Information Collection

21 Cfr Part 510 - Adverse Drug Reaction, Lack Of Effectiveness, Product Defect Report

IC 109308 under ICR 198705-0910-002 · OMB 0910-0012.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0012 can be found here:

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Information Collection (IC) Details

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IC Title:	21 CFR PART 510 - ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 1932 &				No	No
Form	1932A				No	No

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 350	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	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,000	33	217	750
Annual IC Time Burden (Hours)	1,200	125	815	260
Annual IC Cost Burden (Dollars)	0	0	0	0

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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.