E6-21738. Marketed Unapproved Drugs; Public Workshop; Change of Meeting Location and Time

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a change of location and time for the upcoming public workshop on marketed unapproved drugs. Registration for the public workshop is closed. A new address and time are given for those persons who have previously registered with FDA.

DATES:

The public workshop will be held on January 9, 2007, from 8:30 a.m. to 4:30 p.m.

ADDRESSES:

The public workshop will be held in the Universities at Shady Grove, Conference Center Auditorium, bldg. 1, 9640 Gudelsky Dr., Rockville, MD. Directions and information on parking, hotels, and transportation options can be found at http://www.shadygrove.umd.edu/​conference. The agenda for the workshop will be posted at http://www.fda.gov/​cder/​drug/​unapproved_​drugs.

FOR FURTHER INFORMATION CONTACT:

Karen Kirchberg, Center for Drug Evaluation and Research (HFD-330), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-8916, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November 1, 2006 (71 FR 64284), FDA issued a notice announcing a public workshop on issues related to the application process for seeking approval for marketed unapproved drugs. The November 1, 2006, notice invited individuals interested in attending the workshop to register and submit topics for discussion by November 15, 2006. Registration for the workshop is closed. Attendance at the workshop is limited to those persons who have previously registered with FDA.

Because of a greater than anticipated response for attending the public workshop, FDA is announcing in this notice a new location and time.

II. New Location and Time for the Public Workshop

The new location will be the Universities at Shady Grove, Conference Center Auditorium (see ADDRESSES). Directions and information on parking, hotels, and transportation options can be found at http://www.shadygrove.umd.edu/​conference. The new time will be 8:30 a.m. to 4:30 p.m.

Dated: December 14, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.