Form FDA 3542

Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...

Documents and Forms

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

Information Collection (IC) Details

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:

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 %

	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

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.