Regulations.gov document

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

Notice · FDA-2013-N-0578 · posted Jul 11, 2016

Key facts

Document ID FDA-2013-N-0578-0004
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 60 Day Proposed Information Collection
Agency FDA
Docket FDA-2013-N-0578
Posted Jul 11, 2016
Federal Register citation 81 FR 44868
FR document number 2016-16352
Comment period opens Jul 11, 2016
Comments due Sep 10, 2016
Effective date Jul 11, 2016

At a glance

  • 1–9 Pages
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