Information Collection

Reporting - AER for non-prescription drug products (21 CFR 329.100)

IC 234419 under ICR 202405-0910-001 · OMB 0910-0230.

Documents and Forms

Document Name Document Type
0230 Postmarketing Adverse Event Reporting for Nonprescrition Human Drug Products Marketed Without an Approved Application.PDF Other-Agency Guidance
0230 Postmarketing Adverse Event Reporting for Medical Products Dietary Supplements During a Pandemic.pdf Other-Agency Guidance
0230 Providing Submissions in Electronic Format—Postmarketing Safety Reports.pdf Other-Agency Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Reporting - AER for non-prescription drug products (21 CFR 329.100)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 329.100

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance	0230 Postmarketing Adverse Event Reporting for Nonprescrition Human Drug Products Marketed Without an Approved Application.PDF	Yes	Yes	Fillable Fileable
Other-Agency Guidance	0230 Postmarketing Adverse Event Reporting for Medical Products Dietary Supplements During a Pandemic.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	0230 Providing Submissions in Electronic FormatâPostmarketing Safety Reports.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 312	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	19,507	-177,143	196,650
Annual IC Time Burden (Hours)	117,042	-1,062,858	1,179,900
Annual IC Cost Burden (Dollars)	5,000	5,000	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.