Alternative definition : FDA: 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.;