Regulations last checked for updates: Feb 16, 2025

Title 21 - Food and Drugs last revised: Feb 03, 2025
All TitlesTitle 21Chapter IPart 516Subpart B - Subpart B—Designation of a Minor Use or Minor Species New Animal Drug
View all text of Subpart B [§ 516.11 - § 516.52]
§ 516.16 - Eligibility to request designation.

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.

authority: 21 U.S.C. 360ccc-1,360ccc,371
source: 72 FR 41017, July 26, 2007, unless otherwise noted.
cite as: 21 CFR 516.16
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