PART 314: Subparts E through I

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⚠️ Notice: This information collection may be referencing outdated material.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 3938 PART 314: Subparts E through I Form
FDA 3938 Drug Master File FDA-3938_secure_func_R1_v9.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	FDA-3938_secure_func_R1_v9.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: 2,946	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	45,045	43,792	1,253
Annual IC Time Burden (Hours)	444,697	354,989	89,708
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.