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Notes

§1.1430. What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?

21 C.F.R. § 1.1430

FDA will presume that information submitted in a petition requesting a waiver for a type of entity, as well as information in comments submitted on such a petition, does not contain information exempt from public disclosure under part 20 of this chapter and will be made public as part of the docket associated with the petition.
Notes, amendments, and revision history

Source

Source: 87 FR 71077, Nov. 21, 2022, unless otherwise noted.

Authority

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.