Information Collection

Drug Product, Medical Device, And Laboratory Product Problem Reporting Program

IC 109369 under ICR 197805-0910-002 · OMB 0910-0024.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0024 can be found here:

Documents and Forms

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Information Collection (IC) Details

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IC Title:	DRUG PRODUCT, MEDICAL DEVICE, AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?
Form	FD-2519	No	No
Form	FD 2519A	No	No
Form	FD2519F	No	No
Form	FD 2822	No	No

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 10,450	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	7,450	5,450	2,000
Annual IC Time Burden (Hours)	1,243	577	666
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded

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