Document ID: FDA-2016-N-0001-0090
Agency: fda
Document Type: Notice
Title: Pediatric Master Protocols; Public Workshop
Posted Date: 2016-08-05T04:00Z

[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Notices]
[Page 51918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18555]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Pediatric Master Protocols; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), in collaboration with 
the University of Maryland Center of Excellence in Regulatory Science 
and Innovation, is announcing a public workshop titled, ``Pediatric 
Master Protocols''. The objective of the workshop is to discuss 
regulatory and scientific concerns related to pediatric master 
protocols and clinical trial design considerations for these protocols. 
In addition, applications of pediatric master protocols to specific 
pediatric therapeutic areas will be presented.

DATES: The public workshop will be held on September 23, 2016, from 
8:30 a.m. to 4:30 p.m.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Audrey Thomas, Office of Regulatory 
Science and Innovation, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 1, Rm. 4220, Silver Spring, MD 20993-0002, 301-
796-3520, Audrey.Thomas@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The purpose of this public workshop is to 
provide an opportunity for relevant stakeholders including: Clinicians 
and scientists from FDA and other government Agencies, academia, non-
profit organizations, and industry to discuss use of pediatric master 
protocols for development of medical products for children. 
Specifically, the workshop will present the current status of pediatric 
protocol development in the United States, considerations for pediatric 
protocol development internationally, and development of international 
consortia in this area. Clinical trial design considerations and the 
preliminary steps needed for development of pediatric master protocols, 
including the role of in vitro diagnostic tests, will also be 
discussed. Finally, examples of pediatric master protocol development 
for medical products with no, partial, and full extrapolation of data 
from adults to children will be presented. The workshop will include 
two panel sessions for interaction and discussion among the speakers 
and attendees.
    Agenda: The agenda is available at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm507079.htm (FDA has 
verified the Web site address, but FDA is not responsible for 
subsequent changes to the Web site after this document publishes in the 
Federal Register).
    Registration: There is a registration fee to attend this public 
workshop in-person. Seats are limited and registration will be on a 
first-come, first-served basis. To register, please complete 
registration online at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm507079.htm (FDA has verified the Web 
site address, but FDA is not responsible for subsequent changes to the 
Web site after this document publishes in the Federal Register). There 
will be no onsite registration. The costs of registration, to attend 
in-person, for different categories of attendees are as follows:

------------------------------------------------------------------------
                        Category                               Cost
------------------------------------------------------------------------
Industry Representative.................................             $50
Nonprofit Organization and Academic Other Than                        50
 University of Maryland.................................
University of Maryland, College Park and Baltimore......               0
Federal Government......................................               0
------------------------------------------------------------------------

    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. There is no registration fee for access to the 
workshop via the Webcast, but registration is still required. 
Information regarding registration and access to the Webcast link is 
available at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm507079.htm. 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 http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in 
this document, but FDA is not responsible for any subsequent changes to 
the Web sites after this document publishes in the Federal Register.)
    Accommodations: Attendees are responsible for their own hotel 
accommodations. If you need special accommodations while at FDA's White 
Oak Campus due to a disability, please contact Shari Solomon at 
Shari.Solomon@fda.hhs.gov at least 7 days in advance.

    Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18555 Filed 8-4-16; 8:45 am]
 BILLING CODE 4164-01-P