Information Collection

PART 314: Subparts E through I

IC 184605 under ICR 202402-0910-003 · OMB 0910-0001.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.