OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

Outsourcing Facilities: Registration and reporting of drugs under 503B(b)

IC 256583 under ICR 202512-0910-009 · OMB 0910-0800.

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

View Information Collection (IC)

Outsourcing Facilities: Registration and reporting of drugs under 503B(b)
 
No Unchanged
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Statutory Authority 21 USC 353b Sec 503B FFDCA OCT 2022.pdf Yes Yes Fillable Fileable
Other-Agency Guidance 0800 GFI Outsourcing registration and reporting of drugs DEC 2016.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

75 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 8,111 0 0 0 0 8,111
Annual IC Time Burden (Hours) 214 0 0 0 0 214
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.
Something went wrong when downloading this file. If you have any questions, please send an email to [email protected].