83 FR 30595 - The Food and Drug Administration Predictive Toxicology Roadmap and Its Implementation; Public Hearing; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

Page Range		30595-30598
FR Document		2018-14052

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.

Federal Register, Volume 83 Issue 126 (Friday, June 29, 2018)

[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Proposed Rules]
[Pages 30595-30598]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-14052]

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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.

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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, Tracy.Chen@fda.hhs.gov.

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
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/PredictiveToxRoadmap.
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
----------------------------------------------------------------------------------------------------------------
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................. ....................... Jeffery.Rexrode@fda.hhs .......................
.gov.
Request to make an oral presentation. By Friday, August 17, Tracy.Chen@fda.hhs.gov. .......................
2018.
Send PowerPoint slides (10 minutes By Friday August 24, Tracy.Chen@fda.hhs.gov. .......................
maximum). 2018.
Request special accommodations due to By Friday, August 17, shari.solomon@fda.hhs.g .......................
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

30598 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Proposed Rules

IV. Notice of Hearing Under 21 CFR Quality Standards (NAAQS). The SUPPLEMENTARY INFORMATION:
Part 15 infrastructure requirements are designed Throughout this document whenever
The Commissioner is announcing that to ensure that the structural components ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
the public hearing will be held in of each state’s air quality management EPA.
accordance with 21 CFR part 15. The program are adequate to meet the state’s
responsibilities under the CAA. This Table of Contents
hearing will be conducted by a
presiding officer, who will be action is being taken under the Clean I. Background and Purpose
accompanied by FDA senior Air Act. A. What Vermont SIP submissions does
DATES: Written comments must be this rulemaking address?
management from the Office of the B. What is the scope of this rulemaking?
Commissioner and the relevant Centers/ received on or before July 30, 2018.
II. What guidance is EPA using to evaluate
Offices. Under § 15.30(f), the hearing is ADDRESSES: Submit your comments,
these SIP submissions?
informal and the rules of evidence do identified by Docket ID No. EPA–R01– III. EPA’s Review
not apply. No participant may interrupt OAR–2017–0696, to the A. Section 110(a)(2)(A)—Emission Limits
the presentation of another participant. www.regulations.gov website or via and Other Control Measures
Only the presiding officer and panel email to simcox.alison@epa.gov. For B. Section 110(a)(2)(B)—Ambient Air
members can pose questions; they can comments submitted to the Quality Monitoring/Data System
question any person during or after each www.regulations.gov website, follow the C. Section 110(a)(2)(C)—Program for
presentation. Public hearings under part online instructions for submitting Enforcement of Control Measures and for
comments. Once submitted, comments Construction or Modification of
15 are subject to FDA’s policy and
cannot be edited or removed from Stationary Sources
procedures for electronic media D. Section 110(a)(2)(D)—Interstate
coverage of FDA’s public administrative www.regulations.gov. For either manner
Transport
proceedings (21 CFR part 10, subpart C). of submission, the EPA may publish any
E. Section 110(a)(2)(E)—Adequate
Under § 10.205, representatives of the comment received to its public docket. Resources
media may be permitted, subject to Do not submit electronically any F. Section 110(a)(2)(F)—Stationary Source
certain limitations, to videotape, film, or information you consider to be Monitoring System
otherwise record FDA’s public Confidential Business Information (CBI) G. Section 110(a)(2)(G)—Emergency
administrative proceedings, including or other information whose disclosure is Powers
presentations by participants. The restricted by statute. Multimedia H. Section 110(a)(2)(H)—Future SIP
hearing will be transcribed as stipulated submissions (audio, video, etc.) must be Revisions
accompanied by a written comment. I. Section 110(a)(2)(I)—Nonattainment Area
in § 15.30(b) (see Transcripts). To the Plan or Plan Revisions Under Part D
extent that the conditions for the The written comment is considered the
J. Section 110(a)(2)(J)—Consultation With
hearing, as described in this notice, official comment and should include
Government Officials; Public
conflict with any provisions set out in discussion of all points you wish to Notifications; Prevention of Significant
part 15, this notice acts as a waiver of make. The EPA will generally not Deterioration; Visibility Protection
those provisions as specified in consider comments or comment K. Section 110(a)(2)(K)—Air Quality
§ 15.30(h). contents located outside of the primary Modeling/Data
submission (i.e., on the web, cloud, or L. Section 110(a)(2)(L)—Permitting Fees
Dated: June 26, 2018.
other file sharing system). For M. Section 110(a)(2)(M)—Consultation/
Leslie Kux, additional submission methods, please Participation by Affected Local Entities
Associate Commissioner for Policy. contact the person identified in the ‘‘For IV. Proposed Action
[FR Doc. 2018–14052 Filed 6–28–18; 8:45 am] Further Information Contact’’ section. V. Statutory and Executive Order Reviews
BILLING CODE 4164–01–P For the full EPA public comment policy, I. Background and Purpose
information about CBI or multimedia
submissions, and general guidance on A. What Vermont SIP submissions does
ENVIRONMENTAL PROTECTION making effective comments, please visit this rulemaking address?
AGENCY www.epa.gov/dockets/commenting-epa- This rulemaking addresses a SIP
dockets. Publicly available docket submission from the Vermont
40 CFR Part 52 materials are available at Department of Environmental
[EPA–R01–OAR–2017–0696; FRL–9979– www.regulations.gov or at the U.S. Conservation (VT DEC). The state
82—Region 1] Environmental Protection Agency, EPA submitted its infrastructure SIP for the
New England Regional Office, Office of 2012 fine particle (PM2.5 1) National
Air Plan Approval; Vermont; Ecosystem Protection, Air Quality
Infrastructure State Implementation Ambient Air Quality Standard (NAAQS)
Planning Unit, 5 Post Office Square— on October 31, 2017. This included an
Plan Requirements for the 2012 PM2.5 Suite 100, Boston, MA. EPA requests
NAAQS enclosure addressing the ‘‘Good
that if at all possible, you contact the Neighbor’’ (or ‘‘transport’’) provisions
AGENCY: Environmental Protection contact listed in the FOR FURTHER for the 2012 PM2.5 NAAQS (Section
Agency (EPA). INFORMATION CONTACT section to
110(a)(2)(D)(i)(I) of the CAA). Under
schedule your inspection. The Regional sections 110(a)(1) and (2) of the CAA,
ACTION: Proposed rule.
Office’s official hours of business are states are required to submit
SUMMARY: The Environmental Protection Monday through Friday, 8:30 a.m. to
sradovich on DSK3GMQ082PROD with PROPOSALS

infrastructure SIPs to ensure that SIPs
Agency (EPA) is proposing to approve 4:30 p.m., excluding legal holidays. provide for implementation,
elements of a State Implementation Plan FOR FURTHER INFORMATION CONTACT: maintenance, and enforcement of the
(SIP) submission from Vermont that Alison C. Simcox, Air Quality Unit, U.S. NAAQS, including the 2012 PM2.5
addresses the infrastructure Environmental Protection Agency, EPA NAAQS.
requirements of the Clean Air Act (CAA New England Regional Office, 5 Post
or Act)—including the interstate Office Square—Suite 100, (Mail code 1 PM
2.5 refers to particulate matter of 2.5 microns
transport provisions—for the 2012 fine OEP05–2), Boston, MA 02109–3912, tel. or less in diameter, often referred to as ‘‘fine’’
particle (PM2.5) National Ambient Air (617) 918–1684; simcox.alison@epa.gov. particles.

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Document Created: 2018-06-29 01:13:37
Document Modified: 2018-06-29 01:13:37

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		Proposed Rules
Action		Notification of public hearing; request for comments.
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.
Contact		Tracy Chen, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4309A, Silver Spring, MD 20993, [email protected]
FR Citation		83 FR 30595

83 FR 30595 - The Food and Drug Administration Predictive Toxicology Roadmap and Its Implementation; Public Hearing; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration