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:
(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:
(c) When submitted.
Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than every 30 days.