Information Collection

21 CFR 1.282 Reporting; Prior Notice Cancellation Through the ABI/ACS System. Regulation Sets Forth Cancellation Requirements & Information That Prior Notice Is Required to Contain.

IC 46711 under ICR 201312-0910-013 · OMB 0910-0520.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0520 can be found here:

Documents and Forms

Document Name Document Type
Form 3540 21 CFR 1.282 Reporting; Prior Notice Cancellation Through the ABI/ACS System. Regulation Sets Forth Cancellation Requirements & Information That Prior Notice Is Required to Contain. Form
3540 Prior Notice Submission US FDA Industry Systems 3540 Screenshot.htm www.access.fda.gov/ Form

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	21 CFR 1.282 Reporting; Prior Notice Cancellation Through the ABI/ACS System. Regulation Sets Forth Cancellation Requirements & Information That Prior Notice Is Required to Contain.	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1.282

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	3540	Prior Notice Submission	US FDA Industry Systems 3540 Screenshot.htm	http://www.access.fda.gov/	No	No	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 4,098	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	4,098	-15,402	19,500
Annual IC Time Burden (Hours)	1,025	-3,850	4,875
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.