PART 314: Subparts E through I

Applications for FDA Approval to Market a New Drug

OMB: 0910-0001

IC ID: 184605

Information Collection (IC) Details

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PART 314: Subparts E through I CDER
No Unchanged
21 CFR 314.200-314.650

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

Health Consumer Health and Safety


2,946 0
Private Sector Businesses or other for-profits
   99 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 45,045 0 0 0 0 45,045
Annual IC Time Burden (Hours) 444,697 0 0 0 0 444,697
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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