(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,
(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).