Information Collection

Adverse Drug Experiences & Product / Manufacturing Defects Reporting Using FDA Form 1932

IC 37624 under ICR 201001-0910-012 · 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⚠️ Notice: This information collection may be referencing outdated material.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 Adverse Drug Experiences & Product / Manufacturing Defects Reporting Using FDA Form 1932	Form and Instruction
Form FDA 1932 Veterinary Adverse Drug Reaction; Lack of Effectiveness FDA-1932.pdf	Form and Instruction

IC Title:

Adverse Drug Experiences & Product / Manufacturing Defects Reporting Using FDA Form 1932

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 514.80(b)(3) 21 CFR 514.80(b)(1) 21 CFR 514.80(b)(2)(i)&(ii)

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: 404

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
	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	17,897	-25,621	43,518
Annual IC Time Burden (Hours)	17,883	-65,672	83,555
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.