Information Collection

Biological products; recordkeeping under 21 CFR Part 600

IC 185787 under ICR 201801-0910-009 · OMB 0910-0308.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3500A Biological products; recordkeeping under 21 CFR Part 600	Form
3500A MEDWATCH FORM FDA 3500A MEDWATCH.pdf	Form
VAERS-1 Vaccine Adverse Event Reporting System VAERS-1 FORM.pdf	Form and Instruction

IC Title:

Biological products; recordkeeping under 21 CFR Part 600

Agency IC Tracking Number:

CBER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 610.18 21 CFR 600.80

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	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: 263

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	313,724	181,056	132,668
Annual IC Time Burden (Hours)	550,087	-3,164,617	3,714,704
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.