The Food and Drug Administration Predictive Toxicology Roadmap and Its Implementation; Public Hearing; Request for Comments, 30595-30598 [2018-14052]
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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Proposed Rules
inconsistencies between domestic
regulatory regimes?
b. Within statutory constraints, how
can Commerce minimize burdens to
licensees who operate in multiple
countries and are subject to multiple
countries’ regulatory regimes?
Topic 4: Compliance and Enforcement
The Secretary is required to ensure
compliance with the regulations and
with licenses (51 U.S.C. 60123, 15 CFR
960.13–960.15). To meet this obligation,
NOAA must collect information, but it
seeks to minimize the burden on
licensees.
With this background in mind, the
Department seeks general comments on
this topic. In addition, the Department
seeks input in response to the following
specific questions:
a. What are appropriate mechanisms
for ensuring compliance? Currently,
Commerce uses site visits, virtual
inspections, quarterly and annual
audits, and no-notice inspections as
needed.
b. How should Commerce ensure
compliance when multiple parties
(including investors) play a role in a
single licensed system? Options could
include licensing all involved parties, or
holding a single licensee responsible for
the entire system.
c. Are there any improvements the
Department could make to its formal
adjudication procedures in the
regulations?
d. Should Commerce mandate
licensees to use certain technical
standards, or particular software, for
compliance purposes? If so, what
standards or software should Commerce
require?
e. Should Commerce adopt different
compliance policies and procedures for
the different categories described in
Topic 2? If so, what policies and
procedures would be appropriate for the
different categories?
sradovich on DSK3GMQ082PROD with PROPOSALS
g. How should Commerce adjust
conditions in response to the increasing
capabilities of non-U.S. entities? How
frequently should NOAA evaluate those
increasing capabilities?
h. How can Commerce best provide
transparency to licensees regarding
classified national security risks?
This advance notice of proposed
rulemaking was determined to be
significant for purposes of E.O. 12866.
Topic 5: Integration With Other
Licensing and Regulatory Regimes
The Department recognizes that many
NOAA-licensed systems also require
licenses from other U.S. Government
agencies, and occasionally from
agencies in other countries. The
Department seeks to reduce the overall
regulatory burden to licensees, when
possible.
With this background in mind,
Commerce seeks general comments on
this topic. In addition, the Department
seeks input in response to the following
specific questions:
a. Within statutory constraints, how
can Commerce avoid redundancies and
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Classification
Dated: June 25, 2018.
Stephen Volz,
Assistant Administrator for Satellite and
Information Services, National Oceanic and
Atmospheric Administration, Department of
Commerce.
[FR Doc. 2018–14038 Filed 6–28–18; 8:45 am]
BILLING CODE 3510–HR–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA–2018–N–2309]
The Food and Drug Administration
Predictive Toxicology Roadmap and Its
Implementation; Public Hearing;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notification of public hearing;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing a public hearing to solicit
comments on FDA’s Predictive
Toxicology Roadmap, which was issued
by FDA on December 6, 2017. FDA is
seeking comments on how to foster the
development and evaluation of
emerging toxicological methods and
new technologies and incorporate these
methods and technologies into
regulatory review, as applicable.
DATES: The public hearing will be held
on Wednesday, September 12, 2018,
from 9 a.m. to 4 p.m. Persons seeking to
attend or to present at the public
hearing must register by Wednesday,
August 29, 2018. Section III provides
attendance and registration information.
Electronic or written comments will be
accepted after the public hearing until
Friday, October 12, 2018.
ADDRESSES: The public hearing will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993–0002.
Entrance for public hearing participants
SUMMARY:
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30595
(non-FDA employees) is through
Building 1, where routine security
check procedures will be performed. For
parking and security information, please
refer to: https://www.fda.gov/
AboutFDA/WorkingatFDA/Buildingsand
Facilities/WhiteOakCampus
Information/ucm241740.htm.
Electronic Submissions
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
via the https://www.regulations.gov
electronic filing system by midnight
Eastern Time on October 12, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked, and
identified as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
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2018–N–2309 for ‘‘The FDA Predictive
Toxicology Roadmap and its
Implementation; Public Hearing;
Request for Comments.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions: To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
received electronic and written/paper
comments, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tracy Chen, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4309A, Silver Spring,
MD 20993, Tracy.Chen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The scientific discipline of toxicology
is particularly essential to FDA’s
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mission because it is applied across the
breadth of FDA-regulated product areas.
Toxicological testing is performed
during the development and evaluation
of FDA-regulated products, ranging from
human and animal drugs and medical
devices to food and food ingredients,
human biologics, and tobacco products.
Advances in systems biology, stem cells,
engineered tissues, and mathematical
modeling are creating unique
opportunities to improve toxicology’s
predictive ability, potentially enhancing
FDA’s ability to predict risk. Also
critical is the potential of these
advances for replacing, reducing, and/or
refining animal testing. Today, novel
methods such as organs on a chip and
mathematical modeling are generating
unique opportunities that may improve
our ability to quickly and more
accurately predict potential toxicities
and reduce associated risks to the
public.
FDA centers have each taken
significant steps to enhance the use and
evaluation of cutting-edge toxicological
assays. However, more work needs to be
done to achieve broad acceptance of
new toxicology methodologies and
technologies. FDA’s six product centers
have different legal authorities for
evaluating product safety or toxicity.
Nevertheless, more robust
methodological evaluation and datasets
can help speed the acceptance of
emerging predictive toxicology methods
across the regulatory product areas.
FDA recognized that a comprehensive
strategy was needed to evaluate new
methodologies and technologies for
their potential to offer greater predictive
ability and to protect public health.
Acceptance of any new toxicology
testing method will require convincing
data as well as continuous dialogue and
feedback among all relevant
stakeholders, from development to
implementation, including qualification
and acceptance by regulatory
authorities.
To ensure that FDA continues to
employ cutting-edge science to assess
the toxicity of its regulated products and
to leverage advances being made in
toxicology, the Commissioner of Food
and Drugs (the Commissioner) tasked
the Agency’s Toxicology Working Group
with developing a more efficient process
for identifying and qualifying emerging
predictive toxicology technologies.
Established in 2015 and comprised of
senior FDA toxicologists from across the
Agency, the Working Group has deep
expertise in the various FDA product
areas and knowledge of the differing
legal authorities for evaluating toxicity
in those product areas.
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For a new testing method to be
accepted for use in determining the
toxicity of an FDA-regulated product
there must be convincing data to ensure
that the method can be relied upon for
both product development and
regulatory decision-making. FDA
evaluates the test or series of tests for
their applicability, limitations,
relevance, reliability, accuracy,
reproducibility, and sensitivity in the
evaluation of human response and
toxicity. Undergoing this process
requires continuous dialogue and
feedback among all relevant
stakeholders, beginning with developers
and ending with qualification and
acceptance by regulatory authorities.
FDA’s Predictive Toxicology
Roadmap (https://www.fda.gov/
PredictiveToxRoadmap) is a six-part
framework for integrating predictive
toxicology methods into safety and risk
assessments. Among other
recommendations, it calls for FDA
research to identify data gaps and to
support research to ensure that the most
promising technologies are developed,
validated, and integrated into regulatory
use. The roadmap also identifies
toxicology issues that need addressing
for FDA-regulated products and
toxicology areas that could benefit from
improved predictivity. Because this is a
high priority for the Agency, FDA’s
Toxicology Working Group will be
reporting yearly to FDA’s Chief Scientist
on progress made in this important
effort.
II. Topics for Discussion at the Public
Hearing
The purpose of this public meeting is
to invite public comment on how FDA
can better work with its stakeholders to
implement the goals of its Predictive
Toxicology Roadmap. We invite
interested parties to submit comments,
especially on the questions listed below
on each of the six parts in the roadmap.
Comments on additional areas are also
welcome.
A. FDA Toxicology Working Group
FDA has formed a senior-level
Toxicology Working Group under the
direction of the Commissioner to foster
enhanced communication among FDA
product centers and researchers and
leverage FDA resources to advance the
evaluation and integration of emerging
predictive toxicology methods and new
technologies into regulatory safety and
risk assessments.
1. Which goals of the FDA Roadmap
are most important to FDA
stakeholders?
2. What role could FDA stakeholders
play in achieving these goals?
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B. Training
Continuing current education in new
predictive toxicology methods is
essential for FDA regulators.
1. What training topics and
approaches do you think would help
FDA staff to appropriately implement
new alternative methods?
2. Are there relevant courses that you
can recommend?
3. Should FDA partner with its
stakeholders for these training courses
and how might this be achieved?
C. Continued Communication
FDA will continue to reaffirm its
commitment to and support for
incorporating data from newly qualified
toxicology methods into regulatory
submissions and encourage discussions
with stakeholders as part of the
regulatory submission process.
1. How can FDA better communicate
with stakeholders to encourage
discussion on the use of qualified new
toxicology methods early in the
regulatory process?
2. How can new toxicology methods
and approaches be integrated into FDA’s
review of regulated products?
3. What information do stakeholders
need from FDA to qualify alternative
methods for a specific context of use?
D. Collaborations
FDA will continue its long practice of
fostering collaborations across
disciplines nationally and
internationally.
1. What partnerships could be useful
to FDA to advance the roadmap?
2. Are there existing partnerships that
FDA should be involved in to achieve
the roadmap’s goals?
E. Research
FDA’s research programs will identify
data gaps and support research to
ensure that the most promising
technologies are identified, evaluated,
and integrated into product
development and assessment.
1. What data gaps should be
addressed by FDA research and research
conducted by external groups?
2. How can FDA encourage and
support research in areas of importance
to its mission?
3. How could FDA and stakeholders
evaluate whether alternative methods
are appropriately qualified for a specific
context of use?
F. Oversight
The Toxicology Working Group, with
representation from each FDA center,
will track the progress of these
recommendations and report to FDA’s
Chief Scientist annually.
1. How can FDA ensure transparency
in its progress?
2. How can FDA better foster
opportunities to share ideas and
knowledge with its stakeholders?
3. How can FDA highlight
collaborations on the development and
testing of new methods?
III. Participating in the Public Hearing
Registration and Requests To Make an
Oral Presentation: The FDA Conference
Center at the White Oak location is a
Federal facility with security procedures
and limited seating. Attendance will be
free and on a first-come, first-served
basis. If you wish to attend either in
person or by webcast and/or present at
the hearing, please register by Friday,
August 17, 2018, at the following
website at: https://www.fda.gov/
PredictiveToxRoadmap.
FDA will try to accommodate all
persons who wish to make a
presentation. Individuals wishing to
present should identify the number of
the specific question, or questions, they
wish to address. This will help FDA
organize the presentations. Individuals
and organizations with common
interests should consolidate or
coordinate their presentations and
request time for a joint presentation.
FDA will notify registered presenters of
their scheduled presentation times. The
time allotted for each presentation will
depend on the number of individuals
who wish to speak but should last a
maximum of 10 minutes. Presenters are
encouraged to submit an electronic copy
of their presentation to Tracy.Chen@
fda.hhs.gov (See FOR FURTHER
INFORMATION CONTACT) on or before
Friday, August 24, 2018. Persons
registered to make an oral presentation
are encouraged to arrive at the hearing
room early and check in at the onsite
registration table to confirm their
designated presentation time. An
agenda for the hearing and any other
background materials will be made
available 5 days before the hearing at
https://www.fda.gov/Predictive
ToxRoadmap.
If you need special accommodations
because of a disability, please contact
Shari Solomon (shari.solomon@
fda.hhs.gov) no later than Friday,
August 17, 2018, at 12 noon Eastern
Time.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff, 5630
Fishers Lane, Room 1061, Rockville, MD
20852.
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE RULEMAKING
DOCKETS
Date
Electronic address
Address
Public hearing ..............................
September 12, 2018 ..................
...............................................................
FDA White Oak Campus, 10903
New Hampshire Ave., Bldg.
31, Rm. 1503A, Silver Spring,
MD 20993.
Advance registration ....................
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Activity
By Wednesday, August 29,
2018.
....................................................
By Friday, August 17, 2018 .......
https://www.fda.gov/
predictivetoxroadmap.
Jeffery.Rexrode@fda.hhs.gov ..............
Tracy.Chen@fda.hhs.gov .....................
By Friday August 24, 2018 ........
Tracy.Chen@fda.hhs.gov .....................
By Friday, August 17, 2018 .......
shari.solomon@fda.hhs.gov .................
By October 12, 2018 ..................
https://www.regulations.gov ..................
Technical assistance ...................
Request to make an oral presentation.
Send PowerPoint slides (10 minutes maximum).
Request special accommodations
due to a disability.
Submit electronic or written comments.
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Dockets
Management
Staff
(HFA–305), Food and Drug
Administration, 5630 Fishers
Lane, Rm. 1061, Rockville,
MD 20852.
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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Proposed Rules
IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner is announcing that
the public hearing will be held in
accordance with 21 CFR part 15. The
hearing will be conducted by a
presiding officer, who will be
accompanied by FDA senior
management from the Office of the
Commissioner and the relevant Centers/
Offices. Under § 15.30(f), the hearing is
informal and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members can pose questions; they can
question any person during or after each
presentation. Public hearings under part
15 are subject to FDA’s policy and
procedures for electronic media
coverage of FDA’s public administrative
proceedings (21 CFR part 10, subpart C).
Under § 10.205, representatives of the
media may be permitted, subject to
certain limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants. The
hearing will be transcribed as stipulated
in § 15.30(b) (see Transcripts). To the
extent that the conditions for the
hearing, as described in this notice,
conflict with any provisions set out in
part 15, this notice acts as a waiver of
those provisions as specified in
§ 15.30(h).
Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14052 Filed 6–28–18; 8:45 am]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R01–OAR–2017–0696; FRL–9979–
82—Region 1]
Air Plan Approval; Vermont;
Infrastructure State Implementation
Plan Requirements for the 2012 PM2.5
NAAQS
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
sradovich on DSK3GMQ082PROD with PROPOSALS
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve
elements of a State Implementation Plan
(SIP) submission from Vermont that
addresses the infrastructure
requirements of the Clean Air Act (CAA
or Act)—including the interstate
transport provisions—for the 2012 fine
particle (PM2.5) National Ambient Air
SUMMARY:
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Quality Standards (NAAQS). The
infrastructure requirements are designed
to ensure that the structural components
of each state’s air quality management
program are adequate to meet the state’s
responsibilities under the CAA. This
action is being taken under the Clean
Air Act.
DATES: Written comments must be
received on or before July 30, 2018.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R01–
OAR–2017–0696, to the
www.regulations.gov website or via
email to simcox.alison@epa.gov. For
comments submitted to the
www.regulations.gov website, follow the
online instructions for submitting
comments. Once submitted, comments
cannot be edited or removed from
www.regulations.gov. For either manner
of submission, the EPA may publish any
comment received to its public docket.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. The EPA will generally not
consider comments or comment
contents located outside of the primary
submission (i.e., on the web, cloud, or
other file sharing system). For
additional submission methods, please
contact the person identified in the ‘‘For
Further Information Contact’’ section.
For the full EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
www.epa.gov/dockets/commenting-epadockets. Publicly available docket
materials are available at
www.regulations.gov or at the U.S.
Environmental Protection Agency, EPA
New England Regional Office, Office of
Ecosystem Protection, Air Quality
Planning Unit, 5 Post Office Square—
Suite 100, Boston, MA. EPA requests
that if at all possible, you contact the
contact listed in the FOR FURTHER
INFORMATION CONTACT section to
schedule your inspection. The Regional
Office’s official hours of business are
Monday through Friday, 8:30 a.m. to
4:30 p.m., excluding legal holidays.
FOR FURTHER INFORMATION CONTACT:
Alison C. Simcox, Air Quality Unit, U.S.
Environmental Protection Agency, EPA
New England Regional Office, 5 Post
Office Square—Suite 100, (Mail code
OEP05–2), Boston, MA 02109–3912, tel.
(617) 918–1684; simcox.alison@epa.gov.
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SUPPLEMENTARY INFORMATION:
Throughout this document whenever
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
EPA.
Table of Contents
I. Background and Purpose
A. What Vermont SIP submissions does
this rulemaking address?
B. What is the scope of this rulemaking?
II. What guidance is EPA using to evaluate
these SIP submissions?
III. EPA’s Review
A. Section 110(a)(2)(A)—Emission Limits
and Other Control Measures
B. Section 110(a)(2)(B)—Ambient Air
Quality Monitoring/Data System
C. Section 110(a)(2)(C)—Program for
Enforcement of Control Measures and for
Construction or Modification of
Stationary Sources
D. Section 110(a)(2)(D)—Interstate
Transport
E. Section 110(a)(2)(E)—Adequate
Resources
F. Section 110(a)(2)(F)—Stationary Source
Monitoring System
G. Section 110(a)(2)(G)—Emergency
Powers
H. Section 110(a)(2)(H)—Future SIP
Revisions
I. Section 110(a)(2)(I)—Nonattainment Area
Plan or Plan Revisions Under Part D
J. Section 110(a)(2)(J)—Consultation With
Government Officials; Public
Notifications; Prevention of Significant
Deterioration; Visibility Protection
K. Section 110(a)(2)(K)—Air Quality
Modeling/Data
L. Section 110(a)(2)(L)—Permitting Fees
M. Section 110(a)(2)(M)—Consultation/
Participation by Affected Local Entities
IV. Proposed Action
V. Statutory and Executive Order Reviews
I. Background and Purpose
A. What Vermont SIP submissions does
this rulemaking address?
This rulemaking addresses a SIP
submission from the Vermont
Department of Environmental
Conservation (VT DEC). The state
submitted its infrastructure SIP for the
2012 fine particle (PM2.5 1) National
Ambient Air Quality Standard (NAAQS)
on October 31, 2017. This included an
enclosure addressing the ‘‘Good
Neighbor’’ (or ‘‘transport’’) provisions
for the 2012 PM2.5 NAAQS (Section
110(a)(2)(D)(i)(I) of the CAA). Under
sections 110(a)(1) and (2) of the CAA,
states are required to submit
infrastructure SIPs to ensure that SIPs
provide for implementation,
maintenance, and enforcement of the
NAAQS, including the 2012 PM2.5
NAAQS.
1 PM
2.5 refers to particulate matter of 2.5 microns
or less in diameter, often referred to as ‘‘fine’’
particles.
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]]>Agencies
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Proposed Rules]
[Pages 30595-30598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14052]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA-2018-N-2309]
The Food and Drug Administration Predictive Toxicology Roadmap
and Its Implementation; Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public hearing to solicit comments on FDA's Predictive Toxicology
Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking
comments on how to foster the development and evaluation of emerging
toxicological methods and new technologies and incorporate these
methods and technologies into regulatory review, as applicable.
DATES: The public hearing will be held on Wednesday, September 12,
2018, from 9 a.m. to 4 p.m. Persons seeking to attend or to present at
the public hearing must register by Wednesday, August 29, 2018. Section
III provides attendance and registration information. Electronic or
written comments will be accepted after the public hearing until
Friday, October 12, 2018.
ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for public hearing
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to: https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Electronic Submissions
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted via the https://www.regulations.gov electronic filing system
by midnight Eastern Time on October 12, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-
[[Page 30596]]
2018-N-2309 for ``The FDA Predictive Toxicology Roadmap and its
Implementation; Public Hearing; Request for Comments.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions: To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the received electronic and written/paper comments, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Tracy Chen, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4309A, Silver
Spring, MD 20993, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The scientific discipline of toxicology is particularly essential
to FDA's mission because it is applied across the breadth of FDA-
regulated product areas. Toxicological testing is performed during the
development and evaluation of FDA-regulated products, ranging from
human and animal drugs and medical devices to food and food
ingredients, human biologics, and tobacco products. Advances in systems
biology, stem cells, engineered tissues, and mathematical modeling are
creating unique opportunities to improve toxicology's predictive
ability, potentially enhancing FDA's ability to predict risk. Also
critical is the potential of these advances for replacing, reducing,
and/or refining animal testing. Today, novel methods such as organs on
a chip and mathematical modeling are generating unique opportunities
that may improve our ability to quickly and more accurately predict
potential toxicities and reduce associated risks to the public.
FDA centers have each taken significant steps to enhance the use
and evaluation of cutting-edge toxicological assays. However, more work
needs to be done to achieve broad acceptance of new toxicology
methodologies and technologies. FDA's six product centers have
different legal authorities for evaluating product safety or toxicity.
Nevertheless, more robust methodological evaluation and datasets can
help speed the acceptance of emerging predictive toxicology methods
across the regulatory product areas.
FDA recognized that a comprehensive strategy was needed to evaluate
new methodologies and technologies for their potential to offer greater
predictive ability and to protect public health. Acceptance of any new
toxicology testing method will require convincing data as well as
continuous dialogue and feedback among all relevant stakeholders, from
development to implementation, including qualification and acceptance
by regulatory authorities.
To ensure that FDA continues to employ cutting-edge science to
assess the toxicity of its regulated products and to leverage advances
being made in toxicology, the Commissioner of Food and Drugs (the
Commissioner) tasked the Agency's Toxicology Working Group with
developing a more efficient process for identifying and qualifying
emerging predictive toxicology technologies. Established in 2015 and
comprised of senior FDA toxicologists from across the Agency, the
Working Group has deep expertise in the various FDA product areas and
knowledge of the differing legal authorities for evaluating toxicity in
those product areas.
For a new testing method to be accepted for use in determining the
toxicity of an FDA-regulated product there must be convincing data to
ensure that the method can be relied upon for both product development
and regulatory decision-making. FDA evaluates the test or series of
tests for their applicability, limitations, relevance, reliability,
accuracy, reproducibility, and sensitivity in the evaluation of human
response and toxicity. Undergoing this process requires continuous
dialogue and feedback among all relevant stakeholders, beginning with
developers and ending with qualification and acceptance by regulatory
authorities.
FDA's Predictive Toxicology Roadmap (https://www.fda.gov/PredictiveToxRoadmap) is a six-part framework for integrating
predictive toxicology methods into safety and risk assessments. Among
other recommendations, it calls for FDA research to identify data gaps
and to support research to ensure that the most promising technologies
are developed, validated, and integrated into regulatory use. The
roadmap also identifies toxicology issues that need addressing for FDA-
regulated products and toxicology areas that could benefit from
improved predictivity. Because this is a high priority for the Agency,
FDA's Toxicology Working Group will be reporting yearly to FDA's Chief
Scientist on progress made in this important effort.
II. Topics for Discussion at the Public Hearing
The purpose of this public meeting is to invite public comment on
how FDA can better work with its stakeholders to implement the goals of
its Predictive Toxicology Roadmap. We invite interested parties to
submit comments, especially on the questions listed below on each of
the six parts in the roadmap. Comments on additional areas are also
welcome.
A. FDA Toxicology Working Group
FDA has formed a senior-level Toxicology Working Group under the
direction of the Commissioner to foster enhanced communication among
FDA product centers and researchers and leverage FDA resources to
advance the evaluation and integration of emerging predictive
toxicology methods and new technologies into regulatory safety and risk
assessments.
1. Which goals of the FDA Roadmap are most important to FDA
stakeholders?
2. What role could FDA stakeholders play in achieving these goals?
[[Page 30597]]
B. Training
Continuing current education in new predictive toxicology methods
is essential for FDA regulators.
1. What training topics and approaches do you think would help FDA
staff to appropriately implement new alternative methods?
2. Are there relevant courses that you can recommend?
3. Should FDA partner with its stakeholders for these training
courses and how might this be achieved?
C. Continued Communication
FDA will continue to reaffirm its commitment to and support for
incorporating data from newly qualified toxicology methods into
regulatory submissions and encourage discussions with stakeholders as
part of the regulatory submission process.
1. How can FDA better communicate with stakeholders to encourage
discussion on the use of qualified new toxicology methods early in the
regulatory process?
2. How can new toxicology methods and approaches be integrated into
FDA's review of regulated products?
3. What information do stakeholders need from FDA to qualify
alternative methods for a specific context of use?
D. Collaborations
FDA will continue its long practice of fostering collaborations
across disciplines nationally and internationally.
1. What partnerships could be useful to FDA to advance the roadmap?
2. Are there existing partnerships that FDA should be involved in
to achieve the roadmap's goals?
E. Research
FDA's research programs will identify data gaps and support
research to ensure that the most promising technologies are identified,
evaluated, and integrated into product development and assessment.
1. What data gaps should be addressed by FDA research and research
conducted by external groups?
2. How can FDA encourage and support research in areas of
importance to its mission?
3. How could FDA and stakeholders evaluate whether alternative
methods are appropriately qualified for a specific context of use?
F. Oversight
The Toxicology Working Group, with representation from each FDA
center, will track the progress of these recommendations and report to
FDA's Chief Scientist annually.
1. How can FDA ensure transparency in its progress?
2. How can FDA better foster opportunities to share ideas and
knowledge with its stakeholders?
3. How can FDA highlight collaborations on the development and
testing of new methods?
III. Participating in the Public Hearing
Registration and Requests To Make an Oral Presentation: The FDA
Conference Center at the White Oak location is a Federal facility with
security procedures and limited seating. Attendance will be free and on
a first-come, first-served basis. If you wish to attend either in
person or by webcast and/or present at the hearing, please register by
Friday, August 17, 2018, at the following website at: https://www.fda.gov/PredictiveToxRoadmap.
FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the specific question, or questions, they wish to address. This will
help FDA organize the presentations. Individuals and organizations with
common interests should consolidate or coordinate their presentations
and request time for a joint presentation. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak but should last a maximum of 10 minutes. Presenters are
encouraged to submit an electronic copy of their presentation to
[email protected] (See FOR FURTHER INFORMATION CONTACT) on or
before Friday, August 24, 2018. Persons registered to make an oral
presentation are encouraged to arrive at the hearing room early and
check in at the onsite registration table to confirm their designated
presentation time. An agenda for the hearing and any other background
materials will be made available 5 days before the hearing at https://www.fda.gov/PredictiveToxRoadmap.
If you need special accommodations because of a disability, please
contact Shari Solomon ([email protected]) no later than Friday,
August 17, 2018, at 12 noon Eastern Time.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Dockets Management Staff, 5630 Fishers Lane, Room
1061, Rockville, MD 20852.
Table 1--Information on Participation in the Meeting and on Submitting Comments to the Rulemaking Dockets
----------------------------------------------------------------------------------------------------------------
Activity Date Electronic address Address
----------------------------------------------------------------------------------------------------------------
Public hearing....................... September 12, 2018..... ....................... FDA White Oak Campus,
10903 New Hampshire
Ave., Bldg. 31, Rm.
1503A, Silver Spring,
MD 20993.
Advance registration................. By Wednesday, August https://www.fda.gov/ .......................
29, 2018. predictivetoxroadmap.
Technical assistance................. ....................... [email protected] .......................
.gov.
Request to make an oral presentation. By Friday, August 17, [email protected]. .......................
2018.
Send PowerPoint slides (10 minutes By Friday August 24, [email protected]. .......................
maximum). 2018.
Request special accommodations due to By Friday, August 17, [email protected] .......................
a disability. 2018. ov.
Submit electronic or written comments By October 12, 2018.... https:// Dockets Management
www.regulations.gov. Staff (HFA-305), Food
and Drug
Administration, 5630
Fishers Lane, Rm.
1061, Rockville, MD
20852.
----------------------------------------------------------------------------------------------------------------
[[Page 30598]]
IV. Notice of Hearing Under 21 CFR Part 15
The Commissioner is announcing that the public hearing will be held
in accordance with 21 CFR part 15. The hearing will be conducted by a
presiding officer, who will be accompanied by FDA senior management
from the Office of the Commissioner and the relevant Centers/Offices.
Under Sec. 15.30(f), the hearing is informal and the rules of evidence
do not apply. No participant may interrupt the presentation of another
participant. Only the presiding officer and panel members can pose
questions; they can question any person during or after each
presentation. Public hearings under part 15 are subject to FDA's policy
and procedures for electronic media coverage of FDA's public
administrative proceedings (21 CFR part 10, subpart C). Under Sec.
10.205, representatives of the media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see Transcripts). To the extent that the conditions for the
hearing, as described in this notice, conflict with any provisions set
out in part 15, this notice acts as a waiver of those provisions as
specified in Sec. 15.30(h).
Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14052 Filed 6-28-18; 8:45 am]
BILLING CODE 4164-01-P
