The Food and Drug Administration is seeking comment on the Animal Drug User Fee Act regarding the program's performance and reauthorization.
The act authorizes the FDA to collect fees for certain animal drug applications, establishments, products, and sponsors in support of the review of animal drugs. Congress authorized the act in 2003, and the FDA implemented fees in 2004.
The FDA expects to collect $5 million in fees for 2004, $8 million for 2005, and $10 million annually from 2006 to 2008. The FDA anticipates substantial savings to industry in regulatory review and developmental expenses because the fees should help achieve shorter, more predictable review times by increasing FDA review staff and building better management systems.
Documents regarding the program are available at www.fda.gov/cvm/adufa.htm.
The FDA will hold a public meeting about the program from 9 a.m. to 5 p.m. EST Feb. 24 at the DoubleTree Hotel, Plaza II and III, 1750 Rockville Pike, Rockville, MD 20852.
The deadline for requests to make a presentation is Feb. 10 to Aleta Sindelar, Center for Veterinary Medicine (CVM) (HFV-3), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855; (240)276-9004; fax (240) 276-9020; e-mail, email@example.com.
The deadline for written comments is March 26 to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852; or to www.fda.gov/dockets/ecomments. Comments should include the docket number, 2005N-0488.