This document is an FDA notice of availability for a draft guidance titled 'Replacing Color Additives in Approved or Marketed Drug Products.' The guidance provides recommendations for NDA and ANDA holders and drug manufacturers on how to replace color additives in approved or marketed drug products, including documentation requirements and the appropriate regulatory submission pathway. FDA recommends that such changes be submitted as changes being effected in 30 days (CBE-30) supplements rather than as major changes. This is not a NEPA document; it contains no environmental impact analysis.12