Subpart B - Applications

Applications for FDA Approval to Market a New Drug

OMB: 0910-0001

IC ID: 5662

⚠️ Notice: This information collection may be referencing outdated material.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 instructions rev 2021.pdf Instruction
2252 instructions rev 2021.pdf Instruction
FDA-2253-Instructions rev 2021.pdf Instruction
FDA-2253-Instructions rev 2021.pdf Instruction
PDUFA Committment Goals.pdf Other-Performance Goals
PDUFA Committment Goals.pdf Other-Performance Goals
FDARA 2017.pdf Other-Legislative Authority
FDARA 2017.pdf Other-Legislative Authority
21 USC 355 New Drugs.pdf Other-Statutory Authority
21 USC 355 New Drugs.pdf Other-Statutory Authority
FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.pdf Instruction
FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.pdf Instruction
FDA 3331a NDA - Field Alert Report Form FDA 3331a DRAFT FEB 2020.pdf www.fda.gov/drugs/surveillance/field-alert-reports Form and Instruction
FDA 3331a NDA - Field Alert Report Form FDA 3331a DRAFT FEB 2020.pdf www.fda.gov/drugs/surveillance/field-alert-reports Form and Instruction
FDA 2252 Transmittal of annual drug and biologic report under 314 FDA 2252 reports rev 2021.pdf Form
FDA 2252 Transmittal of annual drug and biologic report under 314 FDA 2252 reports rev 2021.pdf Form
FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING F Form FDA 2253 propchanges 9-9-2021.pdf Form
FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING F Form FDA 2253 propchanges 9-9-2021.pdf Form
FDA 3542 Patent Information After Approval FDA 3542 patent info.pdf Form and Instruction
FDA 3542 Patent Information After Approval FDA 3542 patent info.pdf Form and Instruction
FDA 3542a Patent Information Prior to Approval FDA-form-3542A_instructional-supplement_R2.1_secured.pdf Form and Instruction
FDA 3542a Patent Information Prior to Approval FDA-form-3542A_instructional-supplement_R2.1_secured.pdf Form and Instruction
FDA 356h Application to Market a New Drug, Abbreviated New Drug, Form FDA 356h with comments noting changes Aug 2022.pdf Form
FDA 356h Application to Market a New Drug, Abbreviated New Drug, Form FDA 356h with comments noting changes Aug 2022.pdf Form

Information Collection (IC) Details

View Information Collection (IC)

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 21 CFR 310.306

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	FDA 2252	Transmittal of annual drug and biologic report under 314.81	FDA 2252 reports rev 2021.pdf		Yes	Yes	Fillable Fileable
Instruction			2252 instructions rev 2021.pdf		Yes	Yes	Fillable Fileable
Form	FDA 2253	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE	Form FDA 2253 propchanges 9-9-2021.pdf		Yes	Yes	Fillable Fileable
Instruction			FDA-2253-Instructions rev 2021.pdf		Yes	Yes	Fillable Fileable
Other-Performance Goals			PDUFA Committment Goals.pdf		Yes	Yes	Paper Only
Other-Legislative Authority			FDARA 2017.pdf		Yes	Yes	Paper Only
Form and Instruction	FDA 3542	Patent Information After Approval	FDA 3542 patent info.pdf		Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3542a	Patent Information Prior to Approval	FDA-form-3542A_instructional-supplement_R2.1_secured.pdf		Yes	Yes	Fillable Fileable
Other-Statutory Authority			21 USC 355 New Drugs.pdf		Yes	Yes	Fillable Fileable
Form	FDA 356h	Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use	Form FDA 356h with comments noting changes Aug 2022.pdf		Yes	Yes	Fillable Fileable
Instruction			FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.pdf		Yes	Yes	Fillable Fileable

Federal Enterprise Architecture Business Reference Module

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	66,924	66,924
Annual IC Time Burden (Hours)	1,234,195	1,234,195
Annual IC Cost Burden (Dollars)	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.