[Federal Register Volume 84, Number 106 (Monday, June 3, 2019)]
[Notices]
[Pages 25552-25553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11463]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Draft NTP Technical Reports on Prenatal Developmental Toxicity
Studies; Availability of Documents; 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 the
availability of four draft NTP Technical Reports on prenatal
developmental toxicity studies scheduled for peer-review for the
following substances: Tris(chloropropyl) phosphate, 4-
methylcyclohexanemethanol, vinpocetine, and dimethylaminoethanol
bitartrate. The peer-review meeting is open to the public. Registration
is required for in-person meeting attendance, oral comment, and to
access the webcast. Information about the meeting and registration is
available at https://ntp.niehs.gov/go/36051.
DATES:
Meeting: July 31, 2019, 8:30 a.m. to adjournment at approximately
5:00 p.m. Eastern Daylight Time (EDT). The meeting may end earlier or
later than 5:00 p.m. EDT.
Document Availability: The four draft NTP Technical Reports should
be available by June 5, 2019, at https://ntp.niehs.gov/go/36051.
Written Public Comment Submissions: Deadline is July 17, 2019.
Registration for Oral Comments: Deadline is July 17, 2019.
Registration to Attend Meeting In-Person: Deadline is July 17,
2019.
Registration to View Webcast: Deadline is July 31, 2019.
ADDRESSES:
Meeting Location: Conference Room F193, Rall Building, NIEHS, 111
T.W. Alexander Drive, Research Triangle Park, NC 27709.
Meeting web page: The draft reports, preliminary agenda,
registration, and other meeting materials will be available at https://ntp.niehs.gov/go/36051.
Webcast: The URL for viewing the peer-review meeting webcast will
be provided to registrants.
FOR FURTHER INFORMATION CONTACT: Email [email protected]. Dr.
Elizabeth Maull, NIEHS/DNTP, is the Designated Federal Official. Phone:
(984) 287-3157, Fax: (301) 480-3008. Email: [email protected].
SUPPLEMENTARY INFORMATION:
Meeting Attendance Registration: The meeting is open to the public
with time set aside for oral public comment. As meeting space at NIEHS
is under renovation, very limited space is available for in-person
attendance (~15 attendees). Registration for in-person attendance is on
a first-come, first-served basis. After maximum capacity is reached,
persons will be placed on a wait list and notified should an opening
become available. Registration to attend the meeting in person is by
July 17, 2019, at https://ntp.niehs.gov/go/36051 and for the webcast is
July 31, 2019, at https://ntp.niehs.gov/go/36051. The URL for the
webcast will be provided in the email confirming registration. Visitor
and security information for those attending in person is available at
https://www.niehs.nih.gov/about/visiting/index.cfm. Individuals with
disabilities who need accommodation to view the webcast should contact
Susan Blaine by phone: (703) 225-2471 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: NTP invites written and oral public comments
on the draft reports 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 July 17, 2019,
to enable review by the peer-review panel and NTP staff prior to the
meeting. Written public comments should be submitted through the
meeting website at https://ntp.niehs.gov/go/36051. 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.
Oral public comment at this meeting is welcome, with time set aside
for the presentation of oral comments on the draft reports. The agenda
allows for four public comment periods--one comment period per report
(up to 6 commenters, up to 5 minutes per speaker, per report). Persons
wishing to make an oral comment are required to register online at
https://ntp.niehs.gov/go/36051 by July 17, 2019, and indicate whether
they will present comments in-person or via the teleconference line.
Registration is on a first-come, first served basis. Each organization
is allowed one time slot per report. 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 should send a copy of their
slides and/or statement or talking points to Susan Blaine by email:
[email protected] by July 17, 2019. Written statements can
supplement and may expand the oral presentation.
Meeting Materials: The draft NTP technical reports and preliminary
agenda will be available on the NTP website at https://ntp.niehs.gov/go/36051 prior to the meeting. NTP expects
[[Page 25553]]
that the draft reports should be available on the website by June 5,
2019. Additional information will be posted when available or may be
requested in hardcopy from Susan Blaine by phone: (703) 225-2471 or
email: [email protected]. Individuals are encouraged to access the
meeting web page to stay abreast of 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 Susan Blaine 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.
This peer review is being conducted by a panel in attendance at
NIEHS. Peer-review of future draft reports will be conducted in
accordance with Department of Health and Human Services peer-review
policies (https://aspe.hhs.gov/hhs-information-quality-peer-review) and
Office of Management and Budget's Final Information Quality Bulletin
for Peer Review (70 FR 2664, January 4, 2005).
Dated: May 21, 2019.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2019-11463 Filed 5-31-19; 8:45 am]
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