March 17, 2005
FY 2004 Performance Report to Congress for ADUFA Available
The Food and Drug Administration FY 2004 Performance Report to Congress for the Animal Drug User Fee Act (ADUFA) of 2003 has been posted on the FDA/Center for Veterinary Medicine Home Page. FDA agreed, under this new Act, to meet a comprehensive set of performance goals established to show significant improvement in the timeliness and predictability of the new animal drug review process. The report presents the Agency’s accomplishments for FY 2004, the first year operating under ADUFA.
Highlights of the FY 2004 activities and accomplishments include:
ADUFA Performance -- FDA met or exceeded all the review time frames defined under ADUFA for FY 2004 for applications and submissions that have been acted on as of September 30, 2004. Additional applications and submissions received in FY 2004 are pending review and action, but are still within ADUFA time frames. FY 2004 performance will be updated in FY 2005 to reflect these pending actions.
FDA Backlog -- The 833 submissions not associated with abbreviated new animal drug applications (ANADAs) that were pending before September 30, 2003, have been reviewed and acted upon. FDA was required to review and act on pending new animal drug applications (NADAs), supplemental NADAs, and investigational new animal drug submissions (INADs) within 24 months after user fee payments were initiated.
FDA Hiring -- FDA has made substantial progress in recruiting for its review staff and will meet its goal of having 50 percent of additional FDA review staff recruited and on-board by the first quarter of FY 2006.
Guidance Development -- On March 15, 2004, the Agency published Guidance for Industry #170 “Animal Drug User Fees and Fee Waivers and Reductions” to help industry understand the ADUFA fee structure and the options available to individuals who qualify for a fee waiver or reduction. On September 28, 2004, the Agency published Guidance for Industry #173 “Animal Drug Sponsor Fees under the Animal Drug User Fee Act (Draft Guidance)”
FDA is committed to improving the efficiency, quality, and predictability of the new animal drug review process. The Agency is dedicated to exploring new approaches and technologies that offer high quality, cost-effective improvements in FDA’s review of new animal drug applications and submissions.
Issued by:
FDA, Center for Veterinary Medicine,
Office of Management and Communications, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (301) 827-3800 FAX: (301) 827-4065
Internet Web Site
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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