The U.S. Food & Drug Administration reminded the public Aug. 20 that it is seeking public comment as it continues to explore 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 requires an approved new animal drug application (NADA) for each new animal drug in the combination, and a separate approved NADA for the combination new animal drug itself. The intent of this exploration is to consider changes intended to allow combination drug medicated feeds to be made available to the end user in the most efficient manner possible while protecting and promoting the public health, FDA said.
FDA is exploring possible changes to this approval process consistent with a stated performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter. 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.
FDA published a Federal Register notice seeking comment on this initiative on Sept. 9, 2014 (79 FR 53431), and held a public meeting on March 16, 2015 (80 FR 8092). Before and since that public meeting, the agency has met with stakeholders to receive input on this issue. As a next step, FDA will draft recommendations based on feedback received concerning this initiative and will publish a draft recommendations document for public comment.
FDA encourages interested stakeholders to submit comments to the docket (FDA-2014-N-1050) by Sept. 9, 2015, to ensure that the agency can consider these comments before drafting the recommendations.
- ADUFA III Goals Letter (see lines 436-441) (PDF - 123KB)
- 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
- Federal Register Notice of Public Meeting: Regulation of Combination Drug Medicated Feeds