Code of Federal Regulations · Section

§ 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?

21 C.F.R. § 1.1375

View:

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.

21 C.F.R. § 1.1370 21 C.F.R. § 1.1380

Authorizing Statute

General orders
19 U.S.C. § 1490
Definitions; generally
21 U.S.C. § 321
Labeling
15 U.S.C. § 1333
Regulations
42 U.S.C. § 216