82 FR 41420 - Peer Review of Draft NTP Approach to Genomic Dose-Response Modeling; Availability of Documents; Request for Comments; Notice of Expert Panel Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 168 (August 31, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 168 (August 31, 2017)
| Page Range | 41420-41421 | |
| FR Document | 2017-18462 |
[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)] [Notices] [Pages 41420-41421] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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: [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. 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
![41420 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
of sufficient relevance and reliability to the Paperwork Reduction Act of 1995 to the expert panel meeting, NTP will
address the specific regulatory decision (44 U.S.C. 3501–3520). The collections host four webinars that present other
being considered. of information in 21 CFR part 807, approaches to genomic dose-response
This guidance does not affect any subpart E, have been approved under modeling. The expert panel meeting and
Federal, State or local laws or OMB control number 0910–0120; the four webinar presentations leading up to
regulations or foreign laws or collections of information in 21 CFR the meeting are open to the public.
regulations that may otherwise be part 814, subparts A through E Registration is requested for both in-
applicable to the use or collection of (premarket approval), have been person meeting attendance and oral
RWE and that provide protections for approved under OMB control number comment; registration is required to
human subjects or patient privacy. This 0910–0231; the collections of access the meeting webcast. URLs for
guidance should be used to information in 21 CFR part 814, subpart live and archived pre-meeting webinars
complement, but not supersede, other H (humanitarian device exemption), will be available at https://
device-specific and good clinical have been approved under OMB control ntp.niehs.nih.gov/about/org/
practice guidance documents. FDA number 0910–0332; the collections of ntpexpertpanel/.
considered comments received on the information in 21 CFR part 812 DATES:
draft guidance that published in the (investigational device exemption) have Pre-Meeting Webinars: Dates are
Federal Register of July 27, 2016 (81 FR been approved under OMB control posted on the meeting Web site (https://
49228). FDA revised the guidance as number 0910–0078; the collections of ntp.niehs.nih.gov/about/org/
appropriate in response to the information in 21 CFR part 822 ntpexpertpanel/). Registration is not
comments. (postmarket surveillance) have been required to view the pre-meeting
approved under OMB control number webinars.
II. Significance of Guidance
0910–0449; the collections of Meeting: October 23–25, 2017; expert
This guidance is being issued information in 21 CFR 50.23 (exception panel meeting begins at 8:30 a.m.
consistent with FDA’s good guidance from general requirements for informed Eastern Daylight Time (EDT) each day
practices regulation (21 CFR 10.115). consent) have been approved under and continues until adjournment.
The guidance represents the current OMB control number 0910–0586; the Document Availability: Draft
thinking of FDA on use of real-world collections of information in 21 CFR document should be available by
evidence to support regulatory decision- part 54 (financial disclosure by clinical August 23, 2017, at https://
making for medical devices. It does not investigators) have been approved under ntp.niehs.nih.gov/about/org/
establish any rights for any person and OMB control number 0910–0396; the ntpexpertpanel/.
is not binding on FDA or the public. collections of information in 21 CFR Written Public Comment
You can use an alternative approach if 56.115 (institutional review boards Submissions: Deadline is October 13,
it satisfies the requirements of the records) have been approved under 2017.
applicable statutes and regulations. This OMB control number 0910–0130; and Registration for Oral Comments:
guidance is not subject to Executive the collections of information in 21 CFR Deadline is October 13, 2017.
Order 12866. parts 50 subpart B (informed consent of Registration for Meeting and/or to
III. Electronic Access human subjects) and 56 (institutional View Webcast: Deadline is October 25,
review boards) have been approved 2017. Registration to view the meeting
Persons interested in obtaining a copy under OMB control number 0910–0755. via webcast is required.
of the guidance may do so by The collections of information in the
downloading an electronic copy from ADDRESSES:
guidance ‘‘Requests for Feedback on Meeting Location: Rodbell
the internet. A search capability for all Medical Device Submissions: The Pre-
Center for Devices and Radiological Auditorium, Rall Building, NIEHS, 111
Submission Program and Meetings with T.W. Alexander Drive, Research
Health guidance documents is available Food and Drug Administration Staff’’
at https://www.fda.gov/MedicalDevices/ Triangle Park, NC 27709.
have been approved under OMB control Meeting Web site: The draft
DeviceRegulationandGuidance/ number 0910–0756.
GuidanceDocuments/default.htm. document, preliminary agenda,
Guidance documents are also available Dated: August 25, 2017. registration, pre-meeting webinars
at https://www.fda.gov/BiologicsBlood Leslie Kux, details, and other meeting materials will
Vaccines/GuidanceCompliance Associate Commissioner for Policy. be available at https://ntp.niehs.nih.gov/
RegulatoryInformation/default.htm or [FR Doc. 2017–18469 Filed 8–30–17; 8:45 am] about/org/ntpexpertpanel/.
Webcast: The URL for viewing the
https://www.regulations.gov. Persons BILLING CODE 4164–01–P
expert panel meeting webcast will be
unable to download an electronic copy
provided to those who register.
of ‘‘Use of Real-World Evidence to
Support Regulatory Decision-Making for DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:
Medical Devices’’ may send an email HUMAN SERVICES Anna Stamatogiannakis, ICF, 2635
request to CDRH-Guidance@fda.hhs.gov Meridian Parkway, Suite 200, Durham,
National Institutes of Health NC, USA 27713. Phone: (919) 293–1652,
to receive an electronic copy of the
document. Please use the document Fax: (919) 293–1645, Email:
Peer Review of Draft NTP Approach to anna.stamatogiannakis@icf.com.
number 1500012 to identify the Genomic Dose-Response Modeling;
guidance you are requesting. SUPPLEMENTARY INFORMATION:
Availability of Documents; Request for
Background: NTP proposes to use the
sradovich on DSK3GMQ082PROD with NOTICES
IV. Paperwork Reduction Act of 1995 Comments; Notice of Expert Panel
approach embodied in the BMDExpress
Meeting
This guidance refers to previously software to perform gene and pathway-
approved collections of information SUMMARY: The National Toxicology level genomic dose-response modeling
found in FDA regulations and guidance. Program (NTP) announces an expert as part of Tox21 Phase 3 and in vivo
These collections of information are panel meeting and is obtaining screening level studies. NTP seeks
subject to review by the Office of comment on a proposed approach to external scientific input on its proposed
Management and Budget (OMB) under genomic dose-response modeling. Prior approach by an expert panel. NTP’s goal
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![Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 41421
for implementing this approach made available on the NTP Web site. comments will also be available at the
considers a number of factors including Individuals are encouraged to access the meeting, although time allowed for
methods accepted in the peer-review meeting Web site to stay abreast of the presentation by on-site registrants may
literature, ease of translation to risk most current information regarding the be less than that for registered speakers
assessment, and ease of understanding meeting. and will be determined by the number
for the variety of potential end users Request for Comments: NTP invites of speakers who register on-site. Time is
that may not necessarily be experts in written and oral public comments on also being set aside in the agenda for ad
mathematical and systems modeling. A the draft NTP approach. The deadline hoc comments by both in-person
series of four pre-meeting webinars and for submission of written comments is attendees and webcast viewers.
the expert panel meeting aim to review October 13, 2017, to enable review by Information on how to make oral
current approaches and discuss best the peer review panel and NTP staff remarks during those ad hoc comment
practices. The webinar series will prior to the meeting. Written public periods will be provided at the meeting.
provide an overview of various current comments and any other Background Information on Expert
approaches and NTP’s proposed correspondence on NTP’s proposed Panels: NTP panels are technical,
approach to genomic dose-response approach should be sent to the FOR scientific advisory bodies established on
modeling. The expert panel will FURTHER INFORMATION CONTACT. Persons an ‘‘as needed’’ basis to provide
consider information presented in the submitting written comments should independent scientific peer review and
webinars as well as other technical include their name, affiliation, mailing advise NTP on agents of public health
factors during its peer review of NTP’s address, phone, email, and sponsoring concern, new/revised toxicological test
proposed approach. organization (if any). Written comments methods, or other issues. These panels
Pre-Meeting Webinars Registration: received in response to this notice will help ensure transparent, unbiased, and
There is no registration required to be posted on the NTP Web site and the scientifically rigorous input to the
attend the webinars. The URLs for live submitter identified by name, affiliation, program for its use in making credible
and archived webinars will be available and/or sponsoring organization (if any). decisions about human hazard, setting
on the meeting Web site at https:// Guidelines for public comments are at research and testing priorities, and
ntp.niehs.nih.gov/about/org/ https://ntp.niehs.nih.gov/ntp/about_ providing information to regulatory
ntpexpertpanel/; please refer to this ntp/guidelines_public_comments_ agencies about alternative methods.
page for the most current information 508.pdf. NTP welcomes public comment for
about the webinars and the meeting. Oral public comment at this meeting dose-response modeling.
Expert Panel Meeting and is welcome, with time set aside on
Registration: The meeting is open to the October 23 for the formal presentation Dated: August 15, 2017.
public with time set aside for oral of oral remarks on the draft document. John R. Bucher,
public comment. Interested individuals In addition to in-person oral comments Associate Director, National Toxicology
can attend the meeting in person or at the NIEHS, public comments can be Program.
view the webcast. Attendance at NIEHS presented by teleconference line. There [FR Doc. 2017–18462 Filed 8–30–17; 8:45 am]
is limited only by the space available. will be 50 lines for this call; availability BILLING CODE 4140–01–P
For planning purposes, registration to is on a first-come, first-served basis. The
attend the meeting at NIEHS or view the lines will be open from 8:30 a.m. each
webcast is requested. Registration to day until adjournment. Oral comments DEPARTMENT OF THE INTERIOR
attend the meeting in person and/or will be received only during the formal
view the webcast is by October 25, 2017, public comment periods indicated on Fish and Wildlife Service
at https://ntp.niehs.nih.gov/about/org/ the preliminary agenda. The access [FWS–HQ–R–2017–N102;
ntpexpertpanel/. number for the teleconference line will FXRS12630900000–167–FF09R81000; OMB
Attending the Meeting: Visitor and be provided to registrants by email prior Control Number 1018–0140]
security information for those attending to the meeting. Each organization is
in person is available at https:// allowed one time slot. At least 7 Agency Information Collection
www.niehs.nih.gov/about/visiting/ minutes will be allotted to each time Activities; Hunting and Fishing
index.cfm. Individuals with disabilities slot, and if time permits, the allotment Application Forms and Activity
who need accommodation to participate may be extended to 10 minutes at the Reports for National Wildlife Refuges
in this event should contact Anna discretion of the chair. In addition to the
Stamatogiannakis by phone: (919) 293– formal public comment period, there AGENCY: Fish and Wildlife Service,
1652 or email: anna.stamatogiannakis@ will be several opportunities in the Interior.
icf.com. TTY users should contact the agenda for ad hoc comments. ACTION: Notice of Information
Federal TTY Relay Service at (800) 877– Persons wishing to make oral Collection; request for comment.
8339. Requests should be made at least comments during the formal comment
period on October 23 are asked to SUMMARY: In accordance with the
five business days in advance of the
register online at https:// Paperwork Reduction Act of 1995, we,
event.
Meeting Materials: The expert panel ntp.niehs.nih.gov/about/org/ the U.S. Fish and Wildlife Service
meeting agenda will be available on the ntpexpertpanel/ by October 13, 2017, (Service) are proposing to revise an
meeting Web site at https:// and indicate whether they will present information collection.
ntp.niehs.nih.gov/about/org/ comments in person or via the DATES: Interested persons are invited to
teleconference line. Oral public submit comments on or before October
sradovich on DSK3GMQ082PROD with NOTICES
ntpexpertpanel/. The draft document
should be available by August 23, 2017. commenters are asked to send a copy of 30, 2017.
Additional information will be posted their slides and/or statement or talking ADDRESSES: Send your comments on the
when available or may be requested in points to the FOR FURTHER INFORMATION information collection request (ICR) by
hardcopy, see FOR FURTHER INFORMATION CONTACT by October 13, 2017. Written mail to the Service Information
CONTACT. statements can supplement and may Collection Clearance Officer, U.S. Fish
Following the meeting, a report of the expand the oral presentation. and Wildlife Service, MS: BPHC, 5275
panel meeting will be prepared and Registration for in-person oral Leesburg Pike, Falls Church, VA 22041–
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Document Created: 2017-09-23 10:08:17
Document Modified: 2017-09-23 10:08:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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. | |
| Contact | Anna Stamatogiannakis, ICF, 2635 Meridian Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293- 1652, Fax: (919) 293-1645, Email: [email protected] | |
| FR Citation | 82 FR 41420 |
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