Abbreviated New Drug Applications and 505(b)(2) Applications

Documents and Forms

Document Name Document Type
Form Form FDA 3542 Abbreviated New Drug Applications and 505(b)(2) Applications Form and Instruction
Form FDA 3542 Patent Information Submitted Upon and After Approval of Form FDA 3542 revised draft resulting from Oct 2016 FR.pdf Form and Instruction
Form FDA 3542a Patent Information Submitted With the Filing of an NDA, Form FDA 3542a revised draft resulting from Oct FR 2016.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Abbreviated New Drug Applications and 505(b)(2) Applications	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.53(f)(1) and (f)(2) 21 CFR 314.60(f) 21 CFR 314.94(a)(12)(viii) 21 CFR 314.95(c) 21 CFR 314.96(c) and (d) 21 CFR 314.97(b) 21 CFR 314.107(e) 21 CFR 314,50(i)(1) and (i)(6) 21 CFR 314.52(a), (b), (c), and (e) (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form FDA 3542	Patent Information Submitted Upon and After Approval of an NDA or Supplement	Form FDA 3542 revised draft resulting from Oct 2016 FR.pdf		Yes	Yes	Fillable Fileable
Form and Instruction	Form FDA 3542a	Patent Information Submitted With the Filing of an NDA, Amendment, or Supplement	Form FDA 3542a revised draft resulting from Oct FR 2016.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,015	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	2,153	2,153
Annual IC Time Burden (Hours)	2,789	2,789
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.