Supplements and Other Changes to an Approved Application

Prescription Drug Product Labeling; Medication Guide Requirements

OMB: 0910-0393

IC ID: 187330

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Supplements and Other Changes to an Approved Application CDER
No Removed
21 CFR 208; 208.20 21 CFR 314.70(b)(2)(v)(B)  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety


155 0
Private Sector Businesses or other for-profits
   100 %

  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 0 0 0 -155 0 155
Annual IC Time Burden (Hours) 0 0 0 -11,160 0 11,160
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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