21 C.F.R. § 1.1375

What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?

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FDA will presume that information submitted in a petition requesting modified requirements or an exemption, as well as information in comments submitted on such a petition, does not contain information exempt from public disclosure under part 20 of this chapter and will be made public as part of the docket associated with the petition.