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

Documents and forms in this information collection
Document Name	Document Type
0230 Postmarketing Adverse Event Reporting for Nonprescrition Human Drug Products Marketed Without an Approved Application.PDF	Other-Agency Guidance

IC Title:

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.