Information Collection

Form FDA 3486A; Web-based Addendum

IC 178972 under ICR 202301-0910-014 · OMB 0910-0458.

Documents and Forms

Document Name Document Type
Form FDA 3486A Form FDA 3486A; Web-based Addendum Form
FDA 3486A Biological Product Deviation Report; web-based Addendum Form FDA 3486A eForm control no 0910 0458.pdf www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviations Form
FDA 3486A Biological Product Deviation Report; web-based Addendum Form FDA 3486A eForm control no 0910 0458.pdf www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviations Form

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Form FDA 3486A; Web-based Addendum	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 606.171

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 3486A	Biological Product Deviation Report; web-based Addendum	Form FDA 3486A eForm control no 0910 0458.pdf	https://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviations	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 66	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	442	-1,880	2,322
Annual IC Time Burden (Hours)	111	-469	580
Annual IC Cost Burden (Dollars)	0	-26,123	26,123

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.