21 CFR 1.1375 - What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?

Regulations last checked for updates: May 16, 2024

Title 21 - Food and Drugs last revised: May 06, 2024

View all text of Subpart S [§ 1.1300 - § 1.1465]

§ 1.1375 - What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?

FDA will presume that information submitted in a petition requesting modified requirements or an exemption, 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.

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; 42 U.S.C. 216,241,243,262,264,271

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

cite as: 21 CFR 1.1375