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Code of Federal Regulations

ECFRab0ada195a2a1dd

Waivers

1.1405Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?1.1410When will FDA consider whether to waive a requirement of this subpart?1.1415How may I request a waiver for an individual entity?1.1420What process applies to a request for a waiver for an individual entity?1.1425What must be included in a petition requesting a waiver for a type of entity?1.1430What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?1.1435What process applies to a petition requesting a waiver for a type of entity?1.1440What process will FDA follow when waiving a requirement of this subpart on our own initiative?1.1445Under what circumstances may FDA modify or revoke a waiver?1.1450What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?