Information Collection

Recordkeeping - AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1))

IC 234420 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

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Recordkeeping - AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1))	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	Form No.	Form Name	Instrument File	URL	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

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	-246,193	265,700
Annual IC Time Burden (Hours)	156,056	-1,969,544	2,125,600
Annual IC Cost Burden (Dollars)	0	0	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.