21 CFR 171.6
§ 171.6 Amendment of petition.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 171.6, § 171.6 Amendment of petition, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84918
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Full text
After a petition has been filed, the petitioner may submit additional information or data in support thereof. In such cases, if the Commissioner determines that the additional information or data amount to a substantive amendment, the petition as amended will be given a new filing date, and the time limitation will begin to run anew. If nonclinical laboratory studies are involved, additional information and data submitted in support of filed petitions shall include, with respect to each nonclinical study, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.