21 CFR 516.16
§ 516.16 Eligibility to request designation.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 516.16, § 516.16 Eligibility to request designation, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87001
- Permanent ID
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Full text
The person requesting designation must be the sponsor and the real party in interest of the development and the intended or actual production and sales of the drug or the permanent-resident U.S. agent for such a sponsor.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.