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⚠️ Notice: This information collection may be referencing outdated material.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 FDA 3331a Subpart B - Applications 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
FDA 3331a NDA - Field Alert Report Form FDA 3331a DRAFT FEB 2020.pdf www.fda.gov/drugs/surveillance/field-alert-reports Form and Instruction
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:

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	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3331a	NDA - Field Alert Report	Form FDA 3331a DRAFT FEB 2020.pdf	https://www.fda.gov/drugs/surveillance/field-alert-reports	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	Previously Approved
Annual Number of Responses for this IC	71,706	71,706
Annual IC Time Burden (Hours)	2,644,204	2,644,204
Annual IC Cost Burden (Dollars)	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.