CBER How to Write Clear and Concise Reviews A Plain Writing Workshop

CBER needs to acquire a commercial vendor to deliver a tailored off-the-shelf, technical writing course that teaches staff how to write clear and concise technical documents using Plain Language and is tailored to include examples of effectively writing deficiencies to manufacturers using four-part harmony to improve the manufacturer's comprehension of FDA's analysis of the review. CBER requires both initial and refresher classroom training for CBER personnel. The classroom training will help ensure CBER personnel provide clear and concise reviews of deficiencies when writing reports on manufacturer submissions. The course will need to be provided to the CBER population in the following number o iterations: Year 1 -- 12 Initial Sessions 0 Refresher Sessions Year 2 -- 8 Refresher Sessions 4 Initial Sessions Year 3 -- 7 Refresher Sessions 5 Initial Sessions The Contractor shall provide an off-the-shelf CBER tailored course and refresher that covers writing clear and concise review that highlight deficiencies to provide CBER employees with tools and techniques on how to write clear and concise technical and regulatory documents using Plain Writing and Four-Part Harmony. Four Part Harmony is defined as a four-step process that provides the recipient of the deficiency letter with a clear and complete request. The steps are 1) What they provided; 2) What is deficient; 3) What we want; and 4) Why we want it. This consistent method of notifying manufacturers of a deficiency within their application packge ensures consistency between centers and reviewers in how deficiencies meet the requirements outlined in the FDA Reauthorization Act of 2017.