Information Collection

Form FDA 3542

IC 6229 under ICR 201908-0910-017 · OMB 0910-0513.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3542 Form FDA 3542	Form and Instruction
FDA 3542 Patent Declaration After Filing NDA or Supplement Form FDA 3542 Patent Declaration After Filing Exp 2019.pdf	Form and Instruction

IC Title:

Form FDA 3542

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

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

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 and Instruction	FDA 3542	Patent Declaration After Filing NDA or Supplement	Form FDA 3542 Patent Declaration After Filing Exp 2019.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: 281

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 90 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	808	128	680
Annual IC Time Burden (Hours)	8,080	4,680	3,400
Annual IC Cost Burden (Dollars)	711,040	711,040	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.