Mandatory adverse event reporting

Records and Reports Concerning Experience with Approved New Animal Drugs

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0284 can be found here:

Documents and Forms

Document Name Document Type
Form Form FDA 1932 Mandatory adverse event reporting Form and Instruction
Form FDA 1932 Veterinary Adverse Drug Reaction; Lack of Effectiveness FDA-1932.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Mandatory adverse event reporting	Agency IC Tracking Number:	CVM

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 514.80

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form FDA 1932	Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report	FDA-1932.pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 22	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,782	-1	1,783
Annual IC Time Burden (Hours)	1,782	-1	1,783
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.