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)
Food and Drug Administration
Federal Register Volume 83, Issue 142 (July 24, 2018)
| Page Range | 35005-35006 | |
| FR Document | 2018-15779 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 35005
registration is required by clicking the DEPARTMENT OF HEALTH AND 1122, Christopher.Toscano@
links below. HUMAN SERVICES fda.hhs.gov.
Web ID: https:// SUPPLEMENTARY INFORMATION:
adobeconnect.cdc.gov/e3pmwd6fhge/ Food and Drug Administration
event/registration.html. I. Background
[Docket No. FDA–2018–N–0001]
Dial in number: 888–790–3293 (100 Although multiple drugs are known to
seats). Regulatory Perspectives on Otic and cause hearing loss, otic and vestibular
Participant code: 3762458. Vestibular Toxicity: Challenges in toxicities remain a neglected component
DATES: The meeting will be held on Translating Animal Studies to Human in routine drug development. In drug
August 30, 2018, 2:00 p.m. to 5:00 p.m., Risk Assessment; Public Workshop safety evaluations, comparative clinical
EDT. assessments for auditory and vestibular
AGENCY: Food and Drug Administration, systems between animals and humans
ADDRESSES: Web Conference.
HHS. remain largely unexplored. The
FOR FURTHER INFORMATION CONTACT:
ACTION: Notice of public workshop. objective of this public workshop is to
Dometa Ouisley, Office of Science and
Public Health Practice, Centers for identify the challenges involved in the
SUMMARY: The Food and Drug
Disease Control and Prevention, 1600 translation of toxicities from animal
Administration (FDA) is announcing the
Clifton Road NE, Mailstop D–44, toxicology studies to clinical trials, to
following public workshop entitled
Atlanta, Georgia 30333, Telephone: highlight potential endpoints that can
‘‘Regulatory Perspectives on Otic and
(404) 639–7450; Fax: (404) 471–8772; be used in nonclinical and clinical
Vestibular Toxicity: Challenges in
Email: OPHPR.BSC.Questions@cdc.gov. phases of drug development, and to
Translating Animal Studies to Human provide a platform for engaging
SUPPLEMENTARY INFORMATION: Risk Assessment.’’ The purpose of the discussions to improve safety
Purpose: This Board is charged with public workshop is to identify the assessments for ototoxic drugs. This
providing advice and guidance to the challenges involved in the translation of public workshop will bring together
Secretary, Department of Health and toxicities from animal studies to clinical regulatory medical and toxicologist
Human Services (HHS), the Assistant trials, to highlight potential endpoints reviewers, veterinary and clinical
Secretary for Health (ASH), the Director, that can be used in both nonclinical and neurologists, and experts in evaluating
Centers for Disease Control and clinical phases of drug development, auditory and vestibular endpoints.
Prevention (CDC), and the Director, and to provide a platform for engaging
Office of Public Health Preparedness discussions to improve safety II. Topics for Discussion at the Public
and Response (OPHPR), concerning assessments for drugs impacting Workshop
strategies and goals for the programs auditory and vestibular functions. This A regulatory perspective of drug
and research within OPHPR, monitoring public workshop will bring together development and the occurrence of otic
the overall strategic direction and focus regulatory medical and toxicologist and vestibular toxicity will be
of the OPHPR Divisions and Offices, reviewers, veterinary and clinical presented, with a focus on the current
and administration and oversight of neurologists, and experts in evaluating regulatory recommendations on
peer review for OPHPR scientific auditory and vestibular endpoints. assessment of the auditory and
programs. For additional information DATES: The public workshop will be vestibular systems in clinical and
about the Board, please visit: http:// held on August 21, 2018, from 9 a.m. nonclinical studies. Relevant endpoints
www.cdc.gov/phpr/science/ until 12 p.m. See the SUPPLEMENTARY of vestibular and auditory function
counselors.htm. INFORMATION section for registration date (clinical evaluation, non-invasive
Matters to be considered: The agenda and information. electrophysiological measurements, and
will include briefings and BSC ADDRESSES: FDA White Oak Campus, histopathology) will be discussed from
deliberation on the following topics: 10903 New Hampshire Ave., Bldg. 31 a clinical and nonclinical perspective.
Interval updates from OPHPR Divisions Conference Center, the Great Room (Rm. The public workshop will end with an
and Offices including responses to 1503), Silver Spring, MD 20993. open platform discussion between the
issues raised by the Board during the Entrance for the public workshop audience and panelists regarding the
May 2018 in-person BSC meeting; participants (non-FDA employees) is adequacy of the current evaluation and
updates from the Biological Agent through Building 1 where routine potential future approaches towards
Containment working group; and security check procedures will be improving safety assessments for agents
proposed agenda items for the October performed. For parking and security impacting auditory and vestibular
29–30 2018 in-person BSC meeting. information, please refer to https:// functions. We support the principles of
Agenda items are subject to change as www.fda.gov/AboutFDA/ the ‘‘3Rs,’’ to reduce, refine, and replace
priorities dictate. WorkingatFDA/BuildingsandFacilities/ animal use in testing when feasible. We
The Director, Management Analysis WhiteOakCampusInformation/ encourage sponsors to consult with us if
and Services Office, has been delegated ucm241740.htm. it they wish to use a non-animal testing
the authority to sign Federal Register method they believe is suitable,
notices pertaining to announcements of FOR FURTHER INFORMATION CONTACT: adequate, validated, and feasible. We
meetings and other committee Deepa B. Rao, Center for Drug will consider if such an alternative
management activities, for both the Evaluation and Research, Food and method could be assessed for
Centers for Disease Control and Drug Administration, 10903 New equivalency to an animal test method.
Hampshire Ave., Bldg. 22, Rm. 4235,
jstallworth on DSKBBY8HB2PROD with NOTICES
Prevention and the Agency for Toxic III. Participating in the Public
Substances and Disease Registry. Silver Spring, MD 20993, 240–402–
6544, Deepa.Rao@fda.hhs.gov or Workshop
Sherri A. Berger, Christopher D. Toscano, Center for Drug Registration: To register for the public
Chief Operating Officer, Centers for Disease Evaluation and Research, Food and workshop, please visit the following
Control and Prevention. Drug Administration, 10903 New website to register: https://
[FR Doc. 2018–15781 Filed 7–23–18; 8:45 am] Hampshire Ave., Bldg. 22, Rm. 4145, www.eventbrite.com/e/fda-public-
BILLING CODE 4163–19–P Silver Spring, MD 20993, 301–796– workshop-regulatory-perspectives-on-
VerDate Sep<11>2014 13:59 Jul 23, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\24JYN1.SGM 24JYN1](https://thefederalregister.org/doc/83_FR_35147/page/1.svg)
![35006 Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices
otic-vestibular-toxicity-tickets- ACTION: Notice of availability. • Mail/Hand Delivery/Courier (for
47223962142. Please provide complete written/paper submissions): Dockets
contact information for each attendee, SUMMARY: The Food and Drug Management Staff (HFA–305), Food and
including name, title, affiliation, Administration (FDA or Agency) is Drug Administration, 5630 Fishers
address, email, and telephone. announcing the availability of a draft Lane, Rm. 1061, Rockville, MD 20852.
Registration is free and based on guidance for industry entitled ‘‘Inborn • For written/paper comments
space availability, with priority given to Errors of Metabolism That Use Dietary submitted to the Dockets Management
early registrants. Persons interested in Management: Considerations for Staff, FDA will post your comment, as
attending this public workshop must Optimizing and Standardizing Diet in well as any attachments, except for
register by August 20, 2018, midnight Clinical Trials for Drug Product information submitted, marked and
Eastern Time. Early registration is Development.’’ This draft guidance identified, as confidential, if submitted
recommended because seating is describes FDA’s current as detailed in ‘‘Instructions.’’
limited; therefore, FDA may limit the recommendations regarding how to Instructions: All submissions received
number of participants from each optimize and standardize dietary must include the Docket No. FDA–
organization. management in clinical trials for the 2018–D–2647 for ‘‘Inborn Errors of
For any participant in need of sign development of drugs treating inborn Metabolism That Use Dietary
language interpretation, please send an errors of metabolism (IEM) for which Management: Considerations for
email request to Interpreting.Services@ dietary management is a key component Optimizing and Standardizing Diet in
oc.fda.gov. For all other reasonable of patients’ metabolic control. Clinical Trials for Drug Product
accommodations, please contact FDA’s Optimizing dietary management in Development; Draft Guidance for
Office of Equal Employment these patients before entry into and Industry; Availability.’’ Received
Opportunity at 301–796–9400. during the clinical trial(s) is essential to comments will be placed in the docket
Streaming webcast of the public providing an accurate evaluation of the and, except for those submitted as
workshop: This public workshop will efficacy of new drug products. ‘‘Confidential Submissions,’’ publicly
also be webcast at https:// DATES: Submit either electronic or
viewable at https://www.regulations.gov
collaboration.fda.gov/ovtw/. written comments on the draft guidance or at the Dockets Management Staff
If you have never attended a Connect by September 24, 2018 to ensure that between 9 a.m. and 4 p.m., Monday
Pro event before, test your connection at the Agency considers your comment on through Friday.
• Confidential Submissions—To
https://collaboration.fda.gov/common/ this draft guidance before it begins work
submit a comment with confidential
help/en/support/meeting_test.htm. To on the final version of the guidance.
information that you do not wish to be
get a quick overview of the Connect Pro ADDRESSES: You may submit comments made publicly available, submit your
program, visit https://www.adobe.com/ on any guidance at any time as follows: comments only as a written/paper
go/connectpro_overview. FDA has
Electronic Submissions submission. You should submit two
verified the website addresses in this
copies total. One copy will include the
document, as of the date this document Submit electronic comments in the information you claim to be confidential
publishes in the Federal Register, but following way: with a heading or cover note that states
websites are subject to change over time. • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Transcripts: Please be advised that as https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
soon as a transcript of the public instructions for submitting comments. Agency will review this copy, including
workshop is available, it will be Comments submitted electronically, the claimed confidential information, in
accessible at https:// including attachments, to https:// its consideration of comments. The
www.regulations.gov. It may be viewed www.regulations.gov will be posted to second copy, which will have the
at the Dockets Management Staff (HFA– the docket unchanged. Because your claimed confidential information
305), Food and Drug Administration, comment will be made public, you are redacted/blacked out, will be available
5630 Fishers Lane, Rm. 1061, Rockville, solely responsible for ensuring that your for public viewing and posted on
MD 20852. comment does not include any https://www.regulations.gov. Submit
Dated: July 18, 2018. confidential information that you or a both copies to the Dockets Management
Leslie Kux, third party may not wish to be posted, Staff. If you do not wish your name and
Associate Commissioner for Policy. such as medical information, your or contact information to be made publicly
[FR Doc. 2018–15779 Filed 7–23–18; 8:45 am]
anyone else’s Social Security number, or available, you can provide this
confidential business information, such information on the cover sheet and not
BILLING CODE 4164–01–P
as a manufacturing process. Please note in the body of your comments and you
that if you include your name, contact must identify this information as
DEPARTMENT OF HEALTH AND information, or other information that ‘‘confidential.’’ Any information marked
HUMAN SERVICES identifies you in the body of your as ‘‘confidential’’ will not be disclosed
comments, that information will be except in accordance with 21 CFR 10.20
Food and Drug Administration posted on https://www.regulations.gov. and other applicable disclosure law. For
• If you want to submit a comment more information about FDA’s posting
[Docket No. FDA–2018–D–2647]
with confidential information that you of comments to public dockets, see 80
Inborn Errors of Metabolism That Use do not wish to be made available to the FR 56469, September 18, 2015, or access
jstallworth on DSKBBY8HB2PROD with NOTICES
Dietary Management: Considerations public, submit the comment as a the information at: https://www.gpo.gov/
for Optimizing and Standardizing Diet written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
in Clinical Trials for Drug Product manner detailed (see ‘‘Written/Paper 23389.pdf.
Development; Draft Guidance for Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Industry; Availability read background documents or the
Written/Paper Submissions electronic and written/paper comments
AGENCY: Food and Drug Administration, Submit written/paper submissions as received, go to https://
HHS. follows: www.regulations.gov and insert the
VerDate Sep<11>2014 13:59 Jul 23, 2018 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\24JYN1.SGM 24JYN1](https://thefederalregister.org/doc/83_FR_35147/page/2.svg)
Document Created: 2018-07-24 00:10:29
Document Modified: 2018-07-24 00:10:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 35005 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR