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⚠️ Notice: This information collection may be outdated.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

Forms and supporting documents for this ICR
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

Information collection document groups
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

Record metadata
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