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Notes

§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.