
[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Pages 23982-23983]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


Pediatric Clinical Investigator Training 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 the Center for Drug Evaluation and Research are 
announcing a 1-day public

[[Page 23983]]

workshop entitled ``Pediatric Clinical Investigator Training.'' The 
purpose of this workshop is to provide investigators with training and 
expertise in designing and conducting clinical trials in pediatric 
patients that will lead to appropriate labeling. The training course is 
intended to provide investigators with a clear understanding of some of 
the challenges of studying products in the pediatric population when 
the data are intended to be used to support product labeling, an 
overview of extrapolation as it relates to the pediatric population, a 
familiarity with FDA processes and timelines that are specific to 
pediatric product development, and an overview of ethically appropriate 
methods related to the design of clinical trials in the pediatric 
population.

DATES: The public workshop will be held on September 22, 2014, from 8 
a.m. to 5:30 p.m.

ADDRESSES: The public workshop will be held at the Pooks Hill Marriott, 
5151 Pooks Hill Rd., Bethesda, MD 20814. The hotel's telephone number 
is 301-897-9400.

FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of 
Pediatric Therapeutics, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8646, FAX: 301-
847-8640, email: terrie.crescenzi@fda.hhs.gov; or Betsy Sanford, Office 
of Pediatric Therapeutics, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8659, FAX: 301-
847-8640, elizabeth.sanford@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In July 2012, the Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-144) made permanent the pediatric 
initiatives, Best Pharmaceuticals for Children Act and Pediatric 
Research Equity Act, which have stimulated pediatric research over the 
past 15 years. Though much progress has been made, pediatric trials for 
the purpose of developing product use parameters and information are 
still performed much less frequently than adult trials. As such, 
current standards for trials are much more oriented to adult 
scientific, ethical, and clinical processes. This situation is due, in 
part, to the fact that pediatric trials have a number of unique 
attributes and requirements, which must be met if the data are to be 
accepted or used by FDA.
    The development of safe and effective products in the pediatric 
population presents many challenges. These challenges include trial 
design, appropriate endpoints, extrapolation of data from adults, and 
ethical issues. It is extremely important that pediatric researchers 
recognize and understand the challenges and differences between the 
standards for adult trials and pediatric trials. Researchers are 
responsible for ensuring the safe and ethical treatment of pediatric 
patients and obtaining adequate and reliable data to support regulatory 
decisions. There is a critical need for further pediatric research on 
medical products to obtain additional data, which will help ensure that 
these products are safe and effective in the pediatric population. We 
are able to obtain data and information in older children; however, the 
challenge of obtaining data from non-verbal children and neonates is 
much more difficult. This need reinforces our responsibility to educate 
clinical investigators to assure that children are only enrolled in 
research that is scientifically necessary, ethically sound, and 
designed to meet the challenges of review by FDA.

II. Participation in the Public Workshop

A. 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 by sending an email to OPT@fda.hhs.gov 
before September 8, 2014, and include the following information: Name, 
title, affiliation, email address, and telephone number. For those 
without Internet access, please contact Terrie L. Crescenzi or Betsy 
Sanford (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. Registration on the day of the public workshop will be provided 
on a space available basis beginning at 8 a.m.
    Registration information, the agenda and additional background 
materials can be found at http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm392506.htm.
    If you need special accommodations due to a disability, please 
contact Betsy Sanford (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance. Persons attending the course are advised that FDA is 
not responsible for providing access to electrical outlets.

B. Videotaping

    The workshop will be videotaped and available on the Internet at 
http://wcms.fda.gov/FDAgov/NewsEvents/MeetingsConferencesWorkshops/ucm392506.htm?ssSourceSiteId=null&SSContributor=true, approximately 30 
days after the workshop.

    Dated: April 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09695 Filed 4-28-14; 8:45 am]
BILLING CODE 4160-01-P


