Information Collection

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

IC 214783 under ICR 201610-0910-001 · OMB 0910-0786.

Documents and Forms

Documents and forms in this information collection
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:

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	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

Federal Enterprise Architecture Business Reference Module

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 %

table that charts list of burden
	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

table that charts IC Documents
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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.