This Standard Operating Policy and Procedure (SOPP) serves as a guide for Center for Biologics Evaluation and Research (CBER) staff to follow for consistent review and administrative oversight regarding requests by sponsors to recover certain costs for a product that is the subject of an investigational new drug application (IND) or investigational device exemption (IDE) under 21 Code of Federal Regulations (CFR) 312.8 and 21 CFR 812.7 respectively.