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It does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture or preparation of the mature stalks, except the resin extracted therefrom, fiber, oil, or cake or the sterilized seed of the plant which is incapable of germination

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Following the issuance of an RTA or RTF letter, the FDA regulatory health project manager (RHPM) places a call to the applicant notifying them of the letter issued and offering a courtesy copy

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Shuibhne, Niamh, and Laurence Gormley