Title 40

PART 152 SUBPART E

Subpart E - Satisfaction of Data Requirements and Protection of Data Submitters' Rights Source:49 FR 30903, Aug. 1, 1984, unless otherwise noted.

40:26.0.1.1.3.5.1.1SECTION 152.80
   152.80 General.
40:26.0.1.1.3.5.1.2SECTION 152.81
   152.81 Applicability.
40:26.0.1.1.3.5.1.3SECTION 152.82
   152.82 Definitions.
40:26.0.1.1.3.5.1.4SECTION 152.83
   152.83 Definition of exclusive use study.
40:26.0.1.1.3.5.1.5SECTION 152.84
   152.84 When materials must be submitted to the Agency.
40:26.0.1.1.3.5.1.6SECTION 152.85
   152.85 Formulators' exemption.
40:26.0.1.1.3.5.1.7SECTION 152.86
   152.86 The cite-all method.
40:26.0.1.1.3.5.1.8SECTION 152.90
   152.90 The selective method.
40:26.0.1.1.3.5.1.9SECTION 152.91
   152.91 Waiver of a data requirement.
40:26.0.1.1.3.5.1.10SECTION 152.92
   152.92 Submission of a new valid study.
40:26.0.1.1.3.5.1.11SECTION 152.93
   152.93 Citation of a previously submitted valid study.
40:26.0.1.1.3.5.1.12SECTION 152.94
   152.94 Citation of a public literature study or study generated at government expense.
40:26.0.1.1.3.5.1.13SECTION 152.95
   152.95 Citation of all studies in the Agency's files pertinent to a specific data requirement.
40:26.0.1.1.3.5.1.14SECTION 152.96
   152.96 Claim of data gap.
40:26.0.1.1.3.5.1.15SECTION 152.97
   152.97 Rights and obligations regarding the Data Submitters List.
40:26.0.1.1.3.5.1.16SECTION 152.98
   152.98 Procedures for transfer of exclusive use or compensation rights to another person.
40:26.0.1.1.3.5.1.17SECTION 152.99
   152.99 Petitions to cancel registration.