1. Regulations
  2. title 21
  3. chapter I
  4. part 1
  5. subpart S
  6. subjgrp 93
  7. § 1.1375

View all text of Subjgrp 93 [§ 1.1360 - § 1.1400]

§ 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 2223; 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