Form FDA 3542

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

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
Form 3542 Form FDA 3542 Form
3542 Patent Information Submitted Upon and After Approval of FORM FDA 3542.pdf Form

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: Mandatory

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	3542	Patent Information Submitted Upon and After Approval of an NDA or Supplement	FORM FDA 3542.pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 183	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 25 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	512	-94	606
Annual IC Time Burden (Hours)	2,560	-9,560	12,120
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.