The U.S. Food and Drug Administration announced today that it has issued a direct final rule amending a regulation to change when the agency will disclose certain approval-related information, including the summary of information forming the basis for approval (Freedom of Information Summary) and documentation of environmental review, related to new animal drug applications (NADAs). This change will increase transparency of the new animal drug approval process by allowing FDA to more quickly disclose animal drug approval information. The public can comment on the rule for 75 days following publication in the Federal Register. If no significant adverse comments are received, the rule will take effect 135 days following publication.
Currently, regulations mandate that FDA cannot publicly disclose certain data and information related to NADAs until publication in the Federal Register, which can be one to two months after the agency has notified the drug sponsor that it has approved the application. As implemented, this regulation keeps the agency from satisfying a requirement of the Federal Food, Drug, and Cosmetic Act that a list of approved new animal drug products (the CVM Green Book) be updated every 30 days to include each new animal drug which has been approved during that 30-day period. The revised regulation will allow FDA to publicly disclose certain approval-related information regarding NADAs upon approval, which will allow the agency to update the Green Book within the 30-day statutory time frame. This change will also increase transparency of FDA’s approval process by allowing for more timely public disclosure of approval-related information.
To electronically submit comments on the rule, go to www.regulations.gov and insert docket FDA-2014-N-0108. Send written comments to the Division of Dockets Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852. Please include the docket number at the top of each page of your comment.