Information Collection

21 CFR 1.280,1.281 - Reporting: New Prior Notice Submission Submitted Through The PN System Interface. Regulation Sets Forth Information That The Prior Notice Is Required to Contain

IC 46710 under ICR 201005-0910-017 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
Document Name	Document Type
Form 3540 21 CFR 1.280,1.281 - Reporting: New Prior Notice Submission Submitted Through The PN System Interface. Regulation Sets Forth Information That The 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 1.280,1.281 - Reporting: New Prior Notice Submission Submitted Through The PN System Interface. Regulation Sets Forth Information That The 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 1.280-281

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
Form	3540	Prior Notice Submission	US FDA Industry Systems 3540 Screenshot.htm	http://www.access.fda.gov/	No	No	Fillable Fileable Signable

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: 21,500

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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,569,500	-216,452	1,785,952
Annual IC Time Burden (Hours)	580,715	-97,947	678,662
Annual IC Cost Burden (Dollars)	0	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.