Information Collection

Reporting ABs and CBs

IC 208274 under ICR 202206-0910-008 · OMB 0910-0750.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0750 can be found here:

Documents and Forms

Document Name Document Type
0750 Form FDA 3997 user guide.pdf Other-eForm User Guide
0750 Form FDA 3997 user guide.pdf Other-eForm User Guide
0750 Form FDA 3997a user guide.pdf Other-eForm User Guide
0750 Form FDA 3997a user guide.pdf Other-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-eForm User Guide			0750 Form FDA 3997 user guide.pdf		Yes	Yes	Fillable Fileable
Other-eForm User Guide			0750 Form FDA 3997a user guide.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 %

	Approved	Previously Approved
Annual Number of Responses for this IC	30,870	30,870
Annual IC Time Burden (Hours)	8,560	8,560
Annual IC Cost Burden (Dollars)	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.