Subpart B - Applications

Applications for FDA Approval to Market a New Drug

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0001 can be found here:

Documents and Forms

Document Name Document Type
Form 3331 Subpart B - Applications Form and Instruction
3331 NDA-Field Alert Report FORM FDA 3331 1-19-2016.pdf Form and Instruction
2252 Transmittal of Annual Report for Drug and Biologics for FORM FDA 2252 9-11-14.pdf Form
2253 Transmittal of Advertisements and Promotional Labeling f FORM FDA 2253 9-11-14.pdf Form
356 Application to Market a New or Abbreviated New Drug or B FORM 356h - 9-11-14.pdf Form
FORM FDA 3331 1-19-2016.pdf FDA Form 3331 IC Document

Information Collection (IC) Details

IC Title:	Subpart B - Applications	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.50-314.90

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3331	NDA-Field Alert Report	FORM FDA 3331 1-19-2016.pdf	Yes	Yes	Fillable Fileable
Form	2252	Transmittal of Annual Report for Drug and Biologics for Human Use	FORM FDA 2252 9-11-14.pdf	Yes	Yes	Fillable Fileable
Form	2253	Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use	FORM FDA 2253 9-11-14.pdf	Yes	Yes	Fillable Fileable
Form	356	Application to Market a New or Abbreviated New Drug or Biologic for Human Use	FORM 356h - 9-11-14.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 378	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	69,553	69,402	151
Annual IC Time Burden (Hours)	2,641,415	2,351,042	290,373
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
FDA Form 3331	FORM FDA 3331 1-19-2016.pdf	01/19/2016

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