{"data":{"id":"us/21-cfr-312.10","jurisdiction":"us","citation":"21 CFR 312.10","heading":"Waivers.","body":"(a) A sponsor may request FDA to waive applicable requirement under this part. A waiver request may be submitted either in an IND or in an information amendment to an IND. In an emergency, a request may be made by telephone or other rapid communication means. A waiver request is required to contain at least one of the following:\n(1) An explanation why the sponsor's compliance with the requirement is unnecessary or cannot be achieved;\n(2) A description of an alternative submission or course of action that satisfies the purpose of the requirement; or\n(3) Other information justifying a waiver.\n(b) FDA may grant a waiver if it finds that the sponsor's noncompliance would not pose a significant and unreasonable risk to human subjects of the investigation and that one of the following is met:\n(1) The sponsor's compliance with the requirement is unnecessary for the agency to evaluate the application, or compliance cannot be achieved;\n(2) The sponsor's proposed alternative satisfies the requirement; or\n(3) The applicant's submission otherwise justifies a waiver.","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 A—General Provisions"],"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":"53f9a99ecc2a509f85e09dd0e9ce5e17c7a37a0cf54de46b3f9ee7442c6b299c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-312.8","next":"us/21-cfr-312.20"},"notice":"GroundRules: Original legal text. Not legal advice."}