Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 40005 

Hee V. Choi at least 7 days in advance 

of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 18, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17856 Filed 8–22–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–2464] 

Advancing the Development of 

Pediatric Therapeutics: Application of 

‘‘Big Data’’ to Pediatric Safety Studies; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Office of Pediatric 

Therapeutics, Food and Drug 

Administration (FDA), is announcing a 

public workshop entitled ‘‘Advancing 

the Development of Pediatric 

Therapeutics (ADEPT): Application of 

‘‘Big Data’’ to Pediatric Safety Studies.’’ 

The purpose of this 2-day workshop is 

to understand how to access and 

analyze ‘‘Big Data’’ associated with 

safety information in the health care 

setting, and the utility and challenges 

associated with the use of ‘‘Big Data’’ to 

study the safety of therapeutics in 

children. 

DATES: The public workshop will be 

held on September 18 and 19, 2017, 

from 8:30 a.m. to 5 p.m. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held at the DoubleTree by Hilton 

Hotel, 8727 Colesville Rd. (Route 29), 

Silver Spring, MD 20910. 

FOR FURTHER INFORMATION CONTACT: 

Renan A. Bonnel, Office of Pediatric 

Therapeutics, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–8654, Fax: 301–847–8640, 

renan.bonnel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Large volumes of data in the context 

of the health care industry have the 

potential to provide additional 

information related to medication use, 

which may affect the benefit-risk 

assessment of medicines in general and 

pediatric medicines in particular. Since 

pediatric pharmacoepidemiologic 

studies tend to enroll fewer patients 

than adult studies, additional 

information may be needed to better 

understand the safety and efficacy of 

use of these drugs in children. ‘‘Big 

Data’’, including forms of real world 

evidence that may involve large and 

complex data sets, may be particularly 

useful as a supplement to traditional 

studies. Supplementary information 

may include additional clinical trial 

data, registry data, and electronic health 

record information. 

II. Topics for Discussion at the Public 

Workshop 

In this workshop, FDA will gather 

information on the latest developments 

in ‘‘Big Data’’ from the perspective of a 

number of stakeholders and expand the 

conversation to include the utility and 

challenges associated with the use of 

‘‘Big Data’’ in the pediatric setting. Day 

1 will focus on national and 

international uses of ‘‘Big Data’’ in 

health care. Day 2 will focus on ‘‘Big 

Data’’ utility in the pediatric setting, 

including specific challenges associated 

with pediatric data. 

III. Participation in the Public 

Workshop 

Registration: Persons interested in 

attending this workshop must register 

online at: https://www.eventbrite.com/e/ 

public-workshop-advancing-thedevelopment-of-pediatric-therapeuticsadept-application-of-big-data-tickets32470264435 by August 22, 2017. For 

those without internet access, please 

contact Renan A. Bonnel (see FOR

FURTHER INFORMATION CONTACT) to 

register. 

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 22, 2017. Early 

registration is recommended because 

seating is limited; therefore, FDA may 

limit the number of participants. 

Registration information, the agenda, 

and additional background materials 

can be found at https://www.fda.gov/ 

NewsEvents/ 

MeetingsConferencesWorkshops/ 

ucm545847.htm. 

If you need special accommodations 

due to a disability, please contact Renan 

A. Bonnel (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance. 

Persons attending the meeting are 

advised that FDA is not responsible for 

providing access to electrical outlets. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast. 

September 18: Login URL: https://

event.webcasts.com/ 

starthere.jsp?ei=1144352 (morning 

session). 

After the morning session, users will 

be automatically redirected to the 

afternoon link. Should you lose 

connection over lunch, please use the 

following link for the afternoon session 

(Note: the link for the afternoon session 

is different from the morning session): 

Login URL: https://event.webcasts.com/ 

starthere.jsp?ei=1144354 (afternoon 

session). 

September 19: Login URL: https://

event.webcasts.com/ 

starthere.jsp?ei=1144356 (morning 

session). 

After the morning session, users will 

be automatically redirected to the 

afternoon link. Should you lose 

connection over lunch, please use the 

following link for the afternoon session 

(Note: the link for the afternoon session 

is different from the morning session): 

Login URL: https://event.webcasts.com/ 

starthere.jsp?ei=1144357 (afternoon 

session). 

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 Web site addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

Web sites 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 office 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. A link to 

the transcript will be available on the 

internet at https://www.fda.gov/ 

NewsEvents/ 

MeetingsConferencesWorkshops/ 

ucm545847.htm. 

Dated: August 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17783 Filed 8–22–17; 8:45 am] 

BILLING CODE 4164–01–P 


asabaliauskas on DSKBBXCHB2PROD with NOTICES