[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Page 40005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17783]


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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.

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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, 
<a href="/cdn-cgi/l/email-protection#2d5f48434c43034f42434348416d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="d8aabdb6b9b6f6bab7b6b6bdb498bebcb9f6b0b0abf6bfb7ae">[email protected]</span></a>.

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-the-development-of-pediatric-therapeutics-adept-application-of-big-data-tickets-32470264435 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


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