[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]


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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, [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
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               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.
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[[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