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The proposed rule can change during the comment period

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AF instead focused on enhancing connections between SBIR and prime contractors and, through the addition of new TTAs with explicit mandates to work out of selected AF bases, to encourage the transition of SBIR technologies

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It should include: Batch number and lot code Testing methods (HPLC, mass spec, LAL endotoxin) Numeric results and acceptance criteria Analysts signature and date Look for at least 98% purity for clinical use