Pub. L. 112-144, tit. XI, subtit. C, sec. 1134 (as amended)
DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.
SEC. 1134. DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.
(a) In General.—Section 505 (21 U.S.C. 355) is amended by adding at the end the following:
“(w) Deadline for Determination on Certain Petitions. The Secretary shall issue a final, substantive determination on a petition submitted pursuant to subsection (b) of section 314.161 of title 21, Code of Federal Regulations (or any successor regulations), no later than 270 days after the date the petition is submitted.”
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(b) [21 U.S.C. 355 note] Application.—The amendment made by subsection (a) shall apply to any petition that is submitted pursuant to subsection (b) of section 314.161 of title 21, Code of Federal Regulations (or any successor regulations), on or after the date of enactment of this Act.
- Cross-references to the US Code
- 21 U.S.C. 355 note