[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Notices]
[Pages 39271-39272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14230]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Pediatric Clinical Investigator Training; 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, and the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development are announcing a 2-day public 
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. Although we have 
learned a lot about conducting pediatric trials over the past two 
decades, there are still challenges that need to be addressed. The 
training course is intended to provide investigators with: (1) A clear 
understanding of some of the challenges of studying products in the 
pediatric population, including: Pediatric study design, neonates, 
biomarkers, endpoints, orphan drugs and rare disease trial design, 
formulations; (2) an overview of extrapolation as it relates to the 
pediatric population; and (3) 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 12 and 13, 2016, 
from 8 a.m. to 4 p.m. Registration to attend the workshop should be 
completed by September 6, 2016. (See the SUPPLEMENTARY INFORMATION 
section for instructions).

ADDRESSES: This public workshop will be held at the DoubleTree 
Bethesda, 8120 Wisconsin Ave., Bethesda, MD 20814.

FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of 
Pediatric Therapeutics, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 
[email protected]; or Betsy Sanford, Office of Pediatric 
Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, [email protected].

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 (BPCA) and Pediatric 
Research Equity Act, which have stimulated pediatric research over the 
past two decades. The National Institutes of Health section of BPCA 
legislation, however, is due for reauthorization in 2017. Though much 
progress has been made, pediatric trials for the purpose of developing 
product use information are still performed 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 both scientific 
challenges and 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

[[Page 39272]]

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. Much of the progress which has been made in 
obtaining proper therapeutic information in pediatrics has occurred in 
the older and more populous pediatric populations. The challenge of 
obtaining data from non-verbal children, neonates, and for conditions 
existing in limited populations 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. Workshop Attendance and Participation

    If you wish to attend this workshop, visit http://pedsinvesttrain.eventbrite.com. Please register by September 6, 2016. 
Those who are unable to attend the workshop in person can register to 
view a live Webcast of the workshop. You will be asked to indicate in 
your registration if you plan to attend in person or via the Webcast. 
Your registration will also require your complete contact information, 
including name, title, affiliation, address, email address, and phone 
number. Seating will be limited so early registration is recommended. 
Registration is free and will be on a first-come, first-served basis. 
Onsite registration on the day of the workshop will be based on space 
availability. Persons attending the workshop are advised that FDA is 
not responsible for providing access to electrical outlets.
    Registration information, the agenda, and additional background 
materials can be found at http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm392506.htm.
    Webcast: The workshop will be Webcast live and available on the 
Internet.
    The live Webcast on September 12, 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 
September 13, 2016, the live Webcast 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 
Webcast will only be for listening and there will not be an opportunity 
for Webcast participants to speak. The Webcast will be posted after the 
workshop at: http://wcms.fda.gov/FDAgov/NewsEvents/MeetingsConferencesWorkshops/ucm392506.htm?ssSourceSiteId=null&SSContributor=true, approximately 30 
days after the workshop.
    If you need special accommodations due to a disability, please 
contact Betsy Sanford (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance.

    Dated: June 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14230 Filed 6-15-16; 8:45 am]
BILLING CODE 4164-01-P