This guidance describes the Food and Drug Administration’s (FDA, we, or Agency) current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA with accompanying certifications (Form FDA 3674) under section 402(j)(5)(B) of the Public Health Service Act (PHS Act), 42 U.S.C. § 282(j)(5)(B). Section 402(j) of the PHS Act was added by Title VIII, Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85).