[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: [email protected]. Dr. Elizabeth Maull, 
NIEHS/DNTP, Designated Federal Official. Phone: (984) 287-3157, 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 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: [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 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: [email protected] 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: [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 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: 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