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Manufacture amounts and exemption from reporting - drug shortage determinations

IC 250057 under ICR 202603-0910-008 · OMB 0910-0045.

Documents and Forms
Document Name
Document Type
Other-Public Law: CARES Act
Other-Procedural Guidance
Information Collection (IC) Details

View Information Collection (IC)

Manufacture amounts and exemption from reporting - drug shortage determinations
 
No Unchanged
 
Mandatory
 
21 CFR 207

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Public Law: CARES Act CARES Act PL116-136.pdf Yes Yes Fillable Fileable
Other-Procedural Guidance Guidance-FDA-DrugAmountReporting-2023-394-revision-1-clean.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

8,700 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 195,750 0 0 0 0 195,750
Annual IC Time Burden (Hours) 195,750 0 0 0 0 195,750
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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