IC recommended in FDA guidance

Prescription Drug Advertisements and Product Communications

OMB: 0910-0686

IC ID: 232749

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

View Information Collection (IC)

IC recommended in FDA guidance
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 201.10(g) and (h) 21 CFR 202.1(b), (c), and (d)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance GFI CDER PNP in Promotional Labeling.pdf No   Printable Only
Other-Agency Guidance GFI Quant Info 2023.docx Yes Yes Fillable Fileable
Other-Agency Guidance 0857 GFI Payor communications q-and-a JUNE 2018.pdf No   Fillable Fileable

Health Consumer Health and Safety

 

1,181 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 165,076 0 0 9,012 0 156,064
Annual IC Time Burden (Hours) 587,550 0 0 139,353 0 448,197
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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