Information Collection Request

Postmarketing Adverse Drug Experience Reporting

ICR 202303-0910-017 · OMB 0910-0230 · Active

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0230 can be found here:

Forms and Documents

Document	Type	Status	Availability
83-C for 0230 to add Combo Product AER disclosure MARCH 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-20	Available
83-C for 0230 to add Combo Product AER disclosure MARCH 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-20	Repair queued
0230 AER for Drugs SSA 2021 REV.docx	Supporting Statement A	Uploaded 2021-11-21	Available
0230 AER for Drugs SSA 2021 REV.docx	Supporting Statement A	Uploaded 2021-11-21	Repair queued

IC Document Collections

IC ID	Collection	Type	Status
5821	AER Rx products not subject of marketing application		Unchanged
259219	Postmarketing Safety Reporting for Combination Products		New
250441	GFI: Providing PSURs	Other-Agency Guidance	Unchanged
250440	GFI: AER and Records During Pandemic	Other-Agency Guidance	Unchanged
234420	AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1))	Other-Agency Guidance	Unchanged
234419	AER under FFDCA sec. 760 - nonprescription drug products	Other-Agency Guidance	Unchanged
188678	AER records under 314.80 (marketing applications)		Unchanged
188677	AER records for Rx products not subject of marketing application		Unchanged
188676	AER under 314.80 (marketing applications) - quarterly reports	Other-Agency Guidance	Unchanged
188675	AER under 314.80 (marketing applications) - 15 day alerts		Unchanged

ICR Details

Status	Active
Agency/Subagency	HHS/FDA
OMB Control No	0910-0230
Type of Information Collection	No material or nonsubstantive change to a currently approved collection
Previous ICR Reference No	202110-0910-003
Agency Tracking No	CDER
Date Submitted to OIRA	2023-03-20
Requested Expiration Date	1969-12-31