PART 314: Subparts E through I

Applications for FDA Approval to Market a New Drug

Documents and Forms

Document Name Document Type
Form FDA 3938 PART 314: Subparts E through I Form
0001 Form FDA 3938_instructions_07-12-23.pdf Instruction
0001 Form FDA 3938_instructions_07-12-23.pdf Instruction
FDA 3938 Drug Master File 0001 Form FDA 3938_Dyn_Sec_Ext_07-12-23.pdf Form
FDA 3938 Drug Master File 0001 Form FDA 3938_Dyn_Sec_Ext_07-12-23.pdf Form

Information Collection (IC) Details

IC Title:	PART 314: Subparts E through I	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.200-314.650

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 3938	Drug Master File	0001 Form FDA 3938_Dyn_Sec_Ext_07-12-23.pdf		Yes	Yes	Fillable Fileable
Instruction			0001 Form FDA 3938_instructions_07-12-23.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,826	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	44,338	-707	45,045
Annual IC Time Burden (Hours)	395,012	-49,685	444,697
Annual IC Cost Burden (Dollars)	0	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.