FDA Announces 2012 Public Meetings and Comment Periods for Reauthorization of ADUFA and AGDUFA Programs
December 5, 2012
The Food and Drug Administration (FDA) will be holding two public meetings on December 18, 2012. The topic to be discussed is proposed recommendations for the reauthorization of the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA).
The ADUFA meeting will be held from 9 a.m. to 12 p.m. and the AGDUFA meeting from 1 p.m. to 4 p.m. at the Center for Veterinary Medicine, 7519 Standish Place, 3rd Floor, Meeting Room A, Rockville, MD 20855.
ADUFA and AGDUFA give FDA the authority to collect user fees from the animal health industry and have enabled FDA to speed up the application review process for pioneer and generic new animal drugs without compromising the quality of the Agency’s review. These programs expire on September 30, 2013 and FDA has completed negotiations with industry and will convene these public meetings to hear the public's views on the proposed recommendations for reauthorization of ADUFA II and AGDUFA I. The meetings will include a presentation by FDA, and there will be an opportunity for other organizations and individuals to make presentations at the meeting or to submit written comments to the docket.
If you wish to attend and/or present at the ADUFA meeting, please register by email to Jacqueline Farmer at ADUFAReauthorization@fda.hhs.gov and if you wish to attend and/or present at the AGDUFA meeting, please register by email to Jacqueline Farmer at AGDUFAReauthorization@fda.hhs.gov by December 11, 2012. Your e-mail should contain complete contact information for each attendee—name, title, affiliation, address, e-mail, and phone number. Additional contact information for Jacqueline Farmer: Center for Veterinary Medicine (HFV-10), FDA, 7519 Standish Pl., Rockville, MD 20855, 240-276-8695, FAX: 240-276-9744. Onsite registration will be available the day of the meeting; however, early registration is recommended since seating is limited.
Comments can be submitted at the meetings, electronically via http://www.regulations.gov, or in writing to Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. When providing comments, please reference docket number FDA-2011-N-0656 for ADUFA and docket number FDA-2011-N-0655 for AGDUFA.