Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims

Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims

OMB: 0910-0670

IC ID: 193930

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Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims
 
No New
 
Voluntary
 
5 CFR 1320.3(c)(2)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Public Health Monitoring

 

30 0
   
Private Sector Businesses or other for-profits
 
   25 %

  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 70 0 70 0 0 0
Annual IC Time Burden (Hours) 4 0 4 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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