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; Amended Notice
| Published date | 25 January 2019 |
| Citation | 84 FR 368 |
| Record Number | 2019-00112 |
| Section | Notices |
| Court | Health And Human Services Department,National Institutes Of Health |
Federal Register, Volume 84 Issue 17 (Friday, January 25, 2019)
[Federal Register Volume 84, Number 17 (Friday, January 25, 2019)]
[Notices]
[Pages 368-369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00112]
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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; Amended Notice
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: This notice amends Federal Register notice 83 FR 63662,
published December 11, 2018, announcing the availability of the Draft
National Toxicology Program (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 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: Scheduled for February 4, 2019, 9:00 a.m. Eastern Standard
Time (EST) to adjournment. The preliminary agenda is available at
https://
[[Page 369]]
ntp.niehs.nih.gov/go/36051 and will be updated one week before the
meeting.
Document Availability: The draft NTP monograph is available at
https://ntp.niehs.nih.gov/go/36051.
Written Public Comment Submissions: Deadline was January 17, 2019.
Registration for Oral Comments: Deadline is January 28, 2019.
Registration to View Webcast: Deadline is February 4, 2019.
ADDRESSES:
Meeting Location: Webcast.
Meeting web page: The draft NTP monograph, preliminary agenda,
registration, and other meeting materials are available at https://ntp.niehs.nih.gov/go/36051.
Webcast: The URL for viewing the peer-review meeting webcast will
be provided to registrants.
This meeting notice is being published less than 15 days in advance
of the meeting due to the partial Government shutdown of December 2018.
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: NTP-Meetings@icf.com. Dr. Elizabeth Maull,
NIEHS/DNTP, Designated Federal Official. Phone: (984) 287-3157, Email:
maull@niehs.nih.gov.
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 to view the
webcast is open through February 4, 2019, and is found at https://ntp.niehs.nih.gov/go/36051. Registration is required to view the
webcast; the URL for the webcast will be provided in the email
confirming registration. Individuals with disabilities who need
accommodation to view the webcast should contact Canden Byrd by phone:
(919) 293-1660 or email: NTP-Meetings@icf.com. 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 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 has passed.
The agenda will allow for one oral public comment period (up to 12
commenters, up to 5 minutes per speaker). Registration to provide oral
comments is January 28, 2019, at https://ntp.niehs.nih.gov/go/36051.
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: NTP-Meetings@icf.com by the registration deadline.
Meeting Materials: The draft NTP monograph and preliminary agenda
are available on the NTP website at https://ntp.niehs.nih.gov/go/36051.
Additional information will be posted when available or may be
requested in hardcopy from Canden Byrd by phone: (919) 293-1660 or
email: NTP-Meetings@icf.com. 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 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: NTP-Meetings@icf.com. 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: January 17, 2019.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2019-00112 Filed 1-24-19; 8:45 am]
BILLING CODE 4140-01-P
