---
kind: "section"
citation: "16 C.F.R. § 1702.3"
title: "16"
number: "1702.3"
heading: "Substantive requirements."
url: "https://uscodex.org/cfr/16/1702.3"
---

# §1702.3. Substantive requirements.

- (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](/cfr/16/1702.4.md), 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](/cfr/16/1702.7.md),
  - (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](/cfr/16/1702.8..1702.14.md),
- (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).

## Notes

### Authority

Authority: 15 U.S.C. 1471(4), 1472, 1474, 1269(a), 2079(a); 21 U.S.C. 371(a).

### Source

Source: 45 FR 13064, Feb. 28, 1980, unless otherwise noted.