Code of Federal Regulations Title 21. Food and Drugs § 21.312.31 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.