Animal Drug Adverse Event Information Collection Activities

Adverse Experience/Events with Approved New Animal Drugs

Documents and Forms

Document Name Document Type
Form FDA 1932 Animal Drug Adverse Event Information Collection Activities Form and Instruction
FDA 1932 VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, FORM FDA 1932.pdf Form and Instruction
FDA 1932 VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, FORM FDA 1932.pdf Form and Instruction
FDA 1932a VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, FORM FDA 1932a.pdf Form and Instruction
FDA 1932a VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, FORM FDA 1932a.pdf Form and Instruction
FDA 2301 TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FORM FDA 2301.pdf Form and Instruction
FDA 2301 TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FORM FDA 2301.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Animal Drug Adverse Event Information Collection Activities	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	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 1932	VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT	FORM FDA 1932.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 1932a	VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, OR PRODUCT DEFECT REPORT (voluntary reporting)	FORM FDA 1932a.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 2301	TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FOR NEW ANIMAL DRUGS	FORM FDA 2301.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: 417	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	124,444	124,174	270
Annual IC Time Burden (Hours)	172,276	172,006	270
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.