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21 CFR 60.44

§ 60.44 Hearing procedures.

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

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21 CFR 60.44, § 60.44 Hearing procedures, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83565
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Full text

The due diligence hearing shall be conducted in accordance with this part, supplemented by the nonconflicting procedures in part 16. During the due diligence hearing, the applicant and the petitioner shall enjoy all the rights and privileges accorded a person requesting a hearing under part 16. The standard of due diligence set forth in § 60.36 will apply in the due diligence hearing. The party requesting the due diligence hearing shall have the burden of proof at the hearing.

Legislative history

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