§516.12. Purpose.
21 C.F.R. § 516.12
This subpart establishes standards and procedures for determining eligibility for designation and the associated incentives and benefits described in section 573 of the act, including a 7-year period of exclusive marketing rights.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
Source
Source: 72 FR 41017, July 26, 2007, unless otherwise noted.