Draft Report on Carcinogens Monograph on Trichloroethylene; Availability of Documents; Request for Comments; Notice of Meeting, 33203-33205 [2014-13481]

Download as PDF Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices electronic applications to: https:// www.grants.gov. Dated: June 4, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–13443 Filed 6–9–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–P–1107] OXIPLEX/SP Gel; FzioMed, Incorporated’s Petition for Review of the Food and Drug Administration’s Denial of Premarket Approval; Notice of Meeting Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The meeting of the Medical Devices Dispute Resolution Panel scheduled for June 10, 2014, is cancelled. This meeting was announced in the Federal Register of May 14, 2014. FOR FURTHER INFORMATION CONTACT: Pamela D. Scott, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3611, Silver Spring, MD 20993–0002, 301– 796–5433, FAX: 301–847–8510, email: pamelad.scott@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The meeting of the Medical Devices Dispute Resolution Panel (the panel) of the Medical Devices Advisory Committee scheduled for June 10, 2014, is cancelled. On June 10, 2014, the panel was slated to discuss the Center for Device and Radiological Health’s (CDRH’s) denial of a premarket approval application (PMA) for OXIPLEX submitted by FzioMed, the sponsor for OXIPLEX. On August 21, 2007, FzioMed submitted a PMA (PMA P070023) for OXIPLEX. OXIPLEX is an absorbable, clear, viscoelastic gel designed to be applied in the lower back during lumbar spine surgery. The device’s proposed indication is for use as a surgical adjuvant in adult patients with primary leg pain and severe baseline back pain undergoing first surgical intervention (i.e., open or endoscopic posterior lumbar laminectomy, laminotomy, or discectomy) for diagnosed unilateral herniation of lumbar intervertebral disc material associated with radiculopathy. The proposed intended use is for onetime use, up to 3 milliliters, after hemostasis during wound closure, as an adjunct to primary surgical intervention emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:55 Jun 09, 2014 Jkt 232001 to improve patient outcomes by reducing leg pain, back pain, and neurologic symptoms. On October 9, 2012, CDRH issued a decision upholding a not approvable letter in response to the PMA P070023 for OXIPLEX. CDRH determined that PMA P070023 is not approvable based on its conclusion that the data and information offered in support of the PMA do not provide a reasonable assurance that the device is safe and effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling, as required by section 515(d)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(2)). On November 5, 2012, FzioMed requested administrative review of CDRH’s decision to uphold its not approvable letter. Submitted in the form of a petition for reconsideration under 21 CFR 10.33 (see § 814.44(f)(2) (21 CFR 814.44(f)(2)), FzioMed’s petition for review (petition) stated that, in accordance with § 814.44(f), FzioMed considered the decision to uphold the not approvable letter to be a denial of approval of PMA P070023 under § 814.45). Under section 515(d)(4) of the FD&C Act, FzioMed requested review of this denial under section 515(g)(2) of the FD&C Act. Accordingly, as required by § 814.45(e)(3), CDRH issued an order denying approval of the PMA for OXIPLEX on October 21, 2013. Under section 515(g)(2) of the FD&C Act, on October 25, 2013, FDA granted FzioMed’s petition for review of the order denying PMA P070023. In the Federal Register of May 14, 2014 (79 FR 27623), the Office of the Commissioner referred PMA P070023 and the basis for the order denying its approval to the Medical Devices Dispute Resolution Panel, and announced that the panel was scheduled to meet to discuss the clinical and scientific issues raised by CDRH’s Denial Order on June 10, 2014. Since the panel meeting announcement on May 14, 2014, the parties have agreed that the panel meeting should not go forward on June 10, 2014. The Agency is thereby cancelling the June 10, 2014, meeting. Dated: June 5, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–13565 Filed 6–6–14; 11:15 am] BILLING CODE 4164–01–P PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 33203 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Draft Report on Carcinogens Monograph on Trichloroethylene; Availability of Documents; Request for Comments; Notice of Meeting The notice announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monograph on Trichloroethylene (TCE). This document was prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peerreview meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at https:// ntp.niehs.nih.gov/go/38853. DATES: Meeting: August 12, 2014, 8:30 a.m. Eastern Daylight Time (EDT) to adjournment. Document Availability: Draft monograph will be available by June 30, 2014, at https:// ntp.niehs.nih.gov/go/38853. Written Public Comments Submissions: Deadline is July 30, 2014. Registration for Meeting, Oral Comments, and/or to View Webcast: Deadline is August 5, 2014. Registration to view the meeting via the webcast is required. 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 URL for viewing the webcast will be provided to those who register. 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: SUMMARY: Background The RoC is a congressionally mandated, science-based, public health report that identifies agents, substances, E:\FR\FM\10JNN1.SGM 10JNN1 33204 Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices 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. Trichloroethylene was selected as a 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 (1) a 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 Monograph on TCE. Trichloroethylene (CASRN 79–01–6) is a halogenated alkene used primarily in the past as a degreaser for metal parts and more currently as an intermediate for hydrofluorocarbon (e.g., refrigerant) production. It is a common drinking water contaminant and has also been found in contaminated air and soil, and is an ingredient in many consumer products (e.g., aerosols or degreasers for hobbies, crafts and home and automobile maintenance). It is currently listed as reasonably anticipated to be a human carcinogen in the 12th RoC. Additional information about the review of TCE for the RoC is available at https://ntp.niehs.nih.gov/go/37899. emcdonald on DSK67QTVN1PROD with NOTICES Meeting and Registration This meeting is open to the public with time set aside for oral public comment. The public may attend the meeting at NIEHS, where attendance is limited only by the space available, or view the webcast. Registration is required to view the webcast; the URL for the webcast will be provided in the email confirming registration. Individuals who plan to provide oral comments (see below) are encouraged to register online at the meeting Web site (https://ntp.niehs.nih.gov/go/38853) by August 5, 2014, to facilitate planning for the meeting. VerDate Mar<15>2010 16:55 Jun 09, 2014 Jkt 232001 The preliminary agenda and draft monograph should be posted on the NTP Web site (https://ntp.niehs.nih.gov/ go/38853) by June 30, 2014. 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. 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. Danica Andrews at phone: (919) 541–2595 or email: andrewsda@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. Request for Comments The NTP invites written and oral public comments on the draft monograph. The deadline for submission of written comments is July 30, 2014, to enable review by the peerreview panel and NTP staff prior to the meeting. Registration to provide oral comments is by August 5, 2014, 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 monograph. 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 adjournment on August 12, 2014, and oral comments will be received only during the formal public comment period indicated on the preliminary agenda. Each organization (sponsoring organization or affiliation) is allowed one time slot. At least 7 minutes will be allotted to each speaker, PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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 August 5, 2014, 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 in-person oral comments will also be available at the meeting, although time allowed for presentation by on-site registrants may be less than that for 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 PeerReview 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 vita 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. E:\FR\FM\10JNN1.SGM 10JNN1 Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices Dated: June 4, 2014. John R. Bucher, Associate Director, National Toxicology Program. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2014–13481 Filed 6–9–14; 8:45 am] National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting National Institutes of Health BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; 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. emcdonald on DSK67QTVN1PROD with NOTICES Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; ‘‘NIAID Investigator Initiated Program Project Applications (P01)’’. Date: July 1, 2014. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3117, 6700B Rockledge Drive, Bethesda, MD 20817, (Telephone Conference Call). Contact Person: Richard W. Morris, Ph.D., Scientific Review Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, 6700–B Rockledge Drive, MSC–7616, Room 3251, Bethesda, MD 20892–7616, 301–451–2663, rmorris@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: June 4, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–13468 Filed 6–9–14; 8:45 am] 16:55 Jun 09, 2014 Name of Committee: National Institute of Arthritis and Musculoskeletal and Skin Diseases Special Emphasis Panel; Mentored Career Development, Institutional Research Training & Pathways to Independence Applications. Date: June 30, 2014. Time: 11:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Democracy Boulevard, Suite 800, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Charles H Washabaugh, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Arthritis, Musculoskeletal and Skin Diseases, NIH, 6701 Democracy Boulevard, Suite 800, Bethesda, MD 20892 (301) 496–9568 washabac@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research, National Institutes of Health, HHS) Dated: June 4, 2014. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–13472 Filed 6–9–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; 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. BILLING CODE 4140–01–P VerDate Mar<15>2010 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. Jkt 232001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 33205 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 Allergy and Infectious Diseases Special Emphasis Panel; Opportunities for Collaborative Research at the NIH Clinical Center (U01). Date: July 9, 2014. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3122, 6700B Rockledge Drive, Bethesda, MD 20817, (Telephone Conference Call). Contact Person: Brenda Lange-Gustafson, Ph.D., Scientific Review Officer, NIAID/NIH/ DHHS, Scientific Review Program, Room 3122, Bethesda, MD 20892–7616, bgustafson@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: June 4, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–13473 Filed 6–9–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 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. E:\FR\FM\10JNN1.SGM 10JNN1

Agencies

[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33203-33205]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13481]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft Report on Carcinogens Monograph on Trichloroethylene; 
Availability of Documents; Request for Comments; Notice of Meeting

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

DATES: 
    Meeting: August 12, 2014, 8:30 a.m. Eastern Daylight Time (EDT) to 
adjournment. Document Availability: Draft monograph will be available 
by June 30, 2014, at https://ntp.niehs.nih.gov/go/38853.
    Written Public Comments Submissions: Deadline is July 30, 2014.
    Registration for Meeting, Oral Comments, and/or to View Webcast: 
Deadline is August 5, 2014. Registration to view the meeting via the 
webcast is required.

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 URL for viewing the webcast will be provided to those 
who register.

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 RoC is a congressionally mandated, science-based, public health 
report that identifies agents, substances,

[[Page 33204]]

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. 
Trichloroethylene was selected as a 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 
(1) a 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 Monograph on 
TCE.
    Trichloroethylene (CASRN 79-01-6) is a halogenated alkene used 
primarily in the past as a degreaser for metal parts and more currently 
as an intermediate for hydrofluorocarbon (e.g., refrigerant) 
production. It is a common drinking water contaminant and has also been 
found in contaminated air and soil, and is an ingredient in many 
consumer products (e.g., aerosols or degreasers for hobbies, crafts and 
home and automobile maintenance). It is currently listed as reasonably 
anticipated to be a human carcinogen in the 12th RoC. Additional 
information about the review of TCE for the RoC is available at  https://ntp.niehs.nih.gov/go/37899.

Meeting and Registration

    This meeting is open to the public with time set aside for oral 
public comment. The public may attend the meeting at NIEHS, where 
attendance is limited only by the space available, or view the webcast. 
Registration is required to view the webcast; the URL for the webcast 
will be provided in the email confirming registration. Individuals who 
plan to provide oral comments (see below) are encouraged to register 
online at the meeting Web site (https://ntp.niehs.nih.gov/go/38853) by 
August 5, 2014, to facilitate planning for the meeting.
    The preliminary agenda and draft monograph should be posted on the 
NTP Web site (https://ntp.niehs.nih.gov/go/38853) by June 30, 2014. 
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.
    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. Danica Andrews at phone: (919) 541-2595 or email: 
andrewsda@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.

Request for Comments

    The NTP invites written and oral public comments on the draft 
monograph. The deadline for submission of written comments is July 30, 
2014, to enable review by the peer-review panel and NTP staff prior to 
the meeting. Registration to provide oral comments is by August 5, 
2014, 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 monograph. 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 adjournment on August 12, 
2014, and oral comments will be received only during the formal public 
comment period indicated on the preliminary agenda. Each organization 
(sponsoring organization or affiliation) is allowed one time slot. 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 August 5, 2014, 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 in-person oral comments will 
also be available at the meeting, although time allowed for 
presentation by on-site registrants may be less than that for 
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 vita 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.


[[Page 33205]]


    Dated: June 4, 2014.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2014-13481 Filed 6-9-14; 8:45 am]
BILLING CODE 4140-01-P
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