Draft Report on Carcinogens Monographs for ortho-Toluidine and Pentachlorophenol and By-Products of Its Synthesis; Availability of Documents; Request for Comments; Notice of Meeting, 51733-51734 [2013-19928]

Download as PDF Federal Register / Vol. 78, No. 162 / Wednesday, August 21, 2013 / Notices least one candidate orphan drug or device that holds promise for the treatment of a rare disease or condition in order to discuss the processes for putting together an application. In addition, participants in the HUD or orphan drug designation one-on-one sessions are highly encouraged to come prepared with a working draft submission of their particular promising therapy in order to maximize the utility of the one-on-one meetings. Dated: August 16, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–20371 Filed 8–20–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Draft Report on Carcinogens Monographs for ortho-Toluidine and Pentachlorophenol and By-Products of Its Synthesis; Availability of Documents; Request for Comments; Notice of Meeting The notice announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monographs for ortho-Toluidine and Pentachlorophenol and By-products of its Synthesis (hereafter referred to as ‘‘pentachlorophenol’’). These documents were prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). DATES: Meeting: October 7, 2013, 8:30 a.m. to approximately 5:00 p.m. Eastern Daylight Time (EDT) and October 8, 2013, from 8:30 a.m. until adjournment, approximately 11:30 a.m. Document Availability: Draft monographs will be available by August 28, 2013, at https://ntp.niehs.nih.gov/go/ 38853. Public Comments Submissions: Deadline is September 25, 2013. Pre-Registration for Meeting and/or Oral Comments: Deadline is September 30, 2013. ADDRESSES: Meeting Location: Rodbell Auditorium, Rall Building, NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. Agency Meeting Web page: The draft monographs, draft agenda, registration, and other meeting materials will be posted at https://ntp.niehs.nih.gov/go/ 38853. Webcast: The meeting will be available via webcast at https:// mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:29 Aug 20, 2013 Jkt 229001 www.niehs.nih.gov/news/video/ index.cfm. Dr. Lori White, NTP Designated Federal Official, Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box 12233, MD K2–03, Research Triangle Park, NC 27709. Phone: (919) 541–9834, Fax: (301) 480–3272, Email: whiteld@ niehs.nih.gov. Hand Delivery/Courier: 530 Davis Drive, Room 2136, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: Background: The Report on Carcinogens (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. The NTP prepares the RoC on behalf of the Secretary of Health and Human Services. The NTP follows an established, fourpart process for preparation of the RoC (https://ntp.niehs.nih.gov/go/rocprocess). A RoC Monograph is prepared for each candidate substance selected for review for the RoC. Pentachlorophenol and ortho-toluidine were selected as candidate substances following solicitation of public comment, review by the NTP Board of Scientific Counselors on June 21–22, 2012, and approved by the NTP Director (https:// ntp.niehs.nih.gov/go/9741). A draft RoC monograph consists of a (1) cancer evaluation component that reviews all information that may bear on a listing decision, assesses its quality and sufficiency for reaching a listing decision, applies the RoC listing criteria to the relevant scientific information, and recommends a listing status for the candidate substance in the RoC and (2) a substance profile that contains the NTP’s preliminary listing recommendation and a summary of the scientific evidence considered key to reaching that recommendation. This meeting is planned for peer review of the draft RoC Monographs for orthotoluidine and pentachlorophenol. ortho-Toluidine (CASRN 95–53–4) is an arylamine used (directly or as an intermediate) to manufacture herbicides, dyes, pigments, and rubber chemicals. It is currently listed as reasonably anticipated to be a human carcinogen in the 12th RoC. Additional information about the review of orthotoluidine for the RoC is available at https://ntp.niehs.nih.gov/go/37898. Pentachlorophenol (CASRN 87–86–5) is a general biocide that has been used extensively as a fungicide, bactericide, herbicide, and insecticide by agriculture and other industries. In 1987, over-theFOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 51733 counter use was banned and other uses restricted. Currently, pentachlorophenol is defined in the United States as a ‘heavy duty’ wood preservative that is used primarily in the treatment of utility poles and cross arms. The candidate substance is defined as ‘‘pentachlorophenol and by-products of its synthesis.’’ During synthesis of pentachlorophenol, several additional chlorinated molecules are formed as byproducts. In addition, biomonitoring studies have found that people who are exposed to pentachlorophenol or pentachlorophenol-containing products are always exposed to the combination of pentachlorophenol and its byproducts. Additional information about the review of pentachlorophenol for the RoC is available at https:// ntp.niehs.nih.gov/go/37897. Meeting and Registration: The meeting is open to the public with time set aside for oral public comment; attendance at the NIEHS is limited only by the space available. The meeting is scheduled for October 7, 2013, 8:30 a.m. to approximately 5:00 p.m. EDT and October 8, 2013, from 8:30 a.m. until adjournment, approximately 11:30 a.m. Two days are set aside for the meeting; however, it may adjourn sooner if the panel completes its peer review of the draft monographs. Pre-registration to attend the meeting and/or provide oral comments is by September 30, 2013, at https://ntp.niehs.nih.gov/go/38853. Visitor and security information is available at https://www.niehs.nih.gov/ about/visiting/index.cfm. Individuals with disabilities who need accommodation to participate in this event should contact Ms. Robbin Guy at phone: (919) 541–4363 or email: guyr2@ niehs.nih.gov. 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. The preliminary agenda and draft monographs should be posted on the NTP Web site (https://ntp.niehs.nih.gov/ go/38853) by August 28, 2013. Additional information will be posted when available or may be requested in hardcopy, see FOR FURTHER INFORMATION CONTACT. Following the meeting, a report of the peer review will be prepared and made available on the NTP Web site. Registered attendees are encouraged to access the meeting Web page to stay abreast of the most current information regarding the meeting. Request for Comments: The NTP invites written and oral public comments on the draft monographs. The deadline for submission of written comments is September 25, 2013, to enable review by the peer-review panel E:\FR\FM\21AUN1.SGM 21AUN1 mstockstill on DSK4VPTVN1PROD with NOTICES 51734 Federal Register / Vol. 78, No. 162 / Wednesday, August 21, 2013 / Notices and NTP staff prior to the meeting. Preregistration to provide oral comments is by September 30, 2013, at https:// ntp.niehs.nih.gov/go/38853. Public comments and any other correspondence on the draft monographs should be sent to the FOR FURTHER INFORMATION CONTACT. Persons submitting written comments should include their name, affiliation, mailing address, phone, email, and sponsoring organization (if any) with the document. 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/or sponsoring organization. Public comment at this meeting is welcome, with time set aside for the presentation of oral comments on the draft monographs. In addition to inperson oral comments at the meeting at the NIEHS, public comments can be presented by teleconference line. There will be 50 lines for this call; availability will be on a first-come, first-served basis. The lines will be open from 8:30 a.m. until approximately 5:00 p.m. EDT on October 7 and from 8:30 a.m. EDT until adjournment on October 8, and oral comments will be received only during the formal public comment periods indicated on the preliminary agenda. Each organization is allowed one time slot per monograph. At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes at the discretion of the chair. Persons wishing to make an oral presentation are asked to register online at https://ntp.niehs.nih.gov/go/38853 by September 30, 2013, and if possible, to send a copy of their slides and/or statement or talking points at that time. Written statements can supplement and may expand the oral presentation. Registration for oral comments will also be available at the meeting, although time allowed for presentation by on-site registrants may be less than that for preregistered speakers and will be determined by the number of speakers who register on-site. 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. The 12th RoC, the latest edition, was published on June 10, 2011 (available at https://ntp.niehs.nih.gov/go/roc12). The 13th RoC is under development. For each listed substance, the RoC contains a substance profile, which provides information on: Cancer studies that support the listing—including those in humans, animals, and studies on possible mechanisms of action— information about potential sources of VerDate Mar<15>2010 16:29 Aug 20, 2013 Jkt 229001 exposure to humans, and current Federal regulations to limit exposures. 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 the 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. The NTP welcomes nominations of scientific experts for upcoming panels. Scientists interested in serving on an NTP panel should provide a current curriculum vitae to the FOR FURTHER INFORMATION CONTACT. The authority for NTP panels is provided by 42 U.S.C. 217a; section 222 of the Public Health Service (PHS) 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. Emphasis Panel Expedited Review of Biorepository Project. Date: September 12, 2013. Time: 1:00 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: NIEHS/National Institutes of Health, Keystone Building, 530 Davis Drive, Research Triangle Park, NC 27709 (Telephone Conference Call). Contact Person: Sally Eckert-Tilotta, Ph.D., Scientific Review Administrator, Nat. Institute of Environmental Health Sciences, Office of Program Operations, Scientific Review Branch, P.O. Box 12233, Research Triangle Park, NC 27709, (919) 541–1446, eckertt1@niehs.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: August 14, 2013. John R. Bucher, Associate Director, National Toxicology Program. BILLING CODE 4140–01–P Dated: August 15, 2013. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–20343 Filed 8–20–13; 8:45 am] [FR Doc. 2013–19928 Filed 8–20–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Center for Complementary and Alternative Medicine Notice of Meeting National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting 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 would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Environmental Health Sciences Special PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council for Complementary and Alternative Medicine. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting 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 E:\FR\FM\21AUN1.SGM 21AUN1

Agencies

[Federal Register Volume 78, Number 162 (Wednesday, August 21, 2013)]
[Notices]
[Pages 51733-51734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19928]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft Report on Carcinogens Monographs for ortho-Toluidine and 
Pentachlorophenol and By-Products of Its Synthesis; Availability of 
Documents; Request for Comments; Notice of Meeting

SUMMARY: The notice announces a meeting to peer review the Draft Report 
on Carcinogens (RoC) Monographs for ortho-Toluidine and 
Pentachlorophenol and By-products of its Synthesis (hereafter referred 
to as ``pentachlorophenol''). These documents were prepared by the 
Office of the Report on Carcinogens (ORoC), Division of the National 
Toxicology Program (DNTP), National Institute of Environmental Health 
Sciences (NIEHS).

DATES: Meeting: October 7, 2013, 8:30 a.m. to approximately 5:00 p.m. 
Eastern Daylight Time (EDT) and October 8, 2013, from 8:30 a.m. until 
adjournment, approximately 11:30 a.m.
    Document Availability: Draft monographs will be available by August 
28, 2013, at https://ntp.niehs.nih.gov/go/38853.
    Public Comments Submissions: Deadline is September 25, 2013.
    Pre-Registration for Meeting and/or Oral Comments: Deadline is 
September 30, 2013.

ADDRESSES: Meeting Location: Rodbell Auditorium, Rall Building, NIEHS, 
111 T.W. Alexander Drive, Research Triangle Park, NC 27709.
    Agency Meeting Web page: The draft monographs, draft agenda, 
registration, and other meeting materials will be posted at https://ntp.niehs.nih.gov/go/38853.
    Webcast: The meeting will be available via webcast at https://www.niehs.nih.gov/news/video/index.cfm.

FOR FURTHER INFORMATION CONTACT: Dr. Lori White, NTP Designated Federal 
Official, Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box 
12233, MD K2-03, Research Triangle Park, NC 27709. Phone: (919) 541-
9834, Fax: (301) 480-3272, Email: whiteld@niehs.nih.gov. Hand Delivery/
Courier: 530 Davis Drive, Room 2136, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:
    Background: The Report on Carcinogens (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. The NTP prepares the RoC on behalf of the Secretary of Health 
and Human Services.
    The NTP follows an established, four-part process for preparation 
of the RoC (https://ntp.niehs.nih.gov/go/rocprocess). A RoC Monograph is 
prepared for each candidate substance selected for review for the RoC. 
Pentachlorophenol and ortho-toluidine were selected as candidate 
substances following solicitation of public comment, review by the NTP 
Board of Scientific Counselors on June 21-22, 2012, and approved by the 
NTP Director (https://ntp.niehs.nih.gov/go/9741). A draft RoC monograph 
consists of a (1) cancer evaluation component that reviews all 
information that may bear on a listing decision, assesses its quality 
and sufficiency for reaching a listing decision, applies the RoC 
listing criteria to the relevant scientific information, and recommends 
a listing status for the candidate substance in the RoC and (2) a 
substance profile that contains the NTP's preliminary listing 
recommendation and a summary of the scientific evidence considered key 
to reaching that recommendation. This meeting is planned for peer 
review of the draft RoC Monographs for ortho-toluidine and 
pentachlorophenol.
    ortho-Toluidine (CASRN 95-53-4) is an arylamine used (directly or 
as an intermediate) to manufacture herbicides, dyes, pigments, and 
rubber chemicals. It is currently listed as reasonably anticipated to 
be a human carcinogen in the 12th RoC. Additional information about the 
review of ortho-toluidine for the RoC is available at https://ntp.niehs.nih.gov/go/37898.
    Pentachlorophenol (CASRN 87-86-5) is a general biocide that has 
been used extensively as a fungicide, bactericide, herbicide, and 
insecticide by agriculture and other industries. In 1987, over-the-
counter use was banned and other uses restricted. Currently, 
pentachlorophenol is defined in the United States as a `heavy duty' 
wood preservative that is used primarily in the treatment of utility 
poles and cross arms. The candidate substance is defined as 
``pentachlorophenol and by-products of its synthesis.'' During 
synthesis of pentachlorophenol, several additional chlorinated 
molecules are formed as by-products. In addition, biomonitoring studies 
have found that people who are exposed to pentachlorophenol or 
pentachlorophenol-containing products are always exposed to the 
combination of pentachlorophenol and its by-products. Additional 
information about the review of pentachlorophenol for the RoC is 
available at https://ntp.niehs.nih.gov/go/37897.
    Meeting and Registration: The meeting is open to the public with 
time set aside for oral public comment; attendance at the NIEHS is 
limited only by the space available. The meeting is scheduled for 
October 7, 2013, 8:30 a.m. to approximately 5:00 p.m. EDT and October 
8, 2013, from 8:30 a.m. until adjournment, approximately 11:30 a.m. Two 
days are set aside for the meeting; however, it may adjourn sooner if 
the panel completes its peer review of the draft monographs. Pre-
registration to attend the meeting and/or provide oral comments is by 
September 30, 2013, at https://ntp.niehs.nih.gov/go/38853. Visitor and 
security information is available at https://www.niehs.nih.gov/about/visiting/index.cfm. Individuals with disabilities who need 
accommodation to participate in this event should contact Ms. Robbin 
Guy at phone: (919) 541-4363 or email: guyr2@niehs.nih.gov. 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.
    The preliminary agenda and draft monographs should be posted on the 
NTP Web site (https://ntp.niehs.nih.gov/go/38853) by August 28, 2013. 
Additional information will be posted when available or may be 
requested in hardcopy, see FOR FURTHER INFORMATION CONTACT. Following 
the meeting, a report of the peer review will be prepared and made 
available on the NTP Web site. Registered attendees are encouraged to 
access the meeting Web page to stay abreast of the most current 
information regarding the meeting.
    Request for Comments: The NTP invites written and oral public 
comments on the draft monographs. The deadline for submission of 
written comments is September 25, 2013, to enable review by the peer-
review panel

[[Page 51734]]

and NTP staff prior to the meeting. Pre-registration to provide oral 
comments is by September 30, 2013, at https://ntp.niehs.nih.gov/go/38853. Public comments and any other correspondence on the draft 
monographs should be sent to the FOR FURTHER INFORMATION CONTACT. 
Persons submitting written comments should include their name, 
affiliation, mailing address, phone, email, and sponsoring organization 
(if any) with the document. 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/or sponsoring organization.
    Public comment at this meeting is welcome, with time set aside for 
the presentation of oral comments on the draft monographs. In addition 
to in-person oral comments at the meeting at the NIEHS, public comments 
can be presented by teleconference line. There will be 50 lines for 
this call; availability will be on a first-come, first-served basis. 
The lines will be open from 8:30 a.m. until approximately 5:00 p.m. EDT 
on October 7 and from 8:30 a.m. EDT until adjournment on October 8, and 
oral comments will be received only during the formal public comment 
periods indicated on the preliminary agenda. Each organization is 
allowed one time slot per monograph. At least 7 minutes will be 
allotted to each speaker, and if time permits, may be extended to 10 
minutes at the discretion of the chair. Persons wishing to make an oral 
presentation are asked to register online at https://ntp.niehs.nih.gov/go/38853 by September 30, 2013, and if possible, to send a copy of 
their slides and/or statement or talking points at that time. Written 
statements can supplement and may expand the oral presentation. 
Registration for oral comments will also be available at the meeting, 
although time allowed for presentation by on-site registrants may be 
less than that for pre-registered speakers and will be determined by 
the number of speakers who register on-site.
    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. The 12th 
RoC, the latest edition, was published on June 10, 2011 (available at 
https://ntp.niehs.nih.gov/go/roc12). The 13th RoC is under development. 
For each listed substance, the RoC contains a substance profile, which 
provides information on: Cancer studies that support the listing--
including those in humans, animals, and studies on possible mechanisms 
of action--information about potential sources of exposure to humans, 
and current Federal regulations to limit exposures.
    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 the 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. The NTP welcomes 
nominations of scientific experts for upcoming panels. Scientists 
interested in serving on an NTP panel should provide a current 
curriculum vitae to the FOR FURTHER INFORMATION CONTACT. The authority 
for NTP panels is provided by 42 U.S.C. 217a; section 222 of the Public 
Health Service (PHS) 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 14, 2013.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2013-19928 Filed 8-20-13; 8:45 am]
BILLING CODE 4140-01-P
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