View Information Collection (IC)

View Information Collection (IC)

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

Federal Enterprise Architecture Business Reference Module

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	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses for this IC	30,923	0	0	53	0	30,870
Annual IC Time Burden (Hours)	8,653	0	0	93	0	8,560
Annual IC Cost Burden (Dollars)	0	0	0	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.