21 C.F.R. § 1.1365

When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?

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FDA will consider modifying the requirements of this subpart applicable to a food or type of entity, or exempting a food or type of entity from the requirements of this subpart, on our own initiative or in response to a citizen petition submitted under § 10.30 of this chapter by any interested party.