Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 35005 

registration is required by clicking the 

links below. 

Web ID: https://

adobeconnect.cdc.gov/e3pmwd6fhge/ 

event/registration.html. 

Dial in number: 888–790–3293 (100 

seats). 

Participant code: 3762458. 

DATES: The meeting will be held on 

August 30, 2018, 2:00 p.m. to 5:00 p.m., 

EDT. 

ADDRESSES: Web Conference. 

FOR FURTHER INFORMATION CONTACT: 

Dometa Ouisley, Office of Science and 

Public Health Practice, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, Mailstop D–44, 

Atlanta, Georgia 30333, Telephone: 

(404) 639–7450; Fax: (404) 471–8772; 

Email: OPHPR.BSC.Questions@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Purpose: This Board is charged with 

providing advice and guidance to the 

Secretary, Department of Health and 

Human Services (HHS), the Assistant 

Secretary for Health (ASH), the Director, 

Centers for Disease Control and 

Prevention (CDC), and the Director, 

Office of Public Health Preparedness 

and Response (OPHPR), concerning 

strategies and goals for the programs 

and research within OPHPR, monitoring 

the overall strategic direction and focus 

of the OPHPR Divisions and Offices, 

and administration and oversight of 

peer review for OPHPR scientific 

programs. For additional information 

about the Board, please visit: http://

www.cdc.gov/phpr/science/ 

counselors.htm. 

Matters to be considered: The agenda 

will include briefings and BSC 

deliberation on the following topics: 

Interval updates from OPHPR Divisions 

and Offices including responses to 

issues raised by the Board during the 

May 2018 in-person BSC meeting; 

updates from the Biological Agent 

Containment working group; and 

proposed agenda items for the October 

29–30 2018 in-person BSC meeting. 

Agenda items are subject to change as 

priorities dictate. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Sherri A. Berger, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–15781 Filed 7–23–18; 8:45 am] 

BILLING CODE 4163–19–P 

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, Deepa.Rao@fda.hhs.gov 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, Christopher.Toscano@

fda.hhs.gov. 

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-publicworkshop-regulatory-perspectives-onVerDate Sep<11>2014 13:59 Jul 23, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\24JYN1.SGM 24JYN1

jstallworth on DSKBBY8HB2PROD with NOTICES
35006 Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 

otic-vestibular-toxicity-tickets47223962142. 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 Interpreting.Services@

oc.fda.gov. 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2647] 

Inborn Errors of Metabolism That Use 

Dietary Management: Considerations 

for Optimizing and Standardizing Diet 

in Clinical Trials for Drug Product 

Development; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Inborn 

Errors of Metabolism That Use Dietary 

Management: Considerations for 

Optimizing and Standardizing Diet in 

Clinical Trials for Drug Product 

Development.’’ This draft guidance 

describes FDA’s current 

recommendations regarding how to 

optimize and standardize dietary 

management in clinical trials for the 

development of drugs treating inborn 

errors of metabolism (IEM) for which 

dietary management is a key component 

of patients’ metabolic control. 

Optimizing dietary management in 

these patients before entry into and 

during the clinical trial(s) is essential to 

providing an accurate evaluation of the 

efficacy of new drug products. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 24, 2018 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• 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– 

2018–D–2647 for ‘‘Inborn Errors of 

Metabolism That Use Dietary 

Management: Considerations for 

Optimizing and Standardizing Diet in 

Clinical Trials for Drug Product 

Development; Draft Guidance for 

Industry; Availability.’’ 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.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 


jstallworth on DSKBBY8HB2PROD with NOTICES