Regulations.gov document

Agency Information Collection Activities; Proposed Collection; Comment Request; General…

Notice · FDA-2013-N-0578 · posted Sep 19, 2019

Key facts

Document ID FDA-2013-N-0578-0007
Title Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h
Document type Notice
Subtype 30 Day Proposed Information Collection
Agency FDA
Docket FDA-2013-N-0578
Posted Sep 19, 2019
Federal Register citation FR 84 49310
FR document number 2019-20328
Comment period opens Sep 19, 2019
Comments due Nov 19, 2019
Effective date Sep 19, 2019

At a glance

  • 1–9 Pages
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