Procedures for Modified Requirements and Exemptions | Midpage

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Code of Federal Regulations

ECFR587e007cf10e3be

Procedures for Modified Requirements and Exemptions

1.1360Under what circumstances will FDA modify the requirements in this subpart that apply to a food or type of entity or exempt a food or type of entity from the requirements of this subpart?1.1365When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?1.1370What must be included in a petition requesting modified requirements or an exemption from the requirements?1.1375What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?1.1380What process applies to a petition requesting modified requirements or an exemption?1.1385What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?1.1390When will modified requirements that we adopt or an exemption that we grant become effective?1.1395Under what circumstances may FDA revise or revoke modified requirements or an exemption?1.1400What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked?