CARES 3112(e); reporting drug manufacture amounts and exemption from reporting - drug shortage determinations

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

OMB: 0910-0045

IC ID: 250057

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

View Information Collection (IC)

CARES 3112(e); reporting drug 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

Health Consumer Health and Safety

 

12,800 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 288,000 0 0 0 0 288,000
Annual IC Time Burden (Hours) 72,000 0 0 0 0 72,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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