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  • Routine: administrative changes, e.g., change of address, authorized official, or meeting requests. Donor re-entry request: An applicant\'s request to re-enter a deferred donor when regulations and/or guidance do not provide a qualification method or process for their specific situation. (21 CFR 610.41(b)) License re-issuance: request from applicant to change legal name. Lot distribution report: Postmarketing report required by 21 CFR 600.81 to be submitted every six (6) months upon approval/licensing of vaccine or biologic product. Final printed labeling.
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Metadata

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<http://xmlns.com/foaf/0.1/primaryTopic> <https://research.tib.eu/covid-19/entity/C0282413_NCI_FDA>
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<http://www.ontologydesignpatterns.org/cp/owl/informationrealization.owl#realizes> <https://research.tib.eu/covid-19/data/entity/C0282413_NCI_FDA>
<http://purl.org/net/provenance/ns#createdBy>
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