81 FR 26804 - Quantitative Assessment of Assumptions To Support Extrapolation of Efficacy in Pediatrics; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 86 (May 4, 2016)

The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), is announcing a public workshop entitled ``Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.'' The objective of the workshop is to discuss quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. The workshop will also provide a forum for discussion on the use of modeling and simulation for systematic assessment of extrapolation assumptions.

[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Notices]
[Pages 26804-26805]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-10397]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Quantitative Assessment of Assumptions To Support Extrapolation 
of Efficacy in Pediatrics; Public Workshop

AGENCY: Food and Drug Administration, HHS.

[[Page 26805]]


ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA), in collaboration with 
the University of Maryland Center of Excellence in Regulatory Science 
and Innovation (CERSI), is announcing a public workshop entitled 
``Quantitative Assessment of Assumptions to Support Extrapolation of 
Efficacy in Pediatrics.'' The objective of the workshop is to discuss 
quantitative and qualitative approaches for verifying assumptions 
pertaining to disease and therapeutic response similarity between 
adults and children. The workshop will also provide a forum for 
discussion on the use of modeling and simulation for systematic 
assessment of extrapolation assumptions.

DATES: The public workshop will be held on June 1, 2016, from 8 a.m. to 
5 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. 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, Office of the Chief Scientist, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4220, Silver 
Spring, MD 20993-0002, 301-796-3520, [email protected].

SUPPLEMENTARY INFORMATION: The purpose of this public workshop is to 
provide an opportunity for relevant stakeholders, including clinicians, 
academia, industry, and FDA to discuss systematic assessment of data 
needed to support extrapolation of efficacy in pediatric product 
development. Specifically, the workshop will include: (1) Presentations 
on approaches for assessing disease and therapeutic response similarity 
between adults and pediatrics, and (2) discussion of alternative 
approaches to the assessment of extrapolation assumptions in pediatric 
product development, including the use of clinical trial simulation and 
Bayesian approaches. Examples in partial onset seizures, inflammatory 
bowel diseases, and polyarticular juvenile idiopathic arthritis will be 
presented and discussed.
    FDA has verified the Web site addresses in this document, but FDA 
is not responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register.
    Agenda: The agenda is located at www.pharmacy.umaryland.edu/PedsExtrapolation.
    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 www.pharmacy.umaryland.edu/PedsExtrapolation. 
There will be no onsite registration. The costs of registration, to 
attend in person, for the different categories of attendees are as 
follows:

------------------------------------------------------------------------
                            Category                               Cost
------------------------------------------------------------------------
Industry Representative........................................      $50
Nonprofit Organization and Academic other than University of          50
 Maryland......................................................
University of Maryland, College Park and Baltimore.............        0
Federal Government.............................................        0
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    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 access to the Webcast link is available at 
www.pharmacy.umaryland.edu/PedsExtrapolation. 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.
    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 
[email protected] at least 7 days in advance.

    Dated: April 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10397 Filed 5-3-16; 8:45 am]
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