Peer Review of Draft NTP Approach to Genomic Dose-Response Modeling; Availability of Documents; Request for Comments; Notice of Expert Panel Meeting, 41420-41421 [2017-18462]
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Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
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Dated: August 25, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–18469 Filed 8–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Peer Review of Draft NTP Approach to
Genomic Dose-Response Modeling;
Availability of Documents; Request for
Comments; Notice of Expert Panel
Meeting
The National Toxicology
Program (NTP) announces an expert
panel meeting and is obtaining
comment on a proposed approach to
genomic dose-response modeling. Prior
SUMMARY:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
to the expert panel meeting, NTP will
host four webinars that present other
approaches to genomic dose-response
modeling. The expert panel meeting and
four webinar presentations leading up to
the meeting are open to the public.
Registration is requested for both inperson meeting attendance and oral
comment; registration is required to
access the meeting webcast. URLs for
live and archived pre-meeting webinars
will be available at https://
ntp.niehs.nih.gov/about/org/
ntpexpertpanel/.
DATES:
Pre-Meeting Webinars: Dates are
posted on the meeting Web site (https://
ntp.niehs.nih.gov/about/org/
ntpexpertpanel/). Registration is not
required to view the pre-meeting
webinars.
Meeting: October 23–25, 2017; expert
panel meeting begins at 8:30 a.m.
Eastern Daylight Time (EDT) each day
and continues until adjournment.
Document Availability: Draft
document should be available by
August 23, 2017, at https://
ntp.niehs.nih.gov/about/org/
ntpexpertpanel/.
Written Public Comment
Submissions: Deadline is October 13,
2017.
Registration for Oral Comments:
Deadline is October 13, 2017.
Registration for Meeting and/or to
View Webcast: Deadline is October 25,
2017. Registration to view the meeting
via webcast is required.
ADDRESSES:
Meeting Location: Rodbell
Auditorium, Rall Building, NIEHS, 111
T.W. Alexander Drive, Research
Triangle Park, NC 27709.
Meeting Web site: The draft
document, preliminary agenda,
registration, pre-meeting webinars
details, and other meeting materials will
be available at https://ntp.niehs.nih.gov/
about/org/ntpexpertpanel/.
Webcast: The URL for viewing the
expert panel meeting webcast will be
provided to those who register.
FOR FURTHER INFORMATION CONTACT:
Anna Stamatogiannakis, ICF, 2635
Meridian Parkway, Suite 200, Durham,
NC, USA 27713. Phone: (919) 293–1652,
Fax: (919) 293–1645, Email:
anna.stamatogiannakis@icf.com.
SUPPLEMENTARY INFORMATION:
Background: NTP proposes to use the
approach embodied in the BMDExpress
software to perform gene and pathwaylevel genomic dose-response modeling
as part of Tox21 Phase 3 and in vivo
screening level studies. NTP seeks
external scientific input on its proposed
approach by an expert panel. NTP’s goal
E:\FR\FM\31AUN1.SGM
31AUN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
for implementing this approach
considers a number of factors including
methods accepted in the peer-review
literature, ease of translation to risk
assessment, and ease of understanding
for the variety of potential end users
that may not necessarily be experts in
mathematical and systems modeling. A
series of four pre-meeting webinars and
the expert panel meeting aim to review
current approaches and discuss best
practices. The webinar series will
provide an overview of various current
approaches and NTP’s proposed
approach to genomic dose-response
modeling. The expert panel will
consider information presented in the
webinars as well as other technical
factors during its peer review of NTP’s
proposed approach.
Pre-Meeting Webinars Registration:
There is no registration required to
attend the webinars. The URLs for live
and archived webinars will be available
on the meeting Web site at https://
ntp.niehs.nih.gov/about/org/
ntpexpertpanel/; please refer to this
page for the most current information
about the webinars and the meeting.
Expert Panel Meeting and
Registration: The meeting is open to the
public with time set aside for oral
public comment. Interested individuals
can attend the meeting in person or
view the webcast. Attendance at NIEHS
is limited only by the space available.
For planning purposes, registration to
attend the meeting at NIEHS or view the
webcast is requested. Registration to
attend the meeting in person and/or
view the webcast is by October 25, 2017,
at https://ntp.niehs.nih.gov/about/org/
ntpexpertpanel/.
Attending the Meeting: 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 participate
in this event should contact Anna
Stamatogiannakis by phone: (919) 293–
1652 or email: anna.stamatogiannakis@
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.
Meeting Materials: The expert panel
meeting agenda will be available on the
meeting Web site at https://
ntp.niehs.nih.gov/about/org/
ntpexpertpanel/. The draft document
should be available by August 23, 2017.
Additional information will be posted
when available or may be requested in
hardcopy, see FOR FURTHER INFORMATION
CONTACT.
Following the meeting, a report of the
panel meeting will be prepared and
VerDate Sep<11>2014
20:54 Aug 30, 2017
Jkt 241001
made available on the NTP Web site.
Individuals are encouraged to access the
meeting Web site to stay abreast of the
most current information regarding the
meeting.
Request for Comments: NTP invites
written and oral public comments on
the draft NTP approach. The deadline
for submission of written comments is
October 13, 2017, to enable review by
the peer review panel and NTP staff
prior to the meeting. Written public
comments and any other
correspondence on NTP’s proposed
approach should be sent to the FOR
FURTHER INFORMATION CONTACT. Persons
submitting written comments should
include their 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 Web site and the
submitter identified by name, affiliation,
and/or sponsoring organization (if any).
Guidelines for public comments are at
https://ntp.niehs.nih.gov/ntp/about_
ntp/guidelines_public_comments_
508.pdf.
Oral public comment at this meeting
is welcome, with time set aside on
October 23 for the formal presentation
of oral remarks on the draft document.
In addition to in-person oral comments
at the NIEHS, public comments can be
presented by teleconference line. There
will be 50 lines for this call; availability
is on a first-come, first-served basis. The
lines will be open from 8:30 a.m. each
day until adjournment. Oral comments
will be received only during the formal
public comment periods indicated on
the preliminary agenda. The access
number for the teleconference line will
be provided to registrants by email prior
to the meeting. Each organization is
allowed one time slot. At least 7
minutes will be allotted to each time
slot, and if time permits, the allotment
may be extended to 10 minutes at the
discretion of the chair. In addition to the
formal public comment period, there
will be several opportunities in the
agenda for ad hoc comments.
Persons wishing to make oral
comments during the formal comment
period on October 23 are asked to
register online at https://
ntp.niehs.nih.gov/about/org/
ntpexpertpanel/ by October 13, 2017,
and indicate whether they will present
comments in person or via the
teleconference line. Oral public
commenters are asked to send a copy of
their slides and/or statement or talking
points to the FOR FURTHER INFORMATION
CONTACT by October 13, 2017. Written
statements can supplement and may
expand the oral presentation.
Registration for in-person oral
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
41421
comments will also be available at the
meeting, although time allowed for
presentation by on-site registrants may
be less than that for registered speakers
and will be determined by the number
of speakers who register on-site. Time is
also being set aside in the agenda for ad
hoc comments by both in-person
attendees and webcast viewers.
Information on how to make oral
remarks during those ad hoc comment
periods will be provided at the meeting.
Background Information on Expert
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.
NTP welcomes public comment for
dose-response modeling.
Dated: August 15, 2017.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2017–18462 Filed 8–30–17; 8:45 am]
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Fish and Wildlife Service
[FWS–HQ–R–2017–N102;
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Control Number 1018–0140]
Agency Information Collection
Activities; Hunting and Fishing
Application Forms and Activity
Reports for National Wildlife Refuges
Fish and Wildlife Service,
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ACTION: Notice of Information
Collection; request for comment.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, we,
the U.S. Fish and Wildlife Service
(Service) are proposing to revise an
information collection.
DATES: Interested persons are invited to
submit comments on or before October
30, 2017.
ADDRESSES: Send your comments on the
information collection request (ICR) by
mail to the Service Information
Collection Clearance Officer, U.S. Fish
and Wildlife Service, MS: BPHC, 5275
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SUMMARY:
E:\FR\FM\31AUN1.SGM
31AUN1
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[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)]
[Notices]
[Pages 41420-41421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18462]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Peer Review of Draft NTP Approach to Genomic Dose-Response
Modeling; Availability of Documents; Request for Comments; Notice of
Expert Panel Meeting
SUMMARY: The National Toxicology Program (NTP) announces an expert
panel meeting and is obtaining comment on a proposed approach to
genomic dose-response modeling. Prior to the expert panel meeting, NTP
will host four webinars that present other approaches to genomic dose-
response modeling. The expert panel meeting and four webinar
presentations leading up to the meeting are open to the public.
Registration is requested for both in-person meeting attendance and
oral comment; registration is required to access the meeting webcast.
URLs for live and archived pre-meeting webinars will be available at
https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/.
DATES:
Pre-Meeting Webinars: Dates are posted on the meeting Web site
(https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/). Registration is
not required to view the pre-meeting webinars.
Meeting: October 23-25, 2017; expert panel meeting begins at 8:30
a.m. Eastern Daylight Time (EDT) each day and continues until
adjournment.
Document Availability: Draft document should be available by August
23, 2017, at https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/.
Written Public Comment Submissions: Deadline is October 13, 2017.
Registration for Oral Comments: Deadline is October 13, 2017.
Registration for Meeting and/or to View Webcast: Deadline is
October 25, 2017. Registration to view the meeting via webcast is
required.
ADDRESSES:
Meeting Location: Rodbell Auditorium, Rall Building, NIEHS, 111
T.W. Alexander Drive, Research Triangle Park, NC 27709.
Meeting Web site: The draft document, preliminary agenda,
registration, pre-meeting webinars details, and other meeting materials
will be available at https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/.
Webcast: The URL for viewing the expert panel meeting webcast will
be provided to those who register.
FOR FURTHER INFORMATION CONTACT: Anna Stamatogiannakis, ICF, 2635
Meridian Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-
1652, Fax: (919) 293-1645, Email: anna.stamatogiannakis@icf.com.
SUPPLEMENTARY INFORMATION:
Background: NTP proposes to use the approach embodied in the
BMDExpress software to perform gene and pathway-level genomic dose-
response modeling as part of Tox21 Phase 3 and in vivo screening level
studies. NTP seeks external scientific input on its proposed approach
by an expert panel. NTP's goal
[[Page 41421]]
for implementing this approach considers a number of factors including
methods accepted in the peer-review literature, ease of translation to
risk assessment, and ease of understanding for the variety of potential
end users that may not necessarily be experts in mathematical and
systems modeling. A series of four pre-meeting webinars and the expert
panel meeting aim to review current approaches and discuss best
practices. The webinar series will provide an overview of various
current approaches and NTP's proposed approach to genomic dose-response
modeling. The expert panel will consider information presented in the
webinars as well as other technical factors during its peer review of
NTP's proposed approach.
Pre-Meeting Webinars Registration: There is no registration
required to attend the webinars. The URLs for live and archived
webinars will be available on the meeting Web site at https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/; please refer to this page
for the most current information about the webinars and the meeting.
Expert Panel Meeting and Registration: The meeting is open to the
public with time set aside for oral public comment. Interested
individuals can attend the meeting in person or view the webcast.
Attendance at NIEHS is limited only by the space available. For
planning purposes, registration to attend the meeting at NIEHS or view
the webcast is requested. Registration to attend the meeting in person
and/or view the webcast is by October 25, 2017, at https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/.
Attending the Meeting: 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 participate in this event should contact Anna
Stamatogiannakis by phone: (919) 293-1652 or email:
anna.stamatogiannakis@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.
Meeting Materials: The expert panel meeting agenda will be
available on the meeting Web site at https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/. The draft document should be available by August
23, 2017. Additional information will be posted when available or may
be requested in hardcopy, see FOR FURTHER INFORMATION CONTACT.
Following the meeting, a report of the panel meeting will be
prepared and made available on the NTP Web site. Individuals are
encouraged to access the meeting Web site to stay abreast of the most
current information regarding the meeting.
Request for Comments: NTP invites written and oral public comments
on the draft NTP approach. The deadline for submission of written
comments is October 13, 2017, to enable review by the peer review panel
and NTP staff prior to the meeting. Written public comments and any
other correspondence on NTP's proposed approach should be sent to the
FOR FURTHER INFORMATION CONTACT. Persons submitting written comments
should include their 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 Web site and the
submitter identified by name, affiliation, and/or sponsoring
organization (if any). Guidelines for public comments are at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
Oral public comment at this meeting is welcome, with time set aside
on October 23 for the formal presentation of oral remarks on the draft
document. In addition to in-person oral comments at the NIEHS, public
comments can be presented by teleconference line. There will be 50
lines for this call; availability is on a first-come, first-served
basis. The lines will be open from 8:30 a.m. each day until
adjournment. Oral comments will be received only during the formal
public comment periods indicated on the preliminary agenda. The access
number for the teleconference line will be provided to registrants by
email prior to the meeting. Each organization is allowed one time slot.
At least 7 minutes will be allotted to each time slot, and if time
permits, the allotment may be extended to 10 minutes at the discretion
of the chair. In addition to the formal public comment period, there
will be several opportunities in the agenda for ad hoc comments.
Persons wishing to make oral comments during the formal comment
period on October 23 are asked to register online at https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/ by October 13, 2017, and
indicate whether they will present comments in person or via the
teleconference line. Oral public commenters are asked to send a copy of
their slides and/or statement or talking points to the FOR FURTHER
INFORMATION CONTACT by October 13, 2017. Written statements can
supplement and may expand the oral presentation. Registration for in-
person oral comments will also be available at the meeting, although
time allowed for presentation by on-site registrants may be less than
that for registered speakers and will be determined by the number of
speakers who register on-site. Time is also being set aside in the
agenda for ad hoc comments by both in-person attendees and webcast
viewers. Information on how to make oral remarks during those ad hoc
comment periods will be provided at the meeting.
Background Information on Expert 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. NTP welcomes public comment for dose-response
modeling.
Dated: August 15, 2017.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2017-18462 Filed 8-30-17; 8:45 am]
BILLING CODE 4140-01-P