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⚠️ Notice: This information collection may be referencing outdated material.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 FDA 1932 Mandatory adverse event reporting Form and Instruction
FDA 1932 Veterinary Adverse Drug Reaction, Lack of Effectiveness, FDA-1932_05-07-19.pdf Form and Instruction

Information Collection (IC) Details

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

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	FDA 1932	Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report	FDA-1932_05-07-19.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: 15	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	270	-1,512	1,782
Annual IC Time Burden (Hours)	270	-1,512	1,782
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.