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U.S. Department of Health and Human Services

Drugs

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Generic Drug User Fee (GDUF) Public Meeting: December 19, 2011

The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for enactment of a Generic Drug User Fee Act (GDUFA), which will authorize FDA to collect fees and use them for the process for the review of human generic drug applications and associated Type II Active Pharmaceutical Ingredient Drug Master Files (DMFs) and for conducting associated inspections for fiscal years (FYs) 2013-2017.  New legislation would be required for FDA to establish and collect user fees under such a program.  FDA and the regulated industry have developed a proposal for Congressional consideration. In the interest of transparency, and in an effort to voluntarily follow a process similar to the ones set forth in the Federal Food, Drug, and Cosmetic Act for FDA’s other user fee programs, FDA is publishing the negotiated recommendations (the goals letter), holding a meeting at which the public may present its views on such recommendations, and providing an opportunity for the public to provide written comments on such recommendations.  

Date:             December 19, 2011

Time:          10:00 a.m. - 5:00 p.m.
 
Location:     FDA White Oak Campus
                  10903 New Hampshire Ave. Bldg. 2
                  Conference Room 2047
                  Silver Spring, MD 20993
 
Attendees:
If you wish to attend and/or present at the meeting, please email your registration information to GDUFA_Meeting4@fda.hhs.gov by December 12, 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.
 
For those unable to attend in person, FDA will Web cast and provide a telephone audio link to the meeting.  To join the Web meeting, please go to https://collaboration.fda.gov/gdufa/ . For audio, please call 301-796-2700 and enter participant code 121947.  If you have never attended a Connect Pro meeting before, you may wish to test your connection by going to: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
 
Comments: 
We will provide an opportunity for organizations and individuals to submit either electronic or written comments to the docket after the meeting   Comments must be submitted by January 6, 2012. 
 
For More Information :
Please see the Federal Register Notice announcing the Meeting, available here:http://www.gpo.gov/fdsys/pkg/FR-2011-12-08/pdf/2011-31630.pdf .