
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13375-13376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Advancing the Development of Pediatric Therapeutics: Successes 
and Challenges of Performing Long-Term Pediatric Safety Studies; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA) Office of Pediatric 
Therapeutics (OPT) and Center for Drug Evaluation and Research are 
announcing a 2-day public workshop entitled ``Advancing the Development 
of Pediatric Therapeutics (ADEPT): Successes and Challenges of 
Performing Long-Term Pediatric Safety Studies.'' The purpose of this 2-
day public workshop is for FDA to have an open discussion with experts 
in the field examining the need and path forward for long-term 
pediatric safety studies. Day 1 of the public workshop will focus on an 
exposition of the successes and challenges of long-term safety studies 
in children. Day 2 of the public workshop will focus on suggestions for 
the future on study design and implementation of long-term safety 
studies in children. Viewpoints of patient representatives of children 
with chronic conditions and industry will be included.

DATES: The public workshop will be held on April 13 and 14, 2016, from 
8 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--Bethesda, 8120 Wisconsin Ave., Bethesda, MD 20814.

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, email: 
renan.bonnel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Medical product safety studies in children are usually performed 
for 6 months or less. In children, measurement of long-term outcomes is 
particularly challenging since, compared to adults, children are 
undergoing dramatic growth and developmental changes. This 2-day public 
workshop will focus on the challenges of long-term follow-up in 
children receiving medical products. The first day of the public 
workshop will focus on the problems or barriers, including; challenges 
with study design, data capture, infrastructure, and endpoints. 
Viewpoints of parents and industry will be represented. The second day 
of the public workshop will include panel discussions to propose 
solutions to the problems posed on day one and to discuss the 
epidemiological challenges posed by the collection of data on different 
types of adverse events. On both days of the public workshop there will 
be a certain amount of time on the agenda for attendee questions or 
comments.

II. Participation in the Public Workshop

    Registration: There is no fee to attend the public workshop, but 
attendees should register in advance. Space is limited, and 
registration will be on a first-come, first-served basis. Persons 
interested in attending this workshop must register online at: http://pediatricsafety.eventbrite.com before April 7, 2016. For those without 
Internet access, please contact Renan A. Bonnel (see FOR FURTHER 
INFORMATION CONTACT) to register. In the event that a minimum number of 
participants have not registered, the workshop will be postponed. 
Registered participants will be notified of any change. Onsite 
registration will be available if seating permits it. Registration 
information, the agenda, and additional background materials can be 
found at http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm477639.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.
    Web cast: The live Web cast on April 13, 2016, will be available 
at: https://event.webcasts.com/starthere.jsp?ei=1093258. 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 that it is different 
from the morning's session): https://event.webcasts.com/starthere.jsp?ei=1093259. On April 14, 2016, the live Web cast will be 
available at: https://event.webcasts.com/starthere.jsp?ei=1093263. 
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 that it is different 
from the morning's session): https://event.webcasts.com/starthere.jsp?ei=1093265. The Web cast will only be for listening and 
there will not be an opportunity for Web cast participants to speak.
    The videocast will be posted after the workshop at http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm477639.htm.
    Transcripts: Transcripts of the workshop will be available for 
review at the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and 
at http://www.regulations.gov approximately 30 days after the workshop. 
A transcript will also be available in either hard copy or on CD-ROM, 
after submission of a Freedom of Information request. Send written 
requests to the Division of Freedom of Information. The Freedom of 
Information address is available on the Agency's Web site at

[[Page 13376]]

http://www.fda.gov. Send faxed requests to 301-827-9267.

    Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05621 Filed 3-11-16; 8:45 am]
 BILLING CODE 4164-01-P


