503A; Reporting

Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0800

IC ID: 241791

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

View Information Collection (IC)

503A; Reporting
 
No Unchanged
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Memorandum of Understanding 0800 503A final std MOU FDA Cleared.pdf Yes Yes Fillable Fileable
Other-Agency Guidance Document 0800 503A GFI 2016.pdf No   Printable Only

Health Consumer Health and Safety

 

45 0
   
State, Local, and Tribal Governments
 
   100 %

  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 8,879 0 0 0 0 8,879
Annual IC Time Burden (Hours) 7,698 0 0 0 0 7,698
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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