Information Collection

Form FDA 3542

IC 6229 under ICR 201608-0910-016 · OMB 0910-0513.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0513 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3542 Patent Information Submitted Upon and After Approval of an NDA or Supplement Form FDA 3542	Form
3542 Patent Information Submitted Upon and After Approval of FORM FDA 3542.pdf	Form

IC Title:

Form FDA 3542

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.53 21 CFR 314.50(h)

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	3542				Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 200

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 25 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	680	168	512
Annual IC Time Burden (Hours)	3,400	840	2,560
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.

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