{"data":{"id":"us/21-cfr-312.31","jurisdiction":"us","citation":"21 CFR 312.31","heading":"Information amendments.","body":"(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:\n(1) New toxicology, chemistry, or other technical information; or\n(2) A report regarding the discontinuance of a clinical investigation.\n(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:\n(1) A statement of the nature and purpose of the amendment.\n(2) An organized submission of the data in a format appropriate for scientific review.\n(3) If the sponsor desires FDA to comment on an information amendment, a request for such comment.\n(c) When submitted. Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than every 30 days.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 312—INVESTIGATIONAL NEW DRUG APPLICATION","Subpart B—Investigational New Drug Application (IND)"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"9b33059a9d3262c6c3d1d7808a8309538f17ec02a23cae6aff76fb73cec1c8b9","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-312.30","next":"us/21-cfr-312.32"},"notice":"GroundRules: Original legal text. Not legal advice."}