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, 368-369 [2019-00112]

Download as PDF 368 Notices Federal Register Vol. 84, No. 17 Friday, January 25, 2019 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF DEFENSE Department of the Air Force khammond on DSKBBV9HB2PROD with NOTICES 2017 Public Interface Control Working Group and Forum for the NAVSTAR GPS Public Documents AGENCY: Global Positioning System Directorate (GPSD), Department of the Air Force, Department of Defense. ACTION: The Global Positioning System Testing notice. SUMMARY: This notice informs the public that the Space and Missiles Center Global Positioning Systems (GPS) Directorate Engineering (SMC/GPE) Systems Integration Demonstration (SI Demo) team plans to execute a test in February 2019 to investigate legacy receiver week roll-over behavior and analyze any off-nominal behavior exhibited. Additonal details about the test and how interested civil vendors may participate is detailed below. DATES: Questionaire due by February 4, 2019. ADDRESSES: SMC/GPE, 483 North Aviation Boulevard, El Segundo, CA 90245–2808. SUPPLEMENTARY INFORMATION: The Global Positioning System (GPS) week number rollover occurs in the GPS legacy navigation (LNAV) message every 1024 weeks due to the GPS week number being represented by only 10 bits within the LNAV message. The next GPS week number roll over will occur 18 seconds prior to the 0000Z boundary (Coordinated Universal Time) between April 6/7 2019. In most cases, any negative response from a GPS receiver caused by a problem accounting for the 10-bit week number week roll over would likely affect the calendar conversion from GPS time to UTC date/ time and could result in the GPS receiver thinking it had jumped backward in time by 1024 weeks to 21/ 22 August 1999. Many receiver-specific design documents contain requirements that ensure proper handling of a rollover VerDate Sep<11>2014 16:08 Jan 24, 2019 Jkt 247001 event. However, SMC/GPE does not control, maintain, or even have an awareness of the software and requirements baseline of every GPS receiver in operation. Many performance conditions, especially those in older GPS receivers, may differ from expectations laid out in modernized receiver-specific design documents. It should be noted that the modernized civil navigation (CNAV) signals all utilize a 13-bit week number representation and the use of those CNAV signals can delay potential week number roll-over problems to 5/6 January 2137. Below are a few questions whose answers would help SMC/GPE understand your receiver’s expected behavior during the upcoming GPS 10bit week number roll-over: 1. Does your strategy involve user input? 2. Do the users understand and know the procedure? 3. Is the procedure detailed in a manual or other document? 4. Is the procedure, manual, or documentation posted on your website? 5. Are there concerns for any automated systems your receiver is integrated into? 6. Do you plan on posting product advisories for each receiver type? If so, where? 7. Has testing been planned/ completed to confirm receiver performance expectations? 8. Would you be interested in participating in the test by either: 1) Supplying receivers & technical support to test with the government team? 2) Testing using your own test setup and configuration? 9. How many receiver types would you be able to supply/test for this effort? (Note, not all receiver types may be applicable to this test event.) If you wish to participate in this test, please submit the answers to the questions above to SMC/GPE mailbox at smc.gpev.sidemo28@us.af.mil by February 4, 2019. After the submition of the questinaire, the SI Demo team will schedule individual meetings with interested civil vendors to further discuss their participation in the test in more detail. 2Lt Marcy Gouri (marcy.gouri@us.af.mil) or FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 Capt Aaron Knoblauch (aaron.knoblauch@us.af.mil) Henry Williams, Acting Air Force Federal Register Liaison Officer. [FR Doc. 2019–00111 Filed 1–24–19; 8:45 am] BILLING CODE 5001–10–P 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. 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, sublethal exposure to sarin. The peerreview 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:// SUMMARY: E:\FR\FM\25JAN1.SGM 25JAN1 Federal Register / Vol. 84, No. 17 / Friday, January 25, 2019 / Notices 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. khammond on DSKBBV9HB2PROD with NOTICES 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 longterm 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 VerDate Sep<11>2014 16:08 Jan 24, 2019 Jkt 247001 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: NTPMeetings@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: NTPMeetings@icf.com. Individuals are encouraged to access the meeting web page to stay abreast of the most current information regarding the meeting. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 369 Following the meeting, a report of the peer review will be prepared and made available on the NTP website. Background Information on NTP PeerReview 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Cell Biology Integrated Review Group; Nuclear and E:\FR\FM\25JAN1.SGM 25JAN1

Agencies

[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.

-----------------------------------------------------------------------

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

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