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Some experimental models may observe: Temporary recovery-related response variability Changes in tissue-related sensitivity Adaptation-related physiological variability Individual differences in regenerative-response patterns Administration & Handling Considerations Improper storage, reconstitution, or administration techniques may increase the risk of: Administration-site irritation Local inflammation Reduced peptide stability or effectiveness Additional Research Notes Higher-frequency protocols may increase the likelihood of local irritation or sensitivity-related observations

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However, to support the two-step process for first determining whether a requesting hospital is eligible to request an expansion exception and, if so, deciding whether to approve or deny the request, we are proposing to revise existing § 411.362(c)(5) and renumber it at § 411.363(f)(3) to state that individuals and entities in the requesting hospital's community may provide input regarding, but not limited to: (i) whether the hospital is eligible to request the expansion exception