Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original biologics license applications (BLAs) (351(k)s) submitted under the Public Health Service Act (hereafter referred to as 351(k) applications) (hereafter referred to as the Program). The Program is part of the FDA performance commitments under the proposed reauthorization of the Biosimilar User Fee Act (BsUFA), which, if enacted into law, will allow FDA to collect user fees for the review of 351(k) applications for fiscal years (FYs) 2018-2022. As part of the FDA performance commitments described in this document, the Program will be evaluated by an independent contractor in an interim and final assessment.