§ 516.16. Eligibility to request designation.
37 words·~1 min read·
/us/cfr/t21/s§ 516.16·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.