OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

Subpart D - FDA Action on Applications

IC 184601 under ICR 202512-0910-013 · OMB 0910-0001.

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

View Information Collection (IC)

Subpart D - FDA Action on Applications
 
No Unchanged
 
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

 

1,693 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 6,279 0 0 0 0 6,279
Annual IC Time Burden (Hours) 83,584 0 0 0 0 83,584
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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