21 CFR 822.16
§ 822.16 What will you consider in the review of my submission?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 822.16, § 822.16 What will you consider in the review of my submission?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88938
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Full text
First, we will determine that the submission is administratively complete. Then, in accordance with the law, we must determine whether the designated person has appropriate qualifications and experience to conduct the surveillance and whether the surveillance plan will result in the collection of useful data that will answer the surveillance question.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.