[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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