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⚠️ Notice: This information collection may be referencing outdated material.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

IC Title:

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:

table that charts list of 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 %

table that charts list of burden
	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

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.