83 FR 35005 - Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 142 (July 24, 2018)

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.'' The purpose of the public workshop is to identify the challenges involved in the translation of toxicities from animal studies to clinical trials, to highlight potential endpoints that can be used in both nonclinical and clinical phases of drug development, and to provide a platform for engaging discussions to improve safety assessments for drugs impacting auditory and vestibular functions. This public workshop will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular endpoints.

[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)]
[Notices]
[Pages 35005-35006]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]


Regulatory Perspectives on Otic and Vestibular Toxicity: 
Challenges in Translating Animal Studies to Human Risk Assessment; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Regulatory Perspectives on Otic 
and Vestibular Toxicity: Challenges in Translating Animal Studies to 
Human Risk Assessment.'' The purpose of the public workshop is to 
identify the challenges involved in the translation of toxicities from 
animal studies to clinical trials, to highlight potential endpoints 
that can be used in both nonclinical and clinical phases of drug 
development, and to provide a platform for engaging discussions to 
improve safety assessments for drugs impacting auditory and vestibular 
functions. This public workshop will bring together regulatory medical 
and toxicologist reviewers, veterinary and clinical neurologists, and 
experts in evaluating auditory and vestibular endpoints.

DATES: The public workshop will be held on August 21, 2018, from 9 a.m. 
until 12 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. 
Entrance for the public workshop 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.

FOR FURTHER INFORMATION CONTACT: Deepa B. Rao, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4235, Silver Spring, MD 20993, 240-402-
6544, [email protected] or Christopher D. Toscano, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4145, Silver Spring, MD 20993, 301-796-
1122, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Although multiple drugs are known to cause hearing loss, otic and 
vestibular toxicities remain a neglected component in routine drug 
development. In drug safety evaluations, comparative clinical 
assessments for auditory and vestibular systems between animals and 
humans remain largely unexplored. The objective of this public workshop 
is to identify the challenges involved in the translation of toxicities 
from animal toxicology studies to clinical trials, to highlight 
potential endpoints that can be used in nonclinical and clinical phases 
of drug development, and to provide a platform for engaging discussions 
to improve safety assessments for ototoxic drugs. This public workshop 
will bring together regulatory medical and toxicologist reviewers, 
veterinary and clinical neurologists, and experts in evaluating 
auditory and vestibular endpoints.

II. Topics for Discussion at the Public Workshop

    A regulatory perspective of drug development and the occurrence of 
otic and vestibular toxicity will be presented, with a focus on the 
current regulatory recommendations on assessment of the auditory and 
vestibular systems in clinical and nonclinical studies. Relevant 
endpoints of vestibular and auditory function (clinical evaluation, 
non-invasive electrophysiological measurements, and histopathology) 
will be discussed from a clinical and nonclinical perspective. The 
public workshop will end with an open platform discussion between the 
audience and panelists regarding the adequacy of the current evaluation 
and potential future approaches towards improving safety assessments 
for agents impacting auditory and vestibular functions. We support the 
principles of the ``3Rs,'' to reduce, refine, and replace animal use in 
testing when feasible. We encourage sponsors to consult with us if it 
they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an 
alternative method could be assessed for equivalency to an animal test 
method.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website to register: https://www.eventbrite.com/e/fda-public-
workshop-regulatory-perspectives-on-

[[Page 35006]]

otic-vestibular-toxicity-tickets-47223962142. Please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by August 20, 2018, midnight Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization.
    For any participant in need of sign language interpretation, please 
send an email request to [email protected]. For all 
other reasonable accommodations, please contact FDA's Office of Equal 
Employment Opportunity at 301-796-9400.
    Streaming webcast of the public workshop: This public workshop will 
also be webcast at https://collaboration.fda.gov/ovtw/.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

    Dated: July 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15779 Filed 7-23-18; 8:45 am]
BILLING CODE 4164-01-P