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Subpart C - Abbreviated Applications

IC 184600 under ICR 202512-0910-013 · OMB 0910-0001.

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Other-Agency Guidance
Information Collection (IC) Details

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Subpart C - Abbreviated Applications CDER
 
No Unchanged
 
Mandatory
 
21 CFR 314.92 - 314.99

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance GFI Good-ANDA-Submission-Practices-Guidance-for-Industry JAN 2018.pdf https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-anda-submission-practices-guidance-industry Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

354 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 21,744 0 0 0 0 21,744
Annual IC Time Burden (Hours) 1,997,542 0 0 0 0 1,997,542
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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