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Federal forms, ICRs, and supporting documents

Information Collection

Disclosure - Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities GFI, Repackaging GFI, Biological Products GFI,

IC 267944 under ICR 202405-0910-002 · OMB 0910-0858.

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

View Information Collection (IC)

Disclosure - Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities GFI, Repackaging GFI, Biological Products GFI,
 
No New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance CompoundingandRepackagingofRadiopharmaceuticalsbyOF (2024).pdf Yes Yes Fillable Fileable
Other-Agency Guidance Repackaging-of-Certain-Human-Drug-Products-by-Pharmacies-and-Outsourcing-Facilities (2024).pdf Yes Yes Fillable Fileable
Other-Agency Guidance Mixing--Diluting--or-Repackaging-Biological-Products-Outside-the-Scope-of-an-Approved-Biologics-License-Application (2024).pdf Yes No Printable Only

Health Consumer Health and Safety

 

28 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 1,801 0 0 1,801 0 0
Annual IC Time Burden (Hours) 1,009 0 0 1,009 0 0
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.