§ 312.31 - Information amendments.  


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  • § 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.

    [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 53 FR 1918, Jan. 25, 1988; 67 FR 9585, Mar. 4, 2002]