# 16 C.F.R. § 1702.3 (2026): Substantive requirements

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_3

## Section

- **Citation:** 16 C.F.R. § 1702.3 (2026)
- **Heading:** Substantive requirements
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 16 CFR: Commercial Practices / Chapter II: CONSUMER PRODUCT SAFETY COMMISSION / Part 1702: PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS › PETITION PROCEDURES AND REQUIREMENTS / § 1702.3: § 1702.3   Substantive requirements.

## Text

(a) A petition filed under this part shall include the information required by this part, or a satisfactory explanation for the absence of the information. As provided by § 1702.4, a petition which is not complete may be closed. To be considered complete, a petition shall include the following:
(1) A statement of the justification for the exemption in accordance with § 1702.7,
(2) All reasonably available human experience data, reasonably available relevant experimental data (both human and animal), product and packaging specifications, labeling, and marketing history, in accordance with §§ 1702.8 through 1702.14,
(b) As used in this regulation, “reasonably available” information is data in the petitioner's possession; data that has previously been generated by the petitioner, and data that is obtainable from such sources as: Reports from Poison Control Centers; reports of adverse reactions that have been submitted to the petitioner; the medical, pharmacological, and toxicological literature; and information required by the FDA for an Investigational Exemption for a New Drug (IND) or a New Drug Application (NDA).

## Nearby sections

- [16 C.F.R. § 1702.1 (2026) § 1702.1   Purpose and policy.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_1.md)
- [16 C.F.R. § 1702.2 (2026) § 1702.2   Procedural requirements and recommendations.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_2.md)
- [16 C.F.R. § 1702.3 (2026) § 1702.3   Substantive requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_3.md)
- [16 C.F.R. § 1702.4 (2026) § 1702.4   Petitions with insufficient or incomplete information.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_4.md)
- [16 C.F.R. § 1702.5 (2026) § 1702.5   Failure to supply adverse information.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_5.md)
- [16 C.F.R. § 1702.6 (2026) § 1702.6   Trade secrets and other confidential information.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_6.md)
- [16 C.F.R. § 1702.7 (2026) § 1702.7   Justification for the exemption.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_7.md)
- [16 C.F.R. § 1702.8 (2026) § 1702.8   Human experience data.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_8.md)
- [16 C.F.R. § 1702.9 (2026) § 1702.9   Relevant experimental data.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_9.md)
- [16 C.F.R. § 1702.10 (2026) § 1702.10   Human experimental data involving the testing of human subjects.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_10.md)
- [16 C.F.R. § 1702.11 (2026) § 1702.11   Product specifications.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_11.md)
- [16 C.F.R. § 1702.12 (2026) § 1702.12   Packaging specifications.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_12.md)
- [16 C.F.R. § 1702.13 (2026) § 1702.13   Labeling and packaging samples.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_13.md)
- [16 C.F.R. § 1702.14 (2026) § 1702.14   Marketing history.](https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_14.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T16_P1702_S1702_3. Check the current official text before relying on it. Not legal advice.