part_subject: "INVESTIGATIONAL NEW DRUG APPLICATION"
subpart_code: "B"
subpart_subject: "Investigational New Drug Application (IND)"
section_number: "312.31"
section_subject: "Information amendments."
cfr_reference: "21 CFR 312.31"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.