM\09NON1.SGM 09NON1

Agencies

[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]


-----------------------------------------------------------------------

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: canden.byrd@icf.com.

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/). 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: canden.byrd@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.
    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: canden.byrd@icf.com.
    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: canden.byrd@icf.com. 
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: 
canden.byrd@icf.com 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: canden.byrd@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: 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
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