Cardiovascular Outcome Claim Supplement Submission

GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims

OMB: 0910-0670

IC ID: 193930

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Cardiovascular Outcome Claim Supplement Submission
No Modified

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0670 GFI Labeling for Cardiovascular Outcome claims March 2011.pdf No   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 3 0 1
Annual IC Time Burden (Hours) 80 0 0 60 0 20
Annual IC Cost Burden (Dollars) 6,120 0 0 6,120 0 0

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