16 CFR Part 1702
PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS
February 12, 2021
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1702.1
Purpose and policy
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1702.2
Procedural requirements and recommendations
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1702.3
Substantive requirements
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1702.4
Petitions with insufficient or incomplete information
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1702.5
Failure to supply adverse information
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1702.6
Trade secrets and other confidential information
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1702.7
Justification for the exemption
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1702.8
Human experience data
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1702.9
Relevant experimental data
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1702.10
Human experimental data involving the testing of human subjects
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1702.11
Product specifications
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1702.12
Packaging specifications
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1702.13
Labeling and packaging samples
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1702.14
Marketing history
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1702.15
Petitions alleging the incompatibility of child resistant packaging with the particular substance petitioned for exemption
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1702.16
Petitions requesting an exemption for a drug or a new drug
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1702.17
Granting petitions
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1702.18
Denying petitions
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1702.19
Effect of filing petition