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U.S. Department of Health and Human Services

Drugs

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Generic Drug User Fee (GDUF) Public Meeting: May 10, 2011

The Food and Drug Administration (FDA) is announcing a public meeting to provide a public update and to gather additional stakeholder input on the development of a generic drug user fee program. A user fee program could provide necessary supplemental funding, in addition to current Congressional appropriations, to facilitate the timely review of human generic drug applications by FDA, and FDA is currently in negotiations with the regulated industry aimed at providing a consensus proposal for congressional consideration. In the interest of transparency, and to assure that all interested stakeholders views are heard and considered, whether they are present at the negotiations or not, FDA is holding a public meeting to provide an update on the current process and to gather additional input on such a program.

Date:       May 10, 2011

Time:       2:00 p.m. - 3:30 p.m.

Location:  FDA White Oak Campus
               10903 New Hampshire Ave. Bldg. 1
               Conference Rooms 4101, 4103 and 4105
               Silver Spring, MD 20993-002

Attendees:

If you wish to attend and/or present at the meeting, please email your registration information to GDUFA_Meeting2@fda.hhs.gov by May 3, 2011. Your email should contain complete contact information for each attendee, including name, title, affiliation, address, email address, and telephone number. Registration is free and will be on a first-come, first-served basis. Early registration is recommended because seating is limited. FDA may limit the number of participants from each organization as well as the total number of participants, based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. We will try to accommodate all persons who wish to make a presentation. The time allotted for presentations may depend on the number of persons who wish to speak. In general, the meeting format will include a presentation by FDA and presentations by stakeholders and members of the public who have registered in advance to present at the meeting. The amount of time available for presentations will be determined by the number of people who register to make a presentation.

Comments:

We will provide an opportunity for organizations and individuals to submit either electronic or written comments to the docket after the meeting. A Federal Register Notice announcing this public meeting will be published soon.

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