US FDA Adds Shorter NDIN 'Burdens' In 'Program Change,' 'Submissions' Estimate Unchanged

FDA Office of Dietary Supplement Programs still predicts 20 hours are needed for submitting each of the 55 NDINs it expects to receive but adds 5 hours for all 55 for manufacturing process and identity information and 1 hour for identity specifications in table form. Also adds 1 hour for estimated 1 NDIN for administrative procedures list form and template; and 24 minutes for expected 10 for master files written authority.

The US Food and Drug Administration references one of its pending draft guidances for new dietary ingredient notifications in adding blocks of 6 hours, 1 hour or roughly half an hour to its estimates for the time needed to submit a notification.

In a recent Federal Register notice for comments on its estimates before submitting the document for Office of Management...