FDA Announces Public Meetings and Comment Periods for Reauthorization of ADUFA and AGDUFA Programs
September 20, 2011
(Updated September 22, 2011 to include registration information)
The Food and Drug Administration (FDA) will be holding two public meetings on November 7, 2011. The Animal Drug User Fee Act (ADUFA) meeting will be held from 9 a.m. to 12 p.m. and the Animal Generic Drug User Fee Act (AGDUFA) from 1 p.m. to 4 p.m. at the Center for Veterinary Medicine, 7519 Standish Place, 3rd Floor, Room A, Rockville, MD 20855.
If you wish to attend and/or present at the ADUFA meeting, please register by e-mail to ADUFAReauthorization@fda.hhs.gov and if you wish to attend and/or present at the AGDUFA meeting, please register by email to AGDUFAReauthorization@fda.hhs.gov by October 26, 2011. Your e-mail should contain complete contact information for each attendee—name, title, affiliation, address, e-mail, and phone number. Also, please self-identify as a member of one of the following stakeholder categories: Scientific or academic experts; veterinary professionals; patient and consumer advocacy groups; or the regulated industry. Registration is free and will be on a first-come, first-served basis. Onsite registration will be available the day of the meeting; however, early registration is recommended since seating is limited.
ADUFA and AGDUFA give FDA the authority to collect user fees from the animal health industry and use these fees to make the approval process faster and more predictable. These programs expire on September 30, 2013 and before beginning reauthorization negotiations, FDA is seeking public comment on 1) the overall performance of the programs and 2) the aspects that should be retained, changed or discontinued to further strengthen the programs.
Comments can be submitted at the meetings, electronically via http://www.regulations.gov, or in writing to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1060, 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. Comments received by October 26, 2011 will be taken into consideration before the public meetings.