Subpart D - FDA Action on Applications

Applications for FDA Approval to Market a New Drug

OMB: 0910-0001

IC ID: 184601

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

View Information Collection (IC)

Subpart D - FDA Action on Applications CDER
 
No Modified
 
Mandatory
 
21 CFR 314.100-314.170

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0429 GFI PDUFA Meetings.pdf Yes Yes Fillable Fileable
Other-Agency Guidance CDER CBER Dispute Res at Div Level GFI.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

1,620 0
   
Private Sector Businesses or other for-profits
 
   99 %

  Requested 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 6,666 0 0 6,515 0 151
Annual IC Time Burden (Hours) 83,778 0 0 83,028 0 750
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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.

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