September 8, 2014
The U.S. Food and Drug Administration announced today it is inviting public comment on possible modifications to the procedures and requirements for the approval of combination drug medicated feeds.
Currently the use of multiple new animal drugs in the same medicated feed (i.e., a combination drug medicated feed) requires animal drug sponsors to seek approval for each new animal drug in the combination and seek a separate approval for the combination drug itself. The FDA is exploring possible changes to this approval process in accordance with Animal Drug User Fee Amendments of 2013 (ADUFA III) performance goals. ADUFA III authorizes FDA to collect user fees from animal drug sponsors to expedite and modernize the animal drug review process in exchange for FDA agreeing to meet a comprehensive set of performance goals to show significant improvement in the timeliness and predictability of the new animal drug review process.
The FDA is accepting public comments beginning on September 9, 2014. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2014-N-1050 in the search box. Please note that the docket will not be open to accept comments until this date. The comment period will close on September 9, 2015. While comments are welcome at any time, you should submit them by the closing date in order for your comments to be considered in drafting recommendations by September 30, 2016, in accordance with the ADUFA III performance goals.
To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-N-1050 on each page of your written comments.
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- Federal Register Notice: Exploring the feasibility of pursuing statutory revisions and other modifications to existing procedures and requirements related to the approval of combination drug medicated feeds
Please note that the public comment period opens on September 9, 2014.