§ 312.31 Information amendments.

(a) Requirement for information amendment. A sponsor shall report in an information amendment essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report. Examples of information requiring an information amendment include: (1) New toxicology, chemistry, or other technical information; or (2) A report regarding the discontinuance of a clinical investigation. (b) Content and format of an information amendment. An information amendment is required to bear prominent identification of its contents (e.g., “Information Amendment: Chemistry, Manufacturing, and Control”, “Information Amendment: Pharmacology-Toxicology”, “Information Amendment: Clinical”), and to contain the following: (1) A statement of the nature and purpose of the amendment. (2) An organized submission of the data in a format appropriate for scientific review. (3) If the sponsor desires FDA to comment on an information amendment, a request for such comment. (c) When submitted. Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than every 30 days.