83 FR 63662 - Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin; Availability of Document; Request for Comments; Notice of Peer-Review Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 237 (December 11, 2018)

The National Toxicology Program (NTP) announces availability of the Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin for public comment prior to peer review. In partnership with the National Institutes of Health (NIH) Countermeasures Against Chemical Threats (CounterACT) Program, the Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), conducted a systematic review to evaluate the evidence of long-term neurological damage in humans after acute, sub-lethal exposure to sarin. The date for the peer review is not yet set; however, it is anticipated to occur in early 2019. The peer-review meeting will be held by webcast only and open to the public; registration will be required for attendance by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/36051.

[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63662-63664]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26745]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft NTP Monograph on the Systematic Review of Evidence of Long-
Term Neurological Effects Following Acute Exposure to the 
Organophosphorus Nerve Agent Sarin; Availability of Document; Request 
for Comments; Notice of Peer-Review Meeting

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Toxicology Program (NTP) announces availability 
of the Draft NTP Monograph on the Systematic Review of Evidence of 
Long-Term Neurological Effects Following Acute Exposure to the 
Organophosphorus Nerve Agent Sarin for public comment prior to peer 
review. In partnership with the National

[[Page 63663]]

Institutes of Health (NIH) Countermeasures Against Chemical Threats 
(CounterACT) Program, the Office of Health Assessment and Translation 
(OHAT), Division of the National Toxicology Program (DNTP), National 
Institute of Environmental Health Sciences (NIEHS), conducted a 
systematic review to evaluate the evidence of long-term neurological 
damage in humans after acute, sub-lethal exposure to sarin. The date 
for the peer review is not yet set; however, it is anticipated to occur 
in early 2019. The peer-review meeting will be held by webcast only and 
open to the public; registration will be required for attendance by 
webcast and to present oral comments. Information about the meeting and 
registration is available at https://ntp.niehs.nih.gov/go/36051.

DATES: 
    Meeting: When set, the peer-review meeting date will be announced 
on the meeting web page at https://ntp.niehs.nih.gov/go/36051 along 
with deadlines for registration to present oral public comments and to 
view the webcast. The anticipated timeframe is early 2019.
    NTP will also announce the meeting date in an email Listserv 
notice. Persons can subscribe to news updates at https://tools.niehs.nih.gov/webforms/index.cfm/main/formViewer/form_id/361.
    Document Availability: The draft NTP monograph should be available 
by December 5, 2018, at https://ntp.niehs.nih.gov/go/36051.
    Written Public Comment Submissions: Deadline is January 17, 2019.
    Registration for Oral Comments: Please monitor the meeting web page 
at https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the 
oral public comment registration deadline.
    Registration to View Webcast: Please monitor the meeting web page 
at https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the 
webcast registration deadline.

ADDRESSES: 
    Meeting Location: Webcast.
    Meeting web page: The draft NTP monograph, preliminary agenda, 
registration, and other meeting materials will be available at https://ntp.niehs.nih.gov/go/36051.
    Webcast: The URL for viewing the peer-review meeting webcast will 
be provided to registrants.

FOR FURTHER INFORMATION CONTACT: Ms. Canden Byrd, ICF, 2635 Meridian 
Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1660, Fax: 
(919) 293-1645, Email: [email protected].

SUPPLEMENTARY INFORMATION: 
    Background: OHAT serves as an environmental health resource to the 
public and to regulatory and health agencies. This office conducts 
evaluations to assess the evidence that environmental chemicals, 
physical substances, or mixtures (collectively referred to as 
``substances'') cause adverse health effects and provides opinions on 
whether these substances may be of concern given what is known about 
current human exposure levels.
    Sarin is a highly toxic organophosphorus nerve agent that was 
developed for chemical warfare during World War II and continues to be 
used as a weapon. The draft NTP monograph presents the results of the 
systematic review to evaluate the evidence for long-term neurological 
effects in humans following acute, sub-lethal exposure to sarin with 
consideration of human, experimental animal, and mechanistic date.
    Long-term neurological effects of acute exposure to sarin are not 
well characterized. Previous reviews of potential health effects of 
sarin have generally not assessed individual study quality or 
considered multiple evidence streams (human, animal, and mechanistic 
data). In addition, the interpretation of effects of sarin in some 
previous reviews was compounded by concurrent exposure to multiple 
chemicals, such as assessments of health effects in military personnel 
during the Gulf War or other conflicts.
    Meeting Attendance Registration: The meeting is open to the public 
with time set aside for oral public comment. Registration is required 
to view the webcast; the URL for the webcast will be provided in the 
email confirming registration. Please monitor the meeting web page at 
https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the 
webcast registration deadline. Individuals with disabilities who need 
accommodation to view the webcast should contact Canden Byrd by phone: 
(919) 293-1660 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.
    Public Comment Registration: NTP invites written and oral public 
comments on the draft NTP monograph that address scientific or 
technical issues. Guidelines for public comments are at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
    The deadline for submission of written comments is January 17, 
2019. Written public comments should be submitted through the meeting 
website. Persons submitting written comments should include name, 
affiliation, mailing address, phone, email, and sponsoring organization 
(if any). Written comments received in response to this notice will be 
posted on the NTP website, and the submitter will be identified by 
name, affiliation, and sponsoring organization (if any). Comments that 
address scientific or technical issues will be forwarded to the peer-
review panel and NTP staff prior to the meeting.
    The agenda will allow for one oral public comment period (up to 12 
commenters, up to 5 minutes per speaker). The deadline for registration 
to provide oral comments will be announced at https://ntp.niehs.nih.gov/go/36051 after the meeting date is set. Registration 
will be on a first-come, first-served basis. Each organization will be 
allowed one time slot. Oral comments will be presented by 
teleconference line. The access number for the teleconference line will 
be provided to registrants by email prior to the meeting. Commenters 
will be notified approximately one week before the peer-review meeting 
about the actual time allotted per speaker.
    If possible, oral public commenters will be asked to send a copy of 
their slides and/or statement or talking points to Canden Byrd by 
email: [email protected] by the registration deadline.
    Meeting Materials: The draft NTP monograph and preliminary agenda 
will be available on the NTP website at https://ntp.niehs.nih.gov/go/36051. The draft NTP monograph should be available by December 5, 2018. 
Additional information will be posted when available or may be 
requested in hardcopy, contact Canden Byrd by phone: (919) 293-1660 or 
email: [email protected]. Individuals are encouraged to access the 
meeting web page to stay abreast of the most current information 
regarding the meeting.
    Following the meeting, a report of the peer review will be prepared 
and made available on the NTP website.
    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 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

[[Page 63664]]

information to regulatory agencies about alternative methods for 
toxicity screening. NTP welcomes nominations of scientific experts for 
upcoming panels. Scientists interested in serving on an NTP panel 
should provide their current curriculum vitae to Canden Byrd by email: 
[email protected]. The authority for NTP panels is provided by 42 
U.S.C. 217a; section 222 of the Public Health Service 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: November 28, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-26745 Filed 12-10-18; 8:45 am]
BILLING CODE 4140-01-P