part_subject: "INVESTIGATIONAL NEW DRUG APPLICATION"
subpart_code: "A"
subpart_subject: "General Provisions"
section_number: "312.10"
section_subject: "Waivers."
cfr_reference: "21 CFR 312.10"
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"
---
(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:
(1)An explanation why the sponsor's compliance with the requirement is unnecessary or cannot be achieved;
(2)A description of an alternative submission or course of action that satisfies the purpose of the requirement; or
(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:
(1)The sponsor's compliance with the requirement is unnecessary for the agency to evaluate the application, or compliance cannot be achieved;
(2)The sponsor's proposed alternative satisfies the requirement; or
(3)The applicant's submission otherwise justifies a waiver.