Submission of a copy of that portion of each annual report containing authorized generic drug information

Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs

OMB: 0910-0646

IC ID: 190230

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Submission of a copy of that portion of each annual report containing authorized generic drug information
 
No Modified
 
Mandatory
 
21 CFR 314.81(b)(2)(ii)(b)

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

Health Consumer Health and Safety

 

70 0
   
Private Sector Businesses or other for-profits
 
   66 %

  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 490 0 0 90 0 400
Annual IC Time Burden (Hours) 25 0 0 5 0 20
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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