Document ID: FDA-2012-N-0001-0107
Agency: fda
Document Type: Notice
Title: Orphan Product Designation and Grant Workshop Meeting
Posted Date: 2012-08-30T04:00Z

[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Pages 52744-52745]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21398]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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    The Food and Drug Administration's (FDA) Office of Orphan Products 
Development is announcing the following meeting: 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, the FDA Orphan Products Grant program, and the 
European Union (EU) rare disease research programs to participants 
representing pharmaceutical, biotechnology, and device companies, as 
well as academics.
    Date and Time: The meeting will be held on October 12, 2012, 8:30 
a.m. to 5:30 p.m.
    Attendance: Online registration for the workshop will be limited to 
240 participants for the morning session, of which approximately 30 
teams (up to 90 participants) may register for the one-on-one sessions. 
There will be no registration fee for the workshop.
    Location: The meeting will be held at FDA White Oak Campus, 10903 
New Hampshire Ave., Bldg. 31, 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 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/orphan2012/. The medical devices webcast can be accessed by visiting: 
https://collaboration.fda.gov/devices2012/.
    Contact: Erica K. McNeilly at Erica.McNeilly@fda.hhs.gov or J. 
Lloyd Johnson at Lloyd.Johnson@fda.hhs.gov, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5279, Silver 
Spring MD 20993-0002, (301) 796-8660, FAX: (301) 847-8621.
    Registration: Interested participants may register for this meeting 
at the following Web site: https://events-support.com/events/FDA-EMA_Workshop. If you need sign language interpretation during this meeting, 
please contact Erica K. McNeilly at Erica.McNeilly@fda.hhs.gov by 
September 28, 2012.
    The workshop will consist of two simultaneous morning sessions. The 
first will provide an overview of the EMA and FDA Orphan Drug

[[Page 52745]]

Designation programs, while the second will provide an overview of the 
FDA HUD Designation Program. Both morning sessions will also cover the 
Orphan Products Grant Program and the EU rare disease research programs 
as it relates to drugs and biologics, and devices, respectively. Both 
of these morning sessions will also be available by webcast.
    The afternoon session will provide an opportunity for appropriately 
registered on-site participants to have one-on-one meetings with FDA or 
EMA staff members to discuss the specifics on how to apply for an 
orphan product grant, EU rare disease research assistance program, a 
HUD designation, or orphan drug designation. Participants requesting 
one-on-one meetings will need to undergo a second registration process 
with FDA, and are expected to bring information for at 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 of the HUD 
or orphan drug designation one-one-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. The FDA/EMA Orphan Product Designation and Grant Workshop is 
supported by the FDA and the EMA, and is being conducted in partnership 
with the European Organisation for Rare Disease (EURODIS), Genetic 
Alliance, and the National Organization for Rare Diseases (NORD).

    Dated: August 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-21398 Filed 8-29-12; 8:45 am]
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