Information Collection

Reporting ABs and CBs

IC 208274 under ICR 202411-0910-012 · OMB 0910-0750.

Documents and Forms

Document Name Document Type
0750 - Form FDA 3997 user guide_2025.pdf Other-FDA 3997 eForm User Guide
0750 - Form FDA 3997a user guide_2025.pdf Other-FDA 3997a eForm User Guide

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Reporting ABs and CBs	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR Part 1; Subpart M (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-FDA 3997 eForm User Guide			0750 - Form FDA 3997 user guide_2025.pdf		Yes	Yes	Fillable Fileable
Other-FDA 3997a eForm User Guide			0750 - Form FDA 3997a user guide_2025.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 233	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	30,923	53	30,870
Annual IC Time Burden (Hours)	8,653	93	8,560
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.