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)

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.

[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]


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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: 
[email protected]. 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: 
[email protected]. 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]
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