How should I organize an electronic FAP or CAP submission?
You should organize an electronic FAP or CAP submission using the foldering structure available in a downloadable Petition Submission Roadmap (see instructions in Appendix 1 and the roadmap in Appendix 15). The entire Petition Submission Roadmap is organized under the folder entitled “Main directory.” The “Main directory” includes six first-level folders, and several of these first-level folders include second-level and third-level subfolders. We show these folders and subfolders, using an outline format, in Figure IV-1, below.Figure IV-1Outline Representing the Folders and Subfolders in a Petition Submission Roadmap (“Main directory”) • Main directory • Administrative • Designation of Nondisclosable Information • Redacted Document • Incoming Correspondence • Amendment • Update • Administrative Technical • Chemistry • Studies • Stability • Technical Effect • Migration • Other • Methods • References • Safety • Studies • Genetic Toxicity Studies • Short Term Toxicity Studies Rodents • Sh
