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

Postmarketing Adverse Drug Experience Reporting

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

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.