Title 16

PART 1702

Part 1702 - Petitions For Exemptions From Poison Prevention Packaging Act Requirements; Petition Procedures And Requirements

PART 1702 - PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS Authority:15 U.S.C. 1471(4), 1472, 1474, 1269(a), 2079(a); 21 U.S.C. 371(a). Source:45 FR 13064, Feb. 28, 1980, unless otherwise noted.

16:2.0.1.5.119.0.2.1SECTION 1702.1
   1702.1 Purpose and policy.
16:2.0.1.5.119.0.2.2SECTION 1702.2
   1702.2 Procedural requirements and recommendations.
16:2.0.1.5.119.0.2.3SECTION 1702.3
   1702.3 Substantive requirements.
16:2.0.1.5.119.0.2.4SECTION 1702.4
   1702.4 Petitions with insufficient or incomplete information.
16:2.0.1.5.119.0.2.5SECTION 1702.5
   1702.5 Failure to supply adverse information.
16:2.0.1.5.119.0.2.6SECTION 1702.6
   1702.6 Trade secrets and other confidential information.
16:2.0.1.5.119.0.2.7SECTION 1702.7
   1702.7 Justification for the exemption.
16:2.0.1.5.119.0.2.8SECTION 1702.8
   1702.8 Human experience data.
16:2.0.1.5.119.0.2.9SECTION 1702.9
   1702.9 Relevant experimental data.
16:2.0.1.5.119.0.2.10SECTION 1702.10
   1702.10 Human experimental data involving the testing of human subjects.
16:2.0.1.5.119.0.2.11SECTION 1702.11
   1702.11 Product specifications.
16:2.0.1.5.119.0.2.12SECTION 1702.12
   1702.12 Packaging specifications.
16:2.0.1.5.119.0.2.13SECTION 1702.13
   1702.13 Labeling and packaging samples.
16:2.0.1.5.119.0.2.14SECTION 1702.14
   1702.14 Marketing history.
16:2.0.1.5.119.0.2.15SECTION 1702.15
   1702.15 Petitions alleging the incompatibility of child resistant packaging with the particular substance petitioned for exemption.
16:2.0.1.5.119.0.2.16SECTION 1702.16
   1702.16 Petitions requesting an exemption for a drug or a new drug.
16:2.0.1.5.119.0.2.17SECTION 1702.17
   1702.17 Granting petitions.
16:2.0.1.5.119.0.2.18SECTION 1702.18
   1702.18 Denying petitions.
16:2.0.1.5.119.0.2.19SECTION 1702.19
   1702.19 Effect of filing petition.