80 FR 61832 - Draft Report on Carcinogens Monographs on Five Viruses; Availability of Documents; Request for Comments; Notice of Peer-Review Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 198 (October 14, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 198 (October 14, 2015)
| Page Range | 61832-61833 | |
| FR Document | 2015-26050 |
[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)] [Notices] [Pages 61832-61833] From the Federal Register Online [www.thefederalregister.org] [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 http://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 http://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 http://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 (http://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 (http://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 http://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 (http://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 (http://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 http://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 http://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 http://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 http://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
![61832 Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
the formal public comment periods, Dated: October 8, 2015. Dr. Lori White, NTP Designated
which are indicated on the preliminary John R. Bucher, Federal Official, Office of Liaison,
agenda. Each organization (sponsoring Associate Director, NTP. Policy, and Review, DNTP, NIEHS, P.O.
organization or affiliation) is allowed [FR Doc. 2015–26051 Filed 10–13–15; 8:45 am] Box 12233, MD K2–03, Research
one time slot per agenda topic. Each BILLING CODE 4140–01–P
Triangle Park, NC 27709. Phone: (919)
speaker is allotted at least 7 minutes, 541–9834. Email: whiteld@
which if time permits, may be extended niehs.nih.gov. Hand Delivery/Courier:
to 10 minutes at the discretion of the DEPARTMENT OF HEALTH AND 530 Davis Drive, Room 2124,
BSC chair. Persons wishing to present HUMAN SERVICES Morrisville, NC 27560.
oral comments should register on the SUPPLEMENTARY INFORMATION:
BSC meeting Web site by November 24, National Institutes of Health
2015, indicate whether they will present Background
comments in-person or via the Draft Report on Carcinogens The RoC is a congressionally
teleconference line, and identify the Monographs on Five Viruses; mandated, science-based, public health
topic(s) on which they plan to comment. Availability of Documents; Request for report that identifies agents, substances,
The access number for the Comments; Notice of Peer-Review mixtures, or exposures (collectively
teleconference line will be provided to Meeting called ‘‘substances’’) in our environment
registrants by email prior to the meeting. that pose a cancer hazard for people in
SUMMARY: The notice announces a
On-site registration for oral comments the United States. The NTP prepares the
meeting to peer review Draft Report on
will also be available on the meeting RoC on behalf of the Secretary of Health
Carcinogens (RoC) Monographs on Five
day, although time allowed for and Human Services.
Viruses: Epstein-Barr virus [EBV], The NTP follows an established, four-
comments by these registrants may be
human immunodeficiency virus type 1 part process for preparation of the RoC
limited and will be determined by the
[HIV–1], human T-cell lymphotropic (http://ntp.niehs.nih.gov/go/rocprocess).
number of persons who register at the
virus type 1 [HTLV–1], Kaposi sarcoma- A RoC monograph is prepared for each
meeting.
Persons registering to make oral associated herpesvirus [KSHV], and candidate substance selected for review
comments are asked to send a copy of Merkel cell polyomavirus [MCV]. The for the RoC. A draft RoC monograph
their statement and/or PowerPoint monographs were prepared by the consists of (1) a cancer hazard
slides to the Designated Federal Officer Office of the Report on Carcinogens evaluation component that reviews all
by November 24, 2015. Written (ORoC), Division of the National information that may bear on a listing
statements can supplement and may Toxicology Program (DNTP), National decision, assesses its quality and
expand upon the oral presentation. If Institute of Environmental Health sufficiency for reaching a listing
registering on-site and reading from Sciences (NIEHS). The peer-review decision, applies the RoC listing criteria
written text, please bring 20 copies of meeting is open to the public. to the relevant scientific information,
the statement for distribution to the BSC Registration is requested for both public and recommends a listing status for the
and NTP staff and to supplement the attendance and oral comment and candidate substance in the RoC and (2)
record. required to access the webcast. a substance profile that contains the
Background Information on the BSC: Information about the meeting and NTP’s preliminary listing
The BSC is a technical advisory body registration is available at http:// recommendation and a summary of the
comprised of scientists from the public ntp.niehs.nih.gov/go/38853. scientific evidence considered key to
and private sectors that provides DATES: reaching that recommendation.
primary scientific oversight to the NTP. Meeting: December 17, 2015, 8:30 Five viruses, EBV, HIV–1, HTLV–1,
Specifically, the BSC advises the NTP a.m. Eastern Standard Time (EST) to KSHV, and MCV, were selected as
on matters of scientific program content, adjournment. candidate substances following
both present and future, and conducts Document Availability: Draft solicitation of public comment, review
periodic review of the program for the monographs should be available by the by the NTP Board of Scientific
purpose of determining and advising on week of November 2, 2015, at http:// Counselors on April 16–18, 2014, and
the scientific merit of its activities and ntp.niehs.nih.gov/go/38853. approval by the NTP Director (http://
their overall scientific quality. Its Written Public Comments ntp.niehs.nih.gov/go/9741). A RoC
members are selected from recognized Submissions: Deadline is December 3, monograph was prepared for each virus
authorities knowledgeable in fields such 2015. and this meeting is planned for peer
as toxicology, pharmacology, pathology, Registration for Attendance and/or review of the five draft RoC
biochemistry, epidemiology, risk Oral Comments: Deadline is December monographs.
assessment, carcinogenesis, 10, 2015. Registration to view the Approximately 10% of cancers in the
mutagenesis, molecular biology, meeting via the webcast is required. United States and 17.8% worldwide are
behavioral toxicology, neurotoxicology, ADDRESSES: linked to infectious disease. Several
immunotoxicology, reproductive Meeting Location: Rodbell viruses, including hepatitis B virus,
toxicology or teratology, and Auditorium, Rall Building, NIEHS, 111 hepatitis C virus, and some human
biostatistics. Members serve overlapping T.W. Alexander Drive, Research papilloma viruses of the genital-mucosal
terms of up to four years. The BSC Triangle Park, NC 27709. type, are currently listed in the RoC as
usually meets biannually. The authority Agency Meeting Web site: The draft known to be human carcinogens. NTP is
for the BSC is provided by 42 U.S.C. monographs, draft agenda, registration, conducting an evaluation of the
tkelley on DSK3SPTVN1PROD with NOTICES
217a, section 222 of the Public Health and other meeting materials will be following five viruses for possible
Service Act (PHS), as amended. The posted at http://ntp.niehs.nih.gov/go/ listing in the RoC: EBV and KSHV,
BSC is governed by the provisions of the 38853. which are herpesviruses; MCV, which is
Federal Advisory Committee Act, as Webcast: The URL for viewing the a recently discovered polyomavirus; and
amended (5 U.S.C. app.), which sets webcast will be provided to those who HIV–1 and HTLV–1, which are
forth standards for the formation and register. retroviruses. HIV and HTLV–1 infection
use of advisory committees. FOR FURTHER INFORMATION CONTACT: occurs from sexual, parenteral, and
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![Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices 61833
perinatal transmission, whereas applicable), phone, email, and NTP on agents of public health concern,
transmission via saliva is a common sponsoring organization (if any) with new/revised toxicological test methods,
route of exposure for KSHV and EBV. the document. Written comments or other issues. These panels help
Although MCV is found in the skin and received in response to this notice will ensure transparent, unbiased, and
saliva, it is not clear how people are be posted on the meeting Web site, and scientifically rigorous input to the
infected. Additional information about the submitter identified by name, program for its use in making credible
the evaluation of these viruses for the affiliation, and/or sponsoring decisions about human hazard, setting
RoC is available at http:// organization. research and testing priorities, and
ntp.niehs.nih.gov/go/733995. Public comment at this meeting is
providing information to regulatory
welcome, with time set aside for the
Meeting and Registration agencies about alternative methods for
presentation of oral comments on the
This meeting is open to the public draft monographs. In addition to in- toxicity screening. The NTP welcomes
with time set aside for oral public person oral comments at the meeting at nominations of scientific experts for
comment. The public may attend the the NIEHS, public comments can be upcoming panels. Scientists interested
meeting at NIEHS, where attendance is presented by teleconference line. There in serving on an NTP panel should
limited only by the space available, or will be 50 lines for this call; availability provide a current curriculum vitae to
view the webcast. Registration is will be on a first-come, first-served the FOR FURTHER INFORMATION CONTACT.
required to view the webcast; the URL basis. The lines will be open from 8:30 The authority for NTP panels is
for the webcast will be provided in the a.m. until adjournment on December 17, provided by 42 U.S.C. 217a; section 222
email confirming registration. 2015; oral comments will be received of the Public Health Service (PHS) Act,
Individuals who plan to provide oral only during the formal public comment as amended. The panel is governed by
comments (see below) are encouraged to period indicated on the preliminary the Federal Advisory Committee Act, as
register online at the meeting Web site agenda. Each organization (sponsoring amended (5 U.S.C. Appendix 2), which
(http://ntp.niehs.nih.gov/go/38853) by organization or affiliation) is allowed sets forth standards for the formation
December 10, 2015, to facilitate one time slot. At least 7 minutes will be and use of advisory committees.
planning for the meeting. allotted to each speaker, and if time
The preliminary agenda and draft permits, may be extended to 10 minutes Dated: October 7, 2015.
monographs should be posted on the at the discretion of the chair. John R. Bucher,
NTP Web site (http://ntp.niehs.nih.gov/ Persons wishing to make an oral Associate Director, NTP.
go/38853) by the week of November 2, presentation are asked to register online [FR Doc. 2015–26050 Filed 10–13–15; 8:45 am]
2015. Additional information will be at http://ntp.niehs.nih.gov/go/38853 by BILLING CODE 4140–01–P
posted when available or may be December 10, 2015, and if possible, to
requested in hardcopy, see FOR FURTHER send a copy of their slides and/or
INFORMATION CONTACT. Following the statement or talking points at that time. DEPARTMENT OF HEALTH AND
meeting, a report of the peer review will Written statements can supplement and HUMAN SERVICES
be prepared and made available on the may expand the oral presentation.
NTP Web site. Interested individuals are Registration for in-person oral National Institutes of Health
encouraged to access the meeting Web comments will also be available at the
site to stay abreast of the most current meeting, although time allowed for Nominations to the Report on
information regarding the meeting. presentation by on-site registrants may Carcinogens and Office of Health
Visitor and security information is be less than that for registered speakers Assessment and Translation; Request
available at http://www.niehs.nih.gov/ and will be determined by the number for Information; Amended Notice
about/visiting/index.cfm. Individuals of speakers who register on-site.
with disabilities who need SUMMARY: This notice amends Federal
accommodation to participate in this Background Information on the RoC
Register notice 80 FR 60692, published
event should contact Ms. Robbin Guy at Published biennially, each edition of October 7, 2015, requesting information
phone: (919) 541–4363 or email: guyr2@ the RoC is cumulative and consists of on nominations to the Report on
niehs.nih.gov. TTY users should contact substances newly reviewed in addition
Carcinogens and Office of Health
the Federal TTY Relay Service at (800) to those listed in previous editions. For
Assessment and Translation. The
877–8339. Requests should be made at each listed substance, the RoC contains
correct CASRN for vinylidene chloride
least five business days in advance of a substance profile, which provides
the event. information on cancer studies that is 75-35-4. All other information in the
support the listing—including those in original notice has not changed.
Request for Comments Information on nominations is available
humans, animals, and studies on
The NTP invites written and oral possible mechanisms of action— at http://ntp.niehs.nih.gov/go/rocnom
public comments on the draft information about potential sources of and http://ntp.niehs.nih.gov/go/763346.
monographs. The deadline for exposure to humans, and current federal DATES:Deadline for receipt of
submission of written comments is regulations to limit exposures. The 13th information is November 6, 2015.
December 3, 2015, to enable review by RoC, the latest edition, was published
the peer-review panel and NTP staff on October 2, 2014 (available at http:// Dated: October 7, 2015.
prior to the meeting. Registration to ntp.niehs.nih.gov/go/roc13), and the John R. Bucher,
provide oral comments is by December 14th RoC is under development. Associate Director, National Toxicology
tkelley on DSK3SPTVN1PROD with NOTICES
10, 2015, at http://ntp.niehs.nih.gov/go/ Program.
38853. Public comments and any other Background Information on NTP Peer-
[FR Doc. 2015–26054 Filed 10–13–15; 8:45 am]
correspondence on the draft Review Panels
BILLING CODE 4140–01–P
monographs should be sent to the FOR NTP panels are technical, scientific
FURTHER INFORMATION CONTACT. Persons advisory bodies established on an ‘‘as
submitting written comments should needed’’ basis to provide independent
include their name, affiliation (if scientific peer review and advise the
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Document Created: 2018-02-27 08:50:14
Document Modified: 2018-02-27 08:50:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Meeting: December 17, 2015, 8:30 a.m. Eastern Standard Time (EST) to adjournment. | |
| 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: [email protected] Hand Delivery/Courier: 530 Davis Drive, Room 2124, Morrisville, NC 27560. | |
| FR Citation | 80 FR 61832 |
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