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21 CFR 1.1375

§ 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?

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 1.1375, § 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?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/82959
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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.