Draft Report on Carcinogens Monographs on Five Viruses; Availability of Documents; Request for Comments; Notice of Peer-Review Meeting, 61832-61833 [2015-26050]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES 61832 Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices the formal public comment periods, which are indicated on the preliminary agenda. Each organization (sponsoring organization or affiliation) is allowed one time slot per agenda topic. Each speaker is allotted at least 7 minutes, which if time permits, may be extended to 10 minutes at the discretion of the BSC chair. Persons wishing to present oral comments should register on the BSC meeting Web site by November 24, 2015, indicate whether they will present comments in-person or via the teleconference line, and identify the topic(s) on which they plan to comment. The access number for the teleconference line will be provided to registrants by email prior to the meeting. On-site registration for oral comments will also be available on the meeting day, although time allowed for comments by these registrants may be limited and will be determined by the number of persons who register at the meeting. Persons registering to make oral comments are asked to send a copy of their statement and/or PowerPoint slides to the Designated Federal Officer by November 24, 2015. Written statements can supplement and may expand upon the oral presentation. If registering on-site and reading from written text, please bring 20 copies of the statement for distribution to the BSC and NTP staff and to supplement the record. Background Information on the BSC: The BSC is a technical advisory body comprised of scientists from the public and private sectors that provides primary scientific oversight to the NTP. Specifically, the BSC advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and their overall scientific quality. Its members are selected from recognized authorities knowledgeable in fields such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral toxicology, neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. Members serve overlapping terms of up to four years. The BSC usually meets biannually. The authority for the BSC is provided by 42 U.S.C. 217a, section 222 of the Public Health Service Act (PHS), as amended. The BSC is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. app.), which sets forth standards for the formation and use of advisory committees. VerDate Sep<11>2014 16:39 Oct 13, 2015 Jkt 238001 Dated: October 8, 2015. John R. Bucher, Associate Director, NTP. [FR Doc. 2015–26051 Filed 10–13–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Draft Report on Carcinogens Monographs on Five Viruses; Availability of Documents; Request for Comments; Notice of Peer-Review Meeting The notice announces a meeting to peer review Draft Report on Carcinogens (RoC) Monographs on Five Viruses: Epstein-Barr virus [EBV], human immunodeficiency virus type 1 [HIV–1], human T-cell lymphotropic virus type 1 [HTLV–1], Kaposi sarcomaassociated herpesvirus [KSHV], and Merkel cell polyomavirus [MCV]. The monographs 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). 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 is available at https:// ntp.niehs.nih.gov/go/38853. DATES: Meeting: December 17, 2015, 8:30 a.m. Eastern Standard Time (EST) to adjournment. Document Availability: Draft monographs should be available by the week of November 2, 2015, at https:// ntp.niehs.nih.gov/go/38853. Written Public Comments Submissions: Deadline is December 3, 2015. Registration for Attendance and/or Oral Comments: Deadline is December 10, 2015. 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 site: 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: SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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. Email: whiteld@ niehs.nih.gov. Hand Delivery/Courier: 530 Davis Drive, Room 2124, Morrisville, NC 27560. 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. 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. A draft RoC monograph consists of (1) a cancer hazard 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. Five viruses, EBV, HIV–1, HTLV–1, KSHV, and MCV, were selected as candidate substances following solicitation of public comment, review by the NTP Board of Scientific Counselors on April 16–18, 2014, and approval by the NTP Director (https:// ntp.niehs.nih.gov/go/9741). A RoC monograph was prepared for each virus and this meeting is planned for peer review of the five draft RoC monographs. Approximately 10% of cancers in the United States and 17.8% worldwide are linked to infectious disease. Several viruses, including hepatitis B virus, hepatitis C virus, and some human papilloma viruses of the genital-mucosal type, are currently listed in the RoC as known to be human carcinogens. NTP is conducting an evaluation of the following five viruses for possible listing in the RoC: EBV and KSHV, which are herpesviruses; MCV, which is a recently discovered polyomavirus; and HIV–1 and HTLV–1, which are retroviruses. HIV and HTLV–1 infection occurs from sexual, parenteral, and E:\FR\FM\14OCN1.SGM 14OCN1 Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices perinatal transmission, whereas transmission via saliva is a common route of exposure for KSHV and EBV. Although MCV is found in the skin and saliva, it is not clear how people are infected. Additional information about the evaluation of these viruses for the RoC is available at https:// ntp.niehs.nih.gov/go/733995. tkelley on DSK3SPTVN1PROD 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 December 10, 2015, to facilitate planning for the meeting. The preliminary agenda and draft monographs should be posted on the NTP Web site (https://ntp.niehs.nih.gov/ go/38853) by the week of November 2, 2015. 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. Interested individuals are encouraged to access the meeting Web site 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. 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. Request for Comments The NTP invites written and oral public comments on the draft monographs. The deadline for submission of written comments is December 3, 2015, to enable review by the peer-review panel and NTP staff prior to the meeting. Registration to provide oral comments is by December 10, 2015, 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 (if VerDate Sep<11>2014 16:39 Oct 13, 2015 Jkt 238001 61833 applicable), phone, email, and sponsoring organization (if any) with the document. Written comments received in response to this notice will be posted on the meeting Web site, and the submitter 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 adjournment on December 17, 2015; 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 December 10, 2015, 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. 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. 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, animals, and studies on possible mechanisms of action— information about potential sources of exposure to humans, and current federal regulations to limit exposures. The 13th RoC, the latest edition, was published on October 2, 2014 (available at https:// ntp.niehs.nih.gov/go/roc13), and the 14th RoC is under development. SUMMARY: 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 Dated: October 7, 2015. John R. Bucher, Associate Director, NTP. [FR Doc. 2015–26050 Filed 10–13–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Nominations to the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information; Amended Notice This notice amends Federal Register notice 80 FR 60692, published October 7, 2015, requesting information on nominations to the Report on Carcinogens and Office of Health Assessment and Translation. The correct CASRN for vinylidene chloride is 75-35-4. All other information in the original notice has not changed. Information on nominations is available at https://ntp.niehs.nih.gov/go/rocnom and https://ntp.niehs.nih.gov/go/763346. Deadline for receipt of information is November 6, 2015. DATES: Dated: October 7, 2015. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2015–26054 Filed 10–13–15; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\14OCN1.SGM 14OCN1

Agencies

[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Pages 61832-61833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26050]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft Report on Carcinogens Monographs on Five Viruses; 
Availability of Documents; Request for Comments; Notice of Peer-Review 
Meeting

SUMMARY: The notice announces a meeting to peer review Draft Report on 
Carcinogens (RoC) Monographs on Five Viruses: Epstein-Barr virus [EBV], 
human immunodeficiency virus type 1 [HIV-1], human T-cell lymphotropic 
virus type 1 [HTLV-1], Kaposi sarcoma-associated herpesvirus [KSHV], 
and Merkel cell polyomavirus [MCV]. The monographs 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). 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 is available at https://ntp.niehs.nih.gov/go/38853.

DATES: 
    Meeting: December 17, 2015, 8:30 a.m. Eastern Standard Time (EST) 
to adjournment.
    Document Availability: Draft monographs should be available by the 
week of November 2, 2015, at https://ntp.niehs.nih.gov/go/38853.
    Written Public Comments Submissions: Deadline is December 3, 2015.
    Registration for Attendance and/or Oral Comments: Deadline is 
December 10, 2015. 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 site: 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. Email: 
whiteld@niehs.nih.gov. Hand Delivery/Courier: 530 Davis Drive, Room 
2124, Morrisville, NC 27560.

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. 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. 
A draft RoC monograph consists of (1) a cancer hazard 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.
    Five viruses, EBV, HIV-1, HTLV-1, KSHV, and MCV, were selected as 
candidate substances following solicitation of public comment, review 
by the NTP Board of Scientific Counselors on April 16-18, 2014, and 
approval by the NTP Director (https://ntp.niehs.nih.gov/go/9741). A RoC 
monograph was prepared for each virus and this meeting is planned for 
peer review of the five draft RoC monographs.
    Approximately 10% of cancers in the United States and 17.8% 
worldwide are linked to infectious disease. Several viruses, including 
hepatitis B virus, hepatitis C virus, and some human papilloma viruses 
of the genital-mucosal type, are currently listed in the RoC as known 
to be human carcinogens. NTP is conducting an evaluation of the 
following five viruses for possible listing in the RoC: EBV and KSHV, 
which are herpesviruses; MCV, which is a recently discovered 
polyomavirus; and HIV-1 and HTLV-1, which are retroviruses. HIV and 
HTLV-1 infection occurs from sexual, parenteral, and

[[Page 61833]]

perinatal transmission, whereas transmission via saliva is a common 
route of exposure for KSHV and EBV. Although MCV is found in the skin 
and saliva, it is not clear how people are infected. Additional 
information about the evaluation of these viruses for the RoC is 
available at https://ntp.niehs.nih.gov/go/733995.

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 
December 10, 2015, to facilitate planning for the meeting.
    The preliminary agenda and draft monographs should be posted on the 
NTP Web site (https://ntp.niehs.nih.gov/go/38853) by the week of 
November 2, 2015. 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. Interested individuals are 
encouraged to access the meeting Web site 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. 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.

Request for Comments

    The NTP invites written and oral public comments on the draft 
monographs. The deadline for submission of written comments is December 
3, 2015, to enable review by the peer-review panel and NTP staff prior 
to the meeting. Registration to provide oral comments is by December 
10, 2015, 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 (if applicable), phone, email, and 
sponsoring organization (if any) with the document. Written comments 
received in response to this notice will be posted on the meeting Web 
site, and the submitter 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 adjournment on December 17, 
2015; 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 December 10, 2015, 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. 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. 
The 13th RoC, the latest edition, was published on October 2, 2014 
(available at https://ntp.niehs.nih.gov/go/roc13), and the 14th RoC is 
under development.

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: October 7, 2015.
John R. Bucher,
Associate Director, NTP.
[FR Doc. 2015-26050 Filed 10-13-15; 8:45 am]
BILLING CODE 4140-01-P
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