Cardiovascular Outcome Claim Supplement Submission

Labeling Requirements for Human Prescription Drug and Biological Products

OMB: 0910-0572

IC ID: 251540

Information Collection (IC) Details

View Information Collection (IC)

Cardiovascular Outcome Claim Supplement Submission
 
No New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Instruction GFI_Hypertension Indication_ Drug Labeling for Cardiovascular Outcome Claims.pdf https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims Yes Yes Printable Only

Health Consumer Health and Safety

 

4 0
   
Private Sector Businesses or other for-profits
 
   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 4 0 0 4 0 0
Annual IC Time Burden (Hours) 80 0 0 80 0 0
Annual IC Cost Burden (Dollars) 6,120 0 0 6,120 0 0

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