21 CFR §312.31

1. (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. (1)New toxicology, chemistry, or other technical information; or
   2. (2)A report regarding the discontinuance of a clinical investigation.
2. (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. (1)A statement of the nature and purpose of the amendment.
   2. (2)An organized submission of the data in a format appropriate for scientific review.
   3. (3)If the sponsor desires FDA to comment on an information amendment, a request for such comment.
3. (c)When submitted. Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than every 30 days.