16 C.F.R. § 1702.3

Current through May 31, 2024
Section 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 , 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).

16 C.F.R. §1702.3