Information Collection

Biological products; Recordkeeping

IC 185787 under ICR 202403-0910-011 · OMB 0910-0308.

Documents and Forms

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

IC Title:

Agency IC Tracking Number:

CBER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 600; 600.12, 600.80 21 CFR 610.86 (To search for a specific CFR, visit the Code of Federal Regulations.)

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: 109

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	591,759	230,755	361,004
Annual IC Time Burden (Hours)	771,693	187,014	584,679
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.