OMB control number

Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements - Final Rule

OMB 0910-0770 · HHS/FDA.

OMB 0910-0770

Latest Forms, Documents, and Supporting Material

Document Name
Form 3500A 600.81(b)(2) Form
Form 3500A 600.80(h)(2) Form
Form 3500A 329.100(c)(2) Form
Form 3500A 314.80(g)(2) Form
Form 3500A 310.305(e)(2) Form
SUPPORTING STATEMENT FINAL RULE ESR revised #15 11-7-2014.doc Supporting Statement A
600.81(b)(2) Form
600.80(h)(2) Form
329.100(c)(2) Form
314.80(g)(2) Form
310.305(e)(2) Form

All Historical Document Collections

201411-0910-004 Approved without change	New collection (Request for a new OMB Control Number)	2014-11-10
201406-0910-005 Comment filed on proposed rule	New collection (Request for a new OMB Control Number)	2014-06-12