Information Collection

Mandatory adverse event reporting

IC 37624 under ICR 201801-0910-008 · OMB 0910-0284.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

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.