600.80(c)(2)

Adverse Experience Reporting for Licensed Biological Product; and General Records

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0308 can be found here:

Documents and Forms

Document Name Document Type
Form 3500A 600.80(c)(2) Form
3500A MEDWATCH FORM FDA 3500A MEDWATCH.pdf Form
VAERS-1 Vaccine Adverse Event Reporting System VAERS-1 FORM.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	600.80(c)(2)	Agency IC Tracking Number:	CBER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 600.80(c)(2)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	3500A	MEDWATCH	FORM FDA 3500A MEDWATCH.pdf		Yes	Yes	Fillable Fileable Signable
Form and Instruction	VAERS-1	Vaccine Adverse Event Reporting System	VAERS-1 FORM.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 131	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	132,668	75,368	57,300
Annual IC Time Burden (Hours)	3,714,704	2,110,304	1,604,400
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.