Document ID: FDA-2013-N-0001-0079
Agency: fda
Document Type: Notice
Title: The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop
Posted Date: 2013-08-21T04:00Z

[Federal Register Volume 78, Number 162 (Wednesday, August 21, 2013)]
[Notices]
[Pages 51732-51733]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20371]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

The Food and Drug Administration/European Medicines Agency Orphan 
Product Designation and Grant Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration's (FDA) Office of Orphan Products 
Development is announcing the following meeting entitled ``The Food and 
Drug Administration/European Medicines Agency Orphan Product 
Designation and Grant Workshop.'' This 1-day workshop is intended to 
provide valuable information about the FDA and European Medicines 
Agency (EMA) Orphan Drug Designation programs, the FDA Humanitarian Use 
Device (HUD) Designation program, and the FDA Orphan Products Grant 
program to participants representing pharmaceutical, biotechnology, and 
device companies, as well as academics.
    Date and Time: The meeting will be held on October 4, 2013, from 
8:30 a.m. to 4 p.m.
    Location: The meeting will be held at FDA White Oak Campus, 10903 
New Hampshire Ave., Bldg. 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.
    Contact Person: Eleanor Dixon-Terry, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, rm. 5279, Silver Spring, MD 20993-
0002, 301-796-8660, FAX: 301-847-8621, Eleanor.Dixon-Terry@fda.hhs.gov.
    Registration: Interested participants may register for this meeting 
at the following Web site: https://events-support.com/events/FDA_Orphan_Workshop. If you need sign language interpretation during this 
meeting, please contact Eleanor Dixon-Terry at Eleanor.Dixon-Terry@fda.hhs.gov by September 20, 2013.
    Attendance: Online registration for the workshop will be limited to 
240 participants for the morning session, of which approximately 50 
teams (up to 150 participants) may register for the one-on-one 
sessions. There will be no registration fee for the workshop.
    For participants who cannot attend the morning meetings, 
simultaneous live interactive Webcasts will be made available. 
Participants may access the drug and biologics Webcast by visiting the 
following site: https://collaboration.fda.gov/odd100413/. The medical 
devices Webcast can be accessed by visiting: https://collaboration.fda.gov/hudd100413/.

SUPPLEMENTARY INFORMATION: The FDA/EMA Orphan Product Designation and 
Grant Workshop is being conducted in partnership with the European 
Organisation for Rare Diseases, Genetic Alliance, and the National 
Organization for Rare Disorders.
    The morning program includes two simultaneous sessions. The first 
will provide an overview of the FDA and EMA Orphan Drug Designation 
programs, respectively, while the second will provide an overview of 
the FDA HUD Designation Program and Pediatric Device Consortia Grant 
Program. Both morning sessions will also cover the Orphan Products 
Grant Program as they relate to drugs, biologics, and devices. Both of 
these morning sessions will also be available by Webcast.
    The afternoon session (no Webcast), provides an opportunity for 
appropriately registered participants to have one-on-one meetings with 
FDA staff members onsite, to discuss the specifics on how to apply for 
an orphan product grant, a HUD designation, or orphan drug designation. 
It also provides for videoconference sessions with EMA staff 
representatives on EMA orphan drug designation. Participants requesting 
one-on-one meetings are expected to bring information for at

[[Page 51733]]

least one candidate orphan drug or device that holds promise for the 
treatment of a rare disease or condition in order to discuss the 
processes for putting together an application. In addition, 
participants in the HUD or orphan drug designation one-on-one sessions 
are highly encouraged to come prepared with a working draft submission 
of their particular promising therapy in order to maximize the utility 
of the one-on-one meetings.

    Dated: August 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20371 Filed 8-20-13; 8:45 am]
BILLING CODE 4160-01-P